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Placental/Umbilical Cord Blood as a Source of Stem Cells

Policy Number: MP-439

Latest Review Date: February 2019

Category: Medical                                                                 

Policy Grade:  A

Description of Procedure or Service:

This policy addresses the collection, storage and transplantation of placental/umbilical cord blood (“cord blood”) as a source of stem cells for allogeneic and autologous stem-cell transplantation. Potential indications for use of cord blood are not addressed in this policy; they are included in the disease-specific reference policies.

Bone Marrow Disorders

A variety of malignant diseases and nonmalignant bone marrow disorders are treated with myeloablative therapy followed by infusion of allogeneic stem and progenitor cells collected from immunologically compatible donors, either from family members or an unrelated donor identified through a bone marrow donor bank. In some cases, a suitable donor is not found.

Blood harvested from the umbilical cord and placenta shortly after delivery of neonates contains stem and progenitor cells capable of restoring hematopoietic function after myeloablation. This “cord” blood has been used as an alternative source of allogeneic stem cells. Cord blood is readily available and is thought to be antigenically “naive,” thus potentially minimizing the incidence of graft-versus-host disease (GVHD) and permitting the broader use of unrelated cord blood transplants. Unrelated donors are typically typed at low resolution for HLA-A and B and at high resolution only for HLA-DR; HLA matching at four of six loci is considered acceptable. Under this matching protocol, an acceptable donor can be identified for almost any patient.

Several cord blood banks have now been developed in Europe and in the U.S. In addition to obtaining cord blood for specific related or unrelated patients, some cord blood banks are offering the opportunity of collecting and storing a neonate’s cord blood for some unspecified future use in the unlikely event that the child develops a condition that would require autologous transplantation. In addition, some cord blood is collected and stored from a neonate for use by a sibling in whom an allogeneic transplant is anticipated due to a history of leukemia or other condition requiring allogeneic transplant.

Standards and accreditation for cord blood banks are important for assisting transplant programs in knowing whether individual banks have important quality control measures in place to address such issues as monitoring cell loss, change in potency, and prevention of product mix-up. Two major organizations are working toward these accreditation standards; the International NetCord Foundation (NetCord)/ Foundation for the Accreditation of Cellular Therapy (FACT) and the American Association of Blood Banks. NetCord, Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented a program of voluntary inspection and accreditation for cord blood banking. NetCord and FACT publish international standards for cord blood collection, banking and release.  The voluntary program includes standards for collection, testing, processing, storage, and release of cord blood products.

Policy:

Transplantation of cord blood stem cells from related or unrelated donors may be considered medically necessary in patients with an appropriate indication for allogeneic stem-cell transplant.

Transplantation of cord blood stem cells from related or unrelated donors is considered not medically necessary and investigational in all other situations.

Collection and storage of cord blood from a neonate may be considered medically necessary when an allogeneic transplant is imminent in an identified recipient with a diagnosis that is consistent with the possible need for allogeneic transplant.

Prophylactic collection and storage of cord blood from a neonate is considered not medically necessary when proposed for some unspecified future use as an autologous stem-cell transplant in the original donor, or for some unspecified future use as an allogeneic stem-cell transplant in a related or unrelated donor.

Please refer to the reference policies for specific conditions/diseases that have patient selection criteria regarding situations for which allogeneic stem-cell transplantation may be considered medically necessary.

Key Points:

The most recent update via MEDLINE was through November 15, 2018.

The clinical evidence to determine whether the use of technology improves the net health outcome is assessed by evidence reviews. Health outcomes are assessed by the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Outcome measures are validated to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

The net health outcome of technology is assessed by whether the evidence is sufficient enough to draw conclusions, while examining two domains: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. In various conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence is determined by study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is favored to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Cord Blood as Source of Stem Cells for Stem Cell Transplant

Clinical Context and Therapy Purpose

The purpose of using placental and umbilical cord blood as a source of stem cells is to provide an alternative to or an improvement on existing donor sources in patients with an appropriate indication for allogeneic stem cell transplant.

The question addressed in this evidence review is: In individuals with an indication for allogeneic stem cell transplantation. Does the use of placental and umbilical cord blood as a source of stem cells result in an improvement in net health outcomes?

The following PICOTS were used to select literature to inform this review.

Patients

The population of interest are individuals with an appropriate indication for allogeneic stem cell transplant.

Interventions

The test being considered is placental or umbilical cord blood as a source of stem cells for allogeneic hematopoietic cell transplantation.

Comparators

Stem cells from other donor sources.

Outcomes

The outcomes of interest are overall survival (OS), disease-specific survival, resource utilization, and treatment-related mortality.

Timing

The timing of follow-up is initially the first post-transplant year for successful engraftment and monitoring relevant outcomes. Follow-up is life-long for successful transplantation.

Setting

Allogeneic stem cell transplant are managed by a transplant specialist in an inpatient clinical setting.

Study Selection

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse effects, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4.  Studies with duplicative or overlapping populations were excluded.

Related Allogeneic Cord Blood Transplant

The first cord blood transplant was a related cord blood transplant for a child with Fanconi anemia; results were reported in 1989. At least 60 other cord transplants have subsequently been performed in matched-siblings. The results of these transplants demonstrated that cord blood contained sufficient numbers of hematopoietic stem and progenitor cells to reconstitute pediatric patients. A lower incidence of acute and chronic graft-versus-host disease (GVHD) when cord blood, as compared with bone marrow, was used as the source of donor cells was also observed. This led to the idea that cord blood could be banked and used as a source of unrelated donor cells, possibly without full HLA matching.

Unrelated Allogeneic Cord Blood Transplant

The first prospective study of unrelated cord blood transplant was the Cord Blood Transplantation study (COBLT), published in 2005. COBLT was designed to examine the safety of unrelated cord blood transplantation in infants, children, and adults. In children with malignant and nonmalignant conditions, two-year event-free survival was 55% in children with high-risk malignancies and 78% in children with nonmalignant conditions. Across all groups, the cumulative incidence of engraftment by day 42 was 80%. Engraftment and survival were adversely affected by lower cell doses, pretransplant cytomegalovirus seropositivity in the recipient, non-European ancestry, and higher HLA mismatching. This slower engraftment led to longer hospitalizations and greater utilization of medical resources. In the COBLT study, outcomes in adults were inferior to the outcomes achieved in children.

In 2012, Zhang and colleagues published a meta-analysis of studies comparing unrelated donor cord blood transplantation to unrelated donor bone marrow transplantation in patients with acute leukemia.  The authors identified seven studies with a total of 3,389 patients. Pooled rates of engraftment failure (n=5 studies) were 127 events in 694 patients (18%) in the cord blood transplantation group and 57 events in 951 patients (6%) in bone marrow transplantation patients. The rate of engraftment graft failure was significantly higher in cord blood transplantation recipients, p<0.0001. However, rates of acute GVHD were significantly lower in the group receiving cord blood transplantation. Pooled rates of GVHD (n=7 studies) were 397 of 1,179 (34%) in the cord blood group and 953 of 2,189 (44%) in the bone marrow group, p<0.0001. Relapse rates, reported in all studies, did not differ significantly between groups. Several survival outcomes including overall survival, leukemia-free survival and non-relapse mortality favored the bone marrow transplantation group.

Also, numerous retrospective and registry studies have generally found that unrelated cord blood transplantation is effective in both children and adults with hematologic malignancies and children with a variety of nonmalignant conditions.  For example, a 2014 study by Liu et al compared outcomes after unrelated donor cord blood transplantation with matched-sibling donor peripheral blood transplantation. The study included patients ages 16 years or older who had hematologic malignancies. Seventy patients received unrelated cord blood, and 115 patients received human leukocyte antigen-identical peripheral blood stem cells, alone or in combination with bone marrow. Primary engraftment rates were similar in the 2 groups (97% in the cord blood group, 100% in the peripheral blood stem cell group). Rates for most outcomes, including grades III and IV acute GVHD and 3-year disease-free survival, were also similar between groups. However, the rate of chronic GVHD was lower in the unrelated-donor cord blood group. Specifically, limited or extensive chronic GVHD occurred in 12 (21%) of 58 evaluable patients in the cord blood group and in 46 (42%) of 109 evaluable patients in the peripheral blood stem cell group (p=0.005).

Haplo-Cord Blood Transplantation

 

 

Haplo-cord transplants involve a combination of donated cord blood stem cells and half-matched (haploidentical) cells from a related donor.

 

In 2016, Mo et al reported on outcomes after umbilical cord blood and haploidentical hematopoietic cell transplantation in 129 children younger than 14 years old.16 The 2-year probability of OS was 82% (95% confidence interval [CI], 72.2% to 91.8%) in the haploidentical hematopoietic cell transplantation group and 69.9% (95% CI, 58.0% to 81.2%) in the cord blood group. The difference in OS rates between groups was not statistically significant (p=0.07). The 2-year incidence of relapse was also similar in both groups: 16% (95% CI, 6.1% to 26.1%) in the haplo-HCT group and 24.1% (95% CI, 12.5% to 37.5%) in the cord blood group (p=0.17).

 

In 2018, Hsu et al reported on patients with lymphoma or chronic lymphoblastic leukemia who underwent haplo-cord allogeneic stem cell transplantation. Forty-two patients treated between 2007 and 2016 were included in the analysis. After a median survivor follow-up of 42 months, the median 3-year GVHD relapse-free survival, progression-free survival, and OS were 53% (95% CI: 36-68%), 62% (95% CI: 44-75%), and 65% (95% CI: 48-78%), respectively. The aggregate incidence of relapse was 12% at 100 days and 19.5% at 1 year.

 

Double Unit Cord Blood Transplantation

Also, transplantation of 2 umbilical cord blood units (or double-unit transplants) has been evaluated as a strategy to overcome cell dose limitations with 1 cord blood unit in older and heavier patients. Initial experience at a university showed that using 2 units of cord blood for a single transplant in adults improved rates of engraftment and OS. Although cell doses are higher with double-unit transplants, studies published to date have found that survival rates are similar to transplants using single-cord blood units, and there is some suggestion of higher rates of GVHD (see Tables 1 and 2).

Table 1. Summary of Key Trial Characteristics

 

 

 

 

 

Interventions

Author (Year)

Countries

Sites

Dates

Participants

Active

Comparator

Wagner et al (2014)

 

1

 

Patients (age range, 1-21 y) who had high-risk acute leukemia, chronic myeloid leukemia, or myelodysplastic syndrome for whom there were 2 HLA-matched cord blood units available

2 units

1 unit

HLA: human leukocyte antigen.

Table 2. Summary of Key Trial Results (N=224)

Study (Year)

1-Year OS

1-Year DFS

Acute GVHD

Chronic GVHD

  Wagner et al (2014)

 

 

 

 

Single unit (95% CI), %

73 (63 to 80)

70 (60 to 77)

13 (7 to 20)

30 (22 to 39)

Double unit (95% CI), %

65 (56 to 74)

64 (54 to 72)

23 (15 to 31)

32 (23 to 40)

p

0.17

0.011

0.02

0.51

CI: confidence interval; DFS: disease-free survival; GVHD: graft-versus-host disease; OS: overall survival.

Results of observational studies are similar to those of the Wagner RCT (see Tables 3 and 4). In a study by Scaradavou et al, there was a significantly higher risk of acute GVHD (grade II-IV) in recipients of double-cord blood units treated during the first several years of observation. In the later period (2004-2009), rates of acute GVHD (grade II-IV) did not differ significantly between single and double units of cord blood. A 2017 analysis by Baron et al found no significant differences between single- and double- cord blood transplantation for relapse or nonrelapse mortality, with a trend (p=0.08) toward a higher incidence of GVHD with double units.

 

Table 3. Summary of Key Observational Study Characteristics

Treatment

Author (Year)

Study Type

Dates

Participants

Arm 1

Arm 2

Follow-Up

Scaradavou et al (2013)

Comparative cohort

2002-2004

2004-2009

 

Single unit

Double unit

 

Baron et al (2017)

Registry

2004-2014

Adults with first CBT for AML or ALL

Single unit

Double unit

2 y

ALL: acute lymphocytic leukemia; AML: acute myeloid leukemia; CBT: cord blood transplantation.

 

Table 4. Summary of Key Observational Study Results

 

 

 

 

Acute GVHD (95% CI)

Study (Year)

N

Relapse Mortality

Nonrelapse Mortality

2002-2004

2004-2009

Scaradavou et al (2013)

 

 

 

 

 

Single unit

 

 

 

 

 

Double unit

 

 

 

 

 

HR (95% CI)

 

 

 

6.14 (2.54 to 14.87)

1.69 (0.68 to 4.18)

p

 

 

 

<0.001

0.30

 

 

 

 

2004-2014

 

Baron et al (2017)

 

 

 

 

 

Single unit

172

 

 

28%

 

Double unit

362

 

 

36%

 

HR (95% CI)

 

0.9 (0.6 to 1.3)

0.8 (0.5 to 1.2)

 

 

p

 

0.5

0.3

0.08

 

CI: confidence interval; GVHD: graft-versus-host disease; HR: hazard ratio; OS: overall survival.

 

 

Section Summary: Cord Blood as Source of Stem Cells for Stem Cell Transplant

A number of observational studies and a meta-analysis of observational studies have evaluated outcomes after cord blood transplantation compared with stem cells from a different source. One meta-analysis found similar survival outcomes and lower GVHD after cord blood transplantation than bone marrow transplantation. In addition, there was an RCT that compared single-unit and double-unit cord blood transplantation and found similar outcomes.

 

Prophylactic Collection and Storage of Cord Blood

Clinical Context and Therapy Purpose

The purpose of prophylactic collection and storage of placental or umbilical cord blood stem cells is to provide an alternative donor source for individuals without or with an unspecified potential future need for stem cell transplant.

 

The question addressed in this evidence review is: In individuals without or with an unspecified potential future need for stem cell transplantation, does the collection and storage of placenta and umbilical cord blood stem cells, which provides an alternative donor source, improve net health outcomes?

 

The following PICOTS were used to select literature to inform this review.

 

Patients

The population of interest are individuals without or with an unspecified potential future need for stem cell transplant.

 

Interventions

Collection and storage of placental or umbilical cord blood stem cells.

 

Comparators

Comparators include usual care without prophylactic storage of cord blood.

 

Outcomes

The outcomes of interest are OS, disease-specific survival, resource utilization, and treatment-related mortality.

 

Timing

The future use of stored stem cells is unknown and, thus, the follow-up time period to transplant is indeterminate.

 

Setting

Collection and preservation of placental or umbilical cord for future use is carried out at the time of labor and delivery and is carried out by commercial service providers.

 

Study Selection

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with

      a preference for RCTs;

  1. In the absence of such trials, comparative observational studies were sought, with   

      a preference for prospective studies.

  1. To assess long-term outcomes and adverse effects, single-arm studies that capture longer    

      periods of follow-up and/or larger populations were sought.

  1. Studies with duplicative or overlapping populations were excluded.

No studies have compared outcomes after prophylactic collection and storage of cord blood from a neonate for individuals who have an unspecified future need for transplant with standard care without cord blood collection and storage.

 

Also, although blood banks are collecting and storing neonate cord blood for potential future use, data on the use of cord blood for autologous stem cell transplantation are limited. A 2017 position paper from the American Academy of Pediatrics noted that there is little evidence of the safety or effectiveness of autologous cord blood transplantation for treatment of malignant neoplasms. Also, a 2009 survey of pediatric hematologists noted few transplants had been performed using cord blood stored in the absences of a known indication.

 

Section Summary: Prophylactic Collection and Storage of Cord Blood

There is a lack of published evidence on outcomes after prophylactic collection and storage of cord blood from a neonate for individuals who have an unspecified future need for transplant with standard care without cord blood collection and storage.

 

Summary of Evidence

For individuals who have an appropriate indication for allogeneic stem cell transplant who receive cord blood as a source of stem cells, the evidence includes a number of observational studies, a meta-analysis of observational studies, and a randomized controlled trial comparing outcomes after single- or double-cord blood units. Relevant outcomes are overall survival, disease-specific survival, resource utilization, and treatment-related mortality. The meta-analysis of observational studies found similar survival outcomes and lower graft-versus-host disease after cord blood transplantation than bone marrow transplantation. In the randomized controlled trial, survival rates were similar after single- and double-unit cord blood transplantation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who have an unspecified potential future need for stem cell transplant who receive prophylactic collection and storage of cord blood, the evidence includes no published studies. Relevant outcomes are overall survival, disease-specific survival, resource utilization, and treatment-related mortality. No evidence was identified on the safety or effectiveness of autologous cord blood transplantation from prophylactically stored cord blood for the treatment of malignant neoplasms. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

American Academy of Pediatrics

A position statement on cord blood banking for potential future transplantation was published by the American Academy of Pediatrics in 2017. The Academy recommended cord blood banking for public use, with a more limited role for private cord blood banking for families with a known fatal illness that could be rescued by cord blood transplant.

 

United Kingdom Consensus Recommendations on Umbilical Cord Blood Transplantation

In 2015, a consensus conference in the United Kingdom issued the following recommendation on umbilical cord blood transplantation:

 

“We recommend that UCB [umbilical cord blood] should be considered as an alternative source of HSC (hematopoietic stem cells) for transplantation for those patients without a suitably matched sibling or unrelated donor, defined as ‘standard’ or ‘clinical option’ transplants within the BSBMT [British Society of Blood and Marrow Transplantation] transplant indications tables.”

 

American College of Obstetricians and Gynecologists

In 2015, the American College of Obstetricians and Gynecologists published a committee opinion on umbilical cord blood banking. The statement discussed counseling patients about options for umbilical cord blood banking, as well as benefits and limitations of this practice. Relevant recommendations include the following:

 

  • “Umbilical cord blood collection should not compromise obstetric or neonatal care or alter routine practice for the timing of umbilical cord clamping.”

  • “The current indications for cord blood transplant are limited to select genetic, hematologic, and malignant disorders.”

  • “The routine storage of umbilical cord blood as ‘biologic insurance’ against future disease is not recommended.”

 

American Society for Blood and Marrow Transplantation

On behalf of the American Society for Blood and Marrow Transplantation, in 2008 Ballen et al published recommendations related to the banking of umbilical cord blood:

 

  1. Public banking of cord blood is encouraged where possible.

  2. Storage of cord blood for autologous (i.e., personal) use is not recommended.

  3. Family member banking (collecting and storing cord blood for a family member) is recommended when there is a sibling with a disease that may be successfully treated with an allogeneic transplant. Family member banking on behalf of a parent with a disease that may be successfully treated with an allogeneic transplant is only recommended when there are shared HLA antigens between the parents.

 

U.S. Preventive Services Task Force Recommendations

Not applicable

 

 

Key Words:

Cord Blood as a Source of Stem Cells, Transplantation, Placental and Umbilical Cord Blood as a Source of Stem Cells, cord blood, stem cell transplant, placental blood, umbilical cord blood

 

 

Approved by Governing Bodies:

According to the U.S. Food and Drug Administration (FDA), cord blood stored for potential use by a patient unrelated to the donor meets the definitions of “drug” and “biological products.” As such, products must be licensed under a biologics license application or an investigational new drug application before use. Facilities that prepare cord blood units only for autologous and/or first- or second-degree relatives are required to register and list their products, adhere to Good Tissue Practices issued by the FDA, and use applicable processes for donor suitability determination.

 

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

 

 

Current Coding: 

HCPCS Codes:          

S2140 Cord blood harvesting for transplantation, allogenic
S2142  Cord blood derived stem-cell transplantation, allogenic
S2150 Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition

             

            

             

 

 

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  41. U.S. Food and Drug Administration. Guidance for Industry: Minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications. https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187144.pdfUH.

  42. Wagner JE, Jr., Eapen M, Carter S, et al. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. Oct 30 2014; 371(18):1685-1694.

  43. Wagner JE, Rosenthal J, Sweetman R et al. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood 1996; 88(3):795-802.

  44. Wall DA. Regulatory issues in cord blood banking and transplantation. Best Pract Res Clin Haematol 2010; 23(2):171-177.

  45. Wallet HL, Sobh M, Morisset S, et al. Double umbilical cord blood transplantation for hematological malignancies: a long- term analysis from the SFGM-TC registry. Exp Hematol. Jul 2 2013.

  46. Zhang H, Chen J, Que W. A meta-analysis of unrelated donor umbilical cord blood transplantation versus unrelated donor bone marrow transplantation in acute leukemia patients. Biol Blood Marrow Transplant 2012; 18(8):1164-1173.

 

 

Policy History:

Medical Policy Group, September 1998 (3)

Medical Policy Group, January 2003 (3)

Medical Policy Group, June 2010 (2)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group, May 2012 (4): Policy unchanged. Updated Description and References.

Medical Policy Group, January 2013 (4): Update to Description, Key Points, and References

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (3): Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points & References; no change in policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, October 2015 (2): 2105 Updates to Key Points and References, no change to policy statement. 

Medical Policy Panel, January 2016

Medical Policy Group, February 2016 (2): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Key Points and References; No change to policy statement.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7): 2018 Updates to Key Points and References; No change to policy statement.

Medical Policy Panel, January 2019

Medical Policy Group, February, 2019 (3): Updates to 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.