Alicia Ault

NEW ORLEANS — The American Board of Medical Specialties has approved standards to its maintenance of certification program, with a growing emphasis on more public disclosure and more evidence-based continuing medical education, said Dr. Richard E. Hawkins, ABMS senior vice president for professional and scientific affairs.

Speaking to the Society of Gynecologic Surgeons, Dr. Hawkins outlined the actions taken by the ABMS Board of Directors in March.

As part of the maintenance of certification (MOC) process, physicians will now have to provide evidence of participation in practice-based assessment and quality improvement every 2 to 5 years. The ABMS is urging physicians to use nationally approved measures such as those endorsed by the National Quality Forum. By 2011, all 24 of the ABMS member boards will have to document that diplomates are meeting these requirements.

At that time, the ABMS will allow the public to see which physicians are participating in the MOC process, most likely through a searchable Web site, Dr. Hawkins said in an interview. Details on how the data will be presented are still being worked out with the 24 member boards, he said.

The ABMS Board of Directors voted to require all physicians to complete a patient safety self-assessment program at least once during each MOC cycle, beginning in 2010. Because ABMS member boards are at different stages of implementing MOC, some may not be equipped to start requiring this of their diplomates, said Dr. Hawkins. The ABMS board dubbed the patient safety program a "developmental standard," which means that it is essentially a pilot that will be reevaluated during the next 5 years.

ABMS will make modifications, if necessary, said Dr. Hawkins. Even so, the ABMS standards require this module to be in place for all diplomates by 2014, he said.

Physicians who provide direct patient care must demonstrate communication skills using patient surveys with the Consumer Assessment of Healthcare Providers and Systems instrument, or an equivalent survey. The goal is for everyone to have the program in place by 2014, he said.

Similarly, the developmental standard on peer surveys will be implemented by member boards at their own pace, but will still be expected by 2014. Both of these survey requirements will be evaluated and updated as necessary during the next 5 years.

Dr. Hawkins said that some of the surgical boards within ABMS have been discussing the creation of a national surgical clinical registry to track surgeons' performance, a development that is "likely to happen."

Since physicians currently have to report quality data and process improvement to various agencies, the ABMS is working on ways to streamline data collection and reporting for MOC, said Dr. Hawkins.

NEW ORLEANS — The American Board of Medical Specialties has approved standards to its maintenance of certification program, with a growing emphasis on more public disclosure and more evidence-based continuing medical education, said Dr. Richard E. Hawkins, ABMS senior vice president for professional and scientific affairs.

Speaking to the Society of Gynecologic Surgeons, Dr. Hawkins outlined the actions taken by the ABMS Board of Directors in March.

As part of the maintenance of certification (MOC) process, physicians will now have to provide evidence of participation in practice-based assessment and quality improvement every 2 to 5 years. The ABMS is urging physicians to use nationally approved measures such as those endorsed by the National Quality Forum. By 2011, all 24 of the ABMS member boards will have to document that diplomates are meeting these requirements.

At that time, the ABMS will allow the public to see which physicians are participating in the MOC process, most likely through a searchable Web site, Dr. Hawkins said in an interview. Details on how the data will be presented are still being worked out with the 24 member boards, he said.

The ABMS Board of Directors voted to require all physicians to complete a patient safety self-assessment program at least once during each MOC cycle, beginning in 2010. Because ABMS member boards are at different stages of implementing MOC, some may not be equipped to start requiring this of their diplomates, said Dr. Hawkins. The ABMS board dubbed the patient safety program a "developmental standard," which means that it is essentially a pilot that will be reevaluated during the next 5 years.

ABMS will make modifications, if necessary, said Dr. Hawkins. Even so, the ABMS standards require this module to be in place for all diplomates by 2014, he said.

Physicians who provide direct patient care must demonstrate communication skills using patient surveys with the Consumer Assessment of Healthcare Providers and Systems instrument, or an equivalent survey. The goal is for everyone to have the program in place by 2014, he said.

Similarly, the developmental standard on peer surveys will be implemented by member boards at their own pace, but will still be expected by 2014. Both of these survey requirements will be evaluated and updated as necessary during the next 5 years.

Dr. Hawkins said that some of the surgical boards within ABMS have been discussing the creation of a national surgical clinical registry to track surgeons' performance, a development that is "likely to happen."

Since physicians currently have to report quality data and process improvement to various agencies, the ABMS is working on ways to streamline data collection and reporting for MOC, said Dr. Hawkins.

NEW ORLEANS — The American Board of Medical Specialties has approved standards to its maintenance of certification program, with a growing emphasis on more public disclosure and more evidence-based continuing medical education, said Dr. Richard E. Hawkins, ABMS senior vice president for professional and scientific affairs.

Speaking to the Society of Gynecologic Surgeons, Dr. Hawkins outlined the actions taken by the ABMS Board of Directors in March.

As part of the maintenance of certification (MOC) process, physicians will now have to provide evidence of participation in practice-based assessment and quality improvement every 2 to 5 years. The ABMS is urging physicians to use nationally approved measures such as those endorsed by the National Quality Forum. By 2011, all 24 of the ABMS member boards will have to document that diplomates are meeting these requirements.

