Alicia Ault

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said.

To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology.

The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial.

In 2004, the practice—then comprising four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000-$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly.

But the physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005.

The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said.

To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology.

The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial.

In 2004, the practice—then comprising four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000-$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly.

But the physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005.

The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said.

To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology.

The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial.

In 2004, the practice—then comprising four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000-$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly.

But the physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005.

The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

Pfizer Beats Lipitor Challenges

The U.S. Supreme Court has declined to take action on Ranbaxy Laboratories Ltd.'s appeal of a lower court ruling that upheld Pfizer's patent for Lipitor (atorvastatin). The U.S. District Court for the District of Delaware ruled in late 2005 that Lipitor's two patents—due to expire in 2010 and 2011—were valid, and that Ranbaxy's marketing a generic before 2011, as planned, would constitute infringement. Ranbaxy's appeal of the ruling was declined by the Supreme Court in early April. As a result, Lipitor—the world's top-selling drug, with sales of about $13 billion in 2006—is protected from generic competition until 2011. Pfizer also recently sued Ranbaxy, India's largest drug company, to block its efforts to sell a generic version of Caduet (amlodipine/atorvastatin). Finally, Pfizer has won an injunction against sales of Ranbaxy's generic Lipitor in Denmark.

FDA Posts Postapproval Study Data

All postmarketing studies of medical devices ordered by the Food and Drug Administration since January 2005 are now listed on an FDA Web site, the agency reported. The site gives the manufacturer's name and the name of the product being studied, and includes a short description of the trial. It also shows whether a company is submitting required updates to the FDA, but it does not reveal any data, such as interim findings. “Electronic access will give the public an opportunity to see progress being made on a company's postmarket commitments,” said Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health, in a statement. The data site is

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

Skirting Self-Referral on Imaging

A study published online in the journal Health Affairs said that many physicians are finding ways to skirt a Medicare law—known as Stark II—that prohibits most referrals to facilities in which they have an ownership interest. Using data from a large California-based insurer, Jean Mitchell, a professor of public policy at Georgetown University, found that 33% of providers who billed for magnetic resonance imaging (MRI), 22% who billed for computed tomography (CT), and 17% of those who billed for positron emission tomography (PET) were technically self-referring. A majority—61% of MRI billers and 64% of CT billers—did not own the equipment but had lease or payment-per-scan arrangements that would violate federal and state antikickback statutes, said Ms. Mitchell.

ACC Update on Stents for Patients

The American College of Cardiology has published a one-page patient information update on stents. The page notes that only a patient and a physician can decide if a stent is necessary and appropriate for that particular patient. It goes on to outline several points patients should keep in mind, including that stents do not cure coronary artery disease, that all stents reduce symptoms of heart disease, that coated stents are more effective in preventing recurrent blockage, and that it is important to follow a cardiologist's recommendations on taking anticlotting agents such as aspirin, clopidogrel, and ticlopidine. The update can be found on ACC's Web site,

www.acc.org

Angiomax Patent Relief?

The Medicines Co. is seeking congressional intervention again to extend the patent on its anticoagulant Angiomax (bivalirudin), due to expire in 2010. The company missed the deadline for filing a 5-year extension application by 1 day in 2000, and has been seeking to have it rectified since, primarily through the U.S. Patent Office. However, last month, Rep. Duncan Delahunt (D-Mass.) reintroduced a bill to allow the Patent Office to accept unintentionally late filings.

CMS Softens NPI Stance

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

1 in 3 Physicians Now Female

A major demographic shift is underway in medicine as female physicians become more numerous, and this trend will influence the way medical groups recruit and retain physicians throughout their career cycles, according to the 2006 Retention Survey from the American Medical Group Association and Cejka Search, an executive search organization. In 2006, female physicians accounted for 35% of physicians employed in the medical groups responding to the survey, compared with 28% in the previous survey. The study revealed that factors such as “poor cultural fit” and family issues are the driving forces in physician turnover. Part-time and flexible work options also are growing in importance, the survey found.

Pfizer Beats Lipitor Challenges

The U.S. Supreme Court has declined to take action on Ranbaxy Laboratories Ltd.'s appeal of a lower court ruling that upheld Pfizer's patent for Lipitor (atorvastatin). The U.S. District Court for the District of Delaware ruled in late 2005 that Lipitor's two patents—due to expire in 2010 and 2011—were valid, and that Ranbaxy's marketing a generic before 2011, as planned, would constitute infringement. Ranbaxy's appeal of the ruling was declined by the Supreme Court in early April. As a result, Lipitor—the world's top-selling drug, with sales of about $13 billion in 2006—is protected from generic competition until 2011. Pfizer also recently sued Ranbaxy, India's largest drug company, to block its efforts to sell a generic version of Caduet (amlodipine/atorvastatin). Finally, Pfizer has won an injunction against sales of Ranbaxy's generic Lipitor in Denmark.

