Alicia Ault

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.

Covance Makes iPledge Changes

Covance, the company that developed and manages the iPLEDGE risk management program for the acne drug isotretinoin, has formally incorporated changes to the program that were finalized by the Food and Drug Administration in early October. The most important change was an elimination of the 23-day lockout period for women of childbearing potential. At that time, the FDA also said the program would now start the 7-day window for the initial prescription for women of childbearing potential from the date of pregnancy testing, instead of the date of the office visit. For more information on all of the changes, visit

www.ipledgeprogram.com

Melanoma Grant Worth $1.8 Million

Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, has been chosen to be the lead institution for a $1.8 million collaborative melanoma research project funded by a grant from the W.M. Keck Foundation. Also participating are the California Institute for Technology, Childrens Hospital Los Angeles, and the University of Southern California. Researchers will work together to develop a technology that uses blood stem cells to derive T lymphocytes that will be genetically engineered to turn into killer T cells and home in on the melanoma antigen called MART-1. This would be a big advance because only a very small number of melanoma patients' T cells recognize MART-1. Positron emission tomography will be used to evaluate the cells' attack rate and success, according to a statement from the Jonsson Center. Human trials are expected to start early this year.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that "the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities." The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. "FDA's inability to keep up with scientific advances means that American lives are at risk," wrote the panelists, adding that the agency can't fulfill its mission "without substantial and sustained additional appropriations." The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources," said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001-2004, compared with about 35% of adults aged 45-54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

Improvement Through Transparency

Transparency of quality and price information is important or very important for improving the U.S. health care system, according to 77% of 241 health care opinion leaders surveyed in October 2007 by Harris Interactive on behalf of the Commonwealth Fund and Modern Healthcare. Stimulating improvement in provider performance was rated an important or very important goal of transparency by 84% of respondents; 76% also cited encouraging payers to reward quality, and 66% thought helping patients make informed choices was an important or very important goal. More than half (56%) thought that a new public-private national entity should be responsible for setting the standards for measurement and reporting, with 75% saying the costs of such measurement and reporting should be shared by providers, insurers, and the government. Most (88%) felt that adoption of health information technology was an important or very important component of any system of transparency. The online poll surveyed peer-identified leaders and experts in academia, research, health care delivery, business, insurance, government, and labor and advocacy groups.

Covance Makes iPledge Changes

Covance, the company that developed and manages the iPLEDGE risk management program for the acne drug isotretinoin, has formally incorporated changes to the program that were finalized by the Food and Drug Administration in early October. The most important change was an elimination of the 23-day lockout period for women of childbearing potential. At that time, the FDA also said the program would now start the 7-day window for the initial prescription for women of childbearing potential from the date of pregnancy testing, instead of the date of the office visit. For more information on all of the changes, visit

www.ipledgeprogram.com

Melanoma Grant Worth $1.8 Million

Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, has been chosen to be the lead institution for a $1.8 million collaborative melanoma research project funded by a grant from the W.M. Keck Foundation. Also participating are the California Institute for Technology, Childrens Hospital Los Angeles, and the University of Southern California. Researchers will work together to develop a technology that uses blood stem cells to derive T lymphocytes that will be genetically engineered to turn into killer T cells and home in on the melanoma antigen called MART-1. This would be a big advance because only a very small number of melanoma patients' T cells recognize MART-1. Positron emission tomography will be used to evaluate the cells' attack rate and success, according to a statement from the Jonsson Center. Human trials are expected to start early this year.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that "the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities." The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. "FDA's inability to keep up with scientific advances means that American lives are at risk," wrote the panelists, adding that the agency can't fulfill its mission "without substantial and sustained additional appropriations." The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources," said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001-2004, compared with about 35% of adults aged 45-54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

Improvement Through Transparency

Transparency of quality and price information is important or very important for improving the U.S. health care system, according to 77% of 241 health care opinion leaders surveyed in October 2007 by Harris Interactive on behalf of the Commonwealth Fund and Modern Healthcare. Stimulating improvement in provider performance was rated an important or very important goal of transparency by 84% of respondents; 76% also cited encouraging payers to reward quality, and 66% thought helping patients make informed choices was an important or very important goal. More than half (56%) thought that a new public-private national entity should be responsible for setting the standards for measurement and reporting, with 75% saying the costs of such measurement and reporting should be shared by providers, insurers, and the government. Most (88%) felt that adoption of health information technology was an important or very important component of any system of transparency. The online poll surveyed peer-identified leaders and experts in academia, research, health care delivery, business, insurance, government, and labor and advocacy groups.

Covance Makes iPledge Changes

Covance, the company that developed and manages the iPLEDGE risk management program for the acne drug isotretinoin, has formally incorporated changes to the program that were finalized by the Food and Drug Administration in early October. The most important change was an elimination of the 23-day lockout period for women of childbearing potential. At that time, the FDA also said the program would now start the 7-day window for the initial prescription for women of childbearing potential from the date of pregnancy testing, instead of the date of the office visit. For more information on all of the changes, visit

www.ipledgeprogram.com

Melanoma Grant Worth $1.8 Million

Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, has been chosen to be the lead institution for a $1.8 million collaborative melanoma research project funded by a grant from the W.M. Keck Foundation. Also participating are the California Institute for Technology, Childrens Hospital Los Angeles, and the University of Southern California. Researchers will work together to develop a technology that uses blood stem cells to derive T lymphocytes that will be genetically engineered to turn into killer T cells and home in on the melanoma antigen called MART-1. This would be a big advance because only a very small number of melanoma patients' T cells recognize MART-1. Positron emission tomography will be used to evaluate the cells' attack rate and success, according to a statement from the Jonsson Center. Human trials are expected to start early this year.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that "the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities." The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. "FDA's inability to keep up with scientific advances means that American lives are at risk," wrote the panelists, adding that the agency can't fulfill its mission "without substantial and sustained additional appropriations." The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources," said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001-2004, compared with about 35% of adults aged 45-54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

Improvement Through Transparency

Transparency of quality and price information is important or very important for improving the U.S. health care system, according to 77% of 241 health care opinion leaders surveyed in October 2007 by Harris Interactive on behalf of the Commonwealth Fund and Modern Healthcare. Stimulating improvement in provider performance was rated an important or very important goal of transparency by 84% of respondents; 76% also cited encouraging payers to reward quality, and 66% thought helping patients make informed choices was an important or very important goal. More than half (56%) thought that a new public-private national entity should be responsible for setting the standards for measurement and reporting, with 75% saying the costs of such measurement and reporting should be shared by providers, insurers, and the government. Most (88%) felt that adoption of health information technology was an important or very important component of any system of transparency. The online poll surveyed peer-identified leaders and experts in academia, research, health care delivery, business, insurance, government, and labor and advocacy groups.

The Food and Drug Administration said that it wants to require more public disclosure of advisory committee members' conflicts of interest and that the information will be available on a new and improved Web site.

The agency also said it will post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000.

These requirements are only slightly different from what is currently requested, but the waiver forms are clearer and will be made available to the public sooner. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision.

Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings. Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., the president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions. Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she suggested.

The Food and Drug Administration said that it wants to require more public disclosure of advisory committee members' conflicts of interest and that the information will be available on a new and improved Web site.

The agency also said it will post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000.

These requirements are only slightly different from what is currently requested, but the waiver forms are clearer and will be made available to the public sooner. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision.

Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings. Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., the president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions. Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she suggested.

The Food and Drug Administration said that it wants to require more public disclosure of advisory committee members' conflicts of interest and that the information will be available on a new and improved Web site.

The agency also said it will post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000.

These requirements are only slightly different from what is currently requested, but the waiver forms are clearer and will be made available to the public sooner. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision.

Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings. Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., the president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions. Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she suggested.

WASHINGTON — Some Alzheimer's disease-related groups—but not all—are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview. Some of those causes may be treatable, Mr. Hall said.

An Alzheimer's diagnosis is important; knowing it early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost. The exam covers a medical and social history; a review of risk factors for depression; a review of functional ability and level of safety; an assessment of height, weight, blood pressure management, and visual acuity; an ECG and interpretation of the diagnostic test; and education, counseling, and referral.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialog has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

There had once been a similar debate over the utility of screening for cholesterol, he said. Now there is a consensus on how and when to measure lipids, the definition of normal cholesterol levels, and the benefits and risks of treatment.

“I have no doubt that we will get there with Alzheimer's disease at some point; we're simply not there yet,” Dr. Thies said.

WASHINGTON — Some Alzheimer's disease-related groups—but not all—are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview. Some of those causes may be treatable, Mr. Hall said.

