Response to Comments: Pharmacogenomics Testing

A comment was received from a provider indicating that they have done hundreds of pharmacogenetic tests on multiple patients of different ages, races, different drug intolerance and different diagnoses.

These tests have been extremely accurate regarding patient side effect profiles. School of thought differ in efficacy and utilization of information. Testing should be used as a tool for more individualized treatment. It should only be utilized along with appropriate assessment and diagnoses, not as replacement for clinical assessment and judgment.

Thank you for the comment. We agree testing should not be used as a replacement for clinical assessment and judgment.

A comment was received from a certified genetic counselor and faculty member at the University of Maryland School of Medicine. As a certified genetic counselor with expertise in pharmacogenomics the commenter requests consideration in broadening the provider qualification language in the proposed LCD. The commenter would like the LCD to include certified genetic counselors (CGCs) as appropriate providers. While CGCs are not involved in the pharmacologic management of patients, they are important members of the care team. Genetic counselors are specifically trained to identify, coordinate, and interpret genetic testing, including pharmacogenomic testing. Given many physicians and pharmacists report limited knowledge, training and confidence in ordering and interpreting pharmacogenomic testing, broadening the proposed LCD language to allow CGCs to order pharmacogenomic testing will benefit patients and providers alike.

Thank you for the comment. Four PubMed PMID numbers were referenced with the comment without inclusion of full-text articles. Of the submitted PMID list: one concluded “Widespread integration of PGx testing will warrant continued education and point-of-care decisional support. Primary care providers may also benefit from consultation services or team-based care with laboratory medicine specialists, pharmacists, and genetic counselors”; another article discussed knowledge and attitudes on pharmacogenetics among pediatricians; another article discussed an electronic survey to medical schools with a 13.9% response rate, that concluded most respondents believe that physicians and other health care professionals today do not possess an appropriate level of knowledge in pharmacogenomics; however, few institutions report short-term plans to increase pharmacogenomics instruction; another article concluded, “Pharmacists lack confidence in their abilities to interpret and use pharmacogenomic information in clinical care.”

No evidence was submitted for improved patient outcomes based on the type of provider ordering a PGx test. Overall, the treating clinician who has the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and also to prescribe medications for the condition either independently, or in an arrangement as required by all the applicable state laws, is responsible for the patient’s care.

Finally, certified genetic counselors are not currently eligible under Medicare rules and regulations to: (1) receive a Medicare billing number and be granted Medicare billing privileges; or (2) enroll to solely order, certify, or refer the items or services described in the Code of Federal Regulations (CFR 42 Section 424.507). However, we agree healthcare teams, each contributing with their specific knowledge, working in collaboration have the potential to improve patient outcomes.

A comment was received requesting that the proposed LCD be revised to add genetic counselors to the list of providers qualified to order PGx testing. Genetic counselors work closely with providers and pharmacists. They have specialized training that prepares them to understand genetic testing methodology and current national guidelines related to PGx. Genetic counselors review the family/medical history, recommend appropriate PGx testing, evaluate PGx results and provide patient education/resources.

Thank you for the comment. Full-text articles were not included with the comment. Ordering clinicians should “have appropriate knowledge and expertise to counsel patients about heritable conditions, risks for disease, and implications for health management, and to interpret findings of individual genetic tests or collaborate with other health care professionals who can provide these services, such as licensed genetic counselors.” In this regard, an article was reviewed at: https://www.ama-assn.org/delivering-care/ethics/genetic-testing-counseling. Currently, certified genetic counselors are not recognized healthcare providers in the Medicare program, but they may be a part of a patient’s healthcare team working collaboratively with other providers. Regarding whom may order a test, this is limited by regulation. Per the CFR 42 Section 410.32, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary. Non physician practitioners that are enrolled in the program, who are operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit, are also considered for this purpose, as treating and managing a beneficiary’s specific medical problem.

