Oral isotretinoin (Accutane, Amnesteem, Claravis, Sotret) has been available in the United States for treatment of cystic and nodular acne vulgaris for more than 20 years. This medication truly revolutionized our specialty. However, it has also been one of the most controversial drugs approved by the FDA, and now it is a lot more difficult to prescribe and use this beneficial medication, thanks to
iPLEDGE.
iPLEDGE — a Web-based program aimed at eliminating isotretinoin-exposed pregnancies — will ensure 100% compliance from doctors, pharmacists and patients through tracking prescriptions from a central location.
I think there’s an alterior motive to iPLEDGE. I believe it is also aimed to decrease the number of prescriptions written for isotretinoin, since it will be much more cumbersome than the system that was in place previous to its March 1 start date.
Taking Responsibility for Mistakes
Since isotretinoin was approved in 1982, more than 160 babies have been born with drug-induced defects.1 This is unacceptable, I agree. But will iPLEDGE really help?
Is it not enough that we make our female patients sign an informed consent that clearly states the pregnancy risks associated with this drug? Is it not enough that we encourage our female patients to use two forms of birth control while they take isotretinoin? Is the picture of a pregnant woman with a red slash through the image not a clear message that says “don’t get pregnant while you take this medication”?
A dermatologist from Spain was visiting our department last year, and we discussed the System to Manage Accutane Related Teratogenicity (SMART) program (iPLEDGE’s predecessor). He simply laughed. In Spain, he merely tells his patients not to get pregnant, and that’s what they do.
Are our patients less intelligent than patients in Spain? Are our babies any more important than babies in Spain? Is the isotretinoin sold in Spain any less teratogenic? Or is this just a symptom of our society’s unwillingness to take responsibility for our actions?
Physicians haven’t done a very good job either. Robertson and colleagues recently performed a survey of women with an isotretinoin-exposed pregnancy who phoned the teratology information services. Almost 25% of them did not recall having contraception counseling before starting isotretinoin. Once therapy was initiated, only 62% recalled using a birth control method — and only 29% recalled using two forms of birth control. When asked, 56% did not recall monthly pregnancy tests, and nearly 25% of those surveyed did not recall being screened by two pregnancy tests before receiving a prescription.2
While recall and selection biases played a role in the study, these results are undoubtedly disturbing. We physicians are at least partly responsible for the failure of SMART.
Punishing Compliant Patients
The post-rofecoxib (Vioxx) FDA cannot afford another public relations disaster, but enough is enough!
What about the 99.99% of our patients who adhere to the rules and understand the risks? What about the male patients? Must they also go through this complicated process? What about a female patient of child-bearing potential who requires oral isotretinoin for pustular psoriasis? Must she really wait 30 days to get her medication? Isotretinoin would be the drug of choice for this patient; however, she cannot take acitretin (Soriatane), which has a teratogenicity risk that lasts 3 years. For an acute problem like pustular psoriasis, though, a 30-day wait obviously presents some problems.
There are many more questions and many more issues. Unfortunately, we will have to learn to live with iPLEDGE. iPLEDGE will also most certainly add fuel to the fire in regard to litigation brought against doctors who prescribe isotretinoin.
Despite these negatives, it is our duty to continue to prescribe isotretinoin for the patients who need it, at least until a safer and a more effective option is available.
READER RESPONSE
The Pathology Debate Continued
By David E. Tart, M.D.
While Gary Goldenberg, M.D., Section Editor of Issues in Dermatology, claimed in his “The Pathology Debate: Point” in the February issue that a debate between pathologist, dermatologist and dermatopathologist was sparked after an article on fee-splitting ran on the front page of The Wall Street Journal. In North Carolina the debate reached a peak about 2 years ago when the NC Pathology Society petitioned the NC Medical Board to ban the markup of anatomic pathologist services. The NC Medical Board examined the practice and found that it did not constitute fee splitting. The NC Pathology Society then introduced a bill in the NC Senate last year to ban markup of anatomic pathology services.
