Yes, MiniStim PNS received FDA 510k clearance on August 14, 2020.
NS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. PNS is not intended to treat pain in the craniofacial region. The most common treatment areas include the cluneal nerves, the genicular nerves, the tibial nerve, the sacral and pudendal nerves, however the device can be placed at any peripheral nerve in the body neck or below.
Some healthcare insurances may require a trial procedure before the permanent implant, however many do not and accept diagnostic nerve evaluation for confirmation of nerve identification. Some accept confirmation of efficacy denoted by evaluation during the permanent implant procedure. Please contact your patient’s healthcare plan for additional coverage guidance.
Some health plans may require a psych evaluation prior to the permanent implant. Please contact your patient’s health plan for more guidance.
Medicare has a positive National Coverage Determination (NCD) for Electrical Nerve Stimulators, NCD# 100-3., in which Implanted Peripheral Nerve Stimulation is part of PNS NCD.
However, Noridian, a Medicare Administrative Contractor, has a separate positive policy, Local Coverage implanted Decision (LCD), for Peripheral Nerve Stimulators, LCD #L37360 PNS LCD.
Noridian covers the following states:
California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands, Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming.
If you have any questions on these policies, please contact us.
Most commercial health plans have a positive coverage policy for peripheral nerve stimulation. Please contact your patient’s health plan for more guidance.
Some health plans may require a prior authorization and/or predetermination. Please contact your patient’s health plan for more guidance.
MiniStim will use reasonable efforts to provide accurate information herein, but this information should not be construed as providing clinical advice, dictating reimbursement policy, or as a substitute for the judgment of a healthcare provider. It is always the healthcare provider’s responsibility to determine the appropriate codes, charges for services, and use of modifiers for services rendered and to complete and submit coverage or reimbursement-related documentation. Providers should always check with the appropriate payer before submitting claims. Providers are responsible for verifying coverage with payers, including the applicability of any non-coverage policies that may exist. MiniStim assumes no responsibility for the timeliness, accuracy, or completeness of the information provided. Reimbursement laws, regulations, and payer policies change frequently without notice. It is highly recommended that providers consult with their payers, coding specialists, and/or legal counsel regarding coverage, coding, and payment issues.