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Article History

Received: 2 May 2019

Accepted: 24 October 2019

First Online: 9 December 2019

Ethics approval and consent to participate

: This study used publicly available information and did not require ethics approval from the Yale University School of Medicine Human Research Protection Program.

: Not applicable.

: All authors have completed the ICMJE uniform disclosure form at and declare: In the past 36 months, JDW has received research support through the Meta Research Innovation Center at Stanford (METRICS) from the Laura and John Arnold Foundation; JSR has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. In addition, JSR serves as an ad hoc member of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). ACE, CJM, and PL have no additional potential competing interests to disclose.