Even as iPLEDGE continues to disrupt dermatology practices around the country, dermatologists do have some cause for
celebration. The nullification — retroactive to its Jan. 1, 2006, start date — of the 4.4% Medicare cuts mandated by Congress was a small victory. Another positive, but decidedly less definitive, development was the President’s stated intention to seek passage of medical liability reform in Congress this year in his State of the Union address.
The Big Issues Facing Dermatology
However, despite this good news, frustration continues to mount for dermatologists who prescribe isotretinoin, as well as their patients who are trying to start or continue therapy with this medication. In spite of American Academy of Dermatology Association (AADA) objections based on what the AADA considered to be significant obstacles to implementation and compliance, the iPLEDGE program went into effect on March 1 with problems both unexpected and anticipated — and the problems continue for both dermatologists and patients.
And perhaps most troubling of all for those both inside the medical profession and out was the Bush administration’s latest rebuff to medical research: Aggressive efforts to reverse the proposal notwithstanding, the first budget cuts to the National Institutes of Health since 1970 were signed into law in January. A month later, the President proposed that this level be frozen through 2007, all of which will result in an estimated 2% reduction in the total number of grants that can be funded.
Other news affecting all physicians is the “pact” between Congress and the American Medical Association (AMA) allowing for development of performance measures (presumed to be preliminary) to a mandated pay-for-performance link to Medicare compensation in the not-too-distant future.
Here’s a more detailed look at these critical issues.
Medical Liability Reform
Despite President Bush’s message to Congress during his State of the Union address, medical liability reform has yet to be resolved on the national level. As it now stands, laws vary from state to state and the issue remains at a stalemate in Congress, probably through year-end.
Doctors for Medical Liability Reform (DMLR), of which AADA is a founding member, continues to publicize its official national position in support of the $250,000 cap specified in H.R. 5, the HEALTH Act of 2005. Its 2005 campaign toward that end utilized radio, direct mail and the Internet and featured animation and a mini-documentary. This year’s initiative adds to that mix radio tours, paid media/earned media, online/print advertising, direct mail, animations and grassroots advocacy.
However, the DMLR is no longer overly focused on the precise amount of the cap as much as placing a limit on non-economic damages awarded in medical malpractice lawsuits. This is a view shared by the Academy, with which the Alliance of Specialty medicine advocates for medical liability reform legislation in Congress.
In addition to the cap on non-economic damages, the AADA officially supports enactment of legislation that would include the following:
• a reasonable statute of limitations for filing lawsuits
• periodic payment of damages
• an allocation of damages in proportion with fault
• a stipulation that prevents patients’ lawyers from “shopping for the friendliest venues and jurisdictions” where they might win the largest awards or settlements.
AMA Quality Measures Pact with Congress: A Sign of the Times
In a move some practitioners regarded as premature, the American Medical Association (AMA) agreed to develop 140 evidence-based performance measures that will form the foundation for voluntary quality-of-care reporting to Medicare in 2007 and presumably pave the way for full-scale implementation of the Centers for Medicare and Medicaid Services (CMS) pay-for-performance (P4P) initiatives.
According to the pact, which dovetails with the government’s arrangements with various healthcare providers, doctors will voluntarily report to the federal government “on at least three to five quality measures per physician” by the end of 2007.
However, it’s the expectation of Danville, PA, dermatologist Dirk Elston that P4P, which links Medicare payment to adherence to and reporting of practices deemed quality healthcare, will eventually be voluntary in name only, as private insurers will likely require higher out-of-pocket co-payments for visits to providers who don’t adhere to or report measures applying to their specialty.
Pay-for-Performance Adherence Likely to be Mandatory
“Initially, simply reporting data will qualify for incentive pay. With time, pay will be linked to actual performance on the measures,” explains Dr. Elston, who is a member of an AADA task force formed to determine reasonable performance measures for dermatologists.
Alluding to the resistance posed largely by specialists who feared the information could be used to justify cutting their Medicare fees, Dr. Elston points out that it’s not just the government that is pushing for accountability in health care.
“P4P is being driven by major employers like General Electric, who want it as part of the healthcare they purchase for their employees, and private health insurance plans as well as Medicare,” he says, adding, “And it’s definitely coming, with or without the participation of the specialties.”
