Requiring coverage of Alzheimer’s biomarker testing under group health plans, group and individual health insurance coverage, and the Medicaid program

(a)

Private insurance

(1)

In general

Part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following new section:

2730.

Required coverage of Alzheimer’s biomarker testing

(a)

In general

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall provide benefits under such plan or coverage for Alzherimer’s biomarker testing. (b)

Manner of coverage

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall ensure that, with respect to testing for which benefits are required to be provided under such plan or coverage under subsection (a)— (1)the financial requirements applicable to such testing are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan or coverage and there are no separate cost-sharing requirements that are applicable only with respect to such testing; (2)the treatment limitations applicable to such testing are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan or coverage and there are no separate treatment limitations that are applicable only with respect to such testing; (3)in the case such plan or coverage imposes any prior authorization requirement with respect to such testing, the plan or coverage makes a determination with respect to a request for such authorization not later than 72 hours (or 24 hours, in the case the provider submitting such request attests that delay of such testing beyond 24 hours would place an individual’s life or health at serious risk) after receiving such request; (4)in the case such plan or coverage fails to make a determination with respect to a prior authorization request for such testing in accordance with paragraph (3), the plan or coverage treats such request as having been approved; (5)the plan or coverage does not apply any step therapy requirement prior to providing benefits for such testing; and (6)such benefits are provided in a manner that promotes equitable access, including for rural and underserved populations, and supports the use of minimally invasive testing where clinically appropriate. (c)

Alzheimer’s biomarker testing defined

(1)

In general

For purposes of this section, the term Alzheimer’s biomarker testing means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker, including single-analyte tests, multiplex panel tests, protein expression, and whole genome, whole exome, and whole transcriptome sequencing, furnished for a purpose specified in paragraph (2)— (A)in accordance with any Food and Drug Administration labeling indication; (B)to determine eligibility for, or to manage treatment of Alzheimer’s disease with, a drug approved by the Food and Drug Administration; (C)in accordance with any national coverage determination under title XVIII of the Social Security Act; or (D)in accordance with applicable clinical practice guidelines or consensus statements relating to the diagnosis of, treatment selection for, management of, or monitoring of Alzheimer’s disease. (2)

Purposes specified

For purposes of paragraph (1), the purposes specified in this paragraph are the early detection, risk stratification, diagnosis, treatment, appropriate management, or ongoing monitoring of Alzheimer’s disease. (3)

Additional definitions

For purposes of paragraph (1): (A)

Biomarker

The term biomarker means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including gene-drug interactions. (B)

Consensus statement

The term consensus statement means statements developed by an independent, multidisciplinary panel of experts that uses a transparent methodology and reporting structure and include a conflict-of-interest policy. (C)

Clