Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Article Type
Changed
Thu, 12/06/2018 - 20:04
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover about 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Avandia Suspected in Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover about 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Avandia Suspected in Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover about 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Avandia Suspected in Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

Publications
Publications
Topics
Article Type
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Article Type
Changed
Wed, 03/27/2019 - 13:23
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off toward a potentially new therapy for a rare disease, the agency said. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years. TransforMED said it already has helped more than 500 practices convert to patient-centered medical homes.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe Inc., Navigenics Inc., and Pathway Genomics Corp. The companies already offer their tests to consumers by phone or online, and San Diego–based Pathway announced last month that it is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided via telehealth, the survey respondents said. Intel is a developer of telehealth devices.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off toward a potentially new therapy for a rare disease, the agency said. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years. TransforMED said it already has helped more than 500 practices convert to patient-centered medical homes.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe Inc., Navigenics Inc., and Pathway Genomics Corp. The companies already offer their tests to consumers by phone or online, and San Diego–based Pathway announced last month that it is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided via telehealth, the survey respondents said. Intel is a developer of telehealth devices.

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off toward a potentially new therapy for a rare disease, the agency said. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years. TransforMED said it already has helped more than 500 practices convert to patient-centered medical homes.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe Inc., Navigenics Inc., and Pathway Genomics Corp. The companies already offer their tests to consumers by phone or online, and San Diego–based Pathway announced last month that it is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided via telehealth, the survey respondents said. Intel is a developer of telehealth devices.

Publications
Publications
Topics
Article Type
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Most Uninsured Young Adults Will Get Coverage by 2014

Article Type
Changed
Wed, 03/27/2019 - 13:23
Display Headline
Most Uninsured Young Adults Will Get Coverage by 2014

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19–29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%–8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Disclosures: The report was funded by the Commonwealth Fund. There were no other disclosures.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19–29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%–8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Disclosures: The report was funded by the Commonwealth Fund. There were no other disclosures.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19–29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%–8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Disclosures: The report was funded by the Commonwealth Fund. There were no other disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Most Uninsured Young Adults Will Get Coverage by 2014
Display Headline
Most Uninsured Young Adults Will Get Coverage by 2014
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Article Type
Changed
Wed, 03/27/2019 - 13:23
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel, which develops telehealth devices. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided. More than two-thirds said that health care providers probably will implement telehealth technology if financial issues are resolved.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe, Navigenics, and Pathway Genomics. The companies already offer their tests to consumers by phone or online, and Pathway is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks, as well as how they collect, store, and process individual genetic samples collected from consumers.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. As a result of these training sessions and events, the projects received more than 63,000 inquiries from seniors, of which nearly 1,000 were referred for further action, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

 

 

—Jane Anderson

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel, which develops telehealth devices. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided. More than two-thirds said that health care providers probably will implement telehealth technology if financial issues are resolved.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe, Navigenics, and Pathway Genomics. The companies already offer their tests to consumers by phone or online, and Pathway is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks, as well as how they collect, store, and process individual genetic samples collected from consumers.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. As a result of these training sessions and events, the projects received more than 63,000 inquiries from seniors, of which nearly 1,000 were referred for further action, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

 

 

—Jane Anderson

FDA Drafts Transparency Rules

The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes decisions and enforces them. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off. The FDA will accept comments on the public disclosure policies until July 20.

Medical Home Service Expands

The American Academy of Family Physicians subsidiary TransforMED, which helps primary care physicians turn their practices into patient-centered medical homes, has launched a new product aimed at practices with four or fewer physicians. The Small Practice Package bundles the usual components of the product but streamlines the process of converting to medical home practice, the company said. The materials and individualized guidance can come strictly online for a cost of $1,250 per practice per quarter or include on-site assessments at $2,500 per practice per quarter. The TransforMED announcement said that the package will enable small practices to implement the patient-centered medical home model in 2 years.

Survey: Telehealth Improves Care

Eight of ten health care and information technology professionals believe telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel, which develops telehealth devices. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided. More than two-thirds said that health care providers probably will implement telehealth technology if financial issues are resolved.

House Probes Home Gene Testing

Three key House lawmakers have launched an investigation into personal genetic testing kits being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe, Navigenics, and Pathway Genomics. The companies already offer their tests to consumers by phone or online, and Pathway is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks, as well as how they collect, store, and process individual genetic samples collected from consumers.

Growth in Health Accounts

About 10 million Americans are now covered by high-deductible health insurance plans, which make them eligible to open health savings accounts. That's a 25% increase over total enrollment in early 2009, according to a report from the health insurance industry group America's Health Insurance Plans. The fastest-growing market for high-deductible health plans last year was among large groups, where such plans increased by 33%, the report said. The increase of high-deductible plans was 22% among small groups of insured people and 17% among those individually insured. States with the highest percentages of enrollment in high-deductible policies were Vermont, Minnesota, Colorado, Arkansas, Indiana, and Ohio.