It is mainly for that reason that Dr. Elston, who is on the teaching faculty in the departments of pathology and dermatology at Geisinger Medical Center, says specialty societies should remain involved and participate in shaping the system that will inevitably emerge.
“Realistically, this is something that is going to happen whether we want it or not. Either it will be done to us or with us,” he maintains. “We are better off if we have some input into the process.”
Dr. Elston describes how such measures will likely be used and how they will impact their practices.
How Pay-For-Performance Measures Will be Used
“There are some quality measures that dermatologists will agree are good medicine,” he says, using the example of offering a full skin exam for patients who have a history of melanoma.
In this case, the still-to-be-developed software would link the ICD-9 code of melanoma to a code for a full skin exam.
“Quality measure codes can be initially created by the federal government as G-codes. Later, they can become category II CPT codes. We are used to category I codes used for procedures. Category II codes are used to capture quality measures,” he asserts.
Dr. Elston further describes how such a system would handle times when there is a valid reason a physician can’t perform the quality measure.
“There are modifiers that can be added to prevent it from counting against the physician. These are already used by primary care physicians for their quality measures. For example, a primary care physician is supposed to ensure that patients receive screening mammograms. But what if a patient has had bilateral mastectomies? She needs to be excluded from the denominator used to measure the physician’s compliance. When the quality measure is either refused by the patient or not indicated, the modifier is used to remove such patients from the performance measure calculation.”
Dr. Elston emphasizes that reporting will be voluntary, but he sees private payers instituting policies that would penalize physicians for failure to comply.
“Although this is incentive pay, some worry about the result for a physician who decides not to participate and is subsequently placed on a list that could be dubbed something like ‘physicians who don’t participate in quality measures.’ Patients could have to pay a higher co-pay to see a provider who doesn’t report quality data.”
And if that weren’t bad enough, he observes, patients are likely to receive an explanation-of-medical-benefits letter reminding them of their choice and the extra premium they paid.
But accommodating the changes may also come at a cost to reporting physicians, who, according to the AMA-Congress agreement, “should receive” some additional payment to offset the costs of collecting and reporting the data.
Dr. Elston notes that most data are likely to be captured through existing coding software, but eventually, accommodating the coming changes could entail additional investment in electronic medical records. Dr. Elston says he believes it is reasonable to ask that the government and private payers offset these costs through incentive payments.
iPLEDGE Program: A Rocky Start
The FDA’s iPLEDGE pregnancy risk management program went into effect Mar. 1, 2006, complete with many of the “flaws and inefficiencies” the AADA anticipated and sought unsuccessfully to correct, plus others that caught all involved off-guard.
Among the many problems overwhelming the outtake system were “invalid” prescriptions, system rejection of patient information and duplicate patient identification numbers.
“There are a lot of operational problems,” says dermatologist Diane Thiboutot, who had testified on Feb. 10, 2006, before the FDA’s Drug Safety and Risk Management Advisory Committee, in an effort to further delay the mandatory start date.
These problems, she says, are largely related to confusion caused by delayed availability of information on how to correctly use the newly and rapidly developed system as well as unwritten rules — many related to scheduling — embedded within the program.
“First, there was no section on the iPLEDGE site on how to enter information, and FAQs and sections on troubleshooting weren’t populated until after the March 1 start date. Because many details were not known in advance, it was difficult to use the system.”
For example, patients and physicians who were frustrated when unable to enter information into the system and confused when prescriptions were rejected without explanation at pharmacies, needed to be aware that the program required them to schedule visits more than 30 days apart to be valid.
Dr. Thiboutot, a Penn State University College of Medicine Professor of Dermatology maintains that the AADA, which has also been overwhelmed by calls, has necessarily switched gears from efforts to be proactive to a kind of triage approach to handling problems.
Addressing iPledge’s Problems
“We’re trying to address the problems, but that takes time. We’re mainly trying to collect and disseminate information through the Academy’s Web site,” Dr. Thiboutot explains.
The Academy, she says, is now compiling information on these problems as they become aware of them — creating a kind of punch list to be shared with the FDA, the drug manufacturers, and Covance, which is running the system.
To more effectively gather and document these issues, on March 15, the AAD issued a member alert directing physicians to the AAD site for the latest information on iPLEDGE and urging them to make their patients aware that updated guidelines are now posted on the iPLEDGE site.
To report additional problems and viewpoints about the program, the alert further instructed physicians to provide feedback via the isotretinoin@aad.org.
