Alicia Ault

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

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 FDA 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. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

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 FDA 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. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

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 FDA 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. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement. “The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days. With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Votes to Reauthorize Prescription Drug User Fee Act

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to mark-up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of Senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement. “The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days. With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Votes to Reauthorize Prescription Drug User Fee Act

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to mark-up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of Senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement. “The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days. With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Votes to Reauthorize Prescription Drug User Fee Act

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

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 drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would 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 (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to mark-up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of Senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

A Department of Health and Human Services spokeswoman said that more than 600 people participated in the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. He noting that registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance).

Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, Dr. Rich said. In addition, input standards should be established to ensure that the data cover all patients, not just a random sample, and finally, registries should be subject to validation and an audit mechanism, he noted.

CMS also heard about the registries of the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance. The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

A Department of Health and Human Services spokeswoman said that more than 600 people participated in the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. He noting that registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance).

Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, Dr. Rich said. In addition, input standards should be established to ensure that the data cover all patients, not just a random sample, and finally, registries should be subject to validation and an audit mechanism, he noted.

CMS also heard about the registries of the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance. The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

A Department of Health and Human Services spokeswoman said that more than 600 people participated in the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. He noting that registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance).

Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, Dr. Rich said. In addition, input standards should be established to ensure that the data cover all patients, not just a random sample, and finally, registries should be subject to validation and an audit mechanism, he noted.

CMS also heard about the registries of the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance. The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI.

The Centers for Medicare and Medicaid Services has determined that it will not cover vagus nerve stimulation for treatment-resistant depression.

The therapy, marketed by Cyberonics Inc. of Houston, has been used successfully in epilepsy but has been more controversial as a depression treatment. The Food and Drug Administration approved vagus nerve stimulation (VNS) in 2005 for adjunctive long-term treatment of chronic or recurrent depression in patients aged 18 years or older who do not have an adequate response to four or more antidepressant therapies.

But the approval came over the objections of a large number of FDA scientists, according to a year-long investigation by the Senate Finance Committee. The committee's report, issued in March 2006, questioned whether VNS therapy met FDA's safety and effectiveness standards.

In May, CMS issued its final decision. The agency stated that, “there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression.”

Cyberonics has been struggling to gain wider coverage of its device by private health insurers. But, in a statement, the company said that so far, 300 payers have covered VNS for “more than 3,000 patients.”

The Centers for Medicare and Medicaid Services has determined that it will not cover vagus nerve stimulation for treatment-resistant depression.

The therapy, marketed by Cyberonics Inc. of Houston, has been used successfully in epilepsy but has been more controversial as a depression treatment. The Food and Drug Administration approved vagus nerve stimulation (VNS) in 2005 for adjunctive long-term treatment of chronic or recurrent depression in patients aged 18 years or older who do not have an adequate response to four or more antidepressant therapies.

But the approval came over the objections of a large number of FDA scientists, according to a year-long investigation by the Senate Finance Committee. The committee's report, issued in March 2006, questioned whether VNS therapy met FDA's safety and effectiveness standards.

In May, CMS issued its final decision. The agency stated that, “there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression.”

Cyberonics has been struggling to gain wider coverage of its device by private health insurers. But, in a statement, the company said that so far, 300 payers have covered VNS for “more than 3,000 patients.”

The Centers for Medicare and Medicaid Services has determined that it will not cover vagus nerve stimulation for treatment-resistant depression.

The therapy, marketed by Cyberonics Inc. of Houston, has been used successfully in epilepsy but has been more controversial as a depression treatment. The Food and Drug Administration approved vagus nerve stimulation (VNS) in 2005 for adjunctive long-term treatment of chronic or recurrent depression in patients aged 18 years or older who do not have an adequate response to four or more antidepressant therapies.

But the approval came over the objections of a large number of FDA scientists, according to a year-long investigation by the Senate Finance Committee. The committee's report, issued in March 2006, questioned whether VNS therapy met FDA's safety and effectiveness standards.

In May, CMS issued its final decision. The agency stated that, “there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression.”

Cyberonics has been struggling to gain wider coverage of its device by private health insurers. But, in a statement, the company said that so far, 300 payers have covered VNS for “more than 3,000 patients.”

BALTIMORE – Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008. Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go further, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

BALTIMORE – Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008. Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go further, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

BALTIMORE – Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008. Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go further, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

Bipolar Disorder More Common

A new survey indicates that as many as 4% of American adults might have bipolar disorder at some point in their lifetime, higher than the 1% prevalence found in previous surveys. Researchers from the National Institute of Mental Health queried about 9,282 people from 2001 to 2003 as part of the National Comorbidity Survey-Replication. Based on the survey, the authors reached lifetime estimates of 1% for bipolar I disorder 1.1% for bipolar II disorder and 2.4% for subthreshold bipolar disorder. Most patients with a lifetime history of bipolar disorder and lifetime treatment were under the care of psychiatrists; patients with subthreshold bipolar disorder were more likely to receive care from a general medical professional. In looking at the previous 12 months of medication therapy, the authors found that 45% of patients receiving psychiatric care got appropriate medications, compared with only 9% of those getting general medical care. The study appeared in the May issue of the Archives of General Psychiatry.

Drug Abuse Treatment Rare

Results of another government-sponsored survey in the same issue of the Archives finds that 8% of identified drug abusers and less than 40% of people diagnosed with drug dependence ever get treatment. The National Epidemiologic Survey on Alcohol and Related Conditions was conducted by the National Institute on Drug Abuse and the National Institute of Alcohol Abuse and Alcoholism. The researchers also found that 10% of Americans have trouble with drug use or abuse during their lifetimes, including 3% who become dependent at some point. Abuse and dependence were highest among men, Native Americans, people aged 18–44 years, unmarried individuals, and those in a lower socioeconomic stratum or who lived in the West. The data came from face-to-face interviews conducted from 2001 to 2002 with 43,000 adults.

Call to Share Student Mental Info

A new bill in the U.S. House of Representatives would allow schools and universities to share a student's mental health information with parents or guardians, but only if the student is considered a danger to himself or others. Rep. Tim Murphy (R-Pa.), a child psychologist and cochair of the Congressional Mental Health Caucus, sponsored the legislation (H.R. 2220). The bill would clarify the Family Educational Rights and Privacy Act of 1974, which currently inhibits schools from notifying parents when a student might pose a significant risk of suicide, homicide, or assault, according to Rep. Murphy. “We want to remove the barrier that prevents schools from contacting parents to get them the help they need, not only for the safety of their child, but also of others on campus,” he said in a statement. As of press time, the bill had 17 cosponsors and no Senate companion.

THC Levels Highest Ever

With a warning that “this isn't your father's marijuana,” John Walters, the director of the White House Office of National Drug Control Policy, issued a report this spring showing that the levels of tetrahydrocannabinol (THC) in marijuana now available in this country are the highest ever recorded. The University of Mississippi Potency Monitoring Project found that the average THC level was 8.5%, compared with 4% reported in the early 1980s. Further, a larger proportion of pot has a potency of 9% or higher–a trend that has been increasing since the late 1990s, according to the Potency Monitoring Project. The project receives funding from the National Institute on Drug Abuse and has been analyzing seized marijuana samples since 1976. Mr. Walters said the report should serve “as a wake-up call for parents who may still hold outdated notions about the harms of marijuana.”

Improved Ped Paxil Settlement

Public Citizen said it has won greater compensation for parents of children who took the antidepressant Paxil but can't provide documentation of their purchase or related costs. In an earlier complaint (Hoormann, et al. v. SmithKline Beecham Corp.), the defendants alleged the company misled parents by not disclosing that the drug was dangerous and ineffective for children under age 18 years. Paxil maker GlaxoSmithKline was required to put $63.8 million into a fund to pay class members' out-of-pocket expenses and attorneys' fees, but members who could not provide proof of expenses were limited to a $15 payout and a pro rata share of $300,000, depending on the number of claimants. In a revised settlement approved by the Third Judicial Circuit of Madison County, Ill., claimants without documentation will now get up to $100, and the $300,000 pro rata cap is eliminated, Public Citizen said. “The revision significantly improves the value of the settlement, particularly to those class members who are unable to document their claim,” said Jennifer Soble, an attorney with Public Citizen, in a statement. Information on the settlement is at

www.paxilpediatricsettlement.com

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems now serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year. Leslie V. Norwalk is the current acting CMS administrator.

