Nevada § 422.272364 - State Plan for Medicaid: Inclusion of requirement for payment of certain costs for biomarker testing

§ 422.272364. State Plan for Medicaid: Inclusion of requirement for payment of certain costs for biomarker testing

1. Subject to the limitations prescribed by subsection 4, the Director shall include

in the State Plan for Medicaid a requirement that the State pay the nonfederal share

of expenditures incurred for medically necessary biomarker testing for the diagnosis,

treatment, appropriate management and ongoing monitoring of cancer when such biomarker

testing is supported by medical and scientific evidence. Such evidence includes, without limitation: (a) The labeled indications for a biomarker test or medication that has been approved

or cleared by the United States Food and Drug Administration; (b) The indicated tests for a drug that has been approved by the United States Food

and Drug Administration or the warnings and precautions included on the label of such

a drug; (c) A national coverage determination or local coverage determination, as those terms

are defined in 42 C.F.R. § 400.202 ; or (d) Nationally recognized clinical practice guidelines or consensus statements. 2. The Director shall: (a) Ensure that the coverage required by subsection 1 is provided in a manner that

limits disruptions in care and the need for multiple specimens; (b) Include in the State Plan for Medicaid a clear and readily accessible process

for a recipient of Medicaid or provider of health care to: (1) Request an exception to a policy excluding coverage for biomarker testing for

the diagnosis, treatment, management or ongoing monitoring of cancer; or (2) Appeal a denial of coverage for such biomarker testing; and (c) Make the process described in paragraph (b) available on an Internet website maintained

by the Department. 3. If the State Plan for Medicaid requires a recipient of Medicaid to obtain prior

authorization for a biomarker test described in subsection 1, the State Plan must

require a response to a request for such prior authorization: (a) Within 24 hours after receiving an urgent request; or (b) Within 72 hours after receiving any other request. 4. The provisions of this section do not require the State Plan for Medicaid to include

coverage of biomarker testing: (a) For screening purposes; (b) Conducted by a provider of health care for whom the biomarker testing is not within

his or her scope of practice, training and experience; or (c) That has not been determined to be medically necessary by a provider of health

care for whom such a determination is within his or her scope of practice, training

and experience. 5. As used in this section: (a) “ Biomarker ” means a characteristic that is objectively measured and evaluated as an indicator

of a normal biological process, a pathogenic process or a pharmacological response

to a specific therapeutic intervention and includes, without limitation: (1) An interaction between a gene and a drug that is being used by or considered for

use by the patient; (2) A mutation or characteristic of a gene; and (3) The expression of a protein. (b) “ Biomarker testing ” means the analysis of the tissue, blood or other biospecimen of a patient for the

presentation of a biomarker and includes, without limitation, single-analyte tests,

multiplex panel tests and whole genome, whole exome and whole transcriptome sequencing. (c) “ Consensus statement ” means a statement aimed at a specific clinical circumstance that is: (1) Made for the purpose of optimizing the outcomes of clinical care; (2) Made by an independent, multidisciplinary panel of experts that has established

a policy to avoid conflicts of interest; (3) Based on scientific evidence; and (4) Made using a transparent methodology and reporting procedure. (d) “ Medically necessary ” means health care services or products that a prudent provider of health care would

provide to a patient to prevent, diagnose or treat an illness, injury or disease,

or any symptoms thereof, that are necessary and: (1) Provided in accordance with generally accepted standards of medical practice; (2) Not primarily provided for the convenience of the patient or provider of health

care; and (3) Significant in guiding and informing the provider of health care in providing

the most appropriate course of treatment for the patient in order to prevent, delay

or lessen the magnitude of an adverse health outcome. (e) “ Nationally recognized clinical practice guidelines ” means evidence-based guidelines establishing standards of care that include, without

limitation, recommendations intended to optimize care of patients and are: (1) Informed by a systemic review of evidence and an assessment of the risks and benefits

of alternative options for care; and (2) Developed using a transparent methodology and reporting procedure by an independent

organization or society of medical professionals that has established a policy to

avoid conflicts of interest. (f) “ Provider of health care ” has the meaning ascribed to it in NRS 629.031 .