To make a long legislative story short, that bill did not pass as introduced but did result in a mandatory disclosure statement to the patient that is now required whenever anatomic pathology services are purchased and subsequently “marked-up”. Basically, the patient has the choice of direct billing by the pathologist or having my practice serve as the billing agent and patient advocate for these services.
There is in fact a valid viewpoint for those of us who are responsible for providing ethical and reputable dermatopathologist services to our patients. In my particular instance, I am saving most patients $30 to $60 per pathology specimen by handling the dermatopathology services in this manner.
Not a Fee-Splitting Issue
It’s important to note that the issue regarding the mark-up of purchased anatomic dermatopathology services is not one of “fee splitting”, as Dr. Goldenberg described. The American Medical Association (AMA) ethic standard E-6.02, “Fee Splitting,” states that fee splitting is a “payment by or to a physician solely for the referral of a patient”.
When I purchase anatomic pathology services I never receive any payment from the pathologist. If the pathologist paid me a fee or rebate for every case that I sent him, then that would be fee splitting. In point of fact, I guarantee payment for the pathologist’s service whether I get paid or not. I’m, therefore, at risk for nonpayment while the pathologist is fairly certain he will be paid.
A Question of Ethics
As for the question of whether or not it is ethical to “mark-up” anatomic dermatopathology services, I find no difference in this position than in another physician, group or other entity hiring a physician on salary and then billing patients or other payers at a higher rate (usually a fee schedule). Another example would be a physician assistant whose services are virtually always “marked-up”.
Is there something about the services of any one physician or provider that makes it acceptable to bill charges for that provider but “unethical” to do so for another provider? Are the services of a certain physician or specialty deserving to be treated differently than other providers? Frankly, I can see no difference, especially when the arrangement with the anatomic pathologist for referral is a mutually agreeable, arm’s length transaction. It seems self-righteous to establish the work product of one physician as inherently sacred from “mark-up” as compared to another physician or provider.
In fact, the AMA Ethics Principles do not ban re-billing. According to the AMA, “A physician should not charge a markup, commission or profit on the services rendered by others. A markup is excessive charge that exploits patients if it is nothing more than a tacked on amount for a service already provided or acted for by the laboratory.”
Providing a Value-Added Service
Practices that provide seamless access to anatomic pathology services provide value-added service to the patient and the pathologist. It is not simply a “tacked on” fee. The patient only has to deal with a local provider/practice with which he or she is familiar and that has already obtained his demographic and insurance information.
Likewise, the pathologist captures a population of patients for which he or she is provided the essential demographics related to his services. The pathologist only has to send one statement summarizing the services for the period (usually 1 month).
The pathologist is assured of getting paid as billed with little to no administrative hassle at all. He or she doesn’t have to file each claim, doesn’t have to chase down each individual patient demographic information or insurance information, and his or her payment isn’t delayed.
All this work, as well as the risk of non-payment or underpayment, is borne by the re-billing physician or practice. A fair profit reflects the value of this time and effort to the patient and the referral pathology group.
No Regulations
I fear a situation where insurers mandate the lab or pathologist I have to use. If insurance companies mandate lab/pathology sources, they often bid out the services and choose the cheapest source, forcing us to blindly use a lab/pathologist of unknown skill or less-than- optimal skill level. I lose the ability to specify a known quality lab without additional costs to the patient.
In dermatology, the lab specified by the insurer may not even be a reputable, board-certified dermatopathology lab. This places both the patient and me potentially at risk. I choose my dermatopathology lab, not based on price but rather the lab’s quality. It is most certainly not about “cheap”. I am responsible to my patient to assure that the pathologist meets the standard of care for that patient.
Dr. Tart is in practice in Hickory, NC. He is also a Diplomate of the American Board of Dermatology and a Fellow of the American Academy of Dermatology and the American Society of Dermatologic Surgery.
