Mary Ellen Schneider

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the voluntary guidelines is still up for debate.

The guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. They update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under the new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution. The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges (AAMC), which recently released its own report on industry funding of medical education. Although the guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. It also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But others criticized PhRMA for leaving loopholes that allow for much of their marketing activities to continue.

The first major loophole is that the policy is voluntary, said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

Dr. Daniel Carlat of the psychiatry department at Tufts University, Boston, labeled the changes “primarily cosmetic.” PhRMA appears to be decreasing marketing activities, he said, but they are keeping the tactics that are most successful. In addition, although the code prohibits sales representatives and their immediate supervisors from taking physicians out for dinner, there are no restrictions on dinners with pharmaceutical company consultants, said Dr. Carlat.

Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, said ultimately, the medical profession needs to make these changes. Physicians should think about how they can learn about new treatments without meeting with sales representatives, forego samples, and say no to free lunches provided by pharmaceutical companies, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the voluntary guidelines is still up for debate.

The guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. They update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under the new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution. The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges (AAMC), which recently released its own report on industry funding of medical education. Although the guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. It also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But others criticized PhRMA for leaving loopholes that allow for much of their marketing activities to continue.

The first major loophole is that the policy is voluntary, said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

Dr. Daniel Carlat of the psychiatry department at Tufts University, Boston, labeled the changes “primarily cosmetic.” PhRMA appears to be decreasing marketing activities, he said, but they are keeping the tactics that are most successful. In addition, although the code prohibits sales representatives and their immediate supervisors from taking physicians out for dinner, there are no restrictions on dinners with pharmaceutical company consultants, said Dr. Carlat.

Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, said ultimately, the medical profession needs to make these changes. Physicians should think about how they can learn about new treatments without meeting with sales representatives, forego samples, and say no to free lunches provided by pharmaceutical companies, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the voluntary guidelines is still up for debate.

The guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. They update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under the new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution. The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges (AAMC), which recently released its own report on industry funding of medical education. Although the guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. It also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But others criticized PhRMA for leaving loopholes that allow for much of their marketing activities to continue.

The first major loophole is that the policy is voluntary, said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

Dr. Daniel Carlat of the psychiatry department at Tufts University, Boston, labeled the changes “primarily cosmetic.” PhRMA appears to be decreasing marketing activities, he said, but they are keeping the tactics that are most successful. In addition, although the code prohibits sales representatives and their immediate supervisors from taking physicians out for dinner, there are no restrictions on dinners with pharmaceutical company consultants, said Dr. Carlat.

Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, said ultimately, the medical profession needs to make these changes. Physicians should think about how they can learn about new treatments without meeting with sales representatives, forego samples, and say no to free lunches provided by pharmaceutical companies, he said.

More information on the postponement of the Competitive Acquisition Program is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The Centers for Medicare and Medicaid Services has not announced a timeline for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy and bill” system.

The voluntary program took the purchase of these drugs out the hands of physicians. Physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by CMS later. Instead, they received drugs from an approved vendor selected through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., a specialty pharmaceutical health care organization, is the only approved CAP vendor. The company announced over the summer that it would not sign a new contact because the terms presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif. The delay in the program will give CMS some time to consider possible changes that could encourage more participation, she said.

Dr. Kolba, who has not signed up for the CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

But Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said the postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP to obtain expensive injectable drugs like thyrotropin alfa (Thyrogen), a drug that allows physicians to test for recurrence in thyroid cancer without having patients withdraw from their thyroid hormone treatments.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be returned to BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, M2) when submitting claims.

CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

More information on the postponement of the Competitive Acquisition Program is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The Centers for Medicare and Medicaid Services has not announced a timeline for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy and bill” system.

The voluntary program took the purchase of these drugs out the hands of physicians. Physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by CMS later. Instead, they received drugs from an approved vendor selected through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., a specialty pharmaceutical health care organization, is the only approved CAP vendor. The company announced over the summer that it would not sign a new contact because the terms presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif. The delay in the program will give CMS some time to consider possible changes that could encourage more participation, she said.

Dr. Kolba, who has not signed up for the CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

But Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said the postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP to obtain expensive injectable drugs like thyrotropin alfa (Thyrogen), a drug that allows physicians to test for recurrence in thyroid cancer without having patients withdraw from their thyroid hormone treatments.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be returned to BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, M2) when submitting claims.

CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

More information on the postponement of the Competitive Acquisition Program is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The Centers for Medicare and Medicaid Services has not announced a timeline for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy and bill” system.

The voluntary program took the purchase of these drugs out the hands of physicians. Physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by CMS later. Instead, they received drugs from an approved vendor selected through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., a specialty pharmaceutical health care organization, is the only approved CAP vendor. The company announced over the summer that it would not sign a new contact because the terms presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif. The delay in the program will give CMS some time to consider possible changes that could encourage more participation, she said.

Dr. Kolba, who has not signed up for the CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

But Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said the postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP to obtain expensive injectable drugs like thyrotropin alfa (Thyrogen), a drug that allows physicians to test for recurrence in thyroid cancer without having patients withdraw from their thyroid hormone treatments.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be returned to BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, M2) when submitting claims.

CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

The average employer-sponsored health insurance premium rose 5% from 2007 to 2008, with average premiums for family coverage reaching $12,680, according to a report from the Kaiser Family Foundation and the Health Research and Educational Trust.

While experts said the 1-year average increase in premiums was modest, they noted that over the last 9 years the rise in premiums has outpaced growth in both wages and inflation. Since 1999, family premiums have risen from $5,791 to $12,680, while individual premiums have gone from $2,196 to $4,704, according to the report.

