Alicia Ault

NEW ORLEANS – The American Medical Association’s policy-making body wrapped up 2 and a half days of meetings Nov. 15 by calling for a delay in implementation of the ICD-10 coding system, and reiterating its intention to seek the ability to privately broker fees with Medicare patients.

Physicians have long sought to be allowed to engage in so-called "private contracting" with Medicare patients. Under that scenario, Medicare patients could use their benefits to see a physician that does not accept Medicare. Currently, patients have to pay for the entire visit out of their pocket if their physician does not accept Medicare.

The AMA says private contracting will empower patients – and, the group is supporting legislation sponsored by Rep. Tom Price (R-Ga.) that would allow such private contracting. The Medicare Patient Empowerment Act (H.R. 1700) was introduced in May; a companion bill was quickly introduced in the Senate by Lisa Murkowski (R-Alaska).

The AMA House of Delegates reaffirmed support of the legislation, but also called upon the AMA to start a grassroots campaign to get patients involved.

"This is a directive to take action," said Dr. Corey Howard, lead delegate from the Florida delegation, which initiated the resolution seeking a public campaign. "It’s time to start planting those seeds to help the public begin to look at this in a favorable way."

Alabama delegate Dr. Jeff Terry and president of the Medical Association of the State of Alabama said, "A grassroots campaign will allow our politicians to do the right thing." Such a campaign will let politicians know "that we don’t want our congressmen to walk out on a political limb not supported by the public."

The emphasis on private contracting was in part a symptom of the high-pressure environment physicians find themselves in, facing a potential 27% cut in Medicare payments as well as high-cost requirements to implement electronic medical records, said Dr. Robert Wah, chairman of the AMA Board of Trustees.

"The fact that patients may be able to take their benefit where they’d like to, to see the doctors they want to see, is a potential safety valve to all this pressure being exerted on physician practices and patients in the Medicare system," Dr. Wah said in an interview. "So we’re actively pushing at the local level for people to go to their congressmen and ask them to sign on to this legislation."

The push back against the coming implementation of the new ICD-10 coding system in 2013 is also a symptom of physicians feeling overwhelmed by their changing practice environment, Dr. Wah said. The House approved a resolution sponsored by the Alabama and Mississippi delegations, along with the American Urological Association and American Association of Clinical Urologists, to take action to stop the implementation.

The ICD-10 will consist of 69,000 codes, as compared with the 14,000 in ICD-9, currently in use.

"At a time when we are working to get the best value possible for our health care dollar, this massive and expensive undertaking will add administrative expense and create unnecessary workflow disruptions," AMA President Peter W. Carmel said in a statement.

The ICD-10 system has been in development for 10 years but has been delayed several times already. The House of Delegates called on the AMA to mount "a vigorous campaign to seek delay of the implementation date," according to Dr. Wah.

NEW ORLEANS – The American Medical Association’s policy-making body wrapped up 2 and a half days of meetings Nov. 15 by calling for a delay in implementation of the ICD-10 coding system, and reiterating its intention to seek the ability to privately broker fees with Medicare patients.

Physicians have long sought to be allowed to engage in so-called "private contracting" with Medicare patients. Under that scenario, Medicare patients could use their benefits to see a physician that does not accept Medicare. Currently, patients have to pay for the entire visit out of their pocket if their physician does not accept Medicare.

The AMA says private contracting will empower patients – and, the group is supporting legislation sponsored by Rep. Tom Price (R-Ga.) that would allow such private contracting. The Medicare Patient Empowerment Act (H.R. 1700) was introduced in May; a companion bill was quickly introduced in the Senate by Lisa Murkowski (R-Alaska).

The AMA House of Delegates reaffirmed support of the legislation, but also called upon the AMA to start a grassroots campaign to get patients involved.

"This is a directive to take action," said Dr. Corey Howard, lead delegate from the Florida delegation, which initiated the resolution seeking a public campaign. "It’s time to start planting those seeds to help the public begin to look at this in a favorable way."

Alabama delegate Dr. Jeff Terry and president of the Medical Association of the State of Alabama said, "A grassroots campaign will allow our politicians to do the right thing." Such a campaign will let politicians know "that we don’t want our congressmen to walk out on a political limb not supported by the public."

The emphasis on private contracting was in part a symptom of the high-pressure environment physicians find themselves in, facing a potential 27% cut in Medicare payments as well as high-cost requirements to implement electronic medical records, said Dr. Robert Wah, chairman of the AMA Board of Trustees.

"The fact that patients may be able to take their benefit where they’d like to, to see the doctors they want to see, is a potential safety valve to all this pressure being exerted on physician practices and patients in the Medicare system," Dr. Wah said in an interview. "So we’re actively pushing at the local level for people to go to their congressmen and ask them to sign on to this legislation."

The push back against the coming implementation of the new ICD-10 coding system in 2013 is also a symptom of physicians feeling overwhelmed by their changing practice environment, Dr. Wah said. The House approved a resolution sponsored by the Alabama and Mississippi delegations, along with the American Urological Association and American Association of Clinical Urologists, to take action to stop the implementation.

The ICD-10 will consist of 69,000 codes, as compared with the 14,000 in ICD-9, currently in use.

"At a time when we are working to get the best value possible for our health care dollar, this massive and expensive undertaking will add administrative expense and create unnecessary workflow disruptions," AMA President Peter W. Carmel said in a statement.

The ICD-10 system has been in development for 10 years but has been delayed several times already. The House of Delegates called on the AMA to mount "a vigorous campaign to seek delay of the implementation date," according to Dr. Wah.

NEW ORLEANS – The American Medical Association’s policy-making body wrapped up 2 and a half days of meetings Nov. 15 by calling for a delay in implementation of the ICD-10 coding system, and reiterating its intention to seek the ability to privately broker fees with Medicare patients.

Physicians have long sought to be allowed to engage in so-called "private contracting" with Medicare patients. Under that scenario, Medicare patients could use their benefits to see a physician that does not accept Medicare. Currently, patients have to pay for the entire visit out of their pocket if their physician does not accept Medicare.

The AMA says private contracting will empower patients – and, the group is supporting legislation sponsored by Rep. Tom Price (R-Ga.) that would allow such private contracting. The Medicare Patient Empowerment Act (H.R. 1700) was introduced in May; a companion bill was quickly introduced in the Senate by Lisa Murkowski (R-Alaska).

The AMA House of Delegates reaffirmed support of the legislation, but also called upon the AMA to start a grassroots campaign to get patients involved.

"This is a directive to take action," said Dr. Corey Howard, lead delegate from the Florida delegation, which initiated the resolution seeking a public campaign. "It’s time to start planting those seeds to help the public begin to look at this in a favorable way."

Alabama delegate Dr. Jeff Terry and president of the Medical Association of the State of Alabama said, "A grassroots campaign will allow our politicians to do the right thing." Such a campaign will let politicians know "that we don’t want our congressmen to walk out on a political limb not supported by the public."

The emphasis on private contracting was in part a symptom of the high-pressure environment physicians find themselves in, facing a potential 27% cut in Medicare payments as well as high-cost requirements to implement electronic medical records, said Dr. Robert Wah, chairman of the AMA Board of Trustees.

"The fact that patients may be able to take their benefit where they’d like to, to see the doctors they want to see, is a potential safety valve to all this pressure being exerted on physician practices and patients in the Medicare system," Dr. Wah said in an interview. "So we’re actively pushing at the local level for people to go to their congressmen and ask them to sign on to this legislation."

The push back against the coming implementation of the new ICD-10 coding system in 2013 is also a symptom of physicians feeling overwhelmed by their changing practice environment, Dr. Wah said. The House approved a resolution sponsored by the Alabama and Mississippi delegations, along with the American Urological Association and American Association of Clinical Urologists, to take action to stop the implementation.

The ICD-10 will consist of 69,000 codes, as compared with the 14,000 in ICD-9, currently in use.

"At a time when we are working to get the best value possible for our health care dollar, this massive and expensive undertaking will add administrative expense and create unnecessary workflow disruptions," AMA President Peter W. Carmel said in a statement.

The ICD-10 system has been in development for 10 years but has been delayed several times already. The House of Delegates called on the AMA to mount "a vigorous campaign to seek delay of the implementation date," according to Dr. Wah.

NEW ORLEANS – Five therapeutic areas account for two-thirds of the drug shortages in the United States, with oncology taking the hardest hit.

Those shortages may affect as many as a half-million cancer patients, according to a Nov. 14 report from the IMS Institute, a division of health care analytics firm IMS Health.

The ongoing problem was high on the agenda at the interim meeting of the American Medical Association House of Delegates. In response to reports by IMS and an AMA committee, the House of Delegates voted to encourage the AMA to push Congress and the Food and Drug Administration to require manufacturers to create contingency plans in case of shortage.

Some delegates sought to have the AMA back the rights of manufacturers to set prices and recover additional costs in the face of shortages, but the resolution was voted down.

The House-passed policy also urges support for recommendations from a Dec. 2010 summit sponsored by the American Society of Health System Pharmacists (ASHP), the American Society of Anesthesiologists, the American Society of Clinical Oncologists, and the Institute for Safe Medication Practices.

“Drug shortages can delay a patient’s treatment and may force physicians to use alternative drugs that aren’t optimal, leading to an increased potential for errors and adverse outcomes,” said AMA president-elect Jeremy A. Lazarus in a statement.