Oral isotretinoin (Accutane, Amnesteem, Claravis, Sotret) has been available in the United States for treatment of cystic and nodular acne vulgaris for more than 20 years. This medication truly revolutionized our specialty. However, it has also been one of the most controversial drugs approved by the FDA, and now it is a lot more difficult to prescribe and use this beneficial medication, thanks to
iPLEDGE.
iPLEDGE — a Web-based program aimed at eliminating isotretinoin-exposed pregnancies — will ensure 100% compliance from doctors, pharmacists and patients through tracking prescriptions from a central location.
I think there’s an alterior motive to iPLEDGE. I believe it is also aimed to decrease the number of prescriptions written for isotretinoin, since it will be much more cumbersome than the system that was in place previous to its March 1 start date.
Taking Responsibility for Mistakes
Since isotretinoin was approved in 1982, more than 160 babies have been born with drug-induced defects.1 This is unacceptable, I agree. But will iPLEDGE really help?
Is it not enough that we make our female patients sign an informed consent that clearly states the pregnancy risks associated with this drug? Is it not enough that we encourage our female patients to use two forms of birth control while they take isotretinoin? Is the picture of a pregnant woman with a red slash through the image not a clear message that says “don’t get pregnant while you take this medication”?
A dermatologist from Spain was visiting our department last year, and we discussed the System to Manage Accutane Related Teratogenicity (SMART) program (iPLEDGE’s predecessor). He simply laughed. In Spain, he merely tells his patients not to get pregnant, and that’s what they do.
Are our patients less intelligent than patients in Spain? Are our babies any more important than babies in Spain? Is the isotretinoin sold in Spain any less teratogenic? Or is this just a symptom of our society’s unwillingness to take responsibility for our actions?
Physicians haven’t done a very good job either. Robertson and colleagues recently performed a survey of women with an isotretinoin-exposed pregnancy who phoned the teratology information services. Almost 25% of them did not recall having contraception counseling before starting isotretinoin. Once therapy was initiated, only 62% recalled using a birth control method — and only 29% recalled using two forms of birth control. When asked, 56% did not recall monthly pregnancy tests, and nearly 25% of those surveyed did not recall being screened by two pregnancy tests before receiving a prescription.2
While recall and selection biases played a role in the study, these results are undoubtedly disturbing. We physicians are at least partly responsible for the failure of SMART.
Punishing Compliant Patients
The post-rofecoxib (Vioxx) FDA cannot afford another public relations disaster, but enough is enough!
What about the 99.99% of our patients who adhere to the rules and understand the risks? What about the male patients? Must they also go through this complicated process? What about a female patient of child-bearing potential who requires oral isotretinoin for pustular psoriasis? Must she really wait 30 days to get her medication? Isotretinoin would be the drug of choice for this patient; however, she cannot take acitretin (Soriatane), which has a teratogenicity risk that lasts 3 years. For an acute problem like pustular psoriasis, though, a 30-day wait obviously presents some problems.
There are many more questions and many more issues. Unfortunately, we will have to learn to live with iPLEDGE. iPLEDGE will also most certainly add fuel to the fire in regard to litigation brought against doctors who prescribe isotretinoin.
Despite these negatives, it is our duty to continue to prescribe isotretinoin for the patients who need it, at least until a safer and a more effective option is available.
READER RESPONSE
The Pathology Debate Continued
By David E. Tart, M.D.
While Gary Goldenberg, M.D., Section Editor of Issues in Dermatology, claimed in his “The Pathology Debate: Point” in the February issue that a debate between pathologist, dermatologist and dermatopathologist was sparked after an article on fee-splitting ran on the front page of The Wall Street Journal. In North Carolina the debate reached a peak about 2 years ago when the NC Pathology Society petitioned the NC Medical Board to ban the markup of anatomic pathologist services. The NC Medical Board examined the practice and found that it did not constitute fee splitting. The NC Pathology Society then introduced a bill in the NC Senate last year to ban markup of anatomic pathology services.
