Maryland

Yes

Ryan B. Moran, Dr.P.H., Deputy Secretary, Health Care Financing & Medicaid Director, (410) 767-5343

Maryland Department of Health
Herbert R. O’Conor State Office Building, 201 West Preston St., Baltimore, MD 21201 – 2399
(410) 767-6500; 1-877-463-3464 (toll free, Maryland)
fax: (410) 767-6489; tdd: 1-800-735-2258 (toll free)

https://msa.maryland.gov/msa/mdmanual/16dhmh/html/dhmh.html

The following indications for NIPTs testing are investigational and are excluded from coverage:

1. Testing as a follow-up to an abnormal 1st or 2nd trimester screening.
2. Low Fetal Fraction on initial NIPTs testing (counseling and diagnostic testing recommended).
3. Cases with a known co-twin demise (vanishing twin syndrome).
4. Screening for trisomies other than 21, 18 and 13.
5. Screening for single-gene disorders.
6. Whole genome NIPTs.
7. When used to determine genetic cause of miscarriage or fetal demise (e.g., missed abortion, incomplete abortion).

When is Whole Exome Sequencing NOT A COVERED BENEFIT?
The use of WES for indications other than those listed above is considered experimental,
investigational, or unproven.
WES is not covered in the following scenarios*.

1. WES is not covered for uncomplicated Autism Spectrum Disorder, developmental delay, and mild to moderate global developmental delay.
2. WES is not covered when environmental exposures, injury, or infection may reasonably explain the patient’s constellation of symptoms.
3.  WES is considered investigational for:
   1. Prenatal screening for fetal diagnosis.
   2. Preimplantation testing of an embryo.
   3. Purpose of genetic carrier screening.
   4. Genetic disorders in all other situations.
      *This list is not an exhaustive list of all scenarios where WES may not be considered a covered benefit.

When is Whole Genome Sequencing NOT A COVERED BENEFIT?
The use of WGS for indications other than those listed above is considered experimental, investigational, or unproven.
WGS is not covered in, but is not limited to, the following scenarios.

1. WGS is not covered for Uncomplicated Autism Spectrum Disorder, developmental delay, or mild to moderate global developmental delay.
2. WGS is not covered when environmental exposures, injury, or infection may reasonably explain the patient’s constellation of symptoms.
3. WGS is considered investigational for:
   1. Prenatal screening for fetal diagnosis.
   2. Preimplantation testing of an embryo.
   3. Purpose of genetic carrier screening.
   4. Genetic disorders in all other situations.

When is genetic panel testing not covered?

1. Testing, for the purpose of confirming a suspected diagnosis that can be diagnosed based on clinical evaluations alone, will not be covered.
2. Genetic testing, when the clinical utility is not scientifically supported.
3. Testing for conditions, which cannot be altered by a specific treatment or prevented by specific interventions.
4. Providers may not report 81455 with either 81445 or 81450.

Whole genome sequencing (WGS) is the strategy of using next-generation technology to sequence the entire genetic code of a genome. Whole-genome sequencing (WGS), in contrast to (WES), may detect larger deletions or duplications, triple repeat expansions, and pathogenic variants in deep intronic regions; regulatory regions that are outside of the coding regions; and untranslated gene regions.

CPT 81425 – Whole genome sequencing may be considered medically necessary for the evaluation of unexplained congenital anomalies or neurodevelopmental disorders in newborns when all the following criteria are met with supporting medical documentation:

1.  Approved for patients aged less than 1 year of life and currently admitted to or recently discharged from a Neonatal Intensive Care Unit (NICU).
2. Test is ordered by one of the following provider types, who has evaluated the patient and family history, and recommends and/or orders the test:
   1. Neonatologist or neurologist in collaboration with a medical geneticist or certified genetic counselor.
   2. The patient has been evaluated by a board-certified clinician with expertise in clinical genetics and counseled about the potential risks of genetic testing.
   3. Pre- and post-test counseling is performed by an American Board of Medical Genetics or American Board of Genetic Counseling certified genetic counselor.
3.  Clinical indications:
   1. A definitive diagnosis cannot be made based on standard clinical workup.
   2. The patient’s phenotype does not clearly identify a specific disease with an established single gene or multi-gene panel, or the patient has phenotypic characteristics outside of, or in addition to, what has been
      established for the disease.
   3. A genetic etiology is the most likely explanation for the phenotype or clinical scenario despite previous genetic testing (e.g., chromosomal microarray analysis and/or targeted single gene testing), OR when
      previous genetic testing has failed to yield a diagnosis and the affected individual is faced with invasive procedures or testing as the next diagnostic step (e.g., muscle biopsy.)
   4. No other causative circumstances (e.g., environmental exposures, injury, infection) can explain the symptoms.
4. Clinical utility: A definitive diagnosis will have clinical utility (improvement in net health outcomes.) For example:
   1. WGS results have a reasonable potential to directly impact patient management and clinical outcome for the individual being tested.
   2. WGS is more practical than the separate single gene tests or panels that would be recommended based on the differential diagnosis.
   3. Establishing the diagnosis by genetic testing will end or minimize the clinical workup for other disorders.
   4. WGS results may preclude the need for multiple and/or invasive procedures.