In its report, IMS reviewed information for 168 drug shortages reported to both the Food and Drug Administration and the American Society of Health System Pharmacists. The data give more of a real-time snapshot of what’s happening in the supply chain because they use invoice and purchasing data, said Bona Benjamin, ASHP director of medication use–quality improvement, who discussed the report at the interim meeting of the American Medical Association House of Delegates.

The company found that more than 80% of the 168 products in short supply are generics, and more than 80% are injectables. A total of 16% are oncology products; 15% are anti-infectives, 12% are cardiovascular products, 11% are central nervous system products, 9% are for pain, and 9% are vitamins and nutritionals.

There is no doubt that oncology is a problem area, said Ms. Benjamin. She is the liaison between ASHP and the FDA and her association’s point person for the public, physicians, hospitals, and others on shortages.

"Recently with the escalating oncology drug shortages, I’ve gotten many, many, very distressing calls from patients who are not able to get the drugs that they need," she told AMA meeting attendees.

Overall, 232 drugs have been in short supply this year, Ms. Benjamin said, adding that the number could reach 300 before year’s end. In oncology, there were few shortages for many years. The number jumped in 2010 to 24 shortages. There have been 20 so far in 2011, the vast majority injectables, she said.

Dr. Chris Nunnink, delegate to the AMA House from American Society of Clinical Oncology, said that shortages were not only threatening patient care, but also hastening the shift from office-based to hospital-based practices.

Profit margins are slim and declining; shortages are exacerbating that and making new physicians think twice about starting their practices, he said. "Just about every oncologist now is going to a hospital-based practice," said Dr. Nunnink of the Vermont Cancer Center in Colchester.

Patients often end up having to pay more out of pocket for the available alternatives, he said. And, sometimes standard chemotherapy drugs just aren’t available. "I have to say I don’t have Taxol," he said. "To have that conversation with a patient is just incredibly frustrating."

The IMS report concluded that manufacturing issues are largely responsible for the shortages. Companies that get into trouble with the FDA concerning their drug quality either have to suspend manufacturing or stop altogether. Also, many companies have not been prepared to meet the demand for their products, in particular the generic injectables.

Manufacturing and supply of many key products is concentrated in the hands of a few companies, the IMS report found. While there are 100 suppliers of the 168 products studied, half of those products have only 1 or 2 suppliers. Thirteen companies have stopped supplying products on the shortages lists within the past 2 years.

Ms. Benjamin said that 23 of the drugs have only two suppliers, and two-thirds have three or fewer suppliers. If one supplier is hobbled by a production issue, often the other two cannot meet the additional 30% demand, she said. This was the case for propofol; there were shortages for a year because one manufacturer ceased production. The FDA ended up allowing importation from Germany.

The IMS report also found lots of volatility in supply – for certain individual drugs, from particular manufacturers, and in state-to-state distribution. The report broke products into three categories: increasing supply, stable supply, and declining supply.

The declining supply group had decreases of more than 20% when compared with a 3-year base period that ended in 2009. Ms. Benjamin said that for the 75 products in the declining supply group, the amount available for use dropped by half over a 5-year period, from 16 million dosing units to 8 million.

But there are anomalies in every category. Cisplatin was considered to be in stable supply, with a total average supply of 40,000 units, said Ms. Benjamin. But there has been great fluctuation with the availability from each manufacturer – and many supply contracts dictate where purchases can be made. Teva Pharmaceuticals stopped producing cisplatin in 2010. It took awhile for the remaining two manufacturers to ramp up production, so some hospitals and physicians could not get enough, Ms. Benjamin said.

The IMS report also found that the per capita supply of injectables has fallen more than 30% in 13 states. That state data are not easy to understand, Ms. Benjamin said, noting that in some states with high per-capita use, there were no problems with supply.

The ASHP is aware that hoarding and stockpiling are occurring, she said, adding that some institutions and physicians are using their supplies to their advantage, selling them on the gray market. "We’ve heard about doctor theft, selling out the back door of the hospital. ... Lots of egregious practices."

Her organization does not approve of such sales, and also cautions physicians and hospitals against buying products from gray market sellers, she said.

Like the ASHP, the FDA, and several legislative proposals in Congress, the IMS Institute proposed that an early warning system be established to require prompt notification of shortages. The Institute suggests establishing volatility indexes, and borrowing demand forecasting and predictive modeling tools from the financial industry to help manage shortages more closely.

Ms. Benjamin said that the drug industry appears to be stepping up in the wake of President Obama’s Oct. 31 Executive Order calling for more voluntary reporting. The FDA told ASHP representatives in a recent meeting that more companies have been communicating with the agency about shortages, she said.

She also noted that two more senators signed on as cosponsors to a drug shortages bill introduced by Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act. On Nov. 10, Sen. Klobuchar called for a Senate hearing on the shortages issue.

*This story was updated November 15, 2011.

NEW ORLEANS – Five therapeutic areas account for two-thirds of the drug shortages in the United States, with oncology taking the hardest hit.

Those shortages may affect as many as a half-million cancer patients, according to a Nov. 14 report from the IMS Institute, a division of health care analytics firm IMS Health.

The ongoing problem was high on the agenda at the interim meeting of the American Medical Association House of Delegates. In response to reports by IMS and an AMA committee, the House of Delegates voted to encourage the AMA to push Congress and the Food and Drug Administration to require manufacturers to create contingency plans in case of shortage.

Some delegates sought to have the AMA back the rights of manufacturers to set prices and recover additional costs in the face of shortages, but the resolution was voted down.

The House-passed policy also urges support for recommendations from a Dec. 2010 summit sponsored by the American Society of Health System Pharmacists (ASHP), the American Society of Anesthesiologists, the American Society of Clinical Oncologists, and the Institute for Safe Medication Practices.

“Drug shortages can delay a patient’s treatment and may force physicians to use alternative drugs that aren’t optimal, leading to an increased potential for errors and adverse outcomes,” said AMA president-elect Jeremy A. Lazarus in a statement.

In its report, IMS reviewed information for 168 drug shortages reported to both the Food and Drug Administration and the American Society of Health System Pharmacists. The data give more of a real-time snapshot of what’s happening in the supply chain because they use invoice and purchasing data, said Bona Benjamin, ASHP director of medication use–quality improvement, who discussed the report at the interim meeting of the American Medical Association House of Delegates.

The company found that more than 80% of the 168 products in short supply are generics, and more than 80% are injectables. A total of 16% are oncology products; 15% are anti-infectives, 12% are cardiovascular products, 11% are central nervous system products, 9% are for pain, and 9% are vitamins and nutritionals.

There is no doubt that oncology is a problem area, said Ms. Benjamin. She is the liaison between ASHP and the FDA and her association’s point person for the public, physicians, hospitals, and others on shortages.

"Recently with the escalating oncology drug shortages, I’ve gotten many, many, very distressing calls from patients who are not able to get the drugs that they need," she told AMA meeting attendees.

Overall, 232 drugs have been in short supply this year, Ms. Benjamin said, adding that the number could reach 300 before year’s end. In oncology, there were few shortages for many years. The number jumped in 2010 to 24 shortages. There have been 20 so far in 2011, the vast majority injectables, she said.

Dr. Chris Nunnink, delegate to the AMA House from American Society of Clinical Oncology, said that shortages were not only threatening patient care, but also hastening the shift from office-based to hospital-based practices.

Profit margins are slim and declining; shortages are exacerbating that and making new physicians think twice about starting their practices, he said. "Just about every oncologist now is going to a hospital-based practice," said Dr. Nunnink of the Vermont Cancer Center in Colchester.

Patients often end up having to pay more out of pocket for the available alternatives, he said. And, sometimes standard chemotherapy drugs just aren’t available. "I have to say I don’t have Taxol," he said. "To have that conversation with a patient is just incredibly frustrating."

The IMS report concluded that manufacturing issues are largely responsible for the shortages. Companies that get into trouble with the FDA concerning their drug quality either have to suspend manufacturing or stop altogether. Also, many companies have not been prepared to meet the demand for their products, in particular the generic injectables.

Manufacturing and supply of many key products is concentrated in the hands of a few companies, the IMS report found. While there are 100 suppliers of the 168 products studied, half of those products have only 1 or 2 suppliers. Thirteen companies have stopped supplying products on the shortages lists within the past 2 years.

Ms. Benjamin said that 23 of the drugs have only two suppliers, and two-thirds have three or fewer suppliers. If one supplier is hobbled by a production issue, often the other two cannot meet the additional 30% demand, she said. This was the case for propofol; there were shortages for a year because one manufacturer ceased production. The FDA ended up allowing importation from Germany.

The IMS report also found lots of volatility in supply – for certain individual drugs, from particular manufacturers, and in state-to-state distribution. The report broke products into three categories: increasing supply, stable supply, and declining supply.

The declining supply group had decreases of more than 20% when compared with a 3-year base period that ended in 2009. Ms. Benjamin said that for the 75 products in the declining supply group, the amount available for use dropped by half over a 5-year period, from 16 million dosing units to 8 million.

But there are anomalies in every category. Cisplatin was considered to be in stable supply, with a total average supply of 40,000 units, said Ms. Benjamin. But there has been great fluctuation with the availability from each manufacturer – and many supply contracts dictate where purchases can be made. Teva Pharmaceuticals stopped producing cisplatin in 2010. It took awhile for the remaining two manufacturers to ramp up production, so some hospitals and physicians could not get enough, Ms. Benjamin said.

