Latest Review Date: September 2023

Category: Medical                                                

POLICY:

Effective for dates of service November 16, 2023, and after:

The Avery Mark IV™/Spirit diaphragm pacing system as an alternative to mechanical ventilation may be considered medically necessary when all the following criteria is met:

• The individual has chronic central alveolar hypoventilation syndrome/congenital central hypoventilation syndrome; OR

• High quadriplegia at or above C-3; AND

• *18 years and older; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound; AND

• Have intact phrenic nerve function; AND

• Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragmatic/phrenic nerve stimulation will allow the individual to breath without the assistance of a mechanical ventilator for at least 4 continuous hours a day.

*Ages younger than 18 will be reviewed individually.

The Synapse NeuRx® DPS RA/4 Respiratory Stimulation System as an alternative to mechanical ventilation may be considered medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration when all of the following criteria is met:

• 18 years and older; AND

• High quadriplegia at or above C-3; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound; AND

• Have intact phrenic nerve function; AND

• Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragm pacing system will allow the individual to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day; AND

• This device may only be used in a facility that has an institutional review board (IRB) to oversee the clinical application of this device. The IRB must approve the application of this device to ensure that it will be used in accordance with the FDA labeled indication under HDE (documentation of the IRB approval may be requested to ensure compliance with the FDA labeled indication under HDE).

The Synapse NeuRx® DPS Diaphragm Pacing System as an alternative to mechanical ventilation is considered medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration or PMA approval, when all of the following criteria is met:

• FDA age requirement is met (See Governing Bodies); AND

• Amyotrophic lateral sclerosis (ALS) or stable, high spinal cord injuries; AND 

• The individual is experiencing chronic hypoventilation, but has not progressed to an FVC (forced vital capacity) less than 45% predicted; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound (both right and left portions); AND

• Have intact phrenic nerve function; AND

• The individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragm pacing system will allow the individual to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day;

If being used for an HDE indiction: this device may only be used in a facility that has an institutional review board (IRB) to oversee the clinical application of this device. The IRB must approve the application of this device to ensure that it will be used in accordance with the FDA labeled indication under HDE (documentation of the IRB approval may be requested to ensure compliance with the FDA labeled indication under HDE).

Replacement or revisions of diaphragm/phrenic nerve stimulation and diaphragm pacing systems (generator and/or leads) may be considered medically necessary if the individual meets the above criteria, and is no longer under warranty or cannot be repaired.

 Diaphragm/phrenic nerve stimulation and diaphragm pacing systems are considered investigational for all other indications including but not limited to the following:

• When the above criteria is not met;

• In individuals whose phrenic nerve or diaphragm function is not sufficient to achieve adequate diaphragm movement from the electrical stimulation;

• For treatment of any other condition where the phrenic nerve and diaphragm are intact including:

• Obstructive lung disease

• Restrictive lung disease

• Singultus (hiccups)

• Central sleep apnea (see Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea)

• Management of heart failure and treatment of sleep related disorders including but not limited to central sleep apnea(see Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea)

• Underlying cardiac, pulmonary or chest wall disease is present which is significant enough to prevent spontaneous breathing off a ventilator for more than 4 hours even with the use of phrenic nerve or diaphragm pacemaker device.

For phrenic nerve stimulation for central sleep apnea (CSA), please refer to Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea.

Effective for dates of service prior to November 16, 2023:

The Avery Mark IV™/Spirit diaphragm pacing system as an alternative to mechanical ventilation may be considered medically necessary when all of the following criteria is met:

• The individual has chronic central alveolar hypoventilation syndrome/congenital central hypoventilation syndrome; OR

• High quadriplegia at or above C-3; AND

• *18 years and older; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound; AND

• Have intact phrenic nerve function; AND

• Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragmatic/phrenic nerve stimulation will allow the individual to breath without the assistance of a mechanical ventilator for at least 4 continuous hours a day. *Ages younger than 18 will be reviewed individually.