The findings are based on an annual survey of 2,832 randomly selected public and private companies with three or more employees. Of those companies, 1,927 responded to the full survey. The survey was conducted between January and May of this year. The full study is available online at www.kff.orgdoi:10.1377/hlthaff.27.6.w492

The survey showed that more workers are enrolled in plans with higher deductibles. In 2008, 18% of all covered workers had health plan deductibles of at least $1,000 for single coverage, compared with 12% in 2007 and 10% in 2006. And high deductibles were more common among employees at small companies. In 2008, 35% of workers in companies with fewer than 200 employees have deductibles of $1,000 a year for single coverage, compared with 21% last year and 16% in 2006.

American workers can expect to see more cost sharing in 2009. The survey found that among employers who currently offer health benefits, 40% reported that they would be somewhat or very likely to increase the amount that employees pay for health coverage next year.

The average employer-sponsored health insurance premium rose 5% from 2007 to 2008, with average premiums for family coverage reaching $12,680, according to a report from the Kaiser Family Foundation and the Health Research and Educational Trust.

While experts said the 1-year average increase in premiums was modest, they noted that over the last 9 years the rise in premiums has outpaced growth in both wages and inflation. Since 1999, family premiums have risen from $5,791 to $12,680, while individual premiums have gone from $2,196 to $4,704, according to the report.

The findings are based on an annual survey of 2,832 randomly selected public and private companies with three or more employees. Of those companies, 1,927 responded to the full survey. The survey was conducted between January and May of this year. The full study is available online at www.kff.orgdoi:10.1377/hlthaff.27.6.w492

The survey showed that more workers are enrolled in plans with higher deductibles. In 2008, 18% of all covered workers had health plan deductibles of at least $1,000 for single coverage, compared with 12% in 2007 and 10% in 2006. And high deductibles were more common among employees at small companies. In 2008, 35% of workers in companies with fewer than 200 employees have deductibles of $1,000 a year for single coverage, compared with 21% last year and 16% in 2006.

American workers can expect to see more cost sharing in 2009. The survey found that among employers who currently offer health benefits, 40% reported that they would be somewhat or very likely to increase the amount that employees pay for health coverage next year.

The average employer-sponsored health insurance premium rose 5% from 2007 to 2008, with average premiums for family coverage reaching $12,680, according to a report from the Kaiser Family Foundation and the Health Research and Educational Trust.

While experts said the 1-year average increase in premiums was modest, they noted that over the last 9 years the rise in premiums has outpaced growth in both wages and inflation. Since 1999, family premiums have risen from $5,791 to $12,680, while individual premiums have gone from $2,196 to $4,704, according to the report.

The findings are based on an annual survey of 2,832 randomly selected public and private companies with three or more employees. Of those companies, 1,927 responded to the full survey. The survey was conducted between January and May of this year. The full study is available online at www.kff.orgdoi:10.1377/hlthaff.27.6.w492

The survey showed that more workers are enrolled in plans with higher deductibles. In 2008, 18% of all covered workers had health plan deductibles of at least $1,000 for single coverage, compared with 12% in 2007 and 10% in 2006. And high deductibles were more common among employees at small companies. In 2008, 35% of workers in companies with fewer than 200 employees have deductibles of $1,000 a year for single coverage, compared with 21% last year and 16% in 2006.

American workers can expect to see more cost sharing in 2009. The survey found that among employers who currently offer health benefits, 40% reported that they would be somewhat or very likely to increase the amount that employees pay for health coverage next year.

Support for the concept of the patient-centered medical home continues to grow, with the latest nod coming from the federal Advisory Committee on Training in Primary Care Medicine and Dentistry.

The committee, which provides policy advice to Congress and the Health and Human Services secretary, is finalizing a report that recommends that policy makers invest in training physicians on how to operate within the medical home model and evaluate the health outcomes associated with this model of care.

A failure to invest in the medical home model now will impair efforts to improve quality and control costs, the committee wrote. The United States “faces a watershed moment when it can restructure health care to focus on prevention and coordinated, comprehensive care through the adoption of this promising new model of care,” the committee wrote in the draft report.

The report, which is expected to be released in its final form in late 2008, calls for changes to Title VII, Section 747 of the Public Health Service Act. For example, the committee is recommending that the HHS secretary expand the authority of that law to include directing continuing medical education programs to train currently practicing physicians in aspects of the medical home, including interdisciplinary team-based care, care of disadvantaged and vulnerable populations, and the use of information technology.

It also calls on the HHS secretary to promote dissemination of the best practices related to providing a medical home that have been identified by researchers.

Other draft recommendations from the committee include the following:

▸ Funding pilot programs that contribute to the development and evaluation of the medical home, with priority given to those programs that address the needs of underserved populations.

▸ Developing measures to evaluate the medical home in terms of accessibility and patient satisfaction, health status, quality of care, health disparities, and cost.

▸ Implementing key components of the medical home model in academic medical centers, in an effort to prepare faculty educators.

The committee's next report, due out in May 2009, will explore how primary care training would need to be redesigned to further the concept of the medical home. It will also address the difficulties in hand-offs between pediatric and adult medicine specialists when patients with chronic illnesses reach adulthood, as well as on workforce issues and medical school debt.

Support for the concept of the patient-centered medical home continues to grow, with the latest nod coming from the federal Advisory Committee on Training in Primary Care Medicine and Dentistry.

The committee, which provides policy advice to Congress and the Health and Human Services secretary, is finalizing a report that recommends that policy makers invest in training physicians on how to operate within the medical home model and evaluate the health outcomes associated with this model of care.

A failure to invest in the medical home model now will impair efforts to improve quality and control costs, the committee wrote. The United States “faces a watershed moment when it can restructure health care to focus on prevention and coordinated, comprehensive care through the adoption of this promising new model of care,” the committee wrote in the draft report.

The report, which is expected to be released in its final form in late 2008, calls for changes to Title VII, Section 747 of the Public Health Service Act. For example, the committee is recommending that the HHS secretary expand the authority of that law to include directing continuing medical education programs to train currently practicing physicians in aspects of the medical home, including interdisciplinary team-based care, care of disadvantaged and vulnerable populations, and the use of information technology.

It also calls on the HHS secretary to promote dissemination of the best practices related to providing a medical home that have been identified by researchers.

Other draft recommendations from the committee include the following:

▸ Funding pilot programs that contribute to the development and evaluation of the medical home, with priority given to those programs that address the needs of underserved populations.

▸ Developing measures to evaluate the medical home in terms of accessibility and patient satisfaction, health status, quality of care, health disparities, and cost.

▸ Implementing key components of the medical home model in academic medical centers, in an effort to prepare faculty educators.

The committee's next report, due out in May 2009, will explore how primary care training would need to be redesigned to further the concept of the medical home. It will also address the difficulties in hand-offs between pediatric and adult medicine specialists when patients with chronic illnesses reach adulthood, as well as on workforce issues and medical school debt.

Support for the concept of the patient-centered medical home continues to grow, with the latest nod coming from the federal Advisory Committee on Training in Primary Care Medicine and Dentistry.

The committee, which provides policy advice to Congress and the Health and Human Services secretary, is finalizing a report that recommends that policy makers invest in training physicians on how to operate within the medical home model and evaluate the health outcomes associated with this model of care.

A failure to invest in the medical home model now will impair efforts to improve quality and control costs, the committee wrote. The United States “faces a watershed moment when it can restructure health care to focus on prevention and coordinated, comprehensive care through the adoption of this promising new model of care,” the committee wrote in the draft report.

The report, which is expected to be released in its final form in late 2008, calls for changes to Title VII, Section 747 of the Public Health Service Act. For example, the committee is recommending that the HHS secretary expand the authority of that law to include directing continuing medical education programs to train currently practicing physicians in aspects of the medical home, including interdisciplinary team-based care, care of disadvantaged and vulnerable populations, and the use of information technology.

It also calls on the HHS secretary to promote dissemination of the best practices related to providing a medical home that have been identified by researchers.

Other draft recommendations from the committee include the following:

▸ Funding pilot programs that contribute to the development and evaluation of the medical home, with priority given to those programs that address the needs of underserved populations.

▸ Developing measures to evaluate the medical home in terms of accessibility and patient satisfaction, health status, quality of care, health disparities, and cost.

▸ Implementing key components of the medical home model in academic medical centers, in an effort to prepare faculty educators.

The committee's next report, due out in May 2009, will explore how primary care training would need to be redesigned to further the concept of the medical home. It will also address the difficulties in hand-offs between pediatric and adult medicine specialists when patients with chronic illnesses reach adulthood, as well as on workforce issues and medical school debt.

Privacy should be the top priority when developing certification criteria for personal health records, a task force created by the Certification Commission for Healthcare Information Technology has recommended.

Adequate security and interoperability also must be included in certification efforts, according to the task force.

The Certification Commission for Healthcare Information Technology (CCHIT) will use these recommendations as it prepares to begin certifying personal health records (PHRs) in 2009.

The task force recommended that the voluntary certification process should apply to any products or services that collect, receive, store, or use health information provided by consumers. Certification should also apply to products or services that transmit or disclose to a third party any personal health information. This would allow the CCHIT to offer certification to a range of products and applications, from those that offer a PHR application and connectivity as an accessory to an electronic health record (EHR), to stand-alone PHRs.

CCHIT hopes that, just as it did in the EHR field, certification will create a floor of functionality, security, and interoperability, said Dr. Paul Tang, cochair of the PHR Advisory Task Force and vice president and chief medical information officer for the Palo Alto (Calif.) Medical Foundation.

The task force called for requirements to maintain privacy in monitoring and enforcement, and for consumer protection that would allow patients to remove their data if certification is revoked. The group also recommended that standards-based criteria be developed that would require PHRs to send and receive data from as many potential data sources as possible.

If done right, certification would have significant benefits for both physicians and patients, Dr. Tang said. A PHR could provide physicians with better access to secure, authenticated data that could help them make decisions, while patients would have more control over their own care, he said.

In July, the task force made its recommendations and handed over responsibility for PHR certification to a CCHIT work group. That work group will develop the actual certification criteria that will be used to test PHR products starting next July, according to Dr. Jody Pettit, strategic leader for CCHIT's PHR work group.

Privacy should be the top priority when developing certification criteria for personal health records, a task force created by the Certification Commission for Healthcare Information Technology has recommended.

Adequate security and interoperability also must be included in certification efforts, according to the task force.

The Certification Commission for Healthcare Information Technology (CCHIT) will use these recommendations as it prepares to begin certifying personal health records (PHRs) in 2009.

The task force recommended that the voluntary certification process should apply to any products or services that collect, receive, store, or use health information provided by consumers. Certification should also apply to products or services that transmit or disclose to a third party any personal health information. This would allow the CCHIT to offer certification to a range of products and applications, from those that offer a PHR application and connectivity as an accessory to an electronic health record (EHR), to stand-alone PHRs.

CCHIT hopes that, just as it did in the EHR field, certification will create a floor of functionality, security, and interoperability, said Dr. Paul Tang, cochair of the PHR Advisory Task Force and vice president and chief medical information officer for the Palo Alto (Calif.) Medical Foundation.

The task force called for requirements to maintain privacy in monitoring and enforcement, and for consumer protection that would allow patients to remove their data if certification is revoked. The group also recommended that standards-based criteria be developed that would require PHRs to send and receive data from as many potential data sources as possible.