Seniors Did Blow the Whistle

A program that uses volunteers to train senior citizens to identify fraud in the Medicare program recovered $76,176 in 2009 and saved Medicare, Medicaid, and individuals $214,060, but Administration on Aging grants to conduct the program totaled $9.3 million, according to a report from the Department of Health and Human Services Office of Inspector General. The 55 Senior Medicare Patrol Projects had a total of 4,444 active volunteers, who conducted more than 78,000 educational sessions and media and community outreach activities, the report said. As a result of these training sessions and events, the projects received more than 63,000 inquiries from seniors, of which nearly 1,000 were referred for further action, the report said. Since the Senior Medicare Patrol Projects program began in 1997, it has recovered nearly $4.6 million in Medicare funds, the report said, but the program may not be getting full credit for savings attributable to the volunteers' work because it can't account for savings from seniors scrutinizing their bills for fraud and abuse.

 

 

—Jane Anderson

Publications
Publications
Topics
Article Type
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Article Type
Changed
Wed, 03/27/2019 - 13:25
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store

Health Information Grants Set

Fifteen communities will share $220 million in health information technology grant money from the Department of Health and Human Services, and nine of the projects are aimed at improving diabetes treatment. The Beacon Community grants provide funding to “communities at the cutting edge of electronic health record adoption and health information exchange,” the HHS said. For example, the Rhode Island Quality Institute in Providence received nearly $16 million to improve diabetes management and adult immunization rates, while the Western New York Clinical Information Exchange in Buffalo, also received about $16 million in grant funding to develop clinical decision support tools and “innovative telemedicine solutions” to improve care for diabetic patients.

Recovery Funds for Endocrinology

The National Institutes of Health announced it will fund two construction projects supporting endocrinology research as part of an overall $1 billion in American Recovery and Reinvestment Act grants for research infrastructure. Wichita (Kansas) State University will receive nearly $2.2 million to build and renovate labs supporting research into age-related changes in the chemical structure and biological function of follicle-stimulating hormone in women. Meanwhile, New Jersey's Rutgers University will receive about $9.5 million to build a facility for study of the genetic causes of diabetes, autism, schizophrenia, alcoholism, and drug addiction.

Public Citizen Calls for Trial's Halt

The Food and Drug Administration should immediately halt an international trial designed to assess the cardiovascular risks associated with the diabetes drug rosiglitazone (Avandia) because research has already shown that it is more dangerous than its competitor pioglitazone (Actos), advocacy group Public Citizen said in a joint statement with a Canadian scientist. In a letter to the FDA, Public Citizen's Dr. Sidney Wolfe and Dr. David Juurlink, a Toronto researcher who led a large study that in 2009 found rosiglitazone associated with more heart failure and death than pioglitazone, said that continuing the Thiazolidinedione Intervention in Vitamin D Evaluation, TIDE trial, is unethical. Run by drug manufacturer GlaxoSmithKline, the trial began in 2009 and involves 137 sites in 14 countries. “It really does not make sense that this trial should continue,” said Dr. Juurlink in a statement. “These are patients, not guinea pigs.”

FDA Wants New Diabetes Test

Makers of diagnostic tests should develop a product to identify people at risk of developing the disease yet are hidden in seemingly low-risk populations, an FDA official said. Unfortunately, most of the proposals the FDA sees are for screening tests that identify people clearly at high risk for diabetes, and those tests are “not as useful,” said Courtney Harper, Ph.D., of the FDA's Center for Devices and Radiological Health. Most at-risk patients in low-risk populations are not being monitored for the disease nor motivated to make lifestyle changes that could prevent development of type 2 diabetes, Dr. Harper said. She added that another useful tool would be one that puts people in low-risk as well as high-risk categories, she said. Dr. Harper spoke at a type 2 Diabetes Prevention Summit hosted by George Washington University.

Pay Increased for Density Test

Starting June 1, Medicare is increasing payments for dual-energy x-ray absorptiometry (DXA) services. With the increase, DXA payments will be slightly less than 70% of what they were in 2006, when Congress first mandated payment cuts. The current increase is required under the recently enacted health reform law, the Patient Protection and Affordable Care Act. The act increased payments for 2010 and 2011 and called for a study of the impact of past payment reductions. Officials at the Centers for Medicare and Medicaid Services said that procedures performed between Jan. 1 and May 31, 2010, will be retroactively paid at the higher rates, but details on handling those claims are still being worked out, according to the American College of Rheumatology. The college, which praised the increased DXA payment, estimates that the nonfacility fee for CPT code 77080 will rise from the current $45.21 to $97.92. The same service was paid at $143.32 in 2006.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs—which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases—rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Health Information Grants Set

Fifteen communities will share $220 million in health information technology grant money from the Department of Health and Human Services, and nine of the projects are aimed at improving diabetes treatment. The Beacon Community grants provide funding to “communities at the cutting edge of electronic health record adoption and health information exchange,” the HHS said. For example, the Rhode Island Quality Institute in Providence received nearly $16 million to improve diabetes management and adult immunization rates, while the Western New York Clinical Information Exchange in Buffalo, also received about $16 million in grant funding to develop clinical decision support tools and “innovative telemedicine solutions” to improve care for diabetic patients.