It also encouraged them and their patients to report these issues to their Congressmen. In the meantime, the AADA has a long and short list of solutions.
“On the short list are things that can be done quickly without requiring changes to the drug labeling with which the entire iPLEDGE program is linked. The long-term goal is to make additional improvements to the system that may involve changing the labeling.”
More Bad News for Research
In the January issue of Skin & Aging, Jouni J. Uitto, M.D., Ph.D., Chair of the AADA’s Research Committee, expressed disappointment in the “abysmal” 0.7% increase in National Institutes of Health (NIH) funds budgeted for skin research through the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Dr. Uitto, who is also Professor and Chair, Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, shares the widely held view that medical research, already hobbled by the current administration’s cuts, stands to suffer more as the President remains unresponsive to efforts to restore lost funds for domestic programs.
That became clearer still when, to the dismay of Dr. Uitto and the medical research community at large, Congress voted an across-the-board 1% decrease in domestic program funding that leaves skin research in the negative column.
“This resulted in a 0.3% decrease in skin research funds, which means for the first time in more than 30 years, the NIH received less funding than in the prior year. Considering inflation and the increased cost of doing research, this is in reality a major reduction that will not only impact dermatology, but in training young scientists in biomedical research.”
Dr. Uitto further explains that, although the President’s budget for 2007 proposes that NIH funding for 2007 remain the same as in 2006, the total number of research grants that NIH could fund with this funding level would drop by 642, or 2%, below last year’s level. “This is because grants have a built-in escalation, which means the same amount of money can’t fund the same number of grants.”
And less research, he points out, means fewer discoveries, fewer new drugs in development, and fewer new treatments reaching the one in three Americans suffering from a skin disease today.
According to the AADA, maintaining the pace of medical discovery and innovation calls for the kind of budget increases the NIH could count on in the past, 5%, or $1.4 billion more than the amount approved for fiscal year 2006.
Medicare Cuts Nullified
More than a month after measures that decreased Medicare payments went into effect, the President signed into law the Deficit Reduction Act of 2005 (DRA), which nullifies the 4.4% cuts initiated by Congress.
According to the Centers for Medicare & Medicaid Services (CMS) Office of Public Affairs, changes were to be implemented retroactively for the affected period, January 1 to February 8, when the announcement was made.
A February 10 CMS fact sheet stated that its contractors would automatically reprocess claims for services provided on or after Jan. 1, 2006, that were subjected to the 4.4% payment reduction. Reprocessing is expected to be completed by Jul. 1, 2006. It explained that physicians and practitioners paid under Medicare’s physician fee schedule may expect several aggregated (versus claim-by-claim) payments during that time.
Recognizing that higher payment rates could affect a physician’s decision on whether or not to participate in Medicare, the CMS offered a second participation enrollment period Feb. 15 to Mar. 31, 2006, the election of which was retroactive to Jan. 1, 2006.
Even as iPLEDGE continues to disrupt dermatology practices around the country, dermatologists do have some cause for
celebration. The nullification — retroactive to its Jan. 1, 2006, start date — of the 4.4% Medicare cuts mandated by Congress was a small victory. Another positive, but decidedly less definitive, development was the President’s stated intention to seek passage of medical liability reform in Congress this year in his State of the Union address.
The Big Issues Facing Dermatology
However, despite this good news, frustration continues to mount for dermatologists who prescribe isotretinoin, as well as their patients who are trying to start or continue therapy with this medication. In spite of American Academy of Dermatology Association (AADA) objections based on what the AADA considered to be significant obstacles to implementation and compliance, the iPLEDGE program went into effect on March 1 with problems both unexpected and anticipated — and the problems continue for both dermatologists and patients.
And perhaps most troubling of all for those both inside the medical profession and out was the Bush administration’s latest rebuff to medical research: Aggressive efforts to reverse the proposal notwithstanding, the first budget cuts to the National Institutes of Health since 1970 were signed into law in January. A month later, the President proposed that this level be frozen through 2007, all of which will result in an estimated 2% reduction in the total number of grants that can be funded.
Other news affecting all physicians is the “pact” between Congress and the American Medical Association (AMA) allowing for development of performance measures (presumed to be preliminary) to a mandated pay-for-performance link to Medicare compensation in the not-too-distant future.
Here’s a more detailed look at these critical issues.
Medical Liability Reform
Despite President Bush’s message to Congress during his State of the Union address, medical liability reform has yet to be resolved on the national level. As it now stands, laws vary from state to state and the issue remains at a stalemate in Congress, probably through year-end.
Doctors for Medical Liability Reform (DMLR), of which AADA is a founding member, continues to publicize its official national position in support of the $250,000 cap specified in H.R. 5, the HEALTH Act of 2005. Its 2005 campaign toward that end utilized radio, direct mail and the Internet and featured animation and a mini-documentary. This year’s initiative adds to that mix radio tours, paid media/earned media, online/print advertising, direct mail, animations and grassroots advocacy.
However, the DMLR is no longer overly focused on the precise amount of the cap as much as placing a limit on non-economic damages awarded in medical malpractice lawsuits. This is a view shared by the Academy, with which the Alliance of Specialty medicine advocates for medical liability reform legislation in Congress.
In addition to the cap on non-economic damages, the AADA officially supports enactment of legislation that would include the following:
• a reasonable statute of limitations for filing lawsuits
• periodic payment of damages
• an allocation of damages in proportion with fault
• a stipulation that prevents patients’ lawyers from “shopping for the friendliest venues and jurisdictions” where they might win the largest awards or settlements.
AMA Quality Measures Pact with Congress: A Sign of the Times
In a move some practitioners regarded as premature, the American Medical Association (AMA) agreed to develop 140 evidence-based performance measures that will form the foundation for voluntary quality-of-care reporting to Medicare in 2007 and presumably pave the way for full-scale implementation of the Centers for Medicare and Medicaid Services (CMS) pay-for-performance (P4P) initiatives.
According to the pact, which dovetails with the government’s arrangements with various healthcare providers, doctors will voluntarily report to the federal government “on at least three to five quality measures per physician” by the end of 2007.
However, it’s the expectation of Danville, PA, dermatologist Dirk Elston that P4P, which links Medicare payment to adherence to and reporting of practices deemed quality healthcare, will eventually be voluntary in name only, as private insurers will likely require higher out-of-pocket co-payments for visits to providers who don’t adhere to or report measures applying to their specialty.
Pay-for-Performance Adherence Likely to be Mandatory
“Initially, simply reporting data will qualify for incentive pay. With time, pay will be linked to actual performance on the measures,” explains Dr. Elston, who is a member of an AADA task force formed to determine reasonable performance measures for dermatologists.
Alluding to the resistance posed largely by specialists who feared the information could be used to justify cutting their Medicare fees, Dr. Elston points out that it’s not just the government that is pushing for accountability in health care.
“P4P is being driven by major employers like General Electric, who want it as part of the healthcare they purchase for their employees, and private health insurance plans as well as Medicare,” he says, adding, “And it’s definitely coming, with or without the participation of the specialties.”
It is mainly for that reason that Dr. Elston, who is on the teaching faculty in the departments of pathology and dermatology at Geisinger Medical Center, says specialty societies should remain involved and participate in shaping the system that will inevitably emerge.
“Realistically, this is something that is going to happen whether we want it or not. Either it will be done to us or with us,” he maintains. “We are better off if we have some input into the process.”
Dr. Elston describes how such measures will likely be used and how they will impact their practices.
How Pay-For-Performance Measures Will be Used
“There are some quality measures that dermatologists will agree are good medicine,” he says, using the example of offering a full skin exam for patients who have a history of melanoma.
In this case, the still-to-be-developed software would link the ICD-9 code of melanoma to a code for a full skin exam.
“Quality measure codes can be initially created by the federal government as G-codes. Later, they can become category II CPT codes. We are used to category I codes used for procedures. Category II codes are used to capture quality measures,” he asserts.
Dr. Elston further describes how such a system would handle times when there is a valid reason a physician can’t perform the quality measure.
“There are modifiers that can be added to prevent it from counting against the physician. These are already used by primary care physicians for their quality measures. For example, a primary care physician is supposed to ensure that patients receive screening mammograms. But what if a patient has had bilateral mastectomies? She needs to be excluded from the denominator used to measure the physician’s compliance. When the quality measure is either refused by the patient or not indicated, the modifier is used to remove such patients from the performance measure calculation.”
Dr. Elston emphasizes that reporting will be voluntary, but he sees private payers instituting policies that would penalize physicians for failure to comply.
