Effective February 18, 2023
Updates to AIM Specialty Health® Clinical Appropriateness Guidelines
Effective for dates of service on and after February 18, 2023, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Genetic Testing
Updates by section
Carrier Screening in the Prenatal Setting and Preimplantation Genetic Testing
- Clarified testing requirements for Fragile X Syndrome in patients with unexplained ovarian failure
- Clarified carrier screening restrictions for autosomal recessive conditions
- Expanded selected relevant screening for patients at high risk based on ethnicity (e.g., Ashkenazi Jewish, French Canadian, Mennonite) and the conditions for which to test
- Expanded screening when one or both individuals do not have access to biological family history, and allowed preimplantation testing when reproductive donor is of unknown carrier risk
Cell-free DNA Testing (Liquid Biopsy) for the Management of Cancer
- Removed specific language regarding the brand names of tests which are considered medically necessary, and generally does not specifically name the therapeutic agents which must be under consideration, allowing appropriate review of claims when new
therapies or tests are approved by the FDA
Genetic Testing for Inherited Conditions
- Clarified criteria on cardiomyopathies for which testing is medically necessary
- Allowed for broader panels for arrhythmia and cardiomyopathy syndromes
Hereditary Cancer Testing
- Added condition-specific criteria based on National Comprehensive Cancer Network (NCCN) recommendations, as well as other clinical guidelines
- Limited testing in the following scenarios:
- Prostate cancer (in select scenarios) for patients without additional familial risk
- Patients with only a second-degree relative with ovarian cancer
- Patients with breast cancer and family history in some select scenarios (e.g., lobular histology only plus personal or family history of gastric cancer)
Pharmacogenomics Testing
- Limited testing for patients being treated with warfarin
- Specified biomarkers for which one-time testing is considered medically necessary
Somatic Tumor Testing
- Clarified criteria about tumor stage in cutaneous melanoma and cholangiocarcinoma, and about histology in non-small cell lung cancer, ovarian cancer (epithelial) and prostate cancer (adenocarcinoma)
- Chromosmal microarray analysis may require additional review
- Specified the genes that must be included in panels for hematologic malignancy testing
- Allowed testing for patients with metastatic uveal melanoma
- Removed specific language regarding the brand names of tests which are considered medically necessary, and generally does not specifically name the therapeutic agents which must be under consideration, allowing appropriate review of claims when new
therapies or tests are approved by the FDA
Use of Polygenic Risk Scores in Genetic Testing
- Limited polygenic risk score testing
Whole Exome Sequencing and Whole Genome Sequencing
Whole exome sequencing
- Allowed analysis using the same criteria as the initial test
- Limited testing for congenital bilateral hearing loss of unknown etiology, developmental and epileptic encephalopathy, and single anomaly with positive family history
Effective February 3, 2023
Gender Transition/Affirmation Surgery and Related Services, 7.01.557
Standard Benefit Coverage
Genital or "bottom surgery"
Surgery added
Site of service review added
Hysterectomy will be reviewed for medical necessity. Breast reduction, laparoscopic-assisted vaginal hysterectomy, rhinoplasty, and vaginal hysterectomy will also include site of service review.
Genital or "bottom surgery"
Note removed
Hysterectomies for gender transition/affirmation are not subject to medical necessity review
Hair removal (by laser or electrolysis) prior to genital surgery
Medical necessity criteria updated
Hair removal will be done by a physician, nurse practitioner, physician assistant, or by a professional who is licensed, certified, registered, or otherwise approved by the state for hair removal (e.g., a licensed aesthetician)
Expanded Benefit Coverage
Medical necessity criteria updated
Facial, body, or extremity hair removal not related to genital surgery
Recommendations by Licensed Mental Health Professionals
Section title expanded
Now includes "additional timing requirements for surgery and mental health recommendation letters, and for pre-surgery surgeon evaluations"
Medical necessity criteria updated
- Removed requirement that psychiatrists are board-eligible or board-certified
- Evaluations may be performed by and letters written by state licensed master's and doctoral mental health clinicians who aren't licensed to practice independently if mental health professionals who are state licensed to practice independently co-sign
the letters
- Revised mental health recommendation letter content
- Combined two criteria into documentation of the history of the person's gender dysphoria and gender identity transition to include assigned gender at birth, age of awareness of gender incongruence, symptoms of gender dysphoria, and actions
taken to transition to the desired gender
- Past and present treatment for gender dysphoric symptoms has been revised to any current or past psychiatric treatment
- Additional timing requirements for surgery and mental health recommendation letters, and pre-surgery surgeon evaluations now includes the statement: "for facial, body, or extremity hair removal not related to genital surgery, pre-procedure evaluations
by either a referring medical provider or the hair removal provider are acceptable as the pre-surgery surgeon evaluations"
Hysterectomy for Non-Malignant Conditions, 7.01.548
Policy notes updated
- Replaced statement that this policy does not apply to hysterectomy for gender transition/affirming surgeries to reference to medical policy 7.01.557, Gender Transition/Affirmation Surgery and Related Services
- Clarified that the policy does not apply to hysterectomy for gynecologic malignant conditions
Miscellaneous Oncology Drugs, 5.01.540
Drugs added
- Elzonris™ (tagraxofusp-erzs)
- Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children age 2 years and older
- Onivyde® (irinotecan liposome injection)
- Treatment of pancreatic cancer that has spread to other parts of the body
- Treatment of bile duct cancer that has spread to other parts of the body
Site of Service: Select Surgical Procedures, 11.01.524
Policy added
Gender Transition/Affirmation Surgery and Related Services, 7.01.557 added to policy to address breast reduction, laparoscopic-assisted vaginal hysterectomy, rhinoplasty, and vaginal hysterectomy.
Spravato® (esketamine) Nasal Spray, 5.01.609
Indication: Depression
Medical necessity criteria updated
- A trial and failure of four antidepressants from at least two different classes has been reduced to a trial and failure of three antidepressants from two different classes
- A trial and failure of three antidepressants from at least two different classes plus an augmenting agent has been reduced to two antidepressants from two different classes plus an augmenting agent
- No current substance use disorder unless in remission now includes definition of three months of complete abstinence
Indication: New course of Spravato® after previous treatment
Medical necessity criteria updated
No current substance use disorder unless in remission now includes definition of three months of complete abstinence
Investigational criteria updated
Use of Spravato® (esketamine) along with any other formulation of ketamine or with any psychedelic drug is considered investigational
All indications
Medical necessity criteria updated
Use of Spravato® (esketamine) with more than one provider/group/clinic at the same time is considered not medically necessary
Documentation requirements updated
- For failed medication trials, each medication that failed must be individually identified, along for the reason(s) for failure
- For each failed medication trial, there must be documentation of at least 30 continuous days with no or inadequate improvement unless stopped sooner because of intolerable adverse effects
Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders, 2.01.526
Policy statements added
- Types of transcranial magnetic stimulation (TMS) covered
- Deep transcranial magnetic stimulation of the brain
- Standard/conventional repetitive transcranial magnetic stimulation of the brain
- Theta burst stimulation of the brain
- Specific medical conditions where TMS may be considered medically necessary
- Major depression as a component of bipolar disorder
- Major depressive disorder
- Obsessive-compulsive disorder
Investigational criteria updated
- Added list of all other types of transcranial magnetic stimulation (TMS)
- Theta burst stimulation is considered investigational for the treatment of major depression as a component of bipolar disorder and the treatment of obsessive-compulsive disorder
- TMS for all other psychiatric conditions, for all substance use conditions, and for all neurologic conditions are considered investigational
- Use of TMS to boost the effectiveness of other treatment modalities, including but not limited to drugs or other devices, is considered investigational
- Technology computer-assisted TMS of the prefrontal cortex is considered investigational
Major depressive disorder
Medical necessity criteria updated
- Age requirement reduced from 18 years and older to age 15 years and older
- The number of failed medication trials has been reduced from four to three
- Theta burst stimulation has been added as a type of TMS for this condition
Major depression as a component of bipolar disorder
Medical necessity criteria updated
- The number of failed medication trials has been increased from two to three
- Theta burst stimulation is considered investigational for this condition
Obsessive-compulsive disorder
Indication added
Medical necessity criteria added
- Standard/conventional TIM and deep TMS may be considered medically necessary
- Theta burst stimulation is considered investigational for this condition
All indications
Contraindications added
- History of or presence of a brain tumor
- History of repetitive or severe head trauma/traumatic brain injury
Policy sections added
Medical necessity criteria added
- Course of full intensive TMS
- Extended intensive course or extended intensive phase (deep TMS)
- Extended taper
- Accelerated intensive TMS
- Maintenance TMS
- Repeat full intensive course
- Short of brief intensive course
- Consecutive or overlapping courses of TMS for different conditions
- TMS with more than one provider at the same time
- TMS along with Spravato® (esketamine), or ketamine, or any other psychedelic drug
- TMS along with other types of neuromodulation
Effective December 1, 2022
Pharmacologic Treatment of Gout, 5.01.616
Medical necessity criteria updated
Krystexxa® (pegloticase) must be given with oral methotrexate 15 mg weekly, unless there is a medical reason why methotrexate can't be taken
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563
Medical necessity criteria updated
- Tysabri® (natalizumab)
- Patient must have tried and failed treatment with one or more TNF blockers
Effective November 4, 2022
Immune Globulin Therapy, 8.01.503
Site of service review added
- Cutaquig® (immune globulin subcutaneous [human] - hipp)
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523
Site of service review added
- Cutaquig® (immune globulin subcutaneous [human] - hipp)