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Device Companies Would Have to Report Product Samples Under STAR Act

July 5, 2019 in Public Policy by Denise Bell

Drug pricing legislation moving through Congress could force medical device manufacturers to report the value of product samples given to certain healthcare providers. This could include free samples a doctor uses when educating patients on device use. AdvaMed and the Medical Device Manufacturers Association, along with state-based affiliates, including BioUtah, are urging policymakers to exclude medical device samples from such requirements.

In April, the House Ways and Means Committee passed the Prescription Drug STAR Act (H.R. 2113), aimed at bringing transparency to drug pricing. The measure included the Sunshine for Samples Act (H.R. 2064), which creates a new reporting obligation under the Physician Payments Sunshine Act (Sunshine Act) for items that meet the definition of “Product Sample” (defined as products provided that are not intended to be sold and intended for patient use). Both drug and device samples would be covered.

Under the samples legislation, each year, manufacturers would be required to report to CMS the aggregate monetary value and quantity of drug and device samples provided to covered recipients — physicians (or their immediate family members) and teaching hospitals. Beginning in 2023, such data would be posted by CMS to the Open Payments Database, in addition to other types of payments already required by law.

Although the Ways and Means Committee has acted, the Energy and Commerce Committee has yet to report out its version of drug pricing legislation, providing an opportunity to further educate lawmakers and address industry concerns.

As drafted, the Sunshine for Samples Act  inaccurately frames samples as payments of value to physicians. Furthermore, exclusions for educational use and charity care, provided under current law do not appear to apply1.

Since medical device companies generally do not have the infrastructure and systems in place to track and report on product samples, the difficulties associated with meeting this obligation may deter companies from providing products for patient education/training, charity care, and patient demonstrations.

A reduction in the availability of sample devices would have a far-reaching and detrimental impact on patients and care quality. BioUtah, in conjunction with our national association partners, will continue to advocate to exclude medical devices in any final legislation. AdvaMed talking points are available here.

1. Social Security Act Section 1128G(e)(10)(B)(iii), (iv), (v), and (viii) (42 U.S.C. 1320a-7h(e)(10)(B)(iii), (iv), (v), and (viii))