Alicia Ault

The Food and Drug Administration has approved the first “follow-on” version of a human growth hormone, Omnitrope, a recombinant somatotropin made by Sandoz International GmbH.

The approval is notable in that it raises questions about the FDA's process for approving generic biologics. The agency says it still does not have the authority to license such generics. In the case of Omnitrope, the agency determined that it is not therapeutically equivalent to the human growth hormones currently on the market. Thus, Omnitrope is not considered a generic, but is instead deemed to be a follow-on product because it is “sufficiently similar” to Pfizer Inc.'s Genotropin, said the FDA.

Pfizer had filed a petition to block Omnitrope's approval, objecting to Sandoz's use of Pfizer data in its application, which was submitted in mid-2003. Sandoz, meanwhile, sued the FDA last September to force some action on its long-languishing application. In early April, a federal court ordered the agency to move one way or another.

The FDA said its Omnitrope approval did not set an automatic precedent for the approval of other follow-on or generic biologics, as human growth hormone has certain characteristics that make it uniquely suited to a relatively simple approval. Recombinant human growth hormone has only one known active ingredient, and its mechanism of action, toxicity, and efficacy is well understood, said the FDA.

Sandoz used both published data from Pfizer and conducted its own trial in pediatric patients to prove Omnitrope's safety and efficacy. In the 89-patient study, 44 children received Omnitrope and 45 another Genotropin for 9 months in a daily subcutaneous injection of 0.03 mg/kg. At 9 months, height velocity was similar for both, with a mean of 10.7 cm per year.

Omnitrope was approved for growth failure in pediatric patients and growth hormone deficiency in adults. The warnings and precautions for Omnitrope are similar to those for other growth hormone formulations. Patients with diabetes or glucose intolerance should be watched carefully as the drug can induce insulin resistance, according to the FDA-approved label.

In a press release announcing the approval, Sandoz did not comment on whether Omnitrope would cost less than competitors.

The Food and Drug Administration has approved the first “follow-on” version of a human growth hormone, Omnitrope, a recombinant somatotropin made by Sandoz International GmbH.

The approval is notable in that it raises questions about the FDA's process for approving generic biologics. The agency says it still does not have the authority to license such generics. In the case of Omnitrope, the agency determined that it is not therapeutically equivalent to the human growth hormones currently on the market. Thus, Omnitrope is not considered a generic, but is instead deemed to be a follow-on product because it is “sufficiently similar” to Pfizer Inc.'s Genotropin, said the FDA.

Pfizer had filed a petition to block Omnitrope's approval, objecting to Sandoz's use of Pfizer data in its application, which was submitted in mid-2003. Sandoz, meanwhile, sued the FDA last September to force some action on its long-languishing application. In early April, a federal court ordered the agency to move one way or another.

The FDA said its Omnitrope approval did not set an automatic precedent for the approval of other follow-on or generic biologics, as human growth hormone has certain characteristics that make it uniquely suited to a relatively simple approval. Recombinant human growth hormone has only one known active ingredient, and its mechanism of action, toxicity, and efficacy is well understood, said the FDA.

Sandoz used both published data from Pfizer and conducted its own trial in pediatric patients to prove Omnitrope's safety and efficacy. In the 89-patient study, 44 children received Omnitrope and 45 another Genotropin for 9 months in a daily subcutaneous injection of 0.03 mg/kg. At 9 months, height velocity was similar for both, with a mean of 10.7 cm per year.

Omnitrope was approved for growth failure in pediatric patients and growth hormone deficiency in adults. The warnings and precautions for Omnitrope are similar to those for other growth hormone formulations. Patients with diabetes or glucose intolerance should be watched carefully as the drug can induce insulin resistance, according to the FDA-approved label.

In a press release announcing the approval, Sandoz did not comment on whether Omnitrope would cost less than competitors.

The Food and Drug Administration has approved the first “follow-on” version of a human growth hormone, Omnitrope, a recombinant somatotropin made by Sandoz International GmbH.

The approval is notable in that it raises questions about the FDA's process for approving generic biologics. The agency says it still does not have the authority to license such generics. In the case of Omnitrope, the agency determined that it is not therapeutically equivalent to the human growth hormones currently on the market. Thus, Omnitrope is not considered a generic, but is instead deemed to be a follow-on product because it is “sufficiently similar” to Pfizer Inc.'s Genotropin, said the FDA.

Pfizer had filed a petition to block Omnitrope's approval, objecting to Sandoz's use of Pfizer data in its application, which was submitted in mid-2003. Sandoz, meanwhile, sued the FDA last September to force some action on its long-languishing application. In early April, a federal court ordered the agency to move one way or another.

The FDA said its Omnitrope approval did not set an automatic precedent for the approval of other follow-on or generic biologics, as human growth hormone has certain characteristics that make it uniquely suited to a relatively simple approval. Recombinant human growth hormone has only one known active ingredient, and its mechanism of action, toxicity, and efficacy is well understood, said the FDA.

Sandoz used both published data from Pfizer and conducted its own trial in pediatric patients to prove Omnitrope's safety and efficacy. In the 89-patient study, 44 children received Omnitrope and 45 another Genotropin for 9 months in a daily subcutaneous injection of 0.03 mg/kg. At 9 months, height velocity was similar for both, with a mean of 10.7 cm per year.

Omnitrope was approved for growth failure in pediatric patients and growth hormone deficiency in adults. The warnings and precautions for Omnitrope are similar to those for other growth hormone formulations. Patients with diabetes or glucose intolerance should be watched carefully as the drug can induce insulin resistance, according to the FDA-approved label.

In a press release announcing the approval, Sandoz did not comment on whether Omnitrope would cost less than competitors.

Call for Hearing on Tanning Beds

Members of the U.S. House of Representatives are calling for hearings on the existing federal warning language on tanning beds, saying that it does not sufficiently explain the risks, including the potential for skin cancer. Rep. Carolyn Maloney (D-N.Y.), Ginny Brown-Waite (R-Fla.), Sherrod Brown (D-Ohio), and Henry Waxman (D-Calif.) asked the House Energy and Commerce Committee's subcommittee on health to consider the Tanning Accountability and Notification Act (H.R. 4767), which was introduced in February by Rep. Maloney and Rep. Brown-Waite, and would require the Food and Drug Administration to survey consumers about their understanding of the risks. The legislation has been backed by the American Academy of Dermatology. In a statement, Dr. Stephen P. Stone, AAD president, noted, "With the number of skin cancer cases rising in this country each year, especially among young adults, the academy supports this effort to ensure that the current warning labels attached to indoor tanning devices are accurately and fully conveying the adverse events and risks to those using the equipment."

Psoriasis Biologics Coverage in CA

After a year of discussion, Blue Shield of California has agreed to recommendations by the National Psoriasis Foundation to loosen restrictions on biologic therapies for patients with psoriasis and psoriatic arthritis. The foundation estimates that as many as 17,600 of the Blue Shield's 3.2 million members have moderate to severe disease that might require a biologic agent. Under the previous policy, patients could not get a biologic unless at least 30% of their body surface area was affected, and they had already failed two traditional systemic treatments and phototherapy, said Sheila Rittenberg, who is director of advocacy at the National Psoriasis Foundation. Now, the requirements have been lowered to 13% surface area coverage, failure of one systemic therapy, and intolerance, failure, or difficulty accessing phototherapy. Blue Shield's old policy was among the most restrictive in the nation, according to the foundation. The advent of biologics has been a double-edged sword—they are expensive, but they've also put psoriasis on clinicians' and insurers' radar screens, said Ms. Rittenberg. "Now people are paying attention because somebody's got to pay the bill," she said.

Survey: FDA Influenced by Politics

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% of respondents said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA. Most of those polled said FDA advisory panel members should not be allowed to have consulting agreements with, or stock in, drug companies. But Americans showed their tendency to want it all, too. When asked how important it is to have access to new drugs, no matter the cost, 71% said very or somewhat; 93% said the same about getting access to affordable drugs, 72% to experimental drugs without proven safety or efficacy if they offer a choice when there are no other options, and 94% to getting complete safety information.

Sunscreen Ads Fail to Reach Men

Advertisements for sun-protection products are targeted primarily at women, and are failing to reach men, travelers, outdoors enthusiasts, and others at high risk for sun exposure, according to a review of such advertisements published in the May/June issue of the American Journal of Health Promotion. Researchers from Boston University, the Cancer Research Center of Hawaii, and the Veterans Affairs Palo Alto Health Care System reviewed May-September issues of 24 magazines published from 1997 to 2002. The magazines included the top sellers for women, men, teens, parents, travelers, and outdoor enthusiasts. In the 579 issues reviewed, there were 783 ads for products ranging from sunscreens to self-tanning products to moisturizers and cosmetics with SPF. Seventy-seven percent of the ads appeared in women's magazines, with at least four ads in each issue, compared with less than one ad in every issue of a parent or family magazine, and less than one ad in every six issues of outdoors magazines. The majority of the ads running in women's magazines were for cosmetics or moisturizers that contained sun protection. The authors noted that over the study period, the number of ads for those types of products skyrocketed while traditional sunscreen ads declined. That trend is disturbing because the cosmetics ads don't mention the need to use the products before sun exposure or to reapply after exercise or swimming, said the researchers.

ICD-10 Fraud Concerns

The Blue Cross and Blue Shield Association and the Medical Group Management Association are among those objecting to the planned implementation of ICD-10, the newest version of the comprehensive list of diagnostic billing codes used by health care providers. A bill currently being considered in the House would require payers to switch from the current ICD-9 codes to ICD-10 by Oct. 1, 2009. Blue Cross/Blue Shield argued in a statement that the deadline should be pushed back to 2012 "because much has to be done before a switch to ICD-10 can be started … and providers need time to automate their offices and be trained." The Blues are particularly concerned because the switch comes at the same time that Medicare is shrinking the number of its claims processors—many of which are Blues plans—from 50 to 15.

Call for Hearing on Tanning Beds

Members of the U.S. House of Representatives are calling for hearings on the existing federal warning language on tanning beds, saying that it does not sufficiently explain the risks, including the potential for skin cancer. Rep. Carolyn Maloney (D-N.Y.), Ginny Brown-Waite (R-Fla.), Sherrod Brown (D-Ohio), and Henry Waxman (D-Calif.) asked the House Energy and Commerce Committee's subcommittee on health to consider the Tanning Accountability and Notification Act (H.R. 4767), which was introduced in February by Rep. Maloney and Rep. Brown-Waite, and would require the Food and Drug Administration to survey consumers about their understanding of the risks. The legislation has been backed by the American Academy of Dermatology. In a statement, Dr. Stephen P. Stone, AAD president, noted, "With the number of skin cancer cases rising in this country each year, especially among young adults, the academy supports this effort to ensure that the current warning labels attached to indoor tanning devices are accurately and fully conveying the adverse events and risks to those using the equipment."

Psoriasis Biologics Coverage in CA

After a year of discussion, Blue Shield of California has agreed to recommendations by the National Psoriasis Foundation to loosen restrictions on biologic therapies for patients with psoriasis and psoriatic arthritis. The foundation estimates that as many as 17,600 of the Blue Shield's 3.2 million members have moderate to severe disease that might require a biologic agent. Under the previous policy, patients could not get a biologic unless at least 30% of their body surface area was affected, and they had already failed two traditional systemic treatments and phototherapy, said Sheila Rittenberg, who is director of advocacy at the National Psoriasis Foundation. Now, the requirements have been lowered to 13% surface area coverage, failure of one systemic therapy, and intolerance, failure, or difficulty accessing phototherapy. Blue Shield's old policy was among the most restrictive in the nation, according to the foundation. The advent of biologics has been a double-edged sword—they are expensive, but they've also put psoriasis on clinicians' and insurers' radar screens, said Ms. Rittenberg. "Now people are paying attention because somebody's got to pay the bill," she said.

Survey: FDA Influenced by Politics

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% of respondents said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA. Most of those polled said FDA advisory panel members should not be allowed to have consulting agreements with, or stock in, drug companies. But Americans showed their tendency to want it all, too. When asked how important it is to have access to new drugs, no matter the cost, 71% said very or somewhat; 93% said the same about getting access to affordable drugs, 72% to experimental drugs without proven safety or efficacy if they offer a choice when there are no other options, and 94% to getting complete safety information.

Sunscreen Ads Fail to Reach Men

Advertisements for sun-protection products are targeted primarily at women, and are failing to reach men, travelers, outdoors enthusiasts, and others at high risk for sun exposure, according to a review of such advertisements published in the May/June issue of the American Journal of Health Promotion. Researchers from Boston University, the Cancer Research Center of Hawaii, and the Veterans Affairs Palo Alto Health Care System reviewed May-September issues of 24 magazines published from 1997 to 2002. The magazines included the top sellers for women, men, teens, parents, travelers, and outdoor enthusiasts. In the 579 issues reviewed, there were 783 ads for products ranging from sunscreens to self-tanning products to moisturizers and cosmetics with SPF. Seventy-seven percent of the ads appeared in women's magazines, with at least four ads in each issue, compared with less than one ad in every issue of a parent or family magazine, and less than one ad in every six issues of outdoors magazines. The majority of the ads running in women's magazines were for cosmetics or moisturizers that contained sun protection. The authors noted that over the study period, the number of ads for those types of products skyrocketed while traditional sunscreen ads declined. That trend is disturbing because the cosmetics ads don't mention the need to use the products before sun exposure or to reapply after exercise or swimming, said the researchers.

ICD-10 Fraud Concerns

The Blue Cross and Blue Shield Association and the Medical Group Management Association are among those objecting to the planned implementation of ICD-10, the newest version of the comprehensive list of diagnostic billing codes used by health care providers. A bill currently being considered in the House would require payers to switch from the current ICD-9 codes to ICD-10 by Oct. 1, 2009. Blue Cross/Blue Shield argued in a statement that the deadline should be pushed back to 2012 "because much has to be done before a switch to ICD-10 can be started … and providers need time to automate their offices and be trained." The Blues are particularly concerned because the switch comes at the same time that Medicare is shrinking the number of its claims processors—many of which are Blues plans—from 50 to 15.

Call for Hearing on Tanning Beds

Members of the U.S. House of Representatives are calling for hearings on the existing federal warning language on tanning beds, saying that it does not sufficiently explain the risks, including the potential for skin cancer. Rep. Carolyn Maloney (D-N.Y.), Ginny Brown-Waite (R-Fla.), Sherrod Brown (D-Ohio), and Henry Waxman (D-Calif.) asked the House Energy and Commerce Committee's subcommittee on health to consider the Tanning Accountability and Notification Act (H.R. 4767), which was introduced in February by Rep. Maloney and Rep. Brown-Waite, and would require the Food and Drug Administration to survey consumers about their understanding of the risks. The legislation has been backed by the American Academy of Dermatology. In a statement, Dr. Stephen P. Stone, AAD president, noted, "With the number of skin cancer cases rising in this country each year, especially among young adults, the academy supports this effort to ensure that the current warning labels attached to indoor tanning devices are accurately and fully conveying the adverse events and risks to those using the equipment."

Psoriasis Biologics Coverage in CA

After a year of discussion, Blue Shield of California has agreed to recommendations by the National Psoriasis Foundation to loosen restrictions on biologic therapies for patients with psoriasis and psoriatic arthritis. The foundation estimates that as many as 17,600 of the Blue Shield's 3.2 million members have moderate to severe disease that might require a biologic agent. Under the previous policy, patients could not get a biologic unless at least 30% of their body surface area was affected, and they had already failed two traditional systemic treatments and phototherapy, said Sheila Rittenberg, who is director of advocacy at the National Psoriasis Foundation. Now, the requirements have been lowered to 13% surface area coverage, failure of one systemic therapy, and intolerance, failure, or difficulty accessing phototherapy. Blue Shield's old policy was among the most restrictive in the nation, according to the foundation. The advent of biologics has been a double-edged sword—they are expensive, but they've also put psoriasis on clinicians' and insurers' radar screens, said Ms. Rittenberg. "Now people are paying attention because somebody's got to pay the bill," she said.

Survey: FDA Influenced by Politics

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% of respondents said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA. Most of those polled said FDA advisory panel members should not be allowed to have consulting agreements with, or stock in, drug companies. But Americans showed their tendency to want it all, too. When asked how important it is to have access to new drugs, no matter the cost, 71% said very or somewhat; 93% said the same about getting access to affordable drugs, 72% to experimental drugs without proven safety or efficacy if they offer a choice when there are no other options, and 94% to getting complete safety information.

Sunscreen Ads Fail to Reach Men

Advertisements for sun-protection products are targeted primarily at women, and are failing to reach men, travelers, outdoors enthusiasts, and others at high risk for sun exposure, according to a review of such advertisements published in the May/June issue of the American Journal of Health Promotion. Researchers from Boston University, the Cancer Research Center of Hawaii, and the Veterans Affairs Palo Alto Health Care System reviewed May-September issues of 24 magazines published from 1997 to 2002. The magazines included the top sellers for women, men, teens, parents, travelers, and outdoor enthusiasts. In the 579 issues reviewed, there were 783 ads for products ranging from sunscreens to self-tanning products to moisturizers and cosmetics with SPF. Seventy-seven percent of the ads appeared in women's magazines, with at least four ads in each issue, compared with less than one ad in every issue of a parent or family magazine, and less than one ad in every six issues of outdoors magazines. The majority of the ads running in women's magazines were for cosmetics or moisturizers that contained sun protection. The authors noted that over the study period, the number of ads for those types of products skyrocketed while traditional sunscreen ads declined. That trend is disturbing because the cosmetics ads don't mention the need to use the products before sun exposure or to reapply after exercise or swimming, said the researchers.

ICD-10 Fraud Concerns

The Blue Cross and Blue Shield Association and the Medical Group Management Association are among those objecting to the planned implementation of ICD-10, the newest version of the comprehensive list of diagnostic billing codes used by health care providers. A bill currently being considered in the House would require payers to switch from the current ICD-9 codes to ICD-10 by Oct. 1, 2009. Blue Cross/Blue Shield argued in a statement that the deadline should be pushed back to 2012 "because much has to be done before a switch to ICD-10 can be started … and providers need time to automate their offices and be trained." The Blues are particularly concerned because the switch comes at the same time that Medicare is shrinking the number of its claims processors—many of which are Blues plans—from 50 to 15.

WASHINGTON — This winter's flu season is still months away, but officials from the federal government and the American Medical Association say they will be strongly urging physicians to extend influenza vaccine administration beyond its traditional October-December time frame.

The goal is to protect more Americans and to ensure a more even supply throughout the season. The effort comes at a time when the vaccine supply is expected to be the largest in U.S. history, with at least 100 million doses slated to be available.

Centers for Disease Control and Prevention and AMA officials discussed their plans at a press briefing sponsored by the National Foundation for Infectious Diseases.

The two organizations began formulating strategies for encouraging a longer vaccination season at the National Influenza Vaccine Summit in January. They and other stakeholders met again in late June. With several more high-risk groups targeted for vaccination this year—the CDC has defined 12 target groups—it is getting more difficult for physicians to determine how much vaccine to order and how to effectively manage supply, said Nicole M. Smith, Ph.D., of the CDC's Influenza Division.

There are other barriers to convincing physicians to preorder more vaccine: Any unused supply is essentially “money down the drain,” said Dr. Ardis D. Hoven, medical director of the Bluegrass Care Clinic at the University of Kentucky, Lexington, and a member of the AMA's Board of Trustees. The CDC recommendations encompass about 180 million Americans, said Dr. Hoven.

