Joyce Frieden

CHICAGO — Results of a tuning-fork test to identify neuropathy appear to be reproducible in a nondiabetic population, according to findings from a blinded, observational study.

In a presentation at the annual meeting of the American Association of Clinical Endocrinologists, Dr. David S. Oyer of Northwestern University, Chicago, Ill., described how he and an associate used a tuning-fork test to evaluate 147 patients aged 40 years and older. All patients had a history of sciatica, cerebrovascular accident, or chemotherapy.

For the test, a C128 tuning fork was struck to make the ends clang together, and then patients were shown the difference between the vibration sensation and pressure on the patient's toe, malleolus, knee, or sternum. The tuning-fork test was performed again at the end of the dorsal bony prominence of the patient's big toe proximal to the nail. Blinded, the patients then indicated when they could no longer feel the vibration.

Vibration sensation duration was measured in both feet. Patients repeated the test, and the average number of seconds was taken to represent final scores, which were then analyzed for correlations between the right versus left foot, statin versus nonstatin use, and overall difference in sensation by age-group decade. Overall, 80% of patients were within 2 seconds between the right and left feet, suggesting the test's consistency.

The average score for all patients was 12.8 ± 4.7 seconds. Average scores were 14.3 seconds for patients aged 40–49, 14.1 seconds for patients aged 50–59, 12.2 seconds for patients aged 60–69, 9.4 seconds for patients aged 70–79, and 4.8 seconds for patients aged 80–89. There was an average 1.43-second longer vibration sensation in patients not on statins, the researchers noted.

The investigators determined that normal score cutoff values were above 7.5 seconds in those aged 40–49, 6.9 seconds in the 50–59 age group, and 3.8 seconds in the 60–69 age group. Cutoff values could not be determined for those patients older than 70.

Patients' sex, alcohol use, height, NSAID use, smoking history, and other unknown factors may explain the variability in the test results, the researchers suggested. Larger studies may help reduce the degree of variability by age group.

The findings dovetail with those from a previous investigation in which Dr. Oyer found that the tuning-fork test was far more effective than the more widely used monofilament test in detecting distal polyneuropathy. That study involved 45 diabetes patients who had vibration test scores of 0–8 seconds, indicating some level of neuropathy. Of those 45 patients, only 16 had abnormal monofilament test results (Endocr. Pract. 2004;10[Suppl. 1]:20).

“The clanging tuning-fork test detects neuropathy at a much earlier stage than the monofilament test,” Dr. Oyer said in an interview.

Dr. David S. Oyer holds a fork on the toe with two fingers on the stem, timing until the patient cannot feel the vibration. Courtesy Dr. David S. Oyer

CHICAGO — Results of a tuning-fork test to identify neuropathy appear to be reproducible in a nondiabetic population, according to findings from a blinded, observational study.

In a presentation at the annual meeting of the American Association of Clinical Endocrinologists, Dr. David S. Oyer of Northwestern University, Chicago, Ill., described how he and an associate used a tuning-fork test to evaluate 147 patients aged 40 years and older. All patients had a history of sciatica, cerebrovascular accident, or chemotherapy.

For the test, a C128 tuning fork was struck to make the ends clang together, and then patients were shown the difference between the vibration sensation and pressure on the patient's toe, malleolus, knee, or sternum. The tuning-fork test was performed again at the end of the dorsal bony prominence of the patient's big toe proximal to the nail. Blinded, the patients then indicated when they could no longer feel the vibration.

Vibration sensation duration was measured in both feet. Patients repeated the test, and the average number of seconds was taken to represent final scores, which were then analyzed for correlations between the right versus left foot, statin versus nonstatin use, and overall difference in sensation by age-group decade. Overall, 80% of patients were within 2 seconds between the right and left feet, suggesting the test's consistency.

The average score for all patients was 12.8 ± 4.7 seconds. Average scores were 14.3 seconds for patients aged 40–49, 14.1 seconds for patients aged 50–59, 12.2 seconds for patients aged 60–69, 9.4 seconds for patients aged 70–79, and 4.8 seconds for patients aged 80–89. There was an average 1.43-second longer vibration sensation in patients not on statins, the researchers noted.

The investigators determined that normal score cutoff values were above 7.5 seconds in those aged 40–49, 6.9 seconds in the 50–59 age group, and 3.8 seconds in the 60–69 age group. Cutoff values could not be determined for those patients older than 70.

Patients' sex, alcohol use, height, NSAID use, smoking history, and other unknown factors may explain the variability in the test results, the researchers suggested. Larger studies may help reduce the degree of variability by age group.

The findings dovetail with those from a previous investigation in which Dr. Oyer found that the tuning-fork test was far more effective than the more widely used monofilament test in detecting distal polyneuropathy. That study involved 45 diabetes patients who had vibration test scores of 0–8 seconds, indicating some level of neuropathy. Of those 45 patients, only 16 had abnormal monofilament test results (Endocr. Pract. 2004;10[Suppl. 1]:20).

“The clanging tuning-fork test detects neuropathy at a much earlier stage than the monofilament test,” Dr. Oyer said in an interview.

Dr. David S. Oyer holds a fork on the toe with two fingers on the stem, timing until the patient cannot feel the vibration. Courtesy Dr. David S. Oyer

CHICAGO — Results of a tuning-fork test to identify neuropathy appear to be reproducible in a nondiabetic population, according to findings from a blinded, observational study.

In a presentation at the annual meeting of the American Association of Clinical Endocrinologists, Dr. David S. Oyer of Northwestern University, Chicago, Ill., described how he and an associate used a tuning-fork test to evaluate 147 patients aged 40 years and older. All patients had a history of sciatica, cerebrovascular accident, or chemotherapy.

For the test, a C128 tuning fork was struck to make the ends clang together, and then patients were shown the difference between the vibration sensation and pressure on the patient's toe, malleolus, knee, or sternum. The tuning-fork test was performed again at the end of the dorsal bony prominence of the patient's big toe proximal to the nail. Blinded, the patients then indicated when they could no longer feel the vibration.

Vibration sensation duration was measured in both feet. Patients repeated the test, and the average number of seconds was taken to represent final scores, which were then analyzed for correlations between the right versus left foot, statin versus nonstatin use, and overall difference in sensation by age-group decade. Overall, 80% of patients were within 2 seconds between the right and left feet, suggesting the test's consistency.

The average score for all patients was 12.8 ± 4.7 seconds. Average scores were 14.3 seconds for patients aged 40–49, 14.1 seconds for patients aged 50–59, 12.2 seconds for patients aged 60–69, 9.4 seconds for patients aged 70–79, and 4.8 seconds for patients aged 80–89. There was an average 1.43-second longer vibration sensation in patients not on statins, the researchers noted.

The investigators determined that normal score cutoff values were above 7.5 seconds in those aged 40–49, 6.9 seconds in the 50–59 age group, and 3.8 seconds in the 60–69 age group. Cutoff values could not be determined for those patients older than 70.

Patients' sex, alcohol use, height, NSAID use, smoking history, and other unknown factors may explain the variability in the test results, the researchers suggested. Larger studies may help reduce the degree of variability by age group.

The findings dovetail with those from a previous investigation in which Dr. Oyer found that the tuning-fork test was far more effective than the more widely used monofilament test in detecting distal polyneuropathy. That study involved 45 diabetes patients who had vibration test scores of 0–8 seconds, indicating some level of neuropathy. Of those 45 patients, only 16 had abnormal monofilament test results (Endocr. Pract. 2004;10[Suppl. 1]:20).

“The clanging tuning-fork test detects neuropathy at a much earlier stage than the monofilament test,” Dr. Oyer said in an interview.

Dr. David S. Oyer holds a fork on the toe with two fingers on the stem, timing until the patient cannot feel the vibration. Courtesy Dr. David S. Oyer

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

Thyroid Cancer Record

Thyroid cancer diagnoses are expected to set a new record this year, according to the Thyroid Cancer Survivors' Association. The number of newly diagnosed cases is expected to reach a new record of 30,180, which is 17% higher than last year and nearly 50% higher than 4 years ago, the association said, citing information from the Department of Health and Human Services and the American Cancer Society. Association board chair Gary Bloom of Olney, Md., urged doctors to contribute to early detection of thyroid cancer, one of the few cancers that is increasing in incidence. “Done properly, a neck check can be as simple as touching the neck and watching the patient swallow. This can be done very quickly and won't cause any delays for the medical office, but those few minutes could make all the difference in the world when it comes to thyroid cancer.”

Multiple Imaging Pay Cut

Endocrinologists will soon begin feeling the effects of a new Medicare reimbursement policy affecting multiple imaging procedures, according to the Endocrine Society. The policy reduces the payment for the “technical component” of a service when performed on a contiguous body part on the same day and in the same patient. That would include such procedures as dual-energy x-ray absorptiometry scanning or ultrasound on the thyroid, according to the society. Medicare is also capping rates for imaging services that are performed in a physician's office at the same amount as the rates paid to hospital outpatient departments. The portion of the Medicare payment that goes for professional services will not be affected. The provisions are expected to save $3 billion over 5 years, according to the Congressional Budget Office.

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 argues 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. At a press briefing, the association released a report by D. McCarty Thornton, former chief counsel to the HHS Inspector General, which found that forcing the switch to occur in 2009 “will not give the contractors who administer the Medicare fee-for-service claims process and payments systems sufficient time to upgrade their antifraud tools. Without additional time to switch to ICD-10, risks are high that improper and fraudulent Medicare claims will increase substantially.” The Federation of American Hospitals and several other groups disagree; they argue that the update is overdue.

J-1 Visas for Underserved Areas

J-1 visas remain the primary tool for recruiting physicians to work in underserved areas, according to a report by the Government Accountability Office. The GAO surveyed 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands regarding their waiver requests for fiscal years 2003–2005. States and federal agencies reported requesting more than 1,000 waivers in each of the 3 years, although the number requested varied by state: About one-fourth of states requested the maximum number of 30 visas, while slightly more than a quarter requested 10 or fewer. About 80% of states said the 30-waiver limit was adequate for their needs, the report noted. Nearly half of the states' waiver requests were for physicians to practice primary care exclusively, while about 41% were for specialists, such as anesthesiologists or cardiologists. An additional 7% were for psychiatrists, who have different waiver requirements. One state commented that most communities in the state need physicians trained in family medicine and that few physicians with J-1 visas have that training. Similarly, another state noted a lack of demand among its health care facilities for the types of medical specialties held by physicians seeking waivers, the report said.

