INTRODUCTION
State Medicaid programs are required under federal law to cover all Food and Drug Administration–approved prescription drugs for which the manufacturer has entered into a federal rebate agreement, with limited exceptions.1 To promote appropriate prescribing and control costs, most Medicaid programs create a preferred drug list, which denotes drugs that can usually be dispensed without prior authorization. State Medicaid programs gather input on this list from a drug selection committee (e.g., pharmacy and therapeutics committee) composed of stakeholders such as prescribers, pharmacists, and patient advocates.1
Substantial evidence suggests that pharmaceutical industry payments influence physician prescribing.2 For drug selection committees, this finding is concerning because physician members serve a policymaking function. Furthermore, in a previous study, conflict of interest policies for these committees often lacked standardization and comprehensiveness.3 Despite these concerns, pharmaceutical industry payments to drug selection committee members have not been characterized.
METHODS
In September 2021, we conducted a retrospective cohort study of all physician members of Medicaid drug selection committees. We identified all states that used a preferred drug list (46 states and DC).1 To identify physician committee members, we first performed Internet searches to identify state drug selection committee websites. When identified, we used the publicly posted membership roster. When there was no membership roster, we reviewed meeting minutes to identify physician members, whether present or absent. If neither a membership roster nor meeting minutes were available, we directly contacted agency staff or submitted a public records request for the membership roster.
For each physician, we queried the Centers for Medicare & Medicaid Services (CMS) Open Payments database and recorded all payments in 2020, the most recent year of data available. Next, we identified each physician’s primary specialty/subspecialty from the National Plan & Provider Enumeration System (NPPES). Finally, we calculated descriptive statistics on payment type and amount as well as payment amount by physician geography (census region) and specialty/subspecialty. Our Institutional Review Board determined this study to be not human subjects research.
RESULTS
Of 47 committees, 81% (38/47) had one or more physician members that received one or more payments and 26% (12/47) had a majority of physician members that received one or more payments. Of 261 physician committee members, 34% (88/261) received 1602 payments totaling $1,095,560 (Tables 1 and 2). By region, the percentage of physicians receiving a payment was highest in the South (45%, 46/103) and lowest in the West (21%, 11/53). By specialty/subspecialty, the percentage of physicians receiving a payment varied from 0% (e.g., geriatric medicine) to 100% (e.g., adult endocrinology and oncology and/or hematology). By payment type, research payments (e.g., for pre-clinical, observational, and clinical trial research) represented 21.5% of payments but 86.8% of the dollar value paid.
DISCUSSION
We found that over one-third of physician members of Medicaid drug selection committees had received a pharmaceutical industry payment. Given evidence that such payments may influence decision-making, our findings raise substantial concerns.
Current conflict of interest policies may not be adequate. In a previous analysis, the most common policy for drug selection committees was disclosure,3 which can be successful if the disclosed conflict of interest can then be avoided.4 However, in drug selection committees, another similarly knowledgeable committee member without a conflict of interest may not be available, particularly for subspecialists. Therefore, disclosure may not successfully mitigate conflicts of interest. In addition, state ethics laws and policies may apply to committee members given their role in advising the state. Although these laws and policies may limit payment size or type (e.g., to food and beverage only below a certain dollar threshold), such limitations are not likely to eliminate influence.2,5
The National Academy of Medicine, an independent organization, has published recommendations for mitigating conflicts of interest in clinical guideline development.6 The core recommendations are disclosure, divestment of financial investments and cessation of participation in marketing activities or advisory boards, and exclusion of individuals with conflicts of interest, where possible. These recommendations could readily be adapted to Medicaid drug selection committees.
This study has several limitations. First, 2020 was the most recent year of payment data available; however, we identified committee members as of 2021 because historical committee membership was not always available. Second, the state’s drug selection committee may only apply to Medicaid beneficiaries in the fee-for-service program. Medicaid managed care organizations may maintain their own drug selection committee and preferred drug list, which may result in an underestimate of payments. Third, CMS Open Payments data did not include non-physician clinicians (e.g., nurses, physician assistants, and pharmacists) at the time of data collection which may result in an underestimate of payments. Finally, specialty/subspecialty from NPPES may not correspond with board certification or area of practice.
States should consider adopting comprehensive conflict of interest policies to prevent industry influence on public policy and to safeguard public trust.
References
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Mitchell AP, Trivedi NU, Gennarelli RL, et al. Are Financial Payments From the Pharmaceutical Industry Associated With Physician Prescribing? : A Systematic Review. Annal Int Med 2021;174(3):353-361.
Nguyen NY, Bero L. Medicaid drug selection committees and inadequate management of conflicts of interest. JAMA Int Med 2013;173(5):338-343.
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Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice G. In: Graham R, Mancher M, Miller Wolman D, Greenfield S, Steinberg E, eds. Clinical Practice Guidelines We Can Trust. Washington (DC): National Academies Press (US); 2011.
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Bachhuber, M.A., Sugarman, O.K. Pharmaceutical Industry Payments to Physician Members of Medicaid Drug Selection Committees. J GEN INTERN MED 37, 4018–4020 (2022). https://doi.org/10.1007/s11606-022-07518-0
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DOI: https://doi.org/10.1007/s11606-022-07518-0