“Although this is incentive pay, some worry about the result for a physician who decides not to participate and is subsequently placed on a list that could be dubbed something like ‘physicians who don’t participate in quality measures.’ Patients could have to pay a higher co-pay to see a provider who doesn’t report quality data.”
And if that weren’t bad enough, he observes, patients are likely to receive an explanation-of-medical-benefits letter reminding them of their choice and the extra premium they paid.
But accommodating the changes may also come at a cost to reporting physicians, who, according to the AMA-Congress agreement, “should receive” some additional payment to offset the costs of collecting and reporting the data.
Dr. Elston notes that most data are likely to be captured through existing coding software, but eventually, accommodating the coming changes could entail additional investment in electronic medical records. Dr. Elston says he believes it is reasonable to ask that the government and private payers offset these costs through incentive payments.
iPLEDGE Program: A Rocky Start
The FDA’s iPLEDGE pregnancy risk management program went into effect Mar. 1, 2006, complete with many of the “flaws and inefficiencies” the AADA anticipated and sought unsuccessfully to correct, plus others that caught all involved off-guard.
Among the many problems overwhelming the outtake system were “invalid” prescriptions, system rejection of patient information and duplicate patient identification numbers.
“There are a lot of operational problems,” says dermatologist Diane Thiboutot, who had testified on Feb. 10, 2006, before the FDA’s Drug Safety and Risk Management Advisory Committee, in an effort to further delay the mandatory start date.
These problems, she says, are largely related to confusion caused by delayed availability of information on how to correctly use the newly and rapidly developed system as well as unwritten rules — many related to scheduling — embedded within the program.
“First, there was no section on the iPLEDGE site on how to enter information, and FAQs and sections on troubleshooting weren’t populated until after the March 1 start date. Because many details were not known in advance, it was difficult to use the system.”
For example, patients and physicians who were frustrated when unable to enter information into the system and confused when prescriptions were rejected without explanation at pharmacies, needed to be aware that the program required them to schedule visits more than 30 days apart to be valid.
Dr. Thiboutot, a Penn State University College of Medicine Professor of Dermatology maintains that the AADA, which has also been overwhelmed by calls, has necessarily switched gears from efforts to be proactive to a kind of triage approach to handling problems.
Addressing iPledge’s Problems
“We’re trying to address the problems, but that takes time. We’re mainly trying to collect and disseminate information through the Academy’s Web site,” Dr. Thiboutot explains.
The Academy, she says, is now compiling information on these problems as they become aware of them — creating a kind of punch list to be shared with the FDA, the drug manufacturers, and Covance, which is running the system.
To more effectively gather and document these issues, on March 15, the AAD issued a member alert directing physicians to the AAD site for the latest information on iPLEDGE and urging them to make their patients aware that updated guidelines are now posted on the iPLEDGE site.
To report additional problems and viewpoints about the program, the alert further instructed physicians to provide feedback via the isotretinoin@aad.org.
It also encouraged them and their patients to report these issues to their Congressmen. In the meantime, the AADA has a long and short list of solutions.
“On the short list are things that can be done quickly without requiring changes to the drug labeling with which the entire iPLEDGE program is linked. The long-term goal is to make additional improvements to the system that may involve changing the labeling.”
More Bad News for Research
In the January issue of Skin & Aging, Jouni J. Uitto, M.D., Ph.D., Chair of the AADA’s Research Committee, expressed disappointment in the “abysmal” 0.7% increase in National Institutes of Health (NIH) funds budgeted for skin research through the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Dr. Uitto, who is also Professor and Chair, Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, shares the widely held view that medical research, already hobbled by the current administration’s cuts, stands to suffer more as the President remains unresponsive to efforts to restore lost funds for domestic programs.
That became clearer still when, to the dismay of Dr. Uitto and the medical research community at large, Congress voted an across-the-board 1% decrease in domestic program funding that leaves skin research in the negative column.
“This resulted in a 0.3% decrease in skin research funds, which means for the first time in more than 30 years, the NIH received less funding than in the prior year. Considering inflation and the increased cost of doing research, this is in reality a major reduction that will not only impact dermatology, but in training young scientists in biomedical research.”
Dr. Uitto further explains that, although the President’s budget for 2007 proposes that NIH funding for 2007 remain the same as in 2006, the total number of research grants that NIH could fund with this funding level would drop by 642, or 2%, below last year’s level. “This is because grants have a built-in escalation, which means the same amount of money can’t fund the same number of grants.”
