Joyce Frieden

New voluntary guidelines for direct-to-consumer prescription drug advertising that were released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they do not go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct-to-consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D., (R-Tenn.) said in a statement.

Sidney Wolfe, M.D., who is the director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, who is the CEO of PhRMA and a former congressman from Louisiana, said during a press conference that was sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

New voluntary guidelines for direct-to-consumer prescription drug advertising that were released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they do not go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct-to-consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D., (R-Tenn.) said in a statement.

Sidney Wolfe, M.D., who is the director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, who is the CEO of PhRMA and a former congressman from Louisiana, said during a press conference that was sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

New voluntary guidelines for direct-to-consumer prescription drug advertising that were released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they do not go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct-to-consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D., (R-Tenn.) said in a statement.

Sidney Wolfe, M.D., who is the director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, who is the CEO of PhRMA and a former congressman from Louisiana, said during a press conference that was sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

Although the recent spotlight has been on what the federal government will do to rein in the rising numbers of medical imaging procedures, states also are doing their part.

In Maryland, for example, state law requires that only licensed radiologists perform advanced imaging procedures such as CTs, MRIs, or PET scans. Radiologists say that laws like this help decrease the use of inappropriate imaging, which they say is done largely by nonradiologists who use the equipment in their offices.

“We believe Maryland's law is a model that we would like to see in other states,” said Josh Cooper, senior director of government relations at the American College of Radiology, in Reston, Va. Florida has a similar law, but it is not as restrictive as Maryland's, he said.

Another way states are trying to manage the use of imaging equipment is through “certificate of need” laws that require physicians and others setting up imaging facilities to obtain a certificate of need to document that there is a demand in the community for such a facility. Rhode Island has such a law, according to Mr. Cooper.

While the radiologists and their college are keen to support state and federal laws that limit imaging utilization, other physicians say the radiologists are just trying to keep the business for themselves. “The radiology community … claims that growth in imaging is due to 'self-referral' by physicians who own their imaging equipment, and that the quality of images and interpretations by nonradiologists is inferior to those by radiologists,” the Lewin Group, a Falls Church, Va., consulting firm, said in a report for the Coalition for Patient-Centered Imaging, a coalition of medical specialties that wants specialists to be able to perform in-office imaging procedures.

“Our findings suggest that self-referral is not the primary driver of growth in imaging services,” the report stated. “Some of the fastest-growing imaging services, such as MRI and CT scans, are primarily done by radiologists.”

State legislatures are seeking fresh approaches to the issue. A bill currently in the California legislature would exempt only radiologists and cardiac rehabilitation physicians from a ban on physician self-referral.

The California Medical Association (CMA) is opposed to the bill, according to spokeswoman Karen Nikos. The group's opposition is based on its self-referral policy, adopted in 1993, which states, “While CMA recognizes that there is nothing inherently wrong when a physician invests in a facility or when a physician refers a patient to a facility in which the physician has an ownership interest, CMA recognizes that serious ethical questions are raised when referrals are made purely for a profit motive. CMA has a responsibility to create policy and support legislation that would prevent abusive practices such as overutilization and overcharging.”

Advocates on both sides of the issue say they expect these battles to continue. “Our sense is that we will continue to see attempts to both legislate and regulate medical imaging at the state level,” said Barbara Greenan, senior director for advocacy at the American College of Cardiology in Bethesda, Md.

“The ACC will continue to proactively educate state policy makers and payers about the value of office-based imaging, and to oppose efforts to restrict specialist physicians' ability to provide imaging services,” she said.

One way to make sure that cardiovascular imaging is not overutilized is to develop standards for performing such procedures, Ms. Greenan continued, noting that the college is currently developing appropriateness criteria for cardiovascular imaging procedures. However, insurers and government agencies interested in following imaging criteria will be faced with a choice: whether to use the ACC's criteria or criteria developed by the American College of Radiology.

Although the recent spotlight has been on what the federal government will do to rein in the rising numbers of medical imaging procedures, states also are doing their part.

In Maryland, for example, state law requires that only licensed radiologists perform advanced imaging procedures such as CTs, MRIs, or PET scans. Radiologists say that laws like this help decrease the use of inappropriate imaging, which they say is done largely by nonradiologists who use the equipment in their offices.

“We believe Maryland's law is a model that we would like to see in other states,” said Josh Cooper, senior director of government relations at the American College of Radiology, in Reston, Va. Florida has a similar law, but it is not as restrictive as Maryland's, he said.

Another way states are trying to manage the use of imaging equipment is through “certificate of need” laws that require physicians and others setting up imaging facilities to obtain a certificate of need to document that there is a demand in the community for such a facility. Rhode Island has such a law, according to Mr. Cooper.

While the radiologists and their college are keen to support state and federal laws that limit imaging utilization, other physicians say the radiologists are just trying to keep the business for themselves. “The radiology community … claims that growth in imaging is due to 'self-referral' by physicians who own their imaging equipment, and that the quality of images and interpretations by nonradiologists is inferior to those by radiologists,” the Lewin Group, a Falls Church, Va., consulting firm, said in a report for the Coalition for Patient-Centered Imaging, a coalition of medical specialties that wants specialists to be able to perform in-office imaging procedures.

“Our findings suggest that self-referral is not the primary driver of growth in imaging services,” the report stated. “Some of the fastest-growing imaging services, such as MRI and CT scans, are primarily done by radiologists.”

State legislatures are seeking fresh approaches to the issue. A bill currently in the California legislature would exempt only radiologists and cardiac rehabilitation physicians from a ban on physician self-referral.

The California Medical Association (CMA) is opposed to the bill, according to spokeswoman Karen Nikos. The group's opposition is based on its self-referral policy, adopted in 1993, which states, “While CMA recognizes that there is nothing inherently wrong when a physician invests in a facility or when a physician refers a patient to a facility in which the physician has an ownership interest, CMA recognizes that serious ethical questions are raised when referrals are made purely for a profit motive. CMA has a responsibility to create policy and support legislation that would prevent abusive practices such as overutilization and overcharging.”

Advocates on both sides of the issue say they expect these battles to continue. “Our sense is that we will continue to see attempts to both legislate and regulate medical imaging at the state level,” said Barbara Greenan, senior director for advocacy at the American College of Cardiology in Bethesda, Md.

“The ACC will continue to proactively educate state policy makers and payers about the value of office-based imaging, and to oppose efforts to restrict specialist physicians' ability to provide imaging services,” she said.

One way to make sure that cardiovascular imaging is not overutilized is to develop standards for performing such procedures, Ms. Greenan continued, noting that the college is currently developing appropriateness criteria for cardiovascular imaging procedures. However, insurers and government agencies interested in following imaging criteria will be faced with a choice: whether to use the ACC's criteria or criteria developed by the American College of Radiology.

Although the recent spotlight has been on what the federal government will do to rein in the rising numbers of medical imaging procedures, states also are doing their part.

In Maryland, for example, state law requires that only licensed radiologists perform advanced imaging procedures such as CTs, MRIs, or PET scans. Radiologists say that laws like this help decrease the use of inappropriate imaging, which they say is done largely by nonradiologists who use the equipment in their offices.

“We believe Maryland's law is a model that we would like to see in other states,” said Josh Cooper, senior director of government relations at the American College of Radiology, in Reston, Va. Florida has a similar law, but it is not as restrictive as Maryland's, he said.

Another way states are trying to manage the use of imaging equipment is through “certificate of need” laws that require physicians and others setting up imaging facilities to obtain a certificate of need to document that there is a demand in the community for such a facility. Rhode Island has such a law, according to Mr. Cooper.

While the radiologists and their college are keen to support state and federal laws that limit imaging utilization, other physicians say the radiologists are just trying to keep the business for themselves. “The radiology community … claims that growth in imaging is due to 'self-referral' by physicians who own their imaging equipment, and that the quality of images and interpretations by nonradiologists is inferior to those by radiologists,” the Lewin Group, a Falls Church, Va., consulting firm, said in a report for the Coalition for Patient-Centered Imaging, a coalition of medical specialties that wants specialists to be able to perform in-office imaging procedures.

“Our findings suggest that self-referral is not the primary driver of growth in imaging services,” the report stated. “Some of the fastest-growing imaging services, such as MRI and CT scans, are primarily done by radiologists.”

State legislatures are seeking fresh approaches to the issue. A bill currently in the California legislature would exempt only radiologists and cardiac rehabilitation physicians from a ban on physician self-referral.

The California Medical Association (CMA) is opposed to the bill, according to spokeswoman Karen Nikos. The group's opposition is based on its self-referral policy, adopted in 1993, which states, “While CMA recognizes that there is nothing inherently wrong when a physician invests in a facility or when a physician refers a patient to a facility in which the physician has an ownership interest, CMA recognizes that serious ethical questions are raised when referrals are made purely for a profit motive. CMA has a responsibility to create policy and support legislation that would prevent abusive practices such as overutilization and overcharging.”

