Mary Ellen Schneider

Majority of TBIs Are Pediatric

Children and teens ages 5–18 years account for more than half of the 207,830 traumatic brain injuries related to sports or recreation that are treated in U.S. emergency departments each year, according to the Centers for Disease Control and Prevention. This population is at increased risk for concussion during sports and recreational activities, as well as long-term sequelae, delayed recovery, and cumulative consequences of multiple traumatic brain injuries, CDC researchers wrote in the July 27 issue of the Morbidity and Mortality Weekly Report. The activities associated with the greatest number of visits to the ED for traumatic brain injuries in this population included bicycling, football, playground activities, basketball, and soccer. The results are based on data from the National Electronic Injury Surveillance System—All Injury Program from 2001–2005. More information on traumatic brain injury, including physician tool kits, is available online at

www.cdc.gov/ncipc/tbi/tbi.htm

New Stem Cell Legislation Introduced

Members of Congress recently introduced legislation aimed at increasing research into stem cells without the creation or destruction of human embryos for research purposes. The bill, the “Patients First Act of 2007” (H.R. 2807) was introduced by Rep. J. Randy Forbes (R-Va.) and Rep. Daniel Lipinski (D-Ill.). The legislation directs the Department of Health and Human Services to support basic and applied stem cell research that does not involve the creation of a human embryo for research purposes or the destruction or discarding of a living human embryo. It also calls on the HHS secretary to submit a report to Congress detailing the funding of stem cell research. The bill was referred to the House Committee on Energy and Commerce

APhA Urges Delay in Rx Rule

The American Pharmacists Association and three lawmakers have urged CMS to delay implementation of a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1. Although many states have similar requirements, it will take much longer than 3 months to roll out such a program across the country, said APhA executive vice president and CEO John Gans in a statement. The three lawmakers—Rep. Charlie Wilson (D-Ohio), Rep. Marion Berry (D-Ark.), and Rep. Mike Ross (D-Ark.)—say that most physicians do not currently use this type of pads, nor are supplies readily available. “The tamperproof pad law was designed to prevent Medicaid fraud,” the legislators said in a statement. “However, the timeline for implementation could result in patients being turned away from their pharmacies as of Oct. 1, 2007, if doctors fail to write prescriptions on 'tamper-resistant' paper.” The congressmen have introduced a bill that would require only prescriptions for Class II narcotics to be written on the tamperproof prescription pads.

E-Prescribing Called 'Win-Win'

Electronic prescribing could prevent nearly 2 million medication errors and save the federal government $26 billion over the next decade—even after providing funds for equipment, training, and support—if physicians were required to use the technology for their Medicare patients, according to a study released by the Pharmaceutical Care Management Association. The study found that when physicians use e-prescribing to learn their patients' medication history and prescription choices, both patient safety and savings improve dramatically. However, fewer than 1 in 10 physicians actually use e-prescribing, according to PCMA. The group, which represents pharmacy benefit managers, is pushing the Centers for Medicare and Medicaid Services to require e-prescribing for all Medicare Part D prescriptions by 2010.

Most Substance Abusers Work

A new survey by the Substance Abuse and Mental Health Services Administration shows that most of the nation's 16.4 million illicit drug users and 15 million heavy alcohol users are employed full time. The report, available at SAMHSA's Web site, is compiled from the 2002, 2003, and 2004 National Surveys on Drug Use and Health. The data are somewhat misleading because full-time workers account for two-thirds of the survey population, according to SAMHSA. Illicit drug use was highest, at 19%, among the cohort aged 18–25 years, compared with 10% for those aged 26–34 years, 7% for those aged 35–49 years, and 3% for those aged 50–64 years. The highest rates of current use were among food service workers (17%) and construction workers (15%). Alcohol use was highest among construction, mining, excavation, and drilling workers (18%), and installation, maintenance, and repair workers (15%).

Majority of TBIs Are Pediatric

Children and teens ages 5–18 years account for more than half of the 207,830 traumatic brain injuries related to sports or recreation that are treated in U.S. emergency departments each year, according to the Centers for Disease Control and Prevention. This population is at increased risk for concussion during sports and recreational activities, as well as long-term sequelae, delayed recovery, and cumulative consequences of multiple traumatic brain injuries, CDC researchers wrote in the July 27 issue of the Morbidity and Mortality Weekly Report. The activities associated with the greatest number of visits to the ED for traumatic brain injuries in this population included bicycling, football, playground activities, basketball, and soccer. The results are based on data from the National Electronic Injury Surveillance System—All Injury Program from 2001–2005. More information on traumatic brain injury, including physician tool kits, is available online at

www.cdc.gov/ncipc/tbi/tbi.htm

New Stem Cell Legislation Introduced

Members of Congress recently introduced legislation aimed at increasing research into stem cells without the creation or destruction of human embryos for research purposes. The bill, the “Patients First Act of 2007” (H.R. 2807) was introduced by Rep. J. Randy Forbes (R-Va.) and Rep. Daniel Lipinski (D-Ill.). The legislation directs the Department of Health and Human Services to support basic and applied stem cell research that does not involve the creation of a human embryo for research purposes or the destruction or discarding of a living human embryo. It also calls on the HHS secretary to submit a report to Congress detailing the funding of stem cell research. The bill was referred to the House Committee on Energy and Commerce

APhA Urges Delay in Rx Rule

The American Pharmacists Association and three lawmakers have urged CMS to delay implementation of a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1. Although many states have similar requirements, it will take much longer than 3 months to roll out such a program across the country, said APhA executive vice president and CEO John Gans in a statement. The three lawmakers—Rep. Charlie Wilson (D-Ohio), Rep. Marion Berry (D-Ark.), and Rep. Mike Ross (D-Ark.)—say that most physicians do not currently use this type of pads, nor are supplies readily available. “The tamperproof pad law was designed to prevent Medicaid fraud,” the legislators said in a statement. “However, the timeline for implementation could result in patients being turned away from their pharmacies as of Oct. 1, 2007, if doctors fail to write prescriptions on 'tamper-resistant' paper.” The congressmen have introduced a bill that would require only prescriptions for Class II narcotics to be written on the tamperproof prescription pads.

E-Prescribing Called 'Win-Win'

Electronic prescribing could prevent nearly 2 million medication errors and save the federal government $26 billion over the next decade—even after providing funds for equipment, training, and support—if physicians were required to use the technology for their Medicare patients, according to a study released by the Pharmaceutical Care Management Association. The study found that when physicians use e-prescribing to learn their patients' medication history and prescription choices, both patient safety and savings improve dramatically. However, fewer than 1 in 10 physicians actually use e-prescribing, according to PCMA. The group, which represents pharmacy benefit managers, is pushing the Centers for Medicare and Medicaid Services to require e-prescribing for all Medicare Part D prescriptions by 2010.

Most Substance Abusers Work

A new survey by the Substance Abuse and Mental Health Services Administration shows that most of the nation's 16.4 million illicit drug users and 15 million heavy alcohol users are employed full time. The report, available at SAMHSA's Web site, is compiled from the 2002, 2003, and 2004 National Surveys on Drug Use and Health. The data are somewhat misleading because full-time workers account for two-thirds of the survey population, according to SAMHSA. Illicit drug use was highest, at 19%, among the cohort aged 18–25 years, compared with 10% for those aged 26–34 years, 7% for those aged 35–49 years, and 3% for those aged 50–64 years. The highest rates of current use were among food service workers (17%) and construction workers (15%). Alcohol use was highest among construction, mining, excavation, and drilling workers (18%), and installation, maintenance, and repair workers (15%).

Majority of TBIs Are Pediatric

Children and teens ages 5–18 years account for more than half of the 207,830 traumatic brain injuries related to sports or recreation that are treated in U.S. emergency departments each year, according to the Centers for Disease Control and Prevention. This population is at increased risk for concussion during sports and recreational activities, as well as long-term sequelae, delayed recovery, and cumulative consequences of multiple traumatic brain injuries, CDC researchers wrote in the July 27 issue of the Morbidity and Mortality Weekly Report. The activities associated with the greatest number of visits to the ED for traumatic brain injuries in this population included bicycling, football, playground activities, basketball, and soccer. The results are based on data from the National Electronic Injury Surveillance System—All Injury Program from 2001–2005. More information on traumatic brain injury, including physician tool kits, is available online at

www.cdc.gov/ncipc/tbi/tbi.htm

New Stem Cell Legislation Introduced

Members of Congress recently introduced legislation aimed at increasing research into stem cells without the creation or destruction of human embryos for research purposes. The bill, the “Patients First Act of 2007” (H.R. 2807) was introduced by Rep. J. Randy Forbes (R-Va.) and Rep. Daniel Lipinski (D-Ill.). The legislation directs the Department of Health and Human Services to support basic and applied stem cell research that does not involve the creation of a human embryo for research purposes or the destruction or discarding of a living human embryo. It also calls on the HHS secretary to submit a report to Congress detailing the funding of stem cell research. The bill was referred to the House Committee on Energy and Commerce

APhA Urges Delay in Rx Rule

The American Pharmacists Association and three lawmakers have urged CMS to delay implementation of a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1. Although many states have similar requirements, it will take much longer than 3 months to roll out such a program across the country, said APhA executive vice president and CEO John Gans in a statement. The three lawmakers—Rep. Charlie Wilson (D-Ohio), Rep. Marion Berry (D-Ark.), and Rep. Mike Ross (D-Ark.)—say that most physicians do not currently use this type of pads, nor are supplies readily available. “The tamperproof pad law was designed to prevent Medicaid fraud,” the legislators said in a statement. “However, the timeline for implementation could result in patients being turned away from their pharmacies as of Oct. 1, 2007, if doctors fail to write prescriptions on 'tamper-resistant' paper.” The congressmen have introduced a bill that would require only prescriptions for Class II narcotics to be written on the tamperproof prescription pads.

E-Prescribing Called 'Win-Win'

Electronic prescribing could prevent nearly 2 million medication errors and save the federal government $26 billion over the next decade—even after providing funds for equipment, training, and support—if physicians were required to use the technology for their Medicare patients, according to a study released by the Pharmaceutical Care Management Association. The study found that when physicians use e-prescribing to learn their patients' medication history and prescription choices, both patient safety and savings improve dramatically. However, fewer than 1 in 10 physicians actually use e-prescribing, according to PCMA. The group, which represents pharmacy benefit managers, is pushing the Centers for Medicare and Medicaid Services to require e-prescribing for all Medicare Part D prescriptions by 2010.

Most Substance Abusers Work

A new survey by the Substance Abuse and Mental Health Services Administration shows that most of the nation's 16.4 million illicit drug users and 15 million heavy alcohol users are employed full time. The report, available at SAMHSA's Web site, is compiled from the 2002, 2003, and 2004 National Surveys on Drug Use and Health. The data are somewhat misleading because full-time workers account for two-thirds of the survey population, according to SAMHSA. Illicit drug use was highest, at 19%, among the cohort aged 18–25 years, compared with 10% for those aged 26–34 years, 7% for those aged 35–49 years, and 3% for those aged 50–64 years. The highest rates of current use were among food service workers (17%) and construction workers (15%). Alcohol use was highest among construction, mining, excavation, and drilling workers (18%), and installation, maintenance, and repair workers (15%).

SAN DIEGO — In the second year of Medicare Part D, physicians still struggle with prior authorization requests and other hassles, Dr. Kay M. Mitchell said at the annual meeting of the American College of Physicians.

For example, physicians still see requests for prior authorization and step therapy, said Neil M. Kirschner, Ph.D., ACP's senior associate of insurer and regulatory affairs. In addition, in 2007, several drugs were approved under both Medicare Part B and Part D, which could create denials, he said.

Officials at the Centers for Medicare and Medicaid Services recommend that physicians write the diagnosis and “Part D” on the prescription, Dr. Kirschner said.

Physicians might experience some relief in terms of prior authorization and exceptions if their patients haven't changed drug plans, said Dr. Mitchell, a geriatrician and a professor in the department of community internal medicine at the Mayo Clinic in Jacksonville, Fla. CMS officials said prior authorizations and exceptions approved by a drug plan in 2006 are expected to continue this year if the beneficiary is in the same plan and the expiration date hasn't occurred by Dec. 31, 2006. However, if the beneficiary changes plans, physicians might have to go through the same process again. And even if patients remain in the same plan, some physicians have still received prior authorization requests, she said. When faced with prior authorization, have the patient collect the authorization forms and bring them into the office, said Dr. Mitchell.

Some physicians have decided to deal with the extra Part D paperwork by hiring additional staff or designating staff to deal solely with Part D prior authorizations, denials, and appeals, Dr. Mitchell said. Dr. Mitchell prefers to have one of her nurses work on Part D issues because the nurse is already familiar with the patients and their medications. She also recommended staff members working on Part D issues attend continuing medical education meetings that focus on Part D.

Dr. Mitchell said that insurers may ask for documentation justifying a switch in medications. To simplify that process, she recommends, keep a sheet in the front of the chart with information on medication changes and the reasons for the switch.

SAN DIEGO — In the second year of Medicare Part D, physicians still struggle with prior authorization requests and other hassles, Dr. Kay M. Mitchell said at the annual meeting of the American College of Physicians.

For example, physicians still see requests for prior authorization and step therapy, said Neil M. Kirschner, Ph.D., ACP's senior associate of insurer and regulatory affairs. In addition, in 2007, several drugs were approved under both Medicare Part B and Part D, which could create denials, he said.

Officials at the Centers for Medicare and Medicaid Services recommend that physicians write the diagnosis and “Part D” on the prescription, Dr. Kirschner said.

Physicians might experience some relief in terms of prior authorization and exceptions if their patients haven't changed drug plans, said Dr. Mitchell, a geriatrician and a professor in the department of community internal medicine at the Mayo Clinic in Jacksonville, Fla. CMS officials said prior authorizations and exceptions approved by a drug plan in 2006 are expected to continue this year if the beneficiary is in the same plan and the expiration date hasn't occurred by Dec. 31, 2006. However, if the beneficiary changes plans, physicians might have to go through the same process again. And even if patients remain in the same plan, some physicians have still received prior authorization requests, she said. When faced with prior authorization, have the patient collect the authorization forms and bring them into the office, said Dr. Mitchell.

Some physicians have decided to deal with the extra Part D paperwork by hiring additional staff or designating staff to deal solely with Part D prior authorizations, denials, and appeals, Dr. Mitchell said. Dr. Mitchell prefers to have one of her nurses work on Part D issues because the nurse is already familiar with the patients and their medications. She also recommended staff members working on Part D issues attend continuing medical education meetings that focus on Part D.

Dr. Mitchell said that insurers may ask for documentation justifying a switch in medications. To simplify that process, she recommends, keep a sheet in the front of the chart with information on medication changes and the reasons for the switch.

SAN DIEGO — In the second year of Medicare Part D, physicians still struggle with prior authorization requests and other hassles, Dr. Kay M. Mitchell said at the annual meeting of the American College of Physicians.

For example, physicians still see requests for prior authorization and step therapy, said Neil M. Kirschner, Ph.D., ACP's senior associate of insurer and regulatory affairs. In addition, in 2007, several drugs were approved under both Medicare Part B and Part D, which could create denials, he said.

Officials at the Centers for Medicare and Medicaid Services recommend that physicians write the diagnosis and “Part D” on the prescription, Dr. Kirschner said.

Physicians might experience some relief in terms of prior authorization and exceptions if their patients haven't changed drug plans, said Dr. Mitchell, a geriatrician and a professor in the department of community internal medicine at the Mayo Clinic in Jacksonville, Fla. CMS officials said prior authorizations and exceptions approved by a drug plan in 2006 are expected to continue this year if the beneficiary is in the same plan and the expiration date hasn't occurred by Dec. 31, 2006. However, if the beneficiary changes plans, physicians might have to go through the same process again. And even if patients remain in the same plan, some physicians have still received prior authorization requests, she said. When faced with prior authorization, have the patient collect the authorization forms and bring them into the office, said Dr. Mitchell.

Some physicians have decided to deal with the extra Part D paperwork by hiring additional staff or designating staff to deal solely with Part D prior authorizations, denials, and appeals, Dr. Mitchell said. Dr. Mitchell prefers to have one of her nurses work on Part D issues because the nurse is already familiar with the patients and their medications. She also recommended staff members working on Part D issues attend continuing medical education meetings that focus on Part D.

Dr. Mitchell said that insurers may ask for documentation justifying a switch in medications. To simplify that process, she recommends, keep a sheet in the front of the chart with information on medication changes and the reasons for the switch.

Several Medicare Advantage fee-for-service plan sponsors will voluntarily suspend marketing their plans until officials at the Centers for Medicare and Medicaid Services can verify compliance with certain management controls.

The moratorium is part of an effort to halt deceptive marketing in the private fee-for-service Medicare market.

“While most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans. Many of those complaints related to private fee-for-service plans. Ms. Block pointed out the 2,700 complaints are a small fraction of the 1.3 million Medicare beneficiaries enrolled in such plans.

Problems range from agents encouraging the misperception that private plans are just like Medicare and are accepted by all providers who accept Medicare, to cases in which agents told beneficiaries they are still enrolled in Medicare and are purchasing a Medigap supplemental insurance policy.

The private fee-for-service Medicare plans that agreed to suspend marketing are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. They account for about 90% of enrollment in private fee-for-service plans, said the CMS.

The plans were not singled out because of problems with their marketing practices. The concern is with rogue brokers and agents with whom these and other organizations may contract, she said.

The moratorium does not apply to enrollment and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics. It will be lifted on a plan-by-plan basis when the CMS certifies a plan has management controls in place that meet conditions spelled out by the agency earlier this year. For example, plan sponsors must show all of their advertising, marketing, and enrollment materials and include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as Medicare or Medigap and not all providers will accept the plan. All representatives selling products will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans. Plans must also provide a list of individuals who are marketing the plan upon request by the CMS or state agencies.

The CMS will be monitoring all private fee-for-service plans to ensure that they are not engaging in deceptive marketing practices.

Several Medicare Advantage fee-for-service plan sponsors will voluntarily suspend marketing their plans until officials at the Centers for Medicare and Medicaid Services can verify compliance with certain management controls.

The moratorium is part of an effort to halt deceptive marketing in the private fee-for-service Medicare market.

“While most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans. Many of those complaints related to private fee-for-service plans. Ms. Block pointed out the 2,700 complaints are a small fraction of the 1.3 million Medicare beneficiaries enrolled in such plans.