A comment was received from the leaders of the Pharmacogenomics Initiative at MedStar Health. The commenters agree with the approach of using recognized expert resources, such as the United States Food and Drug Administration (FDA) and the Clinical Pharmacogenetics Implementation Consortium (CPIC), to guide the coverage of pharmacogenetic testing. This approach helps ensure coverage reflects the most up-to-date and clinically relevant evidence to help us improve the care of our patients.

The commenters requested clarification for the following statement in the related billing and coding article: “If a laboratory assays two or more genes in a patient in parallel, then those two or more genes will be considered part of the same panel. A panel constitutes a single procedural service, so one CPT code must be submitted for the panel. If the laboratory assays genes in serial, then the laboratory must submit claims for genes individually.” The statement appears to indicate that if 2 or more genes are tested at the same time in parallel then the lab could only bill for one gene. Is that correct?

The commenters indicated that if they have interpreted the language correctly then their recommendation would be that from a clinical perspective there are scenarios where parallel testing of multiple genes is necessary to inform an immediate clinical decision for a single prescribing decision. To illustrate this point, two clinical examples using drug-gene pairs that meet the LCD’s evidence requirements (CPIC Level A or B) are as follows:

• Clinical example 1 – CYP2D6 & CYP2C19 for antidepressants: CPIC guidelines provide recommendations for CYP2D6 and CYP2C19 for five SSRIs (i.e., CYP2C19 for citalopram, escitalopram, sertraline and CYP2D6 for fluvoxamine and paroxetine). Clinically, you would want to test both of these genes to aid the decision of which SSRI to select. The clinical context is that SSRIs are first line to treat depression and other conditions, but no specific agent stands alone as a true first line therapy (one reason why PGx is helpful here).
• Clinical example 2 – TPMT & NUDT15 for thiopurines: CPIC guidelines provide dosing recommendations for thiopurines based on both TPMT and NUDT15. The dose is affected by both of these genes and assessing only one gene would limit the accuracy of the test.

The commenters stated that if their interpretation of those sentences is correct then it may be best to 1) delete them (allow the LCD criteria to stand on a gene by gene basis) or 2) outline clinical scenarios where it is appropriate to test/bill multiple genes at once. Your clarification would be greatly appreciated.

Thank you for the comment. The intent was not to limit coding to one gene, however we recognize that panel testing with multiple genes is common. We recognize coding for panels among payors is not standardized and subject to various coding schemes. Accurate coding is important for reimbursement purposes. We have deleted statements regarding panel coding in the finalized billing and coding article and instead reference the Molecular Pathology and Genetic Testing Article A58918 for further up-to-date guidance for coding and billing of multi-gene tests. Also, in the absence of a CPT code that accurately describes the service being rendered, CPT code 81479 should be used.

A comment was received regarding the proposed LCD for Pharmacogenomics Testing from Mayo Clinic Florida. The commentor indicates that PGx testing is similar to cystic fibrosis (CFTR gene) testing; however, it is much more complex because it is used to identify variants in genes that encode enzymes involved in drug metabolism. Such variants may affect gene expression, enzyme activity and/or ligand (drug) affinity. In fact, one gene may encode an enzyme involved in the metabolism of numerous drugs. New variants are continually being discovered and multiplex panels are constantly being developed or improved upon.

The commentor noted their chief concern with the current proposed LCD is in the wording where it states, “PGx tests are considered germline testing, and therefore only allowed once per lifetime.” As mentioned, new variants are continually being discovered; therefore, multiplex panels are continually being updated or changed. There is considerable inconsistency in variant alleles tested for by the various assay manufacturers. This lack of consistency may require that a patient be retested by another gene panel or retested later in life when a gene is better characterized.

The commentor also indicated that poor payment for panel testing may create a barrier for patients to have it performed, and costs may be higher if only single genes are paid for and not panels. Add to this, the lack of understanding by many providers and other health professionals on how to properly order PGx testing, leading to patients requiring re-testing and work-up.

A “once per lifetime” approach (one and done) might be more applicable for next generation sequencing; however, even when using this platform, a patient’s raw data may need to be retained and reinterpreted as more information is gathered on newer variants that may be applicable to the patient. Rarely, a patient may even need to be resequenced if the original data did not include the entire sequence of relevant loci.

