Medical Policy and Coding Updates April 2021

Effective May 10, 2021

Updates to AIM Specialty Health® Clinical Appropriateness Guidelines

Effective for dates of service on and after May 10, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies

Updates by section:

Conditions for which testing may be medically necessary (Table 1)

The following solid tumor markers were added:

• Cholangiocarcinoma: FGFR2 and FoundationOne^® CDx
• Colorectal cancer: Praxis Extended RAS panel
• Neuroblastoma: chromosomal microarray analysis (CMA), MYCN, ALK
• Non-small cell lung cancer (NSCLC): Oncomine Dx Target Test
• Ovarian cancer: myChoice^® CDx
• Prostate cancer (suspected): SelectMDx
• Prostate cancer: FoundationOne^® CDx
• Tumor agnostic/all solid tumors: microsatellite instability (MSI) and FoundationOne^® CDx

Breast Cancer Gene Expression Classifiers

• Criteria were clarified to confirm the patient has undergone surgery and full pathological staging
• Additional statement added explaining testing is not medically necessary to guide decision making for extended endocrine therapy
• OncotypeDx Recurrence Score test: the definition of unfavorable histological features was clarified

Minimal Residual Disease (MRD)

• Testing criteria were revised to require testing performed on bone marrow

Targeted Molecular Testing for NTRK Fusions

• Criteria were revised

Prostate Cancer (symptomatic cancer screening)

• Added criteria for SelectMDx (81479)
• Criteria for PCA3 (81313), ExomeDx (0005U) and ConfirmMDx (81551) were revised

Effective May 6, 2021

Hereditary Angioedema, 5.01.587

Medical necessity criteria updated

• Berinert^® (pdC1-INH)
  • Added coverage for acquired angioedema
• Cinryze^® (pdC1-INH)
  • Added patient age, limits to danazol use, and acute HAE frequency requirements
• Firazyr^® (icatibant)
  • Requires use of generic icatibant first
• Haegarda^® (pdC1-INH)
  • Added limits to danazol use and acute HAE frequency requirements
• Ruconest^® (rhC1-INH)
  • Age criteria revised to patients 13 and older
• Takhzyro^® (lanadelumab-flyo)
  • Added limits to danazol use, acute HAE frequency requirements, and quantity limit

Effective April 7, 2021

Immune Globulin Therapy, 8.01.503

Site of service review added

• Xembify^®

Miscellaneous Oncology Drugs, 5.01.540

New drug added to policy

• Jelmyto™ (mitomycin)
  • Treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

Site of Service Infusion Drugs and Biologic Agents, 11.01.523

Site of service review added

• Xembify^®

New medical policies

Effective April 1, 2021

Bioengineered Skin and Soft Tissue Substitutes, 7.01.113

New policy

• This policy replaces Bioengineered Skin and Soft Tissue Substitutes, 7.01.582
• The table of investigational products has been updated and expanded
• All statements remain unchanged

Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias, 8.01.538

New policy

• This policy replaces Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias, 8.01.22
• All statements remain unchanged

New pharmacy policies

Effective April 1, 2021

Topical Drugs of Actinic Keratosis and Other Dermatologic Conditions, 5.01.623

New policy

The following brand drugs have been added and may be considered medically necessary when criteria are met:

• Aldara® (imiquimod 5%)
  • Treatment of actinic keratosis in adults
  • Treatment of superficial basal cell carcinoma (sBCC) in adults
  • Treatment of external genital and perianal warts (EGW) in patients age 12 and older
•  Carac® (fluorouracil 0.5%)
  • Treatment of actinic keratosis in adults
• Fluoroplex® (fluorouracil 1%)
  • Treatment of actinic keratosis in adults
• Brand fluorouracil
  • Treatment of actinic keratosis in adults
• Brand imiquimod 3.75%
  • Treatment of actinic keratosis in adults age 18 and older
  • Treatment of external genital and perianal warts (EGW) in patients age 12 and older
• Klisyri® (tirbanibulin)
  • Treatment of actinic keratosis in adults
• Solaraze® (diclofenac 3%)
  • Treatment of actinic keratosis in adults
• Tolak® (fluorouracil 4%)
  • Treatment of actinic keratosis in adults
• Zyclara® (imiquimod 2.5% and 3.75%)
  • Treatment of actinic keratosis in adults age 18 and older
• Zyclara® (imiquimod 3.75%)
  • Treatment of external genital and perianal warts (EGW) in patients age 12 and older