An Alzheimer's diagnosis is important; knowing it early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost. The exam covers a medical and social history; a review of risk factors for depression; a review of functional ability and level of safety; an assessment of height, weight, blood pressure management, and visual acuity; an ECG and interpretation of the diagnostic test; and education, counseling, and referral.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialog has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

There had once been a similar debate over the utility of screening for cholesterol, he said. Now there is a consensus on how and when to measure lipids, the definition of normal cholesterol levels, and the benefits and risks of treatment.

“I have no doubt that we will get there with Alzheimer's disease at some point; we're simply not there yet,” Dr. Thies said.

WASHINGTON — Some Alzheimer's disease-related groups—but not all—are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview. Some of those causes may be treatable, Mr. Hall said.

An Alzheimer's diagnosis is important; knowing it early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost. The exam covers a medical and social history; a review of risk factors for depression; a review of functional ability and level of safety; an assessment of height, weight, blood pressure management, and visual acuity; an ECG and interpretation of the diagnostic test; and education, counseling, and referral.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialog has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

There had once been a similar debate over the utility of screening for cholesterol, he said. Now there is a consensus on how and when to measure lipids, the definition of normal cholesterol levels, and the benefits and risks of treatment.

“I have no doubt that we will get there with Alzheimer's disease at some point; we're simply not there yet,” Dr. Thies said.

Evidence is insufficient to support most of the therapies and medications now in use for posttraumatic stress disorder, concludes an Institute of Medicine panel report issued in October after 9 months of investigation.

“This result was unexpected and may surprise [Veterans Affairs] and others interested in this disorder,” the committee wrote in the preface to its report, “Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence.”

Among the therapies found to be lacking evidence of effectiveness were cognitive restructuring, coping skills training, individual psychotherapy, and group therapy. In addition, not a single drug therapy has sufficient evidence to say it has utility in treating PTSD, said panel chairman Dr. Alfred O. Berg, professor of family medicine at the University of Washington, Seattle, in a telebriefing with reporters.

Only exposure therapy—in which the patient is exposed to a real or surrogate threat in a safe environment—had enough evidence to warrant a conclusion that it is effective, the panel said.

Dr. Berg pointed out that the aim of the report is to spur more sophisticated research into PTSD's causes, diagnosis, and treatment. It is not meant to provide guidelines for clinicians. “Many of the studies that have looked into the effectiveness of PTSD therapies have limitations and therefore do not provide a clear picture of what works and what doesn't.”

The panel was not in complete consensus on all the recommendations. Only two of the eight committee members were psychiatrists, and one—Dr. Thomas A. Mellman of Howard University, Washington—disagreed with the conclusions that selective serotonin reuptake inhibitors were not useful in the general PTSD population and that newer-generation antipsychotics might not be effective.

The Department of Veterans Affairs (VA) requested the IOM study, but its findings have much broader implications, said Dr. Berg, noting that PTSD affects some 12–20 million Americans, only several hundred thousand of whom are veterans. Dr. Berg estimated a lifetime prevalence of 7% in the U.S. population and a current prevalence of 3.6%. In addition, data indicate that 13% of those who have served in Iraq and 6% of those who have served in Afghanistan have experienced PTSD.

Only 90 studies met the committee's criteria for inclusion in its review of the available data. The majority—53—were of pharmaceuticals, and 37 were psychotherapy studies. Many studies had high dropout rates, from 20% to 50%, and statistical analyses used to adjust for that factor weakened results, he said. Studies also had lack of blinding or missing data.

Finally, most of the drug studies were funded by the manufacturers, and most psychotherapies were investigated by their inventors or close collaborators, noted the panel. The IOM committee urged replication of these trials by a broader range of investigators.

The panel reviewed 24 randomized, controlled trials of exposure therapy, some of which had cognitive restructuring or coping skills added as adjunctive therapies.

The evidence also did not address the effects of comorbidities in veterans, including major depression, traumatic brain injury, and substance abuse. So the panel's conclusions might not apply to “the substantial proportion of veterans with one or more important comorbidities,” the report said.

The panel recommended that the VA and other organizations that fund research help identify methods to improve the internal validity of research, to encourage broader investigations into more subgroups of veterans and to find ways to fund comparative effectiveness research. There should also be longer follow-up in trials said the panel, noting that no good data exist on optimal duration of drug or psychotherapy treatment.

