Insight - Fall 2020

Fall 2020 | 6 Industry News FDA Action Could Lower Prescription Drug Prices The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) took actions to help provide safe, effective, and affordable drugs to American patients. The measure is part of the Safe Importation Action Plan that would allow states to import certain prescription drugs from Canada. The final rule implements a provision of federal law that allows FDA- authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The final guidance for industry describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA- approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. “The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.” The rule allows states (including the District of Columbia and territories), Indian tribes and – in certain future circumstances – pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization. Source: FDA CMS Releases Tools to Streamline COVID-19 Lab Testing In late September, the Centers for Medicare & Medicaid Services (CMS) released new tools to reduce paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments (CLIA) certification for COVID-19 testing. Source: CMS NABP ® Home Infusion Therapy Pharmacy Accreditation The National Association of Boards of Pharmacy ® (NABP) announced that the Centers for Medicare & Medicaid Services (CMS) has approved the organization’s Home Infusion Therapy Pharmacy Accreditation. Beginning January 2021, CMS will require accreditation for home infusion therapy services billed to Medicare. As part of the approval process, NABP underwent a thorough review of its accreditation program standards, which were found to meet or exceed the CMS requirements. “As a CMS-deemed DMEPOS accrediting organization since 2006, the inclusion of the CMS approval for our Home Infusion Therapy Pharmacy Accreditation continues to bring value to our robust portfolio of offerings,” said NABP President Timothy D. Fensky, R.Ph., DPh, FACA. “We appreciate the early participation of a number of our DMEPOS-accredited organizations who welcomed the opportunity to adopt this new program in anticipation of the January 2021 deadline. We look forward to seeing additional new and existing customers earn this accreditation and be recognized for the invaluable services they provide to patients relying on home infusion therapy services.” NABP’s Home Infusion Therapy Pharmacy Accreditation, along with its other accreditation offerings, provide new and existing customers with a comprehensive set of accreditations delivered in a streamlined and cost-effective way. Information about NABP’s Home Infusion Therapy Pharmacy Accreditation is available on their website along with its other accreditation offerings at https://nabp.pharmacy/ programs/#accreditation . Source: NABP