The IMS report also found that the per capita supply of injectables has fallen more than 30% in 13 states. That state data are not easy to understand, Ms. Benjamin said, noting that in some states with high per-capita use, there were no problems with supply.

The ASHP is aware that hoarding and stockpiling are occurring, she said, adding that some institutions and physicians are using their supplies to their advantage, selling them on the gray market. "We’ve heard about doctor theft, selling out the back door of the hospital. ... Lots of egregious practices."

Her organization does not approve of such sales, and also cautions physicians and hospitals against buying products from gray market sellers, she said.

Like the ASHP, the FDA, and several legislative proposals in Congress, the IMS Institute proposed that an early warning system be established to require prompt notification of shortages. The Institute suggests establishing volatility indexes, and borrowing demand forecasting and predictive modeling tools from the financial industry to help manage shortages more closely.

Ms. Benjamin said that the drug industry appears to be stepping up in the wake of President Obama’s Oct. 31 Executive Order calling for more voluntary reporting. The FDA told ASHP representatives in a recent meeting that more companies have been communicating with the agency about shortages, she said.

She also noted that two more senators signed on as cosponsors to a drug shortages bill introduced by Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act. On Nov. 10, Sen. Klobuchar called for a Senate hearing on the shortages issue.

*This story was updated November 15, 2011.

NEW ORLEANS – Five therapeutic areas account for two-thirds of the drug shortages in the United States, with oncology taking the hardest hit.

Those shortages may affect as many as a half-million cancer patients, according to a Nov. 14 report from the IMS Institute, a division of health care analytics firm IMS Health.

The ongoing problem was high on the agenda at the interim meeting of the American Medical Association House of Delegates. In response to reports by IMS and an AMA committee, the House of Delegates voted to encourage the AMA to push Congress and the Food and Drug Administration to require manufacturers to create contingency plans in case of shortage.

Some delegates sought to have the AMA back the rights of manufacturers to set prices and recover additional costs in the face of shortages, but the resolution was voted down.

The House-passed policy also urges support for recommendations from a Dec. 2010 summit sponsored by the American Society of Health System Pharmacists (ASHP), the American Society of Anesthesiologists, the American Society of Clinical Oncologists, and the Institute for Safe Medication Practices.

“Drug shortages can delay a patient’s treatment and may force physicians to use alternative drugs that aren’t optimal, leading to an increased potential for errors and adverse outcomes,” said AMA president-elect Jeremy A. Lazarus in a statement.

In its report, IMS reviewed information for 168 drug shortages reported to both the Food and Drug Administration and the American Society of Health System Pharmacists. The data give more of a real-time snapshot of what’s happening in the supply chain because they use invoice and purchasing data, said Bona Benjamin, ASHP director of medication use–quality improvement, who discussed the report at the interim meeting of the American Medical Association House of Delegates.

The company found that more than 80% of the 168 products in short supply are generics, and more than 80% are injectables. A total of 16% are oncology products; 15% are anti-infectives, 12% are cardiovascular products, 11% are central nervous system products, 9% are for pain, and 9% are vitamins and nutritionals.

There is no doubt that oncology is a problem area, said Ms. Benjamin. She is the liaison between ASHP and the FDA and her association’s point person for the public, physicians, hospitals, and others on shortages.

"Recently with the escalating oncology drug shortages, I’ve gotten many, many, very distressing calls from patients who are not able to get the drugs that they need," she told AMA meeting attendees.

Overall, 232 drugs have been in short supply this year, Ms. Benjamin said, adding that the number could reach 300 before year’s end. In oncology, there were few shortages for many years. The number jumped in 2010 to 24 shortages. There have been 20 so far in 2011, the vast majority injectables, she said.

Dr. Chris Nunnink, delegate to the AMA House from American Society of Clinical Oncology, said that shortages were not only threatening patient care, but also hastening the shift from office-based to hospital-based practices.

Profit margins are slim and declining; shortages are exacerbating that and making new physicians think twice about starting their practices, he said. "Just about every oncologist now is going to a hospital-based practice," said Dr. Nunnink of the Vermont Cancer Center in Colchester.

Patients often end up having to pay more out of pocket for the available alternatives, he said. And, sometimes standard chemotherapy drugs just aren’t available. "I have to say I don’t have Taxol," he said. "To have that conversation with a patient is just incredibly frustrating."

The IMS report concluded that manufacturing issues are largely responsible for the shortages. Companies that get into trouble with the FDA concerning their drug quality either have to suspend manufacturing or stop altogether. Also, many companies have not been prepared to meet the demand for their products, in particular the generic injectables.

Manufacturing and supply of many key products is concentrated in the hands of a few companies, the IMS report found. While there are 100 suppliers of the 168 products studied, half of those products have only 1 or 2 suppliers. Thirteen companies have stopped supplying products on the shortages lists within the past 2 years.

Ms. Benjamin said that 23 of the drugs have only two suppliers, and two-thirds have three or fewer suppliers. If one supplier is hobbled by a production issue, often the other two cannot meet the additional 30% demand, she said. This was the case for propofol; there were shortages for a year because one manufacturer ceased production. The FDA ended up allowing importation from Germany.

The IMS report also found lots of volatility in supply – for certain individual drugs, from particular manufacturers, and in state-to-state distribution. The report broke products into three categories: increasing supply, stable supply, and declining supply.

The declining supply group had decreases of more than 20% when compared with a 3-year base period that ended in 2009. Ms. Benjamin said that for the 75 products in the declining supply group, the amount available for use dropped by half over a 5-year period, from 16 million dosing units to 8 million.

But there are anomalies in every category. Cisplatin was considered to be in stable supply, with a total average supply of 40,000 units, said Ms. Benjamin. But there has been great fluctuation with the availability from each manufacturer – and many supply contracts dictate where purchases can be made. Teva Pharmaceuticals stopped producing cisplatin in 2010. It took awhile for the remaining two manufacturers to ramp up production, so some hospitals and physicians could not get enough, Ms. Benjamin said.

The IMS report also found that the per capita supply of injectables has fallen more than 30% in 13 states. That state data are not easy to understand, Ms. Benjamin said, noting that in some states with high per-capita use, there were no problems with supply.

The ASHP is aware that hoarding and stockpiling are occurring, she said, adding that some institutions and physicians are using their supplies to their advantage, selling them on the gray market. "We’ve heard about doctor theft, selling out the back door of the hospital. ... Lots of egregious practices."

Her organization does not approve of such sales, and also cautions physicians and hospitals against buying products from gray market sellers, she said.

Like the ASHP, the FDA, and several legislative proposals in Congress, the IMS Institute proposed that an early warning system be established to require prompt notification of shortages. The Institute suggests establishing volatility indexes, and borrowing demand forecasting and predictive modeling tools from the financial industry to help manage shortages more closely.

Ms. Benjamin said that the drug industry appears to be stepping up in the wake of President Obama’s Oct. 31 Executive Order calling for more voluntary reporting. The FDA told ASHP representatives in a recent meeting that more companies have been communicating with the agency about shortages, she said.

She also noted that two more senators signed on as cosponsors to a drug shortages bill introduced by Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act. On Nov. 10, Sen. Klobuchar called for a Senate hearing on the shortages issue.

*This story was updated November 15, 2011.

The U.S. Preventive Services Task Force has recommended that physicians counsel children, adolescents, and young adults on minimizing their ultraviolet radiation exposure to reduce their risk of skin cancer.

The recommendation was issued in draft form, which means that it is open for comment until Dec. 6. It was based on an evidence review published in February.

The USPTF focused on children and adults aged 10-24 years, grading the evidence supporting its recommendation as a B. Under that rubric, "there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial."

However, the panel concluded that the evidence is "insufficient" to determine the risks and benefits of such counseling for adults.

The American Academy of Dermatology lauded the USPTF for its recommendation but took issue with its conclusion on adults. The AAD "is pleased that the USPSTF has recommended that sun protection counseling is important for children, adolescents, and young adults with fair skin types," said AAD President Ronald L. Moy. "However, the Academy believes sun protection counseling is important for everyone, including the adult population."

When the USPTF last looked at counseling, in 2003, it concluded there was insufficient evidence to support it for either children or adults.

In its update, however, the panel noted there being plenty of data showing that counseling is linked to behavior changes that lead to less sun exposure, at least in children. The USPTF also determined that there were no negative consequences to children being told to stay out of the sun. There was no decrease in outdoor activity or increase in body mass in the studies the panel reviewed. The studies did not assess the impact on vitamin D levels in children or adults.

The committee looked at studies on tanning bed use, also. There was not enough evidence to assess the association between use of tanning beds and the risk of squamous or basal cell carcinoma, reported the panel. A number of studies did, however, show an increased risk of melanoma with tanning beds.

Tanning beds are still an issue for the AAD, though.

"More than 3.5 million skin cancers in more than 2 million people are diagnosed annually, and excessive exposure to ultraviolet radiation from the sun and tanning beds is the most preventable cause of all skin cancers," said Dr. Moy.

The USPTF is funded by the Agency for Healthcare Quality and Research.

The U.S. Preventive Services Task Force has recommended that physicians counsel children, adolescents, and young adults on minimizing their ultraviolet radiation exposure to reduce their risk of skin cancer.

The recommendation was issued in draft form, which means that it is open for comment until Dec. 6. It was based on an evidence review published in February.

The USPTF focused on children and adults aged 10-24 years, grading the evidence supporting its recommendation as a B. Under that rubric, "there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial."