Revised pharmacy policies

Effective April 1, 2021

Pharmacotherapy of Arthropathies, 5.01.550

Medical necessity criteria updated

• Cosentyx® (secukinumab)
  • For the treatment of plaque psoriasis, the patient must have tried and failed four drugs from three or more different drug classes
• Cosentyx® (secukinumab)
  • For the treatment of psoriatic arthritis, the patient must have tried and failed three drugs from two or more different drug classes

Removed from site of service review

• Simponi® (golimumab)

An archived policy is one that's no longer active and is not used for reviews.

Archived April 1, 2021

Acute Inpatient Hospice, 11.01.507

Quantitative Assay for Measurement of HER2 Total Protein Expression and HER2 Dimers, 2.04.76

Deleted April 1, 2021

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582

This policy is replaced with Bioengineered Skin and Soft Tissue Substitutes, 7.01.113

Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias, 8.01.22

This policy is replaced with Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias, 8.01.538

Added codes

Effective April 11, 2021

Effective for dates of service on and after April 11, 2021, the following will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Genetic Testing.

Now reviewed by AIM® Specialty Health and requires prior authorization.

0242U, 0244U, 0245U

Effective April 7, 2021

Miscellaneous Oncology Drugs, 5.01.540

Now requires review for medical necessity and prior authorization.

J9280

Effective April 1, 2021

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582

Now requires review for investigative.

Q4108

Chimeric Antigen Receptor Therapy for Hematologic Malignancies, 8.01.63

Now requires review for medical necessity.

Q2053

Drugs for Rare Diseases, 5.01.576

Now requires review for medical necessity.

C9074

Hospital Beds and Accessories, 1.01.520

Now requires review for medical necessity and prior authorization.

E0270

Hyperbaric Oxygen Therapy, 2.01.04

Now requires review for investigative and prior authorization.

A4575

Immune Globulin Therapy, 8.01.503

Now requires review for medical necessity.

J1554

Microprocessor-Controlled and Powered Prostheses and Orthoses for the Lower Limb, 1.04.503

Now requires review for medical necessity and prior authorization.

K1014

Miscellaneous Oncology Drugs, 5.01.540

Now requires review for medical necessity and prior authorization.

J9280

Miscellaneous Oncology Drugs, 5.01.540

Now requires review for medical necessity.

J9037

Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502

Now requires review for medical necessity and prior authorization.

J9349

Orthopedic Applications of Stem Cell Therapy (Including Allografts and Bone Substitutes Used with Autologous Bone Marrow), 8.01.52

Now requires review for investigative.

0565T, 0566T

Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570

Now requires review for medical necessity.

J1427

Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions, 2.01.16

Now requires review for investigative.

S9055, G0460

Steroid-Eluting Sinus Stents, 7.01.134

Now requires review for investigative.

S1091

Vagus Nerve Stimulation, 7.01.20

Now requires review for investigative.

K1020

Removed codes

Effective April 1, 2021

Blepharoplasty, Blepharoptosis and Brow Ptosis Surgery, 7.01.508

No longer requires review for medical necessity and prior authorization.

67909

Chimeric Antigen Receptor Therapy for Hematologic Malignancies, 8.01.63

No longer requires review for medical necessity.

C9073

Immune Globulin Therapy, 8.01.503

No longer requires review for medical necessity.

C9072

Intra-Articular Hyaluronan Injections for Osteoarthritis, 2.01.31

No longer requires review for medical necessity.

J3333

Miscellaneous Oncology Drugs, 5.01.540

No longer requires review for medical necessity.

C9069

Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502

No longer requires review for medical necessity.

C9070

Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570

No longer requires review for medical necessity.

C9071

Steroid-Eluting Sinus Stents, 7.01.134

Now requires review for investigative.

J7401

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