HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-258-001
Topic:
Spinal Cord and Implantable Peripheral Nerve Stimulators
Section:
Surgery
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
April 2018
 
 

Spinal cord stimulation, also known as dorsal column stimulation, is a reversible therapy applied for neuropathic pain with techniques that include multi-output implanted pulse generators and a choice of electrodes, some of which can be placed percutaneously. The technical goal of this therapy is to achieve stimulation of paresthesia of the dorsal horn of the spinal cord at a subjectively comfortable level, overlapping an individual’s topography of pain. The procedure initially involves a short-term, trial (e. g., three to seven [3-7] days) of percutaneous (temporary) spinal cord stimulation, prior to the subcutaneous (permanent) implantation of the spinal cord stimulation device, to determine whether the spinal cord stimulator device will induce sufficient pain relief to render it medically necessary.

In contrast to spinal cord stimulation, peripheral nerve stimulation involves implantation of electrodes near or on a peripheral nerve to reduce pain. Peripheral nerve field stimulation is a technology that involves placement of electrodes subcutaneously within an area of maximal pain, with the objective of stimulating a region of affected nerves to reduce pain. Depending on the targeted nerve, leads may be placed percutaneously just under the skin or via an open approach for larger deeper peripheral nerves. Similar to spinal cord stimulation, a short term trial is required prior to permanent implantation of a generator. The use of these technologies, used alone or in combination with spinal cord stimulation for treatment of pain conditions is under investigation.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Dorsal Column Spinal Cord Stimulator

A dorsal column spinal cord stimulator (SCS) is considered medically necessary for any of the indications listed below when the associated criteria are met:

A short-term trial (e.g., three to seven [3–7] days) of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to EITHER of the following indications:

·     Failed back syndrome (FBS) with intractable neuropathic leg pain; or

·     Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD)

And when ALL of the following criteria are met:

·         Failure of at least six consecutive months of physician-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, and activity lifestyle modification); and

·         Surgical intervention is not indicated; and

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement.

Permanent implantation of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to EITHER of the following indications:

·         Failed back syndrome (FBS) with intractable neuropathic leg pain; or

·         Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD)

And when ALL of the following criteria are met:

·         Failure of at least six consecutive months of physician-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, activity lifestyle modification)

·         Surgical intervention is not indicated

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement

·         At least a 50% reduction in pain has been demonstrated during a short-term trial of SCS.

 

Chronic Critical Limb Ischemia (CLI)

A short-term trial (e.g., three to seven [3–7] days) of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when BOTH of the following criteria are met:

·         Failure of available conventional multidisciplinary medical (e.g.,pharmacological, physical therapy) and surgical management (e.g., revascularization); and

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement.

Permanent implantation of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when ALL of the following criteria are met:

·         Failure of available conventional multidisciplinary medical (e.g., pharmacological, physical therapy) and surgical management (e.g., revascularization); and

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement; and

·         Beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation.

 

Chronic Stable Angina Pectoris

A short-term trial (e.g., three to seven [3–7] days) of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to chronic stable angina pectoris as medically necessary for myocardial ischemia when ALL of the following criteria are met:

·         Angina pectoris is Canadian Cardiovascular Society (CCS) functional class III or class IV (see Appendix A); and

·         Individual has documented significant coronary artery disease (CAD) and is not a suitable candidate for a revascularization procedure; and

·         Optimal pharmacological treatment using anti-anginal medications (e.g., long-acting nitrates, beta-adrenergic blockers, or calcium-channel antagonists) has failed to adequately improve anginal symptoms; and

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement.

Permanent implantation of a dorsal column spinal cord stimulator (SCS) may be considered medically necessary for the treatment of chronic, intractable pain secondary to chronic stable angina pectoris as medically necessary for myocardial ischemia when ALL of the following criteria are met:

 

·         Angina pectoris is Canadian Cardiovascular Society (CCS) functional class III or class IV (see Appendix A); and

·         The individual has documented significant coronary artery disease (CAD) and is not a suitable candidate for a revascularization procedure; and

·         Optimal pharmacological treatment using anti-angina medications (e.g., long-acting nitrates, beta-adrenergic blockers, or calcium-channel antagonists) has failed to adequately improve anginal symptoms; and

·         An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement; and

·         Beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation.

 

Dorsal Column Spinal Cord Stimulator Replacement

The replacement of a malfunctioning dorsal column spinal cord stimulator (SCS) and/or battery/generator is considered medically necessary for an individual who meets ALL of the above criteria and the existing stimulator and/or battery/generator replacement are/is no longer under warranty.

 

Dorsal Column Spinal Cord Stimulator Not Covered Services

A dorsal column spinal cord stimulator (SCS) is considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature, for ANY other indication including but not limited to:

·         Post-amputation pain (phantom limb pain); or

·         Post-herpetic neuralgia; or

·         Peripheral neuropathy; or

·         Dysesthesias involving the lower extremities secondary to spinal cord injury.

 

Peripheral Nerve Stimulation

Peripheral nerve stimulation, including peripheral nerve field stimulation, is considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature, including ANY of the following:

·         Failed back syndrome (FBS) with intractable neuropathic leg pain; or

·         Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD); or

·         Chronic Critical Limb Ischemia (CLI); or

·         Chronic Stable Angina Pectoris; or

·         Post-amputation pain (phantom limb pain); or

·         Post-herpetic neuralgia; or

·         Peripheral neuropathy; or

·         Dysesthesias involving the lower extremities secondary to spinal cord injury.

 

High Frequency Spinal Cord Stimulation for Chronic Pain

Implantation of a high frequency spinal cord stimulator for treatment of chronic pain is considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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New York Heart Association and Canadian Cardiovascular Society Functional Classifications

 

Class

New York Heart Association Functional Classification

Canadian Cardiovascular Society Functional Classification

I

Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina occurs with strenuous or rapid or prolonged exertion at work or recreation.

II

Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold, in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions.

III

Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Marked limitation of ordinary physical activity. Walking one to two blocks on the level and climbing one flight in normal conditions and at a normal pace.

IV

Patient with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Inability to carry on any physical activity without discomfort—anginal syndrome may be present at rest.

(Heart Failure Society of America [HFSA], 2006; Gibbons, et al., 2002; American Heart Association [AHA], 1994; Canadian Cardiovascular Society [CCS], 1976)
Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Spinal Cord and Implantable Peripheral Nerve Stimulators 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.

The policy position applies to all commercial lines of business


Denial Statements

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.



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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.

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.

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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    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.




    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect 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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    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.