The Synapse NeuRx® DPS RA/4 Respiratory Stimulation System as an alternative to mechanical ventilation may be considered medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration when all of the following criteria is met:

• 18 years and older; AND

• High quadriplegia at or above C-3; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound; AND

• Have intact phrenic nerve function; AND

• Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragm pacing system will allow the individual to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day; AND

• This device may only be used in a facility that has an institutional review board (IRB) to oversee the clinical application of this device. The IRB must approve the application of this device to ensure that it will be used in accordance with the FDA labeled indication under HDE (documentation of the IRB approval may be requested to ensure compliance with the FDA labeled indication under HDE).

The NeuRx DPS Diaphragm Pacing System as an alternative to mechanical ventilation is considered medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration when all of the following criteria is met:

• 21 years of age or older; AND

• Amyotrophic lateral sclerosis (ALS); AND 

• The individual is experiencing chronic hypoventilation, but has not progressed to an FVC (forced vital capacity) less than 45%  predicted; AND

• Diaphragm movement with stimulation visible under fluoroscopy or ultrasound (both right and left portions); AND

• Have intact phrenic nerve function; AND

• The individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of this device; AND

• Diaphragm pacing system will allow the individual to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day; AND

• This device may only be used in a facility that has an institutional review board (IRB) to oversee the clinical application of this device. The IRB must approve the application of this device to ensure that it will be used in accordance with the FDA labeled indication under HDE (documentation of the IRB approval may be requested to ensure compliance with the FDA labeled indication  under HDE).

Replacement or revisions of diaphragm/phrenic nerve stimulation and diaphragm pacing systems (generator and/or leads) may be considered medically necessary if the individual meets the above criteria, and is no longer under warranty or cannot be repaired.

Diaphragm/phrenic nerve stimulation and diaphragm pacing systems are considered investigational for all other indications including but not limited to the following:

• When the above criteria is not met;

• In individuals whose phrenic nerve or diaphragm function is not sufficient to achieve adequate diaphragm movement from the electrical stimulation;

• For treatment of any other condition where the phrenic nerve and diaphragm are intact including:

• Obstructive lung disease

• Restrictive lung disease

• Singultus (hiccups)

• Central sleep apnea (see Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea)

• Management of heart failure and treatment of sleep related disorders including but not limited to central sleep apnea(see Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea)

• Underlying cardiac, pulmonary or chest wall disease is present which is significant enough to prevent spontaneous breathing off a ventilator for more than 4 hours even with the use of phrenic nerve or diaphragm pacemaker device.

For phrenic nerve stimulation for central sleep apnea (CSA), please refer to Medical Policy #730 Phrenic Nerve Stimulation for Central Sleep Apnea.

DESCRIPTION OF PROCEDURE OR SERVICE:

Individuals with high-level vertebrae C1-C3 spinal cord injuries typically experience respiratory muscle paralysis leading to chronic ventilatory insufficiency. The standard therapy for these patients is chronic mechanical ventilation via tracheostomy.

Non-invasive ventilation (NIV) such as positive ventilation or bilevel positive airway pressure is currently the first line treatment for amyotrophic lateral sclerosis (ALS) patients experiencing symptoms of respiratory insufficiency. At some point ALS affects the respiratory muscles so severely that bulbar paresis is combined with severe expiratory and inspiratory muscle weakness. There is a significant risk of impending respiratory failure or death and invasive ventilation becomes the only option for survival.

Diaphragmatic/phrenic nerve stimulation, is an alternative to mechanical ventilation for a select subgroup of individuals. Diaphragmatic/phrenic nerve stimulation, also referred to phrenic pacing, phrenic nerve stimulation, diaphragm pacing, or electrophrenic respiration, is the electrical stimulation of the diaphragm via the phrenic nerve, the major nerve supply to the diaphragm that controls breathing. Patients with partial or complete respiratory insufficiency who have an intact phrenic nerve and diaphragm may be eligible for diaphragmatic/phrenic nerve stimulation. The patient should be alert, mentally competent, motivated and able to complete the training and rehabilitation needed for a successful outcome. Prior to implantation patients may undergo diaphragm electromyography, pulmonary function studies and/or polysomnography (i.e. sleep study). Common indications include patients with high quadriplegia (spinal cord injury) at or above C-3, chronic central alveolar hypoventilation syndrome (CCHS), and amyotrophic lateral sclerosis (ALS).

