||CMS National Guidelines
||Percutaneous Electrical Nerve Stimulation (PENS) - NCD 160.7, and 160.7.1
||December 20, 2007
||January 26, 2009
Electrical nerve stimulation is an accepted modality for the management of chronic, intractable pain and assessment of a patient’s suitability for ongoing treatment with an implanted nerve stimulator. Percutaneous electrical nerve stimulation (PENS) (64555) involves stimulation of peripheral nerves by a needle electrode inserted through the skin. PENS is a diagnostic procedure which is used to test the effectiveness of nerve stimulation prior to the implantation of a permanent nerve stimulator. The procedure involves insertion of neurostimulator electrodes through the skin around or immediately adjacent to the nerve serving the painful area.
Indications and Limitations of Coverage
Percutaneous electrical nerve stimulation is indicated for the evaluation of a patient with chronic pain secondary to injury or disease of a peripheral nerve. PENS is an eligible service when provided in a physician’s office, clinic, or hospital outpatient department for relief of chronic pain. It is covered only when performed by a physician or incident to a physician’s service. If pain is effectively controlled by percutaneous electrical nerve stimulation, implantation of electrodes is eligible.
Generally, the physician should be able to determine whether the patient is likely to derive a significant therapeutic benefit from the continued use of an implanted peripheral nerve stimulator within a trial period of one month. Sometimes, this determination may take longer to make. The medical necessity for continuing use of PENS as a diagnostic service for more than one month must be documented within the medical record.
Claims not meeting the indications and limitations of this policy will be denied as not medically necessary. Effective January 26, 2009, a provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.
- Electrical nerve stimulators do not prevent pain but only alleviate pain as it occurs. A patient can be taught how to employ the stimulator, and once this is done, can use it safely and effectively without direct physician supervision. Consequently, it is inappropriate for a patient to visit his/her physician, physical therapist, or an outpatient clinic on a continuing basis for treatment of pain with electrical nerve stimulation. Once it is determined that electrical nerve stimulation should be continued as therapy, it is expected that a stimulator will be implanted.
When the service is provided for a diagnosis that is not listed in the “Diagnosis Codes” section of this policy, the medical necessity and rationale for providing the service for the unlisted diagnosis must be documented in the medical record. This documentation must be submitted for review to establish medical necessity.
- 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.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
CMS On-Line Pub. 100-3, Chapter 1, Section 160.7 and 160.7.1
Procedure Code Attachments
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.
Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.
Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.
Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.