Latest Review Date: August 2024

Category: Surgery                                                                

POLICY:

All applications of percutaneous electrical nerve stimulation are considered investigational, including but not limited to:

• Percutaneous electrical nerve stimulation (PENS)
• Percutaneous neuromodulation therapy (PNT)
• Percutaneous electrical nerve field stimulation (PENFS)

DESCRIPTION OF PROCEDURE OR SERVICE:

Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) are therapies that combine the features of electroacupuncture and transcutaneous electrical nerve stimulation (TENS). PENS is performed with a few needle electrodes while PNT uses very fine needle-like electrodes which are placed in close proximity to the painful area and stimulate peripheral sensory nerves in the soft tissue.

Chronic Pain

A variety of chronic musculoskeletal or neuropathic pain conditions, including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia, present a substantial burden to individuals, adversely affecting function and quality of life.

Treatment

These chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated as treatments to relieve unremitting pain.

PENS is similar in concept to TENS, but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated.  PENS is generally reserved for individuals who fail to get pain relief from TENS. PENS are also distinguished from acupuncture with electrical stimulation.  In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PENS, the location of stimulation is determined by proximity to the pain. 

Percutaneous neuromodulation therapy (PNT) is a variant of PENS in which fine filament electrode arrays are placed near the area causing pain. Some use the terms PENS and PNT interchangeably. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C-fibers, thus preventing action potential propagation along the pain pathway.

Percutaneous Electrical Nerve Field Stimulation

Because there are few  pharmacologic treatments for children and adolescents with IBS, nonpharmacologic options are commonly explored. Percutaneous electrical nerve field stimulation (PENFS) is a potential treatment option for these individuals. PENFS involves a non-implantable device which stimulates nerves remotely from the site of pain and has been studied for a variety of musculoskeletal or neuropathic pain conditions or for individuals with opioid withdrawal. The IB-Stim device is a type of PENFS that is intended for use only in individuals with IBS. The device is disposable and battery-operated. Key components of the device include a percutaneous electrical nerve field stimulator placed behind the ear which connects to a multi-wire electrode array consisting of 4 leads. The electrodes have thin needles and attach to the ear at points (preauricular, lobule and superior crus) where cranial nerve peripheral branches are located just beneath the skin. A pen light included with the device is used to visualize the neurovasculature features and aid in proper electrode placement.

Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is estimated to affect 5% to 10% of the population globally, and accounts for between 2.4 and 3.5 million physician visits in the United States each year. Up to two-thirds of individuals with IBS are female, and it is most common in individuals less than 50 years of age. The cause of IBS remains unknown, but is believed to be due to a dysfunction in gut-brain interaction. Symptoms of IBS can include diarrhea, constipation, or both. Abdominal pain and bloating are also common IBS symptoms. These symptoms decrease individual quality of life and create a significant healthcare burden. The American College of Gastroenterology (ACG) recommends that individuals diagnosed with IBS are categorized by subtypes: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS with mixed symptoms (IBS-M), or IBS without abnormal stools (IBS-U).

Treatment

First-line treatment of individuals with IBS generally includes dietary changes. If dietary changes fail to achieve therapeutic goals, there are numerous pharmacotherapeutic options for individuals with IBS. Pharmacologic treatment is based on the IBS subtype, and the predominance of either constipation or diarrhea (Table 1). Notably, many IBS treatments are not Food and Drug Administration (FDA)-approved for children or adolescents. The American College of Gastroenterology recommends that gut directed psychotherapy such as cognitive-behavior therapy and gut-directed hypnotherapy may be beneficial for global IBS symptoms.

Table 1. Pharmacologic Treatment of Irritable Bowel Syndrome

IBS-D	IBS-C	Abdominal Pain
Antidiarrheal agents (e.g., loperamide)	Laxatives (e.g., polyethylene glycol)	Antispasmodics (e.g., dicyclomine, hyoscyamine, peppermint oil
Mu-opioid receptor agonist (eluxadoline for refractory patients only)	Chloride channel activator (lubiprostone)	TCA
5-HT3 receptor antagonist (alosetron or ondansetron)	Guanylate cyclase agonists (linaclotide or plecanatide)	SSRI
Antibiotic (rifaximin)	Sodium/hydrogen exchanger 3 (tenapanor)

HT: hydroxytryptamine (serotonin); IBS-C: irritable bowel syndrome with constipation; IBS-D: irritable bowel syndrome with diarrhea; SSRI: selective serotonin reuptake inhibitor; TCA: tricyclic antidepressant.

