mp-241
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Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing, Orthopedic Applications, and Other Non-Orthopedic Conditions

Policy Number: MP-241

Latest Review Date: April 2021

Category: Other                                                                     

Policy Grade: C

 

POLICY:

Recombinant platelet-derived growth factor (i.e., becaplermin) may be considered medically necessary when used as an adjunct to standard wound management for the following indications:

 

  • Neuropathic diabetic ulcers extending into the subcutaneous tissue when all of the following criteria is met:
  • Adequate tissue oxygenation, (as measured by a transcutaneous partial pressure of oxygen of 30 mm Hg or greater on the foot dorsum or at the margin of the ulcer); AND
  • Full thickness ulcer (i.e., stage III or IV), extending through dermis into subcutaneous tissues; AND
  • Participation in a wound-management program, which includes sharp debridement, pressure relief, and infection control

 

  • Pressure ulcers extending into the subcutaneous tissue when all of the following criteria is met:
  • Full-thickness ulcer (stage III or IV), extending through dermis into the subcutaneous tissue; AND
  • Ulcer in an anatomic location that can be off-loaded for the duration of treatment; AND
  • Albumin concentration > 2.5 dL; AND
  • Total lymphocyte count > 1,000; AND
  • Normal values of vitamins A and C

 

Treatments are normally for 20 weeks or complete healing.

 

Other applications of recombinant platelet-derived growth factor (i.e., becaplermin) are considered not medically necessary and investigational, including, but not limited to, ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue.

 

Autologous blood derived preparations (i.e., platelet rich plasma) are considered not medically and investigational, including but not limited to, use in the following:

  • Treatment of acute or chronic wounds including surgical wounds, and non-healing ulcers
  • All orthopedic indications including but not limited to the following situations and conditions:
  •  Primary use (injection)
    • Achilles tendinopathy
    • Lateral epicondylitis
    • Plantar fasciitis
    • Osteochondral lesions
    • Osteoarthritis
    • Dupuytren’s contracture
    • Cartilage degeneration
    • Degenerative disc disease
  • Adjunctive use in surgical procedures
    • ACL reconstruction
    • Hip fracture
    • Long-bone nonunion
    • Patellar tendon repair
    • Rotator cuff repair
    • Spinal fusion
    • Subacromial decompression surgery
    • Total knee arthroplasty

 

DESCRIPTION OF PROCEDURE OR SERVICE:

This policy addresses the use of blood-derived growth factors, including recombinant platelet- derived growth factors (PDGFs) and platelet-rich plasma (PRP), as a treatment of wounds or other miscellaneous non‒orthopedic conditions, including but not limited to treatment of diabetic ulcers, pressure ulcers, and ulcers related to venous stasis.

A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factors, epidermal growth factor, fibroblast growth factors, transforming growth factors, and insulin-like growth factors. Autologous platelets are a rich source of PDGF, transforming growth factors (that function as a mitogen for fibroblasts, smooth muscle cells, osteoblasts), and vascular endothelial growth factors. Recombinant PDGF has also been extensively investigated for clinical use in wound healing.

Autologous platelet concentrate suspended in plasma, also known as platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood. Exposure to a solution of thrombin and calcium chloride degranulates platelets, releasing the various growth factors and results in the polymerization of fibrin from fibrinogen, creating a platelet gel. The platelet gel can then be applied to wounds or may be used as an adjunct to surgery to promote hemostasis and accelerate healing. In the operating room setting, PRP has been investigated as an adjunct to a variety of periodontal, reconstructive, and orthopedic procedures. For example, bone morphogenetic proteins are a type of transforming growth factors, and thus PRP has been used in conjunction with bone-replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries. Alternatively, PRP may be injected directly into various tissues. PRP injections have been proposed as a primary treatment of miscellaneous conditions, such as epicondylitis, plantar fasciitis, and Dupuytren contracture.

PRP is distinguished from fibrin glues or sealants, which have been used for many years as a surgical adjunct to promote local hemostasis at incision sites. Fibrin glue is created from platelet-poor plasma and consists primarily of fibrinogen. Commercial fibrin glues are created from pooled homologous human donors; Tisseel® (Baxter) and Hemaseel® are examples of commercially available fibrin sealants. Autologous fibrin sealants can be created from platelet-poor plasma. This policy does not address the use of fibrin sealants.

Wound Closure Outcomes

This policy addresses the use of recombinant PDGF products and PRP for non-orthopedic indications, which include a number of wound closure-related indications.

For the purposes of this review, the primary end points of interest for studies of wound closure are as follows, consistent with guidance from the FDA for industry in developing products for treatment of chronic cutaneous ulcer and burn wounds:

  1. Incidence of complete wound closure.
  2. Time to complete wound closure (reflecting accelerated wound closure).
  3. Incidence of complete wound closure following surgical wound closure.
  4. Pain control.

KEY POINTS:

The most recent literature update was performed through March 5, 2021. 

Summary of Evidence

The evidence for recombinant PDGF in individuals who have diabetic lower-extremity ulcers or pressure ulcers includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. Results show improved rates of healing with use of recombinant PDGF for diabetic neuropathic ulcers and pressure ulcers. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

The evidence for recombinant PDGF in individuals who have venous ulcers or traumatic wounds includes small RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. It cannot be determined whether recombinant PDGF is effective to treat other wound types, including chronic venous ulcers or acute traumatic wounds. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for PRP in individuals who have chronic wounds or acute surgical or traumatic wounds includes a number of small controlled trials. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The potential benefit of PRP has received considerable interest due to its appeal as a simple, safe, low-cost, and minimally invasive method of applying growth factors. Current results of trials using PRP are mixed and the studies are limited in both size and quality. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Tendinopathies

For individuals with tendinopathy who receive PRP injections, the evidence includes multiple randomized controlled trials (RCTs) and systematic reviews with meta-analyses. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Findings from meta-analyses of RCTs have been mixed and have generally found that PRP did not have a statistically and/or clinically significant impact on symptoms (ie, pain) or functional outcomes.Findings from subsequently published RCTs have also been mixed. In RCTs that have found significantly improved pain outcomes for PRP injections, important relevancy gaps and study conduct limitations preclude reaching strong conclusions based on their findings. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Non‒Tendon Soft Tissue Injury or Inflammation

For individuals with non-tendon soft tissue injury or inflammation (e.g., plantar fasciitis) who receive PRP injections, the evidence includes six small RCTs, multiple prospective observational studies, and a systematic review. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, and treatment-related morbidity. The systematic review, which identified three RCTs on PRP for plantar fasciitis, did not pool study findings. Results among the six RCTs were inconsistent. The largest RCT showed that treatment using PRP compared with corticosteroid injection resulted in statistically mprovement in pain and disability, but not quality of life. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Osteochondral Lesions

For individuals with osteochondral lesions who receive PRP injections, the evidence includes an open-labeled quasi-randomized study. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The quasi-randomized study found a statistically significant greater impact on outcomes in the PRP group than in the group receiving hyaluronic acid. Limitations of the evidence base include lack of adequately randomized studies, lack of blinding, lack of sham controls, and comparison only to an intervention of uncertain efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Primary Treatment for Knee or Hip Osteoarthritis

For individuals with knee or hip OA who receive PRP injections, the evidence includes multiple RCTs and systematic reviews. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, and treatment-related morbidity. Most trials have compared PRP with hyaluronic acid for knee OA. Systematic reviews have generally found that PRP was more effective than placebo or hyaluronic acid in reducing pain and improving function. However, systematic review authors have noted that their findings should be interpreted with caution due to important limitations including significant residual statistical heterogeneity, questionable clinical significance, and high risk of bias in study conduct. RCTs with followup durations of at least 12 months published subsequent to the systematic reviews found statistically significantly greater 12-month reductions in WOMAC scores, but these findings were also limited by important study conduct flaws including potential inadequate control for selection bias and unclear blinding. Also, benefits were not maintained at 5 yearsAlso, using hyaluronic acid as a comparator is questionable, because the evidence demonstrating the benefit of hyaluronic acid treatment for OA is not robust. The single RCT evaluating hip OA reported statistically significant reductions in VAS scores for pain, with no difference in functional scores. Additional studies comparing PRP with placebo and with alternatives other than hyaluronic acid are needed to determine the efficacy of PRP for knee and hip OA. Studies are also needed to determine the optimal protocol for delivering PRP. The evidence is insufficient to determine the effects of the technology on health outcomes.

