Alicia Ault

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment.

In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. More information on eligibility and requirements is at the agency's innovation center's website.

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment.

In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. More information on eligibility and requirements is at the agency's innovation center's website.

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment.

In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. More information on eligibility and requirements is at the agency's innovation center's website.

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the Centers for Medicare and Medicaid (CMS) received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for electronic health records (EHRs) by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren't just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren't just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency's innovation center's website.

Dr. Stuart B. Black, chief of neurology and co-director of the Neuroscience Center at Baylor University Medical Center at Dallas, thought that the newly released rules have some significant and noteworthy changes which may ease many of the requirements to forming ACOs.

The new design for the final rules may make it more attractive for hospitals to consider organizing an ACO. This could put more pressure on staff physicians, including neurologists, to participate in the new health care models. While primary care physicians may only be able to participate in one ACO, it is possible that neurologists and other specialists who are in short supply would be able to belong to more than one ACO, Dr. Black said in an interview.

The rules for credentialing of ACOs may not be something that neurologists and other physicians are accustomed to. Dr. Black, who is chairman of the Texas Neurological Society Medical Economics Committee, emphasized that to maximize the opportunity for shared savings in an ACO, economic criteria will need to be evaluated even more carefully. He indicated that because ACOs are composed of groups of providers who work together to manage and coordinate the care of beneficiaries, cost effectiveness, as well as quality, becomes an integral element in the overall care of patients. If the cost of a physician is excessive relative to his or her peers while providing the same or similar services, this becomes a collective burden to all the ACO members. Dr. Black pointed out that in an ACO, physicians in a leadership position may need to impose economic credentialing criteria on their peers.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The Department of Health and Human Services Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

The full text of the final rule is available at http://bit.ly/oXwIV3

The rules for ACO credentialing may not be something that neurologists and other physicians are accustomed to.

Source DR. BLACK

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the Centers for Medicare and Medicaid (CMS) received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for electronic health records (EHRs) by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren't just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren't just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency's innovation center's website.

Dr. Stuart B. Black, chief of neurology and co-director of the Neuroscience Center at Baylor University Medical Center at Dallas, thought that the newly released rules have some significant and noteworthy changes which may ease many of the requirements to forming ACOs.

The new design for the final rules may make it more attractive for hospitals to consider organizing an ACO. This could put more pressure on staff physicians, including neurologists, to participate in the new health care models. While primary care physicians may only be able to participate in one ACO, it is possible that neurologists and other specialists who are in short supply would be able to belong to more than one ACO, Dr. Black said in an interview.

The rules for credentialing of ACOs may not be something that neurologists and other physicians are accustomed to. Dr. Black, who is chairman of the Texas Neurological Society Medical Economics Committee, emphasized that to maximize the opportunity for shared savings in an ACO, economic criteria will need to be evaluated even more carefully. He indicated that because ACOs are composed of groups of providers who work together to manage and coordinate the care of beneficiaries, cost effectiveness, as well as quality, becomes an integral element in the overall care of patients. If the cost of a physician is excessive relative to his or her peers while providing the same or similar services, this becomes a collective burden to all the ACO members. Dr. Black pointed out that in an ACO, physicians in a leadership position may need to impose economic credentialing criteria on their peers.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The Department of Health and Human Services Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

The full text of the final rule is available at http://bit.ly/oXwIV3

The rules for ACO credentialing may not be something that neurologists and other physicians are accustomed to.

Source DR. BLACK

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the Centers for Medicare and Medicaid (CMS) received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

“Thanks to the generous input of ideas from so many Americans, we've been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders,” Dr. Berwick said.

“When folks see the rules and see the many changes, they will see that CMS listened,” Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for electronic health records (EHRs) by the second year of what will be three-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program's starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance “year” will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren't just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren't just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that “determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.”

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency's innovation center's website.

Dr. Stuart B. Black, chief of neurology and co-director of the Neuroscience Center at Baylor University Medical Center at Dallas, thought that the newly released rules have some significant and noteworthy changes which may ease many of the requirements to forming ACOs.

The new design for the final rules may make it more attractive for hospitals to consider organizing an ACO. This could put more pressure on staff physicians, including neurologists, to participate in the new health care models. While primary care physicians may only be able to participate in one ACO, it is possible that neurologists and other specialists who are in short supply would be able to belong to more than one ACO, Dr. Black said in an interview.

The rules for credentialing of ACOs may not be something that neurologists and other physicians are accustomed to. Dr. Black, who is chairman of the Texas Neurological Society Medical Economics Committee, emphasized that to maximize the opportunity for shared savings in an ACO, economic criteria will need to be evaluated even more carefully. He indicated that because ACOs are composed of groups of providers who work together to manage and coordinate the care of beneficiaries, cost effectiveness, as well as quality, becomes an integral element in the overall care of patients. If the cost of a physician is excessive relative to his or her peers while providing the same or similar services, this becomes a collective burden to all the ACO members. Dr. Black pointed out that in an ACO, physicians in a leadership position may need to impose economic credentialing criteria on their peers.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The Department of Health and Human Services Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

The full text of the final rule is available at http://bit.ly/oXwIV3

The rules for ACO credentialing may not be something that neurologists and other physicians are accustomed to.

Source DR. BLACK

President Obama on Oct. 31 issued an executive order calling on manufacturers to be more proactive in reporting pharmaceutical shortages to the Food and Drug Administration.

The order does not give the FDA any additional authority. Rather, "it will marshal all the resources and regulatory power we already have to make sure Americans don’t leave pharmacies empty handed," Kathleen Sebelius, Health and Human Services secretary, said during a press briefing.

The "announcement today enhances and amplifies efforts we are already undertaking at FDA to monitor and prevent and respond to drug shortages," FDA Commissioner Margaret Hamburg said during the briefing.

Currently, drug makers are required to notify the FDA of an impending shortage if they are a sole-source producer or if the drug is for a life-threatening condition or a life-sustaining treatment, Dr. Hamburg said. The executive order directs the agency to broaden reporting so that it covers more drugs and to further expedite review of new manufacturing sites, drug suppliers, and manufacturing changes.

According to the FDA, the number of reported drug shortages has tripled from 61 in 2005 to 178 last year. The agency issued a report Oct. 31 outlining the shortage issue and its response. Of 127 shortages that were reported in 2010-11, 80% were for sterile injectables, including oncology drugs, antibiotics, and electrolyte/nutrition drugs. The agency found that the main reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).

Shortages continue to be a significant problem. More than 80% of respondents to a recent poll by the Oncology Report said that shortages were affecting their prescribing.

Some shortages have been caused when a manufacturer simply decided to exit the market. But a separate analysis by the Health and Human Services department found that profits were not a key reason for shortages, at least for oncology drugs, Sherry Glied, Ph.D., HHS assistant secretary for planning and evaluation, said during the briefing.

The main issue in oncology is that there’s a greater demand for generics than there is supply, Dr. Glied said.

Dr. Hamburg said that the executive order would help if it spurs manufacturers to notify the agency earlier of impending shortages. The agency prevented 38 shortages in 2010 and 99 so far this year, in part because the manufacturer and the FDA were more proactive, she said.

In a third of the shortages, the agency asked a company to increase production. In 28% of cases, the FDA worked with manufacturers to identify ways of mitigating quality issues by being more flexible, and review of regulatory submissions was expedited in 26% of cases.

In addition to the executive order, the administration took several other steps to address shortages. The FDA sent a letter to drug makers reminding them of their legal responsibility to report the discontinuation of certain drugs and urged more voluntary reporting.

The White House also said that it would give the Department of Justice more authority to investigate potentially exploitative pricing of products in short supply.

The FDA will also double the size of its Drug Shortages Program, from 5 to 11 people, Dr. Hamburg said. She noted that the agency also uses staffers from other divisions to help address shortages.

The White House endorsed legislation that would give the FDA even greater monitoring and enforcement activity. The Preserving Access to Life-Saving Medications Act (S. 296) was introduced in February by Sens. Amy Klobuchar (D-Wisc.) and Bob Casey (R-Pa.).

At press time, the bill had 17 Senate cosponsors. Its House companion, H.R. 2245, was introduced in June by Reps. Tom Rooney (R-Fla.) and Diana DeGette (D-Colo.); that bill has 46 cosponsors.

In a statement, Rep. Rooney said, "I’m very pleased that President Obama is addressing this critical issue and supporting our bipartisan bill. The earlier doctors, suppliers, and the FDA are able to communicate a potential drug shortage, the better equipped they will be to respond and prevent a disruption in supply from occurring."

Rep. DeGette said, "Today’s announcement does not diminish the necessity of passing our bipartisan legislation. Not only does our bill go beyond what the president outlined today, but it will encase in law a common-sense approach to dealing with drugs that are heading toward shortage."

President Obama on Oct. 31 issued an executive order calling on manufacturers to be more proactive in reporting pharmaceutical shortages to the Food and Drug Administration.

The order does not give the FDA any additional authority. Rather, "it will marshal all the resources and regulatory power we already have to make sure Americans don’t leave pharmacies empty handed," Kathleen Sebelius, Health and Human Services secretary, said during a press briefing.

The "announcement today enhances and amplifies efforts we are already undertaking at FDA to monitor and prevent and respond to drug shortages," FDA Commissioner Margaret Hamburg said during the briefing.

Currently, drug makers are required to notify the FDA of an impending shortage if they are a sole-source producer or if the drug is for a life-threatening condition or a life-sustaining treatment, Dr. Hamburg said. The executive order directs the agency to broaden reporting so that it covers more drugs and to further expedite review of new manufacturing sites, drug suppliers, and manufacturing changes.

According to the FDA, the number of reported drug shortages has tripled from 61 in 2005 to 178 last year. The agency issued a report Oct. 31 outlining the shortage issue and its response. Of 127 shortages that were reported in 2010-11, 80% were for sterile injectables, including oncology drugs, antibiotics, and electrolyte/nutrition drugs. The agency found that the main reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).

Shortages continue to be a significant problem. More than 80% of respondents to a recent poll by the Oncology Report said that shortages were affecting their prescribing.

Some shortages have been caused when a manufacturer simply decided to exit the market. But a separate analysis by the Health and Human Services department found that profits were not a key reason for shortages, at least for oncology drugs, Sherry Glied, Ph.D., HHS assistant secretary for planning and evaluation, said during the briefing.

The main issue in oncology is that there’s a greater demand for generics than there is supply, Dr. Glied said.

Dr. Hamburg said that the executive order would help if it spurs manufacturers to notify the agency earlier of impending shortages. The agency prevented 38 shortages in 2010 and 99 so far this year, in part because the manufacturer and the FDA were more proactive, she said.

In a third of the shortages, the agency asked a company to increase production. In 28% of cases, the FDA worked with manufacturers to identify ways of mitigating quality issues by being more flexible, and review of regulatory submissions was expedited in 26% of cases.

In addition to the executive order, the administration took several other steps to address shortages. The FDA sent a letter to drug makers reminding them of their legal responsibility to report the discontinuation of certain drugs and urged more voluntary reporting.

The White House also said that it would give the Department of Justice more authority to investigate potentially exploitative pricing of products in short supply.

The FDA will also double the size of its Drug Shortages Program, from 5 to 11 people, Dr. Hamburg said. She noted that the agency also uses staffers from other divisions to help address shortages.

The White House endorsed legislation that would give the FDA even greater monitoring and enforcement activity. The Preserving Access to Life-Saving Medications Act (S. 296) was introduced in February by Sens. Amy Klobuchar (D-Wisc.) and Bob Casey (R-Pa.).

At press time, the bill had 17 Senate cosponsors. Its House companion, H.R. 2245, was introduced in June by Reps. Tom Rooney (R-Fla.) and Diana DeGette (D-Colo.); that bill has 46 cosponsors.

In a statement, Rep. Rooney said, "I’m very pleased that President Obama is addressing this critical issue and supporting our bipartisan bill. The earlier doctors, suppliers, and the FDA are able to communicate a potential drug shortage, the better equipped they will be to respond and prevent a disruption in supply from occurring."

Rep. DeGette said, "Today’s announcement does not diminish the necessity of passing our bipartisan legislation. Not only does our bill go beyond what the president outlined today, but it will encase in law a common-sense approach to dealing with drugs that are heading toward shortage."

President Obama on Oct. 31 issued an executive order calling on manufacturers to be more proactive in reporting pharmaceutical shortages to the Food and Drug Administration.

The order does not give the FDA any additional authority. Rather, "it will marshal all the resources and regulatory power we already have to make sure Americans don’t leave pharmacies empty handed," Kathleen Sebelius, Health and Human Services secretary, said during a press briefing.

The "announcement today enhances and amplifies efforts we are already undertaking at FDA to monitor and prevent and respond to drug shortages," FDA Commissioner Margaret Hamburg said during the briefing.

Currently, drug makers are required to notify the FDA of an impending shortage if they are a sole-source producer or if the drug is for a life-threatening condition or a life-sustaining treatment, Dr. Hamburg said. The executive order directs the agency to broaden reporting so that it covers more drugs and to further expedite review of new manufacturing sites, drug suppliers, and manufacturing changes.

According to the FDA, the number of reported drug shortages has tripled from 61 in 2005 to 178 last year. The agency issued a report Oct. 31 outlining the shortage issue and its response. Of 127 shortages that were reported in 2010-11, 80% were for sterile injectables, including oncology drugs, antibiotics, and electrolyte/nutrition drugs. The agency found that the main reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).

Shortages continue to be a significant problem. More than 80% of respondents to a recent poll by the Oncology Report said that shortages were affecting their prescribing.

Some shortages have been caused when a manufacturer simply decided to exit the market. But a separate analysis by the Health and Human Services department found that profits were not a key reason for shortages, at least for oncology drugs, Sherry Glied, Ph.D., HHS assistant secretary for planning and evaluation, said during the briefing.

The main issue in oncology is that there’s a greater demand for generics than there is supply, Dr. Glied said.

Dr. Hamburg said that the executive order would help if it spurs manufacturers to notify the agency earlier of impending shortages. The agency prevented 38 shortages in 2010 and 99 so far this year, in part because the manufacturer and the FDA were more proactive, she said.

In a third of the shortages, the agency asked a company to increase production. In 28% of cases, the FDA worked with manufacturers to identify ways of mitigating quality issues by being more flexible, and review of regulatory submissions was expedited in 26% of cases.

In addition to the executive order, the administration took several other steps to address shortages. The FDA sent a letter to drug makers reminding them of their legal responsibility to report the discontinuation of certain drugs and urged more voluntary reporting.

The White House also said that it would give the Department of Justice more authority to investigate potentially exploitative pricing of products in short supply.

The FDA will also double the size of its Drug Shortages Program, from 5 to 11 people, Dr. Hamburg said. She noted that the agency also uses staffers from other divisions to help address shortages.

The White House endorsed legislation that would give the FDA even greater monitoring and enforcement activity. The Preserving Access to Life-Saving Medications Act (S. 296) was introduced in February by Sens. Amy Klobuchar (D-Wisc.) and Bob Casey (R-Pa.).

At press time, the bill had 17 Senate cosponsors. Its House companion, H.R. 2245, was introduced in June by Reps. Tom Rooney (R-Fla.) and Diana DeGette (D-Colo.); that bill has 46 cosponsors.

In a statement, Rep. Rooney said, "I’m very pleased that President Obama is addressing this critical issue and supporting our bipartisan bill. The earlier doctors, suppliers, and the FDA are able to communicate a potential drug shortage, the better equipped they will be to respond and prevent a disruption in supply from occurring."

Rep. DeGette said, "Today’s announcement does not diminish the necessity of passing our bipartisan legislation. Not only does our bill go beyond what the president outlined today, but it will encase in law a common-sense approach to dealing with drugs that are heading toward shortage."

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

"Thanks to the generous input of ideas from so many Americans, we’ve been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders," Dr. Berwick said.

"When folks see the rules and see the many changes, they will see that CMS listened," Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be 3-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program’s starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance "year" will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren’t just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren’t just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that "determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization."

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency’s innovation center’s Web site.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The HHS Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

"Thanks to the generous input of ideas from so many Americans, we’ve been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders," Dr. Berwick said.

"When folks see the rules and see the many changes, they will see that CMS listened," Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be 3-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program’s starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance "year" will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren’t just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren’t just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that "determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization."

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency’s innovation center’s Web site.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The HHS Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

Use of electronic health records is no longer a condition for participating in an accountable care organization, according to the Oct. 20 final rule that will govern how ACOs are constructed and how they will be paid. The change is just one of many in the long-awaited regulation.

The 696-page final rule contains many significant changes that were made in response to the 1,320 comments the agency received on its proposed rule, issued in late March and published April 7 in the Federal Register.

Many physician groups and hospitals complained about various aspects of the proposed rule. They met repeatedly with the agency, CMS Administrator Don Berwick said during a press briefing.

"Thanks to the generous input of ideas from so many Americans, we’ve been able to fine-tune and improve these rules to better meet the needs of a range of stakeholders," Dr. Berwick said.

"When folks see the rules and see the many changes, they will see that CMS listened," Jonathan Blum, CMS deputy administrator and director of the Center for Medicare, said during the briefing.

In the proposed rule, half of primary care physicians in an ACO had to meet the meaningful use criteria for EHRs by the second year of what will be 3-year contracts with the CMS. Under the final rule, EHRs will not be required, but instead be heavily weighted as a measure of quality of care.

The final rule also pushes back the program’s starting dates. Originally, the CMS envisioned a start date of January 2012 for organizations that wanted to participate.

Now, the program will be established by January 2012 with the initial agreements starting in April or July of that year. The first performance "year" will be 18 or 21 months in length, rather than 12 months.

Under the final rule, there are two components to the ACO program: the Shared Savings Program and the Advanced Payment Model.

To be eligible to participate in the Shared Savings Program, ACOs must be able to be held accountable for at least 5,000 beneficiaries a year for each of the 3 years of the agreement. Only certain parties may sponsor an ACO: physicians in group practices, individual practitioner networks, or hospitals. That list was expanded in the final rule to include collaborations between Rural Health Clinics and Federally Qualified Health Centers.

To earn shared savings, ACO participants will have to report on measures that span four quality domains: quality standards, care coordination, preventive health, and at-risk populations. The final rule substantially reduces the number of quality measures, from 65 in five domains to 33 in four domains. In the first year, ACOs that are sharing savings only will be required to report on these measures to receive payment. In the second year, they will need to meet pay-for-performance standards on 25 of the measures, growing to 32 measures in the third year.

In the proposed rule, ACOs could only share savings in the third year of the 3-year agreement. Now, they can share beginning in the first. The CMS says this will help less-experienced organizations gain know-how before they more fully participate in the program. Fuller participation would have ACOs sharing losses, as well.

The savings-only route has ACOs splitting up to 50% of the savings with the CMS. If an ACO chooses to also share losses, it will get up to 60% of the savings. Under the proposed rule, the CMS could withhold 25% of pay-for-performance bonuses, but that has been removed from the final rule.

Also, under the proposed rule, ACOs would only start sharing in the savings after they had passed a minimum threshold set by the CMS. That threshold was established to ensure that the savings weren’t just random, Dr. Berwick said. The minimum still exists under the final rule, but now, if the savings aren’t just due to a random variation in costs, the ACO can share in savings starting with the first dollar, Dr. Berwick said.

The final rule made some changes to how Medicare beneficiaries would be assigned to ACOs, noting that "determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization."

To spur participation in the Shared Savings Program, the CMS also announced that it would make money available to physicians, hospitals, and others for major capital investments under the Advanced Payment Model.

This model will pay a portion of future savings to eligible participants. Once they begin sharing in savings, they will have to repay the money. According to the final rule, eligible ACOs will either receive an upfront, fixed payment; an upfront, variable payment; or a monthly payment of varying amount depending on of the number of Medicare beneficiaries historically attributed to the ACO. More information on eligibility and requirements is at the agency’s innovation center’s Web site.

Simultaneously with the announcement of the final rule, several federal agencies issued additional guidance on how ACOs could steer clear of violating antitrust laws and other measures designed to keep medicine competitive.

The HHS Office of Inspector General also issued an interim final rule on how the ACOs could stay within the antikickback rules.

In the proposed rule, ACOs were required to seek antitrust review from the Federal Trade Commission and the Department of Justice. The final rule lifts that requirement, and instead advises potential ACOs to seek review. Those two agencies issued a final policy statement outlining enforcement plans and indicating that voluntary reviews would likely take about 90 days.

The Washington State chapter of the American College of Emergency Physicians has opened another avenue of discussion in the hopes of overturning a state Medicaid policy that limits nonurgent emergency department visits.

The chapter filed suit on Sept. 30, the day before the new Medicaid policy went into effect. And now, the organization has offered what it hopes will be an alternative solution to help the Health Care Authority (HCA) of Washington meet its budgetary requirements, Dr. Stephen Anderson, president of Washington ACEP, said in an interview.

The plan is aimed at "reducing the perceived ‘overutilization’ and ‘inappropriate’ use of the emergency department that does not impose an arbitrary cap on emergency room visits," according to a draft of the plan made available by Dr. Anderson.

Among the elements of the plan are requiring timely follow-up by primary care physicians, denying payment for ambulance transportation for nonemergency conditions, creating a real-time database to track ED visits, and closer case management. For instance, the patient would be notified when they had used the ED inappropriately.

The plan has not been discussed with the state as of press time, but Dr. Anderson said he is hopeful that the ACEP chapter could reopen negotiations with the HCA.

It is not the first time a payer has attempted to limit ED visits. ACEP successfully got New York State to reverse a policy that would eliminate payment for ED visits for Medicaid patients in the early 1990s, said Dr. Sandra Schneider, ACEP president, in an interview. And the prudent layperson standard came into use as a result of managed care’s efforts to pare back emergency visits, she said.

But the Washington State policy is indicative of a trend in response to a tight fiscal environment; other states are looking at similar policies, said Dr. Schneider – in part because the payers know that "we are the only physicians in this country who are required to see patients," she said.

In 2010, the Washington State legislature, in response to a growing deficit, ordered across the board cuts. Medicaid was not spared, and the HCA was ordered to decrease nonurgent ED visits in collaboration with the state’s medical societies.

Dr. Anderson said that ACEP, the Washington State Medical Association, the Washington State Hospital Association, and the Washington chapter of the American Academy of Pediatrics, among others, met with HCA officials for months to engineer a list of nonurgent conditions.

An original list of 700-800 diagnoses considered nonurgent was floated by the HCA. Through negotiations, "we trimmed it down to 350 diagnoses that we all agreed should be in primary care," Dr. Anderson said.

But when the final policy was issued, the list was back up to 700 conditions that would be considered nonurgent. Beginning Oct. 1, the Medicaid program is paying for only three of these nonemergency visits per patient per year.

"This is a realistic strategy to change clients’ behavior and improve patient care as well as assure taxpayers that we are addressing the state’s continuing financial crisis," said HCA director Doug Porter in a statement issued by the agency announcing the policy in late September.

The list of nonurgent conditions includes chest pain, sudden loss of vision, asthma, miscarriage with hemorrhage, kidney stones, and gallbladder problems. Dr. Anderson said that all of these conditions are typically considered emergent and that they should be exempt under the prudent layperson standard. But the HCA has said that it does not believe that standard applies to its clients, said Dr. Anderson.

Dr. Jeffrey Thompson, HCA’s chief medical officer, said that the standard applies only to managed care, but not to fee-for-service Medicaid. The Medicaid program is "trying to balance access, quality, and cost," said Dr. Thompson, in an interview. To do that and meet the legislature’s requirements, the HCA had to change eligibility, reduce physician payment rates, or change benefits, he said. The first two options are prohibited under various laws, "so the only tool left is to change benefits," he said.

The benefit change should affect few Medicaid recipients, said Dr. Thompson. State data indicate that 13% of recipients account for 43% of all ED visits, he said. Those are costly visits; 28% of all ED visits in the state are paid for by Medicaid. The cost in 2010 was $98 million for 327,965 visits.

The HCA is trying to identify the 11,000 recipients who have been deemed frequent users of the ED. That’s only about 3% of the 2.1 million total Medicaid clients in the state, said Dr. Thompson.

The suit alleges that despite the state’s budgetary issues, the new policy is illegal. The HCA did not follow the legislature’s directive to work cooperatively with the medical societies, and the agency also did not properly adhere to a rule-making process, the suit claims. The policy also conflicts with federal law and "is arbitrary and capricious" because it "includes numerous diagnoses that represent true emergencies," according to the Sept. 30 filing in the Superior Court of Washington for Thurston County.

Dr. Thompson said that there are numerous exceptions to the policy, including if the patient has abnormal vital signs on presentation, has trauma, or abnormal lab findings. Patients who arrive by ambulance or police, for mental health services, or who are admitted will also be exempt.

The emergency room physicians "are in total control of all the coding," said Dr. Thompson.

Dr. Anderson said the exemptions list is "convoluted" and that having to document the exceptions is "one more thing to take you away from treating the patient." And, he said, if the hospital is denied payment but has already paid the physician, the HCA reserves the right to retroactively recover that money from the doctor.

He said he is hopeful that there may be some common ground between ACEP and the HCA in the chapter’s new proposal.

In the meantime, others are taking notice of the HCA’s actions. Dr. Thompson recently gave a Grand Rounds presentation on the ED policy at Johns Hopkins University School of Medicine in Baltimore.

The Washington State chapter of the American College of Emergency Physicians has opened another avenue of discussion in the hopes of overturning a state Medicaid policy that limits nonurgent emergency department visits.

The chapter filed suit on Sept. 30, the day before the new Medicaid policy went into effect. And now, the organization has offered what it hopes will be an alternative solution to help the Health Care Authority (HCA) of Washington meet its budgetary requirements, Dr. Stephen Anderson, president of Washington ACEP, said in an interview.

The plan is aimed at "reducing the perceived ‘overutilization’ and ‘inappropriate’ use of the emergency department that does not impose an arbitrary cap on emergency room visits," according to a draft of the plan made available by Dr. Anderson.