The commentor noted that another problem with the “one and done” approach in PGx testing, and other forms of molecular testing for that matter, is the lack of a central depository for PGx lab results. Many EMRs do not or cannot store patient PGx data and if patients are provided a hard copy, it can be lost, requiring re-testing and work-up if a patient presents to a different hospital system.

In summary, the commentor indicated that PGx is an ever-evolving science in which variant alleles that affect drug metabolism are continually being discovered. Such variants may be detected by single gene assays or multiplexed gene panels; however, inconsistencies exist in the variant alleles tested for, among the various assay manufacturers. Ordering clinicians may be unaware of these manufacturer differences, as well as any previous PGx testing performed on the same patient at another institution. Taken together, patient care will improve if patients are given the opportunity to be retested and reimbursed for PGx testing, if clinically warranted. Thank you in advance for your consideration of this request.

Thank you for your comment. Two full text published articles were included and one full text pre-proof article. We agree with the commentor, the intent was not to limit PGx testing as the language is interpreted, but rather to address duplicate germline testing. Any laboratory test that investigates the same germline genetic content, for the same genetic information, that has already been tested in the same Medicare beneficiary is not medically reasonable and necessary as it is duplicative. The germline sequence of an individual does not change over time, and therefore repeat testing of the same germline content for the same genetic information does not provide new clinical information. Germline testing, including panels containing some genetic content already tested in the same Medicare beneficiary, may be considered medically reasonable and necessary if there is established clinical utility in the remaining, non-duplicative genetic components of the test.

Comments were received from the Precision Medicine Program (PMP) at the University of Florida (UF) Health. The commentor indicated that the cost of PGx testing continues to be a major barrier for patients, especially in older and more economically disadvantaged individuals, including those who receive their care at UF Health. This is concerning given the potential for widening health care disparities. These groups are also more likely to be prescribed drugs with actionable genotypes for which PGx testing may be particularly beneficial. Therefore, they recommend the proposed LCD expand access to PGx testing for Medicare beneficiaries.

The commentor requests the following revisions for the proposed LCD:

1. Expand qualified providers to include those qualified either independently or in an arrangement as required by all applicable state laws.
   Many PGx specialists are pharmacists who are authorized to prescribe and order lab tests only under a collaborative practice agreement with authorized providers or institutions. Even within such institutions, limitations in types of test, timing of ordering, etc., may differ among different departments and practices. The seven other MAC jurisdictions with approved LCDs addressing PGx testing include such a statement.¹ We believe this addition would make pharmacogenomics more accessible to patients and streamline clinical workflows. Most importantly, it will encourage the multidisciplinary care required in robust pharmacogenetic implementation.

2. Edit the definition of “actionable use” to include the U.S. Food and Drug Administration (FDA) Table of Pharmacogenetic Associations.
   When “actionability” is explained in the Covered Indications section, it lists the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines,³ the FDA table of known gene-drug interactions, and the FDA labeling of a medication as references. While CPIC provides guidelines for clinically actionable gene-drug pairs, the recently created FDA Table of Pharmacogenetic Associations (available at: https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations) is also an invaluable resource.⁵ It can provide high-level insight to prescribers on medications with emerging gene-drug association data that may not yet be covered in clinical guidelines. Inclusion of this FDA table will minimize any inconsistencies in the policy that may lead to confusion as to what is considered actionable and therefore covered.
   
   
3. Specifically address non-duplicative additional testing
   By adding the following: “Germline testing, including using gene panels that contain some genetic content that has already been tested in the same Medicare beneficiary may be considered reasonable and necessary provided that there is established clinical utility present in the remaining, non-duplicative genetic components of the test.” Clarifying under what circumstances in which non-duplicative germline testing will be considered reasonable and necessary is important as new, clinically relevant variants are discovered and clinical recommendations evolve regularly based on growing evidence.²

We believe a clear LCD policy will eliminate any question of what PGx testing will be covered and when, making providers more confident when ordering testing for their patients. Uptake of appropriate testing and coverage of such tests will expand access to precision medicine for Medicare patients. We expect that this will allow for more informed prescribing and improve drug related outcomes, minimizing use of ineffective medication and/or avoidable toxicities, and eventually decreasing associated healthcare costs.