And less research, he points out, means fewer discoveries, fewer new drugs in development, and fewer new treatments reaching the one in three Americans suffering from a skin disease today.
According to the AADA, maintaining the pace of medical discovery and innovation calls for the kind of budget increases the NIH could count on in the past, 5%, or $1.4 billion more than the amount approved for fiscal year 2006.
Medicare Cuts Nullified
More than a month after measures that decreased Medicare payments went into effect, the President signed into law the Deficit Reduction Act of 2005 (DRA), which nullifies the 4.4% cuts initiated by Congress.
According to the Centers for Medicare & Medicaid Services (CMS) Office of Public Affairs, changes were to be implemented retroactively for the affected period, January 1 to February 8, when the announcement was made.
A February 10 CMS fact sheet stated that its contractors would automatically reprocess claims for services provided on or after Jan. 1, 2006, that were subjected to the 4.4% payment reduction. Reprocessing is expected to be completed by Jul. 1, 2006. It explained that physicians and practitioners paid under Medicare’s physician fee schedule may expect several aggregated (versus claim-by-claim) payments during that time.
Recognizing that higher payment rates could affect a physician’s decision on whether or not to participate in Medicare, the CMS offered a second participation enrollment period Feb. 15 to Mar. 31, 2006, the election of which was retroactive to Jan. 1, 2006.
Even as iPLEDGE continues to disrupt dermatology practices around the country, dermatologists do have some cause for
celebration. The nullification — retroactive to its Jan. 1, 2006, start date — of the 4.4% Medicare cuts mandated by Congress was a small victory. Another positive, but decidedly less definitive, development was the President’s stated intention to seek passage of medical liability reform in Congress this year in his State of the Union address.
The Big Issues Facing Dermatology
However, despite this good news, frustration continues to mount for dermatologists who prescribe isotretinoin, as well as their patients who are trying to start or continue therapy with this medication. In spite of American Academy of Dermatology Association (AADA) objections based on what the AADA considered to be significant obstacles to implementation and compliance, the iPLEDGE program went into effect on March 1 with problems both unexpected and anticipated — and the problems continue for both dermatologists and patients.
And perhaps most troubling of all for those both inside the medical profession and out was the Bush administration’s latest rebuff to medical research: Aggressive efforts to reverse the proposal notwithstanding, the first budget cuts to the National Institutes of Health since 1970 were signed into law in January. A month later, the President proposed that this level be frozen through 2007, all of which will result in an estimated 2% reduction in the total number of grants that can be funded.
Other news affecting all physicians is the “pact” between Congress and the American Medical Association (AMA) allowing for development of performance measures (presumed to be preliminary) to a mandated pay-for-performance link to Medicare compensation in the not-too-distant future.
Here’s a more detailed look at these critical issues.
Medical Liability Reform
Despite President Bush’s message to Congress during his State of the Union address, medical liability reform has yet to be resolved on the national level. As it now stands, laws vary from state to state and the issue remains at a stalemate in Congress, probably through year-end.
Doctors for Medical Liability Reform (DMLR), of which AADA is a founding member, continues to publicize its official national position in support of the $250,000 cap specified in H.R. 5, the HEALTH Act of 2005. Its 2005 campaign toward that end utilized radio, direct mail and the Internet and featured animation and a mini-documentary. This year’s initiative adds to that mix radio tours, paid media/earned media, online/print advertising, direct mail, animations and grassroots advocacy.
However, the DMLR is no longer overly focused on the precise amount of the cap as much as placing a limit on non-economic damages awarded in medical malpractice lawsuits. This is a view shared by the Academy, with which the Alliance of Specialty medicine advocates for medical liability reform legislation in Congress.
In addition to the cap on non-economic damages, the AADA officially supports enactment of legislation that would include the following:
• a reasonable statute of limitations for filing lawsuits
• periodic payment of damages
• an allocation of damages in proportion with fault
• a stipulation that prevents patients’ lawyers from “shopping for the friendliest venues and jurisdictions” where they might win the largest awards or settlements.