FDA Posts Postapproval Study Data

All postmarketing studies of medical devices ordered by the Food and Drug Administration since January 2005 are now listed on an FDA Web site, the agency reported. The site gives the manufacturer's name and the name of the product being studied, and includes a short description of the trial. It also shows whether a company is submitting required updates to the FDA, but it does not reveal any data, such as interim findings. “Electronic access will give the public an opportunity to see progress being made on a company's postmarket commitments,” said Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health, in a statement. The data site is

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

Skirting Self-Referral on Imaging

A study published online in the journal Health Affairs said that many physicians are finding ways to skirt a Medicare law—known as Stark II—that prohibits most referrals to facilities in which they have an ownership interest. Using data from a large California-based insurer, Jean Mitchell, a professor of public policy at Georgetown University, found that 33% of providers who billed for magnetic resonance imaging (MRI), 22% who billed for computed tomography (CT), and 17% of those who billed for positron emission tomography (PET) were technically self-referring. A majority—61% of MRI billers and 64% of CT billers—did not own the equipment but had lease or payment-per-scan arrangements that would violate federal and state antikickback statutes, said Ms. Mitchell.

ACC Update on Stents for Patients

The American College of Cardiology has published a one-page patient information update on stents. The page notes that only a patient and a physician can decide if a stent is necessary and appropriate for that particular patient. It goes on to outline several points patients should keep in mind, including that stents do not cure coronary artery disease, that all stents reduce symptoms of heart disease, that coated stents are more effective in preventing recurrent blockage, and that it is important to follow a cardiologist's recommendations on taking anticlotting agents such as aspirin, clopidogrel, and ticlopidine. The update can be found on ACC's Web site,

www.acc.org

Angiomax Patent Relief?

The Medicines Co. is seeking congressional intervention again to extend the patent on its anticoagulant Angiomax (bivalirudin), due to expire in 2010. The company missed the deadline for filing a 5-year extension application by 1 day in 2000, and has been seeking to have it rectified since, primarily through the U.S. Patent Office. However, last month, Rep. Duncan Delahunt (D-Mass.) reintroduced a bill to allow the Patent Office to accept unintentionally late filings.

CMS Softens NPI Stance

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

1 in 3 Physicians Now Female

A major demographic shift is underway in medicine as female physicians become more numerous, and this trend will influence the way medical groups recruit and retain physicians throughout their career cycles, according to the 2006 Retention Survey from the American Medical Group Association and Cejka Search, an executive search organization. In 2006, female physicians accounted for 35% of physicians employed in the medical groups responding to the survey, compared with 28% in the previous survey. The study revealed that factors such as “poor cultural fit” and family issues are the driving forces in physician turnover. Part-time and flexible work options also are growing in importance, the survey found.

Pfizer Beats Lipitor Challenges

The U.S. Supreme Court has declined to take action on Ranbaxy Laboratories Ltd.'s appeal of a lower court ruling that upheld Pfizer's patent for Lipitor (atorvastatin). The U.S. District Court for the District of Delaware ruled in late 2005 that Lipitor's two patents—due to expire in 2010 and 2011—were valid, and that Ranbaxy's marketing a generic before 2011, as planned, would constitute infringement. Ranbaxy's appeal of the ruling was declined by the Supreme Court in early April. As a result, Lipitor—the world's top-selling drug, with sales of about $13 billion in 2006—is protected from generic competition until 2011. Pfizer also recently sued Ranbaxy, India's largest drug company, to block its efforts to sell a generic version of Caduet (amlodipine/atorvastatin). Finally, Pfizer has won an injunction against sales of Ranbaxy's generic Lipitor in Denmark.

FDA Posts Postapproval Study Data

All postmarketing studies of medical devices ordered by the Food and Drug Administration since January 2005 are now listed on an FDA Web site, the agency reported. The site gives the manufacturer's name and the name of the product being studied, and includes a short description of the trial. It also shows whether a company is submitting required updates to the FDA, but it does not reveal any data, such as interim findings. “Electronic access will give the public an opportunity to see progress being made on a company's postmarket commitments,” said Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health, in a statement. The data site is

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

Skirting Self-Referral on Imaging

A study published online in the journal Health Affairs said that many physicians are finding ways to skirt a Medicare law—known as Stark II—that prohibits most referrals to facilities in which they have an ownership interest. Using data from a large California-based insurer, Jean Mitchell, a professor of public policy at Georgetown University, found that 33% of providers who billed for magnetic resonance imaging (MRI), 22% who billed for computed tomography (CT), and 17% of those who billed for positron emission tomography (PET) were technically self-referring. A majority—61% of MRI billers and 64% of CT billers—did not own the equipment but had lease or payment-per-scan arrangements that would violate federal and state antikickback statutes, said Ms. Mitchell.

ACC Update on Stents for Patients

The American College of Cardiology has published a one-page patient information update on stents. The page notes that only a patient and a physician can decide if a stent is necessary and appropriate for that particular patient. It goes on to outline several points patients should keep in mind, including that stents do not cure coronary artery disease, that all stents reduce symptoms of heart disease, that coated stents are more effective in preventing recurrent blockage, and that it is important to follow a cardiologist's recommendations on taking anticlotting agents such as aspirin, clopidogrel, and ticlopidine. The update can be found on ACC's Web site,

www.acc.org

Angiomax Patent Relief?

The Medicines Co. is seeking congressional intervention again to extend the patent on its anticoagulant Angiomax (bivalirudin), due to expire in 2010. The company missed the deadline for filing a 5-year extension application by 1 day in 2000, and has been seeking to have it rectified since, primarily through the U.S. Patent Office. However, last month, Rep. Duncan Delahunt (D-Mass.) reintroduced a bill to allow the Patent Office to accept unintentionally late filings.

CMS Softens NPI Stance

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

1 in 3 Physicians Now Female

A major demographic shift is underway in medicine as female physicians become more numerous, and this trend will influence the way medical groups recruit and retain physicians throughout their career cycles, according to the 2006 Retention Survey from the American Medical Group Association and Cejka Search, an executive search organization. In 2006, female physicians accounted for 35% of physicians employed in the medical groups responding to the survey, compared with 28% in the previous survey. The study revealed that factors such as “poor cultural fit” and family issues are the driving forces in physician turnover. Part-time and flexible work options also are growing in importance, the survey found.

The Senate Health, Education, Labor and Pensions Committee has voted to fund another 5 years of the Best Pharmaceuticals for Children Act.

Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1.

The new 5-year program will extend a drug's patent life by 3 months if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

An amendment to strip the patent-life-extensions was defeated.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the Food and Drug Administration has requested studies.

About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high, according to the Health, Education, Labor and Pensions (HELP) committee, so an amendment was added to streamline the process.

In other drug matters, the HELP panel completed its version of the 5-year reauthorization of the Prescription Drug User Fee and Modernization Act, but generally without any restrictions on drug advertising or a requirement that most drugs have a risk management program—proposals that had been championed by Committee Chairman Edward Kennedy (D-Mass.) and his colleague Sen. Michael Enzi (R-Wyo.).

The two senators had been hoping to attach their proposals for improved drug safety to the Prescription Drug User Fee and Modernization Act (PDUFA) reauthorization, but most of their suggestions were defeated or watered down in committee.

The centerpiece of their bill was the risk evaluation and mitigation strategy (REMS) plan, which would have been required for all new chemical entities and biologics.

Instead the HELP committee voted to give Food and Drug Administration authority to determine when a new drug should have a REMS. The panel also voted to require FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety.

The bill “establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered,” Sen. Kennedy said in a statement.

According to a statement by Sen. Enzi, the bill gives the FDA explicit new authority in the postmarketing area—which critics say the agency does not now have.

“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market.

“This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans, when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” he said. “Pulling a drug from the market and denying patients who need it should not be the only tool available to the FDA.”

As passed by the Senate panel, PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drugmakers to publish a registry of all late-phase II, phase III, and phase IV trials, and to make all trial results available in a public database.

The PDUFA legislation still has far to go before it becomes law. The Senate package will now go to the floor for a vote, and the House is still in the early phases of work, with the Energy and Commerce Health Subcommittee continuing to hold hearings.

The Senate Health, Education, Labor and Pensions Committee has voted to fund another 5 years of the Best Pharmaceuticals for Children Act.

Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1.

The new 5-year program will extend a drug's patent life by 3 months if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

An amendment to strip the patent-life-extensions was defeated.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the Food and Drug Administration has requested studies.

About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high, according to the Health, Education, Labor and Pensions (HELP) committee, so an amendment was added to streamline the process.

In other drug matters, the HELP panel completed its version of the 5-year reauthorization of the Prescription Drug User Fee and Modernization Act, but generally without any restrictions on drug advertising or a requirement that most drugs have a risk management program—proposals that had been championed by Committee Chairman Edward Kennedy (D-Mass.) and his colleague Sen. Michael Enzi (R-Wyo.).

The two senators had been hoping to attach their proposals for improved drug safety to the Prescription Drug User Fee and Modernization Act (PDUFA) reauthorization, but most of their suggestions were defeated or watered down in committee.

The centerpiece of their bill was the risk evaluation and mitigation strategy (REMS) plan, which would have been required for all new chemical entities and biologics.

Instead the HELP committee voted to give Food and Drug Administration authority to determine when a new drug should have a REMS. The panel also voted to require FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety.

The bill “establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered,” Sen. Kennedy said in a statement.

According to a statement by Sen. Enzi, the bill gives the FDA explicit new authority in the postmarketing area—which critics say the agency does not now have.

“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market.

“This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans, when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” he said. “Pulling a drug from the market and denying patients who need it should not be the only tool available to the FDA.”

As passed by the Senate panel, PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drugmakers to publish a registry of all late-phase II, phase III, and phase IV trials, and to make all trial results available in a public database.

The PDUFA legislation still has far to go before it becomes law. The Senate package will now go to the floor for a vote, and the House is still in the early phases of work, with the Energy and Commerce Health Subcommittee continuing to hold hearings.

The Senate Health, Education, Labor and Pensions Committee has voted to fund another 5 years of the Best Pharmaceuticals for Children Act.

Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1.

The new 5-year program will extend a drug's patent life by 3 months if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

An amendment to strip the patent-life-extensions was defeated.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the Food and Drug Administration has requested studies.

About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high, according to the Health, Education, Labor and Pensions (HELP) committee, so an amendment was added to streamline the process.

In other drug matters, the HELP panel completed its version of the 5-year reauthorization of the Prescription Drug User Fee and Modernization Act, but generally without any restrictions on drug advertising or a requirement that most drugs have a risk management program—proposals that had been championed by Committee Chairman Edward Kennedy (D-Mass.) and his colleague Sen. Michael Enzi (R-Wyo.).

The two senators had been hoping to attach their proposals for improved drug safety to the Prescription Drug User Fee and Modernization Act (PDUFA) reauthorization, but most of their suggestions were defeated or watered down in committee.

The centerpiece of their bill was the risk evaluation and mitigation strategy (REMS) plan, which would have been required for all new chemical entities and biologics.

Instead the HELP committee voted to give Food and Drug Administration authority to determine when a new drug should have a REMS. The panel also voted to require FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety.

The bill “establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered,” Sen. Kennedy said in a statement.

According to a statement by Sen. Enzi, the bill gives the FDA explicit new authority in the postmarketing area—which critics say the agency does not now have.

“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market.

“This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans, when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” he said. “Pulling a drug from the market and denying patients who need it should not be the only tool available to the FDA.”

As passed by the Senate panel, PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drugmakers to publish a registry of all late-phase II, phase III, and phase IV trials, and to make all trial results available in a public database.

The PDUFA legislation still has far to go before it becomes law. The Senate package will now go to the floor for a vote, and the House is still in the early phases of work, with the Energy and Commerce Health Subcommittee continuing to hold hearings.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology.

“Right now there are inadequate incentives for health care providers to adopt many of these technologies,” Rep. Gonzalez said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said.

Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology (CCHIT), a publicly funded agency that has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology.

“Right now there are inadequate incentives for health care providers to adopt many of these technologies,” Rep. Gonzalez said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said.

Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology (CCHIT), a publicly funded agency that has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer an incentive payment to physicians who make the move to electronic medical records.

Adopting electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology.

“Right now there are inadequate incentives for health care providers to adopt many of these technologies,” Rep. Gonzalez said.

“Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” added Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said.

Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology (CCHIT), a publicly funded agency that has been vetting hardware and software systems.

CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense amounted to less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina at Chapel Hill and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina experienced a 274% increase in its foreign-born population during the 1990s. From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004.

Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” the authors said.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense amounted to less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina at Chapel Hill and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina experienced a 274% increase in its foreign-born population during the 1990s. From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004.

Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” the authors said.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense amounted to less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina at Chapel Hill and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina experienced a 274% increase in its foreign-born population during the 1990s. From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004.

Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” the authors said.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

Alzheimer's Affects 5 Million

About 5.1 million Americans are living with Alzheimer's disease, according to a recent report from the Alzheimer's Association. While most people with the disease are over age 65, 200,000–500,000 people younger than 65 have early-onset Alzheimer's or other dementias. Without improvement in treatment, the group estimated that the prevalence of the disease could reach 11–16 million by 2050. Direct and indirect costs of Alzheimer's disease add up to more than $148 billion a year. Medicare's cost of caring for patients with Alzheimer's and other dementias is expected to climb from $91 billion in 2005 to more than $189 billion by 2015. But Harry Johns, president and CEO of the Alzheimer's Association, expressed hope. “There are currently nine drugs in phase III clinical trials for Alzheimer's, several of which show great promise to slow or stop the progression of the disease,” Mr. Johns said in a statement. “This, combined with advancements in diagnostic tools, has the potential to change the landscape of Alzheimer's.”

Alzheimer's Treatment Delays

Race and ethnicity may play a role in delays in diagnosis and treatment of Alzheimer's disease, according to an Alzheimer's Foundation of America survey. The survey found that 70% of African American and 67% of Hispanic caregivers were likely to dismiss the symptoms of Alzheimer's as old age, compared with 53% of caregivers of other races. Further, about 67% of African American caregivers and 63% of Hispanic caregivers said they did not know enough about the disease to recognize symptoms, compared with 49% of caregivers of other races. The stigma of a diagnosis was also a concern. For example, 36% of African American caregivers cited concerns about stigma as delaying diagnosis, compared with 22% of Hispanic caregivers and 18% of caregivers of other races. The survey, conducted by Harris Interactive and sponsored by Forest Pharmaceuticals Inc., included 655 adults who provide care for someone with the disease.

25% of Stays for Mental Health

One-quarter of all patients age 18 and over admitted to the hospital in 2004 had a mental health or a substance abuse disorder, according to the federal Agency for Healthcare Research and Quality. Almost 2 million admissions were primarily for a mental health or substance abuse issue. Another 6 million patients were admitted for another condition but were subsequently diagnosed with a mental health or substance abuse problem. Dual diagnoses accounted for 1 million of the 8 million total stays, and suicide attempts accounted for 179,000 admissions, with the majority involving patients aged 18–44 years. However, most of the mental health and substance abuse disorders were in older patients, with those over age 80 accounting for 21% of hospitals stays, mostly for dementia. Medicare covered half the inpatient stays, Medicaid paid 18%, and private insurers covered 24%. Eight percent of patients were uninsured. The AHRQ report can be found at

www.ahrq.gov/data/hcup/factbk10/

NIH Launches Addiction Study

In response to the growing prescription drug abuse, the National Institute on Drug Abuse is launching the multisite Prescription Opioid Addiction Treatment Study (POATS). The researchers will examine the efficacy of buprenorphine/naloxone (Suboxone) combined with either intensive or brief drug-counseling approaches. Investigators aim to enroll about 648 participants at 11 sites. “Opioid analgesics were designed to help people in pain, and we want to be sure that those who require them for legitimate reasons can continue to effectively manage their pain,” Dr. Nora D. Volkow, NIDA director, said in a statement. “However, we must also recognize the risk of addiction to pain medications and develop treatments for those who become addicted to them.”

Psych Drug Spending Soars

Spending on medications for mental health conditions surged 150% from 1997 to 2004, rising from $8 billion to $20 billion in that 7-year period, according to AHRQ. The agency said the largest increase was for antipsychotic agents, where spending rose from $1 billion to $4 billion by 2004. But spending for antidepressants dwarfed that total; from 1997 to 2004, spending more than doubled, from $5 billion to $12 billion. The number of overall prescriptions for mental health-related prescriptions rose from 142 million to 244 million; at least 33 million Americans were prescribed a psychotherapeutic drug in 2004. The data are in the AHRQ report, Trends in the Use and Expenditures for the Therapeutic Class Prescribed Psychotherapeutic Agents and All Subclasses, 1997 and 2004.

CMS Extends NPI Deadline

Physicians and other providers who fail to comply with the May 23 deadline to acquire and start using a National Provider Identifier will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period after it became clear that many entities would not be able to fully comply by the original deadline, she said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

Alzheimer's Affects 5 Million

About 5.1 million Americans are living with Alzheimer's disease, according to a recent report from the Alzheimer's Association. While most people with the disease are over age 65, 200,000–500,000 people younger than 65 have early-onset Alzheimer's or other dementias. Without improvement in treatment, the group estimated that the prevalence of the disease could reach 11–16 million by 2050. Direct and indirect costs of Alzheimer's disease add up to more than $148 billion a year. Medicare's cost of caring for patients with Alzheimer's and other dementias is expected to climb from $91 billion in 2005 to more than $189 billion by 2015. But Harry Johns, president and CEO of the Alzheimer's Association, expressed hope. “There are currently nine drugs in phase III clinical trials for Alzheimer's, several of which show great promise to slow or stop the progression of the disease,” Mr. Johns said in a statement. “This, combined with advancements in diagnostic tools, has the potential to change the landscape of Alzheimer's.”

Alzheimer's Treatment Delays

Race and ethnicity may play a role in delays in diagnosis and treatment of Alzheimer's disease, according to an Alzheimer's Foundation of America survey. The survey found that 70% of African American and 67% of Hispanic caregivers were likely to dismiss the symptoms of Alzheimer's as old age, compared with 53% of caregivers of other races. Further, about 67% of African American caregivers and 63% of Hispanic caregivers said they did not know enough about the disease to recognize symptoms, compared with 49% of caregivers of other races. The stigma of a diagnosis was also a concern. For example, 36% of African American caregivers cited concerns about stigma as delaying diagnosis, compared with 22% of Hispanic caregivers and 18% of caregivers of other races. The survey, conducted by Harris Interactive and sponsored by Forest Pharmaceuticals Inc., included 655 adults who provide care for someone with the disease.

25% of Stays for Mental Health

One-quarter of all patients age 18 and over admitted to the hospital in 2004 had a mental health or a substance abuse disorder, according to the federal Agency for Healthcare Research and Quality. Almost 2 million admissions were primarily for a mental health or substance abuse issue. Another 6 million patients were admitted for another condition but were subsequently diagnosed with a mental health or substance abuse problem. Dual diagnoses accounted for 1 million of the 8 million total stays, and suicide attempts accounted for 179,000 admissions, with the majority involving patients aged 18–44 years. However, most of the mental health and substance abuse disorders were in older patients, with those over age 80 accounting for 21% of hospitals stays, mostly for dementia. Medicare covered half the inpatient stays, Medicaid paid 18%, and private insurers covered 24%. Eight percent of patients were uninsured. The AHRQ report can be found at

www.ahrq.gov/data/hcup/factbk10/

NIH Launches Addiction Study

In response to the growing prescription drug abuse, the National Institute on Drug Abuse is launching the multisite Prescription Opioid Addiction Treatment Study (POATS). The researchers will examine the efficacy of buprenorphine/naloxone (Suboxone) combined with either intensive or brief drug-counseling approaches. Investigators aim to enroll about 648 participants at 11 sites. “Opioid analgesics were designed to help people in pain, and we want to be sure that those who require them for legitimate reasons can continue to effectively manage their pain,” Dr. Nora D. Volkow, NIDA director, said in a statement. “However, we must also recognize the risk of addiction to pain medications and develop treatments for those who become addicted to them.”

Psych Drug Spending Soars

Spending on medications for mental health conditions surged 150% from 1997 to 2004, rising from $8 billion to $20 billion in that 7-year period, according to AHRQ. The agency said the largest increase was for antipsychotic agents, where spending rose from $1 billion to $4 billion by 2004. But spending for antidepressants dwarfed that total; from 1997 to 2004, spending more than doubled, from $5 billion to $12 billion. The number of overall prescriptions for mental health-related prescriptions rose from 142 million to 244 million; at least 33 million Americans were prescribed a psychotherapeutic drug in 2004. The data are in the AHRQ report, Trends in the Use and Expenditures for the Therapeutic Class Prescribed Psychotherapeutic Agents and All Subclasses, 1997 and 2004.

CMS Extends NPI Deadline

Physicians and other providers who fail to comply with the May 23 deadline to acquire and start using a National Provider Identifier will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period after it became clear that many entities would not be able to fully comply by the original deadline, she said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

Alzheimer's Affects 5 Million

About 5.1 million Americans are living with Alzheimer's disease, according to a recent report from the Alzheimer's Association. While most people with the disease are over age 65, 200,000–500,000 people younger than 65 have early-onset Alzheimer's or other dementias. Without improvement in treatment, the group estimated that the prevalence of the disease could reach 11–16 million by 2050. Direct and indirect costs of Alzheimer's disease add up to more than $148 billion a year. Medicare's cost of caring for patients with Alzheimer's and other dementias is expected to climb from $91 billion in 2005 to more than $189 billion by 2015. But Harry Johns, president and CEO of the Alzheimer's Association, expressed hope. “There are currently nine drugs in phase III clinical trials for Alzheimer's, several of which show great promise to slow or stop the progression of the disease,” Mr. Johns said in a statement. “This, combined with advancements in diagnostic tools, has the potential to change the landscape of Alzheimer's.”

Alzheimer's Treatment Delays

Race and ethnicity may play a role in delays in diagnosis and treatment of Alzheimer's disease, according to an Alzheimer's Foundation of America survey. The survey found that 70% of African American and 67% of Hispanic caregivers were likely to dismiss the symptoms of Alzheimer's as old age, compared with 53% of caregivers of other races. Further, about 67% of African American caregivers and 63% of Hispanic caregivers said they did not know enough about the disease to recognize symptoms, compared with 49% of caregivers of other races. The stigma of a diagnosis was also a concern. For example, 36% of African American caregivers cited concerns about stigma as delaying diagnosis, compared with 22% of Hispanic caregivers and 18% of caregivers of other races. The survey, conducted by Harris Interactive and sponsored by Forest Pharmaceuticals Inc., included 655 adults who provide care for someone with the disease.

25% of Stays for Mental Health

One-quarter of all patients age 18 and over admitted to the hospital in 2004 had a mental health or a substance abuse disorder, according to the federal Agency for Healthcare Research and Quality. Almost 2 million admissions were primarily for a mental health or substance abuse issue. Another 6 million patients were admitted for another condition but were subsequently diagnosed with a mental health or substance abuse problem. Dual diagnoses accounted for 1 million of the 8 million total stays, and suicide attempts accounted for 179,000 admissions, with the majority involving patients aged 18–44 years. However, most of the mental health and substance abuse disorders were in older patients, with those over age 80 accounting for 21% of hospitals stays, mostly for dementia. Medicare covered half the inpatient stays, Medicaid paid 18%, and private insurers covered 24%. Eight percent of patients were uninsured. The AHRQ report can be found at

www.ahrq.gov/data/hcup/factbk10/

NIH Launches Addiction Study

In response to the growing prescription drug abuse, the National Institute on Drug Abuse is launching the multisite Prescription Opioid Addiction Treatment Study (POATS). The researchers will examine the efficacy of buprenorphine/naloxone (Suboxone) combined with either intensive or brief drug-counseling approaches. Investigators aim to enroll about 648 participants at 11 sites. “Opioid analgesics were designed to help people in pain, and we want to be sure that those who require them for legitimate reasons can continue to effectively manage their pain,” Dr. Nora D. Volkow, NIDA director, said in a statement. “However, we must also recognize the risk of addiction to pain medications and develop treatments for those who become addicted to them.”

Psych Drug Spending Soars

Spending on medications for mental health conditions surged 150% from 1997 to 2004, rising from $8 billion to $20 billion in that 7-year period, according to AHRQ. The agency said the largest increase was for antipsychotic agents, where spending rose from $1 billion to $4 billion by 2004. But spending for antidepressants dwarfed that total; from 1997 to 2004, spending more than doubled, from $5 billion to $12 billion. The number of overall prescriptions for mental health-related prescriptions rose from 142 million to 244 million; at least 33 million Americans were prescribed a psychotherapeutic drug in 2004. The data are in the AHRQ report, Trends in the Use and Expenditures for the Therapeutic Class Prescribed Psychotherapeutic Agents and All Subclasses, 1997 and 2004.

CMS Extends NPI Deadline

Physicians and other providers who fail to comply with the May 23 deadline to acquire and start using a National Provider Identifier will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period after it became clear that many entities would not be able to fully comply by the original deadline, she said. The new compliance guideline can be downloaded from the agency's Web site (

http://www.cms.hhs.gov/NationalProvIdentStand

WASHINGTON – The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, Boston, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business, Charlottesville.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay for performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and, with more and more such measures, will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians–typically seven physicians in four practices in a given year–which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future in which most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, insurers would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM Corp. on testing such a program with its employees in Austin, Tex.

WASHINGTON – The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, Boston, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business, Charlottesville.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay for performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and, with more and more such measures, will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians–typically seven physicians in four practices in a given year–which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future in which most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, insurers would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM Corp. on testing such a program with its employees in Austin, Tex.

WASHINGTON – The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, Boston, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business, Charlottesville.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay for performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and, with more and more such measures, will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians–typically seven physicians in four practices in a given year–which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future in which most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, insurers would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM Corp. on testing such a program with its employees in Austin, Tex.

NEW ORLEANS – Several home care organizations affiliated with hospitals in the New York metropolitan area have determined that nurses trained to screen for depression and to offer interventions can effectively improve outcomes in homebound patients, several presenters said at the annual meeting of the American Association of Geriatric Psychiatry.