To make a long legislative story short, that bill did not pass as introduced but did result in a mandatory disclosure statement to the patient that is now required whenever anatomic pathology services are purchased and subsequently “marked-up”. Basically, the patient has the choice of direct billing by the pathologist or having my practice serve as the billing agent and patient advocate for these services.
There is in fact a valid viewpoint for those of us who are responsible for providing ethical and reputable dermatopathologist services to our patients. In my particular instance, I am saving most patients $30 to $60 per pathology specimen by handling the dermatopathology services in this manner.
Not a Fee-Splitting Issue
It’s important to note that the issue regarding the mark-up of purchased anatomic dermatopathology services is not one of “fee splitting”, as Dr. Goldenberg described. The American Medical Association (AMA) ethic standard E-6.02, “Fee Splitting,” states that fee splitting is a “payment by or to a physician solely for the referral of a patient”.
When I purchase anatomic pathology services I never receive any payment from the pathologist. If the pathologist paid me a fee or rebate for every case that I sent him, then that would be fee splitting. In point of fact, I guarantee payment for the pathologist’s service whether I get paid or not. I’m, therefore, at risk for nonpayment while the pathologist is fairly certain he will be paid.
A Question of Ethics
As for the question of whether or not it is ethical to “mark-up” anatomic dermatopathology services, I find no difference in this position than in another physician, group or other entity hiring a physician on salary and then billing patients or other payers at a higher rate (usually a fee schedule). Another example would be a physician assistant whose services are virtually always “marked-up”.
Is there something about the services of any one physician or provider that makes it acceptable to bill charges for that provider but “unethical” to do so for another provider? Are the services of a certain physician or specialty deserving to be treated differently than other providers? Frankly, I can see no difference, especially when the arrangement with the anatomic pathologist for referral is a mutually agreeable, arm’s length transaction. It seems self-righteous to establish the work product of one physician as inherently sacred from “mark-up” as compared to another physician or provider.
In fact, the AMA Ethics Principles do not ban re-billing. According to the AMA, “A physician should not charge a markup, commission or profit on the services rendered by others. A markup is excessive charge that exploits patients if it is nothing more than a tacked on amount for a service already provided or acted for by the laboratory.”
Providing a Value-Added Service
Practices that provide seamless access to anatomic pathology services provide value-added service to the patient and the pathologist. It is not simply a “tacked on” fee. The patient only has to deal with a local provider/practice with which he or she is familiar and that has already obtained his demographic and insurance information.
Likewise, the pathologist captures a population of patients for which he or she is provided the essential demographics related to his services. The pathologist only has to send one statement summarizing the services for the period (usually 1 month).
The pathologist is assured of getting paid as billed with little to no administrative hassle at all. He or she doesn’t have to file each claim, doesn’t have to chase down each individual patient demographic information or insurance information, and his or her payment isn’t delayed.
All this work, as well as the risk of non-payment or underpayment, is borne by the re-billing physician or practice. A fair profit reflects the value of this time and effort to the patient and the referral pathology group.
No Regulations
I fear a situation where insurers mandate the lab or pathologist I have to use. If insurance companies mandate lab/pathology sources, they often bid out the services and choose the cheapest source, forcing us to blindly use a lab/pathologist of unknown skill or less-than- optimal skill level. I lose the ability to specify a known quality lab without additional costs to the patient.
In dermatology, the lab specified by the insurer may not even be a reputable, board-certified dermatopathology lab. This places both the patient and me potentially at risk. I choose my dermatopathology lab, not based on price but rather the lab’s quality. It is most certainly not about “cheap”. I am responsible to my patient to assure that the pathologist meets the standard of care for that patient.
Dr. Tart is in practice in Hickory, NC. He is also a Diplomate of the American Board of Dermatology and a Fellow of the American Academy of Dermatology and the American Society of Dermatologic Surgery.