References

1. Cicali EJ, Elwood E, Elchynski A, Rattanasuwan T, Cook KJ, Alam B, Nguyen K, Elsey A, Cavallari LH, Johnson JA, Wiisanen K. The University of Florida Health Precision Medicine Program: a 10-Year Look Back. Clin Pharmacol Ther. 2021;109: S50. (PII-020). Virtual poster presentation at American Society of Clinical Pharmacology and Therapeutic 2021 Annual meeting. March 8-17, 2021.
2. Dalton, R, Brown, J, and Duarte, J. Patients with geographic barriers to health care access are prescribed a higher proportion of drugs with pharmacogenetic testing guidelines. Clin Transl Sci. 2021;00:1–12.
3. Clinical Pharmacogenetics Implementation Consortium. cpicpgx.org. Accessed July 22, 2021.
4. Centers for Medicare & Medicaid Services. Medicare Coverage Database. Accessed on 7/22/2021. Available through: https://www.cms.gov/medicare-coverage-database/new-search/search.aspx
5. Table of Pharmacogenetic Associations. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations. Accessed July 22, 2021.

Thank you for the comment. No full text articles were included. Each comment is addressed by number.

1. As noted in other responses to similar comments, collaborative work is encouraged. However, the ordering provider should be the qualified person who will treat the patient with the medications in question. In addition, the ordering provider of a PGx test is restricted to providers who have the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and also to prescribe medications (the provider must be able to do both) for the condition either independently or in an arrangement as required by all the applicable state laws. We believe this language is consistent with the language in the LCD and have added this additional clarification. In this regard, the following documents were reviewed:1). https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58157&ver=4&LCDId=38294&DocID=L38294 and 2) https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38294&DocID=L38294.
2. Thank you for the comment. We agree the FDA Table of Pharmacogenetic Associations is a valuable resource as this table is referenced in the related billing and coding article to list covered PGx tests. We have added the link to the term “actionable use”. The billing and coding article lists currently covered PGx tests and indications and will be updated on a routine basis.
3. Thank you for the comment. The intent was not to limit PGx testing as the language is interpreted, but rather to address duplicate germline testing. Clarification has been added to the finalized LCD and related Article.

Joint comments were received from the Association for Molecular Pathology (AMP) and the College of American Pathologists (CAP).

Covered Indications

The AMP and CAP support the covered indications outlined in this draft LCD. In particular, both groups appreciate that the Clinical Pharmacogenetic Implementation Consortium (CPIC) guidelines are directly referred to. The commenters note that utilization of CPIC guidelines will allow for modification as time goes on and for this coverage policy to evolve with the science. They encourage the continued utilization of pharmacogenomic-related clinical practice guidelines, such as those created by CPIC, in addition to the pharmacogenomic information included in FDA-labeling.¹

Coverage Limitations

The commenters disagree with the statement that “PGx tests are considered germline testing, and therefore only allowed once per lifetime.” Not all PGx tests are the same and the comprehensive nature of PGx tests will improve as the associated science and evidence improves over time, which may warrant an additional PGx test to be performed in some circumstances. Restricting PGx tests to “once per lifetime” will prevent providers and patients from having access to future, state of the art PGx tests, which may improve quality and cost-effectiveness of care. This coverage limitation will ultimately restrict coverage for patients for whom testing would be medically necessary. For example, AMP and CAP have recently published guidelines for minimum requirements for PGx testing.⁴ If a patient previously had testing that did not meet the minimum requirements for testing, the patient may need additional testing to ensure that they received appropriate testing. Additionally, current PGx tests are usually targeted variant testing. If the patient has had an adverse reaction to a medication, more comprehensive testing such as whole sequencing or duplication/deletion analysis may be warranted. Therefore, they recommend deletion of the requirement that PGX tests be allowed only once per lifetime.