Adjunct to Surgery

For individuals with anterior cruciate ligament reconstruction who receive PRP injections, the evidence includes 2 systematic reviews of multiple RCTs and prospective studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. Only 1 of the 2 systematic reviews conducted a meta-analysis; it showed that adjunctive PRP treatment did not result in significant effect on International Knee Documentation Committee scores, a patient-reported, knee-specific outcome measure that assesses pain and functional activity. Individual trials have shown mixed results. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with hip fracture who receive PRP injections, the evidence includes 1 open-labeled RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. The single open-labeled RCT failed to show any statistically significant reduction in the need for surgical revision with the addition of PRP treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with long bone nonunion who receive PRP injections plus orthopedic surgery, the evidence includes three RCTs. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. One trial with a substantial risk of bias failed to show significant differences in patient-reported or clinician-assessed functional outcome scores between those who received PRP plus allogenic bone graft and those who received only allogenic bone graft. While the trial showed a statistically significant increase in the proportion of bones that healed in patients receiving PRP in a modified intention-to-treat analysis, the results did not differ in the intention-to-treat analysis. The second RCT, which compared PRP with rhBMP-7, also failed to show any clinical or radiologic benefits of PRP over morphogenetic protein. The third RCT reported no difference in the number of unions or time to union in patients receiving PRP injections s no treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with rotator cuff repair who receive PRP injections plus orthopedic surgery, the evidence includes multiple RCTs and systematic reviews. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. Although systematic reviews consistently found significant reductions in pain with PRP at 12 months, important study conduct and relevance weaknesses limit interpretation of these findings. Additionally, the pain reductions with PRP were not maintained in longer-term studies. Further, the systematic reviews and meta- analyses failed to show a statistically and/or clinically significant impact on other outcomes. Findings of subsequently published small, single-center RCTs were consistent with the systematic reviews. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with spinal fusion who receive PRP injections plus orthopedic surgery, the evidence includes two controlled prospective studies. The relevant outcomes are symptoms, functional outcomes, health status measures, QOL, morbid events, resource utilization, and treatment-related morbidity. The two studies failed to show any statistically significant differences in fusion rates between the PRP arm and the control arm. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals undergoing spinal fusion who receive PRP injections, the evidence includes a single small RCT and a few observational studies. Relevant outcomes include symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatmentrelated morbidity. Studies have generally failed to show a statistically and/or clinically significant impact on symptoms (ie, pain). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with subacromial decompression surgery who receive PRP injections, the evidence includes 1 small RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. A single small RCT failed to show reduced self-assessed or physician-assessed spinal instability with PRP injections. However, subjective pain, use of pain medications, and objective measures of range of motion showed clinically significant improvements with PRP. Larger trials are required to confirm these benefits. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with total knee arthroplasty who receive PRP injections, the evidence includes 1 small RCT. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, morbid events, resource utilization, and treatment-related morbidity. The RCT showed no significant differences between the PRP and untreated control groups in terms of bleeding, range of motion, swelling around the knee joint, muscle power recovery, pain, or Knee Society Score and Knee Injury and Osteoarthritis Outcome Score. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines And Position Statements

American College of Physicians

In 2015, the American College of Physicians (ACP) published guidelines on treatment of pressure ulcers. The guidelines noted that “although low quality evidence suggests that dressings containing PDGF [platelet-derived growth factors] promote healing, ACP supports the use of other dressings such as hydrocolloid and foam dressings, which are effective at promoting healing and cost less than PDGF dressings.”

Association for the Advancement of Wound Care

In 2010, the Association for the Advancement of Wound Care developed guidelines pressure ulcers and on venous ulcer:

  • Pressure ulcer: growth factors are not indicated at this time (level C evidence – no RCTs available comparing growth factors with A-level dressings)
  • Venous ulcer: platelet derived growth factor has shown no significant effects on venous ulcer healing or recurrence (level A evidence).

National Institute for Health and Care Excellence

In January 2016, NICE updated its guidance on the prevention and management of diabetic foot problems. The guidance states that neither autologous platelet-rich plasma gel nor platelet-derived growth factor should be offered in the treatment of diabetic foot ulcers.

American Academy of Orthopaedic Surgeons

The 2013 American Academy of Orthopaedic Surgeons (AAOS) guidelines were unable to recommend for or against growth factor injections and/or platelet-rich plasma (PRP) for patients with symptomatic osteoarthritis of the knee. A recommendation of inconclusive was based on a single low-quality study and conflicting findings that did not permit a recommendation for or against the intervention. The AAOS recommendation as based on 3 studies published before May 2012.

National Institute for Health and Care Excellence

In 2013, the U.K.’s National Institute for Health and Care Excellence (NICE) issued guidance on use of autologous blood injection for tendinopathy. NICE concluded that the current evidence on the safety and efficacy of autologous blood injection for tendinopathy is “inadequate” in quantity and quality. NICE recommended “this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.”

In 2013, NICE also issued guidance on use of autologous blood injection (with or without techniques for producing PRP) for plantar fasciitis. NICE concluded that the evidence on autologous blood injection for plantar fasciitis raised no major safety concerns but that the evidence on efficacy was “inadequate in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.” In addition, physicians should ensure that patients “understand the uncertainty about the procedure’s efficacy, [be] aware of alternative treatments” and be provided “with clear written information.”

In 2019, the NICE issued guidance on the use of PRP for OA of the knee. The NICE concluded that current evidence on PRP injections for OA of the knee raised “no major safety concerns”;however, the “evidence on efficacy is limited in quality. Therefore, NICE recommended that "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research."

U.S. Preventive Services Task Force Recommendations

Not Applicable.

KEY WORDS:

Autologous platelet derived growth factors, autologous blood derived preparations, platelet-derived growth factors, PDGF, platelet rich plasma, PRP, autologous platelet gel, Autologel, SafeBlood, Medtronic Electromedic, Elmd-500 Autotransfusion system, Plasma Saver, Smart PreP, wound healing, platelet gel, platelet concentrate, autologous blood-derived products, platelet-derived wound healing formulas, epicondylitis, tennis elbow, plantar fasciitis, Dupuytren’s contracture, becaplermin, becaplermin gel, recombinant platelet-derived growth factor

APPROVED BY GOVERNING BODIES:

In 1997, becaplermin gel (Regranex®, Smith & Nephew), a recombinant platelet-derived growth factor (PDGF) product, was approved by the U.S. Food and Drug Administration (FDA) for the following labeled indication:

"Regranex Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, Regranex Gel increases the complete healing of diabetic ulcers. The efficacy of Regranex Gel for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers has not been evaluated."

In 2008, the manufacturer added this black box warning to the labeling for Regranex:

“An increased rate of mortality secondary to malignancy was observed in patients treated with three or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.”

Platelet-Rich Plasma

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Blood products such as platelet-rich plasma are included in these regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore, do not follow the traditional FDA regulatory pathway. To date, FDA has not attempted to regulate activated PRP.

A number of PRP preparation systems are available, many of which were cleared for marketing by FDA through the 510(k) process for producing platelet-rich preparations intended to be mixed with bone graft materials to enhance the bone grafting properties in orthopedic practices. The Aurix System™ (previously called AutoloGel™; Cytomedix) and SafeBlood® (SafeBlood Technologies) are 2 related but distinct autologous blood-derived preparations that can be used at the bedside for immediate application. Both AutoloGel™ and SafeBlood® have been specifically marketed for wound healing. Other devices may be used in the operating room setting (eg, Medtronic Electromedics, Elmd-500 Autotransfusion system, the Plasma Saver device, the SmartPReP® [Harvest Technologies] device). The Magellan™ Autologous Platelet Separator System (Medtronic Sofamor Danek) includes a disposables kit for use with the Magellan™ Autologous Platelet Separator portable tabletop centrifuge. GPS®II (BioMet Biologics), a gravitational platelet separation system, was cleared for marketing by FDA through the 510(k) process for use as disposable separation tube for centrifugation and a dual cannula tip to mix the platelets and thrombin at the surgical site. Filtration or plasmapheresis may also be used to produce platelet-rich concentrates. The use of different devices and procedures can lead to variable concentrations of active platelets and associated proteins, increasing variability between studies of clinical efficacy.

In 2018, the “Boxed Warning” and “Warnings and Precautions” were changed to remove “increased rate of cancer mortality” and “cancer mortality,” respectively.

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 code:

0232T

Injection(s) platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed

0481T

Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed

22899

Unlisted procedure, spine

27599

Unlisted procedure, femur or knee

29999

Unlisted procedure, arthroscopy

41899

Unlisted procedure, dentoalveolar structures

86999

Unlisted transfusion medicine procedure

NOTE: CPT code 20926-Tissue graft, other (DELETED 12/31/19) should not be billed for application of recombinant and autologous platelet derived growth factors.

HCPCS code:

D7921

Collection and application of autologous blood concentrate product

G0460

Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment

P9020

Platelet rich plasma, each unit

S0157

Becaplermin gel 0.01%, 0.5gm

S9055

Procuren or other growth factor preparation to promote wound healing

 

REFERENCES:

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POLICY HISTORY:

Medical Policy Group, May 2005 (3)

Medical Policy Group, June 2005

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment August 6-September 19, 2005

Medical Policy Group, November 2006 (1)

Medical Policy Group, November 2007 (1)

Medical Policy Group, February 2009 (2)

Medical Policy Administration Committee, May 2009

Available for comment April 9-May 23, 2009

Medical Policy Group, April 2010 (1): Policy updated, Description, Key Points, Policy Update, Key Words

Medical Policy Administration Committee, May 2010

Available for comment May 7-June 17, 2010

Medical Policy Group, June 1010 (2)

Medical Policy Administration, June 2010

Available for comment June 18-August 2, 2010

Medical Policy Group, June 2011; Updated Key Points & References

Medical Policy Group, April 2012 (3): 2012 Updates-Key Points & References

Medical Policy Group, November 2012: Added Code D7921 effective 1/1/13.

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (1): Update to Title with addition of ‘recombinant’ and removal of ‘primary and miscellaneous’; Added HCPCS code G0460 with retro effective date of 08/02/2012; condensed Policy section with no change to coverage criteria; update to Key Points and References

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (1): Clarification to policy statements to further define what is not covered, no change to intent of policy or what is covered/non-covered; Update to Key Points and References

Medical Policy Panel, May 2015

Medical Policy Group, June 2015 (2): 2015 Updates to Title, Description, Key Points, Approved by Governing Bodies, Current coding: CPT code 86999 added, and References; policy statement updated to include a list of some of the conditions that are not covered for platelet-rich plasma; no change to intent.

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (2): 2016: Updates to Title, Key Points, Approved by Governing Bodies, and References; no change in policy statement.

Medical Policy Panel, April 2016:

Medical Policy Group, April 2016 (7): 2016 Updates to Key Points, References; no change in policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (7): 2017 Updates to Description, Key Points, Approved by Governing Bodies & References. No change to policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new CPT code 0481T effective 1/1/18 to the Current Coding section.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points & References. No change to policy statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Key Points and References. Policy section updated to remove “not medically necessary” statements. No change in 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.

 

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