Advocates on both sides of the issue say they expect these battles to continue. “Our sense is that we will continue to see attempts to both legislate and regulate medical imaging at the state level,” said Barbara Greenan, senior director for advocacy at the American College of Cardiology in Bethesda, Md.

“The ACC will continue to proactively educate state policy makers and payers about the value of office-based imaging, and to oppose efforts to restrict specialist physicians' ability to provide imaging services,” she said.

One way to make sure that cardiovascular imaging is not overutilized is to develop standards for performing such procedures, Ms. Greenan continued, noting that the college is currently developing appropriateness criteria for cardiovascular imaging procedures. However, insurers and government agencies interested in following imaging criteria will be faced with a choice: whether to use the ACC's criteria or criteria developed by the American College of Radiology.

Sometimes, being equal is just not enough—at least, that's what the Progressive Policy Institute says.

A paper from the a liberal Washington think tank suggests that rather than aiming for simple dollar-for-dollar parity with physical health benefits, advocates for mental health parity should insist that providers be held accountable for delivering high-quality, cost-effective services.

The business community is intrigued by this idea, said David Kendall, senior fellow for health policy at the institute. “Employers see themselves as leaders in the outcomes disclosure field, and their argument has been all along that parity shouldn't mean unlimited entitlement to [mental health] services,” he said. “So if we can find ways to discipline the demand side with outcomes [data], I think that may help break the deadlock on parity.”

One reason the Progressive Policy Institute (PPI) published the paper is that President Bush has “dropped the ball” on reforming the mental health system, even though he himself called for such reforms about 4 years ago, Mr. Kendall said.

In the report, PPI notes that enhanced parity “would bring together a wave of cutting-edge reforms—some proposed, some already proven—that aim to promote effective treatments and tangible results, often reinforced by pay for performance or other incentives.” One example would be Assertive Community Treatment (ACT), in which mobile interdisciplinary teams give 24-hour assistance to hard-to-reach mentally ill patients. “When states fail to adopt such practices, the cost of preventable hospitalization soars.” Parity legislation should “require the disclosure of performance results, not just reimbursement for any service provided,” the report said. “Without some form of accountability, mental health parity risks turning into a blank check for mediocre treatment-as-usual. Legislation should include a requirement to use at least some of the measurements developed by the Substance Abuse and Mental Health Services Administration,” such as its Mental Health Consumer-Oriented Report Card.

Rep. Patrick Kennedy (D-R.I.), chief sponsor of a parity bill in the House of Representatives, said that although accountable mental health care is a laudable goal, Parity Plus is not the way to go about achieving it. “If we are to ever rid the prejudice associated with this country's mental health policy, we cannot at the same time require some kind of higher standard of accountability for mental health care,” he said at a PPI forum on Parity Plus.

Nicholas Meyers, director of government relations at the American Psychiatric Association, in Arlington, Va., agreed. “We appreciate the interest of PPI in the parity issue, but framing and conditioning approval of parity on a range of performance initiatives is both a very dubious political strategy and perpetuates the stigma,” he said. Furthermore, performance measures are still in the early stages of development, especially in the area of pay for performance, Mr. Meyers said. For example, “There are a whole host of technical issues: Who owns the information that's being reported? What protections are provided for confidentiality? How and by whom are measures developed and validated?”

Despite this opposition, PPI's Mr. Kendall thinks that there is one other way a Parity Plus proposal helps to advance the mental health care debate: It puts some of the onus for improvement squarely on the managed care plans.

Sometimes, being equal is just not enough—at least, that's what the Progressive Policy Institute says.

A paper from the a liberal Washington think tank suggests that rather than aiming for simple dollar-for-dollar parity with physical health benefits, advocates for mental health parity should insist that providers be held accountable for delivering high-quality, cost-effective services.

The business community is intrigued by this idea, said David Kendall, senior fellow for health policy at the institute. “Employers see themselves as leaders in the outcomes disclosure field, and their argument has been all along that parity shouldn't mean unlimited entitlement to [mental health] services,” he said. “So if we can find ways to discipline the demand side with outcomes [data], I think that may help break the deadlock on parity.”

One reason the Progressive Policy Institute (PPI) published the paper is that President Bush has “dropped the ball” on reforming the mental health system, even though he himself called for such reforms about 4 years ago, Mr. Kendall said.

In the report, PPI notes that enhanced parity “would bring together a wave of cutting-edge reforms—some proposed, some already proven—that aim to promote effective treatments and tangible results, often reinforced by pay for performance or other incentives.” One example would be Assertive Community Treatment (ACT), in which mobile interdisciplinary teams give 24-hour assistance to hard-to-reach mentally ill patients. “When states fail to adopt such practices, the cost of preventable hospitalization soars.” Parity legislation should “require the disclosure of performance results, not just reimbursement for any service provided,” the report said. “Without some form of accountability, mental health parity risks turning into a blank check for mediocre treatment-as-usual. Legislation should include a requirement to use at least some of the measurements developed by the Substance Abuse and Mental Health Services Administration,” such as its Mental Health Consumer-Oriented Report Card.

Rep. Patrick Kennedy (D-R.I.), chief sponsor of a parity bill in the House of Representatives, said that although accountable mental health care is a laudable goal, Parity Plus is not the way to go about achieving it. “If we are to ever rid the prejudice associated with this country's mental health policy, we cannot at the same time require some kind of higher standard of accountability for mental health care,” he said at a PPI forum on Parity Plus.

Nicholas Meyers, director of government relations at the American Psychiatric Association, in Arlington, Va., agreed. “We appreciate the interest of PPI in the parity issue, but framing and conditioning approval of parity on a range of performance initiatives is both a very dubious political strategy and perpetuates the stigma,” he said. Furthermore, performance measures are still in the early stages of development, especially in the area of pay for performance, Mr. Meyers said. For example, “There are a whole host of technical issues: Who owns the information that's being reported? What protections are provided for confidentiality? How and by whom are measures developed and validated?”

Despite this opposition, PPI's Mr. Kendall thinks that there is one other way a Parity Plus proposal helps to advance the mental health care debate: It puts some of the onus for improvement squarely on the managed care plans.

Sometimes, being equal is just not enough—at least, that's what the Progressive Policy Institute says.

A paper from the a liberal Washington think tank suggests that rather than aiming for simple dollar-for-dollar parity with physical health benefits, advocates for mental health parity should insist that providers be held accountable for delivering high-quality, cost-effective services.

The business community is intrigued by this idea, said David Kendall, senior fellow for health policy at the institute. “Employers see themselves as leaders in the outcomes disclosure field, and their argument has been all along that parity shouldn't mean unlimited entitlement to [mental health] services,” he said. “So if we can find ways to discipline the demand side with outcomes [data], I think that may help break the deadlock on parity.”

One reason the Progressive Policy Institute (PPI) published the paper is that President Bush has “dropped the ball” on reforming the mental health system, even though he himself called for such reforms about 4 years ago, Mr. Kendall said.

In the report, PPI notes that enhanced parity “would bring together a wave of cutting-edge reforms—some proposed, some already proven—that aim to promote effective treatments and tangible results, often reinforced by pay for performance or other incentives.” One example would be Assertive Community Treatment (ACT), in which mobile interdisciplinary teams give 24-hour assistance to hard-to-reach mentally ill patients. “When states fail to adopt such practices, the cost of preventable hospitalization soars.” Parity legislation should “require the disclosure of performance results, not just reimbursement for any service provided,” the report said. “Without some form of accountability, mental health parity risks turning into a blank check for mediocre treatment-as-usual. Legislation should include a requirement to use at least some of the measurements developed by the Substance Abuse and Mental Health Services Administration,” such as its Mental Health Consumer-Oriented Report Card.

Rep. Patrick Kennedy (D-R.I.), chief sponsor of a parity bill in the House of Representatives, said that although accountable mental health care is a laudable goal, Parity Plus is not the way to go about achieving it. “If we are to ever rid the prejudice associated with this country's mental health policy, we cannot at the same time require some kind of higher standard of accountability for mental health care,” he said at a PPI forum on Parity Plus.

Nicholas Meyers, director of government relations at the American Psychiatric Association, in Arlington, Va., agreed. “We appreciate the interest of PPI in the parity issue, but framing and conditioning approval of parity on a range of performance initiatives is both a very dubious political strategy and perpetuates the stigma,” he said. Furthermore, performance measures are still in the early stages of development, especially in the area of pay for performance, Mr. Meyers said. For example, “There are a whole host of technical issues: Who owns the information that's being reported? What protections are provided for confidentiality? How and by whom are measures developed and validated?”

Despite this opposition, PPI's Mr. Kendall thinks that there is one other way a Parity Plus proposal helps to advance the mental health care debate: It puts some of the onus for improvement squarely on the managed care plans.

WASHINGTON — Changing the reimbursement formula for prescription drugs, tightening rules for asset transfers prior to receiving nursing home care, and letting states increase copayments for nonpreferred drugs were among the recommendations of a commission charged with finding ways to cut $10 billion from the Medicaid budget over the next 5 years.

“This needs to be balanced,” commission chair Donald Sundquist, a former Republican governor of Tennessee, said of the list. For example, “we don't want to hit the pharmaceutical companies with everything.”

The Medicaid Commission, which was called for by the fiscal year 2006 federal budget agreement and chartered in May by Health and Human Services Secretary Mike Leavitt, included 13 voting members and 15 nonvoting members representing a variety of interests.

At an August meeting, commissioners heard many proposals for paring down the budget. Ray Sheppach, executive director of the National Governors Association (NGA), outlined steps governors would like to take, including instituting closed formularies, determining each state's dispensing fee (rather than being subject to a federal cap), increasing the rebate from drug manufacturers to 20% from the current 15%, and having more leeway to establish multistate and in-state purchasing pools.

As for reforming the Medicaid long term care program, he said, there is a “fairly sophisticated group of lawyers now who are helping people move their assets or income streams to their children or other people so they can [qualify for] Medicaid.”

To prevent people from taking advantage of loopholes, Mr. Sheppach said the NGA favored increasing the “lookback” period—the period during which transferred assets are still be counted as a beneficiary's assets in determining Medicaid eligibility—from 3 to 5 years. “We also think the type of asset should be expanded so we can look at most assets, including trusts and annuities. And although it will be somewhat controversial, we believe that housing—which is an increasingly valuable asset—should also be put on the table.”

The “lookback” proposal was among those making the list of recommended cuts, as were two other NGA proposals: tiered prescription copays and reform of Medicaid drug reimbursement.

The idea of clamping down on asset transfers caused concern for some commission members. “Do we have enough real information to make those kind of judgments on this point?” asked commission member Gwen Gillenwater of the National Council on Independent Living.

Commission member Douglas Struyk, president and CEO of the Christian Health Care Center, a long-term care facility in Wyckoff, N.J., said beneficiaries sometimes have innocent reasons for transferring assets to their children prior to applying for Medicaid, but those situations are in the minority. “The gaming far exceeds situations where [asset transfer] happens in the normal course of families taking care of different generations,” he said.

Mr. Struyk added that nursing homes must be held harmless financially in circumstances where Medicaid beneficiaries were no longer able to pay for their care because they had transferred assets without bad intention, a sentiment endorsed by other commission members.

The “tiered copayments” proposal, which would let states implement higher copayments for nonpreferred drugs, also attracted a lot of interest.

John Monahan, president of state-sponsored business at WellPoint, the for-profit California Blue Shield plan, said that he favored increased use of generic drugs. “Getting [people to increase] utilization of generic up by even 5% would be an incredible savings.”

John Rugge, M.D., CEO of the Hudson Headwaters Health Network, in Glens Falls, N.Y., added that “with the psychotropic meds, there's a huge danger in [substituting] one antidepressant for another, one atypical antipsychotic for another. They clearly have to be tailored to the individual.”

Commission vice-chair Angus King, former Independent governor of Maine, said he thought the issue could be dealt with because of the ability of the physician to override any preferred drug if it was clinically necessary to do so. He noted that in Maine, such override requests are usually filled within 72 hours.

Commission member Carol Berkowitz, M.D., president of the American Academy of Pediatrics, said she was concerned about how well such an override system would work. Although such requests may take only 72 hours to process in some states, “in my experience it's 30–45 days before it gets approved.”

The idea of higher copays for nonpreferred drugs “is potentially good, but you've got to get the components in place [so it] doesn't have a negative impact on the patients,” added Dr. Berkowitz, who practices in Los Angeles. A suggestion to remove that provision and replace it with another cost-cutting measure was voted down.

Although 24 cost-cutting proposals were on the table at the end of the first day of the commission meeting, when the commission came back the second day, they were presented with a “Chairman's Mark” list of six measures, which totaled an estimated $10.3 billion-$11.1 billion in savings over 5 years.

“We sat out here in the lobby” and took input from members as they came and went, Mr. Sundquist said. The list was approved in its entirety after several attempts to amend it were voted down.

At its next meeting, scheduled for late October, the commission will begin the second phase of its work: making recommendations for long-term restructuring of the Medicaid system.

For information on the Medicaid Commission go to www.cms.hhs.gov/faca/mc/details.asp

WASHINGTON — Changing the reimbursement formula for prescription drugs, tightening rules for asset transfers prior to receiving nursing home care, and letting states increase copayments for nonpreferred drugs were among the recommendations of a commission charged with finding ways to cut $10 billion from the Medicaid budget over the next 5 years.

“This needs to be balanced,” commission chair Donald Sundquist, a former Republican governor of Tennessee, said of the list. For example, “we don't want to hit the pharmaceutical companies with everything.”

The Medicaid Commission, which was called for by the fiscal year 2006 federal budget agreement and chartered in May by Health and Human Services Secretary Mike Leavitt, included 13 voting members and 15 nonvoting members representing a variety of interests.

At an August meeting, commissioners heard many proposals for paring down the budget. Ray Sheppach, executive director of the National Governors Association (NGA), outlined steps governors would like to take, including instituting closed formularies, determining each state's dispensing fee (rather than being subject to a federal cap), increasing the rebate from drug manufacturers to 20% from the current 15%, and having more leeway to establish multistate and in-state purchasing pools.

As for reforming the Medicaid long term care program, he said, there is a “fairly sophisticated group of lawyers now who are helping people move their assets or income streams to their children or other people so they can [qualify for] Medicaid.”

To prevent people from taking advantage of loopholes, Mr. Sheppach said the NGA favored increasing the “lookback” period—the period during which transferred assets are still be counted as a beneficiary's assets in determining Medicaid eligibility—from 3 to 5 years. “We also think the type of asset should be expanded so we can look at most assets, including trusts and annuities. And although it will be somewhat controversial, we believe that housing—which is an increasingly valuable asset—should also be put on the table.”

The “lookback” proposal was among those making the list of recommended cuts, as were two other NGA proposals: tiered prescription copays and reform of Medicaid drug reimbursement.

The idea of clamping down on asset transfers caused concern for some commission members. “Do we have enough real information to make those kind of judgments on this point?” asked commission member Gwen Gillenwater of the National Council on Independent Living.

Commission member Douglas Struyk, president and CEO of the Christian Health Care Center, a long-term care facility in Wyckoff, N.J., said beneficiaries sometimes have innocent reasons for transferring assets to their children prior to applying for Medicaid, but those situations are in the minority. “The gaming far exceeds situations where [asset transfer] happens in the normal course of families taking care of different generations,” he said.

Mr. Struyk added that nursing homes must be held harmless financially in circumstances where Medicaid beneficiaries were no longer able to pay for their care because they had transferred assets without bad intention, a sentiment endorsed by other commission members.

The “tiered copayments” proposal, which would let states implement higher copayments for nonpreferred drugs, also attracted a lot of interest.

John Monahan, president of state-sponsored business at WellPoint, the for-profit California Blue Shield plan, said that he favored increased use of generic drugs. “Getting [people to increase] utilization of generic up by even 5% would be an incredible savings.”

John Rugge, M.D., CEO of the Hudson Headwaters Health Network, in Glens Falls, N.Y., added that “with the psychotropic meds, there's a huge danger in [substituting] one antidepressant for another, one atypical antipsychotic for another. They clearly have to be tailored to the individual.”

Commission vice-chair Angus King, former Independent governor of Maine, said he thought the issue could be dealt with because of the ability of the physician to override any preferred drug if it was clinically necessary to do so. He noted that in Maine, such override requests are usually filled within 72 hours.

Commission member Carol Berkowitz, M.D., president of the American Academy of Pediatrics, said she was concerned about how well such an override system would work. Although such requests may take only 72 hours to process in some states, “in my experience it's 30–45 days before it gets approved.”

The idea of higher copays for nonpreferred drugs “is potentially good, but you've got to get the components in place [so it] doesn't have a negative impact on the patients,” added Dr. Berkowitz, who practices in Los Angeles. A suggestion to remove that provision and replace it with another cost-cutting measure was voted down.

Although 24 cost-cutting proposals were on the table at the end of the first day of the commission meeting, when the commission came back the second day, they were presented with a “Chairman's Mark” list of six measures, which totaled an estimated $10.3 billion-$11.1 billion in savings over 5 years.

“We sat out here in the lobby” and took input from members as they came and went, Mr. Sundquist said. The list was approved in its entirety after several attempts to amend it were voted down.

At its next meeting, scheduled for late October, the commission will begin the second phase of its work: making recommendations for long-term restructuring of the Medicaid system.

For information on the Medicaid Commission go to www.cms.hhs.gov/faca/mc/details.asp

WASHINGTON — Changing the reimbursement formula for prescription drugs, tightening rules for asset transfers prior to receiving nursing home care, and letting states increase copayments for nonpreferred drugs were among the recommendations of a commission charged with finding ways to cut $10 billion from the Medicaid budget over the next 5 years.

“This needs to be balanced,” commission chair Donald Sundquist, a former Republican governor of Tennessee, said of the list. For example, “we don't want to hit the pharmaceutical companies with everything.”

The Medicaid Commission, which was called for by the fiscal year 2006 federal budget agreement and chartered in May by Health and Human Services Secretary Mike Leavitt, included 13 voting members and 15 nonvoting members representing a variety of interests.

At an August meeting, commissioners heard many proposals for paring down the budget. Ray Sheppach, executive director of the National Governors Association (NGA), outlined steps governors would like to take, including instituting closed formularies, determining each state's dispensing fee (rather than being subject to a federal cap), increasing the rebate from drug manufacturers to 20% from the current 15%, and having more leeway to establish multistate and in-state purchasing pools.

As for reforming the Medicaid long term care program, he said, there is a “fairly sophisticated group of lawyers now who are helping people move their assets or income streams to their children or other people so they can [qualify for] Medicaid.”

To prevent people from taking advantage of loopholes, Mr. Sheppach said the NGA favored increasing the “lookback” period—the period during which transferred assets are still be counted as a beneficiary's assets in determining Medicaid eligibility—from 3 to 5 years. “We also think the type of asset should be expanded so we can look at most assets, including trusts and annuities. And although it will be somewhat controversial, we believe that housing—which is an increasingly valuable asset—should also be put on the table.”

The “lookback” proposal was among those making the list of recommended cuts, as were two other NGA proposals: tiered prescription copays and reform of Medicaid drug reimbursement.

The idea of clamping down on asset transfers caused concern for some commission members. “Do we have enough real information to make those kind of judgments on this point?” asked commission member Gwen Gillenwater of the National Council on Independent Living.

Commission member Douglas Struyk, president and CEO of the Christian Health Care Center, a long-term care facility in Wyckoff, N.J., said beneficiaries sometimes have innocent reasons for transferring assets to their children prior to applying for Medicaid, but those situations are in the minority. “The gaming far exceeds situations where [asset transfer] happens in the normal course of families taking care of different generations,” he said.

Mr. Struyk added that nursing homes must be held harmless financially in circumstances where Medicaid beneficiaries were no longer able to pay for their care because they had transferred assets without bad intention, a sentiment endorsed by other commission members.

The “tiered copayments” proposal, which would let states implement higher copayments for nonpreferred drugs, also attracted a lot of interest.

John Monahan, president of state-sponsored business at WellPoint, the for-profit California Blue Shield plan, said that he favored increased use of generic drugs. “Getting [people to increase] utilization of generic up by even 5% would be an incredible savings.”

John Rugge, M.D., CEO of the Hudson Headwaters Health Network, in Glens Falls, N.Y., added that “with the psychotropic meds, there's a huge danger in [substituting] one antidepressant for another, one atypical antipsychotic for another. They clearly have to be tailored to the individual.”

Commission vice-chair Angus King, former Independent governor of Maine, said he thought the issue could be dealt with because of the ability of the physician to override any preferred drug if it was clinically necessary to do so. He noted that in Maine, such override requests are usually filled within 72 hours.

Commission member Carol Berkowitz, M.D., president of the American Academy of Pediatrics, said she was concerned about how well such an override system would work. Although such requests may take only 72 hours to process in some states, “in my experience it's 30–45 days before it gets approved.”

The idea of higher copays for nonpreferred drugs “is potentially good, but you've got to get the components in place [so it] doesn't have a negative impact on the patients,” added Dr. Berkowitz, who practices in Los Angeles. A suggestion to remove that provision and replace it with another cost-cutting measure was voted down.

Although 24 cost-cutting proposals were on the table at the end of the first day of the commission meeting, when the commission came back the second day, they were presented with a “Chairman's Mark” list of six measures, which totaled an estimated $10.3 billion-$11.1 billion in savings over 5 years.

“We sat out here in the lobby” and took input from members as they came and went, Mr. Sundquist said. The list was approved in its entirety after several attempts to amend it were voted down.

At its next meeting, scheduled for late October, the commission will begin the second phase of its work: making recommendations for long-term restructuring of the Medicaid system.

For information on the Medicaid Commission go to www.cms.hhs.gov/faca/mc/details.asp

Hello, October—goodbye, paper Medicare claims.

Oct. 1 marks the date that physicians and other providers may no longer submit any paper Medicare claims; electronically filed claims not in compliance with federal regulations also are prohibited.

The rules are part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). After Oct. 1, paper claims will not be allowed; all electronic claims “that do not meet standards required by [HIPAA] will be returned to the filer for re-submission as compliant claims,” the Centers for Medicare and Medicaid Services (CMS) announced in a statement. “Noncompliant claims will not be processed.”

Paper claims will be accepted only from physician practices with fewer than 10 full-time employees and institutions with fewer than 25 full-time employees, according to a CMS spokesman.

As of June, only about 0.5% of Medicare fee-for-service providers were submitting noncompliant claims, CMS said.

But that figure is a little misleading, according to Rob Tennant, senior policy advisor at the Medical Group Management Association. “That doesn't mean [all] practices are submitting electronically. They're just getting claims to CMS electronically,” he said. “Lots of times, providers will utilize a clearinghouse” that takes providers' paper claims and transfers them into an electronic format for submission.

The CMS statement mentioned onlycompliance rates for claim forms, Mr. Tennant added. Compliance is much lower for other electronic transactions, such as remittances, eligibility status inquiries, and claims inquiries. “These are all very important transactions from providers, and we're hearing from health plans and others that providers aren't there yet.”

Even in rural areas, most family physicians will be prepared to meet the Oct. 1 deadline, said David C. Kibbe, M.D., director of the American Academy of Family Physicians' Center for Health Information Technology.

The AAFP's membership surveys on information technology (IT) have found that more than 90% of its members have computers in offices for billing purposes, and 25% have electronic health records, Dr. Kibbe said. Those figures haven't been broken down with respect to rural versus urban, yet “people make the assumption that because a practice is small or rural, it's unlikely to use IT. That's just not true.”

Dr. Kibbe said recent visits to practices in North Carolina and Tennessee indicate that rural practices aren't behind the curve. “My staff and I made over 25 appearances at state chapter events, everywhere from Alaska to Hawaii, including some very rural areas, and we got a good feeling about what's happening in rural practices.”

Several bills in the Senate propose technology initiatives: Sen. Edward Kennedy (D-Mass.), Sen. Hillary Clinton (D-N.Y.) and Senate Majority Leader Bill Frist (R-Tenn.) have introduced legislation that would offer grants to financially needy providers to enhance their use of health IT, as well as financial assistance to establish regional health IT networks. Another bipartisan bill from Sen. Debbie Stabenow (D-Mich.) and Sen. Olympia Snowe (R-Maine) would spur the use of new information technologies to reduce paperwork costs and improve patient care.

For now, another solution might be to tap into existing resources, Bernard Proy, M.D., a family physician in Corry, Pa., said. For example, federal agencies such as the Department of Veterans Affairs already have an electronic health record in place.

“Individual physicians could tap into that system—which has already been paid for with tax dollars,” he said. At press time, CMS was expected to shortly announce a program to let physicians install a simplified version of the VA's electronic health records system at a low cost.

Jennifer Silverman, associate editor for Practice Trends, contributed to this story.

Hello, October—goodbye, paper Medicare claims.

Oct. 1 marks the date that physicians and other providers may no longer submit any paper Medicare claims; electronically filed claims not in compliance with federal regulations also are prohibited.

The rules are part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). After Oct. 1, paper claims will not be allowed; all electronic claims “that do not meet standards required by [HIPAA] will be returned to the filer for re-submission as compliant claims,” the Centers for Medicare and Medicaid Services (CMS) announced in a statement. “Noncompliant claims will not be processed.”

Paper claims will be accepted only from physician practices with fewer than 10 full-time employees and institutions with fewer than 25 full-time employees, according to a CMS spokesman.

As of June, only about 0.5% of Medicare fee-for-service providers were submitting noncompliant claims, CMS said.

But that figure is a little misleading, according to Rob Tennant, senior policy advisor at the Medical Group Management Association. “That doesn't mean [all] practices are submitting electronically. They're just getting claims to CMS electronically,” he said. “Lots of times, providers will utilize a clearinghouse” that takes providers' paper claims and transfers them into an electronic format for submission.

The CMS statement mentioned onlycompliance rates for claim forms, Mr. Tennant added. Compliance is much lower for other electronic transactions, such as remittances, eligibility status inquiries, and claims inquiries. “These are all very important transactions from providers, and we're hearing from health plans and others that providers aren't there yet.”

Even in rural areas, most family physicians will be prepared to meet the Oct. 1 deadline, said David C. Kibbe, M.D., director of the American Academy of Family Physicians' Center for Health Information Technology.

The AAFP's membership surveys on information technology (IT) have found that more than 90% of its members have computers in offices for billing purposes, and 25% have electronic health records, Dr. Kibbe said. Those figures haven't been broken down with respect to rural versus urban, yet “people make the assumption that because a practice is small or rural, it's unlikely to use IT. That's just not true.”

Dr. Kibbe said recent visits to practices in North Carolina and Tennessee indicate that rural practices aren't behind the curve. “My staff and I made over 25 appearances at state chapter events, everywhere from Alaska to Hawaii, including some very rural areas, and we got a good feeling about what's happening in rural practices.”

Several bills in the Senate propose technology initiatives: Sen. Edward Kennedy (D-Mass.), Sen. Hillary Clinton (D-N.Y.) and Senate Majority Leader Bill Frist (R-Tenn.) have introduced legislation that would offer grants to financially needy providers to enhance their use of health IT, as well as financial assistance to establish regional health IT networks. Another bipartisan bill from Sen. Debbie Stabenow (D-Mich.) and Sen. Olympia Snowe (R-Maine) would spur the use of new information technologies to reduce paperwork costs and improve patient care.

For now, another solution might be to tap into existing resources, Bernard Proy, M.D., a family physician in Corry, Pa., said. For example, federal agencies such as the Department of Veterans Affairs already have an electronic health record in place.

“Individual physicians could tap into that system—which has already been paid for with tax dollars,” he said. At press time, CMS was expected to shortly announce a program to let physicians install a simplified version of the VA's electronic health records system at a low cost.

Jennifer Silverman, associate editor for Practice Trends, contributed to this story.

Hello, October—goodbye, paper Medicare claims.

Oct. 1 marks the date that physicians and other providers may no longer submit any paper Medicare claims; electronically filed claims not in compliance with federal regulations also are prohibited.

The rules are part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). After Oct. 1, paper claims will not be allowed; all electronic claims “that do not meet standards required by [HIPAA] will be returned to the filer for re-submission as compliant claims,” the Centers for Medicare and Medicaid Services (CMS) announced in a statement. “Noncompliant claims will not be processed.”

Paper claims will be accepted only from physician practices with fewer than 10 full-time employees and institutions with fewer than 25 full-time employees, according to a CMS spokesman.

As of June, only about 0.5% of Medicare fee-for-service providers were submitting noncompliant claims, CMS said.

But that figure is a little misleading, according to Rob Tennant, senior policy advisor at the Medical Group Management Association. “That doesn't mean [all] practices are submitting electronically. They're just getting claims to CMS electronically,” he said. “Lots of times, providers will utilize a clearinghouse” that takes providers' paper claims and transfers them into an electronic format for submission.

The CMS statement mentioned onlycompliance rates for claim forms, Mr. Tennant added. Compliance is much lower for other electronic transactions, such as remittances, eligibility status inquiries, and claims inquiries. “These are all very important transactions from providers, and we're hearing from health plans and others that providers aren't there yet.”

Even in rural areas, most family physicians will be prepared to meet the Oct. 1 deadline, said David C. Kibbe, M.D., director of the American Academy of Family Physicians' Center for Health Information Technology.

The AAFP's membership surveys on information technology (IT) have found that more than 90% of its members have computers in offices for billing purposes, and 25% have electronic health records, Dr. Kibbe said. Those figures haven't been broken down with respect to rural versus urban, yet “people make the assumption that because a practice is small or rural, it's unlikely to use IT. That's just not true.”

Dr. Kibbe said recent visits to practices in North Carolina and Tennessee indicate that rural practices aren't behind the curve. “My staff and I made over 25 appearances at state chapter events, everywhere from Alaska to Hawaii, including some very rural areas, and we got a good feeling about what's happening in rural practices.”

Several bills in the Senate propose technology initiatives: Sen. Edward Kennedy (D-Mass.), Sen. Hillary Clinton (D-N.Y.) and Senate Majority Leader Bill Frist (R-Tenn.) have introduced legislation that would offer grants to financially needy providers to enhance their use of health IT, as well as financial assistance to establish regional health IT networks. Another bipartisan bill from Sen. Debbie Stabenow (D-Mich.) and Sen. Olympia Snowe (R-Maine) would spur the use of new information technologies to reduce paperwork costs and improve patient care.

For now, another solution might be to tap into existing resources, Bernard Proy, M.D., a family physician in Corry, Pa., said. For example, federal agencies such as the Department of Veterans Affairs already have an electronic health record in place.

“Individual physicians could tap into that system—which has already been paid for with tax dollars,” he said. At press time, CMS was expected to shortly announce a program to let physicians install a simplified version of the VA's electronic health records system at a low cost.

Jennifer Silverman, associate editor for Practice Trends, contributed to this story.

Medicare Fee Cut Proposed

Physicians face a 4.3% cut to Medicare reimbursements next year unless Congress takes action to change the sustainable growth rate formula. Fixing that formula “is one of the American Academy of Neurology's top federal legislative priorities in 2005,” according to an AAN spokeswoman. The reduction was announced in a proposed rule that would update payment rates and revise payment policies under the program's fee schedule. The Centers for Medicare and Medicaid Services is expected to pay $56.5 billion to 875,000 physicians and other health care professionals in 2006, according to the proposed rule. “The payment reduction shows the need for more effective ways to pay physicians that help them improve quality and avoid unnecessary costs,” CMS Administrator Mark McClellan, M.D., said in a statement. The agency will accept comments on the proposal until Sept. 30 and publish a final rule later this year. Physician reimbursements under Medicare will be cut 26% over the next 6 years unless the sustainable growth rate formula is changed. The AMA recently reported that 38% of physicians will no longer be able to accept new Medicare patients if the first of these cuts begins on Jan. 1.

Power Wheelchair Policy Questions

CMS should issue clearer instructions to carriers on how to make sure beneficiaries getting power wheelchairs have a condition that makes them medically necessary, Sen. Arlen Specter (R-Pa.) and Sen. Rick Santorum (R-Pa.) wrote in a letter to Dr. McClellan. “Providers regularly encounter inconsistencies within the four [carrier] regions on how documentation is interpreted. In addition, providers are faced with the [durable medical equipment regional carriers'] placing extreme emphasis on a physician's chart notes to justify medical necessity, even though physicians do not routinely document medical information in their charts to the level of specificity that the [carriers] are requiring,” the senators wrote. CMS has not yet replied but plans to issue a detailed response soon, a spokeswoman said.

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages, which may be reduced to about $2 million, according to Merck, since Texas law limits punitive damages.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are uneven in the United States with some patients never receiving recommended care and other being subjected to unnecessary diagnostic imaging and surgery, according to NCQA. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who know how to diagnose back problems and explain the pros and cons of treatment options, help them manage their condition and get well again.”

Fraud Bounty Hunters

Private bounty hunters are one way to fight fraud in the Medicaid program, according to Stan Dorn, J.D., senior analyst at the Economic and Social Research Institute. Successfully used by Medicare, the bounty hunter approach allows whistle-blowers to share in funds recovered through prosecutions under the False Claims Act. According to recommendations developed by Andy Schneider, J.D., Medicaid policy expert for Taxpayers Against Fraud, Congress could bolster Medicaid whistle-blower opportunities by increasing payments to states that enact their own False Claims Act and by offering whistle-blowers a minimum of 20% of the federal share of any recovered funds.

Medicare Fee Cut Proposed

Physicians face a 4.3% cut to Medicare reimbursements next year unless Congress takes action to change the sustainable growth rate formula. Fixing that formula “is one of the American Academy of Neurology's top federal legislative priorities in 2005,” according to an AAN spokeswoman. The reduction was announced in a proposed rule that would update payment rates and revise payment policies under the program's fee schedule. The Centers for Medicare and Medicaid Services is expected to pay $56.5 billion to 875,000 physicians and other health care professionals in 2006, according to the proposed rule. “The payment reduction shows the need for more effective ways to pay physicians that help them improve quality and avoid unnecessary costs,” CMS Administrator Mark McClellan, M.D., said in a statement. The agency will accept comments on the proposal until Sept. 30 and publish a final rule later this year. Physician reimbursements under Medicare will be cut 26% over the next 6 years unless the sustainable growth rate formula is changed. The AMA recently reported that 38% of physicians will no longer be able to accept new Medicare patients if the first of these cuts begins on Jan. 1.

Power Wheelchair Policy Questions

CMS should issue clearer instructions to carriers on how to make sure beneficiaries getting power wheelchairs have a condition that makes them medically necessary, Sen. Arlen Specter (R-Pa.) and Sen. Rick Santorum (R-Pa.) wrote in a letter to Dr. McClellan. “Providers regularly encounter inconsistencies within the four [carrier] regions on how documentation is interpreted. In addition, providers are faced with the [durable medical equipment regional carriers'] placing extreme emphasis on a physician's chart notes to justify medical necessity, even though physicians do not routinely document medical information in their charts to the level of specificity that the [carriers] are requiring,” the senators wrote. CMS has not yet replied but plans to issue a detailed response soon, a spokeswoman said.

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages, which may be reduced to about $2 million, according to Merck, since Texas law limits punitive damages.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are uneven in the United States with some patients never receiving recommended care and other being subjected to unnecessary diagnostic imaging and surgery, according to NCQA. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who know how to diagnose back problems and explain the pros and cons of treatment options, help them manage their condition and get well again.”

Fraud Bounty Hunters

Private bounty hunters are one way to fight fraud in the Medicaid program, according to Stan Dorn, J.D., senior analyst at the Economic and Social Research Institute. Successfully used by Medicare, the bounty hunter approach allows whistle-blowers to share in funds recovered through prosecutions under the False Claims Act. According to recommendations developed by Andy Schneider, J.D., Medicaid policy expert for Taxpayers Against Fraud, Congress could bolster Medicaid whistle-blower opportunities by increasing payments to states that enact their own False Claims Act and by offering whistle-blowers a minimum of 20% of the federal share of any recovered funds.

Medicare Fee Cut Proposed

Physicians face a 4.3% cut to Medicare reimbursements next year unless Congress takes action to change the sustainable growth rate formula. Fixing that formula “is one of the American Academy of Neurology's top federal legislative priorities in 2005,” according to an AAN spokeswoman. The reduction was announced in a proposed rule that would update payment rates and revise payment policies under the program's fee schedule. The Centers for Medicare and Medicaid Services is expected to pay $56.5 billion to 875,000 physicians and other health care professionals in 2006, according to the proposed rule. “The payment reduction shows the need for more effective ways to pay physicians that help them improve quality and avoid unnecessary costs,” CMS Administrator Mark McClellan, M.D., said in a statement. The agency will accept comments on the proposal until Sept. 30 and publish a final rule later this year. Physician reimbursements under Medicare will be cut 26% over the next 6 years unless the sustainable growth rate formula is changed. The AMA recently reported that 38% of physicians will no longer be able to accept new Medicare patients if the first of these cuts begins on Jan. 1.

Power Wheelchair Policy Questions

CMS should issue clearer instructions to carriers on how to make sure beneficiaries getting power wheelchairs have a condition that makes them medically necessary, Sen. Arlen Specter (R-Pa.) and Sen. Rick Santorum (R-Pa.) wrote in a letter to Dr. McClellan. “Providers regularly encounter inconsistencies within the four [carrier] regions on how documentation is interpreted. In addition, providers are faced with the [durable medical equipment regional carriers'] placing extreme emphasis on a physician's chart notes to justify medical necessity, even though physicians do not routinely document medical information in their charts to the level of specificity that the [carriers] are requiring,” the senators wrote. CMS has not yet replied but plans to issue a detailed response soon, a spokeswoman said.

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages, which may be reduced to about $2 million, according to Merck, since Texas law limits punitive damages.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are uneven in the United States with some patients never receiving recommended care and other being subjected to unnecessary diagnostic imaging and surgery, according to NCQA. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who know how to diagnose back problems and explain the pros and cons of treatment options, help them manage their condition and get well again.”

Fraud Bounty Hunters

Private bounty hunters are one way to fight fraud in the Medicaid program, according to Stan Dorn, J.D., senior analyst at the Economic and Social Research Institute. Successfully used by Medicare, the bounty hunter approach allows whistle-blowers to share in funds recovered through prosecutions under the False Claims Act. According to recommendations developed by Andy Schneider, J.D., Medicaid policy expert for Taxpayers Against Fraud, Congress could bolster Medicaid whistle-blower opportunities by increasing payments to states that enact their own False Claims Act and by offering whistle-blowers a minimum of 20% of the federal share of any recovered funds.

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati.

“If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said.

“It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick. “A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred. The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said.

This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

Even in the best of circumstances, all of this takes a while, Dr. Barsan said.

That process can be made even longer if the required specialists are on call but not on site, because it can mean another 30–40 minutes to get them in, he added.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

Dr. Broderick noted that the proposed regulation was largely the result of the combined efforts of several medical organizations, including the American Academy of Neurology, the American Stroke Association, and the National Association of EMS Physicians.

“This is a team effort of a lot of organizations who are very passionate about stroke care,” he said.

“To CMS's credit, they really listened well and made an informed and well-articulated decision.”

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati.

“If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said.

“It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick. “A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred. The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said.

This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

Even in the best of circumstances, all of this takes a while, Dr. Barsan said.

That process can be made even longer if the required specialists are on call but not on site, because it can mean another 30–40 minutes to get them in, he added.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

Dr. Broderick noted that the proposed regulation was largely the result of the combined efforts of several medical organizations, including the American Academy of Neurology, the American Stroke Association, and the National Association of EMS Physicians.

“This is a team effort of a lot of organizations who are very passionate about stroke care,” he said.

“To CMS's credit, they really listened well and made an informed and well-articulated decision.”

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati.

“If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said.

“It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick. “A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred. The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said.

This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

Even in the best of circumstances, all of this takes a while, Dr. Barsan said.

That process can be made even longer if the required specialists are on call but not on site, because it can mean another 30–40 minutes to get them in, he added.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

Dr. Broderick noted that the proposed regulation was largely the result of the combined efforts of several medical organizations, including the American Academy of Neurology, the American Stroke Association, and the National Association of EMS Physicians.

“This is a team effort of a lot of organizations who are very passionate about stroke care,” he said.

“To CMS's credit, they really listened well and made an informed and well-articulated decision.”

A new process for appealing Medicare coverage denials is raising concern among some advocates for senior citizens.

“We're concerned about the ability of beneficiaries to get a fair and favorable hearing,” said Vicki Gottlich, senior policy attorney at the Center for Medicare Advocacy, a Mansfield, Conn.-based group that helps beneficiaries with the appeals process. “Our organization and other organizations that do this kind of work have a very high success rate [for Medicare appeals] and we're concerned that the rate is going to go down.”

That could mean collection snags for physicians, she added. For example, if the physician accepts assignment for Medicare, Medicare denies coverage for a claim, and the denial is unsuccessfully appealed by the patient, “the doctor will then have to go collect from the patient. They don't want to do that.”

Under the new process, which is already underway, beneficiaries and providers whose claims are denied will be asked to appeal their claims to an administrative law judge (ALJ) via teleconference. Previously, these appeals were made in person.

“Older people and people with disabilities will have problems” with teleconferences, especially if their vision or hearing is impaired, Ms. Gottlich said. And if they ask for an in-person hearing instead, beneficiaries will waive their right to a timely decision if that request is granted. The new process also specifies that there will be three “regions” for hearing cases in person, rather than beneficiaries being allowed to have hearings in their home states.

Department of Health and Human Services spokesman Bill Hall said there are logistical reasons for waiving the right to speedy resolution in the case of an in-person hearing.

“We have to schedule everyone, allow time for them to travel, and set up a facility for the hearing,” he said. “That does not mean we'll take a year to do it.”

Ms. Gottlich noted that the changes were made in the first place in part because members of Congress were dissatisfied with how long it was taking for beneficiaries to make their way through the appeals process.

“The changes are supposed to protect beneficiaries,” but the system needs better funding to make sure everyone gets their chance to be heard in a timely way, she said. “There are some cases where teleconferencing could work, but for an individual beneficiary who's gone through the whole inhuman system and wants to see a real person, the system doesn't really work.”

Another change in the process places administrative law judges under the jurisdiction of HHS, rather than the Social Security Administration. Further, judges are instructed to place more weight on Medicare regulations than they were before. “The [law] says the administrative law judge is supposed to be independent of [the Centers for Medicare and Medicaid Services], but now they are supposed to give deference to their rules,” Ms. Gottlich said.