Provider Qualifications

Both AMP and CAP have serious concerns as it pertains to the enforceability of the stated provider qualifications proposed in this draft policy. In many states, a PGx test can be ordered by a clinical provider that is not the treating clinician, such as pharmacists and genetic counselors. Restricting the ability to order PGx tests, to only treating clinicians, will lead to patient access issues. In many cases, genetic counselors and/or pharmacists are more, or as knowledgeable as to the actionability of the ordered test than the attending clinician. Given this, the commenters recommend that the term provider qualifications be broadened to include professionals other than solely the treating physician and recommend that the term “treating clinicians” be changed to “clinical provider”.

Coding Guidance

The commenters are concerned about the following language within the coding article that states:

“If a laboratory assays two or more genes in a patient in parallel, then those two or more genes will be considered part of the same panel. A panel constitutes a single procedural service, so one CPT code must be submitted for the panel.”

The commenters indicate that while this may be true in some cases, this is not always true. For example, when pursuing PGx testing to guide phenytoin therapy you need to examine both CYP2C9 and HLA-B; however, these two genes cannot typically be assayed together as one procedure. Independent interrogation of these genes each requires a different methodology. In this example, if a laboratory were to follow the guidance outlined in this article, they would only be able to submit reimbursement for one procedure. The commenters recommend deletion of these two sentences within the guidance.

As mentioned previously, AMP and CAP appreciate the reference to CPIC and FDA guidelines in this draft policy. Table 1 and Table 2 in the Billing and Coding Article includes a list of relevant gene/drug associations from CPIC and FDA sources, respectively. AMP and CAP strongly recommend restructuring Table 1 and Table 2 to show the drug in the first column and then list the corresponding genes in the second column. The FDA’s Table of Pharmacogenetic Associations,² is referenced, which is structured the way in which we recommend. To avoid confusion and ensure accurate gene/drug associations, the commenters ask that Table 1 and 2 in the Billing and Coding Article be revised in this way. Further, AMP and CAP recommend the following additions to Table 1 in the Billing and Coding Article:

• For the CFTR gene, the following CPT code(s) should be added: CPT code 81222³ – CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; duplication/deletion variants; and CPT code 81223 – CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; full gene sequence.
• For the CYP2C9 gene, the following CPT code(s) should be added: CPT code 81381⁴ - HLA Class I typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, B*57:01P), each.

Documentation Requirements

The draft policy includes the following documentation requirements:

- The order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patient’s medical record must reflect that the service billed was medically reasonable and necessary.

- If two or more single genes are tested, rather than a multi-gene panel, then the record must reflect that a clinician individually ordered each gene.

The commenters believe that the above listed documentation requirements will cause significant confusion, given that what CMS designates as a gene panel may not constitute an actual panel from a laboratory perspective. The commenters request that this language be deleted to prevent confusion amongst both the clinical provider and clinical laboratory personnel.

ICD-10 Coding

The commenters request that additional ICD-10 codes be added to this policy to include, but not be limited to the following list:

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.81 Schizophreniform disorder

F20.89 Other schizophrenia

F31.0 Bipolar disorder, current episode hypomanic

F31.11 Bipolar disorder, current episode manic without psychotic features, mild

F31.12 Bipolar disorder, current episode manic without psychotic features, moderate

F31.13 Bipolar disorder, current episode manic without psychotic features, severe

F31.2 Bipolar disorder, current episode manic severe with psychotic features

F31.31 Bipolar disorder, current episode depressed, mild

F31.32 Bipolar disorder, current episode depressed, moderate

F31.4 Bipolar disorder, current episode depressed, severe, without psychotic features

F31.5 Bipolar disorder, current episode depressed, severe, with psychotic features

F31.61 Bipolar disorder, current episode mixed, mild

F31.62 Bipolar disorder, current episode mixed, moderate

F31.63 Bipolar disorder, current episode mixed, severe, without psychotic features

