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.
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While demand for spinal cord stimulation (SCS) devices used in pain management continues to expand at double-digit rates, a small but growing number of highly innovative companies that develop stimulators to specifically target peripheral nerve pain is creating excitement among pain doctors looking for better options to treat an intractable population that's seen little success with standard therapy. With millions of people worldwide suffering from low back pain, severe headaches and migraines, neck pain and other chronic pain, the demand for safe, effective, percutaneously-placed devices remains high. In this article, we'll highlight emerging companies working on PNS devices and provide insights from pain physicians on the pros and cons of these devices.
Senators on June 12 advanced a bill addressing the opioid crisis from the Finance Committee, including sunshine provisions expanding the types of providers that must report payments of value by drug and device manufacturers, requiring an essential Medicare handbook to describe non-opioid alternatives for pain control, and expanding telehealth payments for providers treating beneficiaries with substance use disorders.
The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.