In most years, vaccination peaks in early October, when about 70% of the vaccine supply has been released, according to CDC data. The demand drops off steeply, usually completely, by late December, which means that most years as much as 30% of the supply goes unused.

Dr. William Schaffner, chairman of the preventive medicine department at Vanderbilt University, Nashville, Tenn., and an NFID board member, said that both physicians and patients have fallen into the habit of thinking that if they haven't gotten a shot by late November, they don't need to bother. But he and other officials noted that flu usually peaks in February or March. “We need to persuade them it's not too late to get vaccinated,” said Dr. Schaffner at the briefing.

Physicians have to do some public relations work on their own to make patients aware of this, Dr. Hoven agreed. And physicians have to be persistent with distributors, she added in an interview. They have “to be more proactive in constantly saying 'When am I getting my doses?'” she said.

That might not be an easy job. The Health Industry Distributors Association estimates that there are 600 companies that distribute vaccine from two of the three major manufacturers. GlaxoSmithKline, which will have a projected 47 million doses this fall, sells directly only. An estimated 50 million doses will be produced by Sanofi Pasteur. MedImmune Inc. is slated to produce 3 million doses of its live, attenuated nasal vaccine, FluMist. Another 15–20 million doses might become available if the Food and Drug Administration approves a new vaccine from ID Biomedical, which Glaxo owns also.

The CDC is looking into ways to track the supply so that it can easily locate available doses for physicians, as well, said Dr. Hoven.

Dr. Schaffner said the ramping up of the supply “bodes very well for our attempt to provide protection,” and seems to reflect manufacturers' belief that the market is going to grow.

Physicians and other health care providers are still lagging when it comes to leading by example. Several recent surveys conducted by the AMA and the CDC indicate that only about 40% of health care workers get a flu shot. Dr. Hoven said that often physicians delay getting a shot because they're too busy or want to save the dose for their patients. But she said it's a failing that needs to be corrected.

WASHINGTON — This winter's flu season is still months away, but officials from the federal government and the American Medical Association say they will be strongly urging physicians to extend influenza vaccine administration beyond its traditional October-December time frame.

The goal is to protect more Americans and to ensure a more even supply throughout the season. The effort comes at a time when the vaccine supply is expected to be the largest in U.S. history, with at least 100 million doses slated to be available.

Centers for Disease Control and Prevention and AMA officials discussed their plans at a press briefing sponsored by the National Foundation for Infectious Diseases.

The two organizations began formulating strategies for encouraging a longer vaccination season at the National Influenza Vaccine Summit in January. They and other stakeholders met again in late June. With several more high-risk groups targeted for vaccination this year—the CDC has defined 12 target groups—it is getting more difficult for physicians to determine how much vaccine to order and how to effectively manage supply, said Nicole M. Smith, Ph.D., of the CDC's Influenza Division.

There are other barriers to convincing physicians to preorder more vaccine: Any unused supply is essentially “money down the drain,” said Dr. Ardis D. Hoven, medical director of the Bluegrass Care Clinic at the University of Kentucky, Lexington, and a member of the AMA's Board of Trustees. The CDC recommendations encompass about 180 million Americans, said Dr. Hoven.

In most years, vaccination peaks in early October, when about 70% of the vaccine supply has been released, according to CDC data. The demand drops off steeply, usually completely, by late December, which means that most years as much as 30% of the supply goes unused.

Dr. William Schaffner, chairman of the preventive medicine department at Vanderbilt University, Nashville, Tenn., and an NFID board member, said that both physicians and patients have fallen into the habit of thinking that if they haven't gotten a shot by late November, they don't need to bother. But he and other officials noted that flu usually peaks in February or March. “We need to persuade them it's not too late to get vaccinated,” said Dr. Schaffner at the briefing.

Physicians have to do some public relations work on their own to make patients aware of this, Dr. Hoven agreed. And physicians have to be persistent with distributors, she added in an interview. They have “to be more proactive in constantly saying 'When am I getting my doses?'” she said.

That might not be an easy job. The Health Industry Distributors Association estimates that there are 600 companies that distribute vaccine from two of the three major manufacturers. GlaxoSmithKline, which will have a projected 47 million doses this fall, sells directly only. An estimated 50 million doses will be produced by Sanofi Pasteur. MedImmune Inc. is slated to produce 3 million doses of its live, attenuated nasal vaccine, FluMist. Another 15–20 million doses might become available if the Food and Drug Administration approves a new vaccine from ID Biomedical, which Glaxo owns also.

The CDC is looking into ways to track the supply so that it can easily locate available doses for physicians, as well, said Dr. Hoven.

Dr. Schaffner said the ramping up of the supply “bodes very well for our attempt to provide protection,” and seems to reflect manufacturers' belief that the market is going to grow.

Physicians and other health care providers are still lagging when it comes to leading by example. Several recent surveys conducted by the AMA and the CDC indicate that only about 40% of health care workers get a flu shot. Dr. Hoven said that often physicians delay getting a shot because they're too busy or want to save the dose for their patients. But she said it's a failing that needs to be corrected.

WASHINGTON — This winter's flu season is still months away, but officials from the federal government and the American Medical Association say they will be strongly urging physicians to extend influenza vaccine administration beyond its traditional October-December time frame.

The goal is to protect more Americans and to ensure a more even supply throughout the season. The effort comes at a time when the vaccine supply is expected to be the largest in U.S. history, with at least 100 million doses slated to be available.

Centers for Disease Control and Prevention and AMA officials discussed their plans at a press briefing sponsored by the National Foundation for Infectious Diseases.

The two organizations began formulating strategies for encouraging a longer vaccination season at the National Influenza Vaccine Summit in January. They and other stakeholders met again in late June. With several more high-risk groups targeted for vaccination this year—the CDC has defined 12 target groups—it is getting more difficult for physicians to determine how much vaccine to order and how to effectively manage supply, said Nicole M. Smith, Ph.D., of the CDC's Influenza Division.

There are other barriers to convincing physicians to preorder more vaccine: Any unused supply is essentially “money down the drain,” said Dr. Ardis D. Hoven, medical director of the Bluegrass Care Clinic at the University of Kentucky, Lexington, and a member of the AMA's Board of Trustees. The CDC recommendations encompass about 180 million Americans, said Dr. Hoven.

In most years, vaccination peaks in early October, when about 70% of the vaccine supply has been released, according to CDC data. The demand drops off steeply, usually completely, by late December, which means that most years as much as 30% of the supply goes unused.

Dr. William Schaffner, chairman of the preventive medicine department at Vanderbilt University, Nashville, Tenn., and an NFID board member, said that both physicians and patients have fallen into the habit of thinking that if they haven't gotten a shot by late November, they don't need to bother. But he and other officials noted that flu usually peaks in February or March. “We need to persuade them it's not too late to get vaccinated,” said Dr. Schaffner at the briefing.

Physicians have to do some public relations work on their own to make patients aware of this, Dr. Hoven agreed. And physicians have to be persistent with distributors, she added in an interview. They have “to be more proactive in constantly saying 'When am I getting my doses?'” she said.

That might not be an easy job. The Health Industry Distributors Association estimates that there are 600 companies that distribute vaccine from two of the three major manufacturers. GlaxoSmithKline, which will have a projected 47 million doses this fall, sells directly only. An estimated 50 million doses will be produced by Sanofi Pasteur. MedImmune Inc. is slated to produce 3 million doses of its live, attenuated nasal vaccine, FluMist. Another 15–20 million doses might become available if the Food and Drug Administration approves a new vaccine from ID Biomedical, which Glaxo owns also.

The CDC is looking into ways to track the supply so that it can easily locate available doses for physicians, as well, said Dr. Hoven.

Dr. Schaffner said the ramping up of the supply “bodes very well for our attempt to provide protection,” and seems to reflect manufacturers' belief that the market is going to grow.

Physicians and other health care providers are still lagging when it comes to leading by example. Several recent surveys conducted by the AMA and the CDC indicate that only about 40% of health care workers get a flu shot. Dr. Hoven said that often physicians delay getting a shot because they're too busy or want to save the dose for their patients. But she said it's a failing that needs to be corrected.

Seeing Plaque Is Believing

Patients shown images of their own coronary artery calcium (CAC) comply better with statin therapy, researchers at the Los Angeles Biomedical Research Institute at the Harbor-University of California at Los Angeles Medical Center say. In a study published in Atherosclerosis, Dr. Matthew J. Budoff and colleagues looked at adherence to statin therapy in 505 patients who were among 1,215 consecutive patients who underwent electron beam tomography at the center. Overall, 72% remained on treatment at follow-up, almost 4 years after the baseline scan. As CAC scores increased, so did adherence, according to Dr. Budoff of the medical center's Research and Education Institute. Only 44% of those with a CAC score of zero were adherent, compared with 90% of those with a score in the highest two quartiles. Adherence seemed to be influenced mainly by the scan; the presence or absence of heart disease risk factors did not make a difference, said the authors. A randomized trial is needed to confirm the results, since this study was observational and relied on self-reports of medication use, they said.

High Cholesterol, But Not Worried

An American Heart Association survey found that half of those with a cholesterol level of 200 or more who had other risk factors such as high blood pressure did not think they were at risk for cardiovascular disease. The poll of 756 adults aged 35–75 years who have been diagnosed with high or borderline high cholesterol, also found 15% believed they were at low risk of cardiovascular disease. Seventy-two percent saw their health care provider as a partner in managing their cholesterol. People who discussed their condition more frequently with their provider were more informed on issues such as their personal goals (83% vs. 65% for infrequent discussers) and the importance of following a treatment plan (94% vs. 80%). The AHA released the survey as part of the 2006 Cholesterol Low Down program sponsored by Pfizer Inc.

GAO Raps FDA Decision Making

The Food and Drug Administration lacks a clear and effective process for making decisions about postmarketing drug safety issues, according to a recent report from the Government Accountability Office. The GAO noted that “there has been high turnover of Office of Drug Safety directors in the past 10 years, with eight different directors of the office and its various predecessors.” Communication also is an issue; insufficient communication between the Office of Drug Safety and the Office of New Drugs divisions has been an ongoing concern and has hindered the decision-making process, the report said. The GAO suggested that Congress consider expanding the FDA's authority to require drug makers to conduct additional postmarket studies when needed. The GAO also recommended establishing a mechanism for specifically tracking postmarketing safety issues, and clarifying the Office of Drug Safety's role in the agency's advisory committee meetings. The FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge.

PBMs Say Generics Thwarted

At least 14 brand-name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, according to the Pharmaceutical Care Management Association in a new report. This year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin), the PCMA said. The FDA just approved a generic pravastatin (see p. 2). The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, PCMA noted.

Seeing Plaque Is Believing

Patients shown images of their own coronary artery calcium (CAC) comply better with statin therapy, researchers at the Los Angeles Biomedical Research Institute at the Harbor-University of California at Los Angeles Medical Center say. In a study published in Atherosclerosis, Dr. Matthew J. Budoff and colleagues looked at adherence to statin therapy in 505 patients who were among 1,215 consecutive patients who underwent electron beam tomography at the center. Overall, 72% remained on treatment at follow-up, almost 4 years after the baseline scan. As CAC scores increased, so did adherence, according to Dr. Budoff of the medical center's Research and Education Institute. Only 44% of those with a CAC score of zero were adherent, compared with 90% of those with a score in the highest two quartiles. Adherence seemed to be influenced mainly by the scan; the presence or absence of heart disease risk factors did not make a difference, said the authors. A randomized trial is needed to confirm the results, since this study was observational and relied on self-reports of medication use, they said.

High Cholesterol, But Not Worried

An American Heart Association survey found that half of those with a cholesterol level of 200 or more who had other risk factors such as high blood pressure did not think they were at risk for cardiovascular disease. The poll of 756 adults aged 35–75 years who have been diagnosed with high or borderline high cholesterol, also found 15% believed they were at low risk of cardiovascular disease. Seventy-two percent saw their health care provider as a partner in managing their cholesterol. People who discussed their condition more frequently with their provider were more informed on issues such as their personal goals (83% vs. 65% for infrequent discussers) and the importance of following a treatment plan (94% vs. 80%). The AHA released the survey as part of the 2006 Cholesterol Low Down program sponsored by Pfizer Inc.

GAO Raps FDA Decision Making

The Food and Drug Administration lacks a clear and effective process for making decisions about postmarketing drug safety issues, according to a recent report from the Government Accountability Office. The GAO noted that “there has been high turnover of Office of Drug Safety directors in the past 10 years, with eight different directors of the office and its various predecessors.” Communication also is an issue; insufficient communication between the Office of Drug Safety and the Office of New Drugs divisions has been an ongoing concern and has hindered the decision-making process, the report said. The GAO suggested that Congress consider expanding the FDA's authority to require drug makers to conduct additional postmarket studies when needed. The GAO also recommended establishing a mechanism for specifically tracking postmarketing safety issues, and clarifying the Office of Drug Safety's role in the agency's advisory committee meetings. The FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge.

PBMs Say Generics Thwarted

At least 14 brand-name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, according to the Pharmaceutical Care Management Association in a new report. This year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin), the PCMA said. The FDA just approved a generic pravastatin (see p. 2). The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, PCMA noted.

Seeing Plaque Is Believing

Patients shown images of their own coronary artery calcium (CAC) comply better with statin therapy, researchers at the Los Angeles Biomedical Research Institute at the Harbor-University of California at Los Angeles Medical Center say. In a study published in Atherosclerosis, Dr. Matthew J. Budoff and colleagues looked at adherence to statin therapy in 505 patients who were among 1,215 consecutive patients who underwent electron beam tomography at the center. Overall, 72% remained on treatment at follow-up, almost 4 years after the baseline scan. As CAC scores increased, so did adherence, according to Dr. Budoff of the medical center's Research and Education Institute. Only 44% of those with a CAC score of zero were adherent, compared with 90% of those with a score in the highest two quartiles. Adherence seemed to be influenced mainly by the scan; the presence or absence of heart disease risk factors did not make a difference, said the authors. A randomized trial is needed to confirm the results, since this study was observational and relied on self-reports of medication use, they said.

High Cholesterol, But Not Worried

An American Heart Association survey found that half of those with a cholesterol level of 200 or more who had other risk factors such as high blood pressure did not think they were at risk for cardiovascular disease. The poll of 756 adults aged 35–75 years who have been diagnosed with high or borderline high cholesterol, also found 15% believed they were at low risk of cardiovascular disease. Seventy-two percent saw their health care provider as a partner in managing their cholesterol. People who discussed their condition more frequently with their provider were more informed on issues such as their personal goals (83% vs. 65% for infrequent discussers) and the importance of following a treatment plan (94% vs. 80%). The AHA released the survey as part of the 2006 Cholesterol Low Down program sponsored by Pfizer Inc.

GAO Raps FDA Decision Making

The Food and Drug Administration lacks a clear and effective process for making decisions about postmarketing drug safety issues, according to a recent report from the Government Accountability Office. The GAO noted that “there has been high turnover of Office of Drug Safety directors in the past 10 years, with eight different directors of the office and its various predecessors.” Communication also is an issue; insufficient communication between the Office of Drug Safety and the Office of New Drugs divisions has been an ongoing concern and has hindered the decision-making process, the report said. The GAO suggested that Congress consider expanding the FDA's authority to require drug makers to conduct additional postmarket studies when needed. The GAO also recommended establishing a mechanism for specifically tracking postmarketing safety issues, and clarifying the Office of Drug Safety's role in the agency's advisory committee meetings. The FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge.

PBMs Say Generics Thwarted

At least 14 brand-name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, according to the Pharmaceutical Care Management Association in a new report. This year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin), the PCMA said. The FDA just approved a generic pravastatin (see p. 2). The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, PCMA noted.

An old idea–using peers to facilitate recovery–is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Several self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support–which is defined partly as the sharing of experiential knowledge, skills, and social learning–was included as 1 of the 10 fundamental components of recovery in a consensus statement that was recently released by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy–whether talk therapy or medication–provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said.

He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate who is in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general–not just symptoms going away,” she said.

An old idea–using peers to facilitate recovery–is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Several self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support–which is defined partly as the sharing of experiential knowledge, skills, and social learning–was included as 1 of the 10 fundamental components of recovery in a consensus statement that was recently released by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy–whether talk therapy or medication–provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said.

He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate who is in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general–not just symptoms going away,” she said.

An old idea–using peers to facilitate recovery–is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Several self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support–which is defined partly as the sharing of experiential knowledge, skills, and social learning–was included as 1 of the 10 fundamental components of recovery in a consensus statement that was recently released by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy–whether talk therapy or medication–provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said.

He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate who is in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general–not just symptoms going away,” she said.

Researching Psoriatic Arthritis

The National Psoriasis Foundation has awarded $120,000 in seed money to researchers trying to understand the mechanism of disease for psoriasis and psoriatic arthritis. The idea behind the program is to fund research that will generate preliminary data to be used in grant applications to the National Institutes of Health. The four grants—funded at $30,000 each—were awarded to researchers in Oregon, Utah, Colorado, and New York. One grant recipient at Columbia University will focus on understanding the environment of joints in psoriatic arthritis. The results of this type of research could lead to better therapeutic targets for psoriatic arthritis, according to the Psoriasis Foundation.

Ban Tanning Ads at Teens?

Researchers at the University of Colorado's dermatology department are calling for a ban on tanning salon advertisements that are directed at adolescents, after a small survey of Denver-area high school newspapers found that ads offering indoor tanning services—and usually at a discount—appeared in publications at half the schools. The researchers looked at newspapers printed in 2001 or later at 23 public schools. Forty ads appeared in 131 papers at 11 schools, with most ads appearing in the spring. Fifteen of the forty advertisements offered unlimited tanning for up to 4 months; half offered discounts, including "prom specials." Two advertisements noted that parental permission was required for tanners under the age of 16 years; another warned that no one under 14 years old would be allowed to tan. Although the study was a limited snapshot in time and did not involve a random sample, the results still suggest that tanning advertisements are "abundant" in public high school papers in the Denver area, said the authors. The study was published in the April 2006 issue of the Archives of Dermatology.

Part D Formulary Override Form

A coalition of physician and pharmacist organizations and insurers, led by the American Medical Association, has developed a form that all physicians can use to request a prior authorization or coverage of a nonformulary drug under Medicare's Part D benefit. Partners include the American Psychiatric Association, the American Academy of Family Physicians, the American College of Physicians, the National Council on Aging, the American Pharmacists Association, and America's Health Insurance Plans. "Physicians will now have a simple one-page form to easily communicate to drug plans why a patient needs a specific drug when other similar drugs are also covered by the plan," said AMA board member Dr. Edward Langston in a statement. Using the form, physicians can explain why an alternative drug is needed, why a different dose is required, or why the formulary drug is not acceptable. The exceptions request form is available on the Web sites of the Centers for Medicare and Medicaid Services (

www.cms.hhs.gov

www.ama-assn.org

www.ahip.org

www.aafp.org

Critics Say Generics Thwarted

At least 14 brand name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans, or pharmaceutical benefit managers (PBMs)—negotiate discounts with drug makers on behalf of employers and insurers and are under pressure to keep pharmaceutical prices down so they can offer competitively priced plans to Medicare beneficiaries. The organization says that this year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The Food and Drug Administration just approved a generic pravastatin. The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, noted PCMA.

Polls Say Seniors Satisfied

Two new polls—from the Kaiser Family Foundation and the U.S. Chamber of Commerce—say that Medicare beneficiaries who have enrolled in the Part D plan are very satisfied. Kaiser interviewed 517 seniors in early April; 31% had enrolled in a plan, and among those, 75% said they were very or somewhat satisfied with their plan. Of the 84% who had tried to get a prescription with their plan, 82% had no problems. The U.S. Chamber hired the Tarrance Group to survey 970 registered voters over age 65 in late April. Seventy-eight percent had drug coverage; of those, 43% were covered through a former employer, a union, or the Veterans Administration; 17% through a stand-alone Part D benefit; 13% through a Medicare HMO or PPO; and 23% through some "other" plan. Seventy-two percent of those with Medicare coverage had self-enrolled, and among those, 78% said they were very or somewhat satisfied with their prescription drug coverage. A majority—around 80%—of those who were self-enrolled said they understood how to use the plan, that their premiums and co-payments were affordable, that they had access to high-quality medications, and that the drugs they needed were covered, said Brian Nienaber, a vice president at Tarrance Group, in a conference call with reporters.

Researching Psoriatic Arthritis

The National Psoriasis Foundation has awarded $120,000 in seed money to researchers trying to understand the mechanism of disease for psoriasis and psoriatic arthritis. The idea behind the program is to fund research that will generate preliminary data to be used in grant applications to the National Institutes of Health. The four grants—funded at $30,000 each—were awarded to researchers in Oregon, Utah, Colorado, and New York. One grant recipient at Columbia University will focus on understanding the environment of joints in psoriatic arthritis. The results of this type of research could lead to better therapeutic targets for psoriatic arthritis, according to the Psoriasis Foundation.

Ban Tanning Ads at Teens?

Researchers at the University of Colorado's dermatology department are calling for a ban on tanning salon advertisements that are directed at adolescents, after a small survey of Denver-area high school newspapers found that ads offering indoor tanning services—and usually at a discount—appeared in publications at half the schools. The researchers looked at newspapers printed in 2001 or later at 23 public schools. Forty ads appeared in 131 papers at 11 schools, with most ads appearing in the spring. Fifteen of the forty advertisements offered unlimited tanning for up to 4 months; half offered discounts, including "prom specials." Two advertisements noted that parental permission was required for tanners under the age of 16 years; another warned that no one under 14 years old would be allowed to tan. Although the study was a limited snapshot in time and did not involve a random sample, the results still suggest that tanning advertisements are "abundant" in public high school papers in the Denver area, said the authors. The study was published in the April 2006 issue of the Archives of Dermatology.

Part D Formulary Override Form

A coalition of physician and pharmacist organizations and insurers, led by the American Medical Association, has developed a form that all physicians can use to request a prior authorization or coverage of a nonformulary drug under Medicare's Part D benefit. Partners include the American Psychiatric Association, the American Academy of Family Physicians, the American College of Physicians, the National Council on Aging, the American Pharmacists Association, and America's Health Insurance Plans. "Physicians will now have a simple one-page form to easily communicate to drug plans why a patient needs a specific drug when other similar drugs are also covered by the plan," said AMA board member Dr. Edward Langston in a statement. Using the form, physicians can explain why an alternative drug is needed, why a different dose is required, or why the formulary drug is not acceptable. The exceptions request form is available on the Web sites of the Centers for Medicare and Medicaid Services (

www.cms.hhs.gov

www.ama-assn.org

www.ahip.org

www.aafp.org

Critics Say Generics Thwarted

At least 14 brand name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans, or pharmaceutical benefit managers (PBMs)—negotiate discounts with drug makers on behalf of employers and insurers and are under pressure to keep pharmaceutical prices down so they can offer competitively priced plans to Medicare beneficiaries. The organization says that this year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The Food and Drug Administration just approved a generic pravastatin. The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, noted PCMA.

Polls Say Seniors Satisfied

Two new polls—from the Kaiser Family Foundation and the U.S. Chamber of Commerce—say that Medicare beneficiaries who have enrolled in the Part D plan are very satisfied. Kaiser interviewed 517 seniors in early April; 31% had enrolled in a plan, and among those, 75% said they were very or somewhat satisfied with their plan. Of the 84% who had tried to get a prescription with their plan, 82% had no problems. The U.S. Chamber hired the Tarrance Group to survey 970 registered voters over age 65 in late April. Seventy-eight percent had drug coverage; of those, 43% were covered through a former employer, a union, or the Veterans Administration; 17% through a stand-alone Part D benefit; 13% through a Medicare HMO or PPO; and 23% through some "other" plan. Seventy-two percent of those with Medicare coverage had self-enrolled, and among those, 78% said they were very or somewhat satisfied with their prescription drug coverage. A majority—around 80%—of those who were self-enrolled said they understood how to use the plan, that their premiums and co-payments were affordable, that they had access to high-quality medications, and that the drugs they needed were covered, said Brian Nienaber, a vice president at Tarrance Group, in a conference call with reporters.

Researching Psoriatic Arthritis

The National Psoriasis Foundation has awarded $120,000 in seed money to researchers trying to understand the mechanism of disease for psoriasis and psoriatic arthritis. The idea behind the program is to fund research that will generate preliminary data to be used in grant applications to the National Institutes of Health. The four grants—funded at $30,000 each—were awarded to researchers in Oregon, Utah, Colorado, and New York. One grant recipient at Columbia University will focus on understanding the environment of joints in psoriatic arthritis. The results of this type of research could lead to better therapeutic targets for psoriatic arthritis, according to the Psoriasis Foundation.

Ban Tanning Ads at Teens?

Researchers at the University of Colorado's dermatology department are calling for a ban on tanning salon advertisements that are directed at adolescents, after a small survey of Denver-area high school newspapers found that ads offering indoor tanning services—and usually at a discount—appeared in publications at half the schools. The researchers looked at newspapers printed in 2001 or later at 23 public schools. Forty ads appeared in 131 papers at 11 schools, with most ads appearing in the spring. Fifteen of the forty advertisements offered unlimited tanning for up to 4 months; half offered discounts, including "prom specials." Two advertisements noted that parental permission was required for tanners under the age of 16 years; another warned that no one under 14 years old would be allowed to tan. Although the study was a limited snapshot in time and did not involve a random sample, the results still suggest that tanning advertisements are "abundant" in public high school papers in the Denver area, said the authors. The study was published in the April 2006 issue of the Archives of Dermatology.

Part D Formulary Override Form

A coalition of physician and pharmacist organizations and insurers, led by the American Medical Association, has developed a form that all physicians can use to request a prior authorization or coverage of a nonformulary drug under Medicare's Part D benefit. Partners include the American Psychiatric Association, the American Academy of Family Physicians, the American College of Physicians, the National Council on Aging, the American Pharmacists Association, and America's Health Insurance Plans. "Physicians will now have a simple one-page form to easily communicate to drug plans why a patient needs a specific drug when other similar drugs are also covered by the plan," said AMA board member Dr. Edward Langston in a statement. Using the form, physicians can explain why an alternative drug is needed, why a different dose is required, or why the formulary drug is not acceptable. The exceptions request form is available on the Web sites of the Centers for Medicare and Medicaid Services (

www.cms.hhs.gov

www.ama-assn.org

www.ahip.org

www.aafp.org

Critics Say Generics Thwarted

At least 14 brand name drugs are due to go off patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, but pharmaceutical manufacturers are doing all they can to block generic competition, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans, or pharmaceutical benefit managers (PBMs)—negotiate discounts with drug makers on behalf of employers and insurers and are under pressure to keep pharmaceutical prices down so they can offer competitively priced plans to Medicare beneficiaries. The organization says that this year alone, $1.5 billion could be saved on four drugs due to lose exclusivity: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The Food and Drug Administration just approved a generic pravastatin. The savings estimates assume that 90% of Medicare prescriptions would be switched to generics and that the generic would cost 60% less than the brand name. In 2007, seven popular products—Norvasc (amlodipine), Ambien (zolpidem), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), Lamisil (terbinafine), and Tequin (gatifloxacin)—are due to lose patent protection, which could lead to $700 million in savings that year, noted PCMA.

Polls Say Seniors Satisfied

Two new polls—from the Kaiser Family Foundation and the U.S. Chamber of Commerce—say that Medicare beneficiaries who have enrolled in the Part D plan are very satisfied. Kaiser interviewed 517 seniors in early April; 31% had enrolled in a plan, and among those, 75% said they were very or somewhat satisfied with their plan. Of the 84% who had tried to get a prescription with their plan, 82% had no problems. The U.S. Chamber hired the Tarrance Group to survey 970 registered voters over age 65 in late April. Seventy-eight percent had drug coverage; of those, 43% were covered through a former employer, a union, or the Veterans Administration; 17% through a stand-alone Part D benefit; 13% through a Medicare HMO or PPO; and 23% through some "other" plan. Seventy-two percent of those with Medicare coverage had self-enrolled, and among those, 78% said they were very or somewhat satisfied with their prescription drug coverage. A majority—around 80%—of those who were self-enrolled said they understood how to use the plan, that their premiums and co-payments were affordable, that they had access to high-quality medications, and that the drugs they needed were covered, said Brian Nienaber, a vice president at Tarrance Group, in a conference call with reporters.

Medicare has ruled that microvolt T-wave alternans testing should be covered nationally, calling it an accurate screen for sudden cardiac death.

The test is used primarily to determine candidates for an implantable cardioverter defibrillator, but the Centers for Medicare and Medicaid Services did not require use of the diagnostic to select those patients.

“CMS has determined that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks,” the agency wrote in its coverage decision.

The test is manufactured and sold by Cambridge Heart Inc., based in Bedford, Mass. It was originally approved by the Food and Drug Administration in 2000, but has not been widely adopted. According to the company, only 500 of the $30,000 units have been sold.

Dr. Anne B. Curtis, president of the Heart Rhythm Society, said that clinicians have not been quick to adopt MTWA testing. Although it has been shown to have a high negative predictive value, it has not given clinicians confidence that patients with normal results have a very low likelihood of having a cardiac event, Dr. Curtis said in an interview.