Medicare Formulary Guidance

If officials at a Medicare Part D drug plan change the preferred or nonpreferred formulary drugs, remove dosage forms, or exchange therapeutic alternatives, they must allow beneficiaries currently taking the drug to be exempt from the changes for the rest of the year, according to guidance from the Centers for Medicare and Medicaid Services. Abby L. Block, director of the CMS Center for Beneficiary Choices, issued a memo to Part D sponsors in April outlining policies for formulary changes made after a beneficiary has signed on to a plan at the beginning of the plan year. In addition, Part D plans can change therapeutic categories and classes in a formulary only at the beginning of each plan year, except to account for new therapeutic uses or newly approved drugs. CMS also noted that after March 1, Part D drug plans are only allowed to make “maintenance changes” to their formulary, such as replacing a brand-name drug with a new generic drug. All proposed formulary changes, except for expansions, must be submitted to CMS for review and approval, according to the memo.

Thyroid Cancer Record

Thyroid cancer diagnoses are expected to set a new record this year, according to the Thyroid Cancer Survivors' Association. The number of newly diagnosed cases is expected to reach a new record of 30,180, which is 17% higher than last year and nearly 50% higher than 4 years ago, the association said, citing information from the Department of Health and Human Services and the American Cancer Society. Association board chair Gary Bloom of Olney, Md., urged doctors to contribute to early detection of thyroid cancer, one of the few cancers that is increasing in incidence. “Done properly, a neck check can be as simple as touching the neck and watching the patient swallow. This can be done very quickly and won't cause any delays for the medical office, but those few minutes could make all the difference in the world when it comes to thyroid cancer.”

Multiple Imaging Pay Cut

Endocrinologists will soon begin feeling the effects of a new Medicare reimbursement policy affecting multiple imaging procedures, according to the Endocrine Society. The policy reduces the payment for the “technical component” of a service when performed on a contiguous body part on the same day and in the same patient. That would include such procedures as dual-energy x-ray absorptiometry scanning or ultrasound on the thyroid, according to the society. Medicare is also capping rates for imaging services that are performed in a physician's office at the same amount as the rates paid to hospital outpatient departments. The portion of the Medicare payment that goes for professional services will not be affected. The provisions are expected to save $3 billion over 5 years, according to the Congressional Budget Office.

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 argues 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. At a press briefing, the association released a report by D. McCarty Thornton, former chief counsel to the HHS Inspector General, which found that forcing the switch to occur in 2009 “will not give the contractors who administer the Medicare fee-for-service claims process and payments systems sufficient time to upgrade their antifraud tools. Without additional time to switch to ICD-10, risks are high that improper and fraudulent Medicare claims will increase substantially.” The Federation of American Hospitals and several other groups disagree; they argue that the update is overdue.

J-1 Visas for Underserved Areas

J-1 visas remain the primary tool for recruiting physicians to work in underserved areas, according to a report by the Government Accountability Office. The GAO surveyed 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands regarding their waiver requests for fiscal years 2003–2005. States and federal agencies reported requesting more than 1,000 waivers in each of the 3 years, although the number requested varied by state: About one-fourth of states requested the maximum number of 30 visas, while slightly more than a quarter requested 10 or fewer. About 80% of states said the 30-waiver limit was adequate for their needs, the report noted. Nearly half of the states' waiver requests were for physicians to practice primary care exclusively, while about 41% were for specialists, such as anesthesiologists or cardiologists. An additional 7% were for psychiatrists, who have different waiver requirements. One state commented that most communities in the state need physicians trained in family medicine and that few physicians with J-1 visas have that training. Similarly, another state noted a lack of demand among its health care facilities for the types of medical specialties held by physicians seeking waivers, the report said.

Medicare Formulary Guidance

If officials at a Medicare Part D drug plan change the preferred or nonpreferred formulary drugs, remove dosage forms, or exchange therapeutic alternatives, they must allow beneficiaries currently taking the drug to be exempt from the changes for the rest of the year, according to guidance from the Centers for Medicare and Medicaid Services. Abby L. Block, director of the CMS Center for Beneficiary Choices, issued a memo to Part D sponsors in April outlining policies for formulary changes made after a beneficiary has signed on to a plan at the beginning of the plan year. In addition, Part D plans can change therapeutic categories and classes in a formulary only at the beginning of each plan year, except to account for new therapeutic uses or newly approved drugs. CMS also noted that after March 1, Part D drug plans are only allowed to make “maintenance changes” to their formulary, such as replacing a brand-name drug with a new generic drug. All proposed formulary changes, except for expansions, must be submitted to CMS for review and approval, according to the memo.

Thyroid Cancer Record

Thyroid cancer diagnoses are expected to set a new record this year, according to the Thyroid Cancer Survivors' Association. The number of newly diagnosed cases is expected to reach a new record of 30,180, which is 17% higher than last year and nearly 50% higher than 4 years ago, the association said, citing information from the Department of Health and Human Services and the American Cancer Society. Association board chair Gary Bloom of Olney, Md., urged doctors to contribute to early detection of thyroid cancer, one of the few cancers that is increasing in incidence. “Done properly, a neck check can be as simple as touching the neck and watching the patient swallow. This can be done very quickly and won't cause any delays for the medical office, but those few minutes could make all the difference in the world when it comes to thyroid cancer.”

Multiple Imaging Pay Cut

Endocrinologists will soon begin feeling the effects of a new Medicare reimbursement policy affecting multiple imaging procedures, according to the Endocrine Society. The policy reduces the payment for the “technical component” of a service when performed on a contiguous body part on the same day and in the same patient. That would include such procedures as dual-energy x-ray absorptiometry scanning or ultrasound on the thyroid, according to the society. Medicare is also capping rates for imaging services that are performed in a physician's office at the same amount as the rates paid to hospital outpatient departments. The portion of the Medicare payment that goes for professional services will not be affected. The provisions are expected to save $3 billion over 5 years, according to the Congressional Budget Office.

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 argues 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. At a press briefing, the association released a report by D. McCarty Thornton, former chief counsel to the HHS Inspector General, which found that forcing the switch to occur in 2009 “will not give the contractors who administer the Medicare fee-for-service claims process and payments systems sufficient time to upgrade their antifraud tools. Without additional time to switch to ICD-10, risks are high that improper and fraudulent Medicare claims will increase substantially.” The Federation of American Hospitals and several other groups disagree; they argue that the update is overdue.

J-1 Visas for Underserved Areas

J-1 visas remain the primary tool for recruiting physicians to work in underserved areas, according to a report by the Government Accountability Office. The GAO surveyed 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands regarding their waiver requests for fiscal years 2003–2005. States and federal agencies reported requesting more than 1,000 waivers in each of the 3 years, although the number requested varied by state: About one-fourth of states requested the maximum number of 30 visas, while slightly more than a quarter requested 10 or fewer. About 80% of states said the 30-waiver limit was adequate for their needs, the report noted. Nearly half of the states' waiver requests were for physicians to practice primary care exclusively, while about 41% were for specialists, such as anesthesiologists or cardiologists. An additional 7% were for psychiatrists, who have different waiver requirements. One state commented that most communities in the state need physicians trained in family medicine and that few physicians with J-1 visas have that training. Similarly, another state noted a lack of demand among its health care facilities for the types of medical specialties held by physicians seeking waivers, the report said.

Medicare Formulary Guidance

If officials at a Medicare Part D drug plan change the preferred or nonpreferred formulary drugs, remove dosage forms, or exchange therapeutic alternatives, they must allow beneficiaries currently taking the drug to be exempt from the changes for the rest of the year, according to guidance from the Centers for Medicare and Medicaid Services. Abby L. Block, director of the CMS Center for Beneficiary Choices, issued a memo to Part D sponsors in April outlining policies for formulary changes made after a beneficiary has signed on to a plan at the beginning of the plan year. In addition, Part D plans can change therapeutic categories and classes in a formulary only at the beginning of each plan year, except to account for new therapeutic uses or newly approved drugs. CMS also noted that after March 1, Part D drug plans are only allowed to make “maintenance changes” to their formulary, such as replacing a brand-name drug with a new generic drug. All proposed formulary changes, except for expansions, must be submitted to CMS for review and approval, according to the memo.

Alzheimer's Treatment Initiative

New efforts by the Alzheimer's Association aim to speed the development of drugs to treat the disease. The Alzheimer's Association Effective Treatments Initiative will bring together scientists, early-stage Alzheimer's patients and their families, and experts on the Food and Drug Administration drug approval process; the association also will seek input from government agencies and the pharmaceutical industry. The initiative has four goals: educate the public about value of clinical studies including clinical trials and increased enrollment in such studies; raise the profile and priority of Alzheimer's at all levels of drug development; involve patients in the drug development and review processes; and increase private and public funding for Alzheimer's research. “This is a devastating disease and the need for treatments is more urgent than ever, with 77 million baby boomers turning 60 this year,” said Stephen McConnell, the association's vice president of advocacy and public policy.

Views on Stem Cells

Support for human embryonic stem cell research appears to be growing, with more than three-quarters of Americans who participated in a recent survey saying that they favor some form of the research. The survey, commissioned by the Coalition for the Advancement of Medical Research, found that 72% of Americans favor embryonic stem cell research, up from 68% in 2005. Most Americans also would favor an up or down vote in the Senate on H.R. 810, a bill that would ease restrictions on the use of federal funding for embryonic stem cell research. The legislation was passed in the U.S. House last year and advocates for stem cell research have been calling on Senate Majority Leader Bill Frist (R-Tenn.) to bring the legislation to the Senate floor. About 70% of survey respondents said the Senate should allow a vote on the bill or probably should allow a vote on the bill. In comparison, 18% of respondents said the Senate should not allow a vote on the bill or probably should not allow a vote. About 6% of respondents said they did not know. The poll was conducted by the Opinion Research Corp. and included a sample of 1,000 individuals taken last month.

Too Many Screening Tests?

Physicians are needlessly ordering certain diagnostic tests during routine preventive health exams, which is inflating the cost of medical care, according to a study from Johns Hopkins University. The U.S. Preventive Services Task Force has rated such diagnostics according to level of evidence; the Hopkins researchers looked at five tests. Two tests (complete blood count and hematocrit) had “C” ratings from USPSTF, meaning there was no recommendation for or against their use; three (urinalysis, x-ray, and electrocardiogram) had “D” ratings with a recommendation against routine use. The study, which used National Ambulatory Medical Care Survey data for 1997–2002 for outpatient visits for nonpregnant adults age 21 years or over, was in the May/June issue of the American Journal of Preventive Medicine, and was led by Dr. Dan Merenstein, who is now at Georgetown University. Cost data were obtained from the Medicare fee schedule. Thirty-seven million visits were identified as preventive by physicians and 190 million as such by patients. Most visits were to family physicians, ob.gyns., or internists. Urinalysis was performed most frequently, about 25%–33% of the time, but urine cultures were ordered only 3%–6% of the time. Annual direct costs for hematocrit and urinalysis run about $13–$61 million, depending on if it was a physician- or patient-identified visit, the authors estimated. For the D-rated tests, costs ranged from $47–$194 million.