If done right, certification would have significant benefits for both physicians and patients, Dr. Tang said. A PHR could provide physicians with better access to secure, authenticated data that could help them make decisions, while patients would have more control over their own care, he said.

In July, the task force made its recommendations and handed over responsibility for PHR certification to a CCHIT work group. That work group will develop the actual certification criteria that will be used to test PHR products starting next July, according to Dr. Jody Pettit, strategic leader for CCHIT's PHR work group.

Privacy should be the top priority when developing certification criteria for personal health records, a task force created by the Certification Commission for Healthcare Information Technology has recommended.

Adequate security and interoperability also must be included in certification efforts, according to the task force.

The Certification Commission for Healthcare Information Technology (CCHIT) will use these recommendations as it prepares to begin certifying personal health records (PHRs) in 2009.

The task force recommended that the voluntary certification process should apply to any products or services that collect, receive, store, or use health information provided by consumers. Certification should also apply to products or services that transmit or disclose to a third party any personal health information. This would allow the CCHIT to offer certification to a range of products and applications, from those that offer a PHR application and connectivity as an accessory to an electronic health record (EHR), to stand-alone PHRs.

CCHIT hopes that, just as it did in the EHR field, certification will create a floor of functionality, security, and interoperability, said Dr. Paul Tang, cochair of the PHR Advisory Task Force and vice president and chief medical information officer for the Palo Alto (Calif.) Medical Foundation.

The task force called for requirements to maintain privacy in monitoring and enforcement, and for consumer protection that would allow patients to remove their data if certification is revoked. The group also recommended that standards-based criteria be developed that would require PHRs to send and receive data from as many potential data sources as possible.

If done right, certification would have significant benefits for both physicians and patients, Dr. Tang said. A PHR could provide physicians with better access to secure, authenticated data that could help them make decisions, while patients would have more control over their own care, he said.

In July, the task force made its recommendations and handed over responsibility for PHR certification to a CCHIT work group. That work group will develop the actual certification criteria that will be used to test PHR products starting next July, according to Dr. Jody Pettit, strategic leader for CCHIT's PHR work group.

More information on the postponement of the CAP is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including infused biologics.

The program was put on hold because of "contractual issues" with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or "buy and bill" system.

The voluntary program took the purchase of these drugs out the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with the CMS for CAP because the terms of the contract presented an "unacceptable short- and long-term profit risk."

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is "totally untenable," said Dr. Karen Kolba of Santa Maria, Calif. The delay in the program will give the CMS some time to consider possible changes that could encourage more participation from physicians, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the "all-or-nothing" requirement for ordering drugs.

Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. "It becomes something of an accounting nightmare," she said.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. Those drugs cannot be given away to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, m

The CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, the CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

More information on the postponement of the CAP is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including infused biologics.

The program was put on hold because of "contractual issues" with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or "buy and bill" system.

The voluntary program took the purchase of these drugs out the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with the CMS for CAP because the terms of the contract presented an "unacceptable short- and long-term profit risk."

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is "totally untenable," said Dr. Karen Kolba of Santa Maria, Calif. The delay in the program will give the CMS some time to consider possible changes that could encourage more participation from physicians, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the "all-or-nothing" requirement for ordering drugs.

Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. "It becomes something of an accounting nightmare," she said.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. Those drugs cannot be given away to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, m

The CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, the CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

More information on the postponement of the CAP is available at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including infused biologics.

The program was put on hold because of "contractual issues" with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or "buy and bill" system.

The voluntary program took the purchase of these drugs out the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with the CMS for CAP because the terms of the contract presented an "unacceptable short- and long-term profit risk."

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is "totally untenable," said Dr. Karen Kolba of Santa Maria, Calif. The delay in the program will give the CMS some time to consider possible changes that could encourage more participation from physicians, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the "all-or-nothing" requirement for ordering drugs.

Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is simply impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. "It becomes something of an accounting nightmare," she said.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP in the office after Dec. 31, 2008, those drugs are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. Those drugs cannot be given away to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they should keep in mind that they will once again be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and that they should not use the CAP modifiers (J1, J2, J3, m

The CMS is also advising physicians to contact BioScrip as soon as possible to minimize the amount of unused drugs and facilitate uninterrupted access to Part B drugs.

While the program is on hold, the CMS will be asking physicians to provide feedback on the program. Specifically, agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more flexible and more attractive for vendors and physicians.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date. In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS.

The ICD-9-CM also fails to provide adequate clinical details, according to the CMS.

"Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted," CMS officials wrote in the proposed regulation.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And the CMS contends that because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to the CMS.

But physician groups say the CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot- tested before physicians and others are asked to implement it, AMA said.

"This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition," Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While the MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, the MGMA is asking the CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to the MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to the CMS in January 2007, the ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date. In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS.

The ICD-9-CM also fails to provide adequate clinical details, according to the CMS.

"Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted," CMS officials wrote in the proposed regulation.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And the CMS contends that because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to the CMS.

But physician groups say the CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot- tested before physicians and others are asked to implement it, AMA said.

"This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition," Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While the MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, the MGMA is asking the CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to the MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to the CMS in January 2007, the ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date. In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS.

The ICD-9-CM also fails to provide adequate clinical details, according to the CMS.

"Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted," CMS officials wrote in the proposed regulation.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And the CMS contends that because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to the CMS.

But physician groups say the CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot- tested before physicians and others are asked to implement it, AMA said.

"This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition," Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While the MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, the MGMA is asking the CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to the MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to the CMS in January 2007, the ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians.

The number of Americans without health insurance coverage dropped to 45.7 million in 2007, down from 47 million in 2006, mainly because of increased enrollment in government-funded health insurance programs, according to new data from the U.S. Census Bureau.

The percentage of uninsured Americans fell from 15.8% in 2006 to 15.3% in 2007.

The Census data also showed that fewer U.S. children went without health insurance in 2007. The number of uninsured children fell from 8.7 million in 2006 (11.7%) to 8.1 million in 2007 (11%).

The new figures, which were released by the Census Bureau on Aug. 26, come from the Annual Social and Economic Supplement to the Current Population Survey.

While Census officials are still researching why the number of uninsured Americans has decreased, the data point toward increased enrollment in government-funded health insurance programs. For example, the number of Americans covered by private health insurance stayed about the same at 202 million, but the number of individuals covered by government health insurance programs rose to 83 million from 80.3 million in 2006.

There were statistically significant increases in the percentage of people covered by both Medicare and Medicaid. The number of people with Medicare coverage increased from 40.3 million (13.6%) in 2006 to 41.4 million (13.8%) in 2007, and the number enrolled in Medicaid increased from 38.3 million (12.9%) in 2006 to 39.6 million (13.2%) in 2007.

“The expansion in public coverage is really what's driving this reduction,” said Len Nichols, Ph.D., an economist and director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

As the economy has weakened, more people who previously could not afford private coverage became eligible for public programs, he said. The good news is that the public programs safety net has caught these individuals, Dr. Nichols said, but the downside is that more and more people will drift into government-sponsored coverage if the government remains stalled on health care reform.

A careful analysis of the Census figures shows that the private health insurance system in the United States is “hanging on by its fingernails,” Dr. Nichols said, and is in need of reform.

There are worrisome trends in the Census data that could soon cause the number of uninsured Americans to go back up, said Mark A. Goldberg, senior vice president for policy and strategy at the National Coalition on Health Care. The organization is a nonpartisan coalition focused on achieving coverage for all Americans.

Even though the number of uninsured Americans declined in 2007, the percentage of individuals who were able to obtain either employer-based or individual coverage also dropped. If the current economic downturn continues, safety net programs like Medicaid will be vulnerable to state-level budget cuts, Mr. Goldberg said, and could be unable to keep up with demand.

The latest uninsured figures highlight the need to shore up the employer-based health insurance system, said Karen Davis, Ph.D., president of the Commonwealth Fund. Policy makers need to find ways to make coverage more affordable for employers who want to offer it to their workers and for individuals purchasing their own, she said. Leaders should consider the range of options for expanding coverage under a mixed public-private system, whether it is requiring employers to offer coverage or contribute to it, or requiring individuals to obtain coverage and offering assistance to pay for it, she said.

“The problem is real and the public wants their leaders to do something about it,” Dr. Davis said.

The private health insurance system is 'hanging on by its fingernails' and is in need of reform. DR. NICHOLS

The number of Americans without health insurance coverage dropped to 45.7 million in 2007, down from 47 million in 2006, mainly because of increased enrollment in government-funded health insurance programs, according to new data from the U.S. Census Bureau.

The percentage of uninsured Americans fell from 15.8% in 2006 to 15.3% in 2007.

The Census data also showed that fewer U.S. children went without health insurance in 2007. The number of uninsured children fell from 8.7 million in 2006 (11.7%) to 8.1 million in 2007 (11%).

The new figures, which were released by the Census Bureau on Aug. 26, come from the Annual Social and Economic Supplement to the Current Population Survey.

While Census officials are still researching why the number of uninsured Americans has decreased, the data point toward increased enrollment in government-funded health insurance programs. For example, the number of Americans covered by private health insurance stayed about the same at 202 million, but the number of individuals covered by government health insurance programs rose to 83 million from 80.3 million in 2006.

There were statistically significant increases in the percentage of people covered by both Medicare and Medicaid. The number of people with Medicare coverage increased from 40.3 million (13.6%) in 2006 to 41.4 million (13.8%) in 2007, and the number enrolled in Medicaid increased from 38.3 million (12.9%) in 2006 to 39.6 million (13.2%) in 2007.

“The expansion in public coverage is really what's driving this reduction,” said Len Nichols, Ph.D., an economist and director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

As the economy has weakened, more people who previously could not afford private coverage became eligible for public programs, he said. The good news is that the public programs safety net has caught these individuals, Dr. Nichols said, but the downside is that more and more people will drift into government-sponsored coverage if the government remains stalled on health care reform.

A careful analysis of the Census figures shows that the private health insurance system in the United States is “hanging on by its fingernails,” Dr. Nichols said, and is in need of reform.

There are worrisome trends in the Census data that could soon cause the number of uninsured Americans to go back up, said Mark A. Goldberg, senior vice president for policy and strategy at the National Coalition on Health Care. The organization is a nonpartisan coalition focused on achieving coverage for all Americans.

Even though the number of uninsured Americans declined in 2007, the percentage of individuals who were able to obtain either employer-based or individual coverage also dropped. If the current economic downturn continues, safety net programs like Medicaid will be vulnerable to state-level budget cuts, Mr. Goldberg said, and could be unable to keep up with demand.

The latest uninsured figures highlight the need to shore up the employer-based health insurance system, said Karen Davis, Ph.D., president of the Commonwealth Fund. Policy makers need to find ways to make coverage more affordable for employers who want to offer it to their workers and for individuals purchasing their own, she said. Leaders should consider the range of options for expanding coverage under a mixed public-private system, whether it is requiring employers to offer coverage or contribute to it, or requiring individuals to obtain coverage and offering assistance to pay for it, she said.

“The problem is real and the public wants their leaders to do something about it,” Dr. Davis said.

The private health insurance system is 'hanging on by its fingernails' and is in need of reform. DR. NICHOLS

The number of Americans without health insurance coverage dropped to 45.7 million in 2007, down from 47 million in 2006, mainly because of increased enrollment in government-funded health insurance programs, according to new data from the U.S. Census Bureau.

The percentage of uninsured Americans fell from 15.8% in 2006 to 15.3% in 2007.

The Census data also showed that fewer U.S. children went without health insurance in 2007. The number of uninsured children fell from 8.7 million in 2006 (11.7%) to 8.1 million in 2007 (11%).

The new figures, which were released by the Census Bureau on Aug. 26, come from the Annual Social and Economic Supplement to the Current Population Survey.

While Census officials are still researching why the number of uninsured Americans has decreased, the data point toward increased enrollment in government-funded health insurance programs. For example, the number of Americans covered by private health insurance stayed about the same at 202 million, but the number of individuals covered by government health insurance programs rose to 83 million from 80.3 million in 2006.

There were statistically significant increases in the percentage of people covered by both Medicare and Medicaid. The number of people with Medicare coverage increased from 40.3 million (13.6%) in 2006 to 41.4 million (13.8%) in 2007, and the number enrolled in Medicaid increased from 38.3 million (12.9%) in 2006 to 39.6 million (13.2%) in 2007.

“The expansion in public coverage is really what's driving this reduction,” said Len Nichols, Ph.D., an economist and director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

As the economy has weakened, more people who previously could not afford private coverage became eligible for public programs, he said. The good news is that the public programs safety net has caught these individuals, Dr. Nichols said, but the downside is that more and more people will drift into government-sponsored coverage if the government remains stalled on health care reform.

A careful analysis of the Census figures shows that the private health insurance system in the United States is “hanging on by its fingernails,” Dr. Nichols said, and is in need of reform.

There are worrisome trends in the Census data that could soon cause the number of uninsured Americans to go back up, said Mark A. Goldberg, senior vice president for policy and strategy at the National Coalition on Health Care. The organization is a nonpartisan coalition focused on achieving coverage for all Americans.

Even though the number of uninsured Americans declined in 2007, the percentage of individuals who were able to obtain either employer-based or individual coverage also dropped. If the current economic downturn continues, safety net programs like Medicaid will be vulnerable to state-level budget cuts, Mr. Goldberg said, and could be unable to keep up with demand.

The latest uninsured figures highlight the need to shore up the employer-based health insurance system, said Karen Davis, Ph.D., president of the Commonwealth Fund. Policy makers need to find ways to make coverage more affordable for employers who want to offer it to their workers and for individuals purchasing their own, she said. Leaders should consider the range of options for expanding coverage under a mixed public-private system, whether it is requiring employers to offer coverage or contribute to it, or requiring individuals to obtain coverage and offering assistance to pay for it, she said.

“The problem is real and the public wants their leaders to do something about it,” Dr. Davis said.

The private health insurance system is 'hanging on by its fingernails' and is in need of reform. DR. NICHOLS

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies on electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for the full cost of the required hardware. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians had differing reasons. For example, some opposed the idea of offering EMR subsidies to physicians. Others said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who were considering a direct subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance. “Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbors physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system. Plus, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients.

Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies on electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for the full cost of the required hardware. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians had differing reasons. For example, some opposed the idea of offering EMR subsidies to physicians. Others said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who were considering a direct subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance. “Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbors physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system. Plus, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients.

Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies on electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for the full cost of the required hardware. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians had differing reasons. For example, some opposed the idea of offering EMR subsidies to physicians. Others said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who were considering a direct subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance. “Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbors physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system. Plus, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients.

Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

Immigrants Must Get HPV Vaccine

Young women seeking to immigrate to the United States currently are required to be vaccinated against the human papillomavirus, under an amendment to the Immigration and Nationality Act. Under the 1996 amendment, individuals seeking immigrant visas must provide proof of vaccination for all vaccines recommended by the U.S. Advisory Committee for Immunization Practices. This list, which is updated periodically, now includes HPV vaccination for females aged 11-12 years, with catch-up vaccination among those aged 13-26 years. The addition of the HPV vaccine to the list of required vaccines for immigrants was automatic and required by statute, according to Centers for Disease Control and Prevention spokesman Curtis Allen, and was not part of ACIP deliberations when the committee originally recommended use of the HPV vaccine. According to a spokeswoman for Merck, the HPV vaccine Gardasil costs approximately $290-$375 for the three-dose series. The company was not aware of the immigration policy and did not lobby for that provision, she added.

FDA Backs Calcium/Vitamin D Claim

Food and beverage manufacturers soon will be able to assert a link between the consumption of products containing the combination of calcium and vitamin D and a reduced risk for osteoporosis, under a new Food and Drug Administration rule. The final rule, which was issued last month, goes into effect on Jan. 1, 2010. The health claim does not need to include information on the sex, race, and age of those at risk for osteoporosis or identify the mechanism by which calcium reduces the risk of osteoporosis. Previously, manufacturers could make health claims linking only calcium intake with a reduced risk of osteoporosis. The labeling change is based in part on a health claim petition from the Beverage Institute for Health and Wellness LLC, part of the Coca-Cola Co.

NIH Targets Menopause Symptoms

Officials at the National Institutes of Health have formed a multisite research network to perform randomized clinical trials of treatments for common menopause symptoms. The MsFLASH network (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) includes a data-coordinating center and five clinical research centers, which will be funded at about $4.4 million a year for 5 years. “Studies such as the Women's Health Initiative, which raised concerns about the safety of using menopausal hormone therapy, underscore the urgent need for treatments that have been proven safe and effective for alleviating menopausal symptoms,” Dr. Richard J. Hodes, director of the NIH's National Institute on Aging, said in a statement. “MsFLASH will speed the evaluation of treatments deemed promising by an independent panel at the recent NIH State-of-the-Science Conference on the Management of Menopause-Related Symptoms.” Some of the treatments and interventions being considered for study include antidepressants, paced respiration, yoga, low-dose estradiol patches and gels, and exercise. The effort is being led by officials at the National Institute on Aging, along with the National Institute of Child Health and Human Development, the National Center for Complementary and Alternative Medicine, and the Office of Research on Women's Health.

Calif. Insurers to Cover HIV Tests

Next year, health plans operating in California will be required to pay for routine HIV testing regardless of whether the test is related to the primary diagnosis, under a new law signed by Gov. Arnold Schwarzenegger (R) late last month. Recent data from the federal Centers for Disease Control and Prevention show that “the HIV epidemic is worse than previously known. The alarming new number of infections [underscores] the need to take all possible steps to prevent the spread of this disease,” Gov. Schwarzenegger said in a signing statement. “By preventing the spread of infection, the population [not only is] healthier, but avoids the costly medical interventions required for people living with HIV and AIDS.”

HPV Toolkit Coming in January

To bring clinicians up to speed on the human papillomavirus (HPV) and the vaccine, a new “toolkit” for health care professionals, community educators, and practice managers will be available early next year. The Association of Reproductive Health Professionals, the American Society for Colposcopy and Cervical Pathology, and the Planned Parenthood Federation of America designed and developed the toolkit. Qiagen Inc., Merck & Co., GlaxoSmithKline, Graceway Pharmaceuticals LLC, Roche, and Hologic Inc. provided the funding, according to Sandy Worthington, director of continuing medical education at PPFA, who spoke at the annual ARHP meeting in Washington. The toolkit will contain laminated algorithms, FAQs on laminated cards in lay language to be shared with patients, a manual for community educators, and a manual for medical office managers that contains instructions on billing codes, securing reimbursement, and storage and shipping.

NIH Director Zerhouni Steps Down

Dr. Elias Zerhouni, director of the National Institutes of Health since May 2002, announced that he will step down at the end of October to pursue writing projects and explore other professional opportunities. During his tenure, he worked to lower barriers between disciplines of science and to encourage trans-NIH collaborations, such as the NIH Roadmap for Medical Research, which brought together all 27 NIH institutes and centers to fund research initiatives.

Immigrants Must Get HPV Vaccine

Young women seeking to immigrate to the United States currently are required to be vaccinated against the human papillomavirus, under an amendment to the Immigration and Nationality Act. Under the 1996 amendment, individuals seeking immigrant visas must provide proof of vaccination for all vaccines recommended by the U.S. Advisory Committee for Immunization Practices. This list, which is updated periodically, now includes HPV vaccination for females aged 11-12 years, with catch-up vaccination among those aged 13-26 years. The addition of the HPV vaccine to the list of required vaccines for immigrants was automatic and required by statute, according to Centers for Disease Control and Prevention spokesman Curtis Allen, and was not part of ACIP deliberations when the committee originally recommended use of the HPV vaccine. According to a spokeswoman for Merck, the HPV vaccine Gardasil costs approximately $290-$375 for the three-dose series. The company was not aware of the immigration policy and did not lobby for that provision, she added.

FDA Backs Calcium/Vitamin D Claim

Food and beverage manufacturers soon will be able to assert a link between the consumption of products containing the combination of calcium and vitamin D and a reduced risk for osteoporosis, under a new Food and Drug Administration rule. The final rule, which was issued last month, goes into effect on Jan. 1, 2010. The health claim does not need to include information on the sex, race, and age of those at risk for osteoporosis or identify the mechanism by which calcium reduces the risk of osteoporosis. Previously, manufacturers could make health claims linking only calcium intake with a reduced risk of osteoporosis. The labeling change is based in part on a health claim petition from the Beverage Institute for Health and Wellness LLC, part of the Coca-Cola Co.

NIH Targets Menopause Symptoms

Officials at the National Institutes of Health have formed a multisite research network to perform randomized clinical trials of treatments for common menopause symptoms. The MsFLASH network (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) includes a data-coordinating center and five clinical research centers, which will be funded at about $4.4 million a year for 5 years. “Studies such as the Women's Health Initiative, which raised concerns about the safety of using menopausal hormone therapy, underscore the urgent need for treatments that have been proven safe and effective for alleviating menopausal symptoms,” Dr. Richard J. Hodes, director of the NIH's National Institute on Aging, said in a statement. “MsFLASH will speed the evaluation of treatments deemed promising by an independent panel at the recent NIH State-of-the-Science Conference on the Management of Menopause-Related Symptoms.” Some of the treatments and interventions being considered for study include antidepressants, paced respiration, yoga, low-dose estradiol patches and gels, and exercise. The effort is being led by officials at the National Institute on Aging, along with the National Institute of Child Health and Human Development, the National Center for Complementary and Alternative Medicine, and the Office of Research on Women's Health.

Calif. Insurers to Cover HIV Tests

Next year, health plans operating in California will be required to pay for routine HIV testing regardless of whether the test is related to the primary diagnosis, under a new law signed by Gov. Arnold Schwarzenegger (R) late last month. Recent data from the federal Centers for Disease Control and Prevention show that “the HIV epidemic is worse than previously known. The alarming new number of infections [underscores] the need to take all possible steps to prevent the spread of this disease,” Gov. Schwarzenegger said in a signing statement. “By preventing the spread of infection, the population [not only is] healthier, but avoids the costly medical interventions required for people living with HIV and AIDS.”

HPV Toolkit Coming in January

To bring clinicians up to speed on the human papillomavirus (HPV) and the vaccine, a new “toolkit” for health care professionals, community educators, and practice managers will be available early next year. The Association of Reproductive Health Professionals, the American Society for Colposcopy and Cervical Pathology, and the Planned Parenthood Federation of America designed and developed the toolkit. Qiagen Inc., Merck & Co., GlaxoSmithKline, Graceway Pharmaceuticals LLC, Roche, and Hologic Inc. provided the funding, according to Sandy Worthington, director of continuing medical education at PPFA, who spoke at the annual ARHP meeting in Washington. The toolkit will contain laminated algorithms, FAQs on laminated cards in lay language to be shared with patients, a manual for community educators, and a manual for medical office managers that contains instructions on billing codes, securing reimbursement, and storage and shipping.

NIH Director Zerhouni Steps Down

Dr. Elias Zerhouni, director of the National Institutes of Health since May 2002, announced that he will step down at the end of October to pursue writing projects and explore other professional opportunities. During his tenure, he worked to lower barriers between disciplines of science and to encourage trans-NIH collaborations, such as the NIH Roadmap for Medical Research, which brought together all 27 NIH institutes and centers to fund research initiatives.

Immigrants Must Get HPV Vaccine

Young women seeking to immigrate to the United States currently are required to be vaccinated against the human papillomavirus, under an amendment to the Immigration and Nationality Act. Under the 1996 amendment, individuals seeking immigrant visas must provide proof of vaccination for all vaccines recommended by the U.S. Advisory Committee for Immunization Practices. This list, which is updated periodically, now includes HPV vaccination for females aged 11-12 years, with catch-up vaccination among those aged 13-26 years. The addition of the HPV vaccine to the list of required vaccines for immigrants was automatic and required by statute, according to Centers for Disease Control and Prevention spokesman Curtis Allen, and was not part of ACIP deliberations when the committee originally recommended use of the HPV vaccine. According to a spokeswoman for Merck, the HPV vaccine Gardasil costs approximately $290-$375 for the three-dose series. The company was not aware of the immigration policy and did not lobby for that provision, she added.

FDA Backs Calcium/Vitamin D Claim

Food and beverage manufacturers soon will be able to assert a link between the consumption of products containing the combination of calcium and vitamin D and a reduced risk for osteoporosis, under a new Food and Drug Administration rule. The final rule, which was issued last month, goes into effect on Jan. 1, 2010. The health claim does not need to include information on the sex, race, and age of those at risk for osteoporosis or identify the mechanism by which calcium reduces the risk of osteoporosis. Previously, manufacturers could make health claims linking only calcium intake with a reduced risk of osteoporosis. The labeling change is based in part on a health claim petition from the Beverage Institute for Health and Wellness LLC, part of the Coca-Cola Co.

NIH Targets Menopause Symptoms

Officials at the National Institutes of Health have formed a multisite research network to perform randomized clinical trials of treatments for common menopause symptoms. The MsFLASH network (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) includes a data-coordinating center and five clinical research centers, which will be funded at about $4.4 million a year for 5 years. “Studies such as the Women's Health Initiative, which raised concerns about the safety of using menopausal hormone therapy, underscore the urgent need for treatments that have been proven safe and effective for alleviating menopausal symptoms,” Dr. Richard J. Hodes, director of the NIH's National Institute on Aging, said in a statement. “MsFLASH will speed the evaluation of treatments deemed promising by an independent panel at the recent NIH State-of-the-Science Conference on the Management of Menopause-Related Symptoms.” Some of the treatments and interventions being considered for study include antidepressants, paced respiration, yoga, low-dose estradiol patches and gels, and exercise. The effort is being led by officials at the National Institute on Aging, along with the National Institute of Child Health and Human Development, the National Center for Complementary and Alternative Medicine, and the Office of Research on Women's Health.

Calif. Insurers to Cover HIV Tests

Next year, health plans operating in California will be required to pay for routine HIV testing regardless of whether the test is related to the primary diagnosis, under a new law signed by Gov. Arnold Schwarzenegger (R) late last month. Recent data from the federal Centers for Disease Control and Prevention show that “the HIV epidemic is worse than previously known. The alarming new number of infections [underscores] the need to take all possible steps to prevent the spread of this disease,” Gov. Schwarzenegger said in a signing statement. “By preventing the spread of infection, the population [not only is] healthier, but avoids the costly medical interventions required for people living with HIV and AIDS.”

HPV Toolkit Coming in January

To bring clinicians up to speed on the human papillomavirus (HPV) and the vaccine, a new “toolkit” for health care professionals, community educators, and practice managers will be available early next year. The Association of Reproductive Health Professionals, the American Society for Colposcopy and Cervical Pathology, and the Planned Parenthood Federation of America designed and developed the toolkit. Qiagen Inc., Merck & Co., GlaxoSmithKline, Graceway Pharmaceuticals LLC, Roche, and Hologic Inc. provided the funding, according to Sandy Worthington, director of continuing medical education at PPFA, who spoke at the annual ARHP meeting in Washington. The toolkit will contain laminated algorithms, FAQs on laminated cards in lay language to be shared with patients, a manual for community educators, and a manual for medical office managers that contains instructions on billing codes, securing reimbursement, and storage and shipping.

NIH Director Zerhouni Steps Down

Dr. Elias Zerhouni, director of the National Institutes of Health since May 2002, announced that he will step down at the end of October to pursue writing projects and explore other professional opportunities. During his tenure, he worked to lower barriers between disciplines of science and to encourage trans-NIH collaborations, such as the NIH Roadmap for Medical Research, which brought together all 27 NIH institutes and centers to fund research initiatives.