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Endothelial Keratoplasty

Policy Number: MP-382

Latest Review Date: March 2021

Category: Other

Policy Grade: B

POLICY:

Endothelial keratoplasty (Descemet’s stripping endothelial keratoplasty [DSEK], Descemet’s stripping automated endothelial keratoplasty [DSAEK], Descemet’s membrane endothelial keratoplasty [DMEK], or Descemet’s membrane automated endothelial keratoplasty [DMAEK]) may be considered medically necessary for the treatment of endothelial dysfunction, including but not limited to:

  • Ruptures in Descemet’s membrane; OR
  • Endothelial dystrophy; OR
  • Aphakic, and pseudophakic bullous keratopathy; OR
  • Iridocorneal endothelial (ICE) syndrome; OR
  • Corneal edema attributed to endothelial failure, OR
  • Failure or rejection of a previous corneal transplant.

Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers assisted endothelial keratoplasty (FELEK) are considered investigational.

Endothelial keratoplasty is not medically necessary when endothelial dysfunction is not the primary cause of decreased corneal clarity.

DESCRIPTION OF PROCEDURE OR SERVICE:

Endothelial keratoplasty (EK), also referred to as posterior lamellar keratoplasty, is a form of corneal transplantation in which the diseased inner layer of the cornea, the endothelium, is replaced with healthy donor tissue. Specific techniques include Descemet stripping endothelial keratoplasty (DSEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet membrane endothelial keratoplasty (DMEK), and Descemet membrane automated endothelial keratoplasty (DMAEK). EK, and particularly DSEK, DSAEK, DMEK, and DMAEK, are becoming standard procedures. Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) have also been reported as alternative ways to prepare the donor endothelium.

Corneal Disease

The cornea, a clear, dome-shaped membrane that covers the front of the eye, is a key refractive element of the eye. Layers of the cornea consist of the epithelium (outermost layer), Bowman’s layer, and the stroma, which comprises approximately 90% of the cornea, Descemet’s membrane, and the endothelium. The endothelium removes fluid from the stroma and limits entry of fluid as well, thereby maintaining the ordered arrangement of collagen and preserving the cornea’s transparency. Diseases that affect the endothelial layer include Fuchs’ endothelial dystrophy aphakic and pseudophakic bullous keratopathy (corneal edema following cataract extraction), and failure or rejection of a previous corneal transplant.

Treatment

The established surgical treatment for corneal disease is penetrating keratoplasty (PK), which involves the creation of a large central opening through the cornea and then filling the opening with full thickness donor cornea that is sutured in place. Visual recovery after PK may take one year or more due to slow wound healing of the avascular full thickness incision, and the procedure frequently results in irregular astigmatism due to the sutures and the full-thickness vertical corneal wound. PK is associated with an increased risk of wound dehiscence, endophthalmitis, and total visual loss after relatively minor trauma for years after the index procedure. There is also risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage in which the ocular contents are expelled during the operative procedure, as well as postoperative catastrophic wound failure.

A number of related techniques have been, or are being, developed to selectively replace the diseased endothelial layer. One of the first endothelial keratoplasty (EK) techniques was termed “deep lamellar endothelial keratoplasty”, which used a smaller incision than PK, allowed more rapid visual rehabilitation, and reduced postoperative irregular astigmatism and suture complications. Modified EK techniques include endothelial lamellar keratoplasty, endokeratoplasty; posterior corneal grafting and microkeratome assisted posterior keratoplasty. Most frequently used at this time are Descemet’s stripping endothelial keratoplasty (DSEK) which uses hand-dissected donor tissue, and Descemet’s stripping automated endothelial keratoplasty (DSAEK), which used an automated microkeratome to assist in donor tissue dissection.  These techniques include some donor stroma along with the endothelium and Descemet’s membrane, which results in a thickened stromal layer after transplantation. If the donor tissue is comprised of Descemet’s membrane and endothelium alone the technique is known as Descemet’s membrane endothelial keratoplasty (DMEK). By eliminating the stroma on the donor tissue and possibly reducing stromal interface haze, DMEK is considered to be a potential improvement over DSEK/DSAEK. A variation of DMEK is Descemet’s membrane automated endothelial keratoplasty (DMAEK). DMAEK contains a stromal rim of tissue at the periphery of the DMEK graft to improve adherence and improve handling of the donor tissue. A laser may also be used for stripping in a procedure called femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK).