At that time, the ABMS will allow the public to see which physicians are participating in the MOC process, most likely through a searchable Web site, Dr. Hawkins said in an interview. Details on how the data will be presented are still being worked out with the 24 member boards, he said.

The ABMS Board of Directors voted to require all physicians to complete a patient safety self-assessment program at least once during each MOC cycle, beginning in 2010. Because ABMS member boards are at different stages of implementing MOC, some may not be equipped to start requiring this of their diplomates, said Dr. Hawkins. The ABMS board dubbed the patient safety program a "developmental standard," which means that it is essentially a pilot that will be reevaluated during the next 5 years.

ABMS will make modifications, if necessary, said Dr. Hawkins. Even so, the ABMS standards require this module to be in place for all diplomates by 2014, he said.

Physicians who provide direct patient care must demonstrate communication skills using patient surveys with the Consumer Assessment of Healthcare Providers and Systems instrument, or an equivalent survey. The goal is for everyone to have the program in place by 2014, he said.

Similarly, the developmental standard on peer surveys will be implemented by member boards at their own pace, but will still be expected by 2014. Both of these survey requirements will be evaluated and updated as necessary during the next 5 years.

Dr. Hawkins said that some of the surgical boards within ABMS have been discussing the creation of a national surgical clinical registry to track surgeons' performance, a development that is "likely to happen."

Since physicians currently have to report quality data and process improvement to various agencies, the ABMS is working on ways to streamline data collection and reporting for MOC, said Dr. Hawkins.

Reloxin Approval Delayed

Ipsen and its marketing partner Medicis announced in mid-April that its botulinum toxin type A, Reloxin, (known as Dysport in Europe) would not be approved at the expected time. Instead, the companies reported in a statement that they were "in active labeling and risk evaluation and mitigation strategy discussions" with the Food and Drug Administration for both the therapeutic—cervical dystonia—and the aesthetic indications. Galderma owns European marketing rights for aesthetic uses, and Medicis owns the U.S., Canadian, and Japanese rights. The companies did not say when they expected final approval.

QVC Settles Over Cellulite Cream

The megaretailer QVC Inc. has agreed to pay $7.5 million to settle Federal Trade Commission charges that it violated commission orders dating to 2000 and made false and unsubstantiated claims about an anticellulite cream as well as three dietary supplements. The company's TV-shopping network made unsubstantiated claims that Lipofactor lotion could reduce cellulite, said the FTC statement. "Simply put, we aren't going to let QVC get away with this," said the acting director of FTC's Bureau of Consumer Protection, Eileen Harrington. QVC will pay $6 million for consumer redress and a $1.5 million civil penalty. And the FTC extended the order prohibiting the claims.

NIAMS Touts Stimulus Funds

The government's economic stimulus package offers new opportunities for dermatologic research, Dr. Stephen Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said on the agency's Web site. The stimulus funds are distinct from NIAMS's annual appropriation and will be managed separately, said Dr. Katz. Among the new programs is the Grand Opportunities initiative for projects requiring more than $500,000 per year. Other stimulus funds can be used to accelerate ongoing research. Application deadlines are in June and July, visit

www.niams.nih.gov/Recovery/directors_go_letter.asp

Lupus Research Gets Budget Boost

Congress has dedicated about $5 million to lupus research and education as part of the recently enacted fiscal year 2009 Omnibus Appropriations Act. The law, which was signed in March, includes $4 million to support the National Lupus Patient Registry, about $1 million more than in FY 2008. Congress provided another $1 million for health provider education aimed at improving early diagnosis and treatment of lupus and reducing health disparities. The Lupus Foundation of America specifically praised the health provider education initiative. Educational programs that improve the time to diagnosis are critical, the organization said, because more than half of individuals with lupus report that they had symptoms of the disease for at least 4 years and visited at least three physicians before receiving a diagnosis of lupus.

Path Outlined for Biosimilars

A bipartisan group of legislators has introduced a bill to promote approval of follow-on biologics, or biosimilars. The Pathway for Biosimilars Act (H.R. 1548) is designed to accomplish for follow-on biologics what the Hatch-Waxman Act of 1984 did for generic drugs. The legislation would set up a process within the FDA to expedite approval of new biologics that are based on existing products. However, the bill includes incentives for companies to continue to create innovative products, including 12 years of exclusivity for the original product.

Device Staff Decries FDA Politics

The FDA is a mess of politics, abuse, and misdeeds, according to members of the agency's Office of Device Evaluation, who sent a six-page letter to President Barack Obama in early April. The staff members called on the president to enact sweeping measures "to end the systemic corruption and wrongdoing that permeates all levels of FDA." They said that FDA managers have "abused their power and authority" and "engaged in illegal retaliation against those who speak out." The letter detailed a handful of events in the last few months but said that "the culture of wrongdoing is nothing new but is part of a long-standing pattern of behavior." The letter, with all of the signers' names redacted, was released at a congressional hearing.

Administration Posts Filling Up

The Obama administration has named officials to several top health care-related positions that do not require Senate confirmation, including the director of the White House Office of Health Reform, administrator of the Health Resources and Services Administration, and the new National Coordinator for Health Information Technology. Nancy-Ann DeParle, who ran Medicaid and Medicare under President Clinton, will now lead the White House office. Rural health expert Mary Wakefield, Ph.D., R.N., was selected to head HRSA, joining the agency from the University of North Dakota, Grand Forks. And internist David Blumenthal, former director of the Institute for Health Policy at Massachusetts General Hospital, Boston, will take the lead on creating a nationwide health information technology infrastructure.

Reloxin Approval Delayed

Ipsen and its marketing partner Medicis announced in mid-April that its botulinum toxin type A, Reloxin, (known as Dysport in Europe) would not be approved at the expected time. Instead, the companies reported in a statement that they were "in active labeling and risk evaluation and mitigation strategy discussions" with the Food and Drug Administration for both the therapeutic—cervical dystonia—and the aesthetic indications. Galderma owns European marketing rights for aesthetic uses, and Medicis owns the U.S., Canadian, and Japanese rights. The companies did not say when they expected final approval.

QVC Settles Over Cellulite Cream

The megaretailer QVC Inc. has agreed to pay $7.5 million to settle Federal Trade Commission charges that it violated commission orders dating to 2000 and made false and unsubstantiated claims about an anticellulite cream as well as three dietary supplements. The company's TV-shopping network made unsubstantiated claims that Lipofactor lotion could reduce cellulite, said the FTC statement. "Simply put, we aren't going to let QVC get away with this," said the acting director of FTC's Bureau of Consumer Protection, Eileen Harrington. QVC will pay $6 million for consumer redress and a $1.5 million civil penalty. And the FTC extended the order prohibiting the claims.

NIAMS Touts Stimulus Funds

The government's economic stimulus package offers new opportunities for dermatologic research, Dr. Stephen Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said on the agency's Web site. The stimulus funds are distinct from NIAMS's annual appropriation and will be managed separately, said Dr. Katz. Among the new programs is the Grand Opportunities initiative for projects requiring more than $500,000 per year. Other stimulus funds can be used to accelerate ongoing research. Application deadlines are in June and July, visit

www.niams.nih.gov/Recovery/directors_go_letter.asp

Lupus Research Gets Budget Boost

Congress has dedicated about $5 million to lupus research and education as part of the recently enacted fiscal year 2009 Omnibus Appropriations Act. The law, which was signed in March, includes $4 million to support the National Lupus Patient Registry, about $1 million more than in FY 2008. Congress provided another $1 million for health provider education aimed at improving early diagnosis and treatment of lupus and reducing health disparities. The Lupus Foundation of America specifically praised the health provider education initiative. Educational programs that improve the time to diagnosis are critical, the organization said, because more than half of individuals with lupus report that they had symptoms of the disease for at least 4 years and visited at least three physicians before receiving a diagnosis of lupus.

Path Outlined for Biosimilars

A bipartisan group of legislators has introduced a bill to promote approval of follow-on biologics, or biosimilars. The Pathway for Biosimilars Act (H.R. 1548) is designed to accomplish for follow-on biologics what the Hatch-Waxman Act of 1984 did for generic drugs. The legislation would set up a process within the FDA to expedite approval of new biologics that are based on existing products. However, the bill includes incentives for companies to continue to create innovative products, including 12 years of exclusivity for the original product.

Device Staff Decries FDA Politics

The FDA is a mess of politics, abuse, and misdeeds, according to members of the agency's Office of Device Evaluation, who sent a six-page letter to President Barack Obama in early April. The staff members called on the president to enact sweeping measures "to end the systemic corruption and wrongdoing that permeates all levels of FDA." They said that FDA managers have "abused their power and authority" and "engaged in illegal retaliation against those who speak out." The letter detailed a handful of events in the last few months but said that "the culture of wrongdoing is nothing new but is part of a long-standing pattern of behavior." The letter, with all of the signers' names redacted, was released at a congressional hearing.

Administration Posts Filling Up

The Obama administration has named officials to several top health care-related positions that do not require Senate confirmation, including the director of the White House Office of Health Reform, administrator of the Health Resources and Services Administration, and the new National Coordinator for Health Information Technology. Nancy-Ann DeParle, who ran Medicaid and Medicare under President Clinton, will now lead the White House office. Rural health expert Mary Wakefield, Ph.D., R.N., was selected to head HRSA, joining the agency from the University of North Dakota, Grand Forks. And internist David Blumenthal, former director of the Institute for Health Policy at Massachusetts General Hospital, Boston, will take the lead on creating a nationwide health information technology infrastructure.

Reloxin Approval Delayed

Ipsen and its marketing partner Medicis announced in mid-April that its botulinum toxin type A, Reloxin, (known as Dysport in Europe) would not be approved at the expected time. Instead, the companies reported in a statement that they were "in active labeling and risk evaluation and mitigation strategy discussions" with the Food and Drug Administration for both the therapeutic—cervical dystonia—and the aesthetic indications. Galderma owns European marketing rights for aesthetic uses, and Medicis owns the U.S., Canadian, and Japanese rights. The companies did not say when they expected final approval.

QVC Settles Over Cellulite Cream

The megaretailer QVC Inc. has agreed to pay $7.5 million to settle Federal Trade Commission charges that it violated commission orders dating to 2000 and made false and unsubstantiated claims about an anticellulite cream as well as three dietary supplements. The company's TV-shopping network made unsubstantiated claims that Lipofactor lotion could reduce cellulite, said the FTC statement. "Simply put, we aren't going to let QVC get away with this," said the acting director of FTC's Bureau of Consumer Protection, Eileen Harrington. QVC will pay $6 million for consumer redress and a $1.5 million civil penalty. And the FTC extended the order prohibiting the claims.

NIAMS Touts Stimulus Funds

The government's economic stimulus package offers new opportunities for dermatologic research, Dr. Stephen Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said on the agency's Web site. The stimulus funds are distinct from NIAMS's annual appropriation and will be managed separately, said Dr. Katz. Among the new programs is the Grand Opportunities initiative for projects requiring more than $500,000 per year. Other stimulus funds can be used to accelerate ongoing research. Application deadlines are in June and July, visit

www.niams.nih.gov/Recovery/directors_go_letter.asp

Lupus Research Gets Budget Boost

Congress has dedicated about $5 million to lupus research and education as part of the recently enacted fiscal year 2009 Omnibus Appropriations Act. The law, which was signed in March, includes $4 million to support the National Lupus Patient Registry, about $1 million more than in FY 2008. Congress provided another $1 million for health provider education aimed at improving early diagnosis and treatment of lupus and reducing health disparities. The Lupus Foundation of America specifically praised the health provider education initiative. Educational programs that improve the time to diagnosis are critical, the organization said, because more than half of individuals with lupus report that they had symptoms of the disease for at least 4 years and visited at least three physicians before receiving a diagnosis of lupus.

Path Outlined for Biosimilars

A bipartisan group of legislators has introduced a bill to promote approval of follow-on biologics, or biosimilars. The Pathway for Biosimilars Act (H.R. 1548) is designed to accomplish for follow-on biologics what the Hatch-Waxman Act of 1984 did for generic drugs. The legislation would set up a process within the FDA to expedite approval of new biologics that are based on existing products. However, the bill includes incentives for companies to continue to create innovative products, including 12 years of exclusivity for the original product.

Device Staff Decries FDA Politics

The FDA is a mess of politics, abuse, and misdeeds, according to members of the agency's Office of Device Evaluation, who sent a six-page letter to President Barack Obama in early April. The staff members called on the president to enact sweeping measures "to end the systemic corruption and wrongdoing that permeates all levels of FDA." They said that FDA managers have "abused their power and authority" and "engaged in illegal retaliation against those who speak out." The letter detailed a handful of events in the last few months but said that "the culture of wrongdoing is nothing new but is part of a long-standing pattern of behavior." The letter, with all of the signers' names redacted, was released at a congressional hearing.

Administration Posts Filling Up

The Obama administration has named officials to several top health care-related positions that do not require Senate confirmation, including the director of the White House Office of Health Reform, administrator of the Health Resources and Services Administration, and the new National Coordinator for Health Information Technology. Nancy-Ann DeParle, who ran Medicaid and Medicare under President Clinton, will now lead the White House office. Rural health expert Mary Wakefield, Ph.D., R.N., was selected to head HRSA, joining the agency from the University of North Dakota, Grand Forks. And internist David Blumenthal, former director of the Institute for Health Policy at Massachusetts General Hospital, Boston, will take the lead on creating a nationwide health information technology infrastructure.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period.

The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint.

That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period.

The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint.

That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period.

The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint.

That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc., that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine.

“We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages.

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc., that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine.

“We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages.

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc., that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine.

“We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages.

Retail clinics are projected to increase at a healthy 20%–30% per year over the next 6 years, with sales rising from $548 million in 2008 to $2 billion in 2013, according to a market research report from New York-based Kalorama Information.

Dr. Yul Ejnes, a member of the American College of Physicians' Board of Regents, called the projected boom in retail clinics “just a symptom of a bigger problem,” and a sign of a dysfunctional health care system.

In an interview, he conceded that the retail clinic is a model that's here to stay. But if the medical home concept were “executed to its fullest, on the flip side, the need for retail clinics could diminish.”

Alternatively, retail clinic leaders, such as MinuteClinic President Chip Phillips, see the clinics as successfully filling a gap left by the dwindling number of primary care physicians.

MinuteClinic, the Minneapolis-based subsidiary of CVS Caremark Corp., now claims more than 560 locations in 25 states.

Typically, the clinics offer a menu of services for common ailments such as allergies, bladder infections, pink eye, ear infections, and strep throat. Many also offer screening tests for cholesterol, hypertension, and diabetes. Vaccines are also a significant offering.

The prices for these services are publicly available, with most diagnostic and treatment services running at about $62. Services are provided by nurse practitioners, who are supervised by physicians on contract with MinuteClinic. The clinics are considered in-network providers with 60 insurers.

As of now, “it's hard to tell what impact the recession will have” on the growth of clinics, Mr. Phillips said in an interview.

According to the Kalorama report, the economic downturn could indeed propel people to retail clinics, but it's also possible that as Americans rein in spending, health expenditures also may see a reduction.

“Over the next few years, retail clinics may capture a portion of the business currently serviced by physicians,” the report said.

Some physicians have expressed concern that the retail clinics could supplant or interfere with the attempts to establish a health delivery model based on the patient-centered medical home.

Mr. Phillips disagreed. “We don't see ourselves as competition to the primary care medical home concept,” he said, adding that MinuteClinic's role “is different than, and can be supportive of, the medical home.”

Dr. Ejnes agreed that clinics can fit in with the medical home if lines of communication are kept open between the clinics and primary physicians.

ACP aims to ensure that the clinics adhere to principles it adopted for the sector.

For instance, there should be physician supervision and 24-hour coverage to answer questions that may arise, said Dr. Ejnes, who is also chairman of the ACP's medical service committee.

The American Academy of Family Physicians and the American Medical Association also adopted guidelines for retail clinics in 2006.

The American Academy of Pediatrics specifically stated its opposition to the retail clinic model in a policy statement (Pediatrics 2006;118:2561–2).

Recent market indicators also suggest that reliance on retail clinics may be seasonal in nature. In mid-March, MinuteClinic said that it would shutter 89 clinics until the next cough, cold, and flu season. Over time, it has become clear that the company “didn't need as many of the clinics as we had opened,” Mr. Phillips said. These locations could be taken off line for part of the year without reducing access in those markets.

Retail clinics are projected to increase at a healthy 20%–30% per year over the next 6 years, with sales rising from $548 million in 2008 to $2 billion in 2013, according to a market research report from New York-based Kalorama Information.

Dr. Yul Ejnes, a member of the American College of Physicians' Board of Regents, called the projected boom in retail clinics “just a symptom of a bigger problem,” and a sign of a dysfunctional health care system.

In an interview, he conceded that the retail clinic is a model that's here to stay. But if the medical home concept were “executed to its fullest, on the flip side, the need for retail clinics could diminish.”

Alternatively, retail clinic leaders, such as MinuteClinic President Chip Phillips, see the clinics as successfully filling a gap left by the dwindling number of primary care physicians.

MinuteClinic, the Minneapolis-based subsidiary of CVS Caremark Corp., now claims more than 560 locations in 25 states.

Typically, the clinics offer a menu of services for common ailments such as allergies, bladder infections, pink eye, ear infections, and strep throat. Many also offer screening tests for cholesterol, hypertension, and diabetes. Vaccines are also a significant offering.

The prices for these services are publicly available, with most diagnostic and treatment services running at about $62. Services are provided by nurse practitioners, who are supervised by physicians on contract with MinuteClinic. The clinics are considered in-network providers with 60 insurers.

As of now, “it's hard to tell what impact the recession will have” on the growth of clinics, Mr. Phillips said in an interview.

According to the Kalorama report, the economic downturn could indeed propel people to retail clinics, but it's also possible that as Americans rein in spending, health expenditures also may see a reduction.

“Over the next few years, retail clinics may capture a portion of the business currently serviced by physicians,” the report said.

Some physicians have expressed concern that the retail clinics could supplant or interfere with the attempts to establish a health delivery model based on the patient-centered medical home.

Mr. Phillips disagreed. “We don't see ourselves as competition to the primary care medical home concept,” he said, adding that MinuteClinic's role “is different than, and can be supportive of, the medical home.”

Dr. Ejnes agreed that clinics can fit in with the medical home if lines of communication are kept open between the clinics and primary physicians.

ACP aims to ensure that the clinics adhere to principles it adopted for the sector.

For instance, there should be physician supervision and 24-hour coverage to answer questions that may arise, said Dr. Ejnes, who is also chairman of the ACP's medical service committee.

The American Academy of Family Physicians and the American Medical Association also adopted guidelines for retail clinics in 2006.

The American Academy of Pediatrics specifically stated its opposition to the retail clinic model in a policy statement (Pediatrics 2006;118:2561–2).

Recent market indicators also suggest that reliance on retail clinics may be seasonal in nature. In mid-March, MinuteClinic said that it would shutter 89 clinics until the next cough, cold, and flu season. Over time, it has become clear that the company “didn't need as many of the clinics as we had opened,” Mr. Phillips said. These locations could be taken off line for part of the year without reducing access in those markets.

Retail clinics are projected to increase at a healthy 20%–30% per year over the next 6 years, with sales rising from $548 million in 2008 to $2 billion in 2013, according to a market research report from New York-based Kalorama Information.

Dr. Yul Ejnes, a member of the American College of Physicians' Board of Regents, called the projected boom in retail clinics “just a symptom of a bigger problem,” and a sign of a dysfunctional health care system.

In an interview, he conceded that the retail clinic is a model that's here to stay. But if the medical home concept were “executed to its fullest, on the flip side, the need for retail clinics could diminish.”

Alternatively, retail clinic leaders, such as MinuteClinic President Chip Phillips, see the clinics as successfully filling a gap left by the dwindling number of primary care physicians.

MinuteClinic, the Minneapolis-based subsidiary of CVS Caremark Corp., now claims more than 560 locations in 25 states.

Typically, the clinics offer a menu of services for common ailments such as allergies, bladder infections, pink eye, ear infections, and strep throat. Many also offer screening tests for cholesterol, hypertension, and diabetes. Vaccines are also a significant offering.

The prices for these services are publicly available, with most diagnostic and treatment services running at about $62. Services are provided by nurse practitioners, who are supervised by physicians on contract with MinuteClinic. The clinics are considered in-network providers with 60 insurers.

As of now, “it's hard to tell what impact the recession will have” on the growth of clinics, Mr. Phillips said in an interview.

According to the Kalorama report, the economic downturn could indeed propel people to retail clinics, but it's also possible that as Americans rein in spending, health expenditures also may see a reduction.

“Over the next few years, retail clinics may capture a portion of the business currently serviced by physicians,” the report said.

Some physicians have expressed concern that the retail clinics could supplant or interfere with the attempts to establish a health delivery model based on the patient-centered medical home.

Mr. Phillips disagreed. “We don't see ourselves as competition to the primary care medical home concept,” he said, adding that MinuteClinic's role “is different than, and can be supportive of, the medical home.”

Dr. Ejnes agreed that clinics can fit in with the medical home if lines of communication are kept open between the clinics and primary physicians.

ACP aims to ensure that the clinics adhere to principles it adopted for the sector.

For instance, there should be physician supervision and 24-hour coverage to answer questions that may arise, said Dr. Ejnes, who is also chairman of the ACP's medical service committee.

The American Academy of Family Physicians and the American Medical Association also adopted guidelines for retail clinics in 2006.

The American Academy of Pediatrics specifically stated its opposition to the retail clinic model in a policy statement (Pediatrics 2006;118:2561–2).

Recent market indicators also suggest that reliance on retail clinics may be seasonal in nature. In mid-March, MinuteClinic said that it would shutter 89 clinics until the next cough, cold, and flu season. Over time, it has become clear that the company “didn't need as many of the clinics as we had opened,” Mr. Phillips said. These locations could be taken off line for part of the year without reducing access in those markets.

WASHINGTON — Even as the economic downturn causes private health spending to slow, public sector health spending is rising, according to a federal analysis.

An estimated 3.4 million people may lose private health insurance coverage in 2009 and another 2.6 million may lose coverage in 2010, said Sean Keehan, an actuary at the Centers for Medicare and Medicaid Services' Office of the Actuary.

Total U.S. health care spending was an estimated $2.4 trillion in 2008, which is an increase of 6.1% over 2007, according to the annual projection of health spending trends published online in the journal Health Affairs. This year, spending is expected to grow by only 5.5%.

That rate of growth is expected to far outpace the nation's gross domestic product in 2009. Economists for the CMS said they predict the GDP to shrink by 0.2% this year.

Meanwhile, the health care share of GDP is expected to grow 1.4%—the biggest annual jump as a portion of GDP since economists first started tracking this indicator in 1960, said Christopher Truffer, a CMS actuary. Health spending will account for 17.6% of the GDP in 2009, according to the report (Health Affairs 2009 Feb. 24 [doi:10.1377/hlthaff.28.2.w346]).

The economists projected that overall health spending will rise by only 4.6% in 2010, thanks largely to the mandated 21% reduction in physician payments required under the Sustainable Growth Rate target set by Medicare.

However, since Congress usually eliminates the cuts or grants a fee increase every year, the CMS economists calculated some alternative scenarios. If payments were kept constant, Medicare spending would rise 6.4%, or 3.9% faster than if the cuts went into effect.

Medicaid spending will grow 9.6% in 2009, up from 6.9% in 2008. Private health insurance benefits spending grew an estimated 5.8% in 2008, but will rise only 4.1% in 2009.

The CMS projections make it seem like cost-containment efforts are having a negligible effect on restraining overall health spending. The economists said the Medicare fee cuts would make a difference, but that they did not have the data to calculate whether other cost-containment efforts in the private sector in particular were having any effect on restraining health spending.

WASHINGTON — Even as the economic downturn causes private health spending to slow, public sector health spending is rising, according to a federal analysis.

An estimated 3.4 million people may lose private health insurance coverage in 2009 and another 2.6 million may lose coverage in 2010, said Sean Keehan, an actuary at the Centers for Medicare and Medicaid Services' Office of the Actuary.

Total U.S. health care spending was an estimated $2.4 trillion in 2008, which is an increase of 6.1% over 2007, according to the annual projection of health spending trends published online in the journal Health Affairs. This year, spending is expected to grow by only 5.5%.

That rate of growth is expected to far outpace the nation's gross domestic product in 2009. Economists for the CMS said they predict the GDP to shrink by 0.2% this year.

Meanwhile, the health care share of GDP is expected to grow 1.4%—the biggest annual jump as a portion of GDP since economists first started tracking this indicator in 1960, said Christopher Truffer, a CMS actuary. Health spending will account for 17.6% of the GDP in 2009, according to the report (Health Affairs 2009 Feb. 24 [doi:10.1377/hlthaff.28.2.w346]).

The economists projected that overall health spending will rise by only 4.6% in 2010, thanks largely to the mandated 21% reduction in physician payments required under the Sustainable Growth Rate target set by Medicare.

However, since Congress usually eliminates the cuts or grants a fee increase every year, the CMS economists calculated some alternative scenarios. If payments were kept constant, Medicare spending would rise 6.4%, or 3.9% faster than if the cuts went into effect.

Medicaid spending will grow 9.6% in 2009, up from 6.9% in 2008. Private health insurance benefits spending grew an estimated 5.8% in 2008, but will rise only 4.1% in 2009.

The CMS projections make it seem like cost-containment efforts are having a negligible effect on restraining overall health spending. The economists said the Medicare fee cuts would make a difference, but that they did not have the data to calculate whether other cost-containment efforts in the private sector in particular were having any effect on restraining health spending.

WASHINGTON — Even as the economic downturn causes private health spending to slow, public sector health spending is rising, according to a federal analysis.

An estimated 3.4 million people may lose private health insurance coverage in 2009 and another 2.6 million may lose coverage in 2010, said Sean Keehan, an actuary at the Centers for Medicare and Medicaid Services' Office of the Actuary.

Total U.S. health care spending was an estimated $2.4 trillion in 2008, which is an increase of 6.1% over 2007, according to the annual projection of health spending trends published online in the journal Health Affairs. This year, spending is expected to grow by only 5.5%.

That rate of growth is expected to far outpace the nation's gross domestic product in 2009. Economists for the CMS said they predict the GDP to shrink by 0.2% this year.

Meanwhile, the health care share of GDP is expected to grow 1.4%—the biggest annual jump as a portion of GDP since economists first started tracking this indicator in 1960, said Christopher Truffer, a CMS actuary. Health spending will account for 17.6% of the GDP in 2009, according to the report (Health Affairs 2009 Feb. 24 [doi:10.1377/hlthaff.28.2.w346]).

The economists projected that overall health spending will rise by only 4.6% in 2010, thanks largely to the mandated 21% reduction in physician payments required under the Sustainable Growth Rate target set by Medicare.

However, since Congress usually eliminates the cuts or grants a fee increase every year, the CMS economists calculated some alternative scenarios. If payments were kept constant, Medicare spending would rise 6.4%, or 3.9% faster than if the cuts went into effect.

Medicaid spending will grow 9.6% in 2009, up from 6.9% in 2008. Private health insurance benefits spending grew an estimated 5.8% in 2008, but will rise only 4.1% in 2009.

The CMS projections make it seem like cost-containment efforts are having a negligible effect on restraining overall health spending. The economists said the Medicare fee cuts would make a difference, but that they did not have the data to calculate whether other cost-containment efforts in the private sector in particular were having any effect on restraining health spending.

WASHINGTON — Pharmaceutical companies are turning to social networking sites to reach their customers—both physicians and patients—since it has become increasingly difficult to market their products using traditional approaches.

At a meeting sponsored by a Washington-based public relations company, Waggener Edstrom Worldwide, staffs from drug companies and public relations companies brainstormed on the best ways to maximize opportunities presented by social-networking sites such as Facebook and Twitter without running afoul of federal regulations.

The Food and Drug Administration has not determined how social networking fits into its regulatory construct. Sanjay J. Koyani, director of FDA Web communications, said that the agency was using social networking tools to advance its own goals—for instance, with a Twitter page devoted to tweets (messages of 140 characters or fewer) about agency recalls—but that it is still working out how it would regulate messages presented by pharmaceutical companies.

Even so, the FDA tends to apply current regulations to digital communications, according to an analysis by Waggener Edstrom. Companies are required to present a fair balance between benefit and risk, and may not promote off-label uses.

Mark Gaydos, senior director of regulatory affairs at Sanofi-Aventis, is heading an informal task force of representatives from five drug makers seeking to create voluntary guidelines on the industry's use of social media.

The companies have had discussions with the FDA Division of Drug Marketing, Advertising, and Communications about their efforts, he said.

WASHINGTON — Pharmaceutical companies are turning to social networking sites to reach their customers—both physicians and patients—since it has become increasingly difficult to market their products using traditional approaches.

At a meeting sponsored by a Washington-based public relations company, Waggener Edstrom Worldwide, staffs from drug companies and public relations companies brainstormed on the best ways to maximize opportunities presented by social-networking sites such as Facebook and Twitter without running afoul of federal regulations.

The Food and Drug Administration has not determined how social networking fits into its regulatory construct. Sanjay J. Koyani, director of FDA Web communications, said that the agency was using social networking tools to advance its own goals—for instance, with a Twitter page devoted to tweets (messages of 140 characters or fewer) about agency recalls—but that it is still working out how it would regulate messages presented by pharmaceutical companies.

Even so, the FDA tends to apply current regulations to digital communications, according to an analysis by Waggener Edstrom. Companies are required to present a fair balance between benefit and risk, and may not promote off-label uses.

Mark Gaydos, senior director of regulatory affairs at Sanofi-Aventis, is heading an informal task force of representatives from five drug makers seeking to create voluntary guidelines on the industry's use of social media.

The companies have had discussions with the FDA Division of Drug Marketing, Advertising, and Communications about their efforts, he said.

WASHINGTON — Pharmaceutical companies are turning to social networking sites to reach their customers—both physicians and patients—since it has become increasingly difficult to market their products using traditional approaches.

At a meeting sponsored by a Washington-based public relations company, Waggener Edstrom Worldwide, staffs from drug companies and public relations companies brainstormed on the best ways to maximize opportunities presented by social-networking sites such as Facebook and Twitter without running afoul of federal regulations.

The Food and Drug Administration has not determined how social networking fits into its regulatory construct. Sanjay J. Koyani, director of FDA Web communications, said that the agency was using social networking tools to advance its own goals—for instance, with a Twitter page devoted to tweets (messages of 140 characters or fewer) about agency recalls—but that it is still working out how it would regulate messages presented by pharmaceutical companies.

Even so, the FDA tends to apply current regulations to digital communications, according to an analysis by Waggener Edstrom. Companies are required to present a fair balance between benefit and risk, and may not promote off-label uses.

Mark Gaydos, senior director of regulatory affairs at Sanofi-Aventis, is heading an informal task force of representatives from five drug makers seeking to create voluntary guidelines on the industry's use of social media.

The companies have had discussions with the FDA Division of Drug Marketing, Advertising, and Communications about their efforts, he said.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services (CMS) began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period. The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint. That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services (CMS) began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period. The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint. That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

If President Obama sways Congress with his plans for health reform, hospitals and health providers would receive a bundled payment for care provided in the hospital and during the first 30 days after discharge.

The proposal was submitted as part of the president's budget “blueprint” in late February. A full budget plan is expected to be released some time this month. It's a long way from there to the proposal's becoming law; in some cases, proposals will require congressional action, while in others, they will be accomplished through federal rule making.

Even so, this is not the first time that bundling has been mentioned as a cost-saving mechanism for federal health programs.

The Medicare Payment Assessment Commission (MedPAC) backed bundled payment in its June 2008 report to Congress, and the Centers for Medicare and Medicaid Services (CMS) began a 3-year, five-hospital demonstration project of the concept in January.

Along with bundling payments, the Obama budget also proposed paying less to hospitals with high readmission rates during the 30-day postacute period. The combination of bundling pay and reducing payments should save “roughly $26 billion of wasted money over 10 years,” according to the budget blueprint. That money would be contributed to the $600 billion reserve fund dedicated to financing health reform.

There were few other details offered by the administration. But in December, the Congressional Budget Office analyzed a proposal to bundle payments and estimated that it would create $950 million in savings from 2010 to 2014.

In a note to clients after the blueprint release, experts at Washington Analysis Corp. who follow health policy said, “We expect Congress to consider this idea, especially since this concept has been put forward for several years by CMS, MedPAC and others.”

Washington Analysis said that it also expected to see a proposal to penalize hospitals for high readmission rates in the 2010 hospital payment rule.

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6-3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. Wyeth's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said he disagreed with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived as an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing that “this case illustrates that tragic facts make bad law. The court holds that a state tort jury, rather than the [FDA], is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

Pharmaceutical Research and Manufacturers of America was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said the organization was “extremely gratified” that the court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies.”

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6-3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. Wyeth's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said he disagreed with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived as an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing that “this case illustrates that tragic facts make bad law. The court holds that a state tort jury, rather than the [FDA], is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

Pharmaceutical Research and Manufacturers of America was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said the organization was “extremely gratified” that the court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies.”

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6-3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations.

Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. Wyeth's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said he disagreed with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived as an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing that “this case illustrates that tragic facts make bad law. The court holds that a state tort jury, rather than the [FDA], is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

Pharmaceutical Research and Manufacturers of America was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said the organization was “extremely gratified” that the court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies.”

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations. Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said that the organization was “extremely gratified” that the Court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.”

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations. Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said that the organization was “extremely gratified” that the Court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.”

In an eagerly anticipated opinion, the U.S. Supreme Court has upheld a lower court ruling that Food and Drug Administration approval does not give pharmaceutical companies immunity from product liability lawsuits.

The justices voted 6–3 to affirm the judgment of the Vermont Supreme Court that federal law did not preempt Diana Levine's claim of inadequate warning on the label of promethazine (Phenergan). Ms. Levine received the drug by intravenous push and subsequently lost her arm. She was awarded $6.7 million by a Vermont jury.

A majority of justices rejected the argument by Wyeth Pharmaceuticals Inc., maker of Phenergan, that it was impossible for the company to simultaneously comply with both federal and state laws and regulations. Wyeth could have unilaterally strengthened the label at any time without input or clearance from the FDA, wrote the justices, concurring with the lower court opinion. And, the company's argument that following the duty to warn under state law would have interfered with the FDA's power to preempt state law was “meritless,” according to the majority opinion.

Justice Clarence Thomas voted with the majority, agreeing that Wyeth could have changed its label and complied with both state and federal laws. But he said that he did not agree with the majority's more far-reaching conclusions about preemption, specifically a tendency to override state laws when they were perceived to be an impediment to enforcing federal statutes.

Justice Samuel Alito and Justice Antonin Scalia, joined by Chief Justice John Roberts, dissented, writing in their opinion that “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” That premise is not consistent with previous rulings, they wrote.

Indeed, just last year the U.S. Supreme Court ruled in Riegel v. Medtronic Inc. that FDA approval conferred special protection against product liability suits involving medical devices.

The Pharmaceutical Research and Manufacturers of America said that it was still reviewing the opinions in Wyeth v. Levine. “We continue to believe that the expert scientists and medical professionals at the FDA are in the best position to evaluate the voluminous information about a medicine's benefits and risks and to determine which safety information to include in the drug label,” PhRMA Senior Vice President Ken Johnson said in a statement.

Consumer advocacy group Public Citizen called the ruling a broad rebuff to the industry's attempt to duck tort damages. Brian Wolfman, director of Public Citizen Litigation Group, said that the organization was “extremely gratified” that the Court “upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.”