Problems range from agents encouraging the misperception that private plans are just like Medicare and are accepted by all providers who accept Medicare, to cases in which agents told beneficiaries they are still enrolled in Medicare and are purchasing a Medigap supplemental insurance policy.

The private fee-for-service Medicare plans that agreed to suspend marketing are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. They account for about 90% of enrollment in private fee-for-service plans, said the CMS.

The plans were not singled out because of problems with their marketing practices. The concern is with rogue brokers and agents with whom these and other organizations may contract, she said.

The moratorium does not apply to enrollment and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics. It will be lifted on a plan-by-plan basis when the CMS certifies a plan has management controls in place that meet conditions spelled out by the agency earlier this year. For example, plan sponsors must show all of their advertising, marketing, and enrollment materials and include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as Medicare or Medigap and not all providers will accept the plan. All representatives selling products will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans. Plans must also provide a list of individuals who are marketing the plan upon request by the CMS or state agencies.

The CMS will be monitoring all private fee-for-service plans to ensure that they are not engaging in deceptive marketing practices.

Several Medicare Advantage fee-for-service plan sponsors will voluntarily suspend marketing their plans until officials at the Centers for Medicare and Medicaid Services can verify compliance with certain management controls.

The moratorium is part of an effort to halt deceptive marketing in the private fee-for-service Medicare market.

“While most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans. Many of those complaints related to private fee-for-service plans. Ms. Block pointed out the 2,700 complaints are a small fraction of the 1.3 million Medicare beneficiaries enrolled in such plans.

Problems range from agents encouraging the misperception that private plans are just like Medicare and are accepted by all providers who accept Medicare, to cases in which agents told beneficiaries they are still enrolled in Medicare and are purchasing a Medigap supplemental insurance policy.

The private fee-for-service Medicare plans that agreed to suspend marketing are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. They account for about 90% of enrollment in private fee-for-service plans, said the CMS.

The plans were not singled out because of problems with their marketing practices. The concern is with rogue brokers and agents with whom these and other organizations may contract, she said.

The moratorium does not apply to enrollment and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics. It will be lifted on a plan-by-plan basis when the CMS certifies a plan has management controls in place that meet conditions spelled out by the agency earlier this year. For example, plan sponsors must show all of their advertising, marketing, and enrollment materials and include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as Medicare or Medigap and not all providers will accept the plan. All representatives selling products will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans. Plans must also provide a list of individuals who are marketing the plan upon request by the CMS or state agencies.

The CMS will be monitoring all private fee-for-service plans to ensure that they are not engaging in deceptive marketing practices.

Bill Seeks Increased IVIG Pay

Legislation seeking to increase reimbursement for intravenous immunoglobulin (IVIG) has been introduced in the U.S. House of Representatives. Patient groups and IVIG manufacturers have said that Medicare's current coverage is so low that many physicians have stopped administering the therapy. A survey by the Immune Deficiency Foundation found that since January 2005, almost half of surveyed Medicare beneficiaries with primary immunodeficiency diseases had their treatments postponed by a physician, and 26% had serious health consequences because of the delays. The bill (H.R. 2914) would increase payment for IVIG and for ancillary services. It would also maintain the preadministration fee that physicians have been receiving and provide management fees for home IVIG infusion. H.R. 2914 was introduced by Rep. Kevin Brady (R-Tex.) and, as of press time, had 19 cosponsors, but no companion legislation in the Senate.

CMS Considers PET Coverage

Officials at the Centers for Medicare and Medicaid Services are considering whether to provide Medicare coverage for positron emission tomography (PET) for the diagnosis of chronic osteomyelitis, infections associated with hip arthroplasty, and fever of unknown origin. The agency opened its review of the issue at the end of June after receiving a national coverage decision request from Dr. Javad Parvizi, an orthopedic surgeon at Thomas Jefferson University, and Dr. Abass Alavi, a professor of radiology at the University of Pennsylvania, both in Philadelphia. A decision is expected in March. In a letter to CMS, Dr. Parvizi and Dr. Alavi argued that PET is more sensitive and specific for detecting infection and inflammation than are conventional imaging techniques. The combined use of PET and CT would allow physicians to determine the precise location of sites of infection and inflammation, they wrote. The request letter also included specific clinical criteria to limit overutilization.

Within Our Reach Grants

The American College of Rheumatology Research and Education Foundation recently awarded 15 grants to fund innovative research in rheumatology. The awards are the results of a new fundraising campaign that aims to raise $30 million to fund rheumatoid arthritis research that is not normally supported by the National Institutes of Health or other peer-reviewed funding sources. Since 2006, the “Within Our Reach” program has raised about $17.9 million from the pharmaceutical industry, biotech companies, physicians, and patients. The grants, which began in July, cover the areas of innovative basic research, translational research, and clinical practice. Each of the 15 recipients will be funded for 2 years at $200,000 per year. More information on the grant awards is available at

www.withinourreach.info

CMS Releases Medicaid Rule

CMS has unveiled a new method of setting limits on what the federal government will reimburse state Medicaid agencies for prescription drug payments. As part of the new regulation, states will be required to collect information from physicians about prescription drugs administered in their offices so that the state can collect any rebates offered by drug manufacturers on those products. The final rule will take effect Oct. 1. The regulation is expected to save states and the federal government $8.4 billion over the next 5 years. The change is in part a reaction to a series of reports showing that Medicaid payments to pharmacies for generic drugs were much higher than what pharmacies actually were paying for the drugs. Pharmacies, the reports showed, made the most profit on those generic drugs with the highest markup, creating an incentive to dispense those drugs.

Americans Buy Drugs Overseas

More than 5 million Americans adults, or more than 2% of the U.S. population, have recently purchased prescription drugs from another country, such as Canada or Mexico, according to a survey by the Pharmaceutical Research and Manufacturers of America. The vast majority of consumer importers said they were looking for the best price for medicines, but about half decided to buy their drugs in another country because they didn't have a physician's prescription for the drugs they wanted, the survey found. Importers were more likely to be younger than age 35 years, to be Hispanic, to live in a southern border state, and to spend more out-of-pocket money on prescription drugs than do nonimporters, PhRMA reported. Most of the drugs imported were to treat chronic ailments. PhRMA President and CEO Billy Tauzin said in a statement that importation increases a patient's risk of being exposed to “dangerous counterfeit medicines.”

HHS Expands Vaccine Capacity

The Department of Health and Human Services has awarded two contracts to expand the domestic influenza vaccine manufacturing capacity that could be used in the event of a potential influenza pandemic. The 5-year contracts were awarded to Sanofi Pasteur Inc. ($77.4 million) and MedImmune Inc. ($55.1 million). The contracts provide funding for the renovation of manufacturing facilities and for manufacturing operations for 2 years, with options for an additional 3 years of operations. Upon completion, these facilities will expand domestic pandemic vaccine manufacturing capacity by 16%, according to HHS. In addition, the facilities will expand vaccine availability for the national stockpile.

Bill Seeks Increased IVIG Pay

Legislation seeking to increase reimbursement for intravenous immunoglobulin (IVIG) has been introduced in the U.S. House of Representatives. Patient groups and IVIG manufacturers have said that Medicare's current coverage is so low that many physicians have stopped administering the therapy. A survey by the Immune Deficiency Foundation found that since January 2005, almost half of surveyed Medicare beneficiaries with primary immunodeficiency diseases had their treatments postponed by a physician, and 26% had serious health consequences because of the delays. The bill (H.R. 2914) would increase payment for IVIG and for ancillary services. It would also maintain the preadministration fee that physicians have been receiving and provide management fees for home IVIG infusion. H.R. 2914 was introduced by Rep. Kevin Brady (R-Tex.) and, as of press time, had 19 cosponsors, but no companion legislation in the Senate.

CMS Considers PET Coverage

Officials at the Centers for Medicare and Medicaid Services are considering whether to provide Medicare coverage for positron emission tomography (PET) for the diagnosis of chronic osteomyelitis, infections associated with hip arthroplasty, and fever of unknown origin. The agency opened its review of the issue at the end of June after receiving a national coverage decision request from Dr. Javad Parvizi, an orthopedic surgeon at Thomas Jefferson University, and Dr. Abass Alavi, a professor of radiology at the University of Pennsylvania, both in Philadelphia. A decision is expected in March. In a letter to CMS, Dr. Parvizi and Dr. Alavi argued that PET is more sensitive and specific for detecting infection and inflammation than are conventional imaging techniques. The combined use of PET and CT would allow physicians to determine the precise location of sites of infection and inflammation, they wrote. The request letter also included specific clinical criteria to limit overutilization.

Within Our Reach Grants

The American College of Rheumatology Research and Education Foundation recently awarded 15 grants to fund innovative research in rheumatology. The awards are the results of a new fundraising campaign that aims to raise $30 million to fund rheumatoid arthritis research that is not normally supported by the National Institutes of Health or other peer-reviewed funding sources. Since 2006, the “Within Our Reach” program has raised about $17.9 million from the pharmaceutical industry, biotech companies, physicians, and patients. The grants, which began in July, cover the areas of innovative basic research, translational research, and clinical practice. Each of the 15 recipients will be funded for 2 years at $200,000 per year. More information on the grant awards is available at

www.withinourreach.info

CMS Releases Medicaid Rule

CMS has unveiled a new method of setting limits on what the federal government will reimburse state Medicaid agencies for prescription drug payments. As part of the new regulation, states will be required to collect information from physicians about prescription drugs administered in their offices so that the state can collect any rebates offered by drug manufacturers on those products. The final rule will take effect Oct. 1. The regulation is expected to save states and the federal government $8.4 billion over the next 5 years. The change is in part a reaction to a series of reports showing that Medicaid payments to pharmacies for generic drugs were much higher than what pharmacies actually were paying for the drugs. Pharmacies, the reports showed, made the most profit on those generic drugs with the highest markup, creating an incentive to dispense those drugs.

Americans Buy Drugs Overseas

More than 5 million Americans adults, or more than 2% of the U.S. population, have recently purchased prescription drugs from another country, such as Canada or Mexico, according to a survey by the Pharmaceutical Research and Manufacturers of America. The vast majority of consumer importers said they were looking for the best price for medicines, but about half decided to buy their drugs in another country because they didn't have a physician's prescription for the drugs they wanted, the survey found. Importers were more likely to be younger than age 35 years, to be Hispanic, to live in a southern border state, and to spend more out-of-pocket money on prescription drugs than do nonimporters, PhRMA reported. Most of the drugs imported were to treat chronic ailments. PhRMA President and CEO Billy Tauzin said in a statement that importation increases a patient's risk of being exposed to “dangerous counterfeit medicines.”

HHS Expands Vaccine Capacity

The Department of Health and Human Services has awarded two contracts to expand the domestic influenza vaccine manufacturing capacity that could be used in the event of a potential influenza pandemic. The 5-year contracts were awarded to Sanofi Pasteur Inc. ($77.4 million) and MedImmune Inc. ($55.1 million). The contracts provide funding for the renovation of manufacturing facilities and for manufacturing operations for 2 years, with options for an additional 3 years of operations. Upon completion, these facilities will expand domestic pandemic vaccine manufacturing capacity by 16%, according to HHS. In addition, the facilities will expand vaccine availability for the national stockpile.

Bill Seeks Increased IVIG Pay

Legislation seeking to increase reimbursement for intravenous immunoglobulin (IVIG) has been introduced in the U.S. House of Representatives. Patient groups and IVIG manufacturers have said that Medicare's current coverage is so low that many physicians have stopped administering the therapy. A survey by the Immune Deficiency Foundation found that since January 2005, almost half of surveyed Medicare beneficiaries with primary immunodeficiency diseases had their treatments postponed by a physician, and 26% had serious health consequences because of the delays. The bill (H.R. 2914) would increase payment for IVIG and for ancillary services. It would also maintain the preadministration fee that physicians have been receiving and provide management fees for home IVIG infusion. H.R. 2914 was introduced by Rep. Kevin Brady (R-Tex.) and, as of press time, had 19 cosponsors, but no companion legislation in the Senate.

CMS Considers PET Coverage

Officials at the Centers for Medicare and Medicaid Services are considering whether to provide Medicare coverage for positron emission tomography (PET) for the diagnosis of chronic osteomyelitis, infections associated with hip arthroplasty, and fever of unknown origin. The agency opened its review of the issue at the end of June after receiving a national coverage decision request from Dr. Javad Parvizi, an orthopedic surgeon at Thomas Jefferson University, and Dr. Abass Alavi, a professor of radiology at the University of Pennsylvania, both in Philadelphia. A decision is expected in March. In a letter to CMS, Dr. Parvizi and Dr. Alavi argued that PET is more sensitive and specific for detecting infection and inflammation than are conventional imaging techniques. The combined use of PET and CT would allow physicians to determine the precise location of sites of infection and inflammation, they wrote. The request letter also included specific clinical criteria to limit overutilization.

Within Our Reach Grants

The American College of Rheumatology Research and Education Foundation recently awarded 15 grants to fund innovative research in rheumatology. The awards are the results of a new fundraising campaign that aims to raise $30 million to fund rheumatoid arthritis research that is not normally supported by the National Institutes of Health or other peer-reviewed funding sources. Since 2006, the “Within Our Reach” program has raised about $17.9 million from the pharmaceutical industry, biotech companies, physicians, and patients. The grants, which began in July, cover the areas of innovative basic research, translational research, and clinical practice. Each of the 15 recipients will be funded for 2 years at $200,000 per year. More information on the grant awards is available at

www.withinourreach.info

CMS Releases Medicaid Rule

CMS has unveiled a new method of setting limits on what the federal government will reimburse state Medicaid agencies for prescription drug payments. As part of the new regulation, states will be required to collect information from physicians about prescription drugs administered in their offices so that the state can collect any rebates offered by drug manufacturers on those products. The final rule will take effect Oct. 1. The regulation is expected to save states and the federal government $8.4 billion over the next 5 years. The change is in part a reaction to a series of reports showing that Medicaid payments to pharmacies for generic drugs were much higher than what pharmacies actually were paying for the drugs. Pharmacies, the reports showed, made the most profit on those generic drugs with the highest markup, creating an incentive to dispense those drugs.

Americans Buy Drugs Overseas

More than 5 million Americans adults, or more than 2% of the U.S. population, have recently purchased prescription drugs from another country, such as Canada or Mexico, according to a survey by the Pharmaceutical Research and Manufacturers of America. The vast majority of consumer importers said they were looking for the best price for medicines, but about half decided to buy their drugs in another country because they didn't have a physician's prescription for the drugs they wanted, the survey found. Importers were more likely to be younger than age 35 years, to be Hispanic, to live in a southern border state, and to spend more out-of-pocket money on prescription drugs than do nonimporters, PhRMA reported. Most of the drugs imported were to treat chronic ailments. PhRMA President and CEO Billy Tauzin said in a statement that importation increases a patient's risk of being exposed to “dangerous counterfeit medicines.”

HHS Expands Vaccine Capacity

The Department of Health and Human Services has awarded two contracts to expand the domestic influenza vaccine manufacturing capacity that could be used in the event of a potential influenza pandemic. The 5-year contracts were awarded to Sanofi Pasteur Inc. ($77.4 million) and MedImmune Inc. ($55.1 million). The contracts provide funding for the renovation of manufacturing facilities and for manufacturing operations for 2 years, with options for an additional 3 years of operations. Upon completion, these facilities will expand domestic pandemic vaccine manufacturing capacity by 16%, according to HHS. In addition, the facilities will expand vaccine availability for the national stockpile.

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases.

The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

“We are seeing substantial and verifiable improvements in the quality of care for patients and improved efficiency in the delivery of that care,” Mr. Kuhn said. The results show that Medicare is “on the right track” in terms of providing incentives for coordinating care, he said.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes.

If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings.

These performance payments are in addition to the regular fee-for-service Medicare payments received.

Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements.

In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

Findings from the first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

For example, St. John's Health System is using a Web-based patient registry aimed at helping physicians to plan patient visits.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases.

The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

“We are seeing substantial and verifiable improvements in the quality of care for patients and improved efficiency in the delivery of that care,” Mr. Kuhn said. The results show that Medicare is “on the right track” in terms of providing incentives for coordinating care, he said.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes.

If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings.

These performance payments are in addition to the regular fee-for-service Medicare payments received.

Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements.

In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

Findings from the first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

For example, St. John's Health System is using a Web-based patient registry aimed at helping physicians to plan patient visits.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases.

The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

“We are seeing substantial and verifiable improvements in the quality of care for patients and improved efficiency in the delivery of that care,” Mr. Kuhn said. The results show that Medicare is “on the right track” in terms of providing incentives for coordinating care, he said.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes.

If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings.

These performance payments are in addition to the regular fee-for-service Medicare payments received.

Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements.

In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

Findings from the first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

For example, St. John's Health System is using a Web-based patient registry aimed at helping physicians to plan patient visits.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

At the Spanish Catholic Center health clinics in the Washington area, patients can access one-stop shopping for their chronic medical care.

The health clinics have on-site laboratories and pharmacies so patients can come in for an exam, have blood work performed, and pick up their medicine in a single visit. This type of access, which is especially appealing for the clinic's mostly uninsured population, is one way that the organization strives to provide a “medical home” to its patients, said Dr. Anna Maria Izquierdo-Porrera, an internist who serves as medical director of the Spanish Catholic Center.

“A medical home improves the quality of service that you receive, and whether you're insured or not, there are ways that we can look at how we deliver care [in order] to improve,” Dr. Izquierdo-Porrera said during a press briefing sponsored by the Commonwealth Fund. “It needs to be in a place where the patient trusts you and will come back.”

This approach has been yielding positive results in diabetes control. Physicians at the Spanish Catholic Center have seen a drop in the number of diabetes patients with poor control (hemoglobin A_1c levels greater than 9%) and an increase in the number of patients with good control (HbA_1c levels less than 7%). From 2003 to 2005, the percentage of diabetes patients with poor control fell from 29.6% to 13.7%, and the percentage of those with good control rose from 29.6% to 46.3%, she said.

And now researchers are finding that having access to a medical home makes patients less likely to experience health disparities. In a report released in June, researchers at the Commonwealth Fund said that having a regular provider or place of care that is accessible after hours and is efficiently run can improve the quality of both preventive and chronic care.