However, the panel concluded that the evidence is "insufficient" to determine the risks and benefits of such counseling for adults.

The American Academy of Dermatology lauded the USPTF for its recommendation but took issue with its conclusion on adults. The AAD "is pleased that the USPSTF has recommended that sun protection counseling is important for children, adolescents, and young adults with fair skin types," said AAD President Ronald L. Moy. "However, the Academy believes sun protection counseling is important for everyone, including the adult population."

When the USPTF last looked at counseling, in 2003, it concluded there was insufficient evidence to support it for either children or adults.

In its update, however, the panel noted there being plenty of data showing that counseling is linked to behavior changes that lead to less sun exposure, at least in children. The USPTF also determined that there were no negative consequences to children being told to stay out of the sun. There was no decrease in outdoor activity or increase in body mass in the studies the panel reviewed. The studies did not assess the impact on vitamin D levels in children or adults.

The committee looked at studies on tanning bed use, also. There was not enough evidence to assess the association between use of tanning beds and the risk of squamous or basal cell carcinoma, reported the panel. A number of studies did, however, show an increased risk of melanoma with tanning beds.

Tanning beds are still an issue for the AAD, though.

"More than 3.5 million skin cancers in more than 2 million people are diagnosed annually, and excessive exposure to ultraviolet radiation from the sun and tanning beds is the most preventable cause of all skin cancers," said Dr. Moy.

The USPTF is funded by the Agency for Healthcare Quality and Research.

The U.S. Preventive Services Task Force has recommended that physicians counsel children, adolescents, and young adults on minimizing their ultraviolet radiation exposure to reduce their risk of skin cancer.

The recommendation was issued in draft form, which means that it is open for comment until Dec. 6. It was based on an evidence review published in February.

The USPTF focused on children and adults aged 10-24 years, grading the evidence supporting its recommendation as a B. Under that rubric, "there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial."

However, the panel concluded that the evidence is "insufficient" to determine the risks and benefits of such counseling for adults.

The American Academy of Dermatology lauded the USPTF for its recommendation but took issue with its conclusion on adults. The AAD "is pleased that the USPSTF has recommended that sun protection counseling is important for children, adolescents, and young adults with fair skin types," said AAD President Ronald L. Moy. "However, the Academy believes sun protection counseling is important for everyone, including the adult population."

When the USPTF last looked at counseling, in 2003, it concluded there was insufficient evidence to support it for either children or adults.

In its update, however, the panel noted there being plenty of data showing that counseling is linked to behavior changes that lead to less sun exposure, at least in children. The USPTF also determined that there were no negative consequences to children being told to stay out of the sun. There was no decrease in outdoor activity or increase in body mass in the studies the panel reviewed. The studies did not assess the impact on vitamin D levels in children or adults.

The committee looked at studies on tanning bed use, also. There was not enough evidence to assess the association between use of tanning beds and the risk of squamous or basal cell carcinoma, reported the panel. A number of studies did, however, show an increased risk of melanoma with tanning beds.

Tanning beds are still an issue for the AAD, though.

"More than 3.5 million skin cancers in more than 2 million people are diagnosed annually, and excessive exposure to ultraviolet radiation from the sun and tanning beds is the most preventable cause of all skin cancers," said Dr. Moy.

The USPTF is funded by the Agency for Healthcare Quality and Research.

Physicians who bill for both technical and professional services with nuclear stress imaging and stress echocardiography order such testing at double the rate of those who do not bill for such services, according to a study published online Nov. 8 in JAMA.

Overall, 12.2% of studied patients had a nuclear stress or echocardiography test within 30 days of a postrevascularization outpatient visit. Cardiologists were more likely than primary care physicians to conduct stress tests, at about 12%, compared with 5%, said Dr. Bimal R. Shah of Duke University, Durham, N.C., and colleagues.

The more physicians stood to receive from imaging, the more often they ordered the tests. Physicians who billed for both professional and technical fees ordered stress or echo tests about 13% of the time, compared to a 9% incidence among those who only billed for professional fees, and 5% for those who billed for neither.

According to Dr. Shah, 80% of the nuclear imaging studies would be considered self-referrals by physicians who billed for both technical and professional fees; 63% were self-referrals by those who billed for professional fees only. Rates were similar for echo tests, with 85% considered self-referrals by physicians who billed for both technical and professional fees, and 67% considered self-referrals by those who billed for professional fees only.

"The association between physician billing status for stress tests and testing frequency persisted after adjusting to the extent possible for patient and physician factors that influence testing," Dr. Shah and his colleagues said.

The authors focused on testing that was ordered following coronary revascularization. According to American College of Cardiology Foundation appropriateness utilization criteria, neither nuclear stress testing nor echocardiography is recommended following percutaneous coronary intervention or coronary artery bypass graft. Thus, stress testing in these cases is likely to be more discretionary based on the criteria.

The researchers analyzed United Healthcare data on enrollees aged 18-64 years during the period of 2004-2007. They excluded testing and outpatient visits during the first 90 days after revascularization, as those could be potentially deemed necessary. To determine how many tests might be self-referrals, the authors looked at the proportion of stress tests for which the testing physician’s tax identification number matched the outpatient visit tax ID; the final study population was 17,847 patients (JAMA 2011;306:1993-2000).

Only 14% had symptoms that were given as the indication for that index outpatient visit; 86% had no billing diagnosis code.

Among the physicians studied, 70% (2,111) of cardiologists billed for both technical and professional fees for nuclear stress imaging studies. In all, 14% (416) billed for professional fees only, and 16% (486) did not bill for either. The proportions were similar for cardiology practices, with 50% billing for both professional and technical services, and 19% for professional fees. A total of 31% did not bill for the services.

Of primary care physicians who conducted both nuclear stress testing and echocardiography, 5% (162) billed for both professional and technical fees for stress testing, and 3% (88) billed both fees for echocardiography. In all, 2% (44) and 1% (28) billed for professional fees only. More than 90% did not bill at all for stress testing or echocardiography.

Additionally, analysis determined that nuclear perfusion imaging in cardiologists’ offices increased 215% from 1998 to 2006, and increased by 181% in other physician offices during the same period, the authors said.

"Discretionary stress testing after revascularization has potential financial and clinical disadvantages for patients, including the costs of the tests, the exposure to ionizing radiation as well as potential downstream costs, and consequences from following up false-positive test results," they wrote.

The authors acknowledged that the study period was before, and contemporaneous to, the publication of the American College of Cardiology Foundation appropriateness criteria. Thus, they could not say whether those guidelines might have had any impact on patterns of testing.

The authors noted that they could not analyze the appropriateness of physicians’ decision-making in ordering tests, since it was based largely on administrative data. But they said that previous studies have shown that using ICD-9 coding, as they did, accurately reflects diagnoses.

But this absence of data "prevents understanding physician intent for performing the imaging study," Dr. Brent K. Hollenbeck and Dr. Brahmajee K. Nallamothu of the University of Michigan, Ann Arbor, said in an accompanying editorial (JAMA 2011;306:2028-30).

They also note that the data was observational, and that it is possible that the study could be founded by selective referral, for example, that the patients who needed imaging were referred to physicians who specialized in such testing.

"Collectively, these limitations might explain much of the differences in use according to physician billing status," wrote Dr. Hollenbeck and Dr. Nallamothu.

They acknowledge that the findings are "robust," but they also say that "It is uncertain whether the observed increase in imaging utilization is entirely a bad thing."

A shift from the inpatient to the outpatient setting over the last decade or so has been linked to a dramatic decline in mortality from cardiac disease, they said. Office-based imaging might improve quality of care by leading to potentially earlier diagnosis, and keeping referrals close by may also increase the coordination of care, said Dr. Hollenbeck and Nallamothu.

But they also note that cardiology has been shifting back to the hospital, and that government regulators are creating policies that will likely encourage that move. That could lead to higher costs again, they said.

"Moving forward in the current era of health care reform, the focus should be less about eliminating incentives altogether, and more about getting the price right in the first place," wrote Dr. Hollenbeck and Dr. Nallamothu.

The study was funded by United Healthcare, and one study author was a United Healthcare employee. Dr. Nallamothu reported no conflicts. Dr. Shah and Dr. Hollenbeck both received grants from the Agency for Health Care Research and Quality.

Physicians who bill for both technical and professional services with nuclear stress imaging and stress echocardiography order such testing at double the rate of those who do not bill for such services, according to a study published online Nov. 8 in JAMA.

Overall, 12.2% of studied patients had a nuclear stress or echocardiography test within 30 days of a postrevascularization outpatient visit. Cardiologists were more likely than primary care physicians to conduct stress tests, at about 12%, compared with 5%, said Dr. Bimal R. Shah of Duke University, Durham, N.C., and colleagues.

The more physicians stood to receive from imaging, the more often they ordered the tests. Physicians who billed for both professional and technical fees ordered stress or echo tests about 13% of the time, compared to a 9% incidence among those who only billed for professional fees, and 5% for those who billed for neither.

According to Dr. Shah, 80% of the nuclear imaging studies would be considered self-referrals by physicians who billed for both technical and professional fees; 63% were self-referrals by those who billed for professional fees only. Rates were similar for echo tests, with 85% considered self-referrals by physicians who billed for both technical and professional fees, and 67% considered self-referrals by those who billed for professional fees only.

"The association between physician billing status for stress tests and testing frequency persisted after adjusting to the extent possible for patient and physician factors that influence testing," Dr. Shah and his colleagues said.

The authors focused on testing that was ordered following coronary revascularization. According to American College of Cardiology Foundation appropriateness utilization criteria, neither nuclear stress testing nor echocardiography is recommended following percutaneous coronary intervention or coronary artery bypass graft. Thus, stress testing in these cases is likely to be more discretionary based on the criteria.

The researchers analyzed United Healthcare data on enrollees aged 18-64 years during the period of 2004-2007. They excluded testing and outpatient visits during the first 90 days after revascularization, as those could be potentially deemed necessary. To determine how many tests might be self-referrals, the authors looked at the proportion of stress tests for which the testing physician’s tax identification number matched the outpatient visit tax ID; the final study population was 17,847 patients (JAMA 2011;306:1993-2000).

Only 14% had symptoms that were given as the indication for that index outpatient visit; 86% had no billing diagnosis code.

Among the physicians studied, 70% (2,111) of cardiologists billed for both technical and professional fees for nuclear stress imaging studies. In all, 14% (416) billed for professional fees only, and 16% (486) did not bill for either. The proportions were similar for cardiology practices, with 50% billing for both professional and technical services, and 19% for professional fees. A total of 31% did not bill for the services.

Of primary care physicians who conducted both nuclear stress testing and echocardiography, 5% (162) billed for both professional and technical fees for stress testing, and 3% (88) billed both fees for echocardiography. In all, 2% (44) and 1% (28) billed for professional fees only. More than 90% did not bill at all for stress testing or echocardiography.

Additionally, analysis determined that nuclear perfusion imaging in cardiologists’ offices increased 215% from 1998 to 2006, and increased by 181% in other physician offices during the same period, the authors said.

"Discretionary stress testing after revascularization has potential financial and clinical disadvantages for patients, including the costs of the tests, the exposure to ionizing radiation as well as potential downstream costs, and consequences from following up false-positive test results," they wrote.

The authors acknowledged that the study period was before, and contemporaneous to, the publication of the American College of Cardiology Foundation appropriateness criteria. Thus, they could not say whether those guidelines might have had any impact on patterns of testing.

The authors noted that they could not analyze the appropriateness of physicians’ decision-making in ordering tests, since it was based largely on administrative data. But they said that previous studies have shown that using ICD-9 coding, as they did, accurately reflects diagnoses.

But this absence of data "prevents understanding physician intent for performing the imaging study," Dr. Brent K. Hollenbeck and Dr. Brahmajee K. Nallamothu of the University of Michigan, Ann Arbor, said in an accompanying editorial (JAMA 2011;306:2028-30).

They also note that the data was observational, and that it is possible that the study could be founded by selective referral, for example, that the patients who needed imaging were referred to physicians who specialized in such testing.

"Collectively, these limitations might explain much of the differences in use according to physician billing status," wrote Dr. Hollenbeck and Dr. Nallamothu.

They acknowledge that the findings are "robust," but they also say that "It is uncertain whether the observed increase in imaging utilization is entirely a bad thing."

A shift from the inpatient to the outpatient setting over the last decade or so has been linked to a dramatic decline in mortality from cardiac disease, they said. Office-based imaging might improve quality of care by leading to potentially earlier diagnosis, and keeping referrals close by may also increase the coordination of care, said Dr. Hollenbeck and Nallamothu.

But they also note that cardiology has been shifting back to the hospital, and that government regulators are creating policies that will likely encourage that move. That could lead to higher costs again, they said.

"Moving forward in the current era of health care reform, the focus should be less about eliminating incentives altogether, and more about getting the price right in the first place," wrote Dr. Hollenbeck and Dr. Nallamothu.

The study was funded by United Healthcare, and one study author was a United Healthcare employee. Dr. Nallamothu reported no conflicts. Dr. Shah and Dr. Hollenbeck both received grants from the Agency for Health Care Research and Quality.

Physicians who bill for both technical and professional services with nuclear stress imaging and stress echocardiography order such testing at double the rate of those who do not bill for such services, according to a study published online Nov. 8 in JAMA.

Overall, 12.2% of studied patients had a nuclear stress or echocardiography test within 30 days of a postrevascularization outpatient visit. Cardiologists were more likely than primary care physicians to conduct stress tests, at about 12%, compared with 5%, said Dr. Bimal R. Shah of Duke University, Durham, N.C., and colleagues.

The more physicians stood to receive from imaging, the more often they ordered the tests. Physicians who billed for both professional and technical fees ordered stress or echo tests about 13% of the time, compared to a 9% incidence among those who only billed for professional fees, and 5% for those who billed for neither.

According to Dr. Shah, 80% of the nuclear imaging studies would be considered self-referrals by physicians who billed for both technical and professional fees; 63% were self-referrals by those who billed for professional fees only. Rates were similar for echo tests, with 85% considered self-referrals by physicians who billed for both technical and professional fees, and 67% considered self-referrals by those who billed for professional fees only.

"The association between physician billing status for stress tests and testing frequency persisted after adjusting to the extent possible for patient and physician factors that influence testing," Dr. Shah and his colleagues said.

The authors focused on testing that was ordered following coronary revascularization. According to American College of Cardiology Foundation appropriateness utilization criteria, neither nuclear stress testing nor echocardiography is recommended following percutaneous coronary intervention or coronary artery bypass graft. Thus, stress testing in these cases is likely to be more discretionary based on the criteria.

The researchers analyzed United Healthcare data on enrollees aged 18-64 years during the period of 2004-2007. They excluded testing and outpatient visits during the first 90 days after revascularization, as those could be potentially deemed necessary. To determine how many tests might be self-referrals, the authors looked at the proportion of stress tests for which the testing physician’s tax identification number matched the outpatient visit tax ID; the final study population was 17,847 patients (JAMA 2011;306:1993-2000).

Only 14% had symptoms that were given as the indication for that index outpatient visit; 86% had no billing diagnosis code.

Among the physicians studied, 70% (2,111) of cardiologists billed for both technical and professional fees for nuclear stress imaging studies. In all, 14% (416) billed for professional fees only, and 16% (486) did not bill for either. The proportions were similar for cardiology practices, with 50% billing for both professional and technical services, and 19% for professional fees. A total of 31% did not bill for the services.

Of primary care physicians who conducted both nuclear stress testing and echocardiography, 5% (162) billed for both professional and technical fees for stress testing, and 3% (88) billed both fees for echocardiography. In all, 2% (44) and 1% (28) billed for professional fees only. More than 90% did not bill at all for stress testing or echocardiography.

Additionally, analysis determined that nuclear perfusion imaging in cardiologists’ offices increased 215% from 1998 to 2006, and increased by 181% in other physician offices during the same period, the authors said.

"Discretionary stress testing after revascularization has potential financial and clinical disadvantages for patients, including the costs of the tests, the exposure to ionizing radiation as well as potential downstream costs, and consequences from following up false-positive test results," they wrote.

The authors acknowledged that the study period was before, and contemporaneous to, the publication of the American College of Cardiology Foundation appropriateness criteria. Thus, they could not say whether those guidelines might have had any impact on patterns of testing.

The authors noted that they could not analyze the appropriateness of physicians’ decision-making in ordering tests, since it was based largely on administrative data. But they said that previous studies have shown that using ICD-9 coding, as they did, accurately reflects diagnoses.

But this absence of data "prevents understanding physician intent for performing the imaging study," Dr. Brent K. Hollenbeck and Dr. Brahmajee K. Nallamothu of the University of Michigan, Ann Arbor, said in an accompanying editorial (JAMA 2011;306:2028-30).

They also note that the data was observational, and that it is possible that the study could be founded by selective referral, for example, that the patients who needed imaging were referred to physicians who specialized in such testing.

"Collectively, these limitations might explain much of the differences in use according to physician billing status," wrote Dr. Hollenbeck and Dr. Nallamothu.

They acknowledge that the findings are "robust," but they also say that "It is uncertain whether the observed increase in imaging utilization is entirely a bad thing."

A shift from the inpatient to the outpatient setting over the last decade or so has been linked to a dramatic decline in mortality from cardiac disease, they said. Office-based imaging might improve quality of care by leading to potentially earlier diagnosis, and keeping referrals close by may also increase the coordination of care, said Dr. Hollenbeck and Nallamothu.

But they also note that cardiology has been shifting back to the hospital, and that government regulators are creating policies that will likely encourage that move. That could lead to higher costs again, they said.

"Moving forward in the current era of health care reform, the focus should be less about eliminating incentives altogether, and more about getting the price right in the first place," wrote Dr. Hollenbeck and Dr. Nallamothu.

The study was funded by United Healthcare, and one study author was a United Healthcare employee. Dr. Nallamothu reported no conflicts. Dr. Shah and Dr. Hollenbeck both received grants from the Agency for Health Care Research and Quality.

The Food and Drug Administration on Nov. 4 approved rivaroxaban to reduce the risk of stroke in nonvalvular atrial fibrillation.

It is the second approval for the anticoagulant. In July, rivaroxaban (Xarelto) was approved for reducing the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery. The new indication may spur more use of the product, as physicians continue to look for alternatives to warfarin.

"This approval gives doctors and patients another treatment option for a condition that must be managed carefully," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Rivaroxaban, sold by Janssen Pharmaceuticals Inc., is the only oral anticoagulant approved in the United States thus far that offers once-daily dosing, without the need for routine blood monitoring. It is, however, the second warfarin alternative. In October 2010, the agency approved dabigatran (Pradaxa) for stroke prevention in AF.

While dabigatran has been embraced by physicians – with some 250,000 prescriptions issued by late August – rivaroxaban may face a less enthusiastic audience. At an FDA advisory panel meeting in September on the drug, the panel urged that it only be used as a third-line therapy. Panelists generally said that rivaroxaban did not appear to be as effective as dabigatran, or even warfarin, in some cases.

The approval of rivaroxaban was based on the 14,000-patient study, ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation). Rivaroxaban was found to be similar to warfarin in its ability to prevent stroke, said the FDA.

"In clinical studies, Xarelto was shown to be effective in patients who are at increased risk of stroke, and especially in those with co-morbidities such as high blood pressure or diabetes, and other factors that increase the risk of stroke," said Dr. Robert M. Califf, ROCKET AF study co-chairman and vice chancellor for clinical research at Duke University, Durham, N.C., in a statement issued by Janssen.

"These patients represent many of those with the most to gain from effective anticoagulation."

According to the FDA, bleeding was the most common adverse event reported by patients treated with rivaroxaban in ROCKET AF. The risk of major bleeding was similar to that of warfarin, but it caused less bleeding into the brain and more bleeding into the stomach and intestines.

The drug has a boxed warning that sudden discontinuation increases the risk of stroke.

The Food and Drug Administration on Nov. 4 approved rivaroxaban to reduce the risk of stroke in nonvalvular atrial fibrillation.

It is the second approval for the anticoagulant. In July, rivaroxaban (Xarelto) was approved for reducing the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery. The new indication may spur more use of the product, as physicians continue to look for alternatives to warfarin.

"This approval gives doctors and patients another treatment option for a condition that must be managed carefully," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Rivaroxaban, sold by Janssen Pharmaceuticals Inc., is the only oral anticoagulant approved in the United States thus far that offers once-daily dosing, without the need for routine blood monitoring. It is, however, the second warfarin alternative. In October 2010, the agency approved dabigatran (Pradaxa) for stroke prevention in AF.

While dabigatran has been embraced by physicians – with some 250,000 prescriptions issued by late August – rivaroxaban may face a less enthusiastic audience. At an FDA advisory panel meeting in September on the drug, the panel urged that it only be used as a third-line therapy. Panelists generally said that rivaroxaban did not appear to be as effective as dabigatran, or even warfarin, in some cases.

The approval of rivaroxaban was based on the 14,000-patient study, ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation). Rivaroxaban was found to be similar to warfarin in its ability to prevent stroke, said the FDA.

"In clinical studies, Xarelto was shown to be effective in patients who are at increased risk of stroke, and especially in those with co-morbidities such as high blood pressure or diabetes, and other factors that increase the risk of stroke," said Dr. Robert M. Califf, ROCKET AF study co-chairman and vice chancellor for clinical research at Duke University, Durham, N.C., in a statement issued by Janssen.

"These patients represent many of those with the most to gain from effective anticoagulation."

According to the FDA, bleeding was the most common adverse event reported by patients treated with rivaroxaban in ROCKET AF. The risk of major bleeding was similar to that of warfarin, but it caused less bleeding into the brain and more bleeding into the stomach and intestines.

The drug has a boxed warning that sudden discontinuation increases the risk of stroke.

The Food and Drug Administration on Nov. 4 approved rivaroxaban to reduce the risk of stroke in nonvalvular atrial fibrillation.

It is the second approval for the anticoagulant. In July, rivaroxaban (Xarelto) was approved for reducing the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery. The new indication may spur more use of the product, as physicians continue to look for alternatives to warfarin.

"This approval gives doctors and patients another treatment option for a condition that must be managed carefully," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Rivaroxaban, sold by Janssen Pharmaceuticals Inc., is the only oral anticoagulant approved in the United States thus far that offers once-daily dosing, without the need for routine blood monitoring. It is, however, the second warfarin alternative. In October 2010, the agency approved dabigatran (Pradaxa) for stroke prevention in AF.

While dabigatran has been embraced by physicians – with some 250,000 prescriptions issued by late August – rivaroxaban may face a less enthusiastic audience. At an FDA advisory panel meeting in September on the drug, the panel urged that it only be used as a third-line therapy. Panelists generally said that rivaroxaban did not appear to be as effective as dabigatran, or even warfarin, in some cases.

The approval of rivaroxaban was based on the 14,000-patient study, ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation). Rivaroxaban was found to be similar to warfarin in its ability to prevent stroke, said the FDA.

"In clinical studies, Xarelto was shown to be effective in patients who are at increased risk of stroke, and especially in those with co-morbidities such as high blood pressure or diabetes, and other factors that increase the risk of stroke," said Dr. Robert M. Califf, ROCKET AF study co-chairman and vice chancellor for clinical research at Duke University, Durham, N.C., in a statement issued by Janssen.

"These patients represent many of those with the most to gain from effective anticoagulation."

According to the FDA, bleeding was the most common adverse event reported by patients treated with rivaroxaban in ROCKET AF. The risk of major bleeding was similar to that of warfarin, but it caused less bleeding into the brain and more bleeding into the stomach and intestines.

The drug has a boxed warning that sudden discontinuation increases the risk of stroke.

SAN FRANCISCO – Liability concerns may drive emergency physicians’ decisions regarding patients with possible cardiac conditions, based on the results of two studies presented at the Scientific Assembly of the American College of Emergency Physicians.

Many emergency physicians weighed legal concerns more heavily than actual risk when considering whether to admit a patient for acute coronary syndrome, concluded Dr. David H. Newman and his colleagues.

The conclusion was based on an observational, matched-pairs survey conducted at the emergency departments of St. Luke’s Hospital and Roosevelt Hospital in New York. Patients who were admitted "primarily for acute coronary syndrome" were surveyed after they had discussed their admission with the physician. The admitting doctor also completed a survey after communicating with the patient.

Both were asked whether risk and prognosis were discussed, as well as about the perceived potential benefits of admission and perceived primary purpose of admission.

"Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

When asked to place themselves in the same position as the patient they had just evaluated, physicians often said that they would not have chosen admission for themselves but had admitted the patient, said Dr. Newman, director of clinical research in the department of emergency medicine at Mount Sinai School of Medicine in New York.

During the 18 months of the study, 849 surveys were completed. All patients had primary or secondary complaints of chest pain. Just over half were men. One-third were black, 24% were Hispanic, 23% were white, and 19% were "other" or did not report a race. The largest proportion had attended some high school or graduated (39%), 25% had attended college, 14% had a bachelor’s degree, and 15% had a graduate or professional degree (Ann. Emerg. Med. 2011;58:S210).

Dr. Newman said in an interview that he and his colleagues were surprised to see that education level was not strongly correlated with risk communication or with agreement between the physician and the patient about true risk.

In a post hoc analysis, the authors calculated a mean risk of less than 5% for death, myocardial infarction, or revascularization within 30 days.

The physicians, however, estimated a mean risk for these outcomes of 15%, and patients estimated their risk at 33%.

One-third of patients and 48% of physicians said that coronary risk (the main reason for admission) had not been part of their discussion about admitting the patient. When coronary risk was discussed, agreement between the physician and the patient about the patient’s level of risk was 0.38 (about 40% more likely to agree, compared with random chance).

In 11% of cases, physicians said that concern about liability was one of the reasons for admission. That concern likely represents millions of dollars in health care spending, Dr. Newman said.

In 27% of the cases, the doctor reported that if they were a patient with the same risk, they would not stay overnight.

The results hint that "something is affecting patients’ decision to stay even when someone with a theoretically much more complete understanding of the risks – the doctor – would not stay," Dr. Newman said.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations, or perhaps other system pressures [such as] financial incentives, crowding, resource utilization, [or] time are affecting this conversation," he said. "What we can say with confidence is this: Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

In another study, Dr. Patrick J. Lenehan of Morristown (N.J.) Hospital and colleagues found that a decreasing number of congestive heart failure patients were discharged from the emergency department in 1996-2010.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations."

The authors retrospectively reviewed emergency department visits to 27 suburban, urban, and rural New York and New Jersey hospitals. The facilities had 18,000-72,000 annual visits. Using ICD9 codes, the researched identified patients who had likely CHF. This group included those who had CHF, heart failure, or pulmonary edema as a primary diagnosis, or as a secondary diagnosis if the primary was shortness of breath or dyspnea (Ann. Emerg. Med. 2011;58:S237).

Of 6.6 million emergency department visits, 82,230 (1%) were for CHF. Half of the patients were women, and their mean age was 72 years. The authors found that there was a 63% decrease in the number of patients discharged from 1996 to 2010. In 1996, 24% were discharged. By 2010, only 9% were discharged.

The pattern was the same for male and female patients. Given that there has been no increase in the mean patient age, the difference in discharges is not likely the result of an aging population, the authors said.

The "trend is mainly due to increasing concerns about medical malpractice litigation," they suggested.

The two studies indicate an ongoing crisis and the need to enact liability reform, said Dr. David Seaberg, ACEP president. "The rapidly rising tide of patients coupled with increasing hospital admissions from the emergency department will create pressure on the health system that is not sustainable," Dr. Seaberg said in a statement. "Liability reform could relieve some of that pressure and bring down costs."

No conflicts of interest were reported.

SAN FRANCISCO – Liability concerns may drive emergency physicians’ decisions regarding patients with possible cardiac conditions, based on the results of two studies presented at the Scientific Assembly of the American College of Emergency Physicians.

Many emergency physicians weighed legal concerns more heavily than actual risk when considering whether to admit a patient for acute coronary syndrome, concluded Dr. David H. Newman and his colleagues.

The conclusion was based on an observational, matched-pairs survey conducted at the emergency departments of St. Luke’s Hospital and Roosevelt Hospital in New York. Patients who were admitted "primarily for acute coronary syndrome" were surveyed after they had discussed their admission with the physician. The admitting doctor also completed a survey after communicating with the patient.

Both were asked whether risk and prognosis were discussed, as well as about the perceived potential benefits of admission and perceived primary purpose of admission.

"Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

When asked to place themselves in the same position as the patient they had just evaluated, physicians often said that they would not have chosen admission for themselves but had admitted the patient, said Dr. Newman, director of clinical research in the department of emergency medicine at Mount Sinai School of Medicine in New York.

During the 18 months of the study, 849 surveys were completed. All patients had primary or secondary complaints of chest pain. Just over half were men. One-third were black, 24% were Hispanic, 23% were white, and 19% were "other" or did not report a race. The largest proportion had attended some high school or graduated (39%), 25% had attended college, 14% had a bachelor’s degree, and 15% had a graduate or professional degree (Ann. Emerg. Med. 2011;58:S210).

Dr. Newman said in an interview that he and his colleagues were surprised to see that education level was not strongly correlated with risk communication or with agreement between the physician and the patient about true risk.

In a post hoc analysis, the authors calculated a mean risk of less than 5% for death, myocardial infarction, or revascularization within 30 days.

The physicians, however, estimated a mean risk for these outcomes of 15%, and patients estimated their risk at 33%.

One-third of patients and 48% of physicians said that coronary risk (the main reason for admission) had not been part of their discussion about admitting the patient. When coronary risk was discussed, agreement between the physician and the patient about the patient’s level of risk was 0.38 (about 40% more likely to agree, compared with random chance).

In 11% of cases, physicians said that concern about liability was one of the reasons for admission. That concern likely represents millions of dollars in health care spending, Dr. Newman said.

In 27% of the cases, the doctor reported that if they were a patient with the same risk, they would not stay overnight.

The results hint that "something is affecting patients’ decision to stay even when someone with a theoretically much more complete understanding of the risks – the doctor – would not stay," Dr. Newman said.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations, or perhaps other system pressures [such as] financial incentives, crowding, resource utilization, [or] time are affecting this conversation," he said. "What we can say with confidence is this: Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

In another study, Dr. Patrick J. Lenehan of Morristown (N.J.) Hospital and colleagues found that a decreasing number of congestive heart failure patients were discharged from the emergency department in 1996-2010.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations."

The authors retrospectively reviewed emergency department visits to 27 suburban, urban, and rural New York and New Jersey hospitals. The facilities had 18,000-72,000 annual visits. Using ICD9 codes, the researched identified patients who had likely CHF. This group included those who had CHF, heart failure, or pulmonary edema as a primary diagnosis, or as a secondary diagnosis if the primary was shortness of breath or dyspnea (Ann. Emerg. Med. 2011;58:S237).

Of 6.6 million emergency department visits, 82,230 (1%) were for CHF. Half of the patients were women, and their mean age was 72 years. The authors found that there was a 63% decrease in the number of patients discharged from 1996 to 2010. In 1996, 24% were discharged. By 2010, only 9% were discharged.

The pattern was the same for male and female patients. Given that there has been no increase in the mean patient age, the difference in discharges is not likely the result of an aging population, the authors said.

The "trend is mainly due to increasing concerns about medical malpractice litigation," they suggested.

The two studies indicate an ongoing crisis and the need to enact liability reform, said Dr. David Seaberg, ACEP president. "The rapidly rising tide of patients coupled with increasing hospital admissions from the emergency department will create pressure on the health system that is not sustainable," Dr. Seaberg said in a statement. "Liability reform could relieve some of that pressure and bring down costs."

No conflicts of interest were reported.

SAN FRANCISCO – Liability concerns may drive emergency physicians’ decisions regarding patients with possible cardiac conditions, based on the results of two studies presented at the Scientific Assembly of the American College of Emergency Physicians.

Many emergency physicians weighed legal concerns more heavily than actual risk when considering whether to admit a patient for acute coronary syndrome, concluded Dr. David H. Newman and his colleagues.

The conclusion was based on an observational, matched-pairs survey conducted at the emergency departments of St. Luke’s Hospital and Roosevelt Hospital in New York. Patients who were admitted "primarily for acute coronary syndrome" were surveyed after they had discussed their admission with the physician. The admitting doctor also completed a survey after communicating with the patient.

Both were asked whether risk and prognosis were discussed, as well as about the perceived potential benefits of admission and perceived primary purpose of admission.

"Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

When asked to place themselves in the same position as the patient they had just evaluated, physicians often said that they would not have chosen admission for themselves but had admitted the patient, said Dr. Newman, director of clinical research in the department of emergency medicine at Mount Sinai School of Medicine in New York.

During the 18 months of the study, 849 surveys were completed. All patients had primary or secondary complaints of chest pain. Just over half were men. One-third were black, 24% were Hispanic, 23% were white, and 19% were "other" or did not report a race. The largest proportion had attended some high school or graduated (39%), 25% had attended college, 14% had a bachelor’s degree, and 15% had a graduate or professional degree (Ann. Emerg. Med. 2011;58:S210).

Dr. Newman said in an interview that he and his colleagues were surprised to see that education level was not strongly correlated with risk communication or with agreement between the physician and the patient about true risk.

In a post hoc analysis, the authors calculated a mean risk of less than 5% for death, myocardial infarction, or revascularization within 30 days.

The physicians, however, estimated a mean risk for these outcomes of 15%, and patients estimated their risk at 33%.

One-third of patients and 48% of physicians said that coronary risk (the main reason for admission) had not been part of their discussion about admitting the patient. When coronary risk was discussed, agreement between the physician and the patient about the patient’s level of risk was 0.38 (about 40% more likely to agree, compared with random chance).

In 11% of cases, physicians said that concern about liability was one of the reasons for admission. That concern likely represents millions of dollars in health care spending, Dr. Newman said.

In 27% of the cases, the doctor reported that if they were a patient with the same risk, they would not stay overnight.

The results hint that "something is affecting patients’ decision to stay even when someone with a theoretically much more complete understanding of the risks – the doctor – would not stay," Dr. Newman said.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations, or perhaps other system pressures [such as] financial incentives, crowding, resource utilization, [or] time are affecting this conversation," he said. "What we can say with confidence is this: Doctors and patients in the emergency department are communicating poorly about the risks of death and heart attack, and this is something we need to fix."

In another study, Dr. Patrick J. Lenehan of Morristown (N.J.) Hospital and colleagues found that a decreasing number of congestive heart failure patients were discharged from the emergency department in 1996-2010.

"It is possible that physicians do not recognize the degree to which legal concerns affect these conversations."

The authors retrospectively reviewed emergency department visits to 27 suburban, urban, and rural New York and New Jersey hospitals. The facilities had 18,000-72,000 annual visits. Using ICD9 codes, the researched identified patients who had likely CHF. This group included those who had CHF, heart failure, or pulmonary edema as a primary diagnosis, or as a secondary diagnosis if the primary was shortness of breath or dyspnea (Ann. Emerg. Med. 2011;58:S237).

Of 6.6 million emergency department visits, 82,230 (1%) were for CHF. Half of the patients were women, and their mean age was 72 years. The authors found that there was a 63% decrease in the number of patients discharged from 1996 to 2010. In 1996, 24% were discharged. By 2010, only 9% were discharged.

The pattern was the same for male and female patients. Given that there has been no increase in the mean patient age, the difference in discharges is not likely the result of an aging population, the authors said.

The "trend is mainly due to increasing concerns about medical malpractice litigation," they suggested.

The two studies indicate an ongoing crisis and the need to enact liability reform, said Dr. David Seaberg, ACEP president. "The rapidly rising tide of patients coupled with increasing hospital admissions from the emergency department will create pressure on the health system that is not sustainable," Dr. Seaberg said in a statement. "Liability reform could relieve some of that pressure and bring down costs."

No conflicts of interest were reported.

MelaFind, a noninvasive melanoma detection device, was approved by the Food and Drug Administration on Nov. 2.

The road to approval was marked by some controversy. It included a closely split advisory panel recommendation in November 2010, followed by the May 2011 submission of a citizen petition to the FDA seeking action by the manufacturer, Mela Sciences. The FDA deemed the device approvable in late September, pending agreement between the agency and Mela Sciences on how the device would be used and by whom.

Photo courtesy Mela Sciences

The approval includes a long list of indications and caveats, according to the company. They include the following:

• "MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma.

• It is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should not be used to confirm a clinical diagnosis of melanoma.

• MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer [that is, dermatologists] who have also successfully completed a training program in the appropriate use of MelaFind."

• MelaFind positive lesions should be considered for biopsy. "Non-evaluable" lesions should be carefully reevaluated for biopsy.

• MelaFind is indicated for use only on the following lesions: those with a diameter between 2 mm and 22 mm; lesions accessible by the MelaFind imager; those sufficiently pigmented; lesions that do not contain a scar or fibrosis consistent with previous trauma; those in which the skin is intact; lesions greater than 1 cm away from the eye; and those that do not contain foreign matter. It should not be used on acral, palmar, plantar, mucosal, or subungual areas.

Dr. Darrell S. Rigel, a dermatologist at New York University and a consultant for Mela Sciences, said in a statement that the device "represents one of the most significant advances in early melanoma detection since the advent of the ABCD criteria that our group developed over a quarter century ago."

Dr. Joseph V. Gulfo, president and CEO of Mela Sciences, said that the company aims to launch MelaFind in the United States and Germany in the spring of 2012. "We’re planning a steadfast, deliberate and measured approach to the commercial launch to ensure that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind effectively on the patients who can benefit most from the objective information that the system provides during skin examinations," he said in the statement.

Initially, the device will be sold only to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with the dermatologists to fine-tune the device before rolling it out to a larger number of practices.

The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; its software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

MelaFind, a noninvasive melanoma detection device, was approved by the Food and Drug Administration on Nov. 2.

The road to approval was marked by some controversy. It included a closely split advisory panel recommendation in November 2010, followed by the May 2011 submission of a citizen petition to the FDA seeking action by the manufacturer, Mela Sciences. The FDA deemed the device approvable in late September, pending agreement between the agency and Mela Sciences on how the device would be used and by whom.

Photo courtesy Mela Sciences

The approval includes a long list of indications and caveats, according to the company. They include the following:

• "MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma.

• It is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should not be used to confirm a clinical diagnosis of melanoma.

• MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer [that is, dermatologists] who have also successfully completed a training program in the appropriate use of MelaFind."

• MelaFind positive lesions should be considered for biopsy. "Non-evaluable" lesions should be carefully reevaluated for biopsy.

• MelaFind is indicated for use only on the following lesions: those with a diameter between 2 mm and 22 mm; lesions accessible by the MelaFind imager; those sufficiently pigmented; lesions that do not contain a scar or fibrosis consistent with previous trauma; those in which the skin is intact; lesions greater than 1 cm away from the eye; and those that do not contain foreign matter. It should not be used on acral, palmar, plantar, mucosal, or subungual areas.

Dr. Darrell S. Rigel, a dermatologist at New York University and a consultant for Mela Sciences, said in a statement that the device "represents one of the most significant advances in early melanoma detection since the advent of the ABCD criteria that our group developed over a quarter century ago."

Dr. Joseph V. Gulfo, president and CEO of Mela Sciences, said that the company aims to launch MelaFind in the United States and Germany in the spring of 2012. "We’re planning a steadfast, deliberate and measured approach to the commercial launch to ensure that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind effectively on the patients who can benefit most from the objective information that the system provides during skin examinations," he said in the statement.

Initially, the device will be sold only to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with the dermatologists to fine-tune the device before rolling it out to a larger number of practices.

The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; its software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

MelaFind, a noninvasive melanoma detection device, was approved by the Food and Drug Administration on Nov. 2.

The road to approval was marked by some controversy. It included a closely split advisory panel recommendation in November 2010, followed by the May 2011 submission of a citizen petition to the FDA seeking action by the manufacturer, Mela Sciences. The FDA deemed the device approvable in late September, pending agreement between the agency and Mela Sciences on how the device would be used and by whom.

Photo courtesy Mela Sciences

The approval includes a long list of indications and caveats, according to the company. They include the following:

• "MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma.

• It is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should not be used to confirm a clinical diagnosis of melanoma.

• MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer [that is, dermatologists] who have also successfully completed a training program in the appropriate use of MelaFind."

• MelaFind positive lesions should be considered for biopsy. "Non-evaluable" lesions should be carefully reevaluated for biopsy.

• MelaFind is indicated for use only on the following lesions: those with a diameter between 2 mm and 22 mm; lesions accessible by the MelaFind imager; those sufficiently pigmented; lesions that do not contain a scar or fibrosis consistent with previous trauma; those in which the skin is intact; lesions greater than 1 cm away from the eye; and those that do not contain foreign matter. It should not be used on acral, palmar, plantar, mucosal, or subungual areas.

Dr. Darrell S. Rigel, a dermatologist at New York University and a consultant for Mela Sciences, said in a statement that the device "represents one of the most significant advances in early melanoma detection since the advent of the ABCD criteria that our group developed over a quarter century ago."

Dr. Joseph V. Gulfo, president and CEO of Mela Sciences, said that the company aims to launch MelaFind in the United States and Germany in the spring of 2012. "We’re planning a steadfast, deliberate and measured approach to the commercial launch to ensure that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind effectively on the patients who can benefit most from the objective information that the system provides during skin examinations," he said in the statement.

Initially, the device will be sold only to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with the dermatologists to fine-tune the device before rolling it out to a larger number of practices.

The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; its software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare’s Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

"This payment rate cut would have dire consequences that should not be allowed to happen," CMS Administrator Donald Berwick said in a statement. "We need a permanent SGR fix to solve this problem once and for all."

"Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect," Kathleen Sebelius, Health and Human Services secretary, said in a statement. "We have not and will not let deep cuts to doctors’ payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries’ access to doctors."

The American Medical Association also urged Congress – yet again – to fix the SGR. "The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program," AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that "there is a 20% gap between Medicare payment updates and the cost of caring for seniors."

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians’ fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called "value-based modifier" will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare's Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

“This payment rate cut would have dire consequences that should not be allowed to happen,” CMS Administrator Donald Berwick said in a statement. “We need a permanent SGR fix to solve this problem once and for all.”

“Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect,” Kathleen Sebelius, Health and Human Services secretary, said in a statement. “We have not and will not let deep cuts to doctors' payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries' access to doctors.”T

The American Medical Association also urged Congress – yet again – to fix the SGR. “The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program,” AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that “there is a 20% gap between Medicare payment updates and the cost of caring for seniors.”

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians' fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called “value-based modifier” will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare's Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

“This payment rate cut would have dire consequences that should not be allowed to happen,” CMS Administrator Donald Berwick said in a statement. “We need a permanent SGR fix to solve this problem once and for all.”

“Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect,” Kathleen Sebelius, Health and Human Services secretary, said in a statement. “We have not and will not let deep cuts to doctors' payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries' access to doctors.”T

The American Medical Association also urged Congress – yet again – to fix the SGR. “The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program,” AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that “there is a 20% gap between Medicare payment updates and the cost of caring for seniors.”

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians' fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called “value-based modifier” will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.

If current law stands, physician fees will be cut by 27% in 2012, not the 29% originally projected, according to the final payment rule issued Nov. 1 by the Centers for Medicare and Medicaid Services.

The slight decrease is due to lower-than-expected Medicare cost growth, CMS officials said in a statement. Unless Congress steps in, the reduction will go into effect Jan. 1 as mandated by Medicare's Sustainable Growth Rate (SGR) formula.

Both President Obama, in his budget, and CMS officials have called for an overhaul of the SGR. The agency repeated that call with the issuing of the fee rule.

“This payment rate cut would have dire consequences that should not be allowed to happen,” CMS Administrator Donald Berwick said in a statement. “We need a permanent SGR fix to solve this problem once and for all.”

“Almost every year for more than a decade, doctors have faced this annual threat and the Congress has in turn acted to temporarily prevent these deep reductions from taking effect,” Kathleen Sebelius, Health and Human Services secretary, said in a statement. “We have not and will not let deep cuts to doctors' payments occur. The Obama administration is 100% committed to fixing the flawed Medicare payment system and protecting Medicare beneficiaries' access to doctors.”T

The American Medical Association also urged Congress – yet again – to fix the SGR. “The Joint Select Committee on Deficit Reduction must include repeal of the formula in [its] recommendation to Congress to protect access to care for seniors and stabilize the Medicare program,” AMA President Peter W. Carmel said in a statement. Dr. Carmel added that physician payments are so low that “there is a 20% gap between Medicare payment updates and the cost of caring for seniors.”

Under the final rule, Medicare will issue some $80 billion in payments next year, according to CMS estimates.

In addition to addressing physicians' fees, the final rule includes many cost-cutting and efficiency-oriented provisions. For instance, the CMS is expanding its look at codes that may be overvalued. Previously, the agency focused on high-cost codes in cardiology and radiology. In 2012, it will take a broader look, focusing on codes in each specialty that lead to the highest Medicare expenses.

The goal is to rebalance payments so that primary care is not undervalued, according to the final rule.

The agency is also taking a knife to payments for imaging services by going after multiple images taken of the same patient at the same practice on the same day. The CMS had proposed a 50% cut in the professional component; the final rule makes a 25% reduction.

The final rule made several changes to the electronic health records incentive program and also to the Physician Quality Reporting System (PQRS). For EHRs, physicians now have the option to submit data through several different portals, not just one established by the CMS. The agency also more closely aligned the PQRS requirements with the meaningful use requirements under the EHR Incentive Program.

The rule also establishes measures to be used in the future to pay physicians for higher quality and more efficient care. Payment adjustments will begin in 2015 and be applied to all physicians by 2017.

Under the rule, the so-called “value-based modifier” will use the PQRS core set (which focuses on cardiovascular conditions) and the core, alternative core, and additional EHR Incentive Program measures (which focus on several chronic conditions and preventive measures). Payments to group practices will be based on the core set of the Group Practice Reporting Option measures and measures of preventable hospital admissions for heart failure and chronic obstructive pulmonary disease.

The cost measures will be both total per capita cost and per capita cost for selected conditions including chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes.

The final rule will be published in the Federal Register Nov. 28.

For provisions that are open to comment, the CMS will accept comments until Jan. 3, 2012, and then respond in the 2013 fee rule.