Electronic Health Record Review

The National Governors Association is helping member states form a group to examine the privacy and security issues raised by electronic health records. RTI International, a company that is working with the NGA, has offered subcontracts to 34 state and territory governments for the purpose of forming the Health Information Security and Privacy Collaboration. “The current fragmented health care system is broken and unsustainable, and governors recognize that health information technology offers the promise for improving the system,” NGA Chairman Mike Huckabee (R), governor of Arkansas, said in a statement. Awards for the subcontracts range from $250,000 to $350,000 and will require each state to bring together interested parties who will work together to breach existing barriers to health information exchange. “We are working with states to examine the barriers and opportunities for sharing health information on an interoperable basis,” John Thomasian, director of the association's Center for Best Practices, said in an interview. “What are the things that haven't been encountered yet that will need to be addressed?” Mr. Thomasian asked.

Alzheimer's Treatment Initiative

New efforts by the Alzheimer's Association aim to speed the development of drugs to treat the disease. The Alzheimer's Association Effective Treatments Initiative will bring together scientists, early-stage Alzheimer's patients and their families, and experts on the Food and Drug Administration drug approval process; the association also will seek input from government agencies and the pharmaceutical industry. The initiative has four goals: educate the public about value of clinical studies including clinical trials and increased enrollment in such studies; raise the profile and priority of Alzheimer's at all levels of drug development; involve patients in the drug development and review processes; and increase private and public funding for Alzheimer's research. “This is a devastating disease and the need for treatments is more urgent than ever, with 77 million baby boomers turning 60 this year,” said Stephen McConnell, the association's vice president of advocacy and public policy.

Views on Stem Cells

Support for human embryonic stem cell research appears to be growing, with more than three-quarters of Americans who participated in a recent survey saying that they favor some form of the research. The survey, commissioned by the Coalition for the Advancement of Medical Research, found that 72% of Americans favor embryonic stem cell research, up from 68% in 2005. Most Americans also would favor an up or down vote in the Senate on H.R. 810, a bill that would ease restrictions on the use of federal funding for embryonic stem cell research. The legislation was passed in the U.S. House last year and advocates for stem cell research have been calling on Senate Majority Leader Bill Frist (R-Tenn.) to bring the legislation to the Senate floor. About 70% of survey respondents said the Senate should allow a vote on the bill or probably should allow a vote on the bill. In comparison, 18% of respondents said the Senate should not allow a vote on the bill or probably should not allow a vote. About 6% of respondents said they did not know. The poll was conducted by the Opinion Research Corp. and included a sample of 1,000 individuals taken last month.

Too Many Screening Tests?

Physicians are needlessly ordering certain diagnostic tests during routine preventive health exams, which is inflating the cost of medical care, according to a study from Johns Hopkins University. The U.S. Preventive Services Task Force has rated such diagnostics according to level of evidence; the Hopkins researchers looked at five tests. Two tests (complete blood count and hematocrit) had “C” ratings from USPSTF, meaning there was no recommendation for or against their use; three (urinalysis, x-ray, and electrocardiogram) had “D” ratings with a recommendation against routine use. The study, which used National Ambulatory Medical Care Survey data for 1997–2002 for outpatient visits for nonpregnant adults age 21 years or over, was in the May/June issue of the American Journal of Preventive Medicine, and was led by Dr. Dan Merenstein, who is now at Georgetown University. Cost data were obtained from the Medicare fee schedule. Thirty-seven million visits were identified as preventive by physicians and 190 million as such by patients. Most visits were to family physicians, ob.gyns., or internists. Urinalysis was performed most frequently, about 25%–33% of the time, but urine cultures were ordered only 3%–6% of the time. Annual direct costs for hematocrit and urinalysis run about $13–$61 million, depending on if it was a physician- or patient-identified visit, the authors estimated. For the D-rated tests, costs ranged from $47–$194 million.

Electronic Health Record Review

The National Governors Association is helping member states form a group to examine the privacy and security issues raised by electronic health records. RTI International, a company that is working with the NGA, has offered subcontracts to 34 state and territory governments for the purpose of forming the Health Information Security and Privacy Collaboration. “The current fragmented health care system is broken and unsustainable, and governors recognize that health information technology offers the promise for improving the system,” NGA Chairman Mike Huckabee (R), governor of Arkansas, said in a statement. Awards for the subcontracts range from $250,000 to $350,000 and will require each state to bring together interested parties who will work together to breach existing barriers to health information exchange. “We are working with states to examine the barriers and opportunities for sharing health information on an interoperable basis,” John Thomasian, director of the association's Center for Best Practices, said in an interview. “What are the things that haven't been encountered yet that will need to be addressed?” Mr. Thomasian asked.

Alzheimer's Treatment Initiative

New efforts by the Alzheimer's Association aim to speed the development of drugs to treat the disease. The Alzheimer's Association Effective Treatments Initiative will bring together scientists, early-stage Alzheimer's patients and their families, and experts on the Food and Drug Administration drug approval process; the association also will seek input from government agencies and the pharmaceutical industry. The initiative has four goals: educate the public about value of clinical studies including clinical trials and increased enrollment in such studies; raise the profile and priority of Alzheimer's at all levels of drug development; involve patients in the drug development and review processes; and increase private and public funding for Alzheimer's research. “This is a devastating disease and the need for treatments is more urgent than ever, with 77 million baby boomers turning 60 this year,” said Stephen McConnell, the association's vice president of advocacy and public policy.

Views on Stem Cells

Support for human embryonic stem cell research appears to be growing, with more than three-quarters of Americans who participated in a recent survey saying that they favor some form of the research. The survey, commissioned by the Coalition for the Advancement of Medical Research, found that 72% of Americans favor embryonic stem cell research, up from 68% in 2005. Most Americans also would favor an up or down vote in the Senate on H.R. 810, a bill that would ease restrictions on the use of federal funding for embryonic stem cell research. The legislation was passed in the U.S. House last year and advocates for stem cell research have been calling on Senate Majority Leader Bill Frist (R-Tenn.) to bring the legislation to the Senate floor. About 70% of survey respondents said the Senate should allow a vote on the bill or probably should allow a vote on the bill. In comparison, 18% of respondents said the Senate should not allow a vote on the bill or probably should not allow a vote. About 6% of respondents said they did not know. The poll was conducted by the Opinion Research Corp. and included a sample of 1,000 individuals taken last month.

Too Many Screening Tests?

Physicians are needlessly ordering certain diagnostic tests during routine preventive health exams, which is inflating the cost of medical care, according to a study from Johns Hopkins University. The U.S. Preventive Services Task Force has rated such diagnostics according to level of evidence; the Hopkins researchers looked at five tests. Two tests (complete blood count and hematocrit) had “C” ratings from USPSTF, meaning there was no recommendation for or against their use; three (urinalysis, x-ray, and electrocardiogram) had “D” ratings with a recommendation against routine use. The study, which used National Ambulatory Medical Care Survey data for 1997–2002 for outpatient visits for nonpregnant adults age 21 years or over, was in the May/June issue of the American Journal of Preventive Medicine, and was led by Dr. Dan Merenstein, who is now at Georgetown University. Cost data were obtained from the Medicare fee schedule. Thirty-seven million visits were identified as preventive by physicians and 190 million as such by patients. Most visits were to family physicians, ob.gyns., or internists. Urinalysis was performed most frequently, about 25%–33% of the time, but urine cultures were ordered only 3%–6% of the time. Annual direct costs for hematocrit and urinalysis run about $13–$61 million, depending on if it was a physician- or patient-identified visit, the authors estimated. For the D-rated tests, costs ranged from $47–$194 million.

Electronic Health Record Review

The National Governors Association is helping member states form a group to examine the privacy and security issues raised by electronic health records. RTI International, a company that is working with the NGA, has offered subcontracts to 34 state and territory governments for the purpose of forming the Health Information Security and Privacy Collaboration. “The current fragmented health care system is broken and unsustainable, and governors recognize that health information technology offers the promise for improving the system,” NGA Chairman Mike Huckabee (R), governor of Arkansas, said in a statement. Awards for the subcontracts range from $250,000 to $350,000 and will require each state to bring together interested parties who will work together to breach existing barriers to health information exchange. “We are working with states to examine the barriers and opportunities for sharing health information on an interoperable basis,” John Thomasian, director of the association's Center for Best Practices, said in an interview. “What are the things that haven't been encountered yet that will need to be addressed?” Mr. Thomasian asked.

WASHINGTON — It was 8 a.m., and a nurse at Kaiser Permanente's Santa Clara (Calif.) Medical Center was puzzled about a patient who had been admitted for a small bowel obstruction. Everything seemed fine, but the patient was hypotensive. What should be done?

The nurse decided to call the hospital's rapid response team (RRT). Belinda Chu, R.N., the RRT nurse, considered possible causes for the low blood pressure. She concluded that the nasogastric tube that had been inserted to suction the patient's stomach could cause a high amount of fluid loss from the stomach, leading to an imbalance of fluids and electrolytes.

Ms. Chu recommended that the physician order more fluids to be given to the patient, but 2 hours later the patient was still extremely hypotensive. The physician agreed that the patient needed to be transferred to a higher-care unit for closer monitoring.

This is one example of the work of early-intervention teams. Such teams, which are available 24 hours a day, 7 days a week, vary in makeup, Dr. Andrew Auerbach of the University of California, San Francisco, said at the annual meeting of the Society of Hospital Medicine. The teams also go by different names:

▸ Medical emergency teams (METs). For these, “think of 'code team' in your head,” Dr. Auerbach said. “They can prescribe medications, they probably have airway management skills, and they can get vascular access easily. The term we use is 'ICU at the bedside.'” METs are typically led by intensivist physicians.

▸ RRTs. These teams, on the other hand, “have some but not all of the METs' abilities,” Dr. Auerbach continued. “They begin basic care, and they have the ability to call in other resources, but there's not necessarily a physician at the bedside and not generally an intensivist at the bedside. Instead, they choose to ramp up care as conditions dictate.”

▸ Critical care outreach (CCO) teams. Similar to RRTs, these provide active surveillance to recent ICU discharges in addition to doing RRT functions, he said.