CPT 81426 – Comparator genome sequence analysis is considered medically necessary when the above criteria for WGS (CPT 81425) have been met and WGS is being performed concurrently or has been previously performed.

CPT 81427 – Whole genome reanalysis of previously obtained uninformative whole exome sequence is medically necessary when one of the following criteria is met:

1. There has been an onset of additional symptoms that broadens the phenotype assessed during the original exome evaluation.
2. There has been the birth or diagnosis of a similarly affected first-degree relative that has expanded the clinical picture.

The rule making process for the Maryland GC Licensure Bill is currently underway with the Maryland Board of Physicians. Applications for licensure are not yet open, and we will provide a link on our website to the Maryland Board of Physicians Allied Health Professionals website once instructions and the application are available

Pre and post test counseling is required for non-invasive prenatal testing, whole genome sequencing, panel testing, and whole exome sequencing.

Health‐General
§19‐705.5
Health‐General
§15‐807
COMAR
10.11.03.04
COMAR
10.54.03.03
COMAR
31.11.06.03
COMAR
31.11.12.03

Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism is covered.

Prior authorization is required for some genetic tests.

https://health.maryland.gov/mmcp/Documents/Genetic%20Testing%20Preauth%20Form%20Final%209-19-19.pdfhttps://health.maryland.gov/mmcp/MCOupdates/Documents/PEN%20Authorization%20Form%20Fillable_1.22.2021.pdf

https://health.maryland.gov/mmcp/Documents/2023%20Medical%20Laboratory%20Fee%20Schedule-%20updated%207-12-2023.pdf

Coverage is available, but criteria is unknown.

Coverage is available, but criteria is unknown.

Coverage is available, but criteria is unknown.

Coverage is available, but criteria is unknown.

A genomic sequence analysis panel to evaluate the patient specimen for targeted genetic sequences known to relate to solid organ cancers or to blood or lymph cancers known as hematolymphoid neoplasms.
Preauthorization is Required for:

1. CPT 81445 – applies to solid organ neoplasm type (5-50 genes).
2. CPT 81450- applies to hematolymphoid neoplasm type (5-50 genes).
3. CPT 81455 – applies to the number of genes analyzed for either a solid or hematolymphoid neoplasm (51 or greater genes).

The goal of genomic test panels for cancer is to identify molecular genetic alterations that, in the appropriate context, provide clinical benefit; either in terms of establishing a diagnosis, selecting a molecularly-targeted therapy, or determining prognosis in a way that has a tangible patient impact (influencing therapeutic decisions such as whether or not to undergo a bone marrow transplant, a high intensity chemotherapeutic or radiotherapy regimen, surgical procedures, or palliative care).
Molecular panel testing to identify targeted therapy may be considered medically necessary when utilized for some cancer types. CPT Codes: 81455, 81445, and 81450 will be considered
for coverage when ALL of the criteria below are met, confirmed with supporting medical documentation.

Supporting documentation:

1. A copy of the patient’s medical record supporting the medical necessity for the request for molecular panel testing. This should include the patient’s clinical diagnosis and current condition, medical treatment to date, and previous pertinent medical treatments including all current lab tests that support the request.
2. Documentation must include a statement of how the particular molecular panel test results will directly alter the treatment and/or medical management of the patient’s diagnosed condition. The use of a particular molecular panel may also be considered medically necessary to exclude the use of ineffective targeted therapies when supported by the medical literature.
3. The request must be made by the patient’s oncology provider with support, or in conjunction with, counseling by a medical geneticist or a board-certified genetic counselor.

81445: Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, 5-50 genes (e.g., ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed.
81450: Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA and RNA analysis when performed, 5-50 genes (e.g., BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed.
81455: Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis when performed, 51 or greater genes (e.g., ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed.

Coverage is available, but criteria is unknown.

Non-Invasive Prenatal Testing (NIPTs) will be considered for coverage when ALL of the criteria below are met, confirmed with supporting medical documentation.

No Preauthorization Required for:

1. NIPTs will be a covered benefit without the need for preauthorization: Trisomy 21, 18, 13 Screening with Gender Identification (if chosen).
2. NIPTs is a covered benefit for all pregnant patients, excluding multiple gestation, starting the 10th week of gestation, who elect as their sole option of screening for
   Trisomy 21, 18, & 13 in pregnancy.*
   *ACOG recommends that if a patient chooses NIPTs screening for aneuploidy, only one screening approach should be used. Therefore it is not recommended/covered to also undergo 1st trimester or 2nd trimester serum screening
   Codes:
   81420 Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21.
   81507 Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy.

Preauthorization is Required for:
NIPTs testing for:

• Trisomy screening and Sex Chromosomal Analysis (SCA)
• Trisomy screening , SCA, and microdeletions

Codes:
81422 Fetal chromosomal microdeletion(s) genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood
81479 Unlisted molecular pathology procedure

Will be considered when the recipient meets one or more of the following conditions:

• Fetal ultrasound findings for fetuses with ultrasound abnormalities, especially with either ultrasound structural or gonadal anomalies.
• The recipient must have pre and post-test genetic counseling with a Maternal Fetal Medicine (MFM) physician or certified genetic counselor.

WES will be considered for coverage when all of the criteria below are met, and confirmed with supporting medical documentation.
CPT 81415 – Whole exome sequencing may be considered medically necessary for the evaluation of unexplained congenital anomalies or neurodevelopmental disorders in children when all the following criteria are met:

1. Test is ordered by one of the following provider types, who has evaluated the patient and family history, and recommends and/or orders the test:
   1. Neurologist in collaboration with a medical geneticist or certified genetic counselor.
   2. Developmental pediatrician in collaboration with a medical geneticist or certified genetic counselor.
   3. Psychiatrist in collaboration with a medical geneticist or certified genetic counselor.
2. The patient has been evaluated by a board-certified clinician with expertise in
   clinical genetics and counseled about the potential risks of genetic testing. Pre- and post-test counseling is performed by an American Board of Medical Genetics or American Board of Genetic Counseling certified genetic counselor.
3. The patient and/or parents/legal guardians (if applicable) have been appropriately counseled about the testing by a qualified professional (same or similar to ordering providers) who is involved in the member’s care.
4. The patient has one of the following:
   1. Profound global developmental delay or intellectual disability.
   2.  Family history strongly suggests a genetic etiology, including consanguinity.
   3. Period of unexplained developmental regression (unrelated to autism or epilepsy).
5. Clinical presentation does not fit a well-described syndrome for which single-gene or targeted panel testing (e.g., comparative genomic hybridization/chromosomal microarray analysis) is available.
6. A genetic etiology is the most likely explanation for the phenotype or clinical scenario despite previous genetic testing (e.g., chromosomal microarray analysis and/or targeted single gene testing), OR when previous genetic testing has failed to yield a diagnosis and the affected individual is faced with invasive procedures or testing as the next diagnostic step (e.g., muscle biopsy).
   1. WES is more practical than the separate single gene tests or panels that would be recommended based on the differential diagnosis.
   2. WES results may preclude the need for multiple and/or invasive procedures.
7. No other causative circumstances (e.g. environmental exposures, injury, or infection) can explain the symptoms.
8. WES results have a reasonable potential to directly impact patient management and clinical outcome for the individual being tested

CPT 81416 – Comparator exome sequence analysis is considered medically necessary when the above criteria for WES (CPT 81415) have been met and WES is being performed concurrently or has been previously performed.