ICDs have been shown to improve survival in patients with an ejection fraction at or below 35%, so there is no real incentive to conduct MTWA testing in those patients, especially since so many still have not received ICDs, said Dr. Curtis, who is also chief of cardiovascular services at the University of South Florida, Tampa.

In those high-risk patients, “you clearly would want that patient to have a defibrillator—you don't need any other tests,” agreed Dr. Michael J. Mirro, a trustee of the American College of Cardiology and medical director of the Parkview Research Center, Fort Wayne, Ind. “Where it is going to be of value—and why the academic electrophysiologists are waiting for more clinical data—is to see if it has more compelling positive predictive value in patients in the intermediate-risk group,” Dr. Mirro said in an interview. Dr. Mirro is a shareholder in Cambridge Heart.

Both Dr. Mirro and Dr. Curtis agreed that positive data from an ongoing prospective study, the Alternans Before Cardioverter Defibrillator (ABCD) trial—in addition to wider insurance coverage—would prompt more widespread use of MTWA testing.

The diagnostic has been evaluated prospectively in patients with ischemic cardiomyopathy, nonischemic dilated cardiomyopathy, or mixed cardiomyopathy. In the 19 prospective studies reviewed by CMS, patients had an ejection fraction of 23%–71%. Patients with indeterminate test results were excluded. Overall, the positive predictive value ranged from 0% to 67%, and the negative predictive value ranged from 71% to 100%.

The Heart Rhythm Society and ACC wrote to CMS to urge against making MTWA testing a prerequisite for ICD implantation. Several manufacturers took the same position, and said that Medicare should wait for the results of the ABCD study.

That 42-center trial is being led jointly by St. Jude Medical Inc., Case Western Reserve's MetroHealth Medical Center, and Cambridge Heart. Patients with a positive MTWA test are given an ICD and then followed for a year to evaluate ventricular tachyarrhythmia and death rates. Enrolled patients have ischemic heart disease, a left ventricular ejection fraction less than or equal to 40%, and nonsustained tachycardia.

MTWA testing was previously covered by CMS local contractors and, according to David Chazanovitz, CEO of Cambridge Heart, 10 BlueCross BlueShield plans—even though an October 2005 review by the BlueCross BlueShield Association's Technology Evaluation Center said there was insufficient evidence to recommend the testing. Aetna recently agreed to cover MTWA on a national basis, said Mr. Chazanovitz in an interview.

Currently, about 1.3 million Americans have been deemed eligible for an ICD.

Medicare has ruled that microvolt T-wave alternans testing should be covered nationally, calling it an accurate screen for sudden cardiac death.

The test is used primarily to determine candidates for an implantable cardioverter defibrillator, but the Centers for Medicare and Medicaid Services did not require use of the diagnostic to select those patients.

“CMS has determined that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks,” the agency wrote in its coverage decision.

The test is manufactured and sold by Cambridge Heart Inc., based in Bedford, Mass. It was originally approved by the Food and Drug Administration in 2000, but has not been widely adopted. According to the company, only 500 of the $30,000 units have been sold.

Dr. Anne B. Curtis, president of the Heart Rhythm Society, said that clinicians have not been quick to adopt MTWA testing. Although it has been shown to have a high negative predictive value, it has not given clinicians confidence that patients with normal results have a very low likelihood of having a cardiac event, Dr. Curtis said in an interview.

ICDs have been shown to improve survival in patients with an ejection fraction at or below 35%, so there is no real incentive to conduct MTWA testing in those patients, especially since so many still have not received ICDs, said Dr. Curtis, who is also chief of cardiovascular services at the University of South Florida, Tampa.

In those high-risk patients, “you clearly would want that patient to have a defibrillator—you don't need any other tests,” agreed Dr. Michael J. Mirro, a trustee of the American College of Cardiology and medical director of the Parkview Research Center, Fort Wayne, Ind. “Where it is going to be of value—and why the academic electrophysiologists are waiting for more clinical data—is to see if it has more compelling positive predictive value in patients in the intermediate-risk group,” Dr. Mirro said in an interview. Dr. Mirro is a shareholder in Cambridge Heart.

Both Dr. Mirro and Dr. Curtis agreed that positive data from an ongoing prospective study, the Alternans Before Cardioverter Defibrillator (ABCD) trial—in addition to wider insurance coverage—would prompt more widespread use of MTWA testing.

The diagnostic has been evaluated prospectively in patients with ischemic cardiomyopathy, nonischemic dilated cardiomyopathy, or mixed cardiomyopathy. In the 19 prospective studies reviewed by CMS, patients had an ejection fraction of 23%–71%. Patients with indeterminate test results were excluded. Overall, the positive predictive value ranged from 0% to 67%, and the negative predictive value ranged from 71% to 100%.

The Heart Rhythm Society and ACC wrote to CMS to urge against making MTWA testing a prerequisite for ICD implantation. Several manufacturers took the same position, and said that Medicare should wait for the results of the ABCD study.

That 42-center trial is being led jointly by St. Jude Medical Inc., Case Western Reserve's MetroHealth Medical Center, and Cambridge Heart. Patients with a positive MTWA test are given an ICD and then followed for a year to evaluate ventricular tachyarrhythmia and death rates. Enrolled patients have ischemic heart disease, a left ventricular ejection fraction less than or equal to 40%, and nonsustained tachycardia.

MTWA testing was previously covered by CMS local contractors and, according to David Chazanovitz, CEO of Cambridge Heart, 10 BlueCross BlueShield plans—even though an October 2005 review by the BlueCross BlueShield Association's Technology Evaluation Center said there was insufficient evidence to recommend the testing. Aetna recently agreed to cover MTWA on a national basis, said Mr. Chazanovitz in an interview.

Currently, about 1.3 million Americans have been deemed eligible for an ICD.

Medicare has ruled that microvolt T-wave alternans testing should be covered nationally, calling it an accurate screen for sudden cardiac death.

The test is used primarily to determine candidates for an implantable cardioverter defibrillator, but the Centers for Medicare and Medicaid Services did not require use of the diagnostic to select those patients.

“CMS has determined that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks,” the agency wrote in its coverage decision.

The test is manufactured and sold by Cambridge Heart Inc., based in Bedford, Mass. It was originally approved by the Food and Drug Administration in 2000, but has not been widely adopted. According to the company, only 500 of the $30,000 units have been sold.

Dr. Anne B. Curtis, president of the Heart Rhythm Society, said that clinicians have not been quick to adopt MTWA testing. Although it has been shown to have a high negative predictive value, it has not given clinicians confidence that patients with normal results have a very low likelihood of having a cardiac event, Dr. Curtis said in an interview.

ICDs have been shown to improve survival in patients with an ejection fraction at or below 35%, so there is no real incentive to conduct MTWA testing in those patients, especially since so many still have not received ICDs, said Dr. Curtis, who is also chief of cardiovascular services at the University of South Florida, Tampa.

In those high-risk patients, “you clearly would want that patient to have a defibrillator—you don't need any other tests,” agreed Dr. Michael J. Mirro, a trustee of the American College of Cardiology and medical director of the Parkview Research Center, Fort Wayne, Ind. “Where it is going to be of value—and why the academic electrophysiologists are waiting for more clinical data—is to see if it has more compelling positive predictive value in patients in the intermediate-risk group,” Dr. Mirro said in an interview. Dr. Mirro is a shareholder in Cambridge Heart.

Both Dr. Mirro and Dr. Curtis agreed that positive data from an ongoing prospective study, the Alternans Before Cardioverter Defibrillator (ABCD) trial—in addition to wider insurance coverage—would prompt more widespread use of MTWA testing.

The diagnostic has been evaluated prospectively in patients with ischemic cardiomyopathy, nonischemic dilated cardiomyopathy, or mixed cardiomyopathy. In the 19 prospective studies reviewed by CMS, patients had an ejection fraction of 23%–71%. Patients with indeterminate test results were excluded. Overall, the positive predictive value ranged from 0% to 67%, and the negative predictive value ranged from 71% to 100%.

The Heart Rhythm Society and ACC wrote to CMS to urge against making MTWA testing a prerequisite for ICD implantation. Several manufacturers took the same position, and said that Medicare should wait for the results of the ABCD study.

That 42-center trial is being led jointly by St. Jude Medical Inc., Case Western Reserve's MetroHealth Medical Center, and Cambridge Heart. Patients with a positive MTWA test are given an ICD and then followed for a year to evaluate ventricular tachyarrhythmia and death rates. Enrolled patients have ischemic heart disease, a left ventricular ejection fraction less than or equal to 40%, and nonsustained tachycardia.

MTWA testing was previously covered by CMS local contractors and, according to David Chazanovitz, CEO of Cambridge Heart, 10 BlueCross BlueShield plans—even though an October 2005 review by the BlueCross BlueShield Association's Technology Evaluation Center said there was insufficient evidence to recommend the testing. Aetna recently agreed to cover MTWA on a national basis, said Mr. Chazanovitz in an interview.

Currently, about 1.3 million Americans have been deemed eligible for an ICD.

In a not unexpected, but definitely unwelcome move, the Centers for Medicare and Medicaid Services has announced that it will cut physician pay by 4.6% for 2007.

The federal health program said the scheduled decrease in physician fees is based partly on the fact that spending for physicians' services rose by 8.5% in 2005, with 7.5% of that rise due to growth in the volume and intensity of physician services.

But physician organizations blame the hit on the sustainable growth rate (SGR). If Medicare spending on physicians increases more than the SGR, CMS must cut physician fees; lower spending means higher rates for physicians. But errors made in setting the SGR in 1998 and 1999 have led to annual proposed cutbacks and yearly congressional bailouts. Last year, for instance, medical organizations successfully lobbied Congress to block a proposed 4.4% cut for 2006, but because legislators did not increase fees, payments essentially were frozen at the 2005 rate.

