The Record - Billing chart: Blues highlight medical, benefit policy changes

Billing chart: Blues highlight medical, benefit policy changes

You’ll find the latest information about procedure codes and Blue Cross Blue Shield of Michigan billing guidelines in the following chart.

This billing chart is organized numerically by procedure code. Newly approved procedures will appear under the New Payable Procedures heading. Procedures for which we have changed a billing guideline or added a new payable group will appear under Updates to Payable Procedures. Procedures for which we are clarifying our guidelines will appear under Policy Clarifications. New procedures that are not covered will appear under Experimental Procedures.

You will also see that descriptions for the codes are no longer included. This is a result of recent negotiations with the AMA on use of the codes.

We will publish information about new BCBS groups or changes to group benefits under the Group Benefit Changes heading.

For more detailed descriptions of the BCBSM policies for these procedures, please check under the Medical/Payment Policy tab in Explainer on web-DENIS. To access this online information:

Click on BCBSM Provider Publications & Resources.

Click on Benefit Policy for a Code.

Click on Topic.

Under Topic Criteria, click on the drop-down arrow next to Choose Identifier Type and then click on HCPCS Code.

Enter the procedure code.

Click on Finish.

Click on Search.

Code*

BCBSM changes to:
Basic Benefit and Medical Policy, Group
Variations Payment Policy, Guidelines

UPDATES TO PAYABLE PROCEDURES

32701, 77300, 77520, 77522, 77523, 77525

Basic benefit and medical policy

Charged-particle irradiation with proton or helium ion beams

Charged-particle irradiation with proton or helium ion beams may be considered established for specific patient populations. It’s a useful therapeutic option when indicated.

If safe and effective, charged-particle irradiation with proton or helium ion beams may be open for individual consideration in the treatment of cancer, based on the analysis of dosimetric data, including comparative models if necessary.

Other applications of charged-particle irradiation with proton beams are considered experimental.

Note: There is insufficient evidence to show that PBRT provides an incremental benefit in the treatment of localized prostate cancer when compared to lower cost alternative procedures.

Inclusionary criteria have been updated, effective March 1, 2020.

Inclusions:

Charged-particle irradiation with proton or helium ion beams is established for the following indications:

In the treatment of intracranial arteriovenous malformation not amenable to surgical excision or other conventional forms of treatment or adjacent to critical structures, such as the optic nerve, brain stem or spinal cord.
Primary or metastatic central nervous system malignancies, such as gliomas, when adjacent to critical structures, such as the optic nerve, brain stem or spinal cord and when other standard radiation techniques, such as IMRT or standard stereotactic modalities would not reduce the risk of radiation damage to the critical structure.
Post-operative therapy (with or without conventional high-energy X-rays) in patients who have undergone biopsy or partial resection of chordoma or low-grade (I or II) chondrosarcoma of the basisphenoid region (skull-base chordoma or chondrosarcoma), cervical spine or sacral/lower spine. Patients eligible for this treatment have residual localized tumor without evidence of metastasis.
Primary therapy for melanoma of the uveal tract (iris, choroid or ciliary body), with no evidence of metastasis or extrascleral extension and with tumors up to 24 mm in largest diameter and 14 mm in height, and particularly when plaque brachytherapy isn’t a feasible option.
In the treatment of all pediatric tumor types (through 21 years of age).
Repeat irradiation of previously treated fields where the dose tolerance of surrounding normal structures would be exceeded with 3D conformal radiation or IMRT.

Note: Use of proton beam therapy may require prior authorization to verify that Blue Cross Blue Shield of Michigan and Blue Care Network criteria are met and, where appropriate, to explore the appropriateness of using alternative therapeutic modalities, such as IMRT and 3‑Dimensional Conformal Radiation Therapy.

Exclusions:

All other applications of charged-particle irradiation including, but not limited to, clinically localized prostate cancer, non-small cell lung cancer at any stage or for recurrence, breast cancer, pancreatic cancer and hepatocellular carcinoma are experimental.
Proton beam therapy for the treatment of macular degeneration or choroidal neovascularization and hemangiomas.

POLICY CLARIFICATIONS

64568

Basic benefit and medical policy

Obstructive Sleep Apnea and Snoring — Surgical Treatment policy

Diagnosis G47.33 has been added to procedure code *64568 as payable for the Obstructive Sleep Apnea and Snoring — Surgical Treatment medical policy.

This change is effective May 1, 2019.

69710, 69711, 69714, 69715, 69717, 69718, L8625, L8690, L8691, L8692, L8693, L8694

Basic benefit and medical policy

Unilateral or bilateral fully or partially implanted bone-conduction hearing aids

The safety and effectiveness of unilateral or bilateral fully or partially implanted bone-conduction (bone-anchored) hearing aids have been established. They may be considered a useful therapeutic option when indicated.

The use of a Baha^® Softband may be considered established in children ages 5 and younger meeting criteria for BAHA treatment, but who are determined to have inadequate skeletal maturity to sustain osteointegration of the BAHA device.

The policy has been updated, effective March 1, 2020.

Inclusions:

Conductive hearing loss:

Unilateral or bilateral fully or partially implantable bone-conduction** (bone-anchored) hearing aids may be necessary as an alternative to an air-conduction hearing aid in patients ages 5 and older with conductive or mixed hearing loss who also meet at least one of the following criteria:

Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear
Chronic external otitis or otitis media
Tumors of the external canal or tympanic cavity
Chronic dermatitis of the external canal prohibiting the usage of an air-conduction hearing aid

And meet the following audiologic criteria:

A pure-tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz or better than or equal to 45 dB (OBC and BP100, Baha 4 and Baha 5 devices), 55 dB (Intenso device) or 65 dB (Cordele II and Baha 5 SuperPower devices).

For bilateral implantation, patients should meet the above audiologic criteria in both ears and have symmetrically conductive or mixed hearing loss as defined by a difference between left- and right-side bone-conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

Sensorineural hearing loss:**

A unilateral implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal hearing aid in patients ages 5 and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure-tone average air-conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2 and 3 kHz.

**The Audiant^® bone conductor is a bone-conduction hearing device. While this product is no longer actively marketed, patients with existing Audiant devices may require replacement, removal or repair.

In patients being considered for implantable bone-conduction (bone-anchored) hearing aids, skull bone quality and thickness should be assessed for adequacy to ensure implant stability. Additionally, patients (or caregivers) must be able to perform proper hygiene to prevent infection and ensure the stability of the implants and percutaneous abutments.

Exclusions:

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered experimental.

Established
69930, 92601, 92602, 92603, 92604, 92605, 92606, 92607, 92608, 92609, 92618, L7510, L8614, L8615, L8616, L8617, L8618, L8619, L8621, L8622, L8623 L8624, L8625, L8627, L8628

Basic benefit and medical policy

Cochlear Implant policy

The safety and effectiveness of U.S. Food and Drug Administration-approved bilateral and unilateral cochlear implants and associated hybrid cochlear implant devices have been established.

The implants may be considered useful therapeutic options when indicated.

The criteria have been updated for the Cochlear Implant policy to cover cochlear implants in single-sided deafness per FDA guidelines.

This policy is effective March 1, 2020.

Inclusions:

Bilateral or unilateral cochlear implantation is considered an established, safe and effective therapy if all the following criteria are met:

FDA-approved cochlear implant
Age 12 months or older
Bilateral severe to profound pre- or post-lingual (sensorineural) hearing loss, which is defined as a hearing threshold of pure-tone average of 70 dB hearing loss or greater at 500, 1000, 2000 Hz

Unilateral cochlear implantation is considered established, safe and effective therapy in single-sided deafness^a,b when all the following are met:

FDA-approved cochlear implant
Age 5 or older
Profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear
Profound hearing loss is defined as having a pure-tone average of 90dB hearing loss or greater at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Normal hearing is defined as having a PTA of up to 15 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Mild hearing loss is defined as having a PTA of up to 30 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Mild to moderately severe hearing loss is defined as having a PTA ranging from 31 to up to 55 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

^aIndividuals with single-sided deafness or asymmetrical hearing loss must obtain limited benefit from an appropriately fitted unilateral hearing aid in the ear to be implanted. For individuals ages 18 and older, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant words in quiet when tested in the ear to be implanted alone. For individuals between ages 5 and 18, insufficient functional access to sound in the ear to be implanted.

^bAHL is defined as a profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages between ears.

Replacement of internal or external components in a small subset of members may be considered established when all the following are met:

There is an inadequate response to existing components to the point of one of the following:
- Interfering with the individual’s activities of daily living
- The component is no longer functional and can’t be repaired
Copies of original medical records must be submitted either hard copy or electronically to support medical necessity.

Cochlear implant with a hybrid device that includes the hearing aid integrated into the external sound processor of the cochlear implant (e.g., the Nucleus^® Hybrid L24 Cochlear Implant System) may be considered established for patients age 18 and older who meet all the following criteria:

Bilateral severe-to-profound high frequency sensorineural hearing loss with residual low-frequency hearing sensitivity
Receive limited benefit from appropriately fit bilateral hearing aids
Have the following hearing thresholds:
- Low frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation
- Severe to profound mid-to-high frequency hearing loss (threshold average of 2000, 3000 and 4000 Hz ≥75 dB hearing level) in the ear to be implanted
- Moderately severe to profound mid-to-high frequency hearing loss (threshold average of 2000, 3000 and 4000 Hz ≤ 60 dB hearing level) in the contralateral ear

Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct.

In certain situations, implantation may be considered before age 12 months. One scenario is post meningitis when cochlear ossification may preclude implantation. Another is in cases with a strong family history, because establishing a precise diagnosis is less uncertain.

Contraindications to cochlear implantation may include deafness due to lesions of the eighth cranial (acoustic) nerve, central auditory pathway or brainstem; active or chronic infections of the external or middle ear; and mastoid cavity or tympanic membrane perforation. Cochlear ossification may prevent electrode insertion, and the absence of cochlear development as demonstrated on computed tomography scans remains an absolute contraindication.

Exclusions:

Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model.
Replacement of internal or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device.
Non-FDA approved devices.

Established:
80305, 80306, 80307, G0480, G0481, G0482 G0483, G0659

Experimental:
80320-80377, 83992

Basic benefit and medical policy

Drug Testing in Pain Management and Substance Use Disorder Treatment

Various strategies are available to monitor pain management and treatment of patients with substance use disorder, and multicomponent interventions are often used. One such strategy for monitoring patients is the testing of biologic specimens for the presence or absence of drugs.

Testing guidelines

How clinicians order drug tests will vary depending on the clinical scenario of the individual and the purpose for the testing. National provider organizations have discouraged establishing limits on the frequency of testing and the number of tests allowed in a benefit year out of concern that such limits will potentially undermine physician management and be a barrier to medically necessary testing. Most guidelines suggest that testing in the initial phase of substance use disorder treatment be performed weekly. And, as the individual’s circumstances stabilize, testing may progress to monthly and then less frequently. Based on plan data, it’s extremely unlikely that an individual would require more than a combined total of 25 presumptive and definitive tests in a year.

A definitive drug test is medically necessary and clinically justified when the results of presumptive testing have been evaluated and support that follow-up definitive testing will contribute to clinical decision making. Routine definitive drug testing that is ordered automatically, independent of an analysis of presumptive testing isn’t medically necessary. A definitive drug test that is performed without consideration of a patient’s specific circumstances isn’t medically necessary. The medical record should support the rationale for testing, and this record may be assessed as part of a retrospective review (audit).

Presumptive and definitive drug testing in the outpatient setting may be considered established when criteria is met.

Inclusionary and exclusionary guidelines

(Clinically based guidelines that may support individual consideration and pre-authorization decisions)

This policy addresses drug testing in an outpatient setting.

The policy doesn’t apply to drug testing in an emergency department, acute inpatient medical or behavioral health facility settings, or testing ordered by or on behalf of a provider or facility that receives per-diem reimbursement that includes clinical diagnostic laboratory testing (skilled nursing facility).

Inclusions:

Presumptive drug testing
- For outpatient pain management, presumptive drug testing is considered established:
  - Baseline screening at the initiation of treatment
  - Subsequent monitoring of treatment at an appropriate frequency based on the risk level of the individual, including assessment of aberrant behavior
- For outpatient substance use disorder treatment, presumptive drug testing is considered established:
  - Baseline screening at the initiation of treatment
  - Subsequent screening is based on the risk level of the individual and the substance being used
- For an individual not participating in outpatient pain management or outpatient substance use disorder treatment:
  - When a clinical evaluation suggests use of non-prescribed medications, illegal or other substances.
Definitive/confirmatory drug testing
- Definitive drug testing is considered established:
  - When immunoassays for the relevant drugs aren’t commercially available
  - In situations where definitive drug levels are required for clinical decision making (e.g., unexpected positive test that is inadequately explained by the patient, unexpected negative test, quantitative levels are needed to determine clinical treatment, etc.)