The findings are based on a 2006 survey of 2,837 adults aged 18–64 years. The national sample was designed to target black, Hispanic, and Asian households, and specifically excluded adults aged 65 and older who are eligible to receive Medicare coverage.

The survey found that overall health disparities persist. However, according to the report, strategies such as providing patients with a medical home and increasing health insurance coverage can reduce or even eliminate disparities.

The researchers defined a medical home as a regular provider or source of care that is accessible both during the day and on evenings and weekends. The setting should also be well organized and efficiently run. Only 27% of the respondents reported having a place of care meeting that definition, Dr. Anne Beal, the lead study author and a pediatrician, said during the press briefing.

The uninsured are the least likely to have access to a medical home, the researchers found. About 16% of uninsured respondents receive their care through a medical home, whereas 45% do not have a regular source of care.

In analyzing the impact of the medical home, the researchers found that having a regular place of care really does matter. Nearly three-quarters of adults with a medical home report being able to get the care they need when they need it, compared with 52% of those with a regular provider that is not a medical home. Only 38% of adults without any regular source of care say they can get the care they need when they need it.

And when patients had a medical home, there were no disparities in access to care based on race, Dr. Beal said. Among patients who had a medical home, the same percentage of whites, blacks, and Hispanics—nearly 75%—reported that they always get care when they need it. In addition, about 65% of patients with a medical home, regardless of race, reported receiving reminders for preventive care visits.

“Whenever a patient said that they were in a medical home, we found that there were no disparities in the quality of care that they received,” Dr. Beal said.

The medical home is also important in terms of providing chronic care, the researchers said. The survey found that adults with a medical home were more likely to have a plan to manage their chronic health conditions at home, compared with those without a regular source of care. For example, among adults with hypertension, 42% of those with a medical home reported that they regularly check their blood pressure and that it is well controlled. In contrast, only 25% of individuals with a regular source of care that is not a medical home reported regularly checking their blood pressure and keeping it under control.

The Commonwealth Fund report calls on all providers to take steps to create medical homes for patients, especially among safety net providers.

ELSEVIER GLOBAL MEDICAL NEWS

In a medical home everyone has the same access to care, said Dr. Izquierdo-Porrera. John Troha/Redux Plus

At the Spanish Catholic Center health clinics in the Washington area, patients can access one-stop shopping for their chronic medical care.

The health clinics have on-site laboratories and pharmacies so patients can come in for an exam, have blood work performed, and pick up their medicine in a single visit. This type of access, which is especially appealing for the clinic's mostly uninsured population, is one way that the organization strives to provide a “medical home” to its patients, said Dr. Anna Maria Izquierdo-Porrera, an internist who serves as medical director of the Spanish Catholic Center.

“A medical home improves the quality of service that you receive, and whether you're insured or not, there are ways that we can look at how we deliver care [in order] to improve,” Dr. Izquierdo-Porrera said during a press briefing sponsored by the Commonwealth Fund. “It needs to be in a place where the patient trusts you and will come back.”

This approach has been yielding positive results in diabetes control. Physicians at the Spanish Catholic Center have seen a drop in the number of diabetes patients with poor control (hemoglobin A_1c levels greater than 9%) and an increase in the number of patients with good control (HbA_1c levels less than 7%). From 2003 to 2005, the percentage of diabetes patients with poor control fell from 29.6% to 13.7%, and the percentage of those with good control rose from 29.6% to 46.3%, she said.

And now researchers are finding that having access to a medical home makes patients less likely to experience health disparities. In a report released in June, researchers at the Commonwealth Fund said that having a regular provider or place of care that is accessible after hours and is efficiently run can improve the quality of both preventive and chronic care.

The findings are based on a 2006 survey of 2,837 adults aged 18–64 years. The national sample was designed to target black, Hispanic, and Asian households, and specifically excluded adults aged 65 and older who are eligible to receive Medicare coverage.

The survey found that overall health disparities persist. However, according to the report, strategies such as providing patients with a medical home and increasing health insurance coverage can reduce or even eliminate disparities.

The researchers defined a medical home as a regular provider or source of care that is accessible both during the day and on evenings and weekends. The setting should also be well organized and efficiently run. Only 27% of the respondents reported having a place of care meeting that definition, Dr. Anne Beal, the lead study author and a pediatrician, said during the press briefing.

The uninsured are the least likely to have access to a medical home, the researchers found. About 16% of uninsured respondents receive their care through a medical home, whereas 45% do not have a regular source of care.

In analyzing the impact of the medical home, the researchers found that having a regular place of care really does matter. Nearly three-quarters of adults with a medical home report being able to get the care they need when they need it, compared with 52% of those with a regular provider that is not a medical home. Only 38% of adults without any regular source of care say they can get the care they need when they need it.

And when patients had a medical home, there were no disparities in access to care based on race, Dr. Beal said. Among patients who had a medical home, the same percentage of whites, blacks, and Hispanics—nearly 75%—reported that they always get care when they need it. In addition, about 65% of patients with a medical home, regardless of race, reported receiving reminders for preventive care visits.

“Whenever a patient said that they were in a medical home, we found that there were no disparities in the quality of care that they received,” Dr. Beal said.

The medical home is also important in terms of providing chronic care, the researchers said. The survey found that adults with a medical home were more likely to have a plan to manage their chronic health conditions at home, compared with those without a regular source of care. For example, among adults with hypertension, 42% of those with a medical home reported that they regularly check their blood pressure and that it is well controlled. In contrast, only 25% of individuals with a regular source of care that is not a medical home reported regularly checking their blood pressure and keeping it under control.

The Commonwealth Fund report calls on all providers to take steps to create medical homes for patients, especially among safety net providers.

ELSEVIER GLOBAL MEDICAL NEWS

In a medical home everyone has the same access to care, said Dr. Izquierdo-Porrera. John Troha/Redux Plus

At the Spanish Catholic Center health clinics in the Washington area, patients can access one-stop shopping for their chronic medical care.

The health clinics have on-site laboratories and pharmacies so patients can come in for an exam, have blood work performed, and pick up their medicine in a single visit. This type of access, which is especially appealing for the clinic's mostly uninsured population, is one way that the organization strives to provide a “medical home” to its patients, said Dr. Anna Maria Izquierdo-Porrera, an internist who serves as medical director of the Spanish Catholic Center.

“A medical home improves the quality of service that you receive, and whether you're insured or not, there are ways that we can look at how we deliver care [in order] to improve,” Dr. Izquierdo-Porrera said during a press briefing sponsored by the Commonwealth Fund. “It needs to be in a place where the patient trusts you and will come back.”

This approach has been yielding positive results in diabetes control. Physicians at the Spanish Catholic Center have seen a drop in the number of diabetes patients with poor control (hemoglobin A_1c levels greater than 9%) and an increase in the number of patients with good control (HbA_1c levels less than 7%). From 2003 to 2005, the percentage of diabetes patients with poor control fell from 29.6% to 13.7%, and the percentage of those with good control rose from 29.6% to 46.3%, she said.

And now researchers are finding that having access to a medical home makes patients less likely to experience health disparities. In a report released in June, researchers at the Commonwealth Fund said that having a regular provider or place of care that is accessible after hours and is efficiently run can improve the quality of both preventive and chronic care.

The findings are based on a 2006 survey of 2,837 adults aged 18–64 years. The national sample was designed to target black, Hispanic, and Asian households, and specifically excluded adults aged 65 and older who are eligible to receive Medicare coverage.

The survey found that overall health disparities persist. However, according to the report, strategies such as providing patients with a medical home and increasing health insurance coverage can reduce or even eliminate disparities.

The researchers defined a medical home as a regular provider or source of care that is accessible both during the day and on evenings and weekends. The setting should also be well organized and efficiently run. Only 27% of the respondents reported having a place of care meeting that definition, Dr. Anne Beal, the lead study author and a pediatrician, said during the press briefing.

The uninsured are the least likely to have access to a medical home, the researchers found. About 16% of uninsured respondents receive their care through a medical home, whereas 45% do not have a regular source of care.

In analyzing the impact of the medical home, the researchers found that having a regular place of care really does matter. Nearly three-quarters of adults with a medical home report being able to get the care they need when they need it, compared with 52% of those with a regular provider that is not a medical home. Only 38% of adults without any regular source of care say they can get the care they need when they need it.

And when patients had a medical home, there were no disparities in access to care based on race, Dr. Beal said. Among patients who had a medical home, the same percentage of whites, blacks, and Hispanics—nearly 75%—reported that they always get care when they need it. In addition, about 65% of patients with a medical home, regardless of race, reported receiving reminders for preventive care visits.

“Whenever a patient said that they were in a medical home, we found that there were no disparities in the quality of care that they received,” Dr. Beal said.

The medical home is also important in terms of providing chronic care, the researchers said. The survey found that adults with a medical home were more likely to have a plan to manage their chronic health conditions at home, compared with those without a regular source of care. For example, among adults with hypertension, 42% of those with a medical home reported that they regularly check their blood pressure and that it is well controlled. In contrast, only 25% of individuals with a regular source of care that is not a medical home reported regularly checking their blood pressure and keeping it under control.

The Commonwealth Fund report calls on all providers to take steps to create medical homes for patients, especially among safety net providers.