Among the elements of the plan are requiring timely follow-up by primary care physicians, denying payment for ambulance transportation for nonemergency conditions, creating a real-time database to track ED visits, and closer case management. For instance, the patient would be notified when they had used the ED inappropriately.

The plan has not been discussed with the state as of press time, but Dr. Anderson said he is hopeful that the ACEP chapter could reopen negotiations with the HCA.

It is not the first time a payer has attempted to limit ED visits. ACEP successfully got New York State to reverse a policy that would eliminate payment for ED visits for Medicaid patients in the early 1990s, said Dr. Sandra Schneider, ACEP president, in an interview. And the prudent layperson standard came into use as a result of managed care’s efforts to pare back emergency visits, she said.

But the Washington State policy is indicative of a trend in response to a tight fiscal environment; other states are looking at similar policies, said Dr. Schneider – in part because the payers know that "we are the only physicians in this country who are required to see patients," she said.

In 2010, the Washington State legislature, in response to a growing deficit, ordered across the board cuts. Medicaid was not spared, and the HCA was ordered to decrease nonurgent ED visits in collaboration with the state’s medical societies.

Dr. Anderson said that ACEP, the Washington State Medical Association, the Washington State Hospital Association, and the Washington chapter of the American Academy of Pediatrics, among others, met with HCA officials for months to engineer a list of nonurgent conditions.

An original list of 700-800 diagnoses considered nonurgent was floated by the HCA. Through negotiations, "we trimmed it down to 350 diagnoses that we all agreed should be in primary care," Dr. Anderson said.

But when the final policy was issued, the list was back up to 700 conditions that would be considered nonurgent. Beginning Oct. 1, the Medicaid program is paying for only three of these nonemergency visits per patient per year.

"This is a realistic strategy to change clients’ behavior and improve patient care as well as assure taxpayers that we are addressing the state’s continuing financial crisis," said HCA director Doug Porter in a statement issued by the agency announcing the policy in late September.

The list of nonurgent conditions includes chest pain, sudden loss of vision, asthma, miscarriage with hemorrhage, kidney stones, and gallbladder problems. Dr. Anderson said that all of these conditions are typically considered emergent and that they should be exempt under the prudent layperson standard. But the HCA has said that it does not believe that standard applies to its clients, said Dr. Anderson.

Dr. Jeffrey Thompson, HCA’s chief medical officer, said that the standard applies only to managed care, but not to fee-for-service Medicaid. The Medicaid program is "trying to balance access, quality, and cost," said Dr. Thompson, in an interview. To do that and meet the legislature’s requirements, the HCA had to change eligibility, reduce physician payment rates, or change benefits, he said. The first two options are prohibited under various laws, "so the only tool left is to change benefits," he said.

The benefit change should affect few Medicaid recipients, said Dr. Thompson. State data indicate that 13% of recipients account for 43% of all ED visits, he said. Those are costly visits; 28% of all ED visits in the state are paid for by Medicaid. The cost in 2010 was $98 million for 327,965 visits.

The HCA is trying to identify the 11,000 recipients who have been deemed frequent users of the ED. That’s only about 3% of the 2.1 million total Medicaid clients in the state, said Dr. Thompson.

The suit alleges that despite the state’s budgetary issues, the new policy is illegal. The HCA did not follow the legislature’s directive to work cooperatively with the medical societies, and the agency also did not properly adhere to a rule-making process, the suit claims. The policy also conflicts with federal law and "is arbitrary and capricious" because it "includes numerous diagnoses that represent true emergencies," according to the Sept. 30 filing in the Superior Court of Washington for Thurston County.

Dr. Thompson said that there are numerous exceptions to the policy, including if the patient has abnormal vital signs on presentation, has trauma, or abnormal lab findings. Patients who arrive by ambulance or police, for mental health services, or who are admitted will also be exempt.

The emergency room physicians "are in total control of all the coding," said Dr. Thompson.

Dr. Anderson said the exemptions list is "convoluted" and that having to document the exceptions is "one more thing to take you away from treating the patient." And, he said, if the hospital is denied payment but has already paid the physician, the HCA reserves the right to retroactively recover that money from the doctor.

He said he is hopeful that there may be some common ground between ACEP and the HCA in the chapter’s new proposal.

In the meantime, others are taking notice of the HCA’s actions. Dr. Thompson recently gave a Grand Rounds presentation on the ED policy at Johns Hopkins University School of Medicine in Baltimore.

The Washington State chapter of the American College of Emergency Physicians has opened another avenue of discussion in the hopes of overturning a state Medicaid policy that limits nonurgent emergency department visits.

The chapter filed suit on Sept. 30, the day before the new Medicaid policy went into effect. And now, the organization has offered what it hopes will be an alternative solution to help the Health Care Authority (HCA) of Washington meet its budgetary requirements, Dr. Stephen Anderson, president of Washington ACEP, said in an interview.

The plan is aimed at "reducing the perceived ‘overutilization’ and ‘inappropriate’ use of the emergency department that does not impose an arbitrary cap on emergency room visits," according to a draft of the plan made available by Dr. Anderson.

Among the elements of the plan are requiring timely follow-up by primary care physicians, denying payment for ambulance transportation for nonemergency conditions, creating a real-time database to track ED visits, and closer case management. For instance, the patient would be notified when they had used the ED inappropriately.

The plan has not been discussed with the state as of press time, but Dr. Anderson said he is hopeful that the ACEP chapter could reopen negotiations with the HCA.

It is not the first time a payer has attempted to limit ED visits. ACEP successfully got New York State to reverse a policy that would eliminate payment for ED visits for Medicaid patients in the early 1990s, said Dr. Sandra Schneider, ACEP president, in an interview. And the prudent layperson standard came into use as a result of managed care’s efforts to pare back emergency visits, she said.

But the Washington State policy is indicative of a trend in response to a tight fiscal environment; other states are looking at similar policies, said Dr. Schneider – in part because the payers know that "we are the only physicians in this country who are required to see patients," she said.

In 2010, the Washington State legislature, in response to a growing deficit, ordered across the board cuts. Medicaid was not spared, and the HCA was ordered to decrease nonurgent ED visits in collaboration with the state’s medical societies.

Dr. Anderson said that ACEP, the Washington State Medical Association, the Washington State Hospital Association, and the Washington chapter of the American Academy of Pediatrics, among others, met with HCA officials for months to engineer a list of nonurgent conditions.

An original list of 700-800 diagnoses considered nonurgent was floated by the HCA. Through negotiations, "we trimmed it down to 350 diagnoses that we all agreed should be in primary care," Dr. Anderson said.

But when the final policy was issued, the list was back up to 700 conditions that would be considered nonurgent. Beginning Oct. 1, the Medicaid program is paying for only three of these nonemergency visits per patient per year.

"This is a realistic strategy to change clients’ behavior and improve patient care as well as assure taxpayers that we are addressing the state’s continuing financial crisis," said HCA director Doug Porter in a statement issued by the agency announcing the policy in late September.

The list of nonurgent conditions includes chest pain, sudden loss of vision, asthma, miscarriage with hemorrhage, kidney stones, and gallbladder problems. Dr. Anderson said that all of these conditions are typically considered emergent and that they should be exempt under the prudent layperson standard. But the HCA has said that it does not believe that standard applies to its clients, said Dr. Anderson.

Dr. Jeffrey Thompson, HCA’s chief medical officer, said that the standard applies only to managed care, but not to fee-for-service Medicaid. The Medicaid program is "trying to balance access, quality, and cost," said Dr. Thompson, in an interview. To do that and meet the legislature’s requirements, the HCA had to change eligibility, reduce physician payment rates, or change benefits, he said. The first two options are prohibited under various laws, "so the only tool left is to change benefits," he said.

The benefit change should affect few Medicaid recipients, said Dr. Thompson. State data indicate that 13% of recipients account for 43% of all ED visits, he said. Those are costly visits; 28% of all ED visits in the state are paid for by Medicaid. The cost in 2010 was $98 million for 327,965 visits.

The HCA is trying to identify the 11,000 recipients who have been deemed frequent users of the ED. That’s only about 3% of the 2.1 million total Medicaid clients in the state, said Dr. Thompson.

The suit alleges that despite the state’s budgetary issues, the new policy is illegal. The HCA did not follow the legislature’s directive to work cooperatively with the medical societies, and the agency also did not properly adhere to a rule-making process, the suit claims. The policy also conflicts with federal law and "is arbitrary and capricious" because it "includes numerous diagnoses that represent true emergencies," according to the Sept. 30 filing in the Superior Court of Washington for Thurston County.

Dr. Thompson said that there are numerous exceptions to the policy, including if the patient has abnormal vital signs on presentation, has trauma, or abnormal lab findings. Patients who arrive by ambulance or police, for mental health services, or who are admitted will also be exempt.

The emergency room physicians "are in total control of all the coding," said Dr. Thompson.

Dr. Anderson said the exemptions list is "convoluted" and that having to document the exceptions is "one more thing to take you away from treating the patient." And, he said, if the hospital is denied payment but has already paid the physician, the HCA reserves the right to retroactively recover that money from the doctor.

He said he is hopeful that there may be some common ground between ACEP and the HCA in the chapter’s new proposal.

In the meantime, others are taking notice of the HCA’s actions. Dr. Thompson recently gave a Grand Rounds presentation on the ED policy at Johns Hopkins University School of Medicine in Baltimore.

On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.

California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.

P hoto credit: ©Vidmantas Goldbergas/iStock.com

The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.

"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."

According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.

"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S." 

Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.

Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."

The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.

The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.

On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.

California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.

P hoto credit: ©Vidmantas Goldbergas/iStock.com

The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.

"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."

According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.

"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S." 

Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.

Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."

The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.

The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.

On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.

California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.

P hoto credit: ©Vidmantas Goldbergas/iStock.com

The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.

"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."

According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.

"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S." 

Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.

Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."

The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.

The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.

A package of essential health benefits should build upon benefits offered by most small employers and should adhere to an annual premium target, an Institute of Medicine panel recommended Oct. 6.

While the panel did not suggest coverage of specific services or procedures, it explicitly recommended that costs be taken into account when setting benefits.

"If cost is not taken into account, the [essential health benefits] package becomes increasingly expensive, and individuals and small businesses will find it increasingly unaffordable," according to the panel’s report.

The report also pointed out that health benefits are a resource and "no resource is unlimited." Thus, the package should provide a balance between cost and comprehensiveness, said the committee.

The panel was charged with offering guidance to the Health and Human Services department on how to create an essential benefits package. Under the Affordable Care Act (ACA), all state health insurance exchanges must offer such a package when they start up in 2014.

Setting a premium target will be essential to getting that balance, according to the Institute of Medicine panelists. The target "acknowledges that everybody cannot have everything they want," IOM committee member Christopher F. Koller, who is health insurance commissioner for Rhode Island, said during a press briefing.

"If we ignore rising health costs, we’re set up to fail," said panelist Elizabeth A. McGlynn, director of the Kaiser Permanente Center for Effectiveness Research.

The panel urged transparency and flexibility in all aspects of creating the package, in part in recognition that health care is a dynamic area with constantly evolving technologies and methods of delivery.

"The report recognizes that we had to develop a strategy that works today and in the future," Ms. McGlynn said.

To get to the initial premium target, the committee recommended tying the benefits package to what small employers would have paid, on average, for benefits in 2014. The target should be updated annually, based on medical inflation, according to the report.

The panel also endorsed the use of "medical necessity" to guide decisions on whether certain procedures or services should be covered, and called for transparency in developing rules for that process.

Comparative effectiveness research and evidence-based practices should be used when designing benefits, according to the report. "New and alternative treatments, in the view of the committee, should meet the standard of providing increased health gains at the same or lower cost."

States should have some flexibility in designing their own benefits packages, but only if the packages are consistent with ACA requirements and if not more generous that the federal package, according to the report, which now will be submitted to Health and Human Services.

The agency will quickly review the recommendations, Secretary Kathleen Sebelius said in a statement.

"But before we put forward a proposal, it is critical that we hear from the American people," Ms. Sebelius said. "HHS will initiate a series of listening sessions where Americans from across the country will have the chance to share their thoughts on these issues."

The agency then will propose a rule outlining more specifically how the benefits packages can be designed.

The IOM panel recommended that the secretary establish the initial package by May 1, 2012.

While the panel’s recommendations are not binding, HHS has closely followed previous IOM guidance, most recently in adopting almost wholesale its recommendations on preventive health services for women in a final rule issued in August.

The IOM panel was headed by Dr. John R. Ball, a former executive vice president of the American Society for Clinical Pathology. The panel was dominated by policy experts, but also included Dr. Alan Nelson, a former internist and endocrinologist who has been an adviser to the American College of Physicians.

A package of essential health benefits should build upon benefits offered by most small employers and should adhere to an annual premium target, an Institute of Medicine panel recommended Oct. 6.

While the panel did not suggest coverage of specific services or procedures, it explicitly recommended that costs be taken into account when setting benefits.

"If cost is not taken into account, the [essential health benefits] package becomes increasingly expensive, and individuals and small businesses will find it increasingly unaffordable," according to the panel’s report.

The report also pointed out that health benefits are a resource and "no resource is unlimited." Thus, the package should provide a balance between cost and comprehensiveness, said the committee.

The panel was charged with offering guidance to the Health and Human Services department on how to create an essential benefits package. Under the Affordable Care Act (ACA), all state health insurance exchanges must offer such a package when they start up in 2014.

Setting a premium target will be essential to getting that balance, according to the Institute of Medicine panelists. The target "acknowledges that everybody cannot have everything they want," IOM committee member Christopher F. Koller, who is health insurance commissioner for Rhode Island, said during a press briefing.

"If we ignore rising health costs, we’re set up to fail," said panelist Elizabeth A. McGlynn, director of the Kaiser Permanente Center for Effectiveness Research.

The panel urged transparency and flexibility in all aspects of creating the package, in part in recognition that health care is a dynamic area with constantly evolving technologies and methods of delivery.

"The report recognizes that we had to develop a strategy that works today and in the future," Ms. McGlynn said.

To get to the initial premium target, the committee recommended tying the benefits package to what small employers would have paid, on average, for benefits in 2014. The target should be updated annually, based on medical inflation, according to the report.

The panel also endorsed the use of "medical necessity" to guide decisions on whether certain procedures or services should be covered, and called for transparency in developing rules for that process.

Comparative effectiveness research and evidence-based practices should be used when designing benefits, according to the report. "New and alternative treatments, in the view of the committee, should meet the standard of providing increased health gains at the same or lower cost."

States should have some flexibility in designing their own benefits packages, but only if the packages are consistent with ACA requirements and if not more generous that the federal package, according to the report, which now will be submitted to Health and Human Services.

The agency will quickly review the recommendations, Secretary Kathleen Sebelius said in a statement.

"But before we put forward a proposal, it is critical that we hear from the American people," Ms. Sebelius said. "HHS will initiate a series of listening sessions where Americans from across the country will have the chance to share their thoughts on these issues."

The agency then will propose a rule outlining more specifically how the benefits packages can be designed.

The IOM panel recommended that the secretary establish the initial package by May 1, 2012.

While the panel’s recommendations are not binding, HHS has closely followed previous IOM guidance, most recently in adopting almost wholesale its recommendations on preventive health services for women in a final rule issued in August.

The IOM panel was headed by Dr. John R. Ball, a former executive vice president of the American Society for Clinical Pathology. The panel was dominated by policy experts, but also included Dr. Alan Nelson, a former internist and endocrinologist who has been an adviser to the American College of Physicians.

A package of essential health benefits should build upon benefits offered by most small employers and should adhere to an annual premium target, an Institute of Medicine panel recommended Oct. 6.

While the panel did not suggest coverage of specific services or procedures, it explicitly recommended that costs be taken into account when setting benefits.

"If cost is not taken into account, the [essential health benefits] package becomes increasingly expensive, and individuals and small businesses will find it increasingly unaffordable," according to the panel’s report.

The report also pointed out that health benefits are a resource and "no resource is unlimited." Thus, the package should provide a balance between cost and comprehensiveness, said the committee.

The panel was charged with offering guidance to the Health and Human Services department on how to create an essential benefits package. Under the Affordable Care Act (ACA), all state health insurance exchanges must offer such a package when they start up in 2014.

Setting a premium target will be essential to getting that balance, according to the Institute of Medicine panelists. The target "acknowledges that everybody cannot have everything they want," IOM committee member Christopher F. Koller, who is health insurance commissioner for Rhode Island, said during a press briefing.

"If we ignore rising health costs, we’re set up to fail," said panelist Elizabeth A. McGlynn, director of the Kaiser Permanente Center for Effectiveness Research.

The panel urged transparency and flexibility in all aspects of creating the package, in part in recognition that health care is a dynamic area with constantly evolving technologies and methods of delivery.

"The report recognizes that we had to develop a strategy that works today and in the future," Ms. McGlynn said.

To get to the initial premium target, the committee recommended tying the benefits package to what small employers would have paid, on average, for benefits in 2014. The target should be updated annually, based on medical inflation, according to the report.

The panel also endorsed the use of "medical necessity" to guide decisions on whether certain procedures or services should be covered, and called for transparency in developing rules for that process.

Comparative effectiveness research and evidence-based practices should be used when designing benefits, according to the report. "New and alternative treatments, in the view of the committee, should meet the standard of providing increased health gains at the same or lower cost."

States should have some flexibility in designing their own benefits packages, but only if the packages are consistent with ACA requirements and if not more generous that the federal package, according to the report, which now will be submitted to Health and Human Services.

