“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
“The increased demand for CPAPs and disposables creates opportunities for home medical equipment (HME) and durable medical equipment (DME) suppliers. But a word of caution: The supplier can have no involvement with a home sleep test (HST) administered to a patient covered by Medicare fee-for-service (FFS).”
“In short, Medicare will not pay ABC for the CPAP if ABC is the provider of the sleep test. That term is defined as “the individual or entity that directly or indirectly administers and/or interprets the sleep test and/or furnishes the sleep test device used to administer the sleep test.””
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“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”
“Sleep Review’s matrix compares features such as dimensions, weight, noise level, interface compatibility, operating pressure range, operating modes, features, warranty, and additional information for the following devices: Breas Medical Inc Z2 Auto, Drive Devilbiss Healthcare IntelliPAP2 CPAP System, Philips DreamStation Go, and ResMed AirMini.”