Recovery Funds for Endocrinology

The National Institutes of Health announced it will fund two construction projects supporting endocrinology research as part of an overall $1 billion in American Recovery and Reinvestment Act grants for research infrastructure. Wichita (Kansas) State University will receive nearly $2.2 million to build and renovate labs supporting research into age-related changes in the chemical structure and biological function of follicle-stimulating hormone in women. Meanwhile, New Jersey's Rutgers University will receive about $9.5 million to build a facility for study of the genetic causes of diabetes, autism, schizophrenia, alcoholism, and drug addiction.

Public Citizen Calls for Trial's Halt

The Food and Drug Administration should immediately halt an international trial designed to assess the cardiovascular risks associated with the diabetes drug rosiglitazone (Avandia) because research has already shown that it is more dangerous than its competitor pioglitazone (Actos), advocacy group Public Citizen said in a joint statement with a Canadian scientist. In a letter to the FDA, Public Citizen's Dr. Sidney Wolfe and Dr. David Juurlink, a Toronto researcher who led a large study that in 2009 found rosiglitazone associated with more heart failure and death than pioglitazone, said that continuing the Thiazolidinedione Intervention in Vitamin D Evaluation, TIDE trial, is unethical. Run by drug manufacturer GlaxoSmithKline, the trial began in 2009 and involves 137 sites in 14 countries. “It really does not make sense that this trial should continue,” said Dr. Juurlink in a statement. “These are patients, not guinea pigs.”

FDA Wants New Diabetes Test

Makers of diagnostic tests should develop a product to identify people at risk of developing the disease yet are hidden in seemingly low-risk populations, an FDA official said. Unfortunately, most of the proposals the FDA sees are for screening tests that identify people clearly at high risk for diabetes, and those tests are “not as useful,” said Courtney Harper, Ph.D., of the FDA's Center for Devices and Radiological Health. Most at-risk patients in low-risk populations are not being monitored for the disease nor motivated to make lifestyle changes that could prevent development of type 2 diabetes, Dr. Harper said. She added that another useful tool would be one that puts people in low-risk as well as high-risk categories, she said. Dr. Harper spoke at a type 2 Diabetes Prevention Summit hosted by George Washington University.

Pay Increased for Density Test

Starting June 1, Medicare is increasing payments for dual-energy x-ray absorptiometry (DXA) services. With the increase, DXA payments will be slightly less than 70% of what they were in 2006, when Congress first mandated payment cuts. The current increase is required under the recently enacted health reform law, the Patient Protection and Affordable Care Act. The act increased payments for 2010 and 2011 and called for a study of the impact of past payment reductions. Officials at the Centers for Medicare and Medicaid Services said that procedures performed between Jan. 1 and May 31, 2010, will be retroactively paid at the higher rates, but details on handling those claims are still being worked out, according to the American College of Rheumatology. The college, which praised the increased DXA payment, estimates that the nonfacility fee for CPT code 77080 will rise from the current $45.21 to $97.92. The same service was paid at $143.32 in 2006.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs—which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases—rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

Health Information Grants Set

Fifteen communities will share $220 million in health information technology grant money from the Department of Health and Human Services, and nine of the projects are aimed at improving diabetes treatment. The Beacon Community grants provide funding to “communities at the cutting edge of electronic health record adoption and health information exchange,” the HHS said. For example, the Rhode Island Quality Institute in Providence received nearly $16 million to improve diabetes management and adult immunization rates, while the Western New York Clinical Information Exchange in Buffalo, also received about $16 million in grant funding to develop clinical decision support tools and “innovative telemedicine solutions” to improve care for diabetic patients.

Recovery Funds for Endocrinology

The National Institutes of Health announced it will fund two construction projects supporting endocrinology research as part of an overall $1 billion in American Recovery and Reinvestment Act grants for research infrastructure. Wichita (Kansas) State University will receive nearly $2.2 million to build and renovate labs supporting research into age-related changes in the chemical structure and biological function of follicle-stimulating hormone in women. Meanwhile, New Jersey's Rutgers University will receive about $9.5 million to build a facility for study of the genetic causes of diabetes, autism, schizophrenia, alcoholism, and drug addiction.

Public Citizen Calls for Trial's Halt

The Food and Drug Administration should immediately halt an international trial designed to assess the cardiovascular risks associated with the diabetes drug rosiglitazone (Avandia) because research has already shown that it is more dangerous than its competitor pioglitazone (Actos), advocacy group Public Citizen said in a joint statement with a Canadian scientist. In a letter to the FDA, Public Citizen's Dr. Sidney Wolfe and Dr. David Juurlink, a Toronto researcher who led a large study that in 2009 found rosiglitazone associated with more heart failure and death than pioglitazone, said that continuing the Thiazolidinedione Intervention in Vitamin D Evaluation, TIDE trial, is unethical. Run by drug manufacturer GlaxoSmithKline, the trial began in 2009 and involves 137 sites in 14 countries. “It really does not make sense that this trial should continue,” said Dr. Juurlink in a statement. “These are patients, not guinea pigs.”

FDA Wants New Diabetes Test

Makers of diagnostic tests should develop a product to identify people at risk of developing the disease yet are hidden in seemingly low-risk populations, an FDA official said. Unfortunately, most of the proposals the FDA sees are for screening tests that identify people clearly at high risk for diabetes, and those tests are “not as useful,” said Courtney Harper, Ph.D., of the FDA's Center for Devices and Radiological Health. Most at-risk patients in low-risk populations are not being monitored for the disease nor motivated to make lifestyle changes that could prevent development of type 2 diabetes, Dr. Harper said. She added that another useful tool would be one that puts people in low-risk as well as high-risk categories, she said. Dr. Harper spoke at a type 2 Diabetes Prevention Summit hosted by George Washington University.

Pay Increased for Density Test

Starting June 1, Medicare is increasing payments for dual-energy x-ray absorptiometry (DXA) services. With the increase, DXA payments will be slightly less than 70% of what they were in 2006, when Congress first mandated payment cuts. The current increase is required under the recently enacted health reform law, the Patient Protection and Affordable Care Act. The act increased payments for 2010 and 2011 and called for a study of the impact of past payment reductions. Officials at the Centers for Medicare and Medicaid Services said that procedures performed between Jan. 1 and May 31, 2010, will be retroactively paid at the higher rates, but details on handling those claims are still being worked out, according to the American College of Rheumatology. The college, which praised the increased DXA payment, estimates that the nonfacility fee for CPT code 77080 will rise from the current $45.21 to $97.92. The same service was paid at $143.32 in 2006.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs—which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases—rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

Publications
Publications
Topics
Article Type
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Display Headline
Policy & Practice : Want more health reform news? Subscribe to our podcast – search 'Policy & Practice' in the iTunes store
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Most Uninsured Young Adults to Be Covered Under New Law

Article Type
Changed
Wed, 03/27/2019 - 13:25
Display Headline
Most Uninsured Young Adults to Be Covered Under New Law

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: None.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund released May 21.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19-29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, the report indicated.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: None.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund released May 21.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19-29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, the report indicated.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: None.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund released May 21.

Provisions of the Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Further, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults—defined by the report as aged 19-29 years—a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, since unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said. One-third of all uninsured young people and 46% of those both uninsured and with chronic health problems reported that their health declined because they delayed getting medical care.

In addition in 2009, 60% of young adults without insurance had trouble paying medical bills, compared with 27% of their insured peers, the report indicated.

Medical debt also is a problem, the report found, with 11.3 million young people paying off medical debt. Half of those had asked family for financial help, while 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance. This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Publications
Publications
Topics
Article Type
Display Headline
Most Uninsured Young Adults to Be Covered Under New Law
Display Headline
Most Uninsured Young Adults to Be Covered Under New Law
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Changes in Physician Billing Could Save $7 Billion Yearly

Article Type
Changed
Wed, 03/27/2019 - 13:24
Display Headline
Changes in Physician Billing Could Save $7 Billion Yearly

Implementing a single set of payment rules for multiple payers with a single universal claim form and standard set of rules potentially could save $7 billion per year nationwide in fees for physician and clinical services, according to a study of one institution.

Those changes also could save 4 hours of professional time per physician and 5 hours of practices' staff time each week, according to Bonnie B. Blanchfield, a senior research scientist at Massachusetts General Hospital, Boston, and her coauthors (Health Affairs 2010 April 29 [doi:10.1377/hlthaff.2009.0075]).

“The U.S. health care system has generated byzantine systems of rules and regulations regarding payment for medical services. The result has been a growing and costly bureaucracy, which, in the end, pulls resources from direct patient care,” wrote the investigators.

The authors analyzed what they called the “excessive administrative complexity burden” imposed on a large, urban-based, academic teaching hospital's physician organization that contracts with multiple payers, each with different payment requirements.

For 2006, the study found that the cost of excessive administrative complexity, including expenses and lost revenue, was nearly $45 million for this organization, or nearly 12% of net patient revenue.

This represented $50,250 per physician, the authors said. Of the total estimated administrative complexity burden, almost three-fourths was attributed to the time costs incurred by practicing physicians and their office staffs in preparing paperwork and contacting payers about prescriptions, diagnoses, treatment plans, and referrals, wrote the authors.

“Many of the subspecialty practices within the physician organization even have full-time staff members dedicated to referral processing,” they wrote.

On the revenue side, the study found that nearly 13% of billed charges for non-Medicare claims were denied on initial submission, and that 81% of these eventually are paid after appeals.

Non-Medicare payers ultimately deny more claims than Medicare does, usually because the physician's office has missed the filing limit date because of the initial rejection, the study found. If these legitimate claims had been paid, they would have been worth some $6 million for the physician organization studied.

The federal health reform legislation approved in March directs health plans to implement uniform standards for electronic health information exchange by 2013, but “will not address the larger problems of excessive, different, and changing requirements imposed on the exchange of all health information, including billing information,” they said.

“Thus, administrative complexity is likely to remain high and is likely to be a high-value 'target' for finding savings in ongoing incremental reforms.”

The savings from reducing administrative complexity by implementing a single set of rules and a single claim form could translate into decreased health care costs in general while still allowing different types of insurance products, Ms. Blanchfield and her colleagues noted.

“An incremental move to one set of payment rules would yield significant dollar savings as well as work-life and productivity opportunities for physicians and their office staffs,” the researchers said. “Done carefully, administrative simplification could still leave room for a diversity of insurance products.”

Disclosures: Support for the study was provided by the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors reported no financial conflicts of interest.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Implementing a single set of payment rules for multiple payers with a single universal claim form and standard set of rules potentially could save $7 billion per year nationwide in fees for physician and clinical services, according to a study of one institution.

Those changes also could save 4 hours of professional time per physician and 5 hours of practices' staff time each week, according to Bonnie B. Blanchfield, a senior research scientist at Massachusetts General Hospital, Boston, and her coauthors (Health Affairs 2010 April 29 [doi:10.1377/hlthaff.2009.0075]).

“The U.S. health care system has generated byzantine systems of rules and regulations regarding payment for medical services. The result has been a growing and costly bureaucracy, which, in the end, pulls resources from direct patient care,” wrote the investigators.

The authors analyzed what they called the “excessive administrative complexity burden” imposed on a large, urban-based, academic teaching hospital's physician organization that contracts with multiple payers, each with different payment requirements.

For 2006, the study found that the cost of excessive administrative complexity, including expenses and lost revenue, was nearly $45 million for this organization, or nearly 12% of net patient revenue.

This represented $50,250 per physician, the authors said. Of the total estimated administrative complexity burden, almost three-fourths was attributed to the time costs incurred by practicing physicians and their office staffs in preparing paperwork and contacting payers about prescriptions, diagnoses, treatment plans, and referrals, wrote the authors.

“Many of the subspecialty practices within the physician organization even have full-time staff members dedicated to referral processing,” they wrote.

On the revenue side, the study found that nearly 13% of billed charges for non-Medicare claims were denied on initial submission, and that 81% of these eventually are paid after appeals.

Non-Medicare payers ultimately deny more claims than Medicare does, usually because the physician's office has missed the filing limit date because of the initial rejection, the study found. If these legitimate claims had been paid, they would have been worth some $6 million for the physician organization studied.

The federal health reform legislation approved in March directs health plans to implement uniform standards for electronic health information exchange by 2013, but “will not address the larger problems of excessive, different, and changing requirements imposed on the exchange of all health information, including billing information,” they said.

“Thus, administrative complexity is likely to remain high and is likely to be a high-value 'target' for finding savings in ongoing incremental reforms.”

The savings from reducing administrative complexity by implementing a single set of rules and a single claim form could translate into decreased health care costs in general while still allowing different types of insurance products, Ms. Blanchfield and her colleagues noted.

“An incremental move to one set of payment rules would yield significant dollar savings as well as work-life and productivity opportunities for physicians and their office staffs,” the researchers said. “Done carefully, administrative simplification could still leave room for a diversity of insurance products.”

Disclosures: Support for the study was provided by the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors reported no financial conflicts of interest.

Implementing a single set of payment rules for multiple payers with a single universal claim form and standard set of rules potentially could save $7 billion per year nationwide in fees for physician and clinical services, according to a study of one institution.

Those changes also could save 4 hours of professional time per physician and 5 hours of practices' staff time each week, according to Bonnie B. Blanchfield, a senior research scientist at Massachusetts General Hospital, Boston, and her coauthors (Health Affairs 2010 April 29 [doi:10.1377/hlthaff.2009.0075]).

“The U.S. health care system has generated byzantine systems of rules and regulations regarding payment for medical services. The result has been a growing and costly bureaucracy, which, in the end, pulls resources from direct patient care,” wrote the investigators.

The authors analyzed what they called the “excessive administrative complexity burden” imposed on a large, urban-based, academic teaching hospital's physician organization that contracts with multiple payers, each with different payment requirements.

For 2006, the study found that the cost of excessive administrative complexity, including expenses and lost revenue, was nearly $45 million for this organization, or nearly 12% of net patient revenue.

This represented $50,250 per physician, the authors said. Of the total estimated administrative complexity burden, almost three-fourths was attributed to the time costs incurred by practicing physicians and their office staffs in preparing paperwork and contacting payers about prescriptions, diagnoses, treatment plans, and referrals, wrote the authors.

“Many of the subspecialty practices within the physician organization even have full-time staff members dedicated to referral processing,” they wrote.

On the revenue side, the study found that nearly 13% of billed charges for non-Medicare claims were denied on initial submission, and that 81% of these eventually are paid after appeals.

Non-Medicare payers ultimately deny more claims than Medicare does, usually because the physician's office has missed the filing limit date because of the initial rejection, the study found. If these legitimate claims had been paid, they would have been worth some $6 million for the physician organization studied.

The federal health reform legislation approved in March directs health plans to implement uniform standards for electronic health information exchange by 2013, but “will not address the larger problems of excessive, different, and changing requirements imposed on the exchange of all health information, including billing information,” they said.

“Thus, administrative complexity is likely to remain high and is likely to be a high-value 'target' for finding savings in ongoing incremental reforms.”

The savings from reducing administrative complexity by implementing a single set of rules and a single claim form could translate into decreased health care costs in general while still allowing different types of insurance products, Ms. Blanchfield and her colleagues noted.

“An incremental move to one set of payment rules would yield significant dollar savings as well as work-life and productivity opportunities for physicians and their office staffs,” the researchers said. “Done carefully, administrative simplification could still leave room for a diversity of insurance products.”

Disclosures: Support for the study was provided by the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors reported no financial conflicts of interest.

Publications
Publications
Topics
Article Type
Display Headline
Changes in Physician Billing Could Save $7 Billion Yearly
Display Headline
Changes in Physician Billing Could Save $7 Billion Yearly
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Patients, Physicians Want Disclosure of Financial Ties

Article Type
Changed
Thu, 12/06/2018 - 10:16
Display Headline
Patients, Physicians Want Disclosure of Financial Ties

Physicians, patients, and research participants believe that researchers' financial ties to industry decrease the quality of research evidence, and patients believe that financial ties influence professional behavior and should be disclosed, a review of studies looking at views on financial ties to pharmaceutical and medical device companies found.

For some patients, knowledge of the researchers' financial ties to industry would affect their willingness to participate in research studies, wrote Dr. Cary Gross of Yale University, New Haven, Conn., and his colleagues (Arch. Intern. Med. 2010;170:675-82).

“When any financial tie was disclosed, there was a reduction in the perceived quality of research among research participants and physicians,” they reported.

They noted that in clinical care, patients believed that financial ties also decreased the quality of care and affected prescribing behavior.

The investigators reviewed 11 original quantitative studies of patients', research participants', and journal readers' views about financial ties and perceptions of quality.

In studies considering patient perception of cost, a range of 26%-76% said they believed that gifts to physicians increase the cost of care, although fewer patients thought professional gifts were a problem.

“For instance, in a 2009 study of 903 patients contacted by telephone, 9% disapproved of physicians receiving free drug samples and 16% disapproved of free medical texts, compared with disapproval rates of 55% and 68%, respectively, for paid dinners and golf tournaments,” Dr. Gross and his colleagues wrote.

In other studies, when respondents were asked to rate study disclosure statements, they deemed researchers with financial tie statements to be less trustworthy and less important than those who did not have them, the researchers noted.

For some potential trial participants, disclosure of financial ties affected their willingness to participate.

“Three studies reported that prospective research participants were least willing to participate in a hypothetical clinical trial when a researcher equity ownership was disclosed,” according to Dr. Gross and his colleagues. “Of note, the participants also reported less trust in researchers after disclosure of financial ties.”

The literature review “suggests that a sizeable portion of the public wants to know about physician financial ties,” and that patients and research participants can distinguish between different types of financial ties and determine the relative importance of disclosure of each, the investigators concluded.

In an accompanying editorial, Eric Campbell, Ph.D., of Harvard Medical School, Boston, noted that patients and research participants want access to data on conflicts of interest to make decisions about the potential impacts of industry relationships on the care they receive.

“For example, they want to be able to ascertain if, and to what extent, their prescriptions could be inappropriately influenced by the financial relationships between their physician and pharmaceutical companies,” Dr. Campbell explained.

However, collecting and presenting industry data in a useful way will not be easy, and “for consumers to use the data, it is clear that the quality of the data that is reported by companies must be improved,” he added.

Public disclosure seems like a likely first step toward a more active government and health care institution role in evaluating and managing physician-industry relationships, Dr. Campbell wrote. “This will likely be seen by some physicians as a direct assault on their sense of professional identity and autonomy.” However, “this transparency will help prevent the further erosion of public trust in the medical profession,” he argued.

Disclosures: The literature review was supported in part by a Doris Duke Clinical Research Fellowship. Dr. Gross disclosed having served as an expert witness, and another author disclosed serving as a paid data and safety committee member, for Genzyme Corp. Dr. Campbell did not report any financial disclosures.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Physicians, patients, and research participants believe that researchers' financial ties to industry decrease the quality of research evidence, and patients believe that financial ties influence professional behavior and should be disclosed, a review of studies looking at views on financial ties to pharmaceutical and medical device companies found.

For some patients, knowledge of the researchers' financial ties to industry would affect their willingness to participate in research studies, wrote Dr. Cary Gross of Yale University, New Haven, Conn., and his colleagues (Arch. Intern. Med. 2010;170:675-82).

“When any financial tie was disclosed, there was a reduction in the perceived quality of research among research participants and physicians,” they reported.

They noted that in clinical care, patients believed that financial ties also decreased the quality of care and affected prescribing behavior.

The investigators reviewed 11 original quantitative studies of patients', research participants', and journal readers' views about financial ties and perceptions of quality.

In studies considering patient perception of cost, a range of 26%-76% said they believed that gifts to physicians increase the cost of care, although fewer patients thought professional gifts were a problem.

“For instance, in a 2009 study of 903 patients contacted by telephone, 9% disapproved of physicians receiving free drug samples and 16% disapproved of free medical texts, compared with disapproval rates of 55% and 68%, respectively, for paid dinners and golf tournaments,” Dr. Gross and his colleagues wrote.

In other studies, when respondents were asked to rate study disclosure statements, they deemed researchers with financial tie statements to be less trustworthy and less important than those who did not have them, the researchers noted.

For some potential trial participants, disclosure of financial ties affected their willingness to participate.

“Three studies reported that prospective research participants were least willing to participate in a hypothetical clinical trial when a researcher equity ownership was disclosed,” according to Dr. Gross and his colleagues. “Of note, the participants also reported less trust in researchers after disclosure of financial ties.”

The literature review “suggests that a sizeable portion of the public wants to know about physician financial ties,” and that patients and research participants can distinguish between different types of financial ties and determine the relative importance of disclosure of each, the investigators concluded.

In an accompanying editorial, Eric Campbell, Ph.D., of Harvard Medical School, Boston, noted that patients and research participants want access to data on conflicts of interest to make decisions about the potential impacts of industry relationships on the care they receive.

“For example, they want to be able to ascertain if, and to what extent, their prescriptions could be inappropriately influenced by the financial relationships between their physician and pharmaceutical companies,” Dr. Campbell explained.

However, collecting and presenting industry data in a useful way will not be easy, and “for consumers to use the data, it is clear that the quality of the data that is reported by companies must be improved,” he added.

Public disclosure seems like a likely first step toward a more active government and health care institution role in evaluating and managing physician-industry relationships, Dr. Campbell wrote. “This will likely be seen by some physicians as a direct assault on their sense of professional identity and autonomy.” However, “this transparency will help prevent the further erosion of public trust in the medical profession,” he argued.

Disclosures: The literature review was supported in part by a Doris Duke Clinical Research Fellowship. Dr. Gross disclosed having served as an expert witness, and another author disclosed serving as a paid data and safety committee member, for Genzyme Corp. Dr. Campbell did not report any financial disclosures.

Physicians, patients, and research participants believe that researchers' financial ties to industry decrease the quality of research evidence, and patients believe that financial ties influence professional behavior and should be disclosed, a review of studies looking at views on financial ties to pharmaceutical and medical device companies found.

For some patients, knowledge of the researchers' financial ties to industry would affect their willingness to participate in research studies, wrote Dr. Cary Gross of Yale University, New Haven, Conn., and his colleagues (Arch. Intern. Med. 2010;170:675-82).

“When any financial tie was disclosed, there was a reduction in the perceived quality of research among research participants and physicians,” they reported.

They noted that in clinical care, patients believed that financial ties also decreased the quality of care and affected prescribing behavior.

The investigators reviewed 11 original quantitative studies of patients', research participants', and journal readers' views about financial ties and perceptions of quality.

In studies considering patient perception of cost, a range of 26%-76% said they believed that gifts to physicians increase the cost of care, although fewer patients thought professional gifts were a problem.

“For instance, in a 2009 study of 903 patients contacted by telephone, 9% disapproved of physicians receiving free drug samples and 16% disapproved of free medical texts, compared with disapproval rates of 55% and 68%, respectively, for paid dinners and golf tournaments,” Dr. Gross and his colleagues wrote.

In other studies, when respondents were asked to rate study disclosure statements, they deemed researchers with financial tie statements to be less trustworthy and less important than those who did not have them, the researchers noted.

For some potential trial participants, disclosure of financial ties affected their willingness to participate.

“Three studies reported that prospective research participants were least willing to participate in a hypothetical clinical trial when a researcher equity ownership was disclosed,” according to Dr. Gross and his colleagues. “Of note, the participants also reported less trust in researchers after disclosure of financial ties.”

The literature review “suggests that a sizeable portion of the public wants to know about physician financial ties,” and that patients and research participants can distinguish between different types of financial ties and determine the relative importance of disclosure of each, the investigators concluded.

In an accompanying editorial, Eric Campbell, Ph.D., of Harvard Medical School, Boston, noted that patients and research participants want access to data on conflicts of interest to make decisions about the potential impacts of industry relationships on the care they receive.

“For example, they want to be able to ascertain if, and to what extent, their prescriptions could be inappropriately influenced by the financial relationships between their physician and pharmaceutical companies,” Dr. Campbell explained.

However, collecting and presenting industry data in a useful way will not be easy, and “for consumers to use the data, it is clear that the quality of the data that is reported by companies must be improved,” he added.

Public disclosure seems like a likely first step toward a more active government and health care institution role in evaluating and managing physician-industry relationships, Dr. Campbell wrote. “This will likely be seen by some physicians as a direct assault on their sense of professional identity and autonomy.” However, “this transparency will help prevent the further erosion of public trust in the medical profession,” he argued.

Disclosures: The literature review was supported in part by a Doris Duke Clinical Research Fellowship. Dr. Gross disclosed having served as an expert witness, and another author disclosed serving as a paid data and safety committee member, for Genzyme Corp. Dr. Campbell did not report any financial disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Patients, Physicians Want Disclosure of Financial Ties
Display Headline
Patients, Physicians Want Disclosure of Financial Ties
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Reform May Cover Most Uninsured Young Adults

Article Type
Changed
Wed, 03/27/2019 - 13:25
Display Headline
Reform May Cover Most Uninsured Young Adults

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: No disclosures were reported.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the recently passed Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Furthermore, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults (defined by the report as those aged 19-29 years) a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, as unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said.