AMA Quality Measures Pact with Congress: A Sign of the Times
In a move some practitioners regarded as premature, the American Medical Association (AMA) agreed to develop 140 evidence-based performance measures that will form the foundation for voluntary quality-of-care reporting to Medicare in 2007 and presumably pave the way for full-scale implementation of the Centers for Medicare and Medicaid Services (CMS) pay-for-performance (P4P) initiatives.
According to the pact, which dovetails with the government’s arrangements with various healthcare providers, doctors will voluntarily report to the federal government “on at least three to five quality measures per physician” by the end of 2007.
However, it’s the expectation of Danville, PA, dermatologist Dirk Elston that P4P, which links Medicare payment to adherence to and reporting of practices deemed quality healthcare, will eventually be voluntary in name only, as private insurers will likely require higher out-of-pocket co-payments for visits to providers who don’t adhere to or report measures applying to their specialty.
Pay-for-Performance Adherence Likely to be Mandatory
“Initially, simply reporting data will qualify for incentive pay. With time, pay will be linked to actual performance on the measures,” explains Dr. Elston, who is a member of an AADA task force formed to determine reasonable performance measures for dermatologists.
Alluding to the resistance posed largely by specialists who feared the information could be used to justify cutting their Medicare fees, Dr. Elston points out that it’s not just the government that is pushing for accountability in health care.
“P4P is being driven by major employers like General Electric, who want it as part of the healthcare they purchase for their employees, and private health insurance plans as well as Medicare,” he says, adding, “And it’s definitely coming, with or without the participation of the specialties.”
It is mainly for that reason that Dr. Elston, who is on the teaching faculty in the departments of pathology and dermatology at Geisinger Medical Center, says specialty societies should remain involved and participate in shaping the system that will inevitably emerge.
“Realistically, this is something that is going to happen whether we want it or not. Either it will be done to us or with us,” he maintains. “We are better off if we have some input into the process.”
Dr. Elston describes how such measures will likely be used and how they will impact their practices.
How Pay-For-Performance Measures Will be Used
“There are some quality measures that dermatologists will agree are good medicine,” he says, using the example of offering a full skin exam for patients who have a history of melanoma.
In this case, the still-to-be-developed software would link the ICD-9 code of melanoma to a code for a full skin exam.
“Quality measure codes can be initially created by the federal government as G-codes. Later, they can become category II CPT codes. We are used to category I codes used for procedures. Category II codes are used to capture quality measures,” he asserts.
Dr. Elston further describes how such a system would handle times when there is a valid reason a physician can’t perform the quality measure.
“There are modifiers that can be added to prevent it from counting against the physician. These are already used by primary care physicians for their quality measures. For example, a primary care physician is supposed to ensure that patients receive screening mammograms. But what if a patient has had bilateral mastectomies? She needs to be excluded from the denominator used to measure the physician’s compliance. When the quality measure is either refused by the patient or not indicated, the modifier is used to remove such patients from the performance measure calculation.”
Dr. Elston emphasizes that reporting will be voluntary, but he sees private payers instituting policies that would penalize physicians for failure to comply.
“Although this is incentive pay, some worry about the result for a physician who decides not to participate and is subsequently placed on a list that could be dubbed something like ‘physicians who don’t participate in quality measures.’ Patients could have to pay a higher co-pay to see a provider who doesn’t report quality data.”
And if that weren’t bad enough, he observes, patients are likely to receive an explanation-of-medical-benefits letter reminding them of their choice and the extra premium they paid.
But accommodating the changes may also come at a cost to reporting physicians, who, according to the AMA-Congress agreement, “should receive” some additional payment to offset the costs of collecting and reporting the data.
Dr. Elston notes that most data are likely to be captured through existing coding software, but eventually, accommodating the coming changes could entail additional investment in electronic medical records. Dr. Elston says he believes it is reasonable to ask that the government and private payers offset these costs through incentive payments.
iPLEDGE Program: A Rocky Start
The FDA’s iPLEDGE pregnancy risk management program went into effect Mar. 1, 2006, complete with many of the “flaws and inefficiencies” the AADA anticipated and sought unsuccessfully to correct, plus others that caught all involved off-guard.
Among the many problems overwhelming the outtake system were “invalid” prescriptions, system rejection of patient information and duplicate patient identification numbers.
“There are a lot of operational problems,” says dermatologist Diane Thiboutot, who had testified on Feb. 10, 2006, before the FDA’s Drug Safety and Risk Management Advisory Committee, in an effort to further delay the mandatory start date.
These problems, she says, are largely related to confusion caused by delayed availability of information on how to correctly use the newly and rapidly developed system as well as unwritten rules — many related to scheduling — embedded within the program.
“First, there was no section on the iPLEDGE site on how to enter information, and FAQs and sections on troubleshooting weren’t populated until after the March 1 start date. Because many details were not known in advance, it was difficult to use the system.”
For example, patients and physicians who were frustrated when unable to enter information into the system and confused when prescriptions were rejected without explanation at pharmacies, needed to be aware that the program required them to schedule visits more than 30 days apart to be valid.
Dr. Thiboutot, a Penn State University College of Medicine Professor of Dermatology maintains that the AADA, which has also been overwhelmed by calls, has necessarily switched gears from efforts to be proactive to a kind of triage approach to handling problems.
Addressing iPledge’s Problems
“We’re trying to address the problems, but that takes time. We’re mainly trying to collect and disseminate information through the Academy’s Web site,” Dr. Thiboutot explains.
The Academy, she says, is now compiling information on these problems as they become aware of them — creating a kind of punch list to be shared with the FDA, the drug manufacturers, and Covance, which is running the system.
To more effectively gather and document these issues, on March 15, the AAD issued a member alert directing physicians to the AAD site for the latest information on iPLEDGE and urging them to make their patients aware that updated guidelines are now posted on the iPLEDGE site.
To report additional problems and viewpoints about the program, the alert further instructed physicians to provide feedback via the isotretinoin@aad.org.
It also encouraged them and their patients to report these issues to their Congressmen. In the meantime, the AADA has a long and short list of solutions.
“On the short list are things that can be done quickly without requiring changes to the drug labeling with which the entire iPLEDGE program is linked. The long-term goal is to make additional improvements to the system that may involve changing the labeling.”
More Bad News for Research
In the January issue of Skin & Aging, Jouni J. Uitto, M.D., Ph.D., Chair of the AADA’s Research Committee, expressed disappointment in the “abysmal” 0.7% increase in National Institutes of Health (NIH) funds budgeted for skin research through the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Dr. Uitto, who is also Professor and Chair, Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, shares the widely held view that medical research, already hobbled by the current administration’s cuts, stands to suffer more as the President remains unresponsive to efforts to restore lost funds for domestic programs.
That became clearer still when, to the dismay of Dr. Uitto and the medical research community at large, Congress voted an across-the-board 1% decrease in domestic program funding that leaves skin research in the negative column.
“This resulted in a 0.3% decrease in skin research funds, which means for the first time in more than 30 years, the NIH received less funding than in the prior year. Considering inflation and the increased cost of doing research, this is in reality a major reduction that will not only impact dermatology, but in training young scientists in biomedical research.”
Dr. Uitto further explains that, although the President’s budget for 2007 proposes that NIH funding for 2007 remain the same as in 2006, the total number of research grants that NIH could fund with this funding level would drop by 642, or 2%, below last year’s level. “This is because grants have a built-in escalation, which means the same amount of money can’t fund the same number of grants.”
And less research, he points out, means fewer discoveries, fewer new drugs in development, and fewer new treatments reaching the one in three Americans suffering from a skin disease today.
According to the AADA, maintaining the pace of medical discovery and innovation calls for the kind of budget increases the NIH could count on in the past, 5%, or $1.4 billion more than the amount approved for fiscal year 2006.
Medicare Cuts Nullified
More than a month after measures that decreased Medicare payments went into effect, the President signed into law the Deficit Reduction Act of 2005 (DRA), which nullifies the 4.4% cuts initiated by Congress.
According to the Centers for Medicare & Medicaid Services (CMS) Office of Public Affairs, changes were to be implemented retroactively for the affected period, January 1 to February 8, when the announcement was made.
A February 10 CMS fact sheet stated that its contractors would automatically reprocess claims for services provided on or after Jan. 1, 2006, that were subjected to the 4.4% payment reduction. Reprocessing is expected to be completed by Jul. 1, 2006. It explained that physicians and practitioners paid under Medicare’s physician fee schedule may expect several aggregated (versus claim-by-claim) payments during that time.
Recognizing that higher payment rates could affect a physician’s decision on whether or not to participate in Medicare, the CMS offered a second participation enrollment period Feb. 15 to Mar. 31, 2006, the election of which was retroactive to Jan. 1, 2006.
