Blues highlight medical, benefit policy changes

67027, J7310

Basic Benefit and Medical Policy
Effective Nov. 1, 2013, HCPCS code J7310 may be covered as a standalone item when reported with surgical procedure code *67027.

33224-33226

Basic Benefit and Medical Policy
Additional congestive heart failure diagnosis codes are payable for biventricular pacemakers. The payable diagnosis codes are: 428.0, 428.1, 428.20, 428.21, 428.22, 428.23, 428.30, 428.31, 428.32, 428.33, 428.40, 428.41, 428.42, 428.43 and 428.9.

This change does not apply to General Motors, Ford, Chrysler and UAW Retiree Medical Benefits Trust groups.

Established procedure
71250

Experimental procedures
0174T, 0175T

Basic Benefit and Medical Policy
The safety and effectiveness of low-dose CT scanning of the lung as a screening tool for lung cancer have been established. It is a useful therapeutic option for patients meeting specific patient selection guidelines.

Routine chest radiographs, including computer-aided detection analysis of the X-ray, for the purpose of screening patients for lung cancer is considered experimental. They have not been shown to improve long-term patient clinical outcomes, effective May 1, 2014.

Group Variations
Excludes Chrysler, Ford, General Motors, Delphi and URMBT groups

Inclusionary Guidelines
Low-dose computed tomography scanning, no more frequently than annually, may be appropriate as a screening technique for lung cancer in individuals who meet all of the following criteria (which are based on the results of the National Lung Screening Trial):

• Between 55 and 80 years of age
• History of cigarette smoking of at least 30 “pack years” (A “pack year” is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. A “one-pack year” is the equivalent of 365.24 packs of cigarettes or 7,305 cigarettes.)
• Currently smoke or have quit within the past 15 years

Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

Exclusionary Guidelines

• Low-dose CT scanning as a screening technique for lung cancer in all other situations where the above selection guidelines are not met
• Routine chest radiographs when used as a screening technique for ruling out lung cancer

Basic Benefit and Medical Policy
Effective March 28, 2014, ALPROLIX™ is considered established as safe and effective for its FDA-approved indication in the United States. It is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B.

Inclusionary Guidelines
ALPROLIX™ Coagulation Factor IX (Recombinant) Fc Fusion Protein is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

• Control and prevention of bleeding episodes.
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

For the control and prevention of bleeding episodes, the management of bleeding during surgical procedures and for routine prophylaxis in adults and children with hemophilia B.
Payable for:

• Hemophilia provider network
• Ambulatory Infusion center (ALPROLIX may only b used at the center. It cannot be sent home with the patient.
• Specialty pharmacy )
• Physician’s office

Exclusionary Guidelines
ALPROLIX™ is not indicated for induction of immune tolerance in patients with Hemophilia B.

81228, 81229, S3870

Basic Benefit and Medical Policy
The safety and effectiveness of chromosomal microarray analysis have been established. It may be considered a useful diagnostic option when indicated for patients meeting specific patient selection criteria. Exclusionary criteria have been updated, effective Sept. 1, 2014.

Inclusionary Guidelines
Chromosomal microarray analysis may be considered established for diagnosing a genetic abnormality in children with apparent nonsyndromic cognitive developmental delay, intellectual disability or autism spectrum disorder, according to accepted Diagnostic and Statistical Manual of Mental Disorders-IV criteria when all of the following conditions are met:

• Any indicated biochemical tests for metabolic disease have been performed, and results are non-diagnostic
• FMR1 gene analysis (for Fragile X), when clinically indicated (refer to policy “Genetic Testing for FMR1 mutations (including Fragile X Syndrome), is negative,
• In addition to a diagnosis of nonsyndromic DD/ID or ASD, the child has one or more of the following:
• Two or more major** malformations
• A single major malformation or multiple minor*** malformations, in an infant or child who is also small-for-dates
• A single major malformation and multiple minor malformations

and

• The results for the genetic testing have the potential to impact the clinical management of the patient and
• Testing is requested after the parent(s) have been engaged in face-to-face genetic counseling with a health care professional who has appropriate genetics training and experience.

Note: A malformation refers to abnormal structural development.

**A major malformation is a structural defect that has a significant effect on function of social acceptability. Example: ventricular septal defect or a cleft lip

***A minor malformation is a structural abnormality that has minimal effect on function or societal acceptance. Examples: preauricular ear pit or partial syndactyly (fusion) of the second and third toes

A syndrome is a recognizable pattern of multiple malformations. Syndrome diagnoses are often relatively straightforward and common enough to be clinically recognized without specialized testing. Examples include Down syndrome, neural tube defects and achondroplasia. However, in the very young, or in the case of syndromes with variable presentation, confident identification may be difficult without additional testing.

Exclusionary Guidelines

• Chromosomal microarray analysis is considered experimental in all other cases of suspected genetic abnormality in children with developmental delay, intellectual disability or autism spectrum disorder.
• Chromosomal microarray analysis to confirm the diagnosis of a disorder or syndrome that is routinely diagnosed based on clinical evaluation alone is not medically necessary.
• Panel testing using next-generation sequencing is considered experimental in all cases of suspected genetic abnormality in children with developmental delay, intellectual disability or autism spectrum disorder.
• Chromosomal microarray analysis is considered experimental for prenatal genetic testing. CMA genetic testing of products of conception following pregnancy loss or idiopathic recurrent pregnancy loss.

Multiple codes

Coverage of Routine Services Associated with Clinical Trials

Basic Benefit and Medical Policy
The Blue Cross physicians on the Medical Policy Committee reviewed the Coverage of Routine Services Associated with Clinical Trials policy and determined that the cost of routine services of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in approved clinical trials, will be covered. Covered clinical trials may include Phase II, III and IV.

The cost of routine services during Phase I clinical trials are only covered when the purpose is for therapeutic intent. This policy is effective Jan. 1, 2014.

Note: Expanded clinical trial coverage does not apply to all members. Always check member eligibility and benefits before providing services.

Inclusionary Guidelines

• Costs of routine services associated with clinical trials include all items and services that are otherwise generally available to members receiving an established medical treatment. These include items or services, medical in nature, that are provided in either the experimental or the control arm of a clinical trial:
• Items or services that are typically provided absent a clinical trial (e.g., labs, X-rays, etc.)
• Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent). The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service; in particular, for diagnosis or treatment of complications
• For a clinical trial to qualify for coverage of routine costs, the following requirements must be met:
• The subject or purpose of the trial must be the evaluation of an item or service that falls within a benefit category (e.g., physicians’ services, durable medical equipment, diagnostic tests) and is not normally excluded from coverage (e.g., cosmetic surgery)
• Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

Note: The requirements above are insufficient by themselves to qualify a clinical trial for coverage of routine costs. Clinical trials should also have all the following characteristics:

• The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes and not just to test the item’s safety.
• The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
• The trial does not unjustifiably duplicate existing studies.
• The trial design is appropriate to answer the research question being asked in the trial.
• The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully.
• The trial complies with federal regulations relating to the protection of human subjects.
• All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

All requests for member participation in a clinical trial must include the appropriate supporting documentation, including:

• A complete description of the clinical trial, including the phase of the trial
• Name of the sponsoring organization (NIH, CDC, etc.)
• Patient selection criteria
• Protocol guidelines
• Patient history, including previous treatment therapies
• Appropriate supporting medical literature

Exclusionary Guidelines

• Routine services for clinical trials that do not meet policy guidelines as defined above
• Services that are not covered in an applicable member benefit certificate or rider
• The investigational item or service itself
• Individual device exemption with Category A FDA approval
• Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for condition usually requiring only a single scan)
• Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial
• Phase I clinical trials whose primary purpose is not for therapeutic intent (e.g., prolongation of life, shrinkage of tumor, or improved quality of life, even in absence of cure or dramatic improvement of a condition)

Note: Phase IV clinical trials are performed after the product is released. A specific product or service is covered unless there is a medical policy to the contrary. Data collection, data analysis and other costs for the Phase IV trial are not covered.

0342T

Basic Benefit and Medical Policy
The use of selective HDL dilapidation and plasma reinfusion for the treatment of coronary artery disease or acute coronary syndrome is considered experimental. There is insufficient evidence to permit conclusion on health outcomes and this therapy is not FDA-approved for the treatment of coronary artery disease or acute coronary syndrome. This policy is effective Sept. 1, 2014.

Village of Kalkaska

Effective July 1, 2014, Medicare-eligible retirees of the Village of Kalkaska will have Blue Cross Blue Shield of Michigan’s Medicare Advantage PPO plan, Medicare Plus Blue^SM Group PPO for their medical, surgical and prescription drug benefits. The group number is 60667 with suffix 600. You can identify members by the XYL prefix on their ID cards, like those of other Medicare Plus Blue Group PPO plans.

For information about our Medicare Advantage PPO plan, go to bcbsm.com/provider/ma.