Exclusions:

Drug testing as a third-party requirement (e.g., for employment, licensing, court order, etc.)
Simultaneously testing for the same drug with two specimens from different sources (e.g., blood and urine)

Policy guidelines

One presumptive and one definitive test code may be billed per date of service.

Billing guidelines of definitive drug testing

These guidelines are effective Oct. 1, 2019.

Bill G0480 through G0483 and G0659 as appropriate, for the number of drug classes tested.

Bill 80XXX and 83992 to report the appropriate drug or metabolite testing. The codes are no longer individually reimbursed for the purpose of this policy; however, we request that they are reported with the appropriate G code.

Contracted laboratories

Providers should select contracted laboratories for the processing of drug tests. Referring a member to a nonparticipating laboratory may result in unnecessary services (such as processing tests not originally ordered) and greater financial liability for the member. The referring provider may be held accountable for any inappropriate behavior on the part of the nonparticipating laboratory.

This policy is effective March 1, 2020.

81235, 81275, 81404, 81405, 81479, 81406

Basic benefit and medical policy

Genetic Testing-Molecular Analysis for Targeted Therapy of Non-Small Cell Lung Cancer

The criteria has been updated for the Genetic Testing-Molecular Analysis for Targeted Therapy of Non-Small Cell Lung Cancer policy.

EGFR testing

The safety and effectiveness of analysis of somatic variants in exons 18 (such as G719X), 19 (such as L858R, T790M), 20 (such as S678I), or 21 (such as L861Q) within the EGFR gene have been established to predict treatment response to an EGFR tyrosine kinase inhibitor therapy (e.g., erlotinib [Tarceva^®], gefitinib [Iressa^®] or afatinib [Gilotrif^®]) or osimertinib (Tagrisso) in patients with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC and NSCLC not otherwise specified.
The analysis for other EGFR mutations within exons 22-24, or other applications related to NSCLC, is considered experimental/investigational. The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility of this testing for this indication.

ALK testing

The safety and effectiveness of analysis of somatic rearrangement mutations of the ALK gene have been established. It’s an effective diagnostic option for predicting treatment response to crizotinib (Xalkori^®), ceritinib (Zykadia™), alectinib (Alecensa) or brigatinib (Alunbrig) in patients with advanced lung adenocarcinoma and large cell carcinoma or for patients in whom an adenocarcinoma component can’t be excluded.
Analysis of somatic rearrangement mutations of the ALK gene is considered experimental in all other situations.

BRAF V600E testing

Analysis of the BRAF V600E variant is established to predict treatment response to BRAF or MEK inhibitor therapy (e.g., dabrafenib [Tafinlar] and trametinib [Mekinist^®]) in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.

ROS1 testing

Analysis of somatic rearrangement variants of the ROS1 gene is established to predict treatment response to ALK inhibitor therapy (crizotinib [Xalkori]) in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded.

KRAS testing

Analysis of somatic mutations of the KRAS gene is established as a technique to predict treatment nonresponse to anti-EGFR therapy with tyrosine kinase inhibitors and for the use of the anti-EGFR monoclonal antibody cetuximab in NSCLC. The peer-reviewed medical literature has demonstrated the clinical utility of this testing for this indication.

NTRK gene fusion testing

Analysis of gene fusions is established to predict treatment response to larotrectinib in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.

Other genes

Analysis for genetic alterations in the genes RET, MET and HER2 for targeted therapy in patients with NSCLC is considered experimental. The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility of this testing for this indication.

Tumor mutational burden testing

Analysis of tumor mutational burden for targeted therapy in patients with NSCLC is considered investigational.

This policy is effective March 1, 2020.

92551, 92552, 92553, 92555, 92556, 92557, 92558, 92559, 92563, 92565, 92567, 92568, 92570, 92571, 92575, 92577, 92579, 92582, 92583, 92584, 92585, 92586, 92587, 92588

Basic benefit and medical policy

Standard battery of hearing tests

The standard battery of hearing tests is established as part of an initial workup of a patient with hearing impairment in the corresponding age group.

Specialized hearing tests may be established if the initial standard battery of tests are inconclusive.

Audiometric testing is established for the treatment planning of patients who have hearing disorders that require interventions other than determining the need for or the appropriate type of hearing aid.

The medical policy statement was updated, effective Sept. 1, 2019.

Inclusions:

Standard battery of hearing tests for adults and children:

Pure-tone audiometry, air and bone conduction
Speech audiometry
Word recognition test
Acoustic reflex test and acoustic reflex decay
Tympanometry (impedance testing)

Standard battery of hearing tests for children only:

Select picture audiometry
Conditioning play audiometry

Standard battery of hearing tests for infants only:

Auditory evoked potentials
Visual reinforcement audiometry
Evoked otoacoustic emissions
Acoustic reflex test

Specialized hearing tests for adults and children:

Electrocochleography
Auditory evoked potentials
Tone decay
Stenger test
Sensorineural acuity level test
Evoked otoacoustic test

Exclusions:

Experimental:

Automated audiometry (self-administered or administered by non-audiologists)
Speech in noise, known as SIN
Hearing in noise test, known as HINT
Tests solely used to determine the appropriate type of hearing aid (e.g., SIN, HINT)

Exclusions (tests considered obsolete and thus not medically necessary):

Lombard test (replaced by the Stenger test and auditory evoked potential) (92700)
Alternate binaural loudness balance test (92562)
Short increment sensitivity test (replaced by pure tone audiometry, auditory evoked potential) (92564)
Bekesy audiometry (92560)
Staggered spondaic word test (92572)
Synthetic sentence identification test (92576)

Established
93580

Experimental
93799, 33999

Basic benefit and medical policy

Closure Devices for Patent Foramen Ovale and Atrial Septal Defects policy

The medical policy statement has been updated for the Closure Devices for Patent Foramen Ovale and Atrial Septal Defects policy. The policy effective date is March 1, 2020.

Medical policy statement

Closure of patent foramen ovale, using an FDA-approved device according to the labeled instructions, for a percutaneous transcatheter approach may be considered established when specified criteria are met.

Transcatheter closure of secundum atrial septal defects may be considered established when using a device that has been FDA approved for that purpose and used according to the labeled indications.

Inclusions:

Closure of patent foramen ovale, known as PFO, using a percutaneous transcatheter approach, with an FDA-approved device per labeled instructions, when all the following are met:

Used to reduce the risk of recurrent ischemic stroke
Patient is predominantly between 18 and 60 years of age
Echocardiography confirms diagnosis of patent foramen ovale with a right-to-left interatrial shunt
Documented history of cryptogenic ischemic stroke or TIA due to presumed paradoxical embolism as determined by a neurologist and cardiologist:
- Any other identifiable cause of stroke has been excluded including:
  - Large vessel atherosclerotic disease
  - Small vessel occlusive disease
None of the following are present:
- Uncontrolled vascular risk factors including:
  - Uncontrolled diabetes mellitus
  - Uncontrolled hypertension
- Other sources of right-to-left shunts including:
  - Atrial septal defect
  - Fenestrated septum
- Active endocarditis or other untreated infections
- Inferior vena cava filter

Closure of atrial septal defects with an FDA-approved device, per labeled instructions, when both of the following are met:

There is echocardiographic evidence of ostium secundum atrial septal defect.
There is evidence of right ventricular volume overload or paradoxical embolism.

Exclusions:

Patent foramen ovale with recurrent cryptogenic migraine
Closure of a septal defect when performed using the transmyocardial approach
Open surgery is needed to repair multiple congenital defects or other cardiac defects
Multiple cardiac defects that can’t be covered by the device

A0225, A0398,** A0426-A0429, A0433, A0434, A0998

**A0398 is paid within the global fee and can’t be billed separately.

Basic benefit and medical policy

Ground ambulance service

The safety and effectiveness of ground ambulance service have been established. It may be considered a useful option when indicated for transporting patients when medical circumstances could endanger the patient’s health or life.

Guidelines have been updated, effective March 1, 2020.

Inclusions:

Patients must be transported in a state-licensed vehicle designated as an ambulance and the ambulance must carry personnel qualified to treat the patient. Ambulance transport is medically necessary for:

Transporting a patient to a hospital.
Transferring a patient from a hospital to another treatment location such as another hospital, a skilled nursing facility, a medical clinic or the patient's home. (The attending physician must order the transfer.)
Ambulance providers to respond and treat the patient without transport.

Ambulance services must meet the following criteria:

Services must be medically necessary. Medically necessary means that transportation other than by ambulance could endanger the patient’s health or life.
Emergency ambulance services are considered medically necessary as a result of an accidental injury or medical emergency when requested by an employer, school or public safety official.
Non-emergency ambulance services are covered when medically necessary and authorized by the patient’s physician.
The services must be provided by an approved, state-licensed ambulance provider.
If the services weren’t ordered by the attending physician, extenuating circumstances may warrant individual consideration for the service.
The patient must be transported to the nearest facility equipped to provide the necessary treatment.
Transportation coordination to airfield or heliopad.

Deceased patients:

Ambulance services are medically appropriate only to the place where the patient is found (one-way) if the patient is pronounced dead after the ambulance is called but before it arrives at the scene.
Ambulance services are medically appropriate for the entire ambulance trip (round-trip) if the patient was pronounced dead while en route to or upon arrival at the hospital.

Exclusions:

The following services don’t meet the definition of medically necessary ambulance services:

Use of vehicles not certified by the state as an ambulance
Ambulance trips when a patient isn’t transported
Ambulance services for the convenience of the patient, family or physician.
Coverage is only provided to the place where the patient was found (one-way) if the patient was pronounced dead after the ambulance was called but before it arrives at the scene.
Ambulance services aren’t medically appropriate when the patient was pronounced dead by an authorized individual before the ambulance was called.
Ambulance services aren’t medically appropriate when the patient was found deceased and pronounced at home with ground ambulance transport to morgue for post-mortem care.

Coverage limitations:

Travel and transportation expenses for clinical trials are excluded from coverage. These include, but aren’t limited to, the following examples:

Fees for all types of transportation (e.g., personal vehicle, taxi, medical van, ambulance)
Rental car expenses
Mileage reimbursement for driving a personal vehicle

Established
Q4195, Q4196, Q4203

Experimental
Q4193, Q4197, Q420, Q4202, Q4220, Q4222, Q4226

Basic benefit and medical policy

Skin and tissue substitutes

The safety and effectiveness of skin and tissue substitutes approved by the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been established for patients meeting specified selection criteria. They may be useful therapeutic options when indicated.

Human tissue products are subject to the rules and regulations of banked human tissue by the American Association of Tissue Banks and have been established for patients meeting specified selection criteria. They may be useful therapeutic options when indicated.

The listed procedure codes have been added to the policy and the established criteria updated.

Inclusions:

The following skin and tissue substitutes are considered established as they have been approved by the FDA. This list may not be all-inclusive:

Apligraft^®
Biobrane^®
Cytal^® Burn Matrix
Cytal^® MicroMatrix™
Cytal^® Wound Sheet
Derma-Gide
Dermagraft^®
Endoform Dermal Template™
Epicel^® has FDA humanitarian device approval
E-Z Derm™
Hyalomatrix^®
Integra^® Bilayer Matrix
Integra^® Dermal Regeneration Template
Integra^® Flowable Wound Matrix
MediSkin^®
Oasis^® Burn Matrix
Oasis^® Ultra Tri-Layer Wound Matrix
Oasis^® Wound Matrix
OrCel^®
Permacol™ (Covidien)
PriMatrix™
PuraPly Wound Matrix (PuraPly)
PuraPly Antimicrobial Wound Matrix (PuraPly AM)
Strattice™
Suprathel^®
SurgiMend^®
Talymed™
TenoGlide™
TheraSkin^®
TransCyte^®

Breast reconstructive surgery using allogeneic acellular dermal matrix productsa (including each of the following: AlloDerm^®, AlloMend^®, Cortiva^®, [AlloMax™], DermACELL™, DermaMatrix™, FlexHD^®, FlexHD^® Pliable™, Graftjacket^®) are considered established when one of the following is met:

There is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required.
There is viable but compromised or thin postmastectomy skin flaps that are at risk of dehiscence or necrosis.
The inframammary fold and lateral mammary folds have been undermined during mastectomy and reestablishment of these landmarks is needed.
Various acellular dermal matrix products used in breast reconstruction have similar efficacy. The products listed are those that have been identified for use in breast reconstruction. Additional acellular dermal matrix products may become available for this indication.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers is established when using the following tissue engineered skin substitutes:

AlloPatch^®^a
Apligraft^®^b
Dermagraft^®^b
GraftJacket^® Regenerative Tissue Matrix-Ulcer Repair
Integra^®, Omnigraft™ Dermal Regeneration Matrix (also known as Omnigraft™) and Integra Flowable Wound Matrix
Theraskin^®

Treatment of chronic, noninfected, partial- or full-thickness lower-extremity skin ulcers due to venous insufficiency, which have not adequately responded following a one-month period of conventional user therapy is established when using the following tissue-engineered skin substitutes:

Aplifraf^®^b
OasisTM Wound Matrix^c
Theraskin^®

OrCel™ is considered established when all the following criteria are met:

Used for the treatment of dystrophic epidermolysis bullosa
Used for the treatment of mitten-hand deformity
Standard wound therapy has failed
Provided in accordance with the humanitarian device exemption specifications of the U.S. FDA

The following skin and tissue products and substitutes are considered established for use in the treatment of second- and third-degree burns:

Alloderm
Epicel^® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area ≥30% when provided in accordance with the HDE specifications of the FDA)^d
Integra^® Dermal Regeneration Template^b

^aBanked human tissue
^bFDA premarket approval
^cFDA 510(k) clearance
^dFDA-approved under an HDE

Exclusions:

All other uses of bioengineered skin and soft tissue substitutes listed above unless they meet the following criteria:

FDA approval and provided in accordance with the FDA guidelines
Covered by CMS

All other skin and soft tissue substitutes, including, but not limited to:

ACell^® UBM Hydrated/Lyophilized Wound Dressing
AlloSkin™
AlloSkin™ RT
Aongen™ Collagen Matrix
Architect^® ECM, PX, FX
ArthroFlex™ (Flex Graft)
Atlas Wound Matrix
Avagen Wound Dressing
AxoGuard^® Nerve Protector (AxoGen)
BellaCell HD or SureDerm^®
CollaCare^®
CollaCare^® Dental
Collagen Wound Dressing (Oasis Research)
CollaGUARD^®
CollaMend™
CollaWound™
Coll-e-Derm
Collexa^®
Collieva^®
Conexa™
Coreleader Colla-Pad
CorMatrix^®
Cymetra™ (Micronized AlloDerm™)
Dermadapt™ Wound Dressing
DermaPure™
DermaSpan™
DressSkin
Durepair Regeneration Matrix^®
ENDURAGen™
Excellagen
ExpressGraft™
FlexiGraft^®
GammaGraft
Graftjacket^® Xpress, injectable
Helicoll™
hMatrix^®
Keramatrix^®
Kerecis™
MariGen™/Kerecis™ Omega3™
MatriDerm^®
Matrix HD™
MemoDerm™
Microderm^® biologic wound matrix
MyOwn Skin™
NeoForm™
NuCel
Pelvicol^®/PelviSoft^®
Progenamatrix™
Puros^® Dermis
RegenePro™
Repliform^®
Repriza™
Restrata
SkinTE™
StrataGraft^®
TenSIX™ Acellular Dermal Matrix
TissueMend
TheraForm™ Standard/Sheet
TruSkin™
Veritas^® Collagen Matrix
XCM Biologic^® Tissue Matrix
XenMatrix™ AB

This policy is effective March 1, 2020.

EXPERIMENTAL PROCEDURES

Experimental
27299, 49659, 49999

Basic benefit and medical policy

Surgery for groin pain in athletes

Surgical treatment of groin pain** in athletes who present with the absence of a preoperative anatomical defect is considered experimental.

This policy is effective March 1, 2020.

**Also known as athletic pubalgia, Gilmore groin, osteitis pubis, pubic inguinal pain syndrome, inguinal disruption, slap shot gut, sportsmen groin, footballers groin injury complex, hockey groin syndrome, athletic hernia, sports hernia or core muscle injury.

Experimental
S3900 and 95999

Basic benefit and medical policy

Surface electromyography

Surface electromyography, known as SEMG, is considered experimental to evaluate and monitor back pain. There is insufficient evidence demonstrating how findings from paraspinal SEMG alter patient management or how use of this test improves health outcomes.

Surface electromyography is considered experimental to diagnose or monitor temporomandibular joint, known as TMJ, or craniomandibular disorders, known as CMD. There is insufficient evidence demonstrating how findings from SEMG alter patient management or how use of this test improves health outcomes.

This policy is effective March 1, 2020.

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No portion of this publication may be copied without the express written permission of Blue Cross Blue Shield of Michigan, except that BCBSM participating health care providers may make copies for their personal use. In no event may any portion of this publication be copied or reprinted and used for commercial purposes by any party other than BCBSM.

*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2019 American Medical Association. All rights reserved.