CPT 81417 – Whole exome reanalysis of previously obtained uninformative whole exome sequence is medically necessary when one of the following criteria is met:

1. There has been an onset of additional symptoms that broadens the phenotype assessed during the original exome evaluation.
2. There has been the birth or diagnosis of a similarly affected first-degree relative that has expanded the clinical picture.

myChoice CDx® is a next-generation sequencing based assay that determines homologous recombination deficiency (HRD) status by the detection of “single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes and the determination of Genomic Instability Score
(GIS) which is an algorithmic measurement of Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.” The results of the assay are used to identify individuals with ovarian cancer who may be eligible for treatment with Niraparib (Zejula®) or Olaparib (Lynparza®).
Preauthorization is required.

myChoice Cdx will be considered for coverage when ALL of the criteria below are met, confirmed with supporting medical documentation:

1. Patient is 18 years old or older.
2. Patient has advanced epithelial ovarian cancer, fallopian tube or primary peritoneal cancer and ONE of the following:
   1. Treatment with Niraparib (Zejula), Olaparib (Lynparza), or other medication for which myChoice CDx is an FDA-approved companion diagnostic, is being considered.
   2. FDA label for the drug and indication being considered states companion diagnostic testing for HRD status is necessary for patient selection*.
   3. Has been treated with three or more lines of chemotherapy and are being considered for treatment with Niraparib (Zejula).
   4. Is in complete or partial response to two or more lines of platinum-based chemotherapy and is being considered for maintenance treatment with Niraparib (Zejula).
   5.  Is being considered for first line maintenance treatment with Olaparib (Lynparza) and Bevacimumab. **

*Not all indications for medications with an FDA-approved companion diagnostic test require the results of that test prior to prescribing. myChoice testing would not be considered medically necessary when prescribed for indications that do not require a companion diagnostic.
** In 2020, the FDA approved olaparib (Lynparza) in combination with bevacizumab (Avastatin) “for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.”

The Maryland Department of Health (MDH), Fee-for-Service Program, provides coverage for the following screening tests of average risk* for colon cancer in patients between 45 and 85 years
of age:

1. Stool-Based Test Frequency Fecal Occult Blood Test (FOBT) – once a year
2. Highly sensitive fecal immunochemical test (FIT) – once a year
3. Fecal Immunochemical Test (FIT-DNA) Cologuard – testing option every three years
4. Visualization Tests Colonoscopy – every 10 years or Flexible Sigmoidoscopy – once every five years
5. Imaging Tests: CT colonography (virtual colonoscopy) – once every five years

Colon Cancer Screening – Coverage Updates:

1. Age: Coverage, will now include patients starting at age 45 until age 85. The decision to screen between ages 76 to 85 years should remain individualized and include a discussion on the risks and benefits based on comorbidity status and estimated life expectancy.
2. Cologuard Testing Option: Cologuard can now be considered, without prior authorization, as a screening tool for patients of average risk of colon cancer who meet the following criteria:
   1. Clinical Criteria:
      1. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.
      2. The recipient is between the ages of 45 and 85. The decision to screen between ages 76 to 85 years should be individualized and include a discussion on the risks and benefits based on comorbidity status and
         estimated life expectancy.
      3.  Eligibility for testing is once every three years.
      4. The recipient must be asymptomatic (no signs or symptoms of colorectal disease including, but not limited, to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical
         test).
      5.  The recipient must be at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative
         colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).
         2.1.6. The recipient must not have had a positive result from another colorectal cancer screening method within the last 6 months.

https://health.maryland.gov/mmcp/Documents/NIPTS%20Clinical%20Criteria.pdf

https://health.maryland.gov/mmcp/Documents/Whole%20Exome%20Clinical%20Criteria.pdf

https://www.mdcgc.org/mdlicensure

https://health.maryland.gov/mmcp/Documents/MY%20CHOICE%20CLINICAL%20CRITERIA.pdf

https://health.maryland.gov/mmcp/Documents/Whole%20Genome%20Clinical%20Criteria.pdf

https://health.maryland.gov/mmcp/Documents/Targeted%20Genomic%20Sequencing%20Clinical%20Criteria.pdf

https://health.maryland.gov/mmcp/Documents/Colon%20Cancer%20Screening%20Updates%202021%20.pdf

https://health.maryland.gov/mmcp/epsdt/Documents/FINAL%202022%20Healthy%20Kids%20Provider%20Manual_8.26.2022.pdf#search=durable%20medical%20equipment

https://health.maryland.gov/mmcp/communitysupport/Approved%20Items%20Lists/2021/2021%20August%20Fee%20Schedule.pdf

https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/state-laws-medical-foods-tab.pdf