ELSEVIER GLOBAL MEDICAL NEWS

In a medical home everyone has the same access to care, said Dr. Izquierdo-Porrera. John Troha/Redux Plus

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases. The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes. If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings. These performance payments are in addition to the regular fee-for-service Medicare payments received. Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements. In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

The first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases. The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes. If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings. These performance payments are in addition to the regular fee-for-service Medicare payments received. Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements. In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

The first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

Preliminary results of a demonstration project that allows physician groups to share in savings they earn for the Medicare program has also resulted in quality gains, according to the Centers for Medicare and Medicaid Services.

The Medicare Physician Group Practice Demonstration is a 3-year project that encourages group practices to improve coordination of care for patients with chronic diseases. The project offers the practices financial incentives that meet clinical targets and save the Medicare program money above a certain threshold. In the first year, 10 participating practices were assessed based on their performance on evidence-based diabetes measures.

In the first year (April 2005-March 2006), all participating practices improved their clinical management of diabetes and met targets on at least 7 of 10 measures; two practices improved on all 10 measures.

Measures for the first year included hemoglobin A_1c management and control, blood pressure management, lipid measurement, LDL cholesterol level, urine protein testing, eye exam, foot exam, influenza vaccination, and pneumonia vaccination.

In addition to improving care, the demonstration saved the Medicare program about $9.5 million, Herb Kuhn, CMS acting deputy administrator, said during a press conference to announce the first-year results.

The demonstration includes 10 large, multispecialty group practices with a total of about 224,000 Medicare beneficiaries. The 10 group practices are Dartmouth-Hitchcock Clinic, Bedford, N.H.; Deaconess Billings (Mont.) Clinic; the Everett (Wash.) Clinic; Geisinger Health System, Danville, Pa.; Middlesex Health System, Middletown, Conn.; Marshfield (Wisc.) Clinic; Forsyth Medical Group, Winston-Salem, N.C.; Park Nicollet Health Services, St. Louis Park, Minn.; St. John's Health System, Springfield, Mo.; and University of Michigan Faculty Group Practice, Ann Arbor.

The demonstration encourages physicians to coordinate Part A and Part B Medicare services, invest in new care management programs, and redesign care processes. If these investments save money for the Medicare program, the physician groups are able to share in a portion of the savings. These performance payments are in addition to the regular fee-for-service Medicare payments received. Physician groups may share up to 80% of the savings, which are distributed based on financial performance and achievement of benchmarks in care quality measures, Mr. Kuhn said.

To receive a performance payment, the practices' total Medicare spending growth rate must be more than 2 percentage points lower than a comparison population of Medicare beneficiaries in their local market area.

While all the practices met clinical targets for at least seven diabetes measures, only two practices received performance payments.

The Marshfield Clinic, and the University of Michigan Faculty Group Practice earned performance payments for quality and efficiency improvements. In total, the two groups earned $7.3 million in payments; however, the two practices that met benchmarks in every clinical area—St. John's Health System and the Forsyth Medical Group—did not receive payments.

While other participating practices did achieve lower Medicare spending growth rates than comparison populations in their local markets, their savings did not meet the 2% threshold to share in the Medicare savings, Mr. Kuhn said.

Part of the problem may be that not all practices were able to fully deploy their initiatives in the first year, Mr. Kuhn said. “I think, overall, it's trending in a very positive way.”

The first-year evaluation has revealed an emphasis among the practices on care coordination, chronic disease management, efforts to avoid unnecessary hospitalizations, proactive case management, timely follow-up after hospital stays, and the use of health information technology.

In the second and third years of the program, the group practices will be assessed on additional measures related to heart failure, coronary artery disease, hypertension, and cancer screening.

TORONTO – Higher free testosterone levels appear to be associated with metabolic dysfunction in women from the general population, according to a cross-sectional study of more than 1,600 women in the Framingham Heart Study Offspring Cohort.

Free testosterone was positively associated with body mass index (BMI), waist circumference, diabetes, metabolic syndrome, and systolic and diastolic blood pressure in a community-based sample of women. The findings raise questions about whether higher testosterone levels predispose women to increased cardiovascular risks, lead investigator Dr. Andrea Coviello of Boston University said at the annual meeting of the Endocrine Society.

Studies have shown that women with polycystic ovary syndrome (PCOS) are at a fourfold increased risk for developing diabetes and a twofold increased risk for developing metabolic syndrome. But there are many unanswered questions about the clinical consequences of androgen excess in women who have mild to moderate hyperandrogenism without accompanying PCOS, Dr. Coviello said.

Dr. Coviello and her colleagues measured circulating testosterone levels in 1,678 women from the Framingham Heart Study Offspring Cohort in an effort to find out if healthy women with higher testosterone levels face risks for metabolic problems. They assessed circulating testosterone levels using liquid chromatography tandem mass spectrometry, which has a sensitivity of about 2 ng/dL, and measured sex hormone-binding globulin (SHBG) through immuno-lourometric assay. They also evaluated the relationship between testosterone and metabolic dysfunction, particularly metabolic syndrome and diabetes.

The women in the sample ranged in age from 33 to 87 years, with a mean age of 61. Most of the group was postmenopausal, Dr. Coviello said. They had a mean SHBG of 92 nmol/L, a mean total testosterone of 30 ng/dL, and a mean free testosterone of 3 pg/mL.

The investigators found that free testosterone was positively correlated with BMI, waist circumference, both systolic and diastolic blood pressure, triglycerides, total cholesterol, LDL cholesterol, and fasting glucose. Free testosterone was inversely associated with HDL cholesterol.

In addition, diabetic women had higher free testosterone and lower SHBG levels than women without diabetes. SHBG was inversely correlated with most of the components of metabolic syndrome. For example, higher BMI and waist circumference was associated with lower SHBG. Higher blood pressure, higher total cholesterol, higher triglycerides, and higher LDL cholesterol were all associated with lower SHBG. Higher fasting glucose was associated with a lower SHBG.

For total testosterone, only HDL cholesterol and triglycerides were significantly correlated. HDL cholesterol was positively correlated with total testosterone, and triglycerides were negatively correlated.

There were a number of limitations. The sample included only Caucasian individuals, and there was no information on the timing of the blood draws in relation to menstrual cycle among the premenopausal women. In addition, the reproductive histories were not adequate to determine whether women in the sample had PCOS, Dr. Coviello said.

The study was funded by grants from the National Institutes of Health.

TORONTO – Higher free testosterone levels appear to be associated with metabolic dysfunction in women from the general population, according to a cross-sectional study of more than 1,600 women in the Framingham Heart Study Offspring Cohort.

Free testosterone was positively associated with body mass index (BMI), waist circumference, diabetes, metabolic syndrome, and systolic and diastolic blood pressure in a community-based sample of women. The findings raise questions about whether higher testosterone levels predispose women to increased cardiovascular risks, lead investigator Dr. Andrea Coviello of Boston University said at the annual meeting of the Endocrine Society.

Studies have shown that women with polycystic ovary syndrome (PCOS) are at a fourfold increased risk for developing diabetes and a twofold increased risk for developing metabolic syndrome. But there are many unanswered questions about the clinical consequences of androgen excess in women who have mild to moderate hyperandrogenism without accompanying PCOS, Dr. Coviello said.

Dr. Coviello and her colleagues measured circulating testosterone levels in 1,678 women from the Framingham Heart Study Offspring Cohort in an effort to find out if healthy women with higher testosterone levels face risks for metabolic problems. They assessed circulating testosterone levels using liquid chromatography tandem mass spectrometry, which has a sensitivity of about 2 ng/dL, and measured sex hormone-binding globulin (SHBG) through immuno-lourometric assay. They also evaluated the relationship between testosterone and metabolic dysfunction, particularly metabolic syndrome and diabetes.

The women in the sample ranged in age from 33 to 87 years, with a mean age of 61. Most of the group was postmenopausal, Dr. Coviello said. They had a mean SHBG of 92 nmol/L, a mean total testosterone of 30 ng/dL, and a mean free testosterone of 3 pg/mL.

The investigators found that free testosterone was positively correlated with BMI, waist circumference, both systolic and diastolic blood pressure, triglycerides, total cholesterol, LDL cholesterol, and fasting glucose. Free testosterone was inversely associated with HDL cholesterol.

In addition, diabetic women had higher free testosterone and lower SHBG levels than women without diabetes. SHBG was inversely correlated with most of the components of metabolic syndrome. For example, higher BMI and waist circumference was associated with lower SHBG. Higher blood pressure, higher total cholesterol, higher triglycerides, and higher LDL cholesterol were all associated with lower SHBG. Higher fasting glucose was associated with a lower SHBG.

For total testosterone, only HDL cholesterol and triglycerides were significantly correlated. HDL cholesterol was positively correlated with total testosterone, and triglycerides were negatively correlated.

There were a number of limitations. The sample included only Caucasian individuals, and there was no information on the timing of the blood draws in relation to menstrual cycle among the premenopausal women. In addition, the reproductive histories were not adequate to determine whether women in the sample had PCOS, Dr. Coviello said.

The study was funded by grants from the National Institutes of Health.

TORONTO – Higher free testosterone levels appear to be associated with metabolic dysfunction in women from the general population, according to a cross-sectional study of more than 1,600 women in the Framingham Heart Study Offspring Cohort.

Free testosterone was positively associated with body mass index (BMI), waist circumference, diabetes, metabolic syndrome, and systolic and diastolic blood pressure in a community-based sample of women. The findings raise questions about whether higher testosterone levels predispose women to increased cardiovascular risks, lead investigator Dr. Andrea Coviello of Boston University said at the annual meeting of the Endocrine Society.

Studies have shown that women with polycystic ovary syndrome (PCOS) are at a fourfold increased risk for developing diabetes and a twofold increased risk for developing metabolic syndrome. But there are many unanswered questions about the clinical consequences of androgen excess in women who have mild to moderate hyperandrogenism without accompanying PCOS, Dr. Coviello said.

Dr. Coviello and her colleagues measured circulating testosterone levels in 1,678 women from the Framingham Heart Study Offspring Cohort in an effort to find out if healthy women with higher testosterone levels face risks for metabolic problems. They assessed circulating testosterone levels using liquid chromatography tandem mass spectrometry, which has a sensitivity of about 2 ng/dL, and measured sex hormone-binding globulin (SHBG) through immuno-lourometric assay. They also evaluated the relationship between testosterone and metabolic dysfunction, particularly metabolic syndrome and diabetes.

The women in the sample ranged in age from 33 to 87 years, with a mean age of 61. Most of the group was postmenopausal, Dr. Coviello said. They had a mean SHBG of 92 nmol/L, a mean total testosterone of 30 ng/dL, and a mean free testosterone of 3 pg/mL.

The investigators found that free testosterone was positively correlated with BMI, waist circumference, both systolic and diastolic blood pressure, triglycerides, total cholesterol, LDL cholesterol, and fasting glucose. Free testosterone was inversely associated with HDL cholesterol.

In addition, diabetic women had higher free testosterone and lower SHBG levels than women without diabetes. SHBG was inversely correlated with most of the components of metabolic syndrome. For example, higher BMI and waist circumference was associated with lower SHBG. Higher blood pressure, higher total cholesterol, higher triglycerides, and higher LDL cholesterol were all associated with lower SHBG. Higher fasting glucose was associated with a lower SHBG.

For total testosterone, only HDL cholesterol and triglycerides were significantly correlated. HDL cholesterol was positively correlated with total testosterone, and triglycerides were negatively correlated.

There were a number of limitations. The sample included only Caucasian individuals, and there was no information on the timing of the blood draws in relation to menstrual cycle among the premenopausal women. In addition, the reproductive histories were not adequate to determine whether women in the sample had PCOS, Dr. Coviello said.

The study was funded by grants from the National Institutes of Health.

TORONTO – Offering training to community-based physicians on how to conduct clinical trials is one of many steps the federal government can take to increase minority participation in research, according to recommendations unveiled by the Endocrine Society at its annual meeting.

“Recruitment is very difficult and no matter how much work people do in the community, in the end people go to their doctors and they take the advice of their doctors,” said Dr. Maria Alexander-Bridges, who is head of the Endocrine Society task force that developed the recommendations.

“So we wanted to work primarily on training minority physicians to do research in clinical trials so as to change the face of this process.”

The task force's effort, which began last year, was funded by a grant from the Robert Wood Johnson Foundation's Program on Disparities in Health Care.

One of the first steps recommended by the Endocrine Society was to convene a summit that would include pharmaceutical companies, academia, federal agencies, HMOs, community health networks, and community leaders, said Dr. Alexander-Bridges, who is also at Harvard Medical School, Boston.

The summit would address lingering questions that are critical to improving minority patient recruitment. For example, stakeholders would need to consider whether recruitment should be based on the percentage of certain minority groups in the population or on the number of patients of each subpopulation needed to generate statistically significant data.

Another unresolved question is how to define a minority group, she said.

The Endocrine Society also recommended that:

▸ Congress pass legislation that requires the inclusion of women and minorities in clinical trials for approval of drugs by the Food and Drug Administration.

▸ Congress provide tax incentives or patent extensions to companies that adhere to FDA guidance on the inclusion of minorities in trials.

▸ Officials at the National Institutes of Health and academic institutions establish an infrastructure of minority patient populations from which individual investigators can recruit volunteers.

▸ The NIH create and fund community research advisory boards to promote community-based research.

▸ Medical schools increase enrollment of minority students based on projected population changes over the next 30 years.

“Pharmaceutical companies will understand that this makes good sense,” said Dr. Alfonso Alanis, a member of the Endocrine Society task force. “We need to present this as a business proposition.”

Dr. Alanis, who is a former executive at Eli Lilly, and now is the founding partner of Anaclim, a contract research organization that aims to bring more minorities into clinical research, said his company has had success so far in recruiting minorities to studies.

Working with minority investigators accounts for about 80% of the company's minority recruitment, Dr. Alanis said. About 20% are nonminority investigators who care for minority patients.

Despite the common refrain that minority patients don't trust researchers, Dr. Alanis said the minority patients he has worked with understand the value of being represented in clinical trials.

They may have questions, but they are willing to participate, he said.

Dr. Rhonda Bentley-Lewis, an instructor in medicine at Brigham and Women's Hospital in Boston and a clinical investigator, said she tries to overcome issues of distrust by developing relationships within her community.

For example, she speaks in the community about diabetes prevention and management but doesn't use those talks as a sales pitch for patients to participate in clinical trials.

Dr. Bentley-Lewis, who was also a member of the Endocrine Society's task force, said that one measure of the trust-building these talks provide is that individuals often approach her with questions that they don't ask their own physicians.

When individuals do agree to participate in a trial, she gives them a chance to learn about the study in depth and emphasizes that their relationship is a “partnership,” she said.

TORONTO – Offering training to community-based physicians on how to conduct clinical trials is one of many steps the federal government can take to increase minority participation in research, according to recommendations unveiled by the Endocrine Society at its annual meeting.

“Recruitment is very difficult and no matter how much work people do in the community, in the end people go to their doctors and they take the advice of their doctors,” said Dr. Maria Alexander-Bridges, who is head of the Endocrine Society task force that developed the recommendations.

“So we wanted to work primarily on training minority physicians to do research in clinical trials so as to change the face of this process.”

The task force's effort, which began last year, was funded by a grant from the Robert Wood Johnson Foundation's Program on Disparities in Health Care.

One of the first steps recommended by the Endocrine Society was to convene a summit that would include pharmaceutical companies, academia, federal agencies, HMOs, community health networks, and community leaders, said Dr. Alexander-Bridges, who is also at Harvard Medical School, Boston.

The summit would address lingering questions that are critical to improving minority patient recruitment. For example, stakeholders would need to consider whether recruitment should be based on the percentage of certain minority groups in the population or on the number of patients of each subpopulation needed to generate statistically significant data.

Another unresolved question is how to define a minority group, she said.

The Endocrine Society also recommended that:

▸ Congress pass legislation that requires the inclusion of women and minorities in clinical trials for approval of drugs by the Food and Drug Administration.

▸ Congress provide tax incentives or patent extensions to companies that adhere to FDA guidance on the inclusion of minorities in trials.

▸ Officials at the National Institutes of Health and academic institutions establish an infrastructure of minority patient populations from which individual investigators can recruit volunteers.

▸ The NIH create and fund community research advisory boards to promote community-based research.

▸ Medical schools increase enrollment of minority students based on projected population changes over the next 30 years.

“Pharmaceutical companies will understand that this makes good sense,” said Dr. Alfonso Alanis, a member of the Endocrine Society task force. “We need to present this as a business proposition.”

Dr. Alanis, who is a former executive at Eli Lilly, and now is the founding partner of Anaclim, a contract research organization that aims to bring more minorities into clinical research, said his company has had success so far in recruiting minorities to studies.

Working with minority investigators accounts for about 80% of the company's minority recruitment, Dr. Alanis said. About 20% are nonminority investigators who care for minority patients.

Despite the common refrain that minority patients don't trust researchers, Dr. Alanis said the minority patients he has worked with understand the value of being represented in clinical trials.

They may have questions, but they are willing to participate, he said.

Dr. Rhonda Bentley-Lewis, an instructor in medicine at Brigham and Women's Hospital in Boston and a clinical investigator, said she tries to overcome issues of distrust by developing relationships within her community.

For example, she speaks in the community about diabetes prevention and management but doesn't use those talks as a sales pitch for patients to participate in clinical trials.

Dr. Bentley-Lewis, who was also a member of the Endocrine Society's task force, said that one measure of the trust-building these talks provide is that individuals often approach her with questions that they don't ask their own physicians.

When individuals do agree to participate in a trial, she gives them a chance to learn about the study in depth and emphasizes that their relationship is a “partnership,” she said.

TORONTO – Offering training to community-based physicians on how to conduct clinical trials is one of many steps the federal government can take to increase minority participation in research, according to recommendations unveiled by the Endocrine Society at its annual meeting.

“Recruitment is very difficult and no matter how much work people do in the community, in the end people go to their doctors and they take the advice of their doctors,” said Dr. Maria Alexander-Bridges, who is head of the Endocrine Society task force that developed the recommendations.

“So we wanted to work primarily on training minority physicians to do research in clinical trials so as to change the face of this process.”

The task force's effort, which began last year, was funded by a grant from the Robert Wood Johnson Foundation's Program on Disparities in Health Care.

One of the first steps recommended by the Endocrine Society was to convene a summit that would include pharmaceutical companies, academia, federal agencies, HMOs, community health networks, and community leaders, said Dr. Alexander-Bridges, who is also at Harvard Medical School, Boston.

The summit would address lingering questions that are critical to improving minority patient recruitment. For example, stakeholders would need to consider whether recruitment should be based on the percentage of certain minority groups in the population or on the number of patients of each subpopulation needed to generate statistically significant data.

Another unresolved question is how to define a minority group, she said.

The Endocrine Society also recommended that:

▸ Congress pass legislation that requires the inclusion of women and minorities in clinical trials for approval of drugs by the Food and Drug Administration.

▸ Congress provide tax incentives or patent extensions to companies that adhere to FDA guidance on the inclusion of minorities in trials.

▸ Officials at the National Institutes of Health and academic institutions establish an infrastructure of minority patient populations from which individual investigators can recruit volunteers.

▸ The NIH create and fund community research advisory boards to promote community-based research.

▸ Medical schools increase enrollment of minority students based on projected population changes over the next 30 years.

“Pharmaceutical companies will understand that this makes good sense,” said Dr. Alfonso Alanis, a member of the Endocrine Society task force. “We need to present this as a business proposition.”

Dr. Alanis, who is a former executive at Eli Lilly, and now is the founding partner of Anaclim, a contract research organization that aims to bring more minorities into clinical research, said his company has had success so far in recruiting minorities to studies.

Working with minority investigators accounts for about 80% of the company's minority recruitment, Dr. Alanis said. About 20% are nonminority investigators who care for minority patients.

Despite the common refrain that minority patients don't trust researchers, Dr. Alanis said the minority patients he has worked with understand the value of being represented in clinical trials.

They may have questions, but they are willing to participate, he said.

Dr. Rhonda Bentley-Lewis, an instructor in medicine at Brigham and Women's Hospital in Boston and a clinical investigator, said she tries to overcome issues of distrust by developing relationships within her community.

For example, she speaks in the community about diabetes prevention and management but doesn't use those talks as a sales pitch for patients to participate in clinical trials.

Dr. Bentley-Lewis, who was also a member of the Endocrine Society's task force, said that one measure of the trust-building these talks provide is that individuals often approach her with questions that they don't ask their own physicians.

When individuals do agree to participate in a trial, she gives them a chance to learn about the study in depth and emphasizes that their relationship is a “partnership,” she said.

Several Medicare Advantage fee-for-service plan sponsors have agreed to voluntarily suspend marketing of their plans until officials at the Centers for Medicare and Medicaid Services can verify that they are in compliance with certain management controls.

CMS officials announced that this temporary marketing moratorium is part of an effort to halt deceptive marketing practices being used in the private fee-for-service Medicare market.

“It is our strong belief that while most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors operating in the marketplace that need to be removed from the system,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans, with many of those complaints relating to private fee-for-service plans. However, Ms. Block pointed out that the 2,700 complaints account for a small fraction of the 1.3 million Medicare beneficiaries who have elected to enroll in such plans.

The problems reported range from agents encouraging the misperception that the private plans are just like traditional Medicare and are accepted by all providers who accept Medicare to more blatant cases of deception in which agents have told beneficiaries they are still enrolled in traditional Medicare and are purchasing a Medigap supplemental insurance policy.

The seven private fee-for-service Medicare plans that recently signed an agreement with the CMS to suspend their marketing efforts are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. Together, they account for about 90% of enrollment in private fee-for-service plans, according to the CMS. “These are clearly the major players in the industry,” Ms. Block said.

The plans were not singled out because of particular problems with their marketing practices, Ms. Block said. The real concern relates to actions by a small number of rogue brokers and agents with whom these and other organizations may contract, she said.

The temporary moratorium does not apply to enrollment among the plans and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics.

The marketing moratorium will be lifted on a plan-by-plan basis when the CMS certifies that the plan has both systems and management controls in place that meet conditions spelled out by the agency in guidance earlier this year.

For example, plan sponsors will have to show that all of their advertising, marketing, and enrollment materials include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as traditional Medicare or Medigap and that not all providers will accept the plan. All representatives selling products on behalf of a plan sponsor will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans.

Plans must also agree to provide a list of individuals who are marketing the plan upon request by the CMS or state agencies. The CMS will begin to review plans as soon as they indicate they are in compliance, Ms. Block said.

In addition, the CMS will be monitoring all private fee-for-service plans to ensure they are not engaging in deceptive marketing practices.

“We will be watching very carefully as the entire industry begins marketing in October for the 2008 benefit year,” Ms. Block said.

Several Medicare Advantage fee-for-service plan sponsors have agreed to voluntarily suspend marketing of their plans until officials at the Centers for Medicare and Medicaid Services can verify that they are in compliance with certain management controls.

CMS officials announced that this temporary marketing moratorium is part of an effort to halt deceptive marketing practices being used in the private fee-for-service Medicare market.

“It is our strong belief that while most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors operating in the marketplace that need to be removed from the system,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans, with many of those complaints relating to private fee-for-service plans. However, Ms. Block pointed out that the 2,700 complaints account for a small fraction of the 1.3 million Medicare beneficiaries who have elected to enroll in such plans.

The problems reported range from agents encouraging the misperception that the private plans are just like traditional Medicare and are accepted by all providers who accept Medicare to more blatant cases of deception in which agents have told beneficiaries they are still enrolled in traditional Medicare and are purchasing a Medigap supplemental insurance policy.

The seven private fee-for-service Medicare plans that recently signed an agreement with the CMS to suspend their marketing efforts are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. Together, they account for about 90% of enrollment in private fee-for-service plans, according to the CMS. “These are clearly the major players in the industry,” Ms. Block said.

The plans were not singled out because of particular problems with their marketing practices, Ms. Block said. The real concern relates to actions by a small number of rogue brokers and agents with whom these and other organizations may contract, she said.

The temporary moratorium does not apply to enrollment among the plans and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics.

The marketing moratorium will be lifted on a plan-by-plan basis when the CMS certifies that the plan has both systems and management controls in place that meet conditions spelled out by the agency in guidance earlier this year.

For example, plan sponsors will have to show that all of their advertising, marketing, and enrollment materials include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as traditional Medicare or Medigap and that not all providers will accept the plan. All representatives selling products on behalf of a plan sponsor will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans.

Plans must also agree to provide a list of individuals who are marketing the plan upon request by the CMS or state agencies. The CMS will begin to review plans as soon as they indicate they are in compliance, Ms. Block said.

In addition, the CMS will be monitoring all private fee-for-service plans to ensure they are not engaging in deceptive marketing practices.

“We will be watching very carefully as the entire industry begins marketing in October for the 2008 benefit year,” Ms. Block said.

Several Medicare Advantage fee-for-service plan sponsors have agreed to voluntarily suspend marketing of their plans until officials at the Centers for Medicare and Medicaid Services can verify that they are in compliance with certain management controls.

CMS officials announced that this temporary marketing moratorium is part of an effort to halt deceptive marketing practices being used in the private fee-for-service Medicare market.

“It is our strong belief that while most agents and brokers are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors operating in the marketplace that need to be removed from the system,” Abby Block, director of the Center for Beneficiary Choices at the CMS, said during a press briefing. “This voluntary agreement demonstrates that the plans are stepping up to ensure that deceptive marketing practices end and that beneficiaries fully understand what they are purchasing.”

From last December through April, CMS officials received about 2,700 complaints from beneficiaries regarding Medicare Advantage plans, with many of those complaints relating to private fee-for-service plans. However, Ms. Block pointed out that the 2,700 complaints account for a small fraction of the 1.3 million Medicare beneficiaries who have elected to enroll in such plans.

The problems reported range from agents encouraging the misperception that the private plans are just like traditional Medicare and are accepted by all providers who accept Medicare to more blatant cases of deception in which agents have told beneficiaries they are still enrolled in traditional Medicare and are purchasing a Medigap supplemental insurance policy.

The seven private fee-for-service Medicare plans that recently signed an agreement with the CMS to suspend their marketing efforts are United Healthcare, Humana, WellCare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross Blue Shield of Tennessee. Together, they account for about 90% of enrollment in private fee-for-service plans, according to the CMS. “These are clearly the major players in the industry,” Ms. Block said.

The plans were not singled out because of particular problems with their marketing practices, Ms. Block said. The real concern relates to actions by a small number of rogue brokers and agents with whom these and other organizations may contract, she said.

The temporary moratorium does not apply to enrollment among the plans and does not affect the employer market, where CMS has not received complaints of issues with marketing tactics.

The marketing moratorium will be lifted on a plan-by-plan basis when the CMS certifies that the plan has both systems and management controls in place that meet conditions spelled out by the agency in guidance earlier this year.

For example, plan sponsors will have to show that all of their advertising, marketing, and enrollment materials include model disclaimer language provided by the CMS that private fee-for-service Medicare plans are not the same as traditional Medicare or Medigap and that not all providers will accept the plan. All representatives selling products on behalf of a plan sponsor will have to pass a written test demonstrating familiarity with Medicare and fee-for-service plans.

Plans must also agree to provide a list of individuals who are marketing the plan upon request by the CMS or state agencies. The CMS will begin to review plans as soon as they indicate they are in compliance, Ms. Block said.

In addition, the CMS will be monitoring all private fee-for-service plans to ensure they are not engaging in deceptive marketing practices.

“We will be watching very carefully as the entire industry begins marketing in October for the 2008 benefit year,” Ms. Block said.