CPT 81401, 81405, 81408, 81410, 81411 - Genetic Testing for Marfan Syndrome

Coding  Code Description CPT

81401 MED12 (mediator complex subunit 12)(eg, FG syndrome type 1, Lujan syndrome), common variants (eg, R961W, N1007S)

81405 ACTA2 (actin, alpha 2, smooth muscle, aorta) (eg, thoracic aortic aneurysms and aortic dissections), full gene sequence TGFBR1 (transforming growth factor, beta receptor 1) (eg, Marfan syndrome), full gene sequence

81408 FBN1 (fibrillin 1) (eg, Marfan syndrome), full gene sequence 
MYH11 (myosin, heavy chain 11, smooth muscle) (eg, thoracic aortic aneurysms and aortic dissections), full gene sequence

81410 Aortic dysfunction or dilation (eg, Marfan syndrome, Loeys Dietz syndrome, EhlersDanlos syndrome type IV, arterial tortuosity syndrome); genomic sequence analysis panel, must include sequencing of at least 9 genes, including FBN1, TGFBR1, TGFBR2, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, and MYLK

81411 Aortic dysfunction or dilation (eg, Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); duplication/deletion analysis panel, must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1



Genetic Testing for Marfan Syndrome, Thoracic Aortic Aneurysms and Dissections, and Related Disorders


 Introduction


Connective tissue is one kind of tissue that is found in the body. It connects and provides support to other tissues such as muscles, nerves, and the skin. For example, fat, bone and cartilage are types of connective tissues. Some problems with connective tissue can be inherited. This policy describes when it may be medically necessary to do genetic testing to look for inherited connective tissue disorders. 

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 
Policy Coverage Criteria 

Testing Medical Necessity


Individual genetic testing for the diagnosis of Marfan
Individual genetic testing for the diagnosis of Marfan syndrome, other syndromes associated with thoracic aortic



Testing Medical Necessity

syndrome aneurysms and dissections, and related disorders, and panels comprised entirely of focused genetic testing limited to the following genes*FBN1 and MYH11 and ACTA2, TGFBR1, and TGFBR2 may be considered medically necessary when: * Signs and symptoms of a connective tissue disorder are Individual, targeted familial variant testing for Marfan syndrome

present, but a definitive diagnosis cannot be made using established clinical diagnostic criteria.
Individual, targeted familial variant testing for Marfan syndrome, other syndromes associated with thoracic aortic aneurysms and dissections, and related disorders, for assessing future risk of disease in an asymptomatic individual, may be considered medically necessary when there is a known pathogenic variant in the family. (See Additional Information section below)
Testing Investigational
Genetic testing panels for Marfan syndrome

Additional Information


Genetic testing panels for Marfan syndrome, other syndromes associated with thoracic aortic aneurysms and dissections, and related disorders that are not limited to focused genetic testing that do not meet the criteria for limited focused gene variant testing described above are considered investigational. (See Additional Information section below)

* Tissues that surround organs, blood vessels, and bones are called connective tissue. Changes to certain genes may cause problems with connective tissue. Specific genes can be tested to diagnose connective tissue problems. 


* Syndromes associated with thoracic aortic aneurysms may have established clinical criteria with major and minor criteria, eg, Marfan syndrome (Ghent criteria) and Ehlers-Danlos syndrome type IV, or may be associated with characteristic clinical findings. While most of these syndromes can be diagnosed based on clinical findings, these syndromes may be associated with variability in clinical presentation and may show overlapping features with each other, and with other disorders. The use of genetic testing to establish a diagnosis in a patient with a suspected connective tissue disorder is most useful in those patients who do not meet sufficient clinical diagnostic criteria at the time of initial examination, in patients who have an atypical phenotype and other connective tissue disorders cannot be ruled out, and in individuals who belong to a family in which a pathogenic variant is known (presymptomatic diagnosis).

* Genetic testing has conventionally been used when a definitive diagnosis of one of these syndromes cannot be made. More recently, panels using next-generation sequencing (NGS), which test for multiple genes simultaneously, have been developed for the syndromes associated with thoracic aortic aneurysms and dissections, and other conditions that may have overlapping phenotypes. Although the laboratory-reported sensitivity is high for some of the conditions on the panel, the analytic validity of these panels is unknown, and detection rates of variants of uncertain significance are unknown.

* However, there may be certain clinical scenarios in which focused panel testing may be appropriate to include a narrow list of differential diagnoses of thoracic aortic aneurysms and dissection based on clinical findings.



Panel Testing

Specific CPT codes for genetic panel tests associated with aortic dysfunction or dilation syndromes (81410 and 81411) are described in the coding table above with the genes included in each test.


Related Information 

Genetics Nomenclature Update


The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 2). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 3 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 2. Nomenclature to Report on Variants Found in DNA

Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence
 Variant Change in the DNA sequence 
 Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives



ACMG-AMP Standards and Guidelines for Variant Classification

Previous  Definition

Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.

Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.



Question: Claims processing for CPT Codes 81401-82408 when ICD-9s have been identified for coverage. The structure of these codes raises some practical considerations for claims submission and processing. The molecular pathology codes have a number of subparts, identified by specific genes. This means there could be a number of genes reported with the same CPT code. Each of those genes could have related ICD-9 codes. It would require reporting of the specific gene to be able to link the code with a diagnosis. In this draft coverage policy, 4 of the codes [81401, 81403, 81405, and 81406] have been associated with testing for Lynch Syndrome and would be covered for specific diagnosis codes. However, there are many genes under those same codes and other conditions that would be covered, e.g. lymphoma, leukemia which
are covered conditions (NCD §190.3).

Will claims for other gene testing reported under the same codes be denied because they do not have the ICD-9 for Lynch Syndrome? How are we to report testing for other genes and conditions reported under the same CPT code, so that they are not all inappropriately denied?


Response: These CPT codes are not gene specific and can be used for multiple tests. The higher level CPT codes are noted in the LCD to let providers know they are covered for the conditions listed in the policy. All other conditions are subject to the test being reasonable and medically necessary. We will request additional documentation for conditions or diseases that are not listed in the LCD for 81401, 81403, 81405 and 81406


Documentation Guidelines


Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition that warrants the test(s). Examples of documentation requirements of the ordering physician/nonphysician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).


Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record. Documentation requirements for lab developed tests/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.

Providers are required to code to specificity however, if an unlisted CPT code is used the documentation must clearly identify the unique procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable. If on review the contractor cannot link a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act,
§1833(e).

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.


Many applications of the molecular pathology procedures are not covered services given lack of benefit category (preventive service) and/or failure to reach the reasonable and necessary threshold for coverage (based on quality of clinical evidence and strength of recommendation). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service was not audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Certain tests and procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit by the MAC or other contractors. Tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually relevant to a Medicare beneficiary.







Submittig more than 12 ICD and supplemental DX code

The Centers for Medicare & Medicaid Services (CMS) requires all health plans to submit Health Insurance Portability and Accountability Act (HIPAA)-compliant 837 claims transactions to CMS for Medicare risk adjustment.

Chart review submissions

Electronic transactions related to chart reviews (i.e., resulting from the review of a medical chart) should be identified as such on all HIPAA-compliant 837 transactions.


• Code changes are important for proper reporting and reimbursement of transactions related to chart reviews.
• Proper identification of encounter data chart reviews is important because the CMS timely filing period is longer for chart review encounters (approximately 25 months from the date of service) than for original, or full, encounters (13 months from the date of service).

Please be aware of the following changes when submitting electronic transactions to CarePlus:

•    On encounters generated from a chart review, please submit your HIPAA-compliant 837 transactions with the following values:

*    LOOP 2300
i.    CLM02 = 0
ii.    PWK01 = 09
iii.    PWK02 = AA
o    LOOP 2400
i.    SV101-2 = 99499
ii.    SV102 = 0
iii.    SV101-7 = CR
•    Any diagnosis identified during the chart review also should be submitted on the HIPAA-compliant 837 transaction in the following loop and segment:
o    LOOP 2300
i.    HI01 – HI12 (as needed)


Additional diagnosis codes

CarePlus provides a supplemental Current Procedural Terminology (CPT®) code to assist in reporting additional diagnosis codes for risk adjustment because of practice management system or clearinghouse limitations.

• The supplemental CPT code is intended as a placeholder for additional diagnosis codes exceeding the fourth diagnosis pointer.

• The supplemental code should contain a $0.01 charge to ensure appropriate claim processing; however, there will be no additional reimbursement.




Please be aware of the following changes when submitting electronic transactions to CarePlus:

•    On encounters generated from office visits, please submit your HIPAA-compliant 837 transactions with the following values:
*    LOOP 2400
i.    SV101-2 = 99499
ii.    SV102 = .01
iii.    SV101-7 = DIAGNOSIS CODE LIMITATION
•    Any diagnosis identified during the office visit also should be submitted on the HIPAA-compliant 837 transaction in the following loop and segment:
o    LOOP 2300
i.    HI01 – HI12 (as needed)


Slide notes for submitting more than 19 ICD codes - No fault and worker compensation claims

There  may be times when a beneficiary is severely injured and the RRE has more than 19 ICD diagnosis codes to  report.

Since the Claim Input File Detail Record only has room for 19 ICD diagnosis codes, it is important that an RRE  reports at least one ICD diagnosis code for each injured body part.

In such a situation, it is likely that a number of the diagnosis codes relate to the same body part.  For example,  multiple diagnosis codes could be listed when a back injury occurs.

When there are more than 19 diagnosis  codes, be sure to report at least one diagnosis code for each body part  that was injured.  Eliminate diagnosis codes that refer to a previously reported body part.


submitting more than 12 ICDs example


Submitting more than 12 ICD by claim level

• Diagnoses should be reported in form locator field (FL) 66- 67 a-q on the CMS-1450 claim form. Up to 12 diagnoses can be reported in item 21 on the CMS-1500 paper claim (02/12) (see the 2015 PQRS Implementation Guide) and up to 12 diagnoses can be reported in the header on the electronic claim.

Only one diagnosis can be linked to each line item.

PQRS analyzes claims data using ALL diagnoses from the base claim (item 21 of the  CMS-1500 or electronic equivalent) and service codes for each individual EP (identified by individual NPI).

EPs should review ALL diagnosis and encounter codes listed on the claim to make sure they are capturing ALL measures chosen to report that are applicable to the patient's care.



• All diagnoses reported on the base claim will be included in PQRS  analysis, as some measures require  reporting more than one diagnosis on a claim. 

For line items containing QDC, only one diagnosis from the base claim should be  referenced  in the diagnosis pointer field.

To report a QDC for a measure that requires reporting of multiple diagnoses, enter the reference number in the diagnosis pointer field that corresponds to one of the measure’s diagnoses listed on the base claim. Regardless of the reference number in the diagnosis pointer field, all diagnoses on the claim(s) are considered in PQRS analysis. (See 2015 PQRS Implementation Guide)

• If your billing software limits the number of line items available on a claim, you must add a $0.01 nominal amount to one of the line items on that second claim for a total charge of one penny. 

PQRS analysis will subsequently join the claims based on the same beneficiary for the same date-of-service, for the same TIN/NPI and analyzed
as one claim.

Providers should work with their billing software vendor/clearinghouse regarding line limitations for claims to ensure that diagnoses, QDCs, or nominal charge amounts are not dropped.


In an effort to streamline reporting of QDCs across multiple CMS quality reporting programs, CMS strongly encourages all EPs and practices to begin billing 2015 QDCs with a $0.01 charge. EPs should pursue updating their billing software to accept the $0.01 charge prior to implementing 2015 PQRS. EPs and practices need to work with their billing software or  EHR vendor to ensure that this capability is activated.

CSHCS - Covered Benifits, renewal of coverage


Covered BENEFITS

CSHCS covers services that are medically necessary, related to the beneficiary’s qualifying diagnosis(es), and ordered by the beneficiary’s CSHCS authorized specialist(s) or subspecialist(s). Services are covered and reimbursed according to Medicaid policy unless otherwise stated in this chapter.

The primary CSHCS benefits may include:

* Ambulance

* Care Coordination*

* Case Management*

* Dental (Specialty and General)

* Dietary Formulas (limited)

* Durable Medical Equipment (DME)

* Emergency Department (ED)

* Hearing and Hearing Aids

* Home Health (intermittent visits)

* Hospice*

* Hospital at approved sites (Inpatient/Outpatient)

* Laboratory Tests

* Medical Supplies

* Monitoring Devices (Nonroutine)

* Office Visits to CSHCS Authorized Physicians


* Orthopedic Shoes

* Orthotics and Prosthetics

* Parenteral Nutrition

* Pharmacy

* Physical/Occupational/Speech Therapy

* Radiological Procedures

* Respite*

* Telemedicine

* Transplants and Implants

* Vision

(* Refer to the information and authorization requirements stated in this Section.)





PARTIAL MONTH COVERAGE


If a beneficiary enters or leaves a facility that is not a covered facility (e.g., nursing facility, or intermediate care facility) during a month of eligibility, the beneficiary remains a beneficiary for the remainder of that month. However, services provided to the beneficiary while in the facility are not covered (i.e., reimbursable) by CSHCS as these facilities are responsible for providing the medical care. (Refer to the General Information for Providers Chapter in this manual for additional information for beneficiaries who also have Medicaid coverage.)


RENEWAL OF COVERAGE


The beneficiary’s coverage may be renewed as needed if all eligibility criteria continue to be met and thefamily completes the renewal process. Medical review reports are required according to the timeframes  established based on the primary diagnosis for the beneficiary. An annual financial review is also required. If all of the criteria continue to be met for CSHCS coverage, a new coverage period is typically issued in 12-month increments.

CPT 0069U, 81229, 81327, 81407 - Miscellaneous Genetic and Molecular Diagnostic Tests

Code Description CPT

0069U Oncology (colorectal), microrna, rt-pcr expression profiling of mir-31-3p, formalinfixed paraffin-embedded tissue, algorithm reported as an expression score

81229 Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

81327 SEPT9 (Septin9) (eg, colorectal cancer) methylation analysis

81407 Molecular pathology procedure, Level 8 (eg, analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform)

81479 Unlisted molecular pathology procedure

84999 Unlisted chemistry procedure




Miscellaneous Genetic and Molecular Diagnostic Tests

Introduction


There are many genetic tests. High-quality medical studies show certain genetic tests are helpful when diagnosing some conditions or guiding treatment. However, not all genetic tests have been well studied. In some cases, studies have shown that genetic tests aren’t useful in making a diagnosis or changing care. This policy lists a number of genetic tests where there is not enough evidence in published medical studies to show that they bring health benefits. These tests are considered unproven. 

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Test Name Investigational

* Celiac PLUS * ColonSentry® * ColoVantage® * Crohn’s Prognostic * DecisionDx-Thymoma * DNA Methylation
Pathway Profile * Epi proColon®  * GI Effects® (Stool) * IBD sgi Diagnostic™  * ImmunoGenomic® Profile * Know Error™ * ResponseDX®: Colon * SEPT9 methylated DNA * TransPredict Fc gamma 3a

Coding


All of the tests listed in this policy are considered investigational and grouped according to the categories of genetic testing as outlined in Medical Policy 12.04.91 (General Approach to Genetic Testing; see Related Policies above): * Testing of an affected (symptomatic) individual’s germline to
benefit the individual (excluding reproductive testing) * Diagnostic testing * Prognostic testing * Therapeutic testing  Testing an asymptomatic individual to determine future risk of disease is considered investigational.  

Note: See Table 1 in Evidence Review for additional information about test names listed at the left.


Related Information
 


Genetic testing is considered investigational when criteria are not met, including when there is insufficient evidence to determine whether the technology improves the net health outcome.

Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review

Description
 

There are numerous commercially available genetic and molecular diagnostic, prognostic, and therapeutic tests for individuals with certain diseases and or asymptomatic individuals with a future risk. This medical policy evaluates miscellaneous genetic and molecular diagnostic tests not addressed in a separate review. If a separate medical policy exists, then conclusions reached there supersede conclusions in this policy. The main criterion for inclusion in this policy is the limited evidence on the clinical validity for the test. As a result, these tests do not have clinical utility and the evidence is insufficient to determine the effect on health outcomes. The lack of


clinical utility of these tests is based on criteria outlined in a separate medical policy (see Related Policies).

Background


Tests that are assessed in this medical policy are listed in Table 1. Excluding reproductive testing, there are primarily three reasons why genetic and molecular tests might be useful to a person with a disease: diagnostic testing, prognostic testing, and therapeutic testing. A fourth reason would be testing that is done on an asymptomatic person to determine his/her future risk of developing the disease. 


Diagnostic Tests

Multiple Conditions

Single-nucleotide variants (SNVs) are the most common type of genetic variation, and each SNV represents a difference in a single nucleotide in the DNA sequence. Most commonly, SNVs are found in the DNA between genes and can act as biologic markers of genes and disease association. When SNVs occur within a gene or a gene regulatory region, they can play a more direct role in disease by affecting the gene’s function. SNVs may predict an individual’s response to certain drugs, susceptibility to environmental factors, and the risk of developing certain diseases.
DNA specimen provenance assays can be used to confirm that tissue specimens are correctly matched to the patient of origin. Specimen provenance errors may occur in up to 1% to 2% of pathology tissue specimens  and have serious negative implications for patient care if the error is not corrected. Analysis of DNA microsatellites from tissue specimens can be performed by analyzing long tandem repeats (LTR) and comparing the LTRs of the tissue specimen with LTRs from a patient sample.