EK involves removal of the diseased host endothelium and Descemet’s membrane with special instruments through a small peripheral incision. A donor tissue button is prepared from corneoscleral tissue after removing the anterior donor corneal stroma by hand (e.g., DSEK) or with the assistance of an automated microkeratome (e.g., DSAEK) or laser (FLEK or FELEK).  Donor tissue preparation may be performed by the surgeon in the operating room or by the eye bank and then transported to the operating room for final punch out of the donor tissue button. In order to minimize endothelial damage, the donor tissue must be carefully positioned in the anterior chamber. An air bubble is frequently used to center the donor tissue and facilitate adhesion between the stromal side of the donor lenticule and the host posterior corneal stroma. Repositioning of the donor tissue with application of another air bubble may be required in the first week if the donor tissue dislocates. The small corneal incision is closed with one or more sutures, and steroids or immune-suppressants may be provided either topically or orally to reduce the potential for graft rejection. Visual recovery following EK is typically achieved in four to eight weeks.

Eye Bank Association of America statistics have shown the number of EK cases in the United States increased from 30,710 in 2015 to 35,555 in 2019. The Eye Bank Association of America estimated that, as of 2016, nearly 40% of corneal transplants performed in the United States were endothelial grafts. As with any new surgical technique, questions have been posed about long-term efficacy and risk of complications. EK-specific complications include graft dislocations, endothelial cell loss, and rate of failed grafts. Long-term complications include increased intraocular pressure, graft rejection, and late endothelial failure.

KEY POINTS:

The most recent update was performed with a literature search through December 13, 2020.

Summary of Evidence

For individuals who have endothelial disease of the cornea who receive DSEK or DSAEK, the evidence includes a number of cohort studies, a randomized controlled trial (RCT), and systematic reviews. Relevant outcomes are change in disease status, morbid events, and functional outcomes. The available literature has indicated that these procedures improve visual outcomes and reduce serious complications associated with PK. Specifically, visual recovery occurs much earlier. Because endothelial keratoplasty maintains an intact globe without a sutured donor cornea, astigmatism or the risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage and postoperative catastrophic wound failure are eliminated. The Descemet Endothelial Thickness Comparison Trial (DETECT) RCT reported improved visual acuity outcomes with DMEK compared to ultra-thin DSAEK. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have endothelial disease of the cornea who receive DMEK or DMAEK, the evidence includes a number of cohort studies and systematic reviews. Relevant outcomes are change in disease status, morbid events, and functional outcomes. Evidence from the cohort studies and meta-analyses has consistently shown that the use of DMEK and DMAEK procedures improve visual acuity. When compared with DSEK and DSAEK, DMEK and DMAEK showed significantly greater improvements in visual acuity, both in the short term and through one year of follow-up. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have endothelial disease of the cornea who receive FLEK and femtosecond and excimer laser-assisted endothelial keratoplasty, the evidence includes a multicenter randomized trial that compared FLEK with PK and an RCT comparing femtosecond-prepared DSAEK to microkeratome-prepared DSAEK. Relevant outcomes are change in disease status, morbid events, and functional outcomes. Mean best-corrected visual acuity was worse after FLEK than after PK, and endothelial cell loss was higher with FLEK. With the exception of dislocation and need for repositioning of the FLEK, the percentage of complications was similar between groups. Complications in the FLEK group were due to pupillary block, graft failure, epithelial ingrowth, and elevated intraocular pressure, whereas complications in the PK group were related to sutures and elevated intraocular pressure. Worsened visual acuity and a 100% graft dislocation rate was reported for femtosecond-prepared DSAEK compared to 0% in manually-prepared DSAEK. 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 Ophthalmology

In 2009, the American Academy of Ophthalmology (AAO) published a position paper on endothelial keratoplasty, stating that the optical advantages, speed of visual rehabilitation, and lower risk of catastrophic wound failure have driven the adoption of endothelial keratoplasty as the standard of care for patients with endothelial failure and otherwise healthy corneas. The 2009 AAO position paper was based in large part on an AAO comprehensive review of the literature on Descemet stripping automated endothelial keratoplasty. AAO concluded that “the evidence reviewed suggests Descemet stripping automated endothelial keratoplasty appears safe and efficacious for the treatment of endothelial diseases of the cornea. Evidence from retrospective and prospective Descemet stripping automated endothelial keratoplasty reports described a variety of complications from the procedure, but these complications do not appear to be permanently sight threatening or detrimental to the ultimate vision recovery in the majority of cases. Long-term data on endothelial cell survival and the risk of late endothelial rejection cannot be determined with this review.” “Descemet stripping automated endothelial keratoplasty should not be used in lieu of penetrating keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease. These situations would include concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection, and ectasia after previous laser vision correction surgery.”

National Institute for Health and Clinical Excellence

In 2009, the National Institute for Health and Care Excellence released guidance on corneal endothelial transplantation. Additional data reviewed from the United Kingdom Transplant Register showed lower graft survival rates after endothelial keratoplasty than after penetrating keratoplasty; however, the difference in graft survival between the two procedures was noted to be narrowing with increased experience in endothelial keratoplasty use. The guidance concluded that “current evidence on the safety and efficacy of corneal endothelial transplantation (also known as endothelial keratoplasty is adequate to support the use of this procedure.” The guidance noted that techniques for this procedure continue to evolve, and thorough data collection should continue to allow future review of outcomes.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Deep lamellar endothelial keratoplasty (DLEK), Descemet’s membrane endothelial keratoplasty (DMEK), Descemet’s stripping endothelial keratoplasty (DSEK), Descemet’s stripping automated endothelial keratoplasty (DSAEK), Endothelial keratoplasty (EK), Penetrating keratoplasty (PK), FLEK, FELEK, femtosecond laser-assisted corneal endothelial keratoplasty, femtosecond and excimer lasers-assisted endothelial keratoplasty

APPROVED BY GOVERNING BODIES:

Endothelial keratoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Several microkeratomes have been cleared for marketing by FDA through the 510(k) process.

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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

65756

Keratoplasty (corneal transplant); endothelial

65757

Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure)

REFERENCES:

  1. America EBAA. 2009 Eye banking statistical report. Available online at www.corneas.org/repository/images/pressimages/EBAA%202009%20statistical%20report%20-%20final.pdf.
  2. American Academy of Ophthalmology Health Policy Committee Position Paper on Endothelial Keratoplasty, January 29, 2009.
  3. American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Cornea and Anterior Segment Disorders Panel. Safety and efficacy of Descemet’s stripping automated endothelial keratoplasty (DSAEK). Ophthalmology, 2009.
  4. Anshu A, Price MO, Price FW, Jr. Risk of corneal transplant rejection significantly reduced with Descemet’s membrane endothelial keratoplasty. Ophthalmology 2012; 119(3):536-40.
  5. Anshu A, Price MO, Price FW. Descemet’s stripping endothelial keratoplasty: long-term graft survival and risk factors for failure in eyes with preexisting glaucoma. Ophthalmology 2012 (in press).
  6. Chamberlain W, Lin CC, Austin A, et al. Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty. Ophthalmology. 2019 Jan; 126(1).
  7. Chen ES, Terry MA, Shamie N, et al. Descemet-stripping automated endothelial keratoplasty: six-month results in a prospective study of 100 eyes. Cornea 2008; 27(5):514-20.
  8. Chen ES, Terry MA, Shamie N, et al. Endothelial keratoplasty: Vision, endothelial survival, and complications in a comparative case series of fellow’s vs attending surgeons. Am J Ophthalmol 2009; 148(1):26-31.e2.
  9. Cheng YY, Schouten JS, Tahzib NG et al. Efficacy and safety of femtosecond laser-assisted corneal endothelial Keratoplasty: a randomized multicenter clinical trial. Transplantation 2009; 88(11):1294-302.
  10. Dapena I, Ham L and Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol 2009; 20(4):299-307.
  11. Dapena I, Ham L, Droutsas K et al. Learning curve in Descemet’s membrane endothelial keratoplasty: first series of 135 consecutive cases. Ophthalmology 2011; 118(11):2147-54.
  12. Deng SX, Lee WB, Hammersmith KM, et al. Descemet membrane endothelial keratoplasty: safety and outcomes: a report by the American Academy of Ophthalmology. Ophthalmology. Feb 2018; 125(2):295-310.
  13. Duggan MJ, Rose-Nussbaumer J, Lin CC et al. Corneal Higher-Order Aberrations in Descemet Membrane Endothelial Keratoplasty versus Ultrathin DSAEK in the Descemet Endothelial Thickness Comparison Trial: A Randomized Clinical Trial. Ophthalmology. 2019 Jul; 126(7).
  14. Dunker SL, Dickman MM, Wisse RPL, et al. Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial. Ophthalmology. Sep 2020; 127(9): 1152-1159.
  15. Eye Bank Association of America. 2019 Eye Banking Statistical Report. 2019; https://restoresight.org/wp-content/uploads/2020/04/2019-EBAA-Stat-Report-FINAL.pdf. Accessed February 9, 2021.
  16. Fuest M, Ang M, Htoon HM, et al. Long-term visual outcomes comparing Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty. Am J Ophthalmol. Oct 2017; 182:62-71.
  17. Guerra FP, Anshu A, Price MO et al. Descemet’s membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology 2011; 118(12):2368-73.
  18. Ham L, Dapena I, van Luijk C, et al. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: Review of the first 50 consecutive cases. Eye (Lond). 2009; 23(10): 1990-8.
  19. Heinzelmann S, Bohringer D, Eberwein P, et al. Outcomes of Descemet membrane endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty from a single centre study. Graefes Arch Clin Exp Ophthalmol. Jan 7 2016.
  20. Hirabayashi KE, Chamberlain W, Rose-Nussbaumer J, et al. Corneal Light Scatter After Ultrathin Descemet Stripping Automated Endothelial Keratoplasty Versus Descemet Membrane Endothelial Keratoplasty in Descemet Endothelial Thickness Comparison Trial: A Randomized Controlled Trial. Cornea. 2020 Jan.
  21. Hosny MH, Marrie A, Karim Sidky M, et al. Results of femtosecond laser-assisted Descemet stripping automated endothelial keratoplasty. J Ophthalmol. Jun 11 2017; 2017:8984367.
  22. Ivarsen A, Hjortdal J. Clinical outcome of Descemet's stripping endothelial keratoplasty with femtosecond laser-prepared grafts. Acta Ophthalmol. 2018 Aug; 96(5).
  23. Lee WB, Jacobs DS, Musch DC et al. Descemet’s stripping endothelial keratoplasty: safety and outcomes: a report by the American Academy of Ophthalmology. Ophthalmology 2009; 116(9):1818-30.
  24. Li S, Liu L, Wang W, et al. Efficacy and safety of Descemet's membrane endothelial keratoplasty versus Descemet's stripping endothelial keratoplasty: A systematic review and meta-analysis. PLoS One. Dec 18 2017; 12(12):e0182275.
  25. Li JY, Terry MA, Goshe J et al. Three-year visual acuity outcomes after Descemet’s stripping automated endothelial keratoplasty. Ophthalmology 2012; 119(6):1126-9.
  26. Marques RE, Guerra PS, Sousa DC, et al. DMEK versus DSAEK for Fuchs' endothelial dystrophy: A meta-analysis. Eur J Ophthalmol. 2019 Jan; 29(1).
  27. McCauley MB, Price MO, Fairchild KM et al. Prospective study of visu al outcomes and endothelial survival with Descemet membrane automated endothelial keratoplasty. Cornea 2011; 30(3):315-9.
  28. National Institute for Health and Clinical Excellence. Corneal endothelial transplantation. Available at: www.nice.org.uk/nicemedia/pdf/IPG304Guidance.pdf. Accessed January 29 2018.
  29. National Institute for Health and Care Excellence (NICE). Corneal endothelial transplantation [IPG304]. 2009; https://www.nice.org.uk/guidance/IPG304. Accessed February 9, 2021.
  30. Oellerich S, Baydoun L, Peraza-Nieves J, et al. Multicenter study of 6-month clinical outcomes after Descemet membrane endothelial keratoplasty. Cornea. Dec 2017; 36(12):1467-1476.
  31. Pavlovic I, Shajari M, Herrmann E, et al. Meta-analysis of postoperative outcome parameters comparing Descemet membrane endothelial keratoplasty versus Descemet stripping automated endothelial keratoplasty. Cornea. Dec 2017; 36(12):1445-1451.
  32. Price MO, Giebel AW, Fairchild KM et al. Descemet’s membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology 2009; 116(12):2361-8.
  33. Rose L, Kelliher C and Jun AS. Endothelial keratoplasty: Historical perspectives, current techniques, future directions. Can J Ophthalmol 2009; 44(4):401-5.
  34. Singh A, Zarei-Ghanavati M, Avadhanam V, et al. Systematic review and meta-analysis of clinical outcomes of Descemet membrane endothelial keratoplasty versus Descemet stripping endothelial keratoplasty/Descemet stripping automated endothelial keratoplasty. Cornea. Nov 2017; 36(11):1437-1443.
  35. Singhal D, Maharana PK. RE: "Three-Year Outcome Comparison Between Femtosecond Laser-Assisted and Manual Descemet Membrane Endothelial Keratoplasty". Cornea. 2019 Nov; 38(11).
  36. Sorkin N, Mednick Z, Einan-Lifshitz A, et al. Three-Year Outcome Comparison Between Femtosecond Laser-Assisted and Manual Descemet Membrane Endothelial Keratoplasty. Cornea. 2019 Jul; 38(7).
  37. Stuart AJ, Romano V, Virgili G, et al. Descemet's membrane endothelial keratoplasty (DMEK) versus Descemet's stripping automated endothelial keratoplasty (DSAEK) for corneal endothelial failure. Cochrane Database Syst Rev. 2018 Jun; 6:CD012097.
  38. Tourtas T, Laaser K, Bachmann BO et al. Descemet membrane endothelial keratoplasty versus Descemet stripping automated endothelial keratoplasty. Am J Ophthalmol 2012; 153(6):1082-90e2.
  39. Trinh L, Saubaméa B, Auclin F, et al. A new technique of endothelial graft: the femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK). Acta Ophthalmol. Sep 2013; 91(6):e497-499.
  40. van Dijk K, Ham OL, Tse WH et al. Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Con Lens Anterior Eye 2013; 36(1):13-21.
  41. Vetter JM, Butsch C, Faust M et al. Irregularity of the posterior corneal surface after curved interface femtosecond laser-assisted versus microkeratome-assisted Descemet stripping automated endothelial keratoplasty. Cornea 2013; 32(2):118-24.
  42. Wacker K, Baratz KH, Maguire LJ, et al. Descemet stripping endothelial keratoplasty for Fuchs' endothelial corneal dystrophy: five-year results of a prospective study. Ophthalmology. Jan 2016; 123(1):154-160.
  43. Woo JH, Ang M, Htoon HM, et al. Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty. Am. J. Ophthalmol. 2019 Nov; 207:288-303.