The Medical Group Management Association, which represents medical practice managers, is one group that is very interested in how the appeals process plays out. “We have concerns about how effective arbitration or review will be through a distance,” said Jennifer Miller, external relations liaison at MGMA's Washington office. “How effective can someone be to advocate their position over teleconference? When the rubber hits the road and we start seeing more [cases], we'll have a better feel for it.”

“Before now, someone dealing with disability issues would be trying to adjudicate what may be their third case of this type out of 300 cases, so they may not be as familiar with it,” she said. “Now there will be a specialized group of magistrates—it's going to be a new breed of ALJ.”

Several senators expressed concern about changes to the appeals process. A bill, the Justice for Medicare Beneficiaries Act, sponsored by Sens. Christopher Dodd (D-Conn.), Edward M. Kennedy (D-Mass.), John Kerry (D-Mass.), and Jeff Bingaman (D-N.M.), was introduced earlier this summer and would reverse many of the changes.

For instance, the bill says that judges “shall not be required to give substantial deference to local coverage determination, local medical review policies, or Centers for Medicare and Medicaid Services program guidance.”

The measure also calls for appeal hearings to be in person “unless such individual requests that the hearing be conducted using tele- or video conference technologies.” The bill was referred to the Senate Finance Committee.

A new process for appealing Medicare coverage denials is raising concern among some advocates for senior citizens.

“We're concerned about the ability of beneficiaries to get a fair and favorable hearing,” said Vicki Gottlich, senior policy attorney at the Center for Medicare Advocacy, a Mansfield, Conn.-based group that helps beneficiaries with the appeals process. “Our organization and other organizations that do this kind of work have a very high success rate [for Medicare appeals] and we're concerned that the rate is going to go down.”

That could mean collection snags for physicians, she added. For example, if the physician accepts assignment for Medicare, Medicare denies coverage for a claim, and the denial is unsuccessfully appealed by the patient, “the doctor will then have to go collect from the patient. They don't want to do that.”

Under the new process, which is already underway, beneficiaries and providers whose claims are denied will be asked to appeal their claims to an administrative law judge (ALJ) via teleconference. Previously, these appeals were made in person.

“Older people and people with disabilities will have problems” with teleconferences, especially if their vision or hearing is impaired, Ms. Gottlich said. And if they ask for an in-person hearing instead, beneficiaries will waive their right to a timely decision if that request is granted. The new process also specifies that there will be three “regions” for hearing cases in person, rather than beneficiaries being allowed to have hearings in their home states.

Department of Health and Human Services spokesman Bill Hall said there are logistical reasons for waiving the right to speedy resolution in the case of an in-person hearing.

“We have to schedule everyone, allow time for them to travel, and set up a facility for the hearing,” he said. “That does not mean we'll take a year to do it.”

Ms. Gottlich noted that the changes were made in the first place in part because members of Congress were dissatisfied with how long it was taking for beneficiaries to make their way through the appeals process.

“The changes are supposed to protect beneficiaries,” but the system needs better funding to make sure everyone gets their chance to be heard in a timely way, she said. “There are some cases where teleconferencing could work, but for an individual beneficiary who's gone through the whole inhuman system and wants to see a real person, the system doesn't really work.”

Another change in the process places administrative law judges under the jurisdiction of HHS, rather than the Social Security Administration. Further, judges are instructed to place more weight on Medicare regulations than they were before. “The [law] says the administrative law judge is supposed to be independent of [the Centers for Medicare and Medicaid Services], but now they are supposed to give deference to their rules,” Ms. Gottlich said.

The Medical Group Management Association, which represents medical practice managers, is one group that is very interested in how the appeals process plays out. “We have concerns about how effective arbitration or review will be through a distance,” said Jennifer Miller, external relations liaison at MGMA's Washington office. “How effective can someone be to advocate their position over teleconference? When the rubber hits the road and we start seeing more [cases], we'll have a better feel for it.”

“Before now, someone dealing with disability issues would be trying to adjudicate what may be their third case of this type out of 300 cases, so they may not be as familiar with it,” she said. “Now there will be a specialized group of magistrates—it's going to be a new breed of ALJ.”

Several senators expressed concern about changes to the appeals process. A bill, the Justice for Medicare Beneficiaries Act, sponsored by Sens. Christopher Dodd (D-Conn.), Edward M. Kennedy (D-Mass.), John Kerry (D-Mass.), and Jeff Bingaman (D-N.M.), was introduced earlier this summer and would reverse many of the changes.

For instance, the bill says that judges “shall not be required to give substantial deference to local coverage determination, local medical review policies, or Centers for Medicare and Medicaid Services program guidance.”

The measure also calls for appeal hearings to be in person “unless such individual requests that the hearing be conducted using tele- or video conference technologies.” The bill was referred to the Senate Finance Committee.

A new process for appealing Medicare coverage denials is raising concern among some advocates for senior citizens.

“We're concerned about the ability of beneficiaries to get a fair and favorable hearing,” said Vicki Gottlich, senior policy attorney at the Center for Medicare Advocacy, a Mansfield, Conn.-based group that helps beneficiaries with the appeals process. “Our organization and other organizations that do this kind of work have a very high success rate [for Medicare appeals] and we're concerned that the rate is going to go down.”

That could mean collection snags for physicians, she added. For example, if the physician accepts assignment for Medicare, Medicare denies coverage for a claim, and the denial is unsuccessfully appealed by the patient, “the doctor will then have to go collect from the patient. They don't want to do that.”

Under the new process, which is already underway, beneficiaries and providers whose claims are denied will be asked to appeal their claims to an administrative law judge (ALJ) via teleconference. Previously, these appeals were made in person.

“Older people and people with disabilities will have problems” with teleconferences, especially if their vision or hearing is impaired, Ms. Gottlich said. And if they ask for an in-person hearing instead, beneficiaries will waive their right to a timely decision if that request is granted. The new process also specifies that there will be three “regions” for hearing cases in person, rather than beneficiaries being allowed to have hearings in their home states.

Department of Health and Human Services spokesman Bill Hall said there are logistical reasons for waiving the right to speedy resolution in the case of an in-person hearing.

“We have to schedule everyone, allow time for them to travel, and set up a facility for the hearing,” he said. “That does not mean we'll take a year to do it.”

Ms. Gottlich noted that the changes were made in the first place in part because members of Congress were dissatisfied with how long it was taking for beneficiaries to make their way through the appeals process.

“The changes are supposed to protect beneficiaries,” but the system needs better funding to make sure everyone gets their chance to be heard in a timely way, she said. “There are some cases where teleconferencing could work, but for an individual beneficiary who's gone through the whole inhuman system and wants to see a real person, the system doesn't really work.”

Another change in the process places administrative law judges under the jurisdiction of HHS, rather than the Social Security Administration. Further, judges are instructed to place more weight on Medicare regulations than they were before. “The [law] says the administrative law judge is supposed to be independent of [the Centers for Medicare and Medicaid Services], but now they are supposed to give deference to their rules,” Ms. Gottlich said.

The Medical Group Management Association, which represents medical practice managers, is one group that is very interested in how the appeals process plays out. “We have concerns about how effective arbitration or review will be through a distance,” said Jennifer Miller, external relations liaison at MGMA's Washington office. “How effective can someone be to advocate their position over teleconference? When the rubber hits the road and we start seeing more [cases], we'll have a better feel for it.”

“Before now, someone dealing with disability issues would be trying to adjudicate what may be their third case of this type out of 300 cases, so they may not be as familiar with it,” she said. “Now there will be a specialized group of magistrates—it's going to be a new breed of ALJ.”

Several senators expressed concern about changes to the appeals process. A bill, the Justice for Medicare Beneficiaries Act, sponsored by Sens. Christopher Dodd (D-Conn.), Edward M. Kennedy (D-Mass.), John Kerry (D-Mass.), and Jeff Bingaman (D-N.M.), was introduced earlier this summer and would reverse many of the changes.

For instance, the bill says that judges “shall not be required to give substantial deference to local coverage determination, local medical review policies, or Centers for Medicare and Medicaid Services program guidance.”

The measure also calls for appeal hearings to be in person “unless such individual requests that the hearing be conducted using tele- or video conference technologies.” The bill was referred to the Senate Finance Committee.

WASHINGTON — Expect more health plans to offer limited insurance policies for people who are currently uninsured, Robert Laszewski said at a press briefing sponsored by the Center for Studying Health System Change.

“Insurers are recognizing that the 45 million people who are uninsured are a market,” said Mr. Laszewski, founder and president of Health Policy and Strategy Associates, a consulting firm. “Now, they're not a market for comprehensive major medical insurance, but they are a market for very limited benefits programs, programs that cost perhaps $50-$100 per month.”

He added that such plans—which typically include a wellness checkup every other year, a few visits to a primary care physician, and a drug benefit based on generic drugs—have come under criticism for not doing enough to help the uninsured. “I think that's a false set of arguments,” he said. “Of course they're not going to solve the problems of the uninsured, but [they] do respond to the needs of people who cannot afford health insurance.”