Bipolar Disorder More Common

A new survey indicates that as many as 4% of American adults might have bipolar disorder at some point in their lifetime, higher than the 1% prevalence found in previous surveys. Researchers from the National Institute of Mental Health queried about 9,282 people from 2001 to 2003 as part of the National Comorbidity Survey-Replication. Based on the survey, the authors reached lifetime estimates of 1% for bipolar I disorder 1.1% for bipolar II disorder and 2.4% for subthreshold bipolar disorder. Most patients with a lifetime history of bipolar disorder and lifetime treatment were under the care of psychiatrists; patients with subthreshold bipolar disorder were more likely to receive care from a general medical professional. In looking at the previous 12 months of medication therapy, the authors found that 45% of patients receiving psychiatric care got appropriate medications, compared with only 9% of those getting general medical care. The study appeared in the May issue of the Archives of General Psychiatry.

Drug Abuse Treatment Rare

Results of another government-sponsored survey in the same issue of the Archives finds that 8% of identified drug abusers and less than 40% of people diagnosed with drug dependence ever get treatment. The National Epidemiologic Survey on Alcohol and Related Conditions was conducted by the National Institute on Drug Abuse and the National Institute of Alcohol Abuse and Alcoholism. The researchers also found that 10% of Americans have trouble with drug use or abuse during their lifetimes, including 3% who become dependent at some point. Abuse and dependence were highest among men, Native Americans, people aged 18–44 years, unmarried individuals, and those in a lower socioeconomic stratum or who lived in the West. The data came from face-to-face interviews conducted from 2001 to 2002 with 43,000 adults.

Call to Share Student Mental Info

A new bill in the U.S. House of Representatives would allow schools and universities to share a student's mental health information with parents or guardians, but only if the student is considered a danger to himself or others. Rep. Tim Murphy (R-Pa.), a child psychologist and cochair of the Congressional Mental Health Caucus, sponsored the legislation (H.R. 2220). The bill would clarify the Family Educational Rights and Privacy Act of 1974, which currently inhibits schools from notifying parents when a student might pose a significant risk of suicide, homicide, or assault, according to Rep. Murphy. “We want to remove the barrier that prevents schools from contacting parents to get them the help they need, not only for the safety of their child, but also of others on campus,” he said in a statement. As of press time, the bill had 17 cosponsors and no Senate companion.

THC Levels Highest Ever

With a warning that “this isn't your father's marijuana,” John Walters, the director of the White House Office of National Drug Control Policy, issued a report this spring showing that the levels of tetrahydrocannabinol (THC) in marijuana now available in this country are the highest ever recorded. The University of Mississippi Potency Monitoring Project found that the average THC level was 8.5%, compared with 4% reported in the early 1980s. Further, a larger proportion of pot has a potency of 9% or higher–a trend that has been increasing since the late 1990s, according to the Potency Monitoring Project. The project receives funding from the National Institute on Drug Abuse and has been analyzing seized marijuana samples since 1976. Mr. Walters said the report should serve “as a wake-up call for parents who may still hold outdated notions about the harms of marijuana.”

Improved Ped Paxil Settlement

Public Citizen said it has won greater compensation for parents of children who took the antidepressant Paxil but can't provide documentation of their purchase or related costs. In an earlier complaint (Hoormann, et al. v. SmithKline Beecham Corp.), the defendants alleged the company misled parents by not disclosing that the drug was dangerous and ineffective for children under age 18 years. Paxil maker GlaxoSmithKline was required to put $63.8 million into a fund to pay class members' out-of-pocket expenses and attorneys' fees, but members who could not provide proof of expenses were limited to a $15 payout and a pro rata share of $300,000, depending on the number of claimants. In a revised settlement approved by the Third Judicial Circuit of Madison County, Ill., claimants without documentation will now get up to $100, and the $300,000 pro rata cap is eliminated, Public Citizen said. “The revision significantly improves the value of the settlement, particularly to those class members who are unable to document their claim,” said Jennifer Soble, an attorney with Public Citizen, in a statement. Information on the settlement is at

www.paxilpediatricsettlement.com

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems now serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year. Leslie V. Norwalk is the current acting CMS administrator.

Bipolar Disorder More Common

A new survey indicates that as many as 4% of American adults might have bipolar disorder at some point in their lifetime, higher than the 1% prevalence found in previous surveys. Researchers from the National Institute of Mental Health queried about 9,282 people from 2001 to 2003 as part of the National Comorbidity Survey-Replication. Based on the survey, the authors reached lifetime estimates of 1% for bipolar I disorder 1.1% for bipolar II disorder and 2.4% for subthreshold bipolar disorder. Most patients with a lifetime history of bipolar disorder and lifetime treatment were under the care of psychiatrists; patients with subthreshold bipolar disorder were more likely to receive care from a general medical professional. In looking at the previous 12 months of medication therapy, the authors found that 45% of patients receiving psychiatric care got appropriate medications, compared with only 9% of those getting general medical care. The study appeared in the May issue of the Archives of General Psychiatry.

Drug Abuse Treatment Rare

Results of another government-sponsored survey in the same issue of the Archives finds that 8% of identified drug abusers and less than 40% of people diagnosed with drug dependence ever get treatment. The National Epidemiologic Survey on Alcohol and Related Conditions was conducted by the National Institute on Drug Abuse and the National Institute of Alcohol Abuse and Alcoholism. The researchers also found that 10% of Americans have trouble with drug use or abuse during their lifetimes, including 3% who become dependent at some point. Abuse and dependence were highest among men, Native Americans, people aged 18–44 years, unmarried individuals, and those in a lower socioeconomic stratum or who lived in the West. The data came from face-to-face interviews conducted from 2001 to 2002 with 43,000 adults.

Call to Share Student Mental Info

A new bill in the U.S. House of Representatives would allow schools and universities to share a student's mental health information with parents or guardians, but only if the student is considered a danger to himself or others. Rep. Tim Murphy (R-Pa.), a child psychologist and cochair of the Congressional Mental Health Caucus, sponsored the legislation (H.R. 2220). The bill would clarify the Family Educational Rights and Privacy Act of 1974, which currently inhibits schools from notifying parents when a student might pose a significant risk of suicide, homicide, or assault, according to Rep. Murphy. “We want to remove the barrier that prevents schools from contacting parents to get them the help they need, not only for the safety of their child, but also of others on campus,” he said in a statement. As of press time, the bill had 17 cosponsors and no Senate companion.

THC Levels Highest Ever

With a warning that “this isn't your father's marijuana,” John Walters, the director of the White House Office of National Drug Control Policy, issued a report this spring showing that the levels of tetrahydrocannabinol (THC) in marijuana now available in this country are the highest ever recorded. The University of Mississippi Potency Monitoring Project found that the average THC level was 8.5%, compared with 4% reported in the early 1980s. Further, a larger proportion of pot has a potency of 9% or higher–a trend that has been increasing since the late 1990s, according to the Potency Monitoring Project. The project receives funding from the National Institute on Drug Abuse and has been analyzing seized marijuana samples since 1976. Mr. Walters said the report should serve “as a wake-up call for parents who may still hold outdated notions about the harms of marijuana.”

Improved Ped Paxil Settlement

Public Citizen said it has won greater compensation for parents of children who took the antidepressant Paxil but can't provide documentation of their purchase or related costs. In an earlier complaint (Hoormann, et al. v. SmithKline Beecham Corp.), the defendants alleged the company misled parents by not disclosing that the drug was dangerous and ineffective for children under age 18 years. Paxil maker GlaxoSmithKline was required to put $63.8 million into a fund to pay class members' out-of-pocket expenses and attorneys' fees, but members who could not provide proof of expenses were limited to a $15 payout and a pro rata share of $300,000, depending on the number of claimants. In a revised settlement approved by the Third Judicial Circuit of Madison County, Ill., claimants without documentation will now get up to $100, and the $300,000 pro rata cap is eliminated, Public Citizen said. “The revision significantly improves the value of the settlement, particularly to those class members who are unable to document their claim,” said Jennifer Soble, an attorney with Public Citizen, in a statement. Information on the settlement is at

www.paxilpediatricsettlement.com

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems now serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year. Leslie V. Norwalk is the current acting CMS administrator.