Also in 2007, according to the American Association of Clinical Endocrinologists, the Medicare payment for the technical component of some imaging services will be set at the hospital outpatient payment rate if that rate is lower than the physician fee schedule rate. Technical component payments for ultrasound guidance and bone densitometry would be reduced by over 40% under this scenario.

This year, physician groups again say that they will urge Congress to stop the fee cut and repair the SGR.

“I think Congress agrees that it's not a fair system,” Patrick Hope, legislative counsel for the American College of Physicians, said in an interview. ACP is not optimistic that the SGR will be addressed in 2006, an election year, Mr. Hope said.

Physician organizations said they will try to stop the cuts. Some also will continue to push for a system that would reward physicians with higher fees in exchange for more quality reporting, and tying physician fees to the Medicare Economic Index.

The bill introduced last year by Rep. Nancy Johnson (R-Conn.) is a good starting point for negotiations, Mr. Hope said.

The American Medical Association supported Rep. Johnson's bill, and also will urge Congress to stop the cuts, an AMA spokeswoman said.

In a statement, Dr. Duane Cady, AMA chair, said that the 2007 reduction “is just the tip of the iceberg.” Over 9 years, the pay cuts will total 34%, while practice costs will increase 22%, Dr. Cady said. An AMA survey found that over those years, 73% of physicians will defer buying new equipment and 65% will put off purchases of new information technology—at a time when practitioners are being asked to convert to electronic health records and collect more data on quality and health outcomes.

“You can't expect doctors to move toward electronic health records facing that kind of hit,” Mr. Hope agreed.

Physicians may stop taking new Medicare patients, or, even worse, may have to close their practices. When the overhead is greater than the payment, there won't be any access, plus closures will impact private-pay patients.

Even CMS agreed that the practice environment is getting harder. “Physicians may find it difficult to invest in activities like electronic record systems and support programs for high-risk patients that could enhance quality of care, without increasing medical costs,” Herb B. Kuhn, director of CMS' Center for Medicare Management, wrote to the Medicare Payment Advisory Commission.

The fastest-growing components of physician services included imaging (16% growth), laboratory and other tests (11% growth), and procedures (9% growth), according to the letter. Procedures accounted for 26% of Medicare spending, compared with 14% for imaging and 12% for laboratory and other tests.

An increase in evaluation and management services accounted for the largest portion of the 8.5% overall growth in physician services, but the growth rate—7%—was less than for the other services.

Dr. Cady said that it's not surprising that physician services are increasing, as patients are living longer with chronic conditions and more emphasis is being placed on preventive care.

In a not unexpected, but definitely unwelcome move, the Centers for Medicare and Medicaid Services has announced that it will cut physician pay by 4.6% for 2007.

The federal health program said the scheduled decrease in physician fees is based partly on the fact that spending for physicians' services rose by 8.5% in 2005, with 7.5% of that rise due to growth in the volume and intensity of physician services.

But physician organizations blame the hit on the sustainable growth rate (SGR). If Medicare spending on physicians increases more than the SGR, CMS must cut physician fees; lower spending means higher rates for physicians. But errors made in setting the SGR in 1998 and 1999 have led to annual proposed cutbacks and yearly congressional bailouts. Last year, for instance, medical organizations successfully lobbied Congress to block a proposed 4.4% cut for 2006, but because legislators did not increase fees, payments essentially were frozen at the 2005 rate.

Also in 2007, according to the American Association of Clinical Endocrinologists, the Medicare payment for the technical component of some imaging services will be set at the hospital outpatient payment rate if that rate is lower than the physician fee schedule rate. Technical component payments for ultrasound guidance and bone densitometry would be reduced by over 40% under this scenario.

This year, physician groups again say that they will urge Congress to stop the fee cut and repair the SGR.

“I think Congress agrees that it's not a fair system,” Patrick Hope, legislative counsel for the American College of Physicians, said in an interview. ACP is not optimistic that the SGR will be addressed in 2006, an election year, Mr. Hope said.

Physician organizations said they will try to stop the cuts. Some also will continue to push for a system that would reward physicians with higher fees in exchange for more quality reporting, and tying physician fees to the Medicare Economic Index.

The bill introduced last year by Rep. Nancy Johnson (R-Conn.) is a good starting point for negotiations, Mr. Hope said.

The American Medical Association supported Rep. Johnson's bill, and also will urge Congress to stop the cuts, an AMA spokeswoman said.

In a statement, Dr. Duane Cady, AMA chair, said that the 2007 reduction “is just the tip of the iceberg.” Over 9 years, the pay cuts will total 34%, while practice costs will increase 22%, Dr. Cady said. An AMA survey found that over those years, 73% of physicians will defer buying new equipment and 65% will put off purchases of new information technology—at a time when practitioners are being asked to convert to electronic health records and collect more data on quality and health outcomes.

“You can't expect doctors to move toward electronic health records facing that kind of hit,” Mr. Hope agreed.

Physicians may stop taking new Medicare patients, or, even worse, may have to close their practices. When the overhead is greater than the payment, there won't be any access, plus closures will impact private-pay patients.

Even CMS agreed that the practice environment is getting harder. “Physicians may find it difficult to invest in activities like electronic record systems and support programs for high-risk patients that could enhance quality of care, without increasing medical costs,” Herb B. Kuhn, director of CMS' Center for Medicare Management, wrote to the Medicare Payment Advisory Commission.

The fastest-growing components of physician services included imaging (16% growth), laboratory and other tests (11% growth), and procedures (9% growth), according to the letter. Procedures accounted for 26% of Medicare spending, compared with 14% for imaging and 12% for laboratory and other tests.

An increase in evaluation and management services accounted for the largest portion of the 8.5% overall growth in physician services, but the growth rate—7%—was less than for the other services.

Dr. Cady said that it's not surprising that physician services are increasing, as patients are living longer with chronic conditions and more emphasis is being placed on preventive care.

In a not unexpected, but definitely unwelcome move, the Centers for Medicare and Medicaid Services has announced that it will cut physician pay by 4.6% for 2007.

The federal health program said the scheduled decrease in physician fees is based partly on the fact that spending for physicians' services rose by 8.5% in 2005, with 7.5% of that rise due to growth in the volume and intensity of physician services.

But physician organizations blame the hit on the sustainable growth rate (SGR). If Medicare spending on physicians increases more than the SGR, CMS must cut physician fees; lower spending means higher rates for physicians. But errors made in setting the SGR in 1998 and 1999 have led to annual proposed cutbacks and yearly congressional bailouts. Last year, for instance, medical organizations successfully lobbied Congress to block a proposed 4.4% cut for 2006, but because legislators did not increase fees, payments essentially were frozen at the 2005 rate.

Also in 2007, according to the American Association of Clinical Endocrinologists, the Medicare payment for the technical component of some imaging services will be set at the hospital outpatient payment rate if that rate is lower than the physician fee schedule rate. Technical component payments for ultrasound guidance and bone densitometry would be reduced by over 40% under this scenario.

This year, physician groups again say that they will urge Congress to stop the fee cut and repair the SGR.

“I think Congress agrees that it's not a fair system,” Patrick Hope, legislative counsel for the American College of Physicians, said in an interview. ACP is not optimistic that the SGR will be addressed in 2006, an election year, Mr. Hope said.

Physician organizations said they will try to stop the cuts. Some also will continue to push for a system that would reward physicians with higher fees in exchange for more quality reporting, and tying physician fees to the Medicare Economic Index.

The bill introduced last year by Rep. Nancy Johnson (R-Conn.) is a good starting point for negotiations, Mr. Hope said.

The American Medical Association supported Rep. Johnson's bill, and also will urge Congress to stop the cuts, an AMA spokeswoman said.

In a statement, Dr. Duane Cady, AMA chair, said that the 2007 reduction “is just the tip of the iceberg.” Over 9 years, the pay cuts will total 34%, while practice costs will increase 22%, Dr. Cady said. An AMA survey found that over those years, 73% of physicians will defer buying new equipment and 65% will put off purchases of new information technology—at a time when practitioners are being asked to convert to electronic health records and collect more data on quality and health outcomes.

“You can't expect doctors to move toward electronic health records facing that kind of hit,” Mr. Hope agreed.

Physicians may stop taking new Medicare patients, or, even worse, may have to close their practices. When the overhead is greater than the payment, there won't be any access, plus closures will impact private-pay patients.

Even CMS agreed that the practice environment is getting harder. “Physicians may find it difficult to invest in activities like electronic record systems and support programs for high-risk patients that could enhance quality of care, without increasing medical costs,” Herb B. Kuhn, director of CMS' Center for Medicare Management, wrote to the Medicare Payment Advisory Commission.

The fastest-growing components of physician services included imaging (16% growth), laboratory and other tests (11% growth), and procedures (9% growth), according to the letter. Procedures accounted for 26% of Medicare spending, compared with 14% for imaging and 12% for laboratory and other tests.

An increase in evaluation and management services accounted for the largest portion of the 8.5% overall growth in physician services, but the growth rate—7%—was less than for the other services.

Dr. Cady said that it's not surprising that physician services are increasing, as patients are living longer with chronic conditions and more emphasis is being placed on preventive care.

The American Board of Internal Medicine has announced that those who participate in Medicare's Physician Voluntary Reporting Program can use the same quality data to meet the board's requirements for maintenance of certification.

“Our major interest in doing this is to reduce the burden of redundant measurements that doctors are facing,” said Dr. Christine K. Cassel, president and CEO of ABIM.

Currently, maintenance of certification in internal medicine requires that certain quality indicators be measured by entering medical records data into ABIM Practice Improvement Modules (PIMs). The physicians receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The PIMs generally require physicians to do medical record audits of their patients. Only ABIM's new self-directed PIM, which allows physicians to use data from other sources, can be used with the Physician Voluntary Reporting Program (PVRP), said Dr. Eric Holmboe, vice president for evaluation research at ABIM.