KEY POINTS:

Literature review through August 2023.

SUMMARY OF EVIDENCE:

Diaphragmatic pacing is a therapy intended for individuals with ventilatory failure due to bilateral diaphragm paresis or paralysis. This is aimed at giving these individuals an opportunity to become free or delay the need for invasive mechanical ventilation, improving the quality of life. Diaphragm pacing is a relatively rare procedure, so individuals should be evaluated at centers of expertise.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

AMERICAN ACADEMY OF NEUROLOGY (AAN)

In 2009 (reaffirmed in 2023), the American Academy of Neurology (AAN) issued a practice parameter update on the care of the patient with amyotrophic lateral sclerosis (ALS): drug, nutritional and respiratory therapies an evidence based review. The recommendations in this practice parameter update does not mention diaphragmatic/phrenic nerve stimulation or diaphragm pacing as a treatment.

AMERICAN THORACIC SOCIETY (ATS)

In 2010, the American Thoracic Society clinical policy statement on congenital central hypoventilation syndrome in their discussion of the diagnosis and management of children with congenital central hypoventilation syndrome (CCHS) which states: diaphragm pacers can be used for daytime support of ambulatory children who require full-time ventilator support, in combination with positive pressure ventilation at night.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Diaphragmatic stimulation, phrenic nerve stimulation, diaphragm pacing, electrophrenic respiration, NeuRx RA/4, Neurx DPS, Avery Breathing Pacemaker System, Mark IV System,CCHS, congenital central hypoventilation syndrome, ALS, amyotrophic lateral sclerosis, SCI, spinal cord injury

APPROVED BY GOVERNING BODIES:

Synapse Biomedical Inc.

NeuRx DPS™ RA/4 Respiratory Stimulation System

In June 2008, the NeuRx DPS™ RA/4 Respiratory Stimulation System received FDA approval under the Humanitarian Device Exemption (HDE) process for patients age 18 years and older.

• The device is “intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day”.

• For use only in patients 18 years of age or older.

• HDE H070003

NeuRx DPS Diaphragm Pacing System (DPS)

On September 28, 2011, the FDA issued an approval under an HDE application for use of the NeuRx DPS Diaphragm Pacing System in:

• Amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH), but not progressed to an FVC (forced vital capacity) less than 45% predicted.

• For use only in patients 21 years of age or older.

On March 31, 2023, the FDA issued a PMA approval for use of the NeuRx Diaphragm Pacing System (DPS).

• Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day.

• For use only in patients 18 years of age or older.

• PMA P200018

Avery Biomedical Devices

Mark IV Transmitter

The Mark IV™ is a diaphragmatic/phrenic stimulator system cleared for use by the FDA in the United States for ventilator-dependent individuals in March 1998. The pacemaker is classified as a Class III neurologic therapeutic device requiring premarket approval (PMA).

• The Avery System has PMA approval for all ages, to implant its device in those with  Spinal Cord injury and Central Alveolar Hypoventilation.

Spirit Transmitter

The Spirit Diaphragm Pacing Transmitter is CE Marked under the European Active Implantable Medical Device Directive as of 2017, and received full FDA Approval in November 2019. The transmitter is lightweight and features a backlight for nighttime viewing, clear graphic display, touch controls, and digital precision. For safety, it is also water resistant, has keypad locks, utilizes audible and visual alarms, and features bilateral redundancy.

• The Avery System has PMA approval for all ages, to implant its device in those with  Spinal Cord injury and Central Alveolar Hypoventilation.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

There are no specific CPT codes for this procedure/device.