Most speakers at the conference also were upbeat about the future of consumer-driven health plans, such as health savings accounts (HSAs), although Christine Arnold, an executive director specializing in managed care at New York brokerage firm Morgan Stanley, noted that such plans are still a very small part of employers' health insurance offerings.

“Less than 5% of any HMO's total book of business is right now in any form of consumer-directed health care,” she said. “We may be on the cusp of a product revolution, which I've been hoping for, but I don't think it's here yet.”

Mr. Laszewski added that although consumer-driven health care “is a wonderful thing,” it focuses on first-dollar benefits rather than on the real problem in health care spending: that 75% of the costs are incurred by the 15% of people who are very ill. “It's the sick people who blow through the deductibles and get to the out-of-pocket maximums,” he said. “Sick people are the ones who control costs.”

“When the day is done, the incentives haven't fundamentally changed. In about another year or two, we're going to get this out of our system,” he continued.

Efforts to measure physician quality also came in for much discussion. “While I think 'sabotage' is a strong word, I would say there has been resistance by the health plans because each of them is trying to use this initiative as a competitive advantage,” said Ms. Arnold. “The tug of war is that employers want this on a macro basis—they want a Consumer Reports for providers.”

Two new initiatives could help consumers and employers compare health care quality, Ms. Arnold said. One is the Ambulatory Care Quality Alliance, a project of the American Academy of Family Physicians, the American College of Physicians, America's Health Insurance Plans, and the Agency for Healthcare Research and Quality. “They are trying to put together an objective list of measures. How do we measure who is a good provider? As we think about ways to assess quality, I think we need a standard.”

The second initiative involves a group of employers and consultants who are exploring “care-focused purchasing”—that is, getting health plans to aggregate their provider data so that employers and consumers can see which are the highest quality providers. “Any one health plan can't give you a full picture of [a physician],” she said. “This is an effort by employers to get together to pull providers and health plans in.”

Frederic Martucci, a managing director specializing in not-for-profit companies at Fitch Ratings, a New York credit-rating firm, said Medicare's efforts to measure provider quality will likely impact the health care market. “It's only a little bit, but the camel's nose is in the tent, and as long as Medicare is interested in rewarding providers—especially hospitals—[that exhibit] quality, I think other people are going to jump on the bandwagon.”

WASHINGTON — Expect more health plans to offer limited insurance policies for people who are currently uninsured, Robert Laszewski said at a press briefing sponsored by the Center for Studying Health System Change.

“Insurers are recognizing that the 45 million people who are uninsured are a market,” said Mr. Laszewski, founder and president of Health Policy and Strategy Associates, a consulting firm. “Now, they're not a market for comprehensive major medical insurance, but they are a market for very limited benefits programs, programs that cost perhaps $50-$100 per month.”

He added that such plans—which typically include a wellness checkup every other year, a few visits to a primary care physician, and a drug benefit based on generic drugs—have come under criticism for not doing enough to help the uninsured. “I think that's a false set of arguments,” he said. “Of course they're not going to solve the problems of the uninsured, but [they] do respond to the needs of people who cannot afford health insurance.”

Most speakers at the conference also were upbeat about the future of consumer-driven health plans, such as health savings accounts (HSAs), although Christine Arnold, an executive director specializing in managed care at New York brokerage firm Morgan Stanley, noted that such plans are still a very small part of employers' health insurance offerings.

“Less than 5% of any HMO's total book of business is right now in any form of consumer-directed health care,” she said. “We may be on the cusp of a product revolution, which I've been hoping for, but I don't think it's here yet.”

Mr. Laszewski added that although consumer-driven health care “is a wonderful thing,” it focuses on first-dollar benefits rather than on the real problem in health care spending: that 75% of the costs are incurred by the 15% of people who are very ill. “It's the sick people who blow through the deductibles and get to the out-of-pocket maximums,” he said. “Sick people are the ones who control costs.”

“When the day is done, the incentives haven't fundamentally changed. In about another year or two, we're going to get this out of our system,” he continued.

Efforts to measure physician quality also came in for much discussion. “While I think 'sabotage' is a strong word, I would say there has been resistance by the health plans because each of them is trying to use this initiative as a competitive advantage,” said Ms. Arnold. “The tug of war is that employers want this on a macro basis—they want a Consumer Reports for providers.”

Two new initiatives could help consumers and employers compare health care quality, Ms. Arnold said. One is the Ambulatory Care Quality Alliance, a project of the American Academy of Family Physicians, the American College of Physicians, America's Health Insurance Plans, and the Agency for Healthcare Research and Quality. “They are trying to put together an objective list of measures. How do we measure who is a good provider? As we think about ways to assess quality, I think we need a standard.”

The second initiative involves a group of employers and consultants who are exploring “care-focused purchasing”—that is, getting health plans to aggregate their provider data so that employers and consumers can see which are the highest quality providers. “Any one health plan can't give you a full picture of [a physician],” she said. “This is an effort by employers to get together to pull providers and health plans in.”

Frederic Martucci, a managing director specializing in not-for-profit companies at Fitch Ratings, a New York credit-rating firm, said Medicare's efforts to measure provider quality will likely impact the health care market. “It's only a little bit, but the camel's nose is in the tent, and as long as Medicare is interested in rewarding providers—especially hospitals—[that exhibit] quality, I think other people are going to jump on the bandwagon.”

WASHINGTON — Expect more health plans to offer limited insurance policies for people who are currently uninsured, Robert Laszewski said at a press briefing sponsored by the Center for Studying Health System Change.

“Insurers are recognizing that the 45 million people who are uninsured are a market,” said Mr. Laszewski, founder and president of Health Policy and Strategy Associates, a consulting firm. “Now, they're not a market for comprehensive major medical insurance, but they are a market for very limited benefits programs, programs that cost perhaps $50-$100 per month.”

He added that such plans—which typically include a wellness checkup every other year, a few visits to a primary care physician, and a drug benefit based on generic drugs—have come under criticism for not doing enough to help the uninsured. “I think that's a false set of arguments,” he said. “Of course they're not going to solve the problems of the uninsured, but [they] do respond to the needs of people who cannot afford health insurance.”

Most speakers at the conference also were upbeat about the future of consumer-driven health plans, such as health savings accounts (HSAs), although Christine Arnold, an executive director specializing in managed care at New York brokerage firm Morgan Stanley, noted that such plans are still a very small part of employers' health insurance offerings.

“Less than 5% of any HMO's total book of business is right now in any form of consumer-directed health care,” she said. “We may be on the cusp of a product revolution, which I've been hoping for, but I don't think it's here yet.”

Mr. Laszewski added that although consumer-driven health care “is a wonderful thing,” it focuses on first-dollar benefits rather than on the real problem in health care spending: that 75% of the costs are incurred by the 15% of people who are very ill. “It's the sick people who blow through the deductibles and get to the out-of-pocket maximums,” he said. “Sick people are the ones who control costs.”

“When the day is done, the incentives haven't fundamentally changed. In about another year or two, we're going to get this out of our system,” he continued.

Efforts to measure physician quality also came in for much discussion. “While I think 'sabotage' is a strong word, I would say there has been resistance by the health plans because each of them is trying to use this initiative as a competitive advantage,” said Ms. Arnold. “The tug of war is that employers want this on a macro basis—they want a Consumer Reports for providers.”

Two new initiatives could help consumers and employers compare health care quality, Ms. Arnold said. One is the Ambulatory Care Quality Alliance, a project of the American Academy of Family Physicians, the American College of Physicians, America's Health Insurance Plans, and the Agency for Healthcare Research and Quality. “They are trying to put together an objective list of measures. How do we measure who is a good provider? As we think about ways to assess quality, I think we need a standard.”

The second initiative involves a group of employers and consultants who are exploring “care-focused purchasing”—that is, getting health plans to aggregate their provider data so that employers and consumers can see which are the highest quality providers. “Any one health plan can't give you a full picture of [a physician],” she said. “This is an effort by employers to get together to pull providers and health plans in.”

Frederic Martucci, a managing director specializing in not-for-profit companies at Fitch Ratings, a New York credit-rating firm, said Medicare's efforts to measure provider quality will likely impact the health care market. “It's only a little bit, but the camel's nose is in the tent, and as long as Medicare is interested in rewarding providers—especially hospitals—[that exhibit] quality, I think other people are going to jump on the bandwagon.”

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.) said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and the risks of the medication. The information in the ads should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines. The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.) said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and the risks of the medication. The information in the ads should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines. The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.) said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and the risks of the medication. The information in the ads should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines. The panel's report “will be made public, and also made available to the FDA,” Mr. Tauzin said.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf