Alicia Ault

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

The American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery will hold their annual meetings jointly in Phoenix in October, the groups announced.

The decision was driven largely by the faltering economy, but also by a desire to offer a new and innovative program to the membership of both societies, according to officers of both groups.

The decision to combine forces at one annual meeting was warmly embraced by board members and the membership.

The goal of the collaboration was primarily to make it less cost-prohibitive for dermatologists to network with each other and with manufacturers and other exhibitors, said Dr. Ranella Hirsch, ASCDAS past president.

“We wanted to deliver more—more attendees, more opinion leaders,” she said, adding that “from our point of view, it was a natural partnership between the best of each society.”

Traditionally, the two meetings are held about 6 weeks apart. Combining them reduces hurdles for dermatologists, who now won't have to shut down a practice twice in a short period, or have to choose between the two meetings, said Dr. Phil Werschler, ASCDAS president.

There is a large overlap between the ASDS and ASCDAS membership, he said. But the ASDS meeting has been more surgically oriented, while the ASCDAS meeting has placed more emphasis on aesthetic procedures, he said.

The ASDS is looking forward to offering some of the more basic courses that ASCDAS offers, Dr. Robert Weiss, ASDS president, said in an interview.

ASCDAS also brings cosmeceutical expertise that ASDS usually only touches on; ASDS will offer more content on skin cancer, and topics such as chemical peels and hair transplants that might not be part of the ASCDAS agenda, Dr. Weiss said.

The idea for a joint meeting may also have been spurred by the spirit of unity embodied by the 2008 presidential election, said Dr. Weiss.

The meeting will “show other specialties our unity and it's going to help propel dermatologic surgery,” he predicted.

Representatives from the two societies said that currently there is no plan to hold a joint meeting again in 2010.

The American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery will hold their annual meetings jointly in Phoenix in October, the groups announced.

The decision was driven largely by the faltering economy, but also by a desire to offer a new and innovative program to the membership of both societies, according to officers of both groups.

The decision to combine forces at one annual meeting was warmly embraced by board members and the membership.

The goal of the collaboration was primarily to make it less cost-prohibitive for dermatologists to network with each other and with manufacturers and other exhibitors, said Dr. Ranella Hirsch, ASCDAS past president.

“We wanted to deliver more—more attendees, more opinion leaders,” she said, adding that “from our point of view, it was a natural partnership between the best of each society.”

Traditionally, the two meetings are held about 6 weeks apart. Combining them reduces hurdles for dermatologists, who now won't have to shut down a practice twice in a short period, or have to choose between the two meetings, said Dr. Phil Werschler, ASCDAS president.

There is a large overlap between the ASDS and ASCDAS membership, he said. But the ASDS meeting has been more surgically oriented, while the ASCDAS meeting has placed more emphasis on aesthetic procedures, he said.

The ASDS is looking forward to offering some of the more basic courses that ASCDAS offers, Dr. Robert Weiss, ASDS president, said in an interview.

ASCDAS also brings cosmeceutical expertise that ASDS usually only touches on; ASDS will offer more content on skin cancer, and topics such as chemical peels and hair transplants that might not be part of the ASCDAS agenda, Dr. Weiss said.

The idea for a joint meeting may also have been spurred by the spirit of unity embodied by the 2008 presidential election, said Dr. Weiss.

The meeting will “show other specialties our unity and it's going to help propel dermatologic surgery,” he predicted.

Representatives from the two societies said that currently there is no plan to hold a joint meeting again in 2010.

The American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery will hold their annual meetings jointly in Phoenix in October, the groups announced.

The decision was driven largely by the faltering economy, but also by a desire to offer a new and innovative program to the membership of both societies, according to officers of both groups.

The decision to combine forces at one annual meeting was warmly embraced by board members and the membership.

The goal of the collaboration was primarily to make it less cost-prohibitive for dermatologists to network with each other and with manufacturers and other exhibitors, said Dr. Ranella Hirsch, ASCDAS past president.

“We wanted to deliver more—more attendees, more opinion leaders,” she said, adding that “from our point of view, it was a natural partnership between the best of each society.”

Traditionally, the two meetings are held about 6 weeks apart. Combining them reduces hurdles for dermatologists, who now won't have to shut down a practice twice in a short period, or have to choose between the two meetings, said Dr. Phil Werschler, ASCDAS president.

There is a large overlap between the ASDS and ASCDAS membership, he said. But the ASDS meeting has been more surgically oriented, while the ASCDAS meeting has placed more emphasis on aesthetic procedures, he said.

The ASDS is looking forward to offering some of the more basic courses that ASCDAS offers, Dr. Robert Weiss, ASDS president, said in an interview.

ASCDAS also brings cosmeceutical expertise that ASDS usually only touches on; ASDS will offer more content on skin cancer, and topics such as chemical peels and hair transplants that might not be part of the ASCDAS agenda, Dr. Weiss said.

The idea for a joint meeting may also have been spurred by the spirit of unity embodied by the 2008 presidential election, said Dr. Weiss.

The meeting will “show other specialties our unity and it's going to help propel dermatologic surgery,” he predicted.

Representatives from the two societies said that currently there is no plan to hold a joint meeting again in 2010.

FDA Says Humira Ad Misleading

The Food and Drug Administration said that Abbott Laboratories downplayed the risks associated with the psoriasis therapy Humira (adalimumab) in an ad intended for dermatologists. The ad was misleading because it "suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience," the FDA noted. The drug has many risks, including tuberculosis and invasive fungal infections, and its use should be carefully weighed, the agency wrote in a December letter to Abbott, which contended that the ad gave a full description of the drug's approved use only in small, "nearly illegible" text. Also, the patient pictured in the ad was not representative of approved users since the model showed only a small area of plaque psoriasis. The agency said Abbott should immediately stop the ads. A company spokeswoman said the ad was discontinued in October and that it will "work with the agency to address their concerns."

Phototherapy Copays Prompt Action

The National Psoriasis Foundation has written to insurance commissioners in six states to request that they encourage health plans to eliminate or reduce patients' copayments for phototherapy sessions. Members of a foundation task force on the issue—who are primarily dermatologists—decided to target commissioners in California, Massachusetts, Missouri, New York, Texas, and Utah. The foundation has received two responses, neither of which was very encouraging, said Sheila Rittenberg, the organization's senior director of advocacy and external affairs. The task force effort came after a failed attempt to convince 85 health insurers around the country to cut copayments, she said in an interview. Patients are paying anywhere from $5 to $50 per psoriasis-phototherapy session, and most need several a week, said Ms. Rittenberg. In some cases, she added, patients are being prescribed biologics because they can't afford phototherapy.

Colorings Must Be Declared

Many foods and cosmetics contain carmine and cochineal, but they have been hidden under the rubric of "artificial coloring" or "colors added." The FDA has ruled that manufacturers must clearly state on labels that carmine and cochineal are in those products. The final rule, published Jan. 5, is partly in response to a petition filed by the Center for Science in the Public Interest in 1998. The nonprofit advocacy group contended that because carmine and cochineal extracts—which give products red hues—come from insects, they were the most likely causes of dozens of allergic reactions. The FDA acknowledged that reactions and anaphylaxis have been associated with carmine- and cochineal-colored products, and the agency first proposed requiring disclosure of the two extracts in 2006. But the FDA has refused to ban the colorants. Manufacturers have 2 years to comply with the new labeling requirements.

2009 Predictions on Cosmetic Front

There will be an increase in horror stories about consumers having bargain cosmetic procedures, and Botox will finally get some competition this year, according to a list of predictions from the American Society for Aesthetic Plastic Surgery. The professional society said that the injectable botulinum toxin Reloxin should gain approval in 2009. The organization also said that noninvasive fat-removal techniques will gain credence as they are tested in clinical trials and that men will continue to be a growing segment of the market for cosmetic procedures. The society said its predictions are based on interviews with plastic surgeons.

FDA Says Humira Ad Misleading

The Food and Drug Administration said that Abbott Laboratories downplayed the risks associated with the psoriasis therapy Humira (adalimumab) in an ad intended for dermatologists. The ad was misleading because it "suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience," the FDA noted. The drug has many risks, including tuberculosis and invasive fungal infections, and its use should be carefully weighed, the agency wrote in a December letter to Abbott, which contended that the ad gave a full description of the drug's approved use only in small, "nearly illegible" text. Also, the patient pictured in the ad was not representative of approved users since the model showed only a small area of plaque psoriasis. The agency said Abbott should immediately stop the ads. A company spokeswoman said the ad was discontinued in October and that it will "work with the agency to address their concerns."

Phototherapy Copays Prompt Action

The National Psoriasis Foundation has written to insurance commissioners in six states to request that they encourage health plans to eliminate or reduce patients' copayments for phototherapy sessions. Members of a foundation task force on the issue—who are primarily dermatologists—decided to target commissioners in California, Massachusetts, Missouri, New York, Texas, and Utah. The foundation has received two responses, neither of which was very encouraging, said Sheila Rittenberg, the organization's senior director of advocacy and external affairs. The task force effort came after a failed attempt to convince 85 health insurers around the country to cut copayments, she said in an interview. Patients are paying anywhere from $5 to $50 per psoriasis-phototherapy session, and most need several a week, said Ms. Rittenberg. In some cases, she added, patients are being prescribed biologics because they can't afford phototherapy.

Colorings Must Be Declared

Many foods and cosmetics contain carmine and cochineal, but they have been hidden under the rubric of "artificial coloring" or "colors added." The FDA has ruled that manufacturers must clearly state on labels that carmine and cochineal are in those products. The final rule, published Jan. 5, is partly in response to a petition filed by the Center for Science in the Public Interest in 1998. The nonprofit advocacy group contended that because carmine and cochineal extracts—which give products red hues—come from insects, they were the most likely causes of dozens of allergic reactions. The FDA acknowledged that reactions and anaphylaxis have been associated with carmine- and cochineal-colored products, and the agency first proposed requiring disclosure of the two extracts in 2006. But the FDA has refused to ban the colorants. Manufacturers have 2 years to comply with the new labeling requirements.

2009 Predictions on Cosmetic Front

There will be an increase in horror stories about consumers having bargain cosmetic procedures, and Botox will finally get some competition this year, according to a list of predictions from the American Society for Aesthetic Plastic Surgery. The professional society said that the injectable botulinum toxin Reloxin should gain approval in 2009. The organization also said that noninvasive fat-removal techniques will gain credence as they are tested in clinical trials and that men will continue to be a growing segment of the market for cosmetic procedures. The society said its predictions are based on interviews with plastic surgeons.

FDA Says Humira Ad Misleading

The Food and Drug Administration said that Abbott Laboratories downplayed the risks associated with the psoriasis therapy Humira (adalimumab) in an ad intended for dermatologists. The ad was misleading because it "suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience," the FDA noted. The drug has many risks, including tuberculosis and invasive fungal infections, and its use should be carefully weighed, the agency wrote in a December letter to Abbott, which contended that the ad gave a full description of the drug's approved use only in small, "nearly illegible" text. Also, the patient pictured in the ad was not representative of approved users since the model showed only a small area of plaque psoriasis. The agency said Abbott should immediately stop the ads. A company spokeswoman said the ad was discontinued in October and that it will "work with the agency to address their concerns."

Phototherapy Copays Prompt Action

The National Psoriasis Foundation has written to insurance commissioners in six states to request that they encourage health plans to eliminate or reduce patients' copayments for phototherapy sessions. Members of a foundation task force on the issue—who are primarily dermatologists—decided to target commissioners in California, Massachusetts, Missouri, New York, Texas, and Utah. The foundation has received two responses, neither of which was very encouraging, said Sheila Rittenberg, the organization's senior director of advocacy and external affairs. The task force effort came after a failed attempt to convince 85 health insurers around the country to cut copayments, she said in an interview. Patients are paying anywhere from $5 to $50 per psoriasis-phototherapy session, and most need several a week, said Ms. Rittenberg. In some cases, she added, patients are being prescribed biologics because they can't afford phototherapy.

Colorings Must Be Declared

Many foods and cosmetics contain carmine and cochineal, but they have been hidden under the rubric of "artificial coloring" or "colors added." The FDA has ruled that manufacturers must clearly state on labels that carmine and cochineal are in those products. The final rule, published Jan. 5, is partly in response to a petition filed by the Center for Science in the Public Interest in 1998. The nonprofit advocacy group contended that because carmine and cochineal extracts—which give products red hues—come from insects, they were the most likely causes of dozens of allergic reactions. The FDA acknowledged that reactions and anaphylaxis have been associated with carmine- and cochineal-colored products, and the agency first proposed requiring disclosure of the two extracts in 2006. But the FDA has refused to ban the colorants. Manufacturers have 2 years to comply with the new labeling requirements.

2009 Predictions on Cosmetic Front

There will be an increase in horror stories about consumers having bargain cosmetic procedures, and Botox will finally get some competition this year, according to a list of predictions from the American Society for Aesthetic Plastic Surgery. The professional society said that the injectable botulinum toxin Reloxin should gain approval in 2009. The organization also said that noninvasive fat-removal techniques will gain credence as they are tested in clinical trials and that men will continue to be a growing segment of the market for cosmetic procedures. The society said its predictions are based on interviews with plastic surgeons.

WASHINGTON — A new study shows that Medicare beneficiaries will be paying more out of pocket for cancer therapies in 2009, and also will have more restrictions on access than they had in the past.

The American Cancer Society's Cancer Action Network (ACS CAN) and Avalere Health, a health care consulting company, studied the changing patterns in out-of-pocket payments and presented the results at a meeting sponsored by the two organizations.

Cancer therapies are covered under Part B and Part D of the Medicare program. Beneficiaries are responsible for copayments that vary. The ACS and Avalere analysis was based on claims and formulary data for about 4,500 Medicare prescription drug plans.

The researchers found that the plans have been moving brand-name oral cancer drugs to higher formulary tiers—essentially requiring much higher copayments from patients.

Tier 1 requires no or very low copays. Cost sharing rises with each succeeding tier level, with beneficiaries being asked to make a copayment for tiers 1–3 and a percentage of the drug's cost starting on tier 4. Four-tier formularies are the most common, although some plans use as many as six tiers, said the Avalere and ACS CAN researchers.

In 2009, the drugs Gleevec (imatinib mesylate), Sutent (sunitinib malate), Tarceva (erlotinib), Thalomid (thalidomide), and Tykerb (lapatinib) will all be placed on a top formulary tier, with beneficiaries having to pay 26%–35% of the drugs' cost. These therapies cost anywhere from $2,000 to $5,000 a month, depending on the drug. Sixty-two percent to 74% of plans require prior authorization for these five therapies, and a quarter to a third limit the quantity of the drug, for instance by limiting the number of pills that can be received in a month.

This reflects a growing trend, said the analysts, noting that from 2006 to 2008, a growing number of health plans have moved Gleevec to a formulary tier requiring greater cost sharing. In 2006, only 37% had the drug on tier 4; in 2007, 73% had the drug on tier 4, and by 2008, 74% listed it as a tier 4 therapy, 8% as a tier 5, and 2% as a tier 6. In 2009, 63% of plans will list Gleevec as a tier 4 drug, 13% as a tier 5, and none as a tier 6, according to Avalere and ACS.

Medicare beneficiaries are also paying a greater percentage of each drug's cost in each year since 2006. For Gleevec, Sutent, and Tarceva, beneficiaries paid an average of 27% of the cost in 2006; by 2009, that will rise to 33%.

A generic of the drug tamoxifen, however, is on the lowest formulary tier for most plans. No plans require prior authorization and 2% limit quantities. Patients generally pay nothing or $10 for a tamoxifen prescription.

The analysts also looked at the typical drug mix for breast and colon cancer and calculated how much beneficiaries would pay out of pocket in 2006 and in 2009. For breast cancer, they used an example of a woman with comorbidities, since it provides a more realistic picture of the patient's total cost-sharing burden, said the analysts. For a breast cancer patient with hyperlipidemia, type 2 diabetes, and hypertension, the Part B cost, which includes the premium and physician administration fees (and assumes that the beneficiary does not have supplemental Part B insurance), would decline from $7,196 in 2006 to $4,964 in 2009.

Drugs covered under Part B included Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Taxotere (docetaxel), Kytril (granisetron), Neulasta (pegfilgrastim), and Aloxi (palonosetron) in 2006. In 2009, Taxotere and Kytril were removed and Taxol (paclitaxel) and Benadryl were added. The Part D cost sharing would rise from a range of $1,747–$2,810 in 2006 to $2,122–$3,239 in 2009. Those therapies include Arimidex (anastrozole), dexa-methasone, prochlorperazine, Lipitor (atorvastatin), Glucophage (metformin), hydrochlorothiazide and Ativan (lorazepam). Fosamax (alendronate) was added to the calculations for 2009.

The difference is starker for colon cancer, largely because of the addition of a single therapy. In 2006, the typical regimen—Camptosar (irinotecan), leuco-vorin, fluorouracil, dolasetron, and dexamethasone—was $8,395 for Part B, and Part D cost sharing (for prochlorperazine) ranged from $29 to $825. With fluorouracil and leucovorin dropped and Erbitux (cetuximab) added to the mix in 2009, Part B costs will hit $14,780. Part D sharing will be relatively unchanged at $21–$654. It also appears that beneficiary Part D out-of-pocket costs vary depending on the state of residence. For instance, breast cancer patients living in California would spend about $3,000 in 2009 if they have coverage with the Humana Standard plan, while patients in Illinois and Florida on the same plan would pay several hundred dollars less.

Premiums, deductibles, and cost sharing for various plans vary greatly, the analysts found. At the five largest drug plans, beneficiaries paid anywhere from nothing to $7 for first-tier drugs. Second-tier therapies cost $22–$40; although one plan charged a 28% coinsurance rate and another 25%. With so much variation, it's difficult to make a blanket statement about the impact of cost sharing for beneficiaries, said Sarah Barber, an ACS CAN researcher. How much beneficiaries will shoulder depends on the type of cancer they have, where they live, the mix of drugs they receive, and what plan they have for Part D, she said.

WASHINGTON — A new study shows that Medicare beneficiaries will be paying more out of pocket for cancer therapies in 2009, and also will have more restrictions on access than they had in the past.

The American Cancer Society's Cancer Action Network (ACS CAN) and Avalere Health, a health care consulting company, studied the changing patterns in out-of-pocket payments and presented the results at a meeting sponsored by the two organizations.

Cancer therapies are covered under Part B and Part D of the Medicare program. Beneficiaries are responsible for copayments that vary. The ACS and Avalere analysis was based on claims and formulary data for about 4,500 Medicare prescription drug plans.

The researchers found that the plans have been moving brand-name oral cancer drugs to higher formulary tiers—essentially requiring much higher copayments from patients.

Tier 1 requires no or very low copays. Cost sharing rises with each succeeding tier level, with beneficiaries being asked to make a copayment for tiers 1–3 and a percentage of the drug's cost starting on tier 4. Four-tier formularies are the most common, although some plans use as many as six tiers, said the Avalere and ACS CAN researchers.

In 2009, the drugs Gleevec (imatinib mesylate), Sutent (sunitinib malate), Tarceva (erlotinib), Thalomid (thalidomide), and Tykerb (lapatinib) will all be placed on a top formulary tier, with beneficiaries having to pay 26%–35% of the drugs' cost. These therapies cost anywhere from $2,000 to $5,000 a month, depending on the drug. Sixty-two percent to 74% of plans require prior authorization for these five therapies, and a quarter to a third limit the quantity of the drug, for instance by limiting the number of pills that can be received in a month.

This reflects a growing trend, said the analysts, noting that from 2006 to 2008, a growing number of health plans have moved Gleevec to a formulary tier requiring greater cost sharing. In 2006, only 37% had the drug on tier 4; in 2007, 73% had the drug on tier 4, and by 2008, 74% listed it as a tier 4 therapy, 8% as a tier 5, and 2% as a tier 6. In 2009, 63% of plans will list Gleevec as a tier 4 drug, 13% as a tier 5, and none as a tier 6, according to Avalere and ACS.

Medicare beneficiaries are also paying a greater percentage of each drug's cost in each year since 2006. For Gleevec, Sutent, and Tarceva, beneficiaries paid an average of 27% of the cost in 2006; by 2009, that will rise to 33%.

A generic of the drug tamoxifen, however, is on the lowest formulary tier for most plans. No plans require prior authorization and 2% limit quantities. Patients generally pay nothing or $10 for a tamoxifen prescription.

The analysts also looked at the typical drug mix for breast and colon cancer and calculated how much beneficiaries would pay out of pocket in 2006 and in 2009. For breast cancer, they used an example of a woman with comorbidities, since it provides a more realistic picture of the patient's total cost-sharing burden, said the analysts. For a breast cancer patient with hyperlipidemia, type 2 diabetes, and hypertension, the Part B cost, which includes the premium and physician administration fees (and assumes that the beneficiary does not have supplemental Part B insurance), would decline from $7,196 in 2006 to $4,964 in 2009.

Drugs covered under Part B included Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Taxotere (docetaxel), Kytril (granisetron), Neulasta (pegfilgrastim), and Aloxi (palonosetron) in 2006. In 2009, Taxotere and Kytril were removed and Taxol (paclitaxel) and Benadryl were added. The Part D cost sharing would rise from a range of $1,747–$2,810 in 2006 to $2,122–$3,239 in 2009. Those therapies include Arimidex (anastrozole), dexa-methasone, prochlorperazine, Lipitor (atorvastatin), Glucophage (metformin), hydrochlorothiazide and Ativan (lorazepam). Fosamax (alendronate) was added to the calculations for 2009.

The difference is starker for colon cancer, largely because of the addition of a single therapy. In 2006, the typical regimen—Camptosar (irinotecan), leuco-vorin, fluorouracil, dolasetron, and dexamethasone—was $8,395 for Part B, and Part D cost sharing (for prochlorperazine) ranged from $29 to $825. With fluorouracil and leucovorin dropped and Erbitux (cetuximab) added to the mix in 2009, Part B costs will hit $14,780. Part D sharing will be relatively unchanged at $21–$654. It also appears that beneficiary Part D out-of-pocket costs vary depending on the state of residence. For instance, breast cancer patients living in California would spend about $3,000 in 2009 if they have coverage with the Humana Standard plan, while patients in Illinois and Florida on the same plan would pay several hundred dollars less.

Premiums, deductibles, and cost sharing for various plans vary greatly, the analysts found. At the five largest drug plans, beneficiaries paid anywhere from nothing to $7 for first-tier drugs. Second-tier therapies cost $22–$40; although one plan charged a 28% coinsurance rate and another 25%. With so much variation, it's difficult to make a blanket statement about the impact of cost sharing for beneficiaries, said Sarah Barber, an ACS CAN researcher. How much beneficiaries will shoulder depends on the type of cancer they have, where they live, the mix of drugs they receive, and what plan they have for Part D, she said.

WASHINGTON — A new study shows that Medicare beneficiaries will be paying more out of pocket for cancer therapies in 2009, and also will have more restrictions on access than they had in the past.

The American Cancer Society's Cancer Action Network (ACS CAN) and Avalere Health, a health care consulting company, studied the changing patterns in out-of-pocket payments and presented the results at a meeting sponsored by the two organizations.

Cancer therapies are covered under Part B and Part D of the Medicare program. Beneficiaries are responsible for copayments that vary. The ACS and Avalere analysis was based on claims and formulary data for about 4,500 Medicare prescription drug plans.

The researchers found that the plans have been moving brand-name oral cancer drugs to higher formulary tiers—essentially requiring much higher copayments from patients.

Tier 1 requires no or very low copays. Cost sharing rises with each succeeding tier level, with beneficiaries being asked to make a copayment for tiers 1–3 and a percentage of the drug's cost starting on tier 4. Four-tier formularies are the most common, although some plans use as many as six tiers, said the Avalere and ACS CAN researchers.

In 2009, the drugs Gleevec (imatinib mesylate), Sutent (sunitinib malate), Tarceva (erlotinib), Thalomid (thalidomide), and Tykerb (lapatinib) will all be placed on a top formulary tier, with beneficiaries having to pay 26%–35% of the drugs' cost. These therapies cost anywhere from $2,000 to $5,000 a month, depending on the drug. Sixty-two percent to 74% of plans require prior authorization for these five therapies, and a quarter to a third limit the quantity of the drug, for instance by limiting the number of pills that can be received in a month.

This reflects a growing trend, said the analysts, noting that from 2006 to 2008, a growing number of health plans have moved Gleevec to a formulary tier requiring greater cost sharing. In 2006, only 37% had the drug on tier 4; in 2007, 73% had the drug on tier 4, and by 2008, 74% listed it as a tier 4 therapy, 8% as a tier 5, and 2% as a tier 6. In 2009, 63% of plans will list Gleevec as a tier 4 drug, 13% as a tier 5, and none as a tier 6, according to Avalere and ACS.

Medicare beneficiaries are also paying a greater percentage of each drug's cost in each year since 2006. For Gleevec, Sutent, and Tarceva, beneficiaries paid an average of 27% of the cost in 2006; by 2009, that will rise to 33%.

A generic of the drug tamoxifen, however, is on the lowest formulary tier for most plans. No plans require prior authorization and 2% limit quantities. Patients generally pay nothing or $10 for a tamoxifen prescription.

