Why can’t my patient have that miracle drug?

 

Modern medicine is truly blessed. Dermatology is no exception. With the development of more precise medications, our patients with severe psoriasis and atopic dermatitis no longer have to suffer in misery and social isolation. There is new hope for patients with metastatic melanoma. I recently watched President Jimmy Carter – a man with melanoma in his brain, certainly dead except for the advent of new drugs that are truly miraculous – release a rehabilitated sea turtle.

What is the drawback to such miracles? Cost! The cost of these medications can be extraordinary (hundreds of thousands of dollars a year); and guess what, everyone wants and needs their insurance plans to foot the bill for them. Biosimilars are not going to solve the cost issue, since biologic drugs are difficult to manufacture and get approved. The biosimilars are pricing in at only 5%-10% less than costs of the original biologic.

And expensive drugs like immunotherapies and biologics aren’t solely responsible for the rising costs of dermatologic drugs. Drug companies have systematically raised the costs of prescribed drugs for acne and rosacea, psoriasis, topical corticosteroids, and anti-infectives just because they can. In a survey of four national chain pharmacies, the prices of dermatologic drugs increased between 2009 to 2015, and “far outpaced the national consumer price index inflation rate of 11% between 2009 and 2015.” (JAMA Dermatol. 2016 Feb;152[2]:158-63).

Drug costs obviously drive part of the increase in health care premiums. Insurance companies often make drug coverage as difficult as possible, which makes sense from the insurers’ point of view. They require prior authorizations, have restricted formularies, or even insist patients switch biologics in midstream for cost savings or because of manufacturer rebates.

Sometimes a patient has an adverse event, or even dies, because of insurance plan delays. How can this be legal? Isn’t this the practice of medicine? There ought to be a law!

There is a law. Meet the Employee Retirement Income Security Act (ERISA) of 1974 (Meyer JA. ERISA Preemption: Protecting Employer Laboratories of Health Care Reform. Washington, DC: New Directions for Policy; 1995).

ERISA not only protects pensions (and established individual retirement accounts) but also health benefits. ERISA restricts compensation in lawsuits against insurers to the value of the services withheld or delayed and supersedes state laws (State regulation of managed care and the Employee Retirement Income Security Act. Mariner WK, N Engl J Med. 1996 Dec 26;335[26]:1986-90). This minimal payout makes such lawsuits unattractive to law firms. This is why insurers have become so bold in ignoring physician requests for treatment of their patients. The insurers attitude is: “Go ahead, sue me! You won’t get anything!”

Now, as physicians, we are not only patient advocates, but we also must be husbanders of scarce resources. Should we not pursue 100% clearance of that patient with psoriasis? This issue is worth debating, as the medical reimbursement pond gets sucked dry by medication costs.

Still, if you really hate prior authorizations, demented formularies, step therapy, drug denials, and outright stalling of medical care, you should ask Congress to amend ERISA. In writing about Justice Ruth Bader Ginsburg’s concurring Supreme Court opinion in a 2004 case regarding ERISA (Aetna Health Inc. v. Davila 542 U.S. 200), legal expert David S. Senoff said that amending ERISA “may be the only mechanism to provide patients with adequate compensation for damages as a result of coverage decisions by employer-sponsored health plans.” (Senoff DS. An anticipated decision with far-reaching results. Legal Intelligencer. 2004;230:5-7).

Amending ERISA is not going to happen in our current political environment. I’m not even sure I would want it to happen, since it would raise insurance costs even higher, and could make insurance unaffordable for many more people. Still, you and your patients deserve to know the cause of medication denials. Also, I suspect you have no idea how much an insurance executive will twitch (and a liberal member of Congress will smile) when you mention the possibility of amending ERISA. So if you are having a particularly acrimonious argument with an insurance executive about patient drug coverage, pull this nuke out of your arsenal and rap him or her with it.
 

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].

 

Modern medicine is truly blessed. Dermatology is no exception. With the development of more precise medications, our patients with severe psoriasis and atopic dermatitis no longer have to suffer in misery and social isolation. There is new hope for patients with metastatic melanoma. I recently watched President Jimmy Carter – a man with melanoma in his brain, certainly dead except for the advent of new drugs that are truly miraculous – release a rehabilitated sea turtle.

What is the drawback to such miracles? Cost! The cost of these medications can be extraordinary (hundreds of thousands of dollars a year); and guess what, everyone wants and needs their insurance plans to foot the bill for them. Biosimilars are not going to solve the cost issue, since biologic drugs are difficult to manufacture and get approved. The biosimilars are pricing in at only 5%-10% less than costs of the original biologic.

And expensive drugs like immunotherapies and biologics aren’t solely responsible for the rising costs of dermatologic drugs. Drug companies have systematically raised the costs of prescribed drugs for acne and rosacea, psoriasis, topical corticosteroids, and anti-infectives just because they can. In a survey of four national chain pharmacies, the prices of dermatologic drugs increased between 2009 to 2015, and “far outpaced the national consumer price index inflation rate of 11% between 2009 and 2015.” (JAMA Dermatol. 2016 Feb;152[2]:158-63).

Drug costs obviously drive part of the increase in health care premiums. Insurance companies often make drug coverage as difficult as possible, which makes sense from the insurers’ point of view. They require prior authorizations, have restricted formularies, or even insist patients switch biologics in midstream for cost savings or because of manufacturer rebates.

Sometimes a patient has an adverse event, or even dies, because of insurance plan delays. How can this be legal? Isn’t this the practice of medicine? There ought to be a law!

There is a law. Meet the Employee Retirement Income Security Act (ERISA) of 1974 (Meyer JA. ERISA Preemption: Protecting Employer Laboratories of Health Care Reform. Washington, DC: New Directions for Policy; 1995).