Oral isotretinoin (Accutane, Amnesteem, Claravis, Sotret) has been available in the United States for treatment of cystic and nodular acne vulgaris for more than 20 years. This medication truly revolutionized our specialty. However, it has also been one of the most controversial drugs approved by the FDA, and now it is a lot more difficult to prescribe and use this beneficial medication, thanks to
iPLEDGE.
iPLEDGE — a Web-based program aimed at eliminating isotretinoin-exposed pregnancies — will ensure 100% compliance from doctors, pharmacists and patients through tracking prescriptions from a central location.
I think there’s an alterior motive to iPLEDGE. I believe it is also aimed to decrease the number of prescriptions written for isotretinoin, since it will be much more cumbersome than the system that was in place previous to its March 1 start date.
Taking Responsibility for Mistakes
Since isotretinoin was approved in 1982, more than 160 babies have been born with drug-induced defects.1 This is unacceptable, I agree. But will iPLEDGE really help?
Is it not enough that we make our female patients sign an informed consent that clearly states the pregnancy risks associated with this drug? Is it not enough that we encourage our female patients to use two forms of birth control while they take isotretinoin? Is the picture of a pregnant woman with a red slash through the image not a clear message that says “don’t get pregnant while you take this medication”?
A dermatologist from Spain was visiting our department last year, and we discussed the System to Manage Accutane Related Teratogenicity (SMART) program (iPLEDGE’s predecessor). He simply laughed. In Spain, he merely tells his patients not to get pregnant, and that’s what they do.
Are our patients less intelligent than patients in Spain? Are our babies any more important than babies in Spain? Is the isotretinoin sold in Spain any less teratogenic? Or is this just a symptom of our society’s unwillingness to take responsibility for our actions?
Physicians haven’t done a very good job either. Robertson and colleagues recently performed a survey of women with an isotretinoin-exposed pregnancy who phoned the teratology information services. Almost 25% of them did not recall having contraception counseling before starting isotretinoin. Once therapy was initiated, only 62% recalled using a birth control method — and only 29% recalled using two forms of birth control. When asked, 56% did not recall monthly pregnancy tests, and nearly 25% of those surveyed did not recall being screened by two pregnancy tests before receiving a prescription.2
While recall and selection biases played a role in the study, these results are undoubtedly disturbing. We physicians are at least partly responsible for the failure of SMART.
Punishing Compliant Patients
The post-rofecoxib (Vioxx) FDA cannot afford another public relations disaster, but enough is enough!
What about the 99.99% of our patients who adhere to the rules and understand the risks? What about the male patients? Must they also go through this complicated process? What about a female patient of child-bearing potential who requires oral isotretinoin for pustular psoriasis? Must she really wait 30 days to get her medication? Isotretinoin would be the drug of choice for this patient; however, she cannot take acitretin (Soriatane), which has a teratogenicity risk that lasts 3 years. For an acute problem like pustular psoriasis, though, a 30-day wait obviously presents some problems.
There are many more questions and many more issues. Unfortunately, we will have to learn to live with iPLEDGE. iPLEDGE will also most certainly add fuel to the fire in regard to litigation brought against doctors who prescribe isotretinoin.
Despite these negatives, it is our duty to continue to prescribe isotretinoin for the patients who need it, at least until a safer and a more effective option is available.
READER RESPONSE
The Pathology Debate Continued
By David E. Tart, M.D.
While Gary Goldenberg, M.D., Section Editor of Issues in Dermatology, claimed in his “The Pathology Debate: Point” in the February issue that a debate between pathologist, dermatologist and dermatopathologist was sparked after an article on fee-splitting ran on the front page of The Wall Street Journal. In North Carolina the debate reached a peak about 2 years ago when the NC Pathology Society petitioned the NC Medical Board to ban the markup of anatomic pathologist services. The NC Medical Board examined the practice and found that it did not constitute fee splitting. The NC Pathology Society then introduced a bill in the NC Senate last year to ban markup of anatomic pathology services.