HCPCS:

REFERENCES:

1. American Thoracic Society (ATS). ATS clinical policy statement: congenital central hypoventilation syndrome: genetic basis, diagnosis and management. October 2009. Available at: http://www.thoracic.org/statements/resources/pldd/congenital-central-hypoventilation-syndrome.pdf.
2. Avery Biomedical Devices, Inc. Breathing pacemakers. Available at URL address: http://www.averylabs.com/
3. Chen ML, Tablizo MA, Kun S, Keens TG. Diaphragm pacers as a treatment for congenital central hypoventilation syndrome. Expert Rev Med Devices. 2005 Sep; 2(5):577-85.
4. Clinical Trials.gov. Humanitarian Device Exemption (HDE) Post-Approval Study (PAS) of NeuRx Diaphragm Pacing System (DPS) for Amyotrophic Lateral Sclerosis (ALS). NCT01605006. Available at URL address: http://clinicaltrials.gov/ct2/show/NCT01605006?term=neurx&rank=1
5. Clinical Trials.gov. Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants with Amyotrophic Lateral Sclerosis (ALS). First Posted January 27, 2017. Last Updated on January 27, 2017. NCT03034317. Available at URL address: https://clinicaltrials.gov/ct2/show/NCT03034317
6. Clinical Trials.gov. Motor-Point Stimulation for Conditioning the Diaphragm of Patients with Amyotrophic Lateral Sclerosis (ALS). NCT00420719. Available at URL address: http://clinicaltrials.gov/show/NCT00420719
7. Clinical Trials.gov. Diaphragmatic Pacemaker in Tetraplegic Patients with Spinal Cord Injuries. NCT01385384. First received on June 23, 2011. Last updated on March 19, 2013. Available at URL address: http://clinicaltrials.gov/ct2/show/NCT01385384?term=NCT01385384&rank=1
8. DiPALS Writing Committee; DiPALS Study Group Collaborators. Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial. Lancet Neurol 2015; 14: 883–92.
9. Dres M, de Abreu MG, Merdji H, Müller-Redetzky H, Dellweg D, Randerath WJ, Mortaza S, Jung B, Bruells C, Moerer O, Scharffenberg M, Jaber S, Besset S, Bitter T, Geise A, Heine A, Malfertheiner MV, Kortgen A, Benzaquen J, Nelson T, Uhrig A, Moenig O, Meziani F, Demoule A, Similowski T; RESCUE-2 Study Group Investigators. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients. Am J Respir Crit Care Med. 2022 May 15;205(10):1169-1178. doi: 10.1164/rccm.202107-1709OC.
10. Garara B, Wood A, Marcus HJ, Tsang K, Wilson MH, Khan M. Intramuscular diaphragmatic stimulation for patients with traumatic high cervical injuries and ventilator dependent respiratory failure: A systematic review of safety and effectiveness. Injury. 2016 Mar;47(3):539-44.
11. Gonzalez-Bermejo J, Morélot-Panzini C, Salachas F, et al. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012; 13(1):44-54.
12. Gonzalez-Bermejo J, Morélot-Panzini C, Tanguy ML, et al. Early diaphragm pacing in patients with amyotrophic lateral sclerosis (RespiStimALS): a randomised controlled triple-blind trial. Lancet Neurol. 2016; 15(12):1217-1227.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Mahajan KR, Bach JR, Saporito L, Perez N. Diaphragm pacing and noninvasive respiratory management of amyotrophic lateral sclerosis/motor neuron disease. Muscle Nerve. 2012; 46(6):851- 855.
15. Miller, R.G., et al., Practice parameter update: The care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 2009. 73(15): p. 1218-26. Reaffirmed 2023.
16. McDermott CJ, Bradburn MJ, Maguire C, et al. DiPALS: Diaphragm pacing in patients with amyotrophic lateral sclerosis - a randomised controlled trial. health technol assess. 2016; 20(45):1- 186.
17. National Institute for Health and Clinical Excellence (NICE) Intramuscular Diaphragm Stimulation for Ventilator-Dependent Chronic Respiratory Failure Caused by Motor Neuron Disease. Interventional Procedure Guidance (IPG593). Published September 2017.
18. National Institute for Health and Clinical Excellence (NICE). IPG594. Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries. Sep 27, 2017a. Available at URL address: https://www.nice.org.uk/guidance/ipg594
19. Onders RP, Khansarinia S, Weiser T, et al. Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: positive implications for ventilator weaning in intensive care units. Surgery. 2010; 148(4):893-897; discussion 897-898. 5
20. Onders RP, Ponsky TA, Elmo M, et al. First reported experience with intramuscular diaphragm pacing in replacing positive pressure mechanical ventilators in children. J Pediatr Surg. 2011; 46(1):72-76.
21. Posluszny JA Jr, Onders R, Kerwin AJ, et al. Multicenter review of diaphragm pacing in spinal cord injury: successful not only in weaning from ventilators but also in bridging to independent respiration. J Trauma Acute Care Surg. 2014; 76(2):303-309.
22. Romero FJ, Gambarrutta C, Garcia-Forcada A, et al. Long-term evaluation of phrenic nerve pacing for respiratory failure due to high cervical spinal cord injury. Spinal Cord. 2012; 50(12):895-898.
23. Synapse Biomedical Inc. NeuRx DPS™. Available at URL address: http://www.synapsebiomedical.com/about-neurx-dps/
24. U.S. Food and Drug Administration (FDA). Part 882 Neurological devices. Sec. 882.5830. Implanted diaphragmatic/phrenic nerve stimulator. April 8, 1986. Revised April 1, 2018. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.583.
25. U.S. Food and Drug Administration. Humanitarian Device Exemption Database. NeuRx DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc., Oberlin, OH). Summary of Safety and Probable Benefit. No. H070003. Rockville, MD: FDA. June 17, 2008. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375540.
26. U.S. Food and Drug Administration (FDA). Humanitarian Device Exemption Database. NeuRx DPS Diaphragm Pacing System (Synapse Biomedical, Inc., Oberlin, OH). Summary of Safety and Probable Benefit. No. H100006. Rockville, MD: FDA. September 28, 2011. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375558.
27. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) Premarket Approvals for the Avery Breathing Pacemaker System Mark IV (Avery Biomedical Device, Inc., Commack, NY). Summary of Safety and Effectiveness. No. P860026. Rockville, MD: FDA. February 25, 1987; updated 2003. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860026S006.
28. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health Premarket Approvals for the NeuRX Diaphragm Pacing System (DPS) (Synapse Biomedical Inc., Oberlin, OH). Summary of Safety and Effectiveness. No. P200018: FDA. March 31, 2023. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200018
29. Vashisht R, Chowdhury YS. Diaphragmatic Pacing. [Updated 2023 May 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557793/
30. Weese-Mayer D, Berry-Kravis E, Ceccherini I, et. al. American Thoracic Society (ATS) Clinical Policy Statement: Congenital Central Hypoventilation Syndrome: Genetic Basis, Diagnosis and Management. September 2009. Am J Respir Crit Care Med Vol 181 pp 626-644, 2010
31. Woo A, Tchoe HJ, Shin HW, Shin CM, Lim CM. Assisted Breathing with a Diaphragm Pacing System: A Systematic Review. Yonsei Med J. 2020 Dec;61(12):1024-1033.

POLICY HISTORY:

Medical Policy Group, August 2020 (6): New medical policy. Draft date through September 19, 2020.

Medical Policy Group, August 2021 (6): Updates to Key Points, Practice Guidelines and Governing Bodies.

Medical Policy Group, November 2021: 2022 Annual Coding Update. Revised 64575/64580.

Medical Policy Group, July 2022 (6): Updates to Key Points and References.

Medical Policy Group, September 2023 (6): Updates to Policy statement to include new PMA approval for NeuRx and high SCI, Key Points, Key Words, Governing Bodies, Practice Guidelines, Benefit Application, Current Coding(+95970/95971/95972) and References. On Draft for comment October 1, 2023- November 15, 2023.

Medical Policy Group, November 2023: 2024 Annual CPT Coding Update. Revised 64590, 64595.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.