The analysts also looked at the typical drug mix for breast and colon cancer and calculated how much beneficiaries would pay out of pocket in 2006 and in 2009. For breast cancer, they used an example of a woman with comorbidities, since it provides a more realistic picture of the patient's total cost-sharing burden, said the analysts. For a breast cancer patient with hyperlipidemia, type 2 diabetes, and hypertension, the Part B cost, which includes the premium and physician administration fees (and assumes that the beneficiary does not have supplemental Part B insurance), would decline from $7,196 in 2006 to $4,964 in 2009.

Drugs covered under Part B included Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Taxotere (docetaxel), Kytril (granisetron), Neulasta (pegfilgrastim), and Aloxi (palonosetron) in 2006. In 2009, Taxotere and Kytril were removed and Taxol (paclitaxel) and Benadryl were added. The Part D cost sharing would rise from a range of $1,747–$2,810 in 2006 to $2,122–$3,239 in 2009. Those therapies include Arimidex (anastrozole), dexa-methasone, prochlorperazine, Lipitor (atorvastatin), Glucophage (metformin), hydrochlorothiazide and Ativan (lorazepam). Fosamax (alendronate) was added to the calculations for 2009.

The difference is starker for colon cancer, largely because of the addition of a single therapy. In 2006, the typical regimen—Camptosar (irinotecan), leuco-vorin, fluorouracil, dolasetron, and dexamethasone—was $8,395 for Part B, and Part D cost sharing (for prochlorperazine) ranged from $29 to $825. With fluorouracil and leucovorin dropped and Erbitux (cetuximab) added to the mix in 2009, Part B costs will hit $14,780. Part D sharing will be relatively unchanged at $21–$654. It also appears that beneficiary Part D out-of-pocket costs vary depending on the state of residence. For instance, breast cancer patients living in California would spend about $3,000 in 2009 if they have coverage with the Humana Standard plan, while patients in Illinois and Florida on the same plan would pay several hundred dollars less.

Premiums, deductibles, and cost sharing for various plans vary greatly, the analysts found. At the five largest drug plans, beneficiaries paid anywhere from nothing to $7 for first-tier drugs. Second-tier therapies cost $22–$40; although one plan charged a 28% coinsurance rate and another 25%. With so much variation, it's difficult to make a blanket statement about the impact of cost sharing for beneficiaries, said Sarah Barber, an ACS CAN researcher. How much beneficiaries will shoulder depends on the type of cancer they have, where they live, the mix of drugs they receive, and what plan they have for Part D, she said.

BALTIMORE — After a daylong discussion, a panel of Medicare advisers tentatively said they support use of computed tomographic colonography to screen for colorectal cancer in average-risk Medicare beneficiaries.

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was given an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, and then was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, when compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to offer coverage of CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March, the American Cancer Society, the U.S. Multi-Society Task Force on Co-lorectal Cancer, and the American College of Radiology issued new cancer screening guidelines, which included the statement that CTC was an acceptable option.

A majority of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6 mm to less than 10 mm, and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were quite concerned about those extracolonic findings, and said that they could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found that it was comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy has the potential for serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. While CTC has no significant harms per 18,000 patients, there is uncertainty regarding the radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

The screening should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

BALTIMORE — After a daylong discussion, a panel of Medicare advisers tentatively said they support use of computed tomographic colonography to screen for colorectal cancer in average-risk Medicare beneficiaries.

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was given an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, and then was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, when compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to offer coverage of CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March, the American Cancer Society, the U.S. Multi-Society Task Force on Co-lorectal Cancer, and the American College of Radiology issued new cancer screening guidelines, which included the statement that CTC was an acceptable option.

A majority of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6 mm to less than 10 mm, and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were quite concerned about those extracolonic findings, and said that they could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found that it was comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy has the potential for serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. While CTC has no significant harms per 18,000 patients, there is uncertainty regarding the radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

The screening should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

BALTIMORE — After a daylong discussion, a panel of Medicare advisers tentatively said they support use of computed tomographic colonography to screen for colorectal cancer in average-risk Medicare beneficiaries.

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was given an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, and then was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, when compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to offer coverage of CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March, the American Cancer Society, the U.S. Multi-Society Task Force on Co-lorectal Cancer, and the American College of Radiology issued new cancer screening guidelines, which included the statement that CTC was an acceptable option.

A majority of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6 mm to less than 10 mm, and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were quite concerned about those extracolonic findings, and said that they could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found that it was comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy has the potential for serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. While CTC has no significant harms per 18,000 patients, there is uncertainty regarding the radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

The screening should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.