Test Description: DNA Methylation Pathway Profile


The DNA Methylation Pathway Profile (Great Plains Laboratory) analyzes SNVs associated with certain biochemical processes, including methionine metabolism, detoxification, hormone imbalances, and vitamin D function. Intended uses for the test include clarification of a diagnosis suggested by other testing and as an indication for supplements and diet modifications.


Test Description: Know Error DNA Specimen Provenance Assay


The Know Error test (Strand Diagnostics) compares the LTRs of tissue samples with LTRs from a buccal swab of the patient. The intended use of the test is to confirm tissue of origin and avoid specimen provenance errors due to switching of patient samples, mislabeling, or sample contamination.

Celiac Disease 


Previously called sprue, celiac sprue, gluten-sensitive enteropathy, gluten intolerance, nontropical sprue, or idiopathic steatorrhea, celiac disease is an immune-based reaction to gluten (water insoluble proteins in wheat, barley, rye) that primarily affects the small intestine. Celiac disease occurs almost exclusively in patients who carry at least 1 human leukocyte antigen DQ2 or DQ8; the negative predictive value of having neither allele exceeds 98%.

 Serum antibodies to tissue transglutaminase, endomysium, and deamidated gliadin peptide (DGP) support a diagnosis of celiac disease, but diagnostic confirmation requires duodenal biopsy taken when patients are on a gluten-containing diet.

CPT 20974, 20975, E0747 - Electrical Bone Growth stimulator


Code Description CPT

20974 Electrical stimulation to aid bone healing; noninvasive (non-operative)

20975 Electrical stimulation to aid bone healing; invasive (operative)

HCPCS

E0747 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications

E0749 Osteogenesis stimulator, electrical, surgically implanted

Electrical Bone Growth Stimulation of the Appendicular Skeleton


Introduction

An electrical bone growth stimulator can be used to help a broken bone heal in certain situations. The stimulators send electrical pulses or current through tissues, toward the bone. Electrical bone growth stimulators appear to encourage the growth of bone cells. Electrical bone growth stimulators are either noninvasive, invasive (implantable), or semi-invasive (semiimplantable).
* Noninvasive stimulators deliver current through small patches (electrodes) or coils placed near the broken bone.
* Invasive electrical stimulation use devices that are implanted in the body.
* Semi-invasive stimulators use needle-like electrodes placed through the skin.

This policy discusses when noninvasive electrical bone growth stimulators may be approved.

Invasive and semi-invasive bone growth stimulators are considered unproven (investigational). More study is needed on these two types of stimulators to see if they are safe and effective.


Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Procedure Medical Necessity Noninvasive electrical bone growth stimulation

Noninvasive electrical bone growth stimulation may be considered medically necessary as treatment of fracture nonunions or congenital pseudoarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet

ALL of the following criteria:

* At least 3 months have passed since the date of fracture AND
* Serial radiographs have confirmed that no progressive signs of healing have occurred AND
* The fracture gap is 1 cm or less AND
* The fracture can be adequately immobilized AND
* The patient is of an age likely to comply with nonweight bearing for fractures of the pelvis and lower extremities


Procedure Investigational Noninvasive electrical bone growth stimulation

Investigational applications of electrical bone growth stimulation include, but are not limited to:

* Delayed union
* Fresh fracture
* Stress fractures
* Immediate postsurgical treatment after appendicular skeletal surgery

Procedure Investigational

* Arthrodesis
* Failed arthrodesis

Implantable and semiinvasive electrical bone growth stimulators Implantable and semi-invasive electrical bone growth stimulators are considered investigational.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:

* Relevant history and physical supporting diagnoses of fracture nonunions or congenital pseudoarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities)

In addition, for diagnosis of diagnosis of fracture nonunion, ALL of the following criteria must be met:
* The fracture happened at least 3 months ago
* Serial radiographs confirm that no progressive signs of healing have occurred
* The width of the break is less than 1 centimeter (about 1/3 of an inch)
* Patient is able to limit physical movements
* Patient is of an age likely to comply with staying nonweight bearing during treatment for fractures of the pelvis and lower extremities



Definition of Terms

Appendicular skeleton: The appendicular skeleton includes the bones of the shoulder girdle, the upper extremities, the pelvis, and the lower extremities.

Congenital pseudoarthrosis: Congenital pseudarthrosis of the tibia (CPT) is a rare condition that is usually seen shortly after birth and is rarely diagnosed after the age of two. It appears as a bowing of the tibial bone and could led to a fracture if not found before the child begins to walk. Children with CPT may have poor healing ability and attempts to unite the small bone fragments can cause damage to the tibia and/or ankle joint. Congenital pseudarthrosis of the tibia has been linked to Type 1 neurofibromatosis but the exact cause of CPT is unknown.2 Delayed union: Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the injury or the most recent intervention. In contrast, fracture nonunion (described below) serial radiographsshow no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as “ununited fractures.”

Fracture nonunion: No consensus on the definition of fracture nonunions currently exists. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion such as pain, difficulty weight bearing (Bhandari et al, 2012). The original U.S. Food and Drug Administration (FDA) labeling of fracture nonunions defined them as fractures not showing progressive healing after at least 9 months from the original injury. The labeling states: “A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of 3 months.” This timeframe is not based on physiologic principles but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect

the complicated variables present in fractures (ie, degree of soft tissue damage, alignment of the bone fragments, vascularity, quality of the underlying bone stock). Some fractures may show no signs of healing, based on serial radiographs as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. The current policy of requiring a 3- month timeframe for lack of progression of healing is consistent with the definition of nonunion   as described in the clinical literature.Fresh fracture: A fracture is most commonly defined as “fresh” for 7 days after its occurrence. Most fresh closed fractures heal without complications with the use of standard fracture care (ie, closed reduction and cast immobilization).

Benefit Application State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration*approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity. Noninvasive electrical bone growth stimulation devices may be adjudicated according to the benefits for durable medical equipment.

Evidence Review Description

In the appendicular skeleton, electrical stimulation with either implantable electrodes or noninvasive surface stimulators has been investigated to facilitate the healing of fresh fractures, stress fractures, delayed union, nonunion, congenital pseudoarthroses, and arthrodesis.

Background

Delayed Fracture Healing


Most bone fractures heal spontaneously over a few months postinjury. Approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services.


There is no standard definition of a fracture nonunion.2 The Food and Drug Administration (FDA) labeling for one of the electrical stimulators included in this review defined nonunion as follows:

"A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables present in fractures (ie, the degree of soft tissue damage, alignment of the bone fragments, vascularity, quality of the underlying bone stock). Other proposed definitions of nonunion involve 3 to 6 months from the original injury, or simply when serial radiographs fail to show any further healing. According to FDA labeling for a low-intensity pulsed ultrasound device, “a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.” Factors contributing to a nonunion include: which bone is fractured, fracture site, the degree of bone loss, time since injury, the extent of soft tissue injury, and patient factors (eg, smoking, diabetes, systemic disease).1

Delayed union is generally considered a failure to heal between 3 and 9 months postfracture, after which the fracture site would be considered a nonunion. Delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) Together, delayed union and nonunion are sometimes referred to as "ununited fractures." To determine fracture healing status, it is important to include both radiographic and clinical criteria. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation. Fractures at certain locations (eg, scaphoid, proximal fifth metatarsal) are at greater risk of delayed union due to a tenuous blood supply. Systemic factors — including immunosuppression, cancer, and tobacco use — may also predispose patients to fracture nonunion, along with certain medications (eg, nonsteroidal anti-inflammatory drugs, fluoroquinolones).

Treatment

Individuals with recognized delayed fracture unions might begin by reducing the risk factors for delayed unions or nonunions but may progress to surgical repair if it persists. Electrical and Electromagnetic Bone Growth Stimulators Different applications of electrical and electromagnetic fields have been used to promote healing of delayed and nonunion fractures: invasive, noninvasive, and semi-invasive.

* Invasive: Invasive stimulation involves the surgical implantation of a cathode at the fracture to produce direct-current electrical stimulation. Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and, although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.

* Noninvasive: Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24-hours per day until healing occurs, or up to 9 months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed on the skin over the fracture and are worn for 6-hours to 8-hours per day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field. This device involves a 30-minute treatment period each day for 9 months. Patient compliance may be an issue with externally worn devices.

* Semi-Invasive: Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply, obviating the need for a surgical procedure to remove the generator when treatment is finished.

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