Training requirements for nonphysician members of all of these teams vary, but Advanced Cardiac Life Support and Pediatric Advanced Life Support seem to be minimal requirements for all teams.

Criteria for activating the teams differ from one hospital to another, but in general, hospital staff members or anyone else in the room with the patient are encouraged to call the team after noticing any of the following: abnormal vital signs, a change in symptoms, a change in mental status, a perceived risk of harm or imminent deterioration, or a feeling that something is “just not right,” Dr. Auerbach said.

Team members are usually contacted via overhead speaker or by pager. “The [teams] tend to be underutilized even if the clinical criteria and triggering process is extraordinarily simple, so the systems can be there, but you have to really encourage people … to use it,” Dr. Auerbach said.

Once the team arrives at the bedside, he emphasized, “there should not be any negative feedback that this was an inappropriate call, or you were weak, and why couldn't you do this yourself. You should just reinforce that triggering the [team] was in fact appropriate and say, 'I'm glad to be here. How can I help?'”

Once activated, the team makes an initial diagnosis and starts appropriate interventions. The team should be able to make transfer decisions on its own and have access to the intensive care unit, Dr. Auerbach said.

Dr. Auerbach was part of a group of physicians who participated in a consensus conference on early-intervention systems held last year in Pittsburgh. The attendees discussed development of outcomes measures and criteria for using teams. The results of the conference are expected appear soon in a peer-reviewed journal, he said.

Gauging the Impact

Studies of early-intervention systems are mixed on the question of whether they improve the quality of care, said Dr. Kaveh Shojania of the department of medicine at the University of Ottawa (Ontario).

“There have been about eight before-and-after studies, most of which show pretty dramatic benefits,” but there have been major methodologic problems with some of them, Dr. Shojania said at the meeting. A large randomized, controlled trial in Australia found the teams to be of no benefit, but there are questions about that study's methodology as well, he added.

Hospitals that have implemented the teams have had varying results. At the University of Pittsburgh Medical Center, it used to be that if the patient decompensated, “you would get on the horn to the ICU or the critical care attending physician” and send the patient to the ICU. “That was how we took care of 'I'm a little bit worried' situations,” explained Dr. David J. McAdams of the University of Pittsburgh.

But in 1988, a physician's wife who was an inpatient became critically ill while on the med/surg unit. The critical care doctor arrived and performed an intervention at the bedside. “The physician said, 'This is a great idea. Why don't we do this for everybody?'” he said.

After that, the hospital began devising ways to help patients before they decompensated. But the criteria were practitioner-centered, so only certain staff could decide to call for help. And adhering to the hospital's chain of command often meant initially calling the least-experienced person, such as an intern.

“It was 'delegation to the dumbest,'” Dr. McAdams said. “In a crisis situation, this leads to delays and disaster.”

In 1999, the hospital revised its criteria to make it more specific and to make it patient-centered; it also allowed anyone to call a code, he continued. Hospital officials also decided that neither hospitalists nor residents needed to be involved in the response; instead, the attending critical care physician answers the call.

The teams get an average of two to six calls per day, Dr. McAdams said. The hospital also has found that the more people call for an RRT—which the hospital calls a “Condition C” code—the fewer times they get “Condition A” calls, which are more serious. And although the data are not yet complete, Dr. McAdams said he suspects that the program has reduced the number of preventable deaths.

Full-Time Nurses

Kaiser Permanente in Santa Clara is one hospital that has just begun to experiment with RRTs; it fully implemented its teams in April. But Kaiser has decided to do things a little differently. Rather than having all RRT members—the RRT nurse, the respiratory therapy supervisor, and a physician—all work on the team in addition to their regular jobs, Kaiser hired RRT nurses to be on the team full-time, 24 hours a day.

“The RRT nurse has no other patient responsibilities,” explained Dr. Allison Schwanda, chief of hospital-based medicine at the facility. When the nurse is not answering RRT calls, he or she rounds on all patients transferred out of the ICU and follows up on RRT calls within 12 hours to ensure that patients remain stable. He or she also “asks the nurses if there is anyone they're worried about. We think that even gets us intervening earlier than what we might get with a call to the RRT.”

The RRT nurse must handle a delicate balancing act: keeping the primary care physicians involved in care of the patient without creating barriers to activating the RRT. As a result, the team has developed a notification system to keep doctors in the loop. “Then it's up to that [doctor] whether they want to come bedside,” she said.

If the nurse in charge needs backup, she can call in the “second tier” for help: an intensivist during the day or the hospitalist at night. So far, the RRT is averaging 21/2 to 3 calls per day, or about 1 per shift, Dr. Schwanda said. The response to each call averages 30–90 minutes.

Although several speakers were enthusiastic about the potential of RRTs, not everyone in the audience was as impressed. “I remain skeptical due to the methodologic issues [in] the studies that are out there,” said Dr. Shaun Frost, a hospitalist at HealthPartners Medical Group and Clinics, Minneapolis. “And I'm amazed at the amount of resources thrown at this activity,” such as Kaiser's hiring several full-time nurses.

Keeping Response Teams in Play

Dr. King outlined some of the lessons that hospital staff have learned about working with rapid response teams:

▸ Have needed equipment available. “We need oxygen!” “And a crash cart!” After those cries were heard several times, oxygen and crash carts were put in centralized locations and additional ones were placed near the security guards and in the lobby.

▸ Don't forget about hypoglycemia. Often, the team would see a patient and say, “He looks hypoglycemic,” but there would be no glucometer available. The team eventually added a glucometer, glucagon, and glucose tablets to its supply bag.

▸ Make detecting a problem easier. The hospital is piloting a vital signs sheet that highlights in yellow any physiologic markers of decline. “It actually says, 'MD or RRT should be called'” on the sheet, Dr. King said.

WASHINGTON — It was 8 a.m., and a nurse at Kaiser Permanente's Santa Clara (Calif.) Medical Center was puzzled about a patient who had been admitted for a small bowel obstruction. Everything seemed fine, but the patient was hypotensive. What should be done?

The nurse decided to call the hospital's rapid response team (RRT). Belinda Chu, R.N., the RRT nurse, considered possible causes for the low blood pressure. She concluded that the nasogastric tube that had been inserted to suction the patient's stomach could cause a high amount of fluid loss from the stomach, leading to an imbalance of fluids and electrolytes.

Ms. Chu recommended that the physician order more fluids to be given to the patient, but 2 hours later the patient was still extremely hypotensive. The physician agreed that the patient needed to be transferred to a higher-care unit for closer monitoring.

This is one example of the work of early-intervention teams. Such teams, which are available 24 hours a day, 7 days a week, vary in makeup, Dr. Andrew Auerbach of the University of California, San Francisco, said at the annual meeting of the Society of Hospital Medicine. The teams also go by different names:

▸ Medical emergency teams (METs). For these, “think of 'code team' in your head,” Dr. Auerbach said. “They can prescribe medications, they probably have airway management skills, and they can get vascular access easily. The term we use is 'ICU at the bedside.'” METs are typically led by intensivist physicians.

▸ RRTs. These teams, on the other hand, “have some but not all of the METs' abilities,” Dr. Auerbach continued. “They begin basic care, and they have the ability to call in other resources, but there's not necessarily a physician at the bedside and not generally an intensivist at the bedside. Instead, they choose to ramp up care as conditions dictate.”

▸ Critical care outreach (CCO) teams. Similar to RRTs, these provide active surveillance to recent ICU discharges in addition to doing RRT functions, he said.

Training requirements for nonphysician members of all of these teams vary, but Advanced Cardiac Life Support and Pediatric Advanced Life Support seem to be minimal requirements for all teams.

Criteria for activating the teams differ from one hospital to another, but in general, hospital staff members or anyone else in the room with the patient are encouraged to call the team after noticing any of the following: abnormal vital signs, a change in symptoms, a change in mental status, a perceived risk of harm or imminent deterioration, or a feeling that something is “just not right,” Dr. Auerbach said.

Team members are usually contacted via overhead speaker or by pager. “The [teams] tend to be underutilized even if the clinical criteria and triggering process is extraordinarily simple, so the systems can be there, but you have to really encourage people … to use it,” Dr. Auerbach said.

Once the team arrives at the bedside, he emphasized, “there should not be any negative feedback that this was an inappropriate call, or you were weak, and why couldn't you do this yourself. You should just reinforce that triggering the [team] was in fact appropriate and say, 'I'm glad to be here. How can I help?'”

Once activated, the team makes an initial diagnosis and starts appropriate interventions. The team should be able to make transfer decisions on its own and have access to the intensive care unit, Dr. Auerbach said.

Dr. Auerbach was part of a group of physicians who participated in a consensus conference on early-intervention systems held last year in Pittsburgh. The attendees discussed development of outcomes measures and criteria for using teams. The results of the conference are expected appear soon in a peer-reviewed journal, he said.

Gauging the Impact

Studies of early-intervention systems are mixed on the question of whether they improve the quality of care, said Dr. Kaveh Shojania of the department of medicine at the University of Ottawa (Ontario).

“There have been about eight before-and-after studies, most of which show pretty dramatic benefits,” but there have been major methodologic problems with some of them, Dr. Shojania said at the meeting. A large randomized, controlled trial in Australia found the teams to be of no benefit, but there are questions about that study's methodology as well, he added.

Hospitals that have implemented the teams have had varying results. At the University of Pittsburgh Medical Center, it used to be that if the patient decompensated, “you would get on the horn to the ICU or the critical care attending physician” and send the patient to the ICU. “That was how we took care of 'I'm a little bit worried' situations,” explained Dr. David J. McAdams of the University of Pittsburgh.

But in 1988, a physician's wife who was an inpatient became critically ill while on the med/surg unit. The critical care doctor arrived and performed an intervention at the bedside. “The physician said, 'This is a great idea. Why don't we do this for everybody?'” he said.

After that, the hospital began devising ways to help patients before they decompensated. But the criteria were practitioner-centered, so only certain staff could decide to call for help. And adhering to the hospital's chain of command often meant initially calling the least-experienced person, such as an intern.

“It was 'delegation to the dumbest,'” Dr. McAdams said. “In a crisis situation, this leads to delays and disaster.”

In 1999, the hospital revised its criteria to make it more specific and to make it patient-centered; it also allowed anyone to call a code, he continued. Hospital officials also decided that neither hospitalists nor residents needed to be involved in the response; instead, the attending critical care physician answers the call.