It's not yet known how many physicians will participate in Medicare's PVRP. Some physicians have balked because it is voluntary and potentially costly to set up the systems required, and there is no immediate upside because pay for performance is still far down the road, Dr. Cassel said.

The ABIM move will give physicians an incentive to participate in the PVRP because “it permits data to be collected once, and it can be used for multiple purposes,” she said in a statement.

“We're not sure what the uptake of our membership will be” for PVRP, said Dr. Michael S. Barr, vice president for practice advocacy and improvement for the American College of Physicians. But he agreed that streamlining of data collection will help reduce the burden on internists and subspecialists. And it could make the quality assessment aspect of the maintenance of certification process easier, he said.

“It's a good concept,” Dr. Barr said, but he added that “it's very early in this voluntary reporting program, so how it's going to work in terms of data flowing back to the physician and then to ABIM for the maintenance of certification—that's yet to be worked out.”

Dr. Cassel said technical details were still being ironed out.

Initially, the Centers for Medicare and Medicaid Services proposed that physicians use the new Healthcare Common Procedure Coding System and its “G” codes for quality reporting, which would have required many physicians to upgrade their practice management software. ACP and other physician groups argued for using CPT category II codes, as that would generally allow them to use existing billing systems to report quality data.

The CPT II codes are also more likely to be used by commercial insurers, Dr. Barr said.

In late March, CMS announced that physicians could use CPT II codes instead of G codes, in the areas where CPT II codes had been developed. “CMS listened,” he said.

Physicians are being asked to report on the 16 measures—7 of which relate to primary care—that are part of the starter set established by CMS in January. There are CPT II codes for five of those seven primary care measures, Dr. Barr said.

CMS is also allowing the use of three modifiers developed for CPT II. The 1P, 2P, and 3P modifiers allow a physician to exclude a patient from the reporting for several reasons, including if the treatment is contraindicated; if the patient declined care for economic, social, religious, or other reasons; or if there is a payer-related limitation, Dr. Barr said.

The next sets of codes will be issued on July 15 and Nov. 15.

The agency will begin reporting back to physicians sometime later this year, Dr. Barr added.

Dr. John Tooker, ACP executive vice president, said that PVRP participation is in physicians' interest. “The voluntary nature of the PVRP will allow physicians to pilot the use of their data to initiate quality improvement planning, work toward maintenance of certification, and prepare for the day that Medicare attaches financial incentives to those results.”

The American Board of Internal Medicine has announced that those who participate in Medicare's Physician Voluntary Reporting Program can use the same quality data to meet the board's requirements for maintenance of certification.

“Our major interest in doing this is to reduce the burden of redundant measurements that doctors are facing,” said Dr. Christine K. Cassel, president and CEO of ABIM.

Currently, maintenance of certification in internal medicine requires that certain quality indicators be measured by entering medical records data into ABIM Practice Improvement Modules (PIMs). The physicians receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The PIMs generally require physicians to do medical record audits of their patients. Only ABIM's new self-directed PIM, which allows physicians to use data from other sources, can be used with the Physician Voluntary Reporting Program (PVRP), said Dr. Eric Holmboe, vice president for evaluation research at ABIM.

It's not yet known how many physicians will participate in Medicare's PVRP. Some physicians have balked because it is voluntary and potentially costly to set up the systems required, and there is no immediate upside because pay for performance is still far down the road, Dr. Cassel said.

The ABIM move will give physicians an incentive to participate in the PVRP because “it permits data to be collected once, and it can be used for multiple purposes,” she said in a statement.

“We're not sure what the uptake of our membership will be” for PVRP, said Dr. Michael S. Barr, vice president for practice advocacy and improvement for the American College of Physicians. But he agreed that streamlining of data collection will help reduce the burden on internists and subspecialists. And it could make the quality assessment aspect of the maintenance of certification process easier, he said.

“It's a good concept,” Dr. Barr said, but he added that “it's very early in this voluntary reporting program, so how it's going to work in terms of data flowing back to the physician and then to ABIM for the maintenance of certification—that's yet to be worked out.”

Dr. Cassel said technical details were still being ironed out.

Initially, the Centers for Medicare and Medicaid Services proposed that physicians use the new Healthcare Common Procedure Coding System and its “G” codes for quality reporting, which would have required many physicians to upgrade their practice management software. ACP and other physician groups argued for using CPT category II codes, as that would generally allow them to use existing billing systems to report quality data.

The CPT II codes are also more likely to be used by commercial insurers, Dr. Barr said.

In late March, CMS announced that physicians could use CPT II codes instead of G codes, in the areas where CPT II codes had been developed. “CMS listened,” he said.

Physicians are being asked to report on the 16 measures—7 of which relate to primary care—that are part of the starter set established by CMS in January. There are CPT II codes for five of those seven primary care measures, Dr. Barr said.

CMS is also allowing the use of three modifiers developed for CPT II. The 1P, 2P, and 3P modifiers allow a physician to exclude a patient from the reporting for several reasons, including if the treatment is contraindicated; if the patient declined care for economic, social, religious, or other reasons; or if there is a payer-related limitation, Dr. Barr said.

The next sets of codes will be issued on July 15 and Nov. 15.

The agency will begin reporting back to physicians sometime later this year, Dr. Barr added.

Dr. John Tooker, ACP executive vice president, said that PVRP participation is in physicians' interest. “The voluntary nature of the PVRP will allow physicians to pilot the use of their data to initiate quality improvement planning, work toward maintenance of certification, and prepare for the day that Medicare attaches financial incentives to those results.”

The American Board of Internal Medicine has announced that those who participate in Medicare's Physician Voluntary Reporting Program can use the same quality data to meet the board's requirements for maintenance of certification.

“Our major interest in doing this is to reduce the burden of redundant measurements that doctors are facing,” said Dr. Christine K. Cassel, president and CEO of ABIM.

Currently, maintenance of certification in internal medicine requires that certain quality indicators be measured by entering medical records data into ABIM Practice Improvement Modules (PIMs). The physicians receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

The PIMs generally require physicians to do medical record audits of their patients. Only ABIM's new self-directed PIM, which allows physicians to use data from other sources, can be used with the Physician Voluntary Reporting Program (PVRP), said Dr. Eric Holmboe, vice president for evaluation research at ABIM.

It's not yet known how many physicians will participate in Medicare's PVRP. Some physicians have balked because it is voluntary and potentially costly to set up the systems required, and there is no immediate upside because pay for performance is still far down the road, Dr. Cassel said.

The ABIM move will give physicians an incentive to participate in the PVRP because “it permits data to be collected once, and it can be used for multiple purposes,” she said in a statement.

“We're not sure what the uptake of our membership will be” for PVRP, said Dr. Michael S. Barr, vice president for practice advocacy and improvement for the American College of Physicians. But he agreed that streamlining of data collection will help reduce the burden on internists and subspecialists. And it could make the quality assessment aspect of the maintenance of certification process easier, he said.

“It's a good concept,” Dr. Barr said, but he added that “it's very early in this voluntary reporting program, so how it's going to work in terms of data flowing back to the physician and then to ABIM for the maintenance of certification—that's yet to be worked out.”

Dr. Cassel said technical details were still being ironed out.

Initially, the Centers for Medicare and Medicaid Services proposed that physicians use the new Healthcare Common Procedure Coding System and its “G” codes for quality reporting, which would have required many physicians to upgrade their practice management software. ACP and other physician groups argued for using CPT category II codes, as that would generally allow them to use existing billing systems to report quality data.

The CPT II codes are also more likely to be used by commercial insurers, Dr. Barr said.

In late March, CMS announced that physicians could use CPT II codes instead of G codes, in the areas where CPT II codes had been developed. “CMS listened,” he said.

Physicians are being asked to report on the 16 measures—7 of which relate to primary care—that are part of the starter set established by CMS in January. There are CPT II codes for five of those seven primary care measures, Dr. Barr said.

CMS is also allowing the use of three modifiers developed for CPT II. The 1P, 2P, and 3P modifiers allow a physician to exclude a patient from the reporting for several reasons, including if the treatment is contraindicated; if the patient declined care for economic, social, religious, or other reasons; or if there is a payer-related limitation, Dr. Barr said.

The next sets of codes will be issued on July 15 and Nov. 15.

The agency will begin reporting back to physicians sometime later this year, Dr. Barr added.

Dr. John Tooker, ACP executive vice president, said that PVRP participation is in physicians' interest. “The voluntary nature of the PVRP will allow physicians to pilot the use of their data to initiate quality improvement planning, work toward maintenance of certification, and prepare for the day that Medicare attaches financial incentives to those results.”

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane. For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.)

Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 members of the medical faculty at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding, according to Dr. Hollier. In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm. But just because LSU found positions for its residents does not mean the school was going to be paid for their salaries and upkeep.

Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amdedee said the school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. At LSU, 76 of the 172 students in the graduating class decided to stay in-state.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years. At Tulane, about 8,000 students have applied for 155 positions.

ELSEVIER GLOBAL MEDICAL NEWS

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane. For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.)

Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 members of the medical faculty at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding, according to Dr. Hollier. In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm. But just because LSU found positions for its residents does not mean the school was going to be paid for their salaries and upkeep.

Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amdedee said the school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. At LSU, 76 of the 172 students in the graduating class decided to stay in-state.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years. At Tulane, about 8,000 students have applied for 155 positions.

ELSEVIER GLOBAL MEDICAL NEWS

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane. For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.)

Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 members of the medical faculty at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding, according to Dr. Hollier. In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm. But just because LSU found positions for its residents does not mean the school was going to be paid for their salaries and upkeep.

Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amdedee said the school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. At LSU, 76 of the 172 students in the graduating class decided to stay in-state.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years. At Tulane, about 8,000 students have applied for 155 positions.

ELSEVIER GLOBAL MEDICAL NEWS