The agency will quickly review the recommendations, Secretary Kathleen Sebelius said in a statement.

"But before we put forward a proposal, it is critical that we hear from the American people," Ms. Sebelius said. "HHS will initiate a series of listening sessions where Americans from across the country will have the chance to share their thoughts on these issues."

The agency then will propose a rule outlining more specifically how the benefits packages can be designed.

The IOM panel recommended that the secretary establish the initial package by May 1, 2012.

While the panel’s recommendations are not binding, HHS has closely followed previous IOM guidance, most recently in adopting almost wholesale its recommendations on preventive health services for women in a final rule issued in August.

The IOM panel was headed by Dr. John R. Ball, a former executive vice president of the American Society for Clinical Pathology. The panel was dominated by policy experts, but also included Dr. Alan Nelson, a former internist and endocrinologist who has been an adviser to the American College of Physicians.

The Centers for Medicare and Medicaid Services said on Sept. 30 that it is soliciting comments on a proposal to cover laparoscopic sleeve gastrectomy for Medicare patients.

Currently, that procedure is not covered by the federal health program. In its solicitation, the agency said it is asking the public "whether there is adequate evidence, including clinical trials, for evaluating health outcomes of laparoscopic sleeve gastrectomy (LSG) for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination."

LSG is a procedure in which the vast majority of the stomach is removed, leaving a tube or sleeve. It may be a first step before a gastric bypass, or it may be the primary procedure. It is an option for patients with a very high body mass index (BMI) who cannot tolerate a bypass procedure. Postoperatively, patients do not experience dumping or malabsorption of nutrients. However, if weight is regained, the decision about what to do next is not easy (World J. Gastroenterol. 2008;14:821-7).

Medicare has covered three bariatric procedures since 2006: open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch.

The procedures are reimbursed only for Medicare beneficiaries who have a BMI of 35 kg/m² or greater; who have at least one obesity-related comorbidity, such as cardiovascular disease, chronic obstructive pulmonary disease, or type 2 diabetes mellitus; and who have not been successfully treated otherwise.

In order to be covered, the procedures must be performed at facilities certified either by the American College of Surgeons (ACS) as a level I bariatric surgery center or by the American Society for Metabolic and Bariatric Surgery as a bariatric surgery center of excellence (BSCOE).

Open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, and open adjustable gastric banding are among the bariatric procedures that are not currently covered.

A recent observational study presented at the annual meeting of the American Surgical Association found that at 1 year after surgery, LSG was associated with morbidity and effectiveness rates that fell between those of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y bypass procedures.

The absolute reduction in BMI at 1 year was smallest in the laparoscopic adjustable gastric banding group at about 6, greatest with open or laparoscopic Roux-en-Y gastric bypass at about 15, and intermediate at close to 12 with LSG.

The study, based on prospective, longitudinal, standardized data from 109 hospitals, was the first to come out of the ACS Bariatric Surgery Center Network accreditation program. Additional years of follow-up are planned, according to Dr. Matthew M. Hutter, an ACS Fellow with Massachusetts General Hospital, Boston.

Dr. Hutter reported no financial conflicts.

CMS will seek public comment until Oct. 30. The agency plans to issue a proposed decision by March 30, 2012, and to make a final decision by June 30.

The Centers for Medicare and Medicaid Services said on Sept. 30 that it is soliciting comments on a proposal to cover laparoscopic sleeve gastrectomy for Medicare patients.

Currently, that procedure is not covered by the federal health program. In its solicitation, the agency said it is asking the public "whether there is adequate evidence, including clinical trials, for evaluating health outcomes of laparoscopic sleeve gastrectomy (LSG) for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination."

LSG is a procedure in which the vast majority of the stomach is removed, leaving a tube or sleeve. It may be a first step before a gastric bypass, or it may be the primary procedure. It is an option for patients with a very high body mass index (BMI) who cannot tolerate a bypass procedure. Postoperatively, patients do not experience dumping or malabsorption of nutrients. However, if weight is regained, the decision about what to do next is not easy (World J. Gastroenterol. 2008;14:821-7).

Medicare has covered three bariatric procedures since 2006: open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch.

The procedures are reimbursed only for Medicare beneficiaries who have a BMI of 35 kg/m² or greater; who have at least one obesity-related comorbidity, such as cardiovascular disease, chronic obstructive pulmonary disease, or type 2 diabetes mellitus; and who have not been successfully treated otherwise.

In order to be covered, the procedures must be performed at facilities certified either by the American College of Surgeons (ACS) as a level I bariatric surgery center or by the American Society for Metabolic and Bariatric Surgery as a bariatric surgery center of excellence (BSCOE).

Open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, and open adjustable gastric banding are among the bariatric procedures that are not currently covered.

A recent observational study presented at the annual meeting of the American Surgical Association found that at 1 year after surgery, LSG was associated with morbidity and effectiveness rates that fell between those of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y bypass procedures.

The absolute reduction in BMI at 1 year was smallest in the laparoscopic adjustable gastric banding group at about 6, greatest with open or laparoscopic Roux-en-Y gastric bypass at about 15, and intermediate at close to 12 with LSG.

The study, based on prospective, longitudinal, standardized data from 109 hospitals, was the first to come out of the ACS Bariatric Surgery Center Network accreditation program. Additional years of follow-up are planned, according to Dr. Matthew M. Hutter, an ACS Fellow with Massachusetts General Hospital, Boston.

Dr. Hutter reported no financial conflicts.

CMS will seek public comment until Oct. 30. The agency plans to issue a proposed decision by March 30, 2012, and to make a final decision by June 30.

The Centers for Medicare and Medicaid Services said on Sept. 30 that it is soliciting comments on a proposal to cover laparoscopic sleeve gastrectomy for Medicare patients.

Currently, that procedure is not covered by the federal health program. In its solicitation, the agency said it is asking the public "whether there is adequate evidence, including clinical trials, for evaluating health outcomes of laparoscopic sleeve gastrectomy (LSG) for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination."

LSG is a procedure in which the vast majority of the stomach is removed, leaving a tube or sleeve. It may be a first step before a gastric bypass, or it may be the primary procedure. It is an option for patients with a very high body mass index (BMI) who cannot tolerate a bypass procedure. Postoperatively, patients do not experience dumping or malabsorption of nutrients. However, if weight is regained, the decision about what to do next is not easy (World J. Gastroenterol. 2008;14:821-7).

Medicare has covered three bariatric procedures since 2006: open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch.

The procedures are reimbursed only for Medicare beneficiaries who have a BMI of 35 kg/m² or greater; who have at least one obesity-related comorbidity, such as cardiovascular disease, chronic obstructive pulmonary disease, or type 2 diabetes mellitus; and who have not been successfully treated otherwise.

In order to be covered, the procedures must be performed at facilities certified either by the American College of Surgeons (ACS) as a level I bariatric surgery center or by the American Society for Metabolic and Bariatric Surgery as a bariatric surgery center of excellence (BSCOE).

Open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, and open adjustable gastric banding are among the bariatric procedures that are not currently covered.

A recent observational study presented at the annual meeting of the American Surgical Association found that at 1 year after surgery, LSG was associated with morbidity and effectiveness rates that fell between those of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y bypass procedures.

The absolute reduction in BMI at 1 year was smallest in the laparoscopic adjustable gastric banding group at about 6, greatest with open or laparoscopic Roux-en-Y gastric bypass at about 15, and intermediate at close to 12 with LSG.

The study, based on prospective, longitudinal, standardized data from 109 hospitals, was the first to come out of the ACS Bariatric Surgery Center Network accreditation program. Additional years of follow-up are planned, according to Dr. Matthew M. Hutter, an ACS Fellow with Massachusetts General Hospital, Boston.

Dr. Hutter reported no financial conflicts.

CMS will seek public comment until Oct. 30. The agency plans to issue a proposed decision by March 30, 2012, and to make a final decision by June 30.

WASHINGTON – An assay that can detect the presence of epidermal growth factor receptor mutations in non–small cell lung cancer patients is being vastly underused in the United States, according to a study presented at the conference sponsored by the American Association for Cancer Research.

An EGFR diagnostic was launched by Genzyme Corp. in 2005. Patients with EGFR mutations generally respond better to certain therapies – such as erlotinib (Tarceva) and geftinib (Iressa) – that target these mutations.

Earlier this year, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommended EGFR testing for lung cancer patients. ASCO’s provisional clinical opinion advocated that patients with advanced NSCLC who were being considered for treatment with a tyrosine kinase inhibitor should be tested for EGFR mutations. The NCCN called for EGFR testing after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma, but not in patients with squamous cell disease which is less likely to be EGFR positive.

And yet, it appears that the assay is not being widely used, said Julie Lynch, R.N., a research assistant at the University of Massachusetts, Boston, who conducted the study.

After conducting a systematic review of erlotinib trials, Ms. Lynch, a PhD nursing candidate, was concerned that few blacks or Hispanics were enrolled. She decided to determine whether minorities might not be included because they were not being tested for the EGFR mutations.

Genzyme agreed to share the data it had with Ms. Lynch. The Genzyme database represents an estimated 98% of community hospital use of the EGFR assay. However, it does not present a comprehensive picture. Ms. Lynch had very little data from the 59 cancer centers with special designation from the National Cancer Institute. Many of these NCI centers have separate licenses from Genzyme or conduct their own assays for research purposes.

To get a better picture of where these tests were being used, she merged Genzyme’s data on EGFR testing with six public data sets, from the U.S. Census Bureau, the Centers for Disease Control and Prevention, the National Institute of Standards and Technology, the Centers for Medicare and Medicaid Services, and the NCI. She linked test orders to specific providers to create a nationwide map that shows county-by-county use of EGFR testing.

Ms. Lynch found that in 2010, some 6,056 tests were ordered by acute care hospitals, 93 by federal hospitals (primarily Veterans Affairs hospitals), 527 by pathology labs, and 258 by independent outpatient oncology clinics or physicians. She was able to ascertain that some 1,019 EGFR tests were ordered by NCI centers, but again, this is likely only a partial tally.

To put these numbers in perspective, the American Cancer Society estimates that there will be about 221,130 new cases diagnosed in 2011 for all types of lung cancer combined. Non–small cell lung cancers account for 80%-90% of all lung cancers.

Test orders seemed to be clustered around NCI-designated centers, Ms. Lynch said in an interview. Most likely, community hospitals that were within a relatively close distance to those NCI centers ordered more EGFR tests to compete.

Her data showed huge regional variations in EGFR use. The test was ordered in only 357 of the 3,142 counties in the United States. The largest concentrations were in Nassau County, N.Y.; New York County, N.Y.; Baltimore County, Md.; Kent County, Mich.; and Cook County, Ill. Also in the top 10 were Brooklyn, N.Y., and the counties surrounding Phoenix, Boston, Miami, and Los Angeles. Most of those top users were very close to an NCI-designated center.

When Ms. Lynch excluded the tests ordered by NCI centers, she found a bleak picture: Not a single test was ordered in Alaska; there is no NCI-designated center in that state. Only one test was ordered in Montana, one in Vermont and two in Wyoming; there are no NCI centers in those states. Only five tests were ordered in Utah, despite the presence of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Only six tests were ordered in Arkansas and six in New Mexico.

The top states for EGFR use were Illinois (272 tests), Maryland (284), Massachusetts (334), Pennsylvania (338), California (352), Florida (496), and New York (1,024).

She found that the counties with the highest lung cancer incidence have the lowest rate of EGFR use. It’s also apparent that minorities and people with a lower socioeconomic and educational status, or those who live in rural areas, are not getting access to the EGFR test, said Ms. Lynch.

She is currently accumulating Medicare-specific data for EGFR testing, which, along with the Genzyme data, should give a complete picture. The federal health program began reimbursing EGFR testing in 2009.

Ms. Lynch ruled out reimbursement issues and technological constraints as factors in underuse of the tests, but acknowledged that even with Medicare coverage, it could be an expensive proposition for a beneficiary, as they have a 20% copay. The test costs $600-$800, she said.

EGFR testing needs to be more widespread, said Ms. Lynch, noting that not only does it help patients get the best treatment, but that it also provides crucial data for the development of new therapies.

The study was funded by grants from the U.S. Department of Education and the National Institutes of Health, and was aided by the provision of data by Genzyme Genetics. Ms. Lynch is a former employee of Genentech Corp.

WASHINGTON – An assay that can detect the presence of epidermal growth factor receptor mutations in non–small cell lung cancer patients is being vastly underused in the United States, according to a study presented at the conference sponsored by the American Association for Cancer Research.

An EGFR diagnostic was launched by Genzyme Corp. in 2005. Patients with EGFR mutations generally respond better to certain therapies – such as erlotinib (Tarceva) and geftinib (Iressa) – that target these mutations.

Earlier this year, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommended EGFR testing for lung cancer patients. ASCO’s provisional clinical opinion advocated that patients with advanced NSCLC who were being considered for treatment with a tyrosine kinase inhibitor should be tested for EGFR mutations. The NCCN called for EGFR testing after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma, but not in patients with squamous cell disease which is less likely to be EGFR positive.

And yet, it appears that the assay is not being widely used, said Julie Lynch, R.N., a research assistant at the University of Massachusetts, Boston, who conducted the study.

After conducting a systematic review of erlotinib trials, Ms. Lynch, a PhD nursing candidate, was concerned that few blacks or Hispanics were enrolled. She decided to determine whether minorities might not be included because they were not being tested for the EGFR mutations.

Genzyme agreed to share the data it had with Ms. Lynch. The Genzyme database represents an estimated 98% of community hospital use of the EGFR assay. However, it does not present a comprehensive picture. Ms. Lynch had very little data from the 59 cancer centers with special designation from the National Cancer Institute. Many of these NCI centers have separate licenses from Genzyme or conduct their own assays for research purposes.

To get a better picture of where these tests were being used, she merged Genzyme’s data on EGFR testing with six public data sets, from the U.S. Census Bureau, the Centers for Disease Control and Prevention, the National Institute of Standards and Technology, the Centers for Medicare and Medicaid Services, and the NCI. She linked test orders to specific providers to create a nationwide map that shows county-by-county use of EGFR testing.

Ms. Lynch found that in 2010, some 6,056 tests were ordered by acute care hospitals, 93 by federal hospitals (primarily Veterans Affairs hospitals), 527 by pathology labs, and 258 by independent outpatient oncology clinics or physicians. She was able to ascertain that some 1,019 EGFR tests were ordered by NCI centers, but again, this is likely only a partial tally.

To put these numbers in perspective, the American Cancer Society estimates that there will be about 221,130 new cases diagnosed in 2011 for all types of lung cancer combined. Non–small cell lung cancers account for 80%-90% of all lung cancers.

Test orders seemed to be clustered around NCI-designated centers, Ms. Lynch said in an interview. Most likely, community hospitals that were within a relatively close distance to those NCI centers ordered more EGFR tests to compete.

Her data showed huge regional variations in EGFR use. The test was ordered in only 357 of the 3,142 counties in the United States. The largest concentrations were in Nassau County, N.Y.; New York County, N.Y.; Baltimore County, Md.; Kent County, Mich.; and Cook County, Ill. Also in the top 10 were Brooklyn, N.Y., and the counties surrounding Phoenix, Boston, Miami, and Los Angeles. Most of those top users were very close to an NCI-designated center.

When Ms. Lynch excluded the tests ordered by NCI centers, she found a bleak picture: Not a single test was ordered in Alaska; there is no NCI-designated center in that state. Only one test was ordered in Montana, one in Vermont and two in Wyoming; there are no NCI centers in those states. Only five tests were ordered in Utah, despite the presence of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Only six tests were ordered in Arkansas and six in New Mexico.

The top states for EGFR use were Illinois (272 tests), Maryland (284), Massachusetts (334), Pennsylvania (338), California (352), Florida (496), and New York (1,024).

She found that the counties with the highest lung cancer incidence have the lowest rate of EGFR use. It’s also apparent that minorities and people with a lower socioeconomic and educational status, or those who live in rural areas, are not getting access to the EGFR test, said Ms. Lynch.

She is currently accumulating Medicare-specific data for EGFR testing, which, along with the Genzyme data, should give a complete picture. The federal health program began reimbursing EGFR testing in 2009.

Ms. Lynch ruled out reimbursement issues and technological constraints as factors in underuse of the tests, but acknowledged that even with Medicare coverage, it could be an expensive proposition for a beneficiary, as they have a 20% copay. The test costs $600-$800, she said.

EGFR testing needs to be more widespread, said Ms. Lynch, noting that not only does it help patients get the best treatment, but that it also provides crucial data for the development of new therapies.

The study was funded by grants from the U.S. Department of Education and the National Institutes of Health, and was aided by the provision of data by Genzyme Genetics. Ms. Lynch is a former employee of Genentech Corp.

WASHINGTON – An assay that can detect the presence of epidermal growth factor receptor mutations in non–small cell lung cancer patients is being vastly underused in the United States, according to a study presented at the conference sponsored by the American Association for Cancer Research.

An EGFR diagnostic was launched by Genzyme Corp. in 2005. Patients with EGFR mutations generally respond better to certain therapies – such as erlotinib (Tarceva) and geftinib (Iressa) – that target these mutations.

Earlier this year, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommended EGFR testing for lung cancer patients. ASCO’s provisional clinical opinion advocated that patients with advanced NSCLC who were being considered for treatment with a tyrosine kinase inhibitor should be tested for EGFR mutations. The NCCN called for EGFR testing after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma, but not in patients with squamous cell disease which is less likely to be EGFR positive.

