Alicia Ault

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency's "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company's Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

The Web site was submitted to the FDA's Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA's warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil's FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression – that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which 'Safety Concerns' is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency's letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company's Web site, and declined further comment. A check of Hill's pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

This news organization and "The Pink Sheet" are owned by Elsevier.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency's "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company's Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

The Web site was submitted to the FDA's Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA's warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil's FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression – that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which 'Safety Concerns' is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency's letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company's Web site, and declined further comment. A check of Hill's pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

This news organization and "The Pink Sheet" are owned by Elsevier.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency's "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company's Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

The Web site was submitted to the FDA's Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA's warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil's FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression – that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which 'Safety Concerns' is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency's letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company's Web site, and declined further comment. A check of Hill's pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

This news organization and "The Pink Sheet" are owned by Elsevier.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency’s "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company’s Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

[FDA Takes On Drug-Tainted Dietary Supplements]

The Web site was submitted to the FDA’s Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA’s warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil’s FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression -– that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which ‘Safety Concerns’ is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency’s letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company’s Web site, and declined further comment. A check of Hill’s pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

Internal Medicine News Digital Network and "The Pink Sheet" are owned by Elsevier.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency’s "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company’s Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

[FDA Takes On Drug-Tainted Dietary Supplements]

The Web site was submitted to the FDA’s Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA’s warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil’s FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression -– that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which ‘Safety Concerns’ is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency’s letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company’s Web site, and declined further comment. A check of Hill’s pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

Internal Medicine News Digital Network and "The Pink Sheet" are owned by Elsevier.

The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency’s "Bad Ad" program.

The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company’s Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

[FDA Takes On Drug-Tainted Dietary Supplements]

The Web site was submitted to the FDA’s Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.

In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.

The FDA’s warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.

In the letter, the agency noted that, according to Derma-Smoothe Body Oil’s FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."

The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression -– that are in the approved labeling, according to the FDA.

The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.

"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.

"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which ‘Safety Concerns’ is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.

The FDA asked Hill to cease and desist the promotion, and to respond to the agency’s letter by Dec. 17.

According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company’s Web site, and declined further comment. A check of Hill’s pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."

Internal Medicine News Digital Network and "The Pink Sheet" are owned by Elsevier.

Botulinum toxins, including Botox and Dysport, are being associated with increasing reports of paralysis away from injection sites, difficulties in swallowing, incontinence, and breathing problems, according to the Institute for Safe Medication Practices.

The institute reviews and analyzes reports to the Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program.

Photo (c)DenGuy/istock.com

The group cited 6 deaths, 18 cases of disability, and 100 other serious injuries in the first quarter of 2010. Previous quarters have averaged 30-50 adverse events and one patient death associated with the toxin. Seventy-nine of the cases (64%) in the latest quarter were associated with Botox, 26 (21%) with Botox Cosmetic, 17 (14%) with Dysport, and 2 cases with undetermined brands.

The watchdog group charged that the Botox label downplays the potential for the drug to spread during dermatologic use.

Botulinum toxins, including Botox and Dysport, are being associated with increasing reports of paralysis away from injection sites, difficulties in swallowing, incontinence, and breathing problems, according to the Institute for Safe Medication Practices.

The institute reviews and analyzes reports to the Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program.

Photo (c)DenGuy/istock.com

The group cited 6 deaths, 18 cases of disability, and 100 other serious injuries in the first quarter of 2010. Previous quarters have averaged 30-50 adverse events and one patient death associated with the toxin. Seventy-nine of the cases (64%) in the latest quarter were associated with Botox, 26 (21%) with Botox Cosmetic, 17 (14%) with Dysport, and 2 cases with undetermined brands.

The watchdog group charged that the Botox label downplays the potential for the drug to spread during dermatologic use.

Botulinum toxins, including Botox and Dysport, are being associated with increasing reports of paralysis away from injection sites, difficulties in swallowing, incontinence, and breathing problems, according to the Institute for Safe Medication Practices.

The institute reviews and analyzes reports to the Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program.

Photo (c)DenGuy/istock.com

The group cited 6 deaths, 18 cases of disability, and 100 other serious injuries in the first quarter of 2010. Previous quarters have averaged 30-50 adverse events and one patient death associated with the toxin. Seventy-nine of the cases (64%) in the latest quarter were associated with Botox, 26 (21%) with Botox Cosmetic, 17 (14%) with Dysport, and 2 cases with undetermined brands.

The watchdog group charged that the Botox label downplays the potential for the drug to spread during dermatologic use.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON – For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General’s Office report on smoking, issued Dec. 9.

© kutay tanir/iStockphoto.com

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. "This report focuses on how tobacco smoke causes damage to every organ in your body," she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

"I believe it’s very important that every American knows what’s happening in their bodies, particularly those who are trying to quit." She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she’d told him about the new findings.

The 700-page "Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease" determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth.

Just one cigarette can trigger a heart attack or stroke, she said. In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today’s cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that "there is no safe level of exposure to tobacco smoke," and, she added, "If you’re a smoker, the best time to quit is right now."

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. "Today’s report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers," he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration’s ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. "If we’re a less healthy nation, we’re not competitive in a global economy," she added.

The Surgeon General's office has created a consumer-friendly version of the new report and a printable, one-page fact sheet for physicians to use in discussing the report with their patients. [Also, read the full Surgeon General’s report.]

The report only focuses on smoking’s effects on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document Nov. 19 that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. "The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America’s children and their families," Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. For instance, incentives should "adequately reflect the relative contributions of participating physicians," and practices that participate in ACOs and achieve recognition as medical homes "should receive additional financial incentives," according to the Joint Principles.

The Medicare Payment Advisory Commission (MedPAC) has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, "If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality."

Shared savings also could "help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs," Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

"If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home," he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.