Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and transfers of value made to healthcare providers. On August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published a Proposed Rule seeking to expand the Open Payments program, including the number and types of covered recipients and payment categories. As a result, drug manufacturers have at least two reasons to quickly conduct a comprehensive internal examination of their Open Payments program.
President Donald Trump announced that, as of September 24, 2018, additional tariffs of 10% were imposed on hundreds of chemical ingredients, many of which are used in the manufacturing of dietary supplements, cosmetics, and over-the-counter (OTC) drug products. Manufacturers have had to develop contingency plans and strategies for dealing with the imposition of these tariffs. Such contingency plans may include renegotiating supplier contracts; re-sourcing the ingredients; and notifying distributors and customers of disruptions, delays, or price changes. A rise in the tariff rate to 25% for these products, scheduled for January 1, 2019, has been delayed pending current negotiations with China, and during this period no exclusion requests on particular products are being accepted by the Office of the US Trade Representative.