Evaluation of Clinical Compendia Used for Medicare Part D Coverage Determinations for Off-label Prescribing in Dermatology

Barbieri, John S.; Claire, Kayla St; Mostaghimi, Arash; Albrecht, Joerg

doi:10.1001/jamadermatol.2018.5052

Cited by 7 publications

(11 citation statements)

References 24 publications

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“…It is estimated to represent 36% of the prescribing in intensive care units 11 and 13% to 71% of the prescribing in adult oncology patients 12 . Similar challenges with Medicare Part D denials of medically appropriate therapies are identified and well documented in dermatology 13 …”

Section: Discussionmentioning

confidence: 97%

A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients

Lushin

McDermott

Truax

et al. 2021

American Journal of Transplantation

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Medicare Part D plans make coverage decisions according to FDA‐labeled indications and off‐label uses endorsed by two CMS‐recognized compendia. Patients who rely on Medicare Part D for immunosuppressive drug coverage are at risk for denied coverage when these medications are prescribed off‐label. The purpose of this multicenter collaboration was to assemble a case series documenting situations where immunosuppressive therapies prescribed for transplant patients were denied by Medicare Part D prescription drug plans. This case series documents 66 instances in 39 patients where immunosuppressive drug claims were denied coverage due to off‐label use not endorsed by the compendia. Patients were recipients of lung (n = 28, 72%), heart (n = 7, 18%), or liver (n = 4, 10%) transplants. Denied claims were for mycophenolate mofetil (n = 22, 33%), azathioprine (n = 18, 27%), sirolimus (n = 15, 23%), mycophenolate sodium (n = 5, 8%), everolimus (n = 5, 8%), and belatacept (n = 1, 1%). Most denials were upheld across all the levels of attempted appeal, including those escalated to a Medicare Administrative Law Judge. This case series demonstrates a critical flaw in the construct of the Medicare Prescription Drug Benefit. The currently referenced compendia are not up to date and do not reflect best practices in organ transplantation.

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Section: Discussionmentioning

confidence: 97%

A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients

Lushin

McDermott

Truax

et al. 2021

American Journal of Transplantation

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“…The wide gap between FDA labeling and routine clinical practice is well known throughout medicine, with off-label indications commonly used in routine practice. [45][46][47][48][49][50][51][52] This disparity is the result of the FDA drug approval process, which relies on drug manufacturers to fund the required, supporting research. The motivations supporting these financial investments are lost once the drug patent expires.…”

Section: Fdamentioning

confidence: 99%

Regulatory Challenges to Emergency Medicine Procedural Sedation

Green

Norse

Jackson

et al. 2021

Annals of Emergency Medicine

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As currently written, national regulatory guidance on procedural sedation has elements that are contradictory, confusing, and out of date. As a result, hospital procedural sedation policies are often widely inconsistent between institutions despite similar settings and resources, putting emergency department (ED) patients at risk by denying them uniform access to safe, effective, and appropriate procedural sedation care. Many hospitals have chosen to take overly conservative stances with respect to regulatory compliance to minimize their perceived risk. Herein, we review and critique standards and policies from the Centers for Medicare & Medicaid Services, The Joint Commission, state nursing boards, the Food and Drug Administration, and others with respect to their effect on ED procedural sedation. Where appropriate, we recommend modifications of and enhancements to their guidance that would improve the access of ED patients to modern, safe, and effective procedural sedation care. [

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“…1 Insurance companies frequently utilize FDA guidelines and drug compendia to dictate treatment coverage; however, these resources are frequently outdated and lacking in scope. 2 We agree that treatment coverage should not be restricted by FDA approval. To lend further credence to their declaration, herein we provide evidence of disparity in prior authorization (PA) rates between diseases with and without an FDA-indicated treatment.…”

mentioning

confidence: 97%

Reply to: “Lack of a US Food and Drug Administration indication should not limit access to appropriate treatment”

Savage

Flood

Popatia

et al. 2019

Journal of the American Academy of Dermatology

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Evaluation of Clinical Compendia Used for Medicare Part D Coverage Determinations for Off-label Prescribing in Dermatology

Cited by 7 publications

References 24 publications

A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients

A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients

Regulatory Challenges to Emergency Medicine Procedural Sedation

Reply to: “Lack of a US Food and Drug Administration indication should not limit access to appropriate treatment”

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