One of the report's reviewers, Dr. Arthur S. Blank Jr., agreed higher-quality trials of PTSD interventions are needed, but he differed on how those trials should be carried out.

Those studies should be more naturalistic, said Dr. Blank, who served as an Army psychiatrist in Vietnam and as the national director of war veterans counseling centers at the VA headquarters. Most PTSD patients are receiving multiple interventions simultaneously. Studies should be conducted to examine therapies in the way they are administered, said Dr. Blank of the department of psychiatry at George Washington University, Washington.

He also criticized the committee's approach to reviewing the evidence, arguing that randomized, controlled trials cannot truly document the effectiveness of interpersonal psychotherapy.

Evidence is insufficient to support most of the therapies and medications now in use for posttraumatic stress disorder, concludes an Institute of Medicine panel report issued in October after 9 months of investigation.

“This result was unexpected and may surprise [Veterans Affairs] and others interested in this disorder,” the committee wrote in the preface to its report, “Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence.”

Among the therapies found to be lacking evidence of effectiveness were cognitive restructuring, coping skills training, individual psychotherapy, and group therapy. In addition, not a single drug therapy has sufficient evidence to say it has utility in treating PTSD, said panel chairman Dr. Alfred O. Berg, professor of family medicine at the University of Washington, Seattle, in a telebriefing with reporters.

Only exposure therapy—in which the patient is exposed to a real or surrogate threat in a safe environment—had enough evidence to warrant a conclusion that it is effective, the panel said.

Dr. Berg pointed out that the aim of the report is to spur more sophisticated research into PTSD's causes, diagnosis, and treatment. It is not meant to provide guidelines for clinicians. “Many of the studies that have looked into the effectiveness of PTSD therapies have limitations and therefore do not provide a clear picture of what works and what doesn't.”

The panel was not in complete consensus on all the recommendations. Only two of the eight committee members were psychiatrists, and one—Dr. Thomas A. Mellman of Howard University, Washington—disagreed with the conclusions that selective serotonin reuptake inhibitors were not useful in the general PTSD population and that newer-generation antipsychotics might not be effective.

The Department of Veterans Affairs (VA) requested the IOM study, but its findings have much broader implications, said Dr. Berg, noting that PTSD affects some 12–20 million Americans, only several hundred thousand of whom are veterans. Dr. Berg estimated a lifetime prevalence of 7% in the U.S. population and a current prevalence of 3.6%. In addition, data indicate that 13% of those who have served in Iraq and 6% of those who have served in Afghanistan have experienced PTSD.

Only 90 studies met the committee's criteria for inclusion in its review of the available data. The majority—53—were of pharmaceuticals, and 37 were psychotherapy studies. Many studies had high dropout rates, from 20% to 50%, and statistical analyses used to adjust for that factor weakened results, he said. Studies also had lack of blinding or missing data.

Finally, most of the drug studies were funded by the manufacturers, and most psychotherapies were investigated by their inventors or close collaborators, noted the panel. The IOM committee urged replication of these trials by a broader range of investigators.

The panel reviewed 24 randomized, controlled trials of exposure therapy, some of which had cognitive restructuring or coping skills added as adjunctive therapies.

The evidence also did not address the effects of comorbidities in veterans, including major depression, traumatic brain injury, and substance abuse. So the panel's conclusions might not apply to “the substantial proportion of veterans with one or more important comorbidities,” the report said.

The panel recommended that the VA and other organizations that fund research help identify methods to improve the internal validity of research, to encourage broader investigations into more subgroups of veterans and to find ways to fund comparative effectiveness research. There should also be longer follow-up in trials said the panel, noting that no good data exist on optimal duration of drug or psychotherapy treatment.

One of the report's reviewers, Dr. Arthur S. Blank Jr., agreed higher-quality trials of PTSD interventions are needed, but he differed on how those trials should be carried out.

Those studies should be more naturalistic, said Dr. Blank, who served as an Army psychiatrist in Vietnam and as the national director of war veterans counseling centers at the VA headquarters. Most PTSD patients are receiving multiple interventions simultaneously. Studies should be conducted to examine therapies in the way they are administered, said Dr. Blank of the department of psychiatry at George Washington University, Washington.

He also criticized the committee's approach to reviewing the evidence, arguing that randomized, controlled trials cannot truly document the effectiveness of interpersonal psychotherapy.

Evidence is insufficient to support most of the therapies and medications now in use for posttraumatic stress disorder, concludes an Institute of Medicine panel report issued in October after 9 months of investigation.

“This result was unexpected and may surprise [Veterans Affairs] and others interested in this disorder,” the committee wrote in the preface to its report, “Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence.”

Among the therapies found to be lacking evidence of effectiveness were cognitive restructuring, coping skills training, individual psychotherapy, and group therapy. In addition, not a single drug therapy has sufficient evidence to say it has utility in treating PTSD, said panel chairman Dr. Alfred O. Berg, professor of family medicine at the University of Washington, Seattle, in a telebriefing with reporters.

Only exposure therapy—in which the patient is exposed to a real or surrogate threat in a safe environment—had enough evidence to warrant a conclusion that it is effective, the panel said.

Dr. Berg pointed out that the aim of the report is to spur more sophisticated research into PTSD's causes, diagnosis, and treatment. It is not meant to provide guidelines for clinicians. “Many of the studies that have looked into the effectiveness of PTSD therapies have limitations and therefore do not provide a clear picture of what works and what doesn't.”

The panel was not in complete consensus on all the recommendations. Only two of the eight committee members were psychiatrists, and one—Dr. Thomas A. Mellman of Howard University, Washington—disagreed with the conclusions that selective serotonin reuptake inhibitors were not useful in the general PTSD population and that newer-generation antipsychotics might not be effective.

The Department of Veterans Affairs (VA) requested the IOM study, but its findings have much broader implications, said Dr. Berg, noting that PTSD affects some 12–20 million Americans, only several hundred thousand of whom are veterans. Dr. Berg estimated a lifetime prevalence of 7% in the U.S. population and a current prevalence of 3.6%. In addition, data indicate that 13% of those who have served in Iraq and 6% of those who have served in Afghanistan have experienced PTSD.

Only 90 studies met the committee's criteria for inclusion in its review of the available data. The majority—53—were of pharmaceuticals, and 37 were psychotherapy studies. Many studies had high dropout rates, from 20% to 50%, and statistical analyses used to adjust for that factor weakened results, he said. Studies also had lack of blinding or missing data.

Finally, most of the drug studies were funded by the manufacturers, and most psychotherapies were investigated by their inventors or close collaborators, noted the panel. The IOM committee urged replication of these trials by a broader range of investigators.

The panel reviewed 24 randomized, controlled trials of exposure therapy, some of which had cognitive restructuring or coping skills added as adjunctive therapies.

The evidence also did not address the effects of comorbidities in veterans, including major depression, traumatic brain injury, and substance abuse. So the panel's conclusions might not apply to “the substantial proportion of veterans with one or more important comorbidities,” the report said.

The panel recommended that the VA and other organizations that fund research help identify methods to improve the internal validity of research, to encourage broader investigations into more subgroups of veterans and to find ways to fund comparative effectiveness research. There should also be longer follow-up in trials said the panel, noting that no good data exist on optimal duration of drug or psychotherapy treatment.

One of the report's reviewers, Dr. Arthur S. Blank Jr., agreed higher-quality trials of PTSD interventions are needed, but he differed on how those trials should be carried out.

Those studies should be more naturalistic, said Dr. Blank, who served as an Army psychiatrist in Vietnam and as the national director of war veterans counseling centers at the VA headquarters. Most PTSD patients are receiving multiple interventions simultaneously. Studies should be conducted to examine therapies in the way they are administered, said Dr. Blank of the department of psychiatry at George Washington University, Washington.

He also criticized the committee's approach to reviewing the evidence, arguing that randomized, controlled trials cannot truly document the effectiveness of interpersonal psychotherapy.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007 and $1 billion more than estimated in the proposed outpatient rule, said CMS.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A_1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low-dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase—from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%-180% increases.

Some neurologic device implant procedures will also see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City.

For gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007 and $1 billion more than estimated in the proposed outpatient rule, said CMS.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A_1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low-dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase—from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%-180% increases.

Some neurologic device implant procedures will also see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City.

For gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007 and $1 billion more than estimated in the proposed outpatient rule, said CMS.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A_1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low-dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase—from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%-180% increases.

Some neurologic device implant procedures will also see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City.

For gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.