ERISA not only protects pensions (and established individual retirement accounts) but also health benefits. ERISA restricts compensation in lawsuits against insurers to the value of the services withheld or delayed and supersedes state laws (State regulation of managed care and the Employee Retirement Income Security Act. Mariner WK, N Engl J Med. 1996 Dec 26;335[26]:1986-90). This minimal payout makes such lawsuits unattractive to law firms. This is why insurers have become so bold in ignoring physician requests for treatment of their patients. The insurers attitude is: “Go ahead, sue me! You won’t get anything!”

Now, as physicians, we are not only patient advocates, but we also must be husbanders of scarce resources. Should we not pursue 100% clearance of that patient with psoriasis? This issue is worth debating, as the medical reimbursement pond gets sucked dry by medication costs.

Still, if you really hate prior authorizations, demented formularies, step therapy, drug denials, and outright stalling of medical care, you should ask Congress to amend ERISA. In writing about Justice Ruth Bader Ginsburg’s concurring Supreme Court opinion in a 2004 case regarding ERISA (Aetna Health Inc. v. Davila 542 U.S. 200), legal expert David S. Senoff said that amending ERISA “may be the only mechanism to provide patients with adequate compensation for damages as a result of coverage decisions by employer-sponsored health plans.” (Senoff DS. An anticipated decision with far-reaching results. Legal Intelligencer. 2004;230:5-7).

Amending ERISA is not going to happen in our current political environment. I’m not even sure I would want it to happen, since it would raise insurance costs even higher, and could make insurance unaffordable for many more people. Still, you and your patients deserve to know the cause of medication denials. Also, I suspect you have no idea how much an insurance executive will twitch (and a liberal member of Congress will smile) when you mention the possibility of amending ERISA. So if you are having a particularly acrimonious argument with an insurance executive about patient drug coverage, pull this nuke out of your arsenal and rap him or her with it.
 

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].

 

Modern medicine is truly blessed. Dermatology is no exception. With the development of more precise medications, our patients with severe psoriasis and atopic dermatitis no longer have to suffer in misery and social isolation. There is new hope for patients with metastatic melanoma. I recently watched President Jimmy Carter – a man with melanoma in his brain, certainly dead except for the advent of new drugs that are truly miraculous – release a rehabilitated sea turtle.

What is the drawback to such miracles? Cost! The cost of these medications can be extraordinary (hundreds of thousands of dollars a year); and guess what, everyone wants and needs their insurance plans to foot the bill for them. Biosimilars are not going to solve the cost issue, since biologic drugs are difficult to manufacture and get approved. The biosimilars are pricing in at only 5%-10% less than costs of the original biologic.

And expensive drugs like immunotherapies and biologics aren’t solely responsible for the rising costs of dermatologic drugs. Drug companies have systematically raised the costs of prescribed drugs for acne and rosacea, psoriasis, topical corticosteroids, and anti-infectives just because they can. In a survey of four national chain pharmacies, the prices of dermatologic drugs increased between 2009 to 2015, and “far outpaced the national consumer price index inflation rate of 11% between 2009 and 2015.” (JAMA Dermatol. 2016 Feb;152[2]:158-63).

Drug costs obviously drive part of the increase in health care premiums. Insurance companies often make drug coverage as difficult as possible, which makes sense from the insurers’ point of view. They require prior authorizations, have restricted formularies, or even insist patients switch biologics in midstream for cost savings or because of manufacturer rebates.

Sometimes a patient has an adverse event, or even dies, because of insurance plan delays. How can this be legal? Isn’t this the practice of medicine? There ought to be a law!

There is a law. Meet the Employee Retirement Income Security Act (ERISA) of 1974 (Meyer JA. ERISA Preemption: Protecting Employer Laboratories of Health Care Reform. Washington, DC: New Directions for Policy; 1995).

ERISA not only protects pensions (and established individual retirement accounts) but also health benefits. ERISA restricts compensation in lawsuits against insurers to the value of the services withheld or delayed and supersedes state laws (State regulation of managed care and the Employee Retirement Income Security Act. Mariner WK, N Engl J Med. 1996 Dec 26;335[26]:1986-90). This minimal payout makes such lawsuits unattractive to law firms. This is why insurers have become so bold in ignoring physician requests for treatment of their patients. The insurers attitude is: “Go ahead, sue me! You won’t get anything!”

Now, as physicians, we are not only patient advocates, but we also must be husbanders of scarce resources. Should we not pursue 100% clearance of that patient with psoriasis? This issue is worth debating, as the medical reimbursement pond gets sucked dry by medication costs.

Still, if you really hate prior authorizations, demented formularies, step therapy, drug denials, and outright stalling of medical care, you should ask Congress to amend ERISA. In writing about Justice Ruth Bader Ginsburg’s concurring Supreme Court opinion in a 2004 case regarding ERISA (Aetna Health Inc. v. Davila 542 U.S. 200), legal expert David S. Senoff said that amending ERISA “may be the only mechanism to provide patients with adequate compensation for damages as a result of coverage decisions by employer-sponsored health plans.” (Senoff DS. An anticipated decision with far-reaching results. Legal Intelligencer. 2004;230:5-7).

Amending ERISA is not going to happen in our current political environment. I’m not even sure I would want it to happen, since it would raise insurance costs even higher, and could make insurance unaffordable for many more people. Still, you and your patients deserve to know the cause of medication denials. Also, I suspect you have no idea how much an insurance executive will twitch (and a liberal member of Congress will smile) when you mention the possibility of amending ERISA. So if you are having a particularly acrimonious argument with an insurance executive about patient drug coverage, pull this nuke out of your arsenal and rap him or her with it.
 

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].