One-third of all uninsured young people—and 46% of those who both are uninsured and have chronic health problems—reported that their health declined because they delayed getting medical care.

In addition, 60% of young adults without insurance had trouble paying medical bills in 2009, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people who are trying to pay it off. Half of those had asked family for financial help, whereas 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes that are too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance.

This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of new patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: No disclosures were reported.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the recently passed Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Furthermore, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults (defined by the report as those aged 19-29 years) a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, as unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said.

One-third of all uninsured young people—and 46% of those who both are uninsured and have chronic health problems—reported that their health declined because they delayed getting medical care.

In addition, 60% of young adults without insurance had trouble paying medical bills in 2009, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people who are trying to pay it off. Half of those had asked family for financial help, whereas 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes that are too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance.

This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of new patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Major Finding: About half of uninsured young adults will get health insurance coverage by 2014, and most others in that group will be eligible for premium subsidies under the new health insurance reform law, which may enable them to seek needed care and alleviate debt.

Data Source: Commonwealth Fund Survey of Young Adults, 2009

Disclosures: No disclosures were reported.

Health reform could benefit young adults more than any other uninsured group, expanding coverage to almost all 13.7 million of them through a combination of insurance reforms, subsidies, and Medicaid expansion, according to a new report from the Commonwealth Fund.

Provisions of the recently passed Affordable Care Act that extend coverage of young adults as dependents to age 26 years probably will cover about 1.2 million of that population by the end of 2011. Extending Medicaid eligibility could provide coverage to another 7.1 million young people, beginning in 2014, the Commonwealth Fund report said.

Furthermore, combining premium subsidies with opportunities to purchase coverage via a health insurance exchange will provide the remaining uninsured young adults (defined by the report as those aged 19-29 years) a chance to obtain affordable coverage beginning in 2014.

“The benefit of the Affordable Care Act of 2010 for young adults cannot be overstated,” Sara Collins, Ph.D., lead author of the report, said during a press briefing. “All told, the provisions have the potential to cover 13.7 million young adults,” or the same number that were uninsured in 2008.

However, that figure probably underestimates the current number of uninsured young adults, as unemployment has risen dramatically in that population since 2008.

Health care costs represent a significant problem for this group, whether or not they are insured, according to the report. A total of 76% of uninsured young adults and 37% of those with insurance went without needed care in 2009 because of its cost, the report said.

One-third of all uninsured young people—and 46% of those who both are uninsured and have chronic health problems—reported that their health declined because they delayed getting medical care.

In addition, 60% of young adults without insurance had trouble paying medical bills in 2009, compared with 27% of their insured peers, according to the report.

Medical debt also is a problem, the report found, with 11.3 million young people who are trying to pay it off. Half of those had asked family for financial help, whereas 39% said they were unable to meet other financial obligations such as student loans because of their medical debt.

More than half of the 13.7 million uninsured young adults are in families with incomes that will make them newly eligible for Medicaid under the health care reform law. Another 30% are in families whose incomes will qualify them for health insurance premium subsidies so they will not have to spend more than 3%-8% of their income on health insurance premiums. And 12% live in families whose incomes will qualify them for health insurance–premium subsidies so they won't have to spend more than 9.5% of their income on premiums, the Commonwealth Fund study found.

Fewer than 1 million uninsured young adults are expected to have incomes that are too high to qualify for premium assistance, the study authors said.

Many of those who will become newly insured through the law's provisions probably will seek care from primary care physicians rather than getting free care from emergency departments, noted Dr. Collins, the Commonwealth Fund's vice president for affordable health insurance.

This has the potential to help primary care physicians because “these people will be coming in with insurance cards” that will cover much of their care.

“A lot of people have been getting free care,” she said. “Now, providers will be reimbursed for care.”

It's not clear whether the new law will lead to a significant shortage of primary care physicians to care for the influx of new patients, but Dr. Collins said that the law authorizes a significant increase in funding for community health centers, which could take up some of the slack.

The report, “Rite of Passage: Young Adults and the Affordable Care Act of 2010,” was based on federal health insurance data and a national telephone survey of 2,002 young adults.

Publications
Publications
Topics
Article Type
Display Headline
Reform May Cover Most Uninsured Young Adults
Display Headline
Reform May Cover Most Uninsured Young Adults
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

FDA Issues Guidance on Waivers, Conflicts of Interest

Article Type
Changed
Wed, 03/27/2019 - 16:03
Display Headline
FDA Issues Guidance on Waivers, Conflicts of Interest

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf

Publications
Publications
Topics
Article Type
Display Headline
FDA Issues Guidance on Waivers, Conflicts of Interest
Display Headline
FDA Issues Guidance on Waivers, Conflicts of Interest
Article Source

PURLs Copyright

Inside the Article

Article PDF Media