KEY POINTS:

The most recent literature review was updated through June 12, 2024.

Summary of Evidence

For individuals who have chronic pain conditions (e.g., back, neck, neuropathy, headache, hyperalgesia) who receive PENS, the evidence includes primarily small controlled trials and two systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Two systematic reviews have not revealed consistent benefit from PENS in musculoskeletal pain disorders. One review concluded that PENS could decrease pain intensity but not related disability, while the other found no significant differences between PENS and TENS in mitigation of pain. These conclusions are uncertain due to important methodological limitations in individual trials included in these reviews, such as high heterogeneity with regard to application methods. In the highest quality trial of PENS conducted to date in chronic low back pain, no difference in outcomes was found between the active (30 minutes of stimulation with 10 needles) and the sham (5 minutes of stimulation with 2 needles) treatments. Smaller trials, which have reported positive results, are limited by unclear blinding and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic pain conditions (e.g., knee osteoarthritis) who receive percutaneous neuromodulation therapy, the evidence consists of a randomized controlled trial. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The single trial is limited by lack of investigator blinding, unclear participant blinding, and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with irritable bowel syndrome (IBS) who receive percutaneous electrical nerve field stimulation (PENFS), the evidence includes a subgroup analysis of a single randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The RCT (N=115) included a heterogeneous population of adolescent individuals aged 11 to 18 years with pain-related functional gastrointestinal disorders. Treatment was administered for 3 weeks, and reductions in pain were observed with the active device compared with a sham PENFS device at the end of treatment and end of follow-up (maximum of 12 weeks). The subgroup of individuals with IBS also had improved pain at the end of treatment with the active device compared with the sham device. However, the trial is limited by its small sample size, heterogeneous population of gastrointestinal disorders, lack of bowel habit measurement, and the short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Neurology et al

The American Academy of Neurology, American Association of Neuromuscular and Electrodiagnostic Medicine, and American Academy of Physical Medicine and Rehabilitation reaffirmed 2011 evidence-based guidelines on the treatment of painful diabetic neuropathy in 2016. The guidelines concluded that, based on a class I study, electrical stimulation is probably effective in lessening the pain of diabetic neuropathy and improving quality of life and recommended that PENS be considered for the treatment of painful diabetic neuropathy (level B). The guidelines were retired and replaced in 2022 with a guideline dedicated to oral and topical treatment of painful diabetic polyneuropathy. In these updated guidelines, there is no mention of any electrical stimulation strategies for pain.

American College of Gastroenterology

The American College of Gastroenterology (ACG) updated their recommendations for irritable bowel syndrome (IBS) management in 2021. The ACG recommendations do not include percutaneous electrical nerve field stimulation.

The American Gastroenterological Association

The American Gastroenterological Association (AGA) updated guidelines for both IBS with constipation and IBS with diarrhea in 2022.  Neither of these guidelines include recommendations for percutaneous electrical nerve field stimulation.

American Society of Anesthesiologists et al

The 2010 Practice guidelines for chronic pain management from the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine state that subcutaneous peripheral nerve stimulation may be used in multimodal treatment of patients with painful peripheral nerve injuries who have not responded to other therapies (Category B2 evidence, observational studies).

American College of Physicians and American Pain Society

Joint clinical practice guidelines on the diagnosis and treatment of low back pain from the American College of Physicians and the American Pain Society in 2007 indicated uncertainty over whether PENS should be considered a novel therapy or a form of electroacupuncture. The guidelines concluded that PENS is not widely available. The guidelines also concluded that TENS has not been proven effective for chronic low back pain. These guidelines were updated in 2017 and authors stated that evidence was insufficient to determine harms associated with PENS thus, no recommendation was made.

