|Highmark Commercial Medical Policy - Pennsylvania|
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Dorsal column stimulation, (spinal cord stimulation) and High Frequency Stimulation (HF10 Therapy) may be considered medically necessary for the relief of chronic intractable neurogenic pain of the trunk and/or limbs when ALL of the following conditions have been met:
The use of spinal cord stimulation for conditions other than chronic intractable neurogenic pain of the trunk and/or limbs, (for example, chronic stable refractory angina or peripheral ischemia) is considered experimental/investigational and therefore non-covered. The medical effectiveness of such therapy has not been established.
Unilateral or bilateral deep brain stimulation (DBS) of the thalamic ventralis intermedius nucleus (VIM) may be considered medically necessary for the treatment of intractable tremors due to essential tremor or Parkinson's disease (PD), when ALL of the following criteria are met:
Unilateral or bilateral deep brain stimulation of the subthalamic nucleus (STN) or globus pallidus interna (GPi) for the treatment of Parkinson's disease may be considered medically necessary when ALL of the following criteria are met:
Deep brain stimulation may be considered medically necessary when it is used as a treatment for chronic intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above.
Intensive electronic analysis and programming of a deep brain stimulator may be necessary immediately following implantation to achieve optimal stimulus parameters. Recognizing these needs, six (6) such programming visits will be covered within 60 days of the surgical implantation of the deep brain stimulator, and once every 30 days thereafter, as necessary.
Deep brain stimulation is considered experimental/investigational and therefore non-covered when used in ANY ONE of the following situations:
Scientific evidence does not support the use of deep brain stimulation for any of the above indications.
Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) may be considered medically necessary when used for the treatment of chronic intractable pain and as a means of assessing the need for continued treatment with an implanted electrical nerve stimulator.
The use of PENS and TENS for conditions other than chronic intractable pain is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indications.
Transcutaneous electrical nerve stimulation (TENS) may be considered medically necessary when the chronic intractable pain causes significant disruption of function when all of the following have been met:
Supplies for electrical stimulation device may be considered medically necessary when annual documentation is noted in the patient’s medical record.
Utilization of electrodes is included in the monthly supplies and the separate billing of electrodes is considered unbundling. Normal utilization with a covered electrical stimulation device is:
Implanted peripheral nerve stimulators may be considered medically necessary when used to alleviate chronic intractable neurogenic pain when ALL of the following criteria are met:
The use of peripheral nerve stimulation for post-herpetic neuralgia and for all other indications is considered experimental /investigational. Scientific evidence does not support the use of peripheral nerve stimulation other than the indications as stated above.
Subcutaneous target stimulation, peripheral subcutaneous field stimulation (PSFS), or peripheral nerve field stimulation (PNFS) is considered experimental/investigational for the treatment of chronic pain of peripheral nerves, and therefore, non-covered. There is a lack of scientific literature to support the efficacy of these devices.
Phrenic nerve stimulator implantation may be considered medically necessary:
The use of phrenic nerve stimulation for ANY other indications is considered experimental/investigational and therefore non-covered. Scientific evidence does not support the use of phrenic nerve stimulation other than the above indications as stated above.
The implantation of a vagus (vagal) nerve stimulator for seizure control may be considered medically necessary only when used as a last resort for patients with epilepsy with partial onset seizures. Medical necessity is limited to those cases where the seizures cannot be controlled by any other method, i.e., surgery or medication.
The use of Vagus (vagal) nerve stimulation is considered experimental/investigational as a treatment of other conditions, including but not limited to heart failure, fibromyalgia, depression, essential tremor, obesity, headaches, tinnitus, and traumatic brain injury and therefore non-covered. Scientific evidence has not demonstrated the long-term clinical efficacy of VNS and its impact on treatment-resistant depression.
Nonimplantable vagus nerve stimulation devices are considered Experimental/Investigational and, therefore, non-covered for all indications. There is lack of long term evidence based literature to confirm the efficacy and safety of these devices.
Implantable Hypoglossal Nerve Stimulators
The percutaneous or open (via incision) implantation of neuromuscular neurostimulator electrodes for chronic pain relief is considered experimental/investigational, and therefore non-covered. The clinical value of intramuscular stimulation for pain relief has not been validated by randomized controlled studies.
Occipital nerve stimulation (ONS) is considered experimental/investigational for all indications, and therefore, non-covered. Scientific evidence does not support its use for any indications.
Replacement batteries are not eligible for payment and therefore non-covered.
Use of electrical nerve stimulators and related services other than those specifically addressed within this policy, e.g., percutaneous neuromodulation therapy (PNT), or for conditions other than those addressed within this policy (e.g., multiple sclerosis, muscular dystrophy, or other motor function disorders), is considered experimental/investigational and therefore non-covered. Scientific evidence does not support the use of electrical stimulators or related services for any other indications.
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Electrical Nerve Stimulation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
A network provider can bill the member for the non-covered service.
Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as not medically necessary.
08/2016, Criteria Established for HF 10 Spinal Cord Stimulation Therapy
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.