And yet, it appears that the assay is not being widely used, said Julie Lynch, R.N., a research assistant at the University of Massachusetts, Boston, who conducted the study.

After conducting a systematic review of erlotinib trials, Ms. Lynch, a PhD nursing candidate, was concerned that few blacks or Hispanics were enrolled. She decided to determine whether minorities might not be included because they were not being tested for the EGFR mutations.

Genzyme agreed to share the data it had with Ms. Lynch. The Genzyme database represents an estimated 98% of community hospital use of the EGFR assay. However, it does not present a comprehensive picture. Ms. Lynch had very little data from the 59 cancer centers with special designation from the National Cancer Institute. Many of these NCI centers have separate licenses from Genzyme or conduct their own assays for research purposes.

To get a better picture of where these tests were being used, she merged Genzyme’s data on EGFR testing with six public data sets, from the U.S. Census Bureau, the Centers for Disease Control and Prevention, the National Institute of Standards and Technology, the Centers for Medicare and Medicaid Services, and the NCI. She linked test orders to specific providers to create a nationwide map that shows county-by-county use of EGFR testing.

Ms. Lynch found that in 2010, some 6,056 tests were ordered by acute care hospitals, 93 by federal hospitals (primarily Veterans Affairs hospitals), 527 by pathology labs, and 258 by independent outpatient oncology clinics or physicians. She was able to ascertain that some 1,019 EGFR tests were ordered by NCI centers, but again, this is likely only a partial tally.

To put these numbers in perspective, the American Cancer Society estimates that there will be about 221,130 new cases diagnosed in 2011 for all types of lung cancer combined. Non–small cell lung cancers account for 80%-90% of all lung cancers.

Test orders seemed to be clustered around NCI-designated centers, Ms. Lynch said in an interview. Most likely, community hospitals that were within a relatively close distance to those NCI centers ordered more EGFR tests to compete.

Her data showed huge regional variations in EGFR use. The test was ordered in only 357 of the 3,142 counties in the United States. The largest concentrations were in Nassau County, N.Y.; New York County, N.Y.; Baltimore County, Md.; Kent County, Mich.; and Cook County, Ill. Also in the top 10 were Brooklyn, N.Y., and the counties surrounding Phoenix, Boston, Miami, and Los Angeles. Most of those top users were very close to an NCI-designated center.

When Ms. Lynch excluded the tests ordered by NCI centers, she found a bleak picture: Not a single test was ordered in Alaska; there is no NCI-designated center in that state. Only one test was ordered in Montana, one in Vermont and two in Wyoming; there are no NCI centers in those states. Only five tests were ordered in Utah, despite the presence of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Only six tests were ordered in Arkansas and six in New Mexico.

The top states for EGFR use were Illinois (272 tests), Maryland (284), Massachusetts (334), Pennsylvania (338), California (352), Florida (496), and New York (1,024).

She found that the counties with the highest lung cancer incidence have the lowest rate of EGFR use. It’s also apparent that minorities and people with a lower socioeconomic and educational status, or those who live in rural areas, are not getting access to the EGFR test, said Ms. Lynch.

She is currently accumulating Medicare-specific data for EGFR testing, which, along with the Genzyme data, should give a complete picture. The federal health program began reimbursing EGFR testing in 2009.

Ms. Lynch ruled out reimbursement issues and technological constraints as factors in underuse of the tests, but acknowledged that even with Medicare coverage, it could be an expensive proposition for a beneficiary, as they have a 20% copay. The test costs $600-$800, she said.

EGFR testing needs to be more widespread, said Ms. Lynch, noting that not only does it help patients get the best treatment, but that it also provides crucial data for the development of new therapies.

The study was funded by grants from the U.S. Department of Education and the National Institutes of Health, and was aided by the provision of data by Genzyme Genetics. Ms. Lynch is a former employee of Genentech Corp.

Graceway Pharmaceuticals LLC has declared Chapter 11 bankruptcy and simultaneously agreed to sell its assets to Galderma S.A. The sale is authorized under Section 363 of the United States Bankruptcy code.

Bristol, Tenn.–based Graceway filed for bankruptcy on Sept. 29 in the U.S. Bankruptcy Court – Delaware District. The company announced on Sept. 28 that it had reached a definitive agreement with Galderma S.A. to purchase all of Graceway’s U.S. and Canadian assets.

Under the filing, however, the Court could accept higher bids for Graceway. The company is required to put up a public sale notice and an auction will be held at a later date.

The process will be supervised by the U.S. Bankruptcy Court.

Galderma will pay a reported $275 million for Graceway. The company is deep in debt, $872 million as of Sept. 28, with less than $500 million of assets, according to the bankruptcy filing.

Graceway products include Zyclara (imiquimod) cream, 3.75%; Aldara (imiquimod) cream, 5%; Maxair Autohaler (pirbuterol acetate inhalation aerosol); Atopiclair nonsteroidal cream; and Estrasorb (estradiol topical emulsion). Galderma sells products in 70 countries for such dermatologic conditions as acne, rosacea, onychomycosis, psoriasis, and steroid-responsive dermatoses, pigmentary disorders, and skin cancer. The company’s brands include Epiduo, Oracea, Clobex, Azzalure/Dysport, Cetaphil, Tri-Luma, and Restylane.

According to a company statement, Graceway expects to complete the sale to Galderma by January, "with minimal disruption to the business."

The case is In re: Graceway Pharmaceuticals LLC, U.S. Bankruptcy Court, District of Delaware, No. 11-13036.

Graceway Pharmaceuticals LLC has declared Chapter 11 bankruptcy and simultaneously agreed to sell its assets to Galderma S.A. The sale is authorized under Section 363 of the United States Bankruptcy code.

Bristol, Tenn.–based Graceway filed for bankruptcy on Sept. 29 in the U.S. Bankruptcy Court – Delaware District. The company announced on Sept. 28 that it had reached a definitive agreement with Galderma S.A. to purchase all of Graceway’s U.S. and Canadian assets.

Under the filing, however, the Court could accept higher bids for Graceway. The company is required to put up a public sale notice and an auction will be held at a later date.

The process will be supervised by the U.S. Bankruptcy Court.

Galderma will pay a reported $275 million for Graceway. The company is deep in debt, $872 million as of Sept. 28, with less than $500 million of assets, according to the bankruptcy filing.

Graceway products include Zyclara (imiquimod) cream, 3.75%; Aldara (imiquimod) cream, 5%; Maxair Autohaler (pirbuterol acetate inhalation aerosol); Atopiclair nonsteroidal cream; and Estrasorb (estradiol topical emulsion). Galderma sells products in 70 countries for such dermatologic conditions as acne, rosacea, onychomycosis, psoriasis, and steroid-responsive dermatoses, pigmentary disorders, and skin cancer. The company’s brands include Epiduo, Oracea, Clobex, Azzalure/Dysport, Cetaphil, Tri-Luma, and Restylane.

According to a company statement, Graceway expects to complete the sale to Galderma by January, "with minimal disruption to the business."

The case is In re: Graceway Pharmaceuticals LLC, U.S. Bankruptcy Court, District of Delaware, No. 11-13036.

Graceway Pharmaceuticals LLC has declared Chapter 11 bankruptcy and simultaneously agreed to sell its assets to Galderma S.A. The sale is authorized under Section 363 of the United States Bankruptcy code.

Bristol, Tenn.–based Graceway filed for bankruptcy on Sept. 29 in the U.S. Bankruptcy Court – Delaware District. The company announced on Sept. 28 that it had reached a definitive agreement with Galderma S.A. to purchase all of Graceway’s U.S. and Canadian assets.

Under the filing, however, the Court could accept higher bids for Graceway. The company is required to put up a public sale notice and an auction will be held at a later date.

The process will be supervised by the U.S. Bankruptcy Court.

Galderma will pay a reported $275 million for Graceway. The company is deep in debt, $872 million as of Sept. 28, with less than $500 million of assets, according to the bankruptcy filing.

Graceway products include Zyclara (imiquimod) cream, 3.75%; Aldara (imiquimod) cream, 5%; Maxair Autohaler (pirbuterol acetate inhalation aerosol); Atopiclair nonsteroidal cream; and Estrasorb (estradiol topical emulsion). Galderma sells products in 70 countries for such dermatologic conditions as acne, rosacea, onychomycosis, psoriasis, and steroid-responsive dermatoses, pigmentary disorders, and skin cancer. The company’s brands include Epiduo, Oracea, Clobex, Azzalure/Dysport, Cetaphil, Tri-Luma, and Restylane.

According to a company statement, Graceway expects to complete the sale to Galderma by January, "with minimal disruption to the business."

The case is In re: Graceway Pharmaceuticals LLC, U.S. Bankruptcy Court, District of Delaware, No. 11-13036.