National Institute for Health and Care Excellence

In 2013, the National Institute for Health and Care Excellence (NICE) published guidance on PENS. It concluded that the "Current evidence on the safety of [PENS] for refractory neuropathic pain raises no major safety concerns and there is evidence of efficacy in the short term."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Percutaneous Electrical Nerve Stimulation, PENS, Percutaneous Neuromodulation Therapy, PNT, Urgent PC Neuromodulation System, Deepwave Percutaneous Neuromodulation Pain Therapy System, electrical nerve stimulation, percutaneous, stimulation, percutaneous electrical nerve, IB-Stim, electrical nerve field stimulator, percutaneous electrical nerve field stimulation, PENFS

APPROVED BY GOVERNING BODIES:

In 2002, the Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The labeled indication is: “...  for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.”

In 2006, the Deepwave Percutaneous Neuromodulation Pain Therapy System (Biowave) was cleared for marketing by FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to the Vertis Neuromodulation system and a Biowave neuromodulation therapy unit.  The Deepwave system includes a sterile single-use percutaneous electrode array that contains 1014 microneedles in a 1.5-inch diameter area. The needles are 736 μm (0.736 mm) in length; the patch is reported to feel like sandpaper or Velcro.

In 2019, the IB-Stim device (previously known as Neuro-Stim; Innovative Health Solutions, Inc.) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the de novo 513(f)(2) process (DEN180057). Both the IB-Stim and the similar NSS-2 BRIDGE device (Innovative Health Solutions, Inc.) are derivatives of the Electro Auricular Device (Navigant Consulting, Inc.). The IB-Stim device is indicated for individuals 11 to 18 years of age with functional abdominal pain associated with IBS when combined with other IBS therapies. It is intended to be used for 120 hours per week up to 3 consecutive weeks. The First Relief v1 (DyAnsys, Inc.) device was deemed substantially equivalent to the IB-Stim device in 2020. FDA product code: QHH.

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

CURRENT CODING:

The correct CPT code to use for percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy is the unlisted CPT code 64999. CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553-64561) are not appropriate, because percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy use percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy are not implanted, so CPT code 64590 is also not appropriate.

CPT Codes:

64999	Unlisted procedure, nervous system
0720T	Percutaneous electrical nerve field stimulation, cranial nerves, without implantation

REFERENCES:

1. Ahmed HE, White PF, Craig WF et al. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache 2000; 40(4):311-5.
2. Beltran-Alacreu H, Serrano-Munoz D, Martin-Caro D, et al. Percutaneous versus transcutaneous electrical nerve stimulation for the treatment of musculoskeletal pain. A systematic review and meta-analysis. Pain Med. Aug 01 2022; 23 (8): 1387-1400.
3. Benzon HT, Connis RT, De Leon-Casasola OA, et al. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4): 810-33. 
4. Bril V, England J, Franklin GM et al. Evidence-based guideline:  Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation.  Neurology 2011; 76(20):1758-65.
5. Chang L, Sultan S, Lembo A, et al. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome with Constipation. Gastroenterology. Jul 2022; 163(1): 118-136. 
6. Chou R, Qaseem A, Snow V et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007; 147(7):478-91. 
7. da Graca-Tarragó M, Deitos A, Patrícia Brietzke A, et al. Electrical Intramuscular Stimulation in Osteoarthritis Enhances the Inhibitory Systems in Pain Processing at Cortical and Cortical Spinal System. Pain Med. May 01 2016; 17(5): 877-891.
8. Definition & Facts for Irritable Bowel Syndrome. National Institute of Diabetes and Digestive and Kidney Diseases. www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome/definition-facts. 
9. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. Jan2005; 113(1-2): 9-19.
10. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. Feb 2008; 9(2): 105-21.
11. Elbadawy MA. Effectiveness of Periosteal Stimulation Therapy and Home Exercise Program in the Rehabilitation of Patients With Advanced Knee Osteoarthritis. Clin J Pain. Mar 2017; 33(3): 254-263. 
12. Gewandter JS, Dworkin RH, Turk DC, et al. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain. Jul 2015; 156(7): 1184-1197.
13. Ghoname EA, White PF, Ahmed HE, et al. Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain. Nov 1999; 83(2): 193-9. 
14. Ghoname EA, Craig WF, White PF et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA 1999; 281(9):818-23.
15. Ghoname ES, Craig WF, White PF et al. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. Apr 1999; 88(4):841-6.
16. Hamza MA, Ghoname EA, White PF et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. Mar 2000; 23(3): 365-70.
17. IBS Facts and Statistics. International Foundation for Gastrointestinal Disorders. aboutibs.org/what-is-ibs/facts-about-ibs/.  
18. IB-STIM. FDA Classification. ibstim.com/fda-classification/.
19. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
20. Kang RW, Lewis PB, Kramer A et al. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics 2007; 30(6):439-45.
21. Kovacic K, Hainsworth K, Sood M, et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. Oct 2017; 2(10): 727-737.
22. Krasaelap A, Sood MR, Li BUK, et al. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. Aug 2020; 18(9): 1987-1994.e2.
23. Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. Jan 01 2021; 116(1): 17-44.
24. Lembo A, Sultan S, Chang L, et al. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. Jul 2022; 163(1): 137-151.
25. National Institute for Health and Care Excellence (NICE). Percutaneous electrical nerve stimulation for refractory neuropathic pain (IPG 450). 2013 www.nice.org.uk/nicemedia/live/13961/63356/63356.pdf. 
26. National Institute for Health and Care Excellence. 2022 Neurostimulation of lumbar muscles for refractory nonspecific chronic low back pain: Interventional Procedures Guidance. www.nice.org.uk/guidance/ipg739. 
27. Plaza-Manzano G, Gomez-Chiguano GF, Cleland JA, et al. Effectiveness of percutaneous electrical nerve stimulation for musculoskeletal pain: A systematic review and meta-analysis. Eur J Pain. Jul 2020; 24(6): 1023-1044.
28. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Apr 04 2017; 166(7): 514-530. 
29. Raphael JH, Raheem TA, Southall JL et al. Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med. Oct 2011; 12(10):1515-22.
30. US Food and Drug Administration. IB-Stim. DEN180057. July 7, 2019. www.accessdata.fda.gov/cdrh_docs/reviews/DEN180057.pdf
31. Weiner DK, Rudy TE, Glick RM, et al. Efficacy of percutaneous electrical nerve stimulation for the treatment of chronic low back pain in older adults. J Am Geriatr Soc. May 2003; 51(5): 599-608. 
32. White PF, Craig WF, Vakharia AS et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation affect the acute analgesic response? Anesth Analg. Oct 2000; 91(4):949-54.
33. Yokoyama M, Sun X, Oku S et al. Comparison of percutaneous electrical nerve stimulation with transcutaneous electrical nerve stimulation for long-term pain relief in patients with chronic low back pain. Anesth Analg. Jun 2004; 98(6):1552-6.

POLICY HISTORY:

Medical Policy Group, December 2002

Medical Policy Group, November 2004

Medical Policy Group, February 2006 (3)

Medical Policy Group, February 2010 (2)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Panel, August 2011

Medical Policy Group, September 2011 (2): Key Points, References updated

Medical Policy Group, August 2012 (2): Description, Key Points, References updated

Medical Policy Panel, July 2013

Medical Policy Group, July 2013 (2): 2013 Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (4):  Updated Key Points.  No changes to the policy at this time.

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (6):  Updated Key Points; no change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (6):  Updated Description, Key Points, Practice Guidelines, no change to policy statement.

Medical Policy Panel, June 2018

Medical Policy Group, August 2018 (6): Updates to Description and Key Points.

Medical Policy Panel, June 2019

Medical Policy Group, June 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Panel, June 2020

Medical Policy Group, June 2020 (3): 2020 Updates to Key Points, and References. No changes to policy statement or intent.

Medical Policy Panel, June 2021

Medical Policy Group, July 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, References and Key Words: added: IB-Stim. Policy statement updated to remove “not medically necessary”, no other changes to policy statement or intent.

Medical Policy Group, June 2022: 2022 Quarterly Coding Update. Added CPT code 0720T to the Current coding section.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, May 2023

Medical Policy Group, June 2023 (3): Updated the following sections specific to IB-Stim device: Description, Approved By Governing Bodies, Key Points, Practice Guidelines and Position Statements and References. Key Words added: percutaneous electrical nerve field stimulation, and PENFS. No change to policy statement or intent.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (3): Policy title changed from Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT) to Percutaneous Electrical Nerve Stimulation Applications. Clarification of policy statement to include percutaneous electrical nerve field stimulation (IB-Stim) treatment. 

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (3): Updates to Description, Key Points, and References. No changes to policy statement or intent.

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.