FDA, CMS Will Use Parallel Review For Pain-Control Alternatives To Opioids, Medicare Official Says
The Medicare agency is working with US FDA on a parallel review process for non-addictive medical device pain control products and non-opioid drug alternatives to treat chronic pain, Kimberly Brandt, a CMS deputy administrator, told the Senate Finance Committee April 19.
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Bills Advancing In US Congress Would Hasten FDA Reviews Of Non-Opioid Medtech Alternatives
The Senate Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Health Subcommittee each passed bills this week to expedite approval pathways for non-opioid devices and drugs to control pain and prevent further addictions. Other opioid bills passed by the House subpanel seek to remove reimbursement challenges for opioid-alternative pain control devices.
HHS Secretary Nominee Azar Advances In Senate
US HHS Secretary Nominee Alex Azar was approved by the Senate Finance Committee on Jan. 17, sending his nomination to the full Senate for consideration. The former pharmaceutical company executive supports approval of additional telehealth reimbursements and, at a recent confirmation hearing, he discussed more access to durable medical equipment for patients in competitive bidding program areas.
FDA Extends Parallel Review Program ‘Indefinitely’
The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.