F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features

F31.71 Bipolar disorder, in partial remission, most recent episode hypomanic

F31.73 Bipolar disorder, in partial remission, most recent episode manic

F31.75 Bipolar disorder, in partial remission, most recent episode depressed

F31.77 Bipolar disorder, in partial remission, most recent episode mixed

F32.1 Major depressive disorder, single episode, moderate

F32.2 Major depressive disorder, single episode, severe without psychotic features

F32.3 Major depressive disorder, single episode, severe with psychotic features

F32.4 Major depressive disorder, single episode, in partial remission

F33.1 Major depressive disorder, recurrent, moderate

F33.2 Major depressive disorder, recurrent severe without psychotic features

F33.3 Major depressive disorder, recurrent, severe with psychotic symptoms

F33.41 Major depressive disorder, recurrent, in partial remission

F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type

F90.1 Attention-deficit hyperactivity disorder, predominantly hyperactive type

F90.2 Attention-deficit hyperactivity disorder, combined type

Z94.2 Lung transplant status

Z94.3 Heart and lungs transplant status

Z94.81 Bone marrow transplant status

Z94.82 Intestine transplant status

Z94.83 Pancreas transplant status

Z94.84 Stem cells transplant status

¹ https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling

² https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations

³ https://cpicpgx.org/guidelines/guideline-for-ivacaftor-and-cftr/

⁴ https://www.jmdjournal.org/article/S1525-1578(18)30594-4/fulltext

Thank you again for the opportunity to review and comment on this proposed policy.

(Responses are numbered to correspond to the comment topics)

1. Covered Indications.

Thank you for the comment. As the commenters suggest, the intent is for coverage to evolve as the science evolves.

2. Coverage Limitations.

Thank you for the comment. The intent was not to limit PGx testing as the language is interpreted, but rather to address duplicate germline testing. We have added clarification in the finalized LCD and Article.

3. Provider Qualifications.

Thank you for the comment. Several similar comments were received. As noted in other responses to similar comments, collaborative work is encouraged. The ordering provider should be the qualified person who will treat the patient with the medications in question. In addition, the ordering provider of a PGx test is restricted to providers who have the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and also to prescribe medications (the provider must be able to do both) for the condition either independently or in an arrangement as required by all the applicable state laws. We believe this language is consistent with the language in the LCD and have added this additional clarification. In addition, ordering clinicians should “have appropriate knowledge and expertise to counsel patients about heritable conditions, risks for disease, and implications for health management, and to interpret findings of individual genetic tests or collaborate with other health care professionals who can provide these services, such as licensed genetic counselors.” In this regard, an article was reviewed at: https://www.ama-assn.org/delivering-care/ethics/genetic-testing-counseling. Currently, certified genetic counselors are not recognized healthcare providers in the Medicare program, but they may be a part of a patient’s healthcare team working collaboratively with other providers.

4. Coding Guidance

Thank you for the comment. a) We agree these statements may cause confusion and have removed the statements. Coding for multi gene tests is addressed in the Molecular Pathology and Genetic Testing Article  A58918. b) We decline to list the drug in the first column and the gene in the second column. We believe the current table, which includes a column for both generic and brand drug names, is sufficient for clinical providers. c) We note that CPT 81220 CFTR gene analysis is listed as common variants; 81222 as duplication/deletion variants; 81223 as full gene sequence. The CPIC guideline May 2019 update includes 38 total variants with variant details whereas the CPT codes do not include these details. We decline to add these additional codes to the related coding and billing article, however consideration may be given on an individual basis with evidence. In addition, we note CPT code 81381 – HLA Class I typing, high resolution (i.e., alleles or allele groups); one allele or allele group (e.g., B*57:01P), each, is already in the list.

5. Documentation Requirements

Thank you for the comment. We agree this language may cause confusion and have removed it. Coding for multi-gene tests is addressed in the Molecular Pathology and Genetic Testing Article A58918 .

6. ICD-10 Coding

The code list will be reviewed and added to as appropriate. ICD-10-CM Codes Z94.X and Z94.XX will not be added as transplant services are bundled in Part A.