To make a long legislative story short, that bill did not pass as introduced but did result in a mandatory disclosure statement to the patient that is now required whenever anatomic pathology services are purchased and subsequently “marked-up”. Basically, the patient has the choice of direct billing by the pathologist or having my practice serve as the billing agent and patient advocate for these services.
There is in fact a valid viewpoint for those of us who are responsible for providing ethical and reputable dermatopathologist services to our patients. In my particular instance, I am saving most patients $30 to $60 per pathology specimen by handling the dermatopathology services in this manner.
Not a Fee-Splitting Issue
It’s important to note that the issue regarding the mark-up of purchased anatomic dermatopathology services is not one of “fee splitting”, as Dr. Goldenberg described. The American Medical Association (AMA) ethic standard E-6.02, “Fee Splitting,” states that fee splitting is a “payment by or to a physician solely for the referral of a patient”.
When I purchase anatomic pathology services I never receive any payment from the pathologist. If the pathologist paid me a fee or rebate for every case that I sent him, then that would be fee splitting. In point of fact, I guarantee payment for the pathologist’s service whether I get paid or not. I’m, therefore, at risk for nonpayment while the pathologist is fairly certain he will be paid.
A Question of Ethics
As for the question of whether or not it is ethical to “mark-up” anatomic dermatopathology services, I find no difference in this position than in another physician, group or other entity hiring a physician on salary and then billing patients or other payers at a higher rate (usually a fee schedule). Another example would be a physician assistant whose services are virtually always “marked-up”.
Is there something about the services of any one physician or provider that makes it acceptable to bill charges for that provider but “unethical” to do so for another provider? Are the services of a certain physician or specialty deserving to be treated differently than other providers? Frankly, I can see no difference, especially when the arrangement with the anatomic pathologist for referral is a mutually agreeable, arm’s length transaction. It seems self-righteous to establish the work product of one physician as inherently sacred from “mark-up” as compared to another physician or provider.
In fact, the AMA Ethics Principles do not ban re-billing. According to the AMA, “A physician should not charge a markup, commission or profit on the services rendered by others. A markup is excessive charge that exploits patients if it is nothing more than a tacked on amount for a service already provided or acted for by the laboratory.”
Providing a Value-Added Service
Practices that provide seamless access to anatomic pathology services provide value-added service to the patient and the pathologist. It is not simply a “tacked on” fee. The patient only has to deal with a local provider/practice with which he or she is familiar and that has already obtained his demographic and insurance information.
Likewise, the pathologist captures a population of patients for which he or she is provided the essential demographics related to his services. The pathologist only has to send one statement summarizing the services for the period (usually 1 month).
The pathologist is assured of getting paid as billed with little to no administrative hassle at all. He or she doesn’t have to file each claim, doesn’t have to chase down each individual patient demographic information or insurance information, and his or her payment isn’t delayed.
All this work, as well as the risk of non-payment or underpayment, is borne by the re-billing physician or practice. A fair profit reflects the value of this time and effort to the patient and the referral pathology group.
No Regulations
I fear a situation where insurers mandate the lab or pathologist I have to use. If insurance companies mandate lab/pathology sources, they often bid out the services and choose the cheapest source, forcing us to blindly use a lab/pathologist of unknown skill or less-than- optimal skill level. I lose the ability to specify a known quality lab without additional costs to the patient.
In dermatology, the lab specified by the insurer may not even be a reputable, board-certified dermatopathology lab. This places both the patient and me potentially at risk. I choose my dermatopathology lab, not based on price but rather the lab’s quality. It is most certainly not about “cheap”. I am responsible to my patient to assure that the pathologist meets the standard of care for that patient.
Dr. Tart is in practice in Hickory, NC. He is also a Diplomate of the American Board of Dermatology and a Fellow of the American Academy of Dermatology and the American Society of Dermatologic Surgery.