POLICY HISTORY:

Medical Policy Group, August 2009 (2)

Medical Policy Administration Committee, September 2009

Available for comment September 4-October 19, 2009

Medical Policy Panel, August 2010

Medical Policy Group, September 2010 (2)

Medical Policy Group, September 2012 (2): Update to Description, Key Points and References

Medical Policy Panel, September 2013

Medical Policy Group, October 2013 (2):  Policy updated with literature search.  DMEK [Descemet’s membrane endothelial keratoplasty] and DMAEK [Descemet’s membrane automated endothelial keratoplasty] added as covered indications.  FLEK and FELEK added as investigational.  Description, Key Points, Key Words, and References updated to support new policy statements and literature findings.

Medical Policy Administration Committee, October 2013

Available for comments October 16 through November 30, 2013

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (1): updated policy with current literature review; no change to policy statement

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (6): Updates to Key Points; no change in policy statement.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Description, Key Points, Approved by Governing Bodies, Benefit Application, and References: no change in policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Description, Key Points. Removed old policy statement.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Key Points and References.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Description, Key Points and References. No change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points and References.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (9): 2021 Updates to Key Points, Description, References. Policy statement updated to add “Endothelial keratoplasty is not medically necessary when endothelial dysfunction is not the primary cause of decreased corneal clarity” and to remove “not medically necessary”, no change to policy 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.