The teams get an average of two to six calls per day, Dr. McAdams said. The hospital also has found that the more people call for an RRT—which the hospital calls a “Condition C” code—the fewer times they get “Condition A” calls, which are more serious. And although the data are not yet complete, Dr. McAdams said he suspects that the program has reduced the number of preventable deaths.

Full-Time Nurses

Kaiser Permanente in Santa Clara is one hospital that has just begun to experiment with RRTs; it fully implemented its teams in April. But Kaiser has decided to do things a little differently. Rather than having all RRT members—the RRT nurse, the respiratory therapy supervisor, and a physician—all work on the team in addition to their regular jobs, Kaiser hired RRT nurses to be on the team full-time, 24 hours a day.

“The RRT nurse has no other patient responsibilities,” explained Dr. Allison Schwanda, chief of hospital-based medicine at the facility. When the nurse is not answering RRT calls, he or she rounds on all patients transferred out of the ICU and follows up on RRT calls within 12 hours to ensure that patients remain stable. He or she also “asks the nurses if there is anyone they're worried about. We think that even gets us intervening earlier than what we might get with a call to the RRT.”

The RRT nurse must handle a delicate balancing act: keeping the primary care physicians involved in care of the patient without creating barriers to activating the RRT. As a result, the team has developed a notification system to keep doctors in the loop. “Then it's up to that [doctor] whether they want to come bedside,” she said.

If the nurse in charge needs backup, she can call in the “second tier” for help: an intensivist during the day or the hospitalist at night. So far, the RRT is averaging 21/2 to 3 calls per day, or about 1 per shift, Dr. Schwanda said. The response to each call averages 30–90 minutes.

Although several speakers were enthusiastic about the potential of RRTs, not everyone in the audience was as impressed. “I remain skeptical due to the methodologic issues [in] the studies that are out there,” said Dr. Shaun Frost, a hospitalist at HealthPartners Medical Group and Clinics, Minneapolis. “And I'm amazed at the amount of resources thrown at this activity,” such as Kaiser's hiring several full-time nurses.

Keeping Response Teams in Play

Dr. King outlined some of the lessons that hospital staff have learned about working with rapid response teams:

▸ Have needed equipment available. “We need oxygen!” “And a crash cart!” After those cries were heard several times, oxygen and crash carts were put in centralized locations and additional ones were placed near the security guards and in the lobby.

▸ Don't forget about hypoglycemia. Often, the team would see a patient and say, “He looks hypoglycemic,” but there would be no glucometer available. The team eventually added a glucometer, glucagon, and glucose tablets to its supply bag.

▸ Make detecting a problem easier. The hospital is piloting a vital signs sheet that highlights in yellow any physiologic markers of decline. “It actually says, 'MD or RRT should be called'” on the sheet, Dr. King said.

WASHINGTON — It was 8 a.m., and a nurse at Kaiser Permanente's Santa Clara (Calif.) Medical Center was puzzled about a patient who had been admitted for a small bowel obstruction. Everything seemed fine, but the patient was hypotensive. What should be done?

The nurse decided to call the hospital's rapid response team (RRT). Belinda Chu, R.N., the RRT nurse, considered possible causes for the low blood pressure. She concluded that the nasogastric tube that had been inserted to suction the patient's stomach could cause a high amount of fluid loss from the stomach, leading to an imbalance of fluids and electrolytes.

Ms. Chu recommended that the physician order more fluids to be given to the patient, but 2 hours later the patient was still extremely hypotensive. The physician agreed that the patient needed to be transferred to a higher-care unit for closer monitoring.

This is one example of the work of early-intervention teams. Such teams, which are available 24 hours a day, 7 days a week, vary in makeup, Dr. Andrew Auerbach of the University of California, San Francisco, said at the annual meeting of the Society of Hospital Medicine. The teams also go by different names:

▸ Medical emergency teams (METs). For these, “think of 'code team' in your head,” Dr. Auerbach said. “They can prescribe medications, they probably have airway management skills, and they can get vascular access easily. The term we use is 'ICU at the bedside.'” METs are typically led by intensivist physicians.

▸ RRTs. These teams, on the other hand, “have some but not all of the METs' abilities,” Dr. Auerbach continued. “They begin basic care, and they have the ability to call in other resources, but there's not necessarily a physician at the bedside and not generally an intensivist at the bedside. Instead, they choose to ramp up care as conditions dictate.”

▸ Critical care outreach (CCO) teams. Similar to RRTs, these provide active surveillance to recent ICU discharges in addition to doing RRT functions, he said.

Training requirements for nonphysician members of all of these teams vary, but Advanced Cardiac Life Support and Pediatric Advanced Life Support seem to be minimal requirements for all teams.

Criteria for activating the teams differ from one hospital to another, but in general, hospital staff members or anyone else in the room with the patient are encouraged to call the team after noticing any of the following: abnormal vital signs, a change in symptoms, a change in mental status, a perceived risk of harm or imminent deterioration, or a feeling that something is “just not right,” Dr. Auerbach said.

Team members are usually contacted via overhead speaker or by pager. “The [teams] tend to be underutilized even if the clinical criteria and triggering process is extraordinarily simple, so the systems can be there, but you have to really encourage people … to use it,” Dr. Auerbach said.

Once the team arrives at the bedside, he emphasized, “there should not be any negative feedback that this was an inappropriate call, or you were weak, and why couldn't you do this yourself. You should just reinforce that triggering the [team] was in fact appropriate and say, 'I'm glad to be here. How can I help?'”

Once activated, the team makes an initial diagnosis and starts appropriate interventions. The team should be able to make transfer decisions on its own and have access to the intensive care unit, Dr. Auerbach said.

Dr. Auerbach was part of a group of physicians who participated in a consensus conference on early-intervention systems held last year in Pittsburgh. The attendees discussed development of outcomes measures and criteria for using teams. The results of the conference are expected appear soon in a peer-reviewed journal, he said.

Gauging the Impact

Studies of early-intervention systems are mixed on the question of whether they improve the quality of care, said Dr. Kaveh Shojania of the department of medicine at the University of Ottawa (Ontario).

“There have been about eight before-and-after studies, most of which show pretty dramatic benefits,” but there have been major methodologic problems with some of them, Dr. Shojania said at the meeting. A large randomized, controlled trial in Australia found the teams to be of no benefit, but there are questions about that study's methodology as well, he added.

Hospitals that have implemented the teams have had varying results. At the University of Pittsburgh Medical Center, it used to be that if the patient decompensated, “you would get on the horn to the ICU or the critical care attending physician” and send the patient to the ICU. “That was how we took care of 'I'm a little bit worried' situations,” explained Dr. David J. McAdams of the University of Pittsburgh.

But in 1988, a physician's wife who was an inpatient became critically ill while on the med/surg unit. The critical care doctor arrived and performed an intervention at the bedside. “The physician said, 'This is a great idea. Why don't we do this for everybody?'” he said.

After that, the hospital began devising ways to help patients before they decompensated. But the criteria were practitioner-centered, so only certain staff could decide to call for help. And adhering to the hospital's chain of command often meant initially calling the least-experienced person, such as an intern.

“It was 'delegation to the dumbest,'” Dr. McAdams said. “In a crisis situation, this leads to delays and disaster.”

In 1999, the hospital revised its criteria to make it more specific and to make it patient-centered; it also allowed anyone to call a code, he continued. Hospital officials also decided that neither hospitalists nor residents needed to be involved in the response; instead, the attending critical care physician answers the call.

The teams get an average of two to six calls per day, Dr. McAdams said. The hospital also has found that the more people call for an RRT—which the hospital calls a “Condition C” code—the fewer times they get “Condition A” calls, which are more serious. And although the data are not yet complete, Dr. McAdams said he suspects that the program has reduced the number of preventable deaths.

Full-Time Nurses

Kaiser Permanente in Santa Clara is one hospital that has just begun to experiment with RRTs; it fully implemented its teams in April. But Kaiser has decided to do things a little differently. Rather than having all RRT members—the RRT nurse, the respiratory therapy supervisor, and a physician—all work on the team in addition to their regular jobs, Kaiser hired RRT nurses to be on the team full-time, 24 hours a day.

“The RRT nurse has no other patient responsibilities,” explained Dr. Allison Schwanda, chief of hospital-based medicine at the facility. When the nurse is not answering RRT calls, he or she rounds on all patients transferred out of the ICU and follows up on RRT calls within 12 hours to ensure that patients remain stable. He or she also “asks the nurses if there is anyone they're worried about. We think that even gets us intervening earlier than what we might get with a call to the RRT.”

The RRT nurse must handle a delicate balancing act: keeping the primary care physicians involved in care of the patient without creating barriers to activating the RRT. As a result, the team has developed a notification system to keep doctors in the loop. “Then it's up to that [doctor] whether they want to come bedside,” she said.

If the nurse in charge needs backup, she can call in the “second tier” for help: an intensivist during the day or the hospitalist at night. So far, the RRT is averaging 21/2 to 3 calls per day, or about 1 per shift, Dr. Schwanda said. The response to each call averages 30–90 minutes.

Although several speakers were enthusiastic about the potential of RRTs, not everyone in the audience was as impressed. “I remain skeptical due to the methodologic issues [in] the studies that are out there,” said Dr. Shaun Frost, a hospitalist at HealthPartners Medical Group and Clinics, Minneapolis. “And I'm amazed at the amount of resources thrown at this activity,” such as Kaiser's hiring several full-time nurses.

Keeping Response Teams in Play

Dr. King outlined some of the lessons that hospital staff have learned about working with rapid response teams:

▸ Have needed equipment available. “We need oxygen!” “And a crash cart!” After those cries were heard several times, oxygen and crash carts were put in centralized locations and additional ones were placed near the security guards and in the lobby.

▸ Don't forget about hypoglycemia. Often, the team would see a patient and say, “He looks hypoglycemic,” but there would be no glucometer available. The team eventually added a glucometer, glucagon, and glucose tablets to its supply bag.

▸ Make detecting a problem easier. The hospital is piloting a vital signs sheet that highlights in yellow any physiologic markers of decline. “It actually says, 'MD or RRT should be called'” on the sheet, Dr. King said.

NMHA Names New President

The National Mental Health Association has named David L. Shern, Ph.D., as the organization's new president and CEO. Dr. Shern is currently dean of the Louis de la Parte Florida Mental Health Institute at the University of South Florida, Tampa, and has had 30 years' experience in mental health, particularly in the translation of research into policy and practice. “David Shern has the vision, expertise, and background to lead NMHA into a new era,” said Sergio Aguilar Gaxiola, the association's acting chair. His “leadership will enable NMHA to make significant inroads in public opinion, policies, and services for the mental health of all Americans.”

Drug-Related ED Visits

Of the 2 million drug-related visits to emergency departments that occurred in 2004, the majority (1.3 million) were for drug misuse or abuse, according to data from the Substance Abuse and Mental Health Services Administration. The findings appear in a new report, “Drug Abuse Warning Network, 2004: National Estimates of Drug-Related Emergency Department Visits.” Of the ED visits for misuse or abuse, 30% involved illicit drugs; 25% involved prescription or over-the-counter medications; 15% percent involved illicit drugs and alcohol; 8% involved illicit drugs and pharmaceuticals; and 14% involved illicit drugs, pharmaceuticals, and alcohol. “Most of the 1.3 million visits to emergency rooms involving drug or alcohol misuse or abuse are an opportunity for the health care system to intervene and direct patients to appropriate follow-up care,” noted SAMHSA Administrator Charles Curie. Since the survey is considered a new baseline, no comparative data from previous years were available.

Hospital Payments Increased

Medicare is increasing overall payments to inpatient psychiatric facilities an average of 4% beginning next month, the Centers for Medicare and Medicaid Services announced. The increase will go to about 1,800 facilities, including hospitals which only treat psychiatric patients, distinct psychiatric units in acute care hospitals, and critical access hospitals that are paid under a prospective payment system. “We think that's a fair increase,” said Mark Covall, executive director of the National Association of Psychiatric Health Systems, adding that this is the first increase since CMS implemented the prospective payment system for inpatient psychiatric facilities in early 2005.

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 is also 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 FDA's authority to require drugmakers 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. FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Part D: No Help for Poor Seniors

Less than one-fourth of the Medicare beneficiaries eligible for subsidies under Medicare Part D have enrolled in a plan, according to a report from Families USA. The report, based primarily on enrollment data from the Centers for Medicare and Medicaid Services, found that only 1.7 million of the 7.2 million low-income seniors eligible for the subsidies–or about 24%–have enrolled in Part D. And in 16 states and the District of Columbia, at least four out of five seniors eligible for low-income subsidies are not receiving them, according to the report. “Contrary to promises by the President and congressional leaders, low-income seniors are not receiving help to make their medicines affordable,” said Ron Pollack, the group's executive director. “These are the very people who need help the most, yet the administration's promises to them are much more rhetorical than real.”

Malpractice “Crisis” Questioned

The idea that malpractice premiums have risen greatly and constitute a “crisis” for physicians is false, according to an article in the May/June issue of Health Affairs. Author Marc A. Rodwin, Ph.D., a law professor at Suffolk University, Boston, and Suffolk law students Hak J. Chang and Jeffrey Clausen, looked at American Medical Association surveys of self-employed physicians from 1970 to 2000. The surveys indicated that, in constant 2000 dollars, premiums rose until 1986, then declined until 1996, and then started rising again but were still lower in 2000 than in 1986. In terms of practice expenses, malpractice premiums rose from being an average of 6% of total expenses in 1970 to 11% in 1986, dropped back to 6% in 1996 and rose to 7% in 2000. The authors acknowledged that their study had limitations, such as the fact that a premium crisis might not be apparent in the study if it existed in only a few states, and that it didn't take into account the effect of state caps on damage awards.

NMHA Names New President

The National Mental Health Association has named David L. Shern, Ph.D., as the organization's new president and CEO. Dr. Shern is currently dean of the Louis de la Parte Florida Mental Health Institute at the University of South Florida, Tampa, and has had 30 years' experience in mental health, particularly in the translation of research into policy and practice. “David Shern has the vision, expertise, and background to lead NMHA into a new era,” said Sergio Aguilar Gaxiola, the association's acting chair. His “leadership will enable NMHA to make significant inroads in public opinion, policies, and services for the mental health of all Americans.”

Drug-Related ED Visits

Of the 2 million drug-related visits to emergency departments that occurred in 2004, the majority (1.3 million) were for drug misuse or abuse, according to data from the Substance Abuse and Mental Health Services Administration. The findings appear in a new report, “Drug Abuse Warning Network, 2004: National Estimates of Drug-Related Emergency Department Visits.” Of the ED visits for misuse or abuse, 30% involved illicit drugs; 25% involved prescription or over-the-counter medications; 15% percent involved illicit drugs and alcohol; 8% involved illicit drugs and pharmaceuticals; and 14% involved illicit drugs, pharmaceuticals, and alcohol. “Most of the 1.3 million visits to emergency rooms involving drug or alcohol misuse or abuse are an opportunity for the health care system to intervene and direct patients to appropriate follow-up care,” noted SAMHSA Administrator Charles Curie. Since the survey is considered a new baseline, no comparative data from previous years were available.

Hospital Payments Increased

Medicare is increasing overall payments to inpatient psychiatric facilities an average of 4% beginning next month, the Centers for Medicare and Medicaid Services announced. The increase will go to about 1,800 facilities, including hospitals which only treat psychiatric patients, distinct psychiatric units in acute care hospitals, and critical access hospitals that are paid under a prospective payment system. “We think that's a fair increase,” said Mark Covall, executive director of the National Association of Psychiatric Health Systems, adding that this is the first increase since CMS implemented the prospective payment system for inpatient psychiatric facilities in early 2005.

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 is also 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 FDA's authority to require drugmakers 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. FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Part D: No Help for Poor Seniors

Less than one-fourth of the Medicare beneficiaries eligible for subsidies under Medicare Part D have enrolled in a plan, according to a report from Families USA. The report, based primarily on enrollment data from the Centers for Medicare and Medicaid Services, found that only 1.7 million of the 7.2 million low-income seniors eligible for the subsidies–or about 24%–have enrolled in Part D. And in 16 states and the District of Columbia, at least four out of five seniors eligible for low-income subsidies are not receiving them, according to the report. “Contrary to promises by the President and congressional leaders, low-income seniors are not receiving help to make their medicines affordable,” said Ron Pollack, the group's executive director. “These are the very people who need help the most, yet the administration's promises to them are much more rhetorical than real.”

Malpractice “Crisis” Questioned

The idea that malpractice premiums have risen greatly and constitute a “crisis” for physicians is false, according to an article in the May/June issue of Health Affairs. Author Marc A. Rodwin, Ph.D., a law professor at Suffolk University, Boston, and Suffolk law students Hak J. Chang and Jeffrey Clausen, looked at American Medical Association surveys of self-employed physicians from 1970 to 2000. The surveys indicated that, in constant 2000 dollars, premiums rose until 1986, then declined until 1996, and then started rising again but were still lower in 2000 than in 1986. In terms of practice expenses, malpractice premiums rose from being an average of 6% of total expenses in 1970 to 11% in 1986, dropped back to 6% in 1996 and rose to 7% in 2000. The authors acknowledged that their study had limitations, such as the fact that a premium crisis might not be apparent in the study if it existed in only a few states, and that it didn't take into account the effect of state caps on damage awards.

NMHA Names New President

The National Mental Health Association has named David L. Shern, Ph.D., as the organization's new president and CEO. Dr. Shern is currently dean of the Louis de la Parte Florida Mental Health Institute at the University of South Florida, Tampa, and has had 30 years' experience in mental health, particularly in the translation of research into policy and practice. “David Shern has the vision, expertise, and background to lead NMHA into a new era,” said Sergio Aguilar Gaxiola, the association's acting chair. His “leadership will enable NMHA to make significant inroads in public opinion, policies, and services for the mental health of all Americans.”

Drug-Related ED Visits

Of the 2 million drug-related visits to emergency departments that occurred in 2004, the majority (1.3 million) were for drug misuse or abuse, according to data from the Substance Abuse and Mental Health Services Administration. The findings appear in a new report, “Drug Abuse Warning Network, 2004: National Estimates of Drug-Related Emergency Department Visits.” Of the ED visits for misuse or abuse, 30% involved illicit drugs; 25% involved prescription or over-the-counter medications; 15% percent involved illicit drugs and alcohol; 8% involved illicit drugs and pharmaceuticals; and 14% involved illicit drugs, pharmaceuticals, and alcohol. “Most of the 1.3 million visits to emergency rooms involving drug or alcohol misuse or abuse are an opportunity for the health care system to intervene and direct patients to appropriate follow-up care,” noted SAMHSA Administrator Charles Curie. Since the survey is considered a new baseline, no comparative data from previous years were available.

Hospital Payments Increased

Medicare is increasing overall payments to inpatient psychiatric facilities an average of 4% beginning next month, the Centers for Medicare and Medicaid Services announced. The increase will go to about 1,800 facilities, including hospitals which only treat psychiatric patients, distinct psychiatric units in acute care hospitals, and critical access hospitals that are paid under a prospective payment system. “We think that's a fair increase,” said Mark Covall, executive director of the National Association of Psychiatric Health Systems, adding that this is the first increase since CMS implemented the prospective payment system for inpatient psychiatric facilities in early 2005.

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 is also 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 FDA's authority to require drugmakers 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. FDA called the report “well done” and said that the GAO's conclusions were “reasonable and consistent with actions” already underway or planned.

Part D: No Help for Poor Seniors

Less than one-fourth of the Medicare beneficiaries eligible for subsidies under Medicare Part D have enrolled in a plan, according to a report from Families USA. The report, based primarily on enrollment data from the Centers for Medicare and Medicaid Services, found that only 1.7 million of the 7.2 million low-income seniors eligible for the subsidies–or about 24%–have enrolled in Part D. And in 16 states and the District of Columbia, at least four out of five seniors eligible for low-income subsidies are not receiving them, according to the report. “Contrary to promises by the President and congressional leaders, low-income seniors are not receiving help to make their medicines affordable,” said Ron Pollack, the group's executive director. “These are the very people who need help the most, yet the administration's promises to them are much more rhetorical than real.”

Malpractice “Crisis” Questioned

The idea that malpractice premiums have risen greatly and constitute a “crisis” for physicians is false, according to an article in the May/June issue of Health Affairs. Author Marc A. Rodwin, Ph.D., a law professor at Suffolk University, Boston, and Suffolk law students Hak J. Chang and Jeffrey Clausen, looked at American Medical Association surveys of self-employed physicians from 1970 to 2000. The surveys indicated that, in constant 2000 dollars, premiums rose until 1986, then declined until 1996, and then started rising again but were still lower in 2000 than in 1986. In terms of practice expenses, malpractice premiums rose from being an average of 6% of total expenses in 1970 to 11% in 1986, dropped back to 6% in 1996 and rose to 7% in 2000. The authors acknowledged that their study had limitations, such as the fact that a premium crisis might not be apparent in the study if it existed in only a few states, and that it didn't take into account the effect of state caps on damage awards.

WASHINGTON — Payments for drugs to treat cancer deserve more scrutiny, Dr. Lee Newcomer, business leader of Oncology Services for United Healthcare, said at a conference sponsored by Elsevier Oncology.

For example, he continued, United Healthcare decided to take a closer look at 180 breast cancer patients who were prescribed trastuzumab (Herceptin), a drug indicated only for patients who have a HER2/neu gene.

“I asked the oncology office to send us the report; 12% of patients who were getting Herceptin did not have a HER2/neu gene anywhere in their medical records,” he said. “That's a dangerous drug. It's got a high incidence of heart failure.”

As a result, Dr. Newcomer said he had no choice but to require physicians who prescribed the drug to staple a report showing the patient had the gene to their first Herceptin prescription claim. After the first prescription, “the rest will go straight through,” he added.

Another issue is how to make chemotherapy more cost effective. “Right now, in the world of oncology, you have every incentive to use the most expensive chemotherapy regimen that works” because there is more profit in the expensive drugs, said Dr. Newcomer, formerly an oncologist in private practice. “That is part of how you make your practice income. I used to make my income that way.”

Dr. Newcomer is considering a program in which United pays physicians the same profit they used to get from each chemotherapy regimen—in the form of a disease-management fee—but the plan also buys the drugs instead of having the physicians buy them.

“You let me go out and get the best possible price for that drug, because as United Healthcare, I've got a little more clout than your office does,” he said, noting that he spent $1.1 billion on drugs last year.

Under that plan, “[oncologists] win—you still keep the margins at your office,” he continued.

“I win because patients are going to get a lower premium. [Large pharmaceutical companies] lose, but that's going to happen,” he said.

The idea behind the proposal is that “I want to pay you a lung cancer management fee, but have you be indifferent to which drug gives you the best margin, because we're going to go out and purchase it directly from the manufacturers,” Dr. Newcomer said. “Your money doesn't come any more from which drug you choose. It comes from the disease-management fee.”

Dr. Newcomer also wants to look more closely at off-label use of cancer drugs. This issue came to his attention when he looked at prescriptions for bevacizumab (Avastin), a colorectal cancer drug, and found that over a 4-month period, 80% of the prescriptions were for colorectal cancer, but the other 20% were for “every other cancer you can imagine—head and neck cancer, pancreas, bone, you name it. Every cancer was on that list, and I have to ask, why? Where's the evidence? Who really benefits from that?”

One way to find out the results of off-label use of cancer drugs is to enroll the patient in a clinical trial of an off-label drug. United already pays patient expenses in clinical trials that are approved by the National Cancer Institute, according to Dr. Newcomer.

The other option, he continued, is to create registries—possibly in conjunction with the Centers for Medicare and Medicaid Services, “and start finding out whether this stuff works [off-label] or not, instead of having every single office in the country try one or two patients and we never gain any knowledge from that endeavor.”

Another area Dr. Newcomer's office is examining is rationalizing end-of-life care for cancer patients.

“This is of personal interest to me because in my six-man [oncology] group, three of us had almost 90% of our patients die in the hospital, and the other three, where I was, had 90% of our patients die in hospice,” he said. “As we had discussions about that, it was a difference in philosophy, but we couldn't quite figure out how we would approach what the right number was.”

Dr. Newcomer referred to a study by the Quality Oncology Practice Initiative, which looked at end-of-life chemotherapy in about 30 oncology practices. The study found that in some practices, patients got no chemotherapy in the last few weeks of life, and in other practices, 40%–50% of terminally ill patients were getting chemotherapy.

“That [last] one sounds a little high. Zero sounds a little low. Where's the norm, and how do we get there?” he said.

“This is a big deal, because third-, fourth-, and fifth-line chemotherapy is a huge cost, and we need to figure out what's reasonable. I do not know the answer to that. All I'm asking for is to get the discussion started.”

Elsevier Oncology and this news organization are both wholly owned subsidiaries of Elsevier.

WASHINGTON — Payments for drugs to treat cancer deserve more scrutiny, Dr. Lee Newcomer, business leader of Oncology Services for United Healthcare, said at a conference sponsored by Elsevier Oncology.

For example, he continued, United Healthcare decided to take a closer look at 180 breast cancer patients who were prescribed trastuzumab (Herceptin), a drug indicated only for patients who have a HER2/neu gene.

“I asked the oncology office to send us the report; 12% of patients who were getting Herceptin did not have a HER2/neu gene anywhere in their medical records,” he said. “That's a dangerous drug. It's got a high incidence of heart failure.”

As a result, Dr. Newcomer said he had no choice but to require physicians who prescribed the drug to staple a report showing the patient had the gene to their first Herceptin prescription claim. After the first prescription, “the rest will go straight through,” he added.

Another issue is how to make chemotherapy more cost effective. “Right now, in the world of oncology, you have every incentive to use the most expensive chemotherapy regimen that works” because there is more profit in the expensive drugs, said Dr. Newcomer, formerly an oncologist in private practice. “That is part of how you make your practice income. I used to make my income that way.”

Dr. Newcomer is considering a program in which United pays physicians the same profit they used to get from each chemotherapy regimen—in the form of a disease-management fee—but the plan also buys the drugs instead of having the physicians buy them.

“You let me go out and get the best possible price for that drug, because as United Healthcare, I've got a little more clout than your office does,” he said, noting that he spent $1.1 billion on drugs last year.

Under that plan, “[oncologists] win—you still keep the margins at your office,” he continued.

“I win because patients are going to get a lower premium. [Large pharmaceutical companies] lose, but that's going to happen,” he said.

The idea behind the proposal is that “I want to pay you a lung cancer management fee, but have you be indifferent to which drug gives you the best margin, because we're going to go out and purchase it directly from the manufacturers,” Dr. Newcomer said. “Your money doesn't come any more from which drug you choose. It comes from the disease-management fee.”

Dr. Newcomer also wants to look more closely at off-label use of cancer drugs. This issue came to his attention when he looked at prescriptions for bevacizumab (Avastin), a colorectal cancer drug, and found that over a 4-month period, 80% of the prescriptions were for colorectal cancer, but the other 20% were for “every other cancer you can imagine—head and neck cancer, pancreas, bone, you name it. Every cancer was on that list, and I have to ask, why? Where's the evidence? Who really benefits from that?”

One way to find out the results of off-label use of cancer drugs is to enroll the patient in a clinical trial of an off-label drug. United already pays patient expenses in clinical trials that are approved by the National Cancer Institute, according to Dr. Newcomer.

The other option, he continued, is to create registries—possibly in conjunction with the Centers for Medicare and Medicaid Services, “and start finding out whether this stuff works [off-label] or not, instead of having every single office in the country try one or two patients and we never gain any knowledge from that endeavor.”

Another area Dr. Newcomer's office is examining is rationalizing end-of-life care for cancer patients.

“This is of personal interest to me because in my six-man [oncology] group, three of us had almost 90% of our patients die in the hospital, and the other three, where I was, had 90% of our patients die in hospice,” he said. “As we had discussions about that, it was a difference in philosophy, but we couldn't quite figure out how we would approach what the right number was.”

Dr. Newcomer referred to a study by the Quality Oncology Practice Initiative, which looked at end-of-life chemotherapy in about 30 oncology practices. The study found that in some practices, patients got no chemotherapy in the last few weeks of life, and in other practices, 40%–50% of terminally ill patients were getting chemotherapy.

“That [last] one sounds a little high. Zero sounds a little low. Where's the norm, and how do we get there?” he said.

“This is a big deal, because third-, fourth-, and fifth-line chemotherapy is a huge cost, and we need to figure out what's reasonable. I do not know the answer to that. All I'm asking for is to get the discussion started.”

Elsevier Oncology and this news organization are both wholly owned subsidiaries of Elsevier.

WASHINGTON — Payments for drugs to treat cancer deserve more scrutiny, Dr. Lee Newcomer, business leader of Oncology Services for United Healthcare, said at a conference sponsored by Elsevier Oncology.

For example, he continued, United Healthcare decided to take a closer look at 180 breast cancer patients who were prescribed trastuzumab (Herceptin), a drug indicated only for patients who have a HER2/neu gene.

“I asked the oncology office to send us the report; 12% of patients who were getting Herceptin did not have a HER2/neu gene anywhere in their medical records,” he said. “That's a dangerous drug. It's got a high incidence of heart failure.”

As a result, Dr. Newcomer said he had no choice but to require physicians who prescribed the drug to staple a report showing the patient had the gene to their first Herceptin prescription claim. After the first prescription, “the rest will go straight through,” he added.

Another issue is how to make chemotherapy more cost effective. “Right now, in the world of oncology, you have every incentive to use the most expensive chemotherapy regimen that works” because there is more profit in the expensive drugs, said Dr. Newcomer, formerly an oncologist in private practice. “That is part of how you make your practice income. I used to make my income that way.”

Dr. Newcomer is considering a program in which United pays physicians the same profit they used to get from each chemotherapy regimen—in the form of a disease-management fee—but the plan also buys the drugs instead of having the physicians buy them.

“You let me go out and get the best possible price for that drug, because as United Healthcare, I've got a little more clout than your office does,” he said, noting that he spent $1.1 billion on drugs last year.

Under that plan, “[oncologists] win—you still keep the margins at your office,” he continued.

“I win because patients are going to get a lower premium. [Large pharmaceutical companies] lose, but that's going to happen,” he said.

The idea behind the proposal is that “I want to pay you a lung cancer management fee, but have you be indifferent to which drug gives you the best margin, because we're going to go out and purchase it directly from the manufacturers,” Dr. Newcomer said. “Your money doesn't come any more from which drug you choose. It comes from the disease-management fee.”

Dr. Newcomer also wants to look more closely at off-label use of cancer drugs. This issue came to his attention when he looked at prescriptions for bevacizumab (Avastin), a colorectal cancer drug, and found that over a 4-month period, 80% of the prescriptions were for colorectal cancer, but the other 20% were for “every other cancer you can imagine—head and neck cancer, pancreas, bone, you name it. Every cancer was on that list, and I have to ask, why? Where's the evidence? Who really benefits from that?”

One way to find out the results of off-label use of cancer drugs is to enroll the patient in a clinical trial of an off-label drug. United already pays patient expenses in clinical trials that are approved by the National Cancer Institute, according to Dr. Newcomer.

The other option, he continued, is to create registries—possibly in conjunction with the Centers for Medicare and Medicaid Services, “and start finding out whether this stuff works [off-label] or not, instead of having every single office in the country try one or two patients and we never gain any knowledge from that endeavor.”

Another area Dr. Newcomer's office is examining is rationalizing end-of-life care for cancer patients.

“This is of personal interest to me because in my six-man [oncology] group, three of us had almost 90% of our patients die in the hospital, and the other three, where I was, had 90% of our patients die in hospice,” he said. “As we had discussions about that, it was a difference in philosophy, but we couldn't quite figure out how we would approach what the right number was.”

Dr. Newcomer referred to a study by the Quality Oncology Practice Initiative, which looked at end-of-life chemotherapy in about 30 oncology practices. The study found that in some practices, patients got no chemotherapy in the last few weeks of life, and in other practices, 40%–50% of terminally ill patients were getting chemotherapy.

“That [last] one sounds a little high. Zero sounds a little low. Where's the norm, and how do we get there?” he said.

“This is a big deal, because third-, fourth-, and fifth-line chemotherapy is a huge cost, and we need to figure out what's reasonable. I do not know the answer to that. All I'm asking for is to get the discussion started.”

Elsevier Oncology and this news organization are both wholly owned subsidiaries of Elsevier.

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for reimbursing infusion drugs, "essential services are underreimbursed or not reimbursed at all," said Mr. Coplon, chief executive officer of the West Clinic, a Memphis, Tenn., oncology practice. "But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase."

To stay in business, practices have to look more closely at the revenue that they are getting for their services. For example, "on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment," he noted.

One way to increase revenue is to increase the amount the practice brings in from private payers, he continued.

"Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative," he advised. "If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business."

Another way to increase revenue is to diversify, Mr. Coplon said.

Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, how about adding radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? he asked.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should also consider whether their billing procedures are "optimal." In an optimal practice, "80% of receivables should be less than 90 days overdue," said Ms. Buell. "And if your practice is more than 50% Medicare, you should be doing much better than that."

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for reimbursing infusion drugs, "essential services are underreimbursed or not reimbursed at all," said Mr. Coplon, chief executive officer of the West Clinic, a Memphis, Tenn., oncology practice. "But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase."

To stay in business, practices have to look more closely at the revenue that they are getting for their services. For example, "on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment," he noted.

One way to increase revenue is to increase the amount the practice brings in from private payers, he continued.

"Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative," he advised. "If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business."

Another way to increase revenue is to diversify, Mr. Coplon said.

Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, how about adding radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? he asked.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should also consider whether their billing procedures are "optimal." In an optimal practice, "80% of receivables should be less than 90 days overdue," said Ms. Buell. "And if your practice is more than 50% Medicare, you should be doing much better than that."

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for reimbursing infusion drugs, "essential services are underreimbursed or not reimbursed at all," said Mr. Coplon, chief executive officer of the West Clinic, a Memphis, Tenn., oncology practice. "But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase."

To stay in business, practices have to look more closely at the revenue that they are getting for their services. For example, "on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment," he noted.

One way to increase revenue is to increase the amount the practice brings in from private payers, he continued.

"Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative," he advised. "If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business."

Another way to increase revenue is to diversify, Mr. Coplon said.

Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, how about adding radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? he asked.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should also consider whether their billing procedures are "optimal." In an optimal practice, "80% of receivables should be less than 90 days overdue," said Ms. Buell. "And if your practice is more than 50% Medicare, you should be doing much better than that."

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” Dr. Maupin said. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Dr. Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” she said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” Dr. Maupin said. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Dr. Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” she said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” Dr. Maupin said. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Dr. Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” she said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

WASHINGTON — Diabetic cardiomyopathy is likely to become a more common problem in diabetic patients, but several new therapies in the pipeline look promising, Dr. Francisco Villarreal said at a meeting sponsored by the National Hispanic Medical Association.

“This is something we will have to watch for in our young people developing diabetes, and it takes a long time to evolve,” said Dr. Villarreal of the division of cardiology at the University of California, San Diego.

The term “diabetic cardiomyopathy” will become much better known in the near future, Dr. Villarreal predicted. The term “refers to pathological changes in the hearts of certain diabetics in the absence of an underlying identifiable cause.”

“Very frequently we associate diabetes with atherosclerosis, but in these patients we could not identify problems with blood vessels or the presence of hypertension. But we could document changes that occurred at the cellular level—be it muscle cells or cells that produce fibrous tissue—and also at the tissue level. These structural changes are characterized by myocardial hypertrophy and also by the presence of excess fibrotic tissue—in particular, collagens,” he explained.

Diabetic cardiomyopathy appears to play a role in the increased rate of heart failure in diabetic patients, according to Dr. Villarreal. The Strong Heart Study concluded that the extent and frequency of diastolic dysfunction was directly proportional to level of hemoglobin A_1c (Circulation 2000;101:2271–6). The Framingham heart study led to similar conclusions (Prog. Cardiovasc. Dis. 1985;27:255–70).

“When they looked at the risk of heart failure in diabetics and nondiabetics, in adult diabetic males, the risk was about two times that of [nondiabetic males], and in females, it was about five times,” he said. “But even worse, these risks multiplied about twice when observing young individuals—in young males, it was a four times higher risk, and in young females, eight times higher. It was also noted that each 1% elevation in HbA_1c levels led to an increase of about 50% in the risk of heart failure.”

In one study, Doppler echocardiography documented the presence of diastolic dysfunction in up to 60% of well-controlled type 2 diabetic patients, Dr. Villarreal noted (Diabetes Care 2001;24:5–10).

Two compounds in the therapeutic pipeline appear promising, he noted. Early studies of ruboxistaurin, a novel highly selective inhibitor of protein kinase C-β, suggest that it may curb diabetes-related blindness, nephropathy, and neuropathy. None of these trials involved cardiac diseases, but “it is likely that these drugs probably will also benefit the heart,” he said. Another compound, alagebrium (ALT-711), may help collagen become more compliant, Dr. Villarreal said.

WASHINGTON — Diabetic cardiomyopathy is likely to become a more common problem in diabetic patients, but several new therapies in the pipeline look promising, Dr. Francisco Villarreal said at a meeting sponsored by the National Hispanic Medical Association.

“This is something we will have to watch for in our young people developing diabetes, and it takes a long time to evolve,” said Dr. Villarreal of the division of cardiology at the University of California, San Diego.

The term “diabetic cardiomyopathy” will become much better known in the near future, Dr. Villarreal predicted. The term “refers to pathological changes in the hearts of certain diabetics in the absence of an underlying identifiable cause.”

“Very frequently we associate diabetes with atherosclerosis, but in these patients we could not identify problems with blood vessels or the presence of hypertension. But we could document changes that occurred at the cellular level—be it muscle cells or cells that produce fibrous tissue—and also at the tissue level. These structural changes are characterized by myocardial hypertrophy and also by the presence of excess fibrotic tissue—in particular, collagens,” he explained.

Diabetic cardiomyopathy appears to play a role in the increased rate of heart failure in diabetic patients, according to Dr. Villarreal. The Strong Heart Study concluded that the extent and frequency of diastolic dysfunction was directly proportional to level of hemoglobin A_1c (Circulation 2000;101:2271–6). The Framingham heart study led to similar conclusions (Prog. Cardiovasc. Dis. 1985;27:255–70).

“When they looked at the risk of heart failure in diabetics and nondiabetics, in adult diabetic males, the risk was about two times that of [nondiabetic males], and in females, it was about five times,” he said. “But even worse, these risks multiplied about twice when observing young individuals—in young males, it was a four times higher risk, and in young females, eight times higher. It was also noted that each 1% elevation in HbA_1c levels led to an increase of about 50% in the risk of heart failure.”

In one study, Doppler echocardiography documented the presence of diastolic dysfunction in up to 60% of well-controlled type 2 diabetic patients, Dr. Villarreal noted (Diabetes Care 2001;24:5–10).

Two compounds in the therapeutic pipeline appear promising, he noted. Early studies of ruboxistaurin, a novel highly selective inhibitor of protein kinase C-β, suggest that it may curb diabetes-related blindness, nephropathy, and neuropathy. None of these trials involved cardiac diseases, but “it is likely that these drugs probably will also benefit the heart,” he said. Another compound, alagebrium (ALT-711), may help collagen become more compliant, Dr. Villarreal said.

WASHINGTON — Diabetic cardiomyopathy is likely to become a more common problem in diabetic patients, but several new therapies in the pipeline look promising, Dr. Francisco Villarreal said at a meeting sponsored by the National Hispanic Medical Association.

“This is something we will have to watch for in our young people developing diabetes, and it takes a long time to evolve,” said Dr. Villarreal of the division of cardiology at the University of California, San Diego.

The term “diabetic cardiomyopathy” will become much better known in the near future, Dr. Villarreal predicted. The term “refers to pathological changes in the hearts of certain diabetics in the absence of an underlying identifiable cause.”

“Very frequently we associate diabetes with atherosclerosis, but in these patients we could not identify problems with blood vessels or the presence of hypertension. But we could document changes that occurred at the cellular level—be it muscle cells or cells that produce fibrous tissue—and also at the tissue level. These structural changes are characterized by myocardial hypertrophy and also by the presence of excess fibrotic tissue—in particular, collagens,” he explained.

Diabetic cardiomyopathy appears to play a role in the increased rate of heart failure in diabetic patients, according to Dr. Villarreal. The Strong Heart Study concluded that the extent and frequency of diastolic dysfunction was directly proportional to level of hemoglobin A_1c (Circulation 2000;101:2271–6). The Framingham heart study led to similar conclusions (Prog. Cardiovasc. Dis. 1985;27:255–70).

“When they looked at the risk of heart failure in diabetics and nondiabetics, in adult diabetic males, the risk was about two times that of [nondiabetic males], and in females, it was about five times,” he said. “But even worse, these risks multiplied about twice when observing young individuals—in young males, it was a four times higher risk, and in young females, eight times higher. It was also noted that each 1% elevation in HbA_1c levels led to an increase of about 50% in the risk of heart failure.”

In one study, Doppler echocardiography documented the presence of diastolic dysfunction in up to 60% of well-controlled type 2 diabetic patients, Dr. Villarreal noted (Diabetes Care 2001;24:5–10).

Two compounds in the therapeutic pipeline appear promising, he noted. Early studies of ruboxistaurin, a novel highly selective inhibitor of protein kinase C-β, suggest that it may curb diabetes-related blindness, nephropathy, and neuropathy. None of these trials involved cardiac diseases, but “it is likely that these drugs probably will also benefit the heart,” he said. Another compound, alagebrium (ALT-711), may help collagen become more compliant, Dr. Villarreal said.