Nurses are the front line for providing care to homebound patients but do not often recognize depression symptoms or have the ability to clearly communicate the issue to physicians, noted Ellen Brown, a registered nurse who developed an education and intervention program while at Cornell University, New York. She is now with the Stein Gerontological Institute in Miami.

The education program includes a video with portrayals of patients with symptoms of depression and suicidal ideation, a “nuts and bolts” tool kit that includes a checklist of symptoms and information to gather, and a two-session training course that uses role-playing and other interactive methods.

Several pilot studies by Ms. Brown and her colleagues had shown that the program improved nurses' ability to communicate information to physicians. But it was not clear whether these improvements with simulated cases would translate into better patient management in the real world, she said.

The home care agency at the Montefiore Medical Center, New York, put the training module to the test, said Dr. Paula Marcus of the department of psychiatry at the Albert Einstein College of Medicine, New York. In 2004, the hospital's home care agency was given a 3-year grant from the United Jewish Appeal to integrate psychiatric services.

The Montefiore home care agency's daily census averages 1,200 people who will be in the system for 6 weeks or less and 650 who are in longer term. To teach them how to identify depression in the home care setting, about 100 nurses, and physical, occupational, and speech therapists were given two 2-hour sessions over several weeks, which included viewing the video.

Since that time, thousands of patients have been screened for depression, and hundreds have been referred to the Montefiore home care agency's behavioral health program, Dr. Marcus said.

Once patients are referred to behavioral health, they are screened by a social worker and sent to a geriatric psychiatrist or geriatric psychiatry fellow if necessary. So far, psychiatrists have made an average 120–150 initial home evaluations yearly, Dr. Marcus said.

The home care agency also has been able to bill Medicare, Medicaid, and private insurers for the psychiatric visits, she said.

In a real-world test of a different model, the home care agency in Albany County, New York, sent licensed clinical social workers into the homes of medically ill patients who had been identified as severely depressed. Dr. Zvi Gellis, director of the Center for Mental Health and Aging Research at the State University of New York at Albany, presented initial results.

In the pilot, 30 patients received a behavioral intervention called problem-solving therapy for 1 hour a week for 6 weeks. The steps of that program include breaking down the problem, identifying potential solutions, creating those solutions, and then executing them. The patients also were given “homework,” being asked to substitute two pleasurable activities a day for negative thoughts.

They were compared with 32 patients who received basic home care, some psychoeducation, but no problem-solving therapy. The mean age of the patients was 77. Eighty-five percent were white, and 80% lived alone–a risk factor for depression, Dr. Gellis noted.

They were evaluated using the Hamilton Depression Rating Scale, the Geriatric Depression Scale, and self-reported satisfaction scores. The independent assessments were conducted by blinded evaluators at the end of the sessions, and then 3 and 6 months after therapy. There was a 50% reduction in the Hamilton score for the treatment group at 6 weeks and 3 months–from 20 to 10, compared with a minor drop for the control group, Dr. Gellis said.

The Geriatric Depression Scale score dropped from almost 14 to 8 for the treatment group at all three time intervals, compared with about a 1-point decline–from 14 to 13–for the control arm.

NEW ORLEANS – Several home care organizations affiliated with hospitals in the New York metropolitan area have determined that nurses trained to screen for depression and to offer interventions can effectively improve outcomes in homebound patients, several presenters said at the annual meeting of the American Association of Geriatric Psychiatry.

Nurses are the front line for providing care to homebound patients but do not often recognize depression symptoms or have the ability to clearly communicate the issue to physicians, noted Ellen Brown, a registered nurse who developed an education and intervention program while at Cornell University, New York. She is now with the Stein Gerontological Institute in Miami.

The education program includes a video with portrayals of patients with symptoms of depression and suicidal ideation, a “nuts and bolts” tool kit that includes a checklist of symptoms and information to gather, and a two-session training course that uses role-playing and other interactive methods.

Several pilot studies by Ms. Brown and her colleagues had shown that the program improved nurses' ability to communicate information to physicians. But it was not clear whether these improvements with simulated cases would translate into better patient management in the real world, she said.

The home care agency at the Montefiore Medical Center, New York, put the training module to the test, said Dr. Paula Marcus of the department of psychiatry at the Albert Einstein College of Medicine, New York. In 2004, the hospital's home care agency was given a 3-year grant from the United Jewish Appeal to integrate psychiatric services.

The Montefiore home care agency's daily census averages 1,200 people who will be in the system for 6 weeks or less and 650 who are in longer term. To teach them how to identify depression in the home care setting, about 100 nurses, and physical, occupational, and speech therapists were given two 2-hour sessions over several weeks, which included viewing the video.

Since that time, thousands of patients have been screened for depression, and hundreds have been referred to the Montefiore home care agency's behavioral health program, Dr. Marcus said.

Once patients are referred to behavioral health, they are screened by a social worker and sent to a geriatric psychiatrist or geriatric psychiatry fellow if necessary. So far, psychiatrists have made an average 120–150 initial home evaluations yearly, Dr. Marcus said.

The home care agency also has been able to bill Medicare, Medicaid, and private insurers for the psychiatric visits, she said.

In a real-world test of a different model, the home care agency in Albany County, New York, sent licensed clinical social workers into the homes of medically ill patients who had been identified as severely depressed. Dr. Zvi Gellis, director of the Center for Mental Health and Aging Research at the State University of New York at Albany, presented initial results.

In the pilot, 30 patients received a behavioral intervention called problem-solving therapy for 1 hour a week for 6 weeks. The steps of that program include breaking down the problem, identifying potential solutions, creating those solutions, and then executing them. The patients also were given “homework,” being asked to substitute two pleasurable activities a day for negative thoughts.

They were compared with 32 patients who received basic home care, some psychoeducation, but no problem-solving therapy. The mean age of the patients was 77. Eighty-five percent were white, and 80% lived alone–a risk factor for depression, Dr. Gellis noted.

They were evaluated using the Hamilton Depression Rating Scale, the Geriatric Depression Scale, and self-reported satisfaction scores. The independent assessments were conducted by blinded evaluators at the end of the sessions, and then 3 and 6 months after therapy. There was a 50% reduction in the Hamilton score for the treatment group at 6 weeks and 3 months–from 20 to 10, compared with a minor drop for the control group, Dr. Gellis said.

The Geriatric Depression Scale score dropped from almost 14 to 8 for the treatment group at all three time intervals, compared with about a 1-point decline–from 14 to 13–for the control arm.

NEW ORLEANS – Several home care organizations affiliated with hospitals in the New York metropolitan area have determined that nurses trained to screen for depression and to offer interventions can effectively improve outcomes in homebound patients, several presenters said at the annual meeting of the American Association of Geriatric Psychiatry.

Nurses are the front line for providing care to homebound patients but do not often recognize depression symptoms or have the ability to clearly communicate the issue to physicians, noted Ellen Brown, a registered nurse who developed an education and intervention program while at Cornell University, New York. She is now with the Stein Gerontological Institute in Miami.

The education program includes a video with portrayals of patients with symptoms of depression and suicidal ideation, a “nuts and bolts” tool kit that includes a checklist of symptoms and information to gather, and a two-session training course that uses role-playing and other interactive methods.

Several pilot studies by Ms. Brown and her colleagues had shown that the program improved nurses' ability to communicate information to physicians. But it was not clear whether these improvements with simulated cases would translate into better patient management in the real world, she said.

The home care agency at the Montefiore Medical Center, New York, put the training module to the test, said Dr. Paula Marcus of the department of psychiatry at the Albert Einstein College of Medicine, New York. In 2004, the hospital's home care agency was given a 3-year grant from the United Jewish Appeal to integrate psychiatric services.

The Montefiore home care agency's daily census averages 1,200 people who will be in the system for 6 weeks or less and 650 who are in longer term. To teach them how to identify depression in the home care setting, about 100 nurses, and physical, occupational, and speech therapists were given two 2-hour sessions over several weeks, which included viewing the video.

Since that time, thousands of patients have been screened for depression, and hundreds have been referred to the Montefiore home care agency's behavioral health program, Dr. Marcus said.

Once patients are referred to behavioral health, they are screened by a social worker and sent to a geriatric psychiatrist or geriatric psychiatry fellow if necessary. So far, psychiatrists have made an average 120–150 initial home evaluations yearly, Dr. Marcus said.

The home care agency also has been able to bill Medicare, Medicaid, and private insurers for the psychiatric visits, she said.

In a real-world test of a different model, the home care agency in Albany County, New York, sent licensed clinical social workers into the homes of medically ill patients who had been identified as severely depressed. Dr. Zvi Gellis, director of the Center for Mental Health and Aging Research at the State University of New York at Albany, presented initial results.

In the pilot, 30 patients received a behavioral intervention called problem-solving therapy for 1 hour a week for 6 weeks. The steps of that program include breaking down the problem, identifying potential solutions, creating those solutions, and then executing them. The patients also were given “homework,” being asked to substitute two pleasurable activities a day for negative thoughts.

They were compared with 32 patients who received basic home care, some psychoeducation, but no problem-solving therapy. The mean age of the patients was 77. Eighty-five percent were white, and 80% lived alone–a risk factor for depression, Dr. Gellis noted.

They were evaluated using the Hamilton Depression Rating Scale, the Geriatric Depression Scale, and self-reported satisfaction scores. The independent assessments were conducted by blinded evaluators at the end of the sessions, and then 3 and 6 months after therapy. There was a 50% reduction in the Hamilton score for the treatment group at 6 weeks and 3 months–from 20 to 10, compared with a minor drop for the control group, Dr. Gellis said.

The Geriatric Depression Scale score dropped from almost 14 to 8 for the treatment group at all three time intervals, compared with about a 1-point decline–from 14 to 13–for the control arm.

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

The FDA “is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” Mr. Lutter said in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees.

It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, Mr. Lutter said, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds. The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” Mr. Lurie said, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, Mr. Lutter said.

To submit electronic comments, visit www.regulations.govwww.fda.gov/?dockets/ecomments

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

The FDA “is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” Mr. Lutter said in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees.

It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, Mr. Lutter said, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds. The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” Mr. Lurie said, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, Mr. Lutter said.

To submit electronic comments, visit www.regulations.govwww.fda.gov/?dockets/ecomments

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

The FDA “is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” Mr. Lutter said in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees.

It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, Mr. Lutter said, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds. The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” Mr. Lurie said, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, Mr. Lutter said.

To submit electronic comments, visit www.regulations.govwww.fda.gov/?dockets/ecomments

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch. “I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel, said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said.

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch. “I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel, said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said.

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch. “I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel, said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said.