The Advanced Medical Technology Association (Advamed) said FDA commissioner Stephen Hahn addressed a special meeting of the Advamed board of directors regarding steps the agency and industry can take to address the ongoing COVID-19 pandemic. The March 17 Advamed statement offered few details of the meeting, however. Kevin Lobo, Advamed’s board chairman and CEO of Stryker Corp., of Kalamazoo, Mich., thanked Hahn for the meeting, stating that the medical technology industry “is doing everything we can to help treat and stop the spread of the coronavirus.” Scott Whitaker, Advamed’s president and CEO, said the meeting was devoted nearly exclusively to efforts to thwart the COVID-19 outbreak, and that device makers “look forward to continuing our work to get the medical technologies essential to this fight to where they’re needed most.”
The Office of the U.S. Trade Representative announced an extension of exemptions from tariffs on good imported from China, a list that includes inoculator sets. Breast pumps are also on the list of extended exclusions.
The U.S. Office of Inspector General (OIG) said it would not subject health care providers to sanctions for waiving co-insurance payments from Medicare beneficiaries for telehealth services. OIG’s action comes as the Centers for Medicare and Medicaid Services announced a similar policy directed toward expanded coverage of telehealth. OIG said this policy is contingent upon fulfillment each of two conditions, including that the telehealth services be among those covered by applicable coverage and payment policies, and that the services are provided during the time period included in the public health emergency declaration directed toward the COVID-19 outbreak.
Citing industry concerns about visitors and the health of FDA staff and those who conduct inspections for the agency under contract at the state level, the agency announced March 18 that it is temporarily postponing all routine surveillance facility inspections in the U.S. However, for-cause domestic inspection assignments will be evaluated and will proceed if considered mission-critical, FDA Commissioner Stephen Hahn said. Last week, the agency postponed most foreign facility inspections through April.
The antitrust division of the U.S. Department of Justice said it has adopted a series of temporary measures regarding civil merger investigations for the duration of the COVID-19 public health emergency. DoJ said it will rely more extensively on telework to review mergers, requesting an additional 30 days from merging parties to review the transaction after the parties have fulfilled documentation requests. Parties to a merger will be able to electronically file to fulfill the documentation requirements of Hart-Scott-Rodino regulations, and all depositions will be rescheduled for videoconferencing.