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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules state that the implantation of spinal cord stimulators (SCS) may be covered as therapies for the relief
of chronic intractable pain. SCS is best suited for neuropathic pain but may have some limited value in other
types of nociceptive severe, intractable pain. Therapy consists of a short trial with a percutaneous implantation
of neurostimulator electrode(s) in the epidural space for assessing a patient's suitability for ongoing treatment
with a permanent surgically implanted nerve stimulator. Performance and documentation of an effective trial is
a prerequisite for permanent nerve stimulation. In situations where the spinal cord stimulator has been working
well but is in need of replacement for battery change, malfunction or end of stimulator life, a new trial is not
needed to replace the stimulator.
Selection of patients for implantation of spinal cord stimulators is critical to success of this therapy. SCS
therapy should be considered as a late option after more conservative attempts such as medications, physical
therapy, psychological therapy or other modalities have been tried.
Patients must have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to
implantation. (Such screening must include psychological, as well as physical evaluation). Documentation of
the history and careful screening must be available in the patient chart if requested. Patients being selected for a
trial
Must not have active substance abuse issues.
Must undergo proper patient education, discussion, and disclosure including an extensive discussion of the
risks and benefits of this therapy.
Must undergo appropriate psychological screening
Many experts recommend that the temporary neurostimulator be placed in an ASC or outpatient hospital
setting. However, the temporary neurostimulator trial can be done in an office setting if all the sterility,
equipment, professional training and support personnel required for the proper surgery, and follow up of the
patient are available. Permanent neurostimulators must be placed in an ASC or hospital. Physicians performing
SCS trials in the office setting must have like privileges at a local hospital or ASC, or the providers must be
subspecialty boarded in Pain Medicine by the American Board of Anesthesiology.
It is preferable that physicians performing the SCS trial will also perform the permanent implant. If the
physician implanting the trial neurostimulator does not or cannot implant the permanent neurostimulator, the
patient should be informed of this in writing and given the name of the referral surgeon who will implant the
permanent neurostimulator(s).
It is expected that accurate patient selection will lead to most patients going on to receive permanent implants.
Only patients who experience a positive response to a trial should proceed to a permanent implantation. All
trials which proceed to permanent implant must have adequate documentation in the chart to support that
decision. A successful trial should be associated with at least a 50% reduction of target pain, or 50% reduction
of analgesic medications, and show some element of functional improvement. (Patients with reflex sympathetic
dystrophy may show lower levels of improvement since it takes longer periods for improvement than the
typical 1-2-week trial). Physician judgment and experience will also be taken into account.
Physicians with a low trial to permanent implant ratio (less than 50%) will be subject to post-payment review
and may be asked to submit documentation as to the patient selection criteria, the radiologic imaging
demonstrating proper lead placement, and the medical necessity of the trials.
They will reimburse for placement of a maximum of 2 leads or 16 "contacts," and for 2 SCS trials per
anatomic spinal region per patient per lifetime (with exceptions allowed for technical limitations for the initial
trials or for use of different modalities of stimulation, including new technology). More than 2 SCS trials per
anatomic spinal region per patient per lifetime is not considered reasonable and necessary.
You can find these rules in the Local Coverage Determination (LCD) for Spinal Cord Stimulators for Chronic
Pain, L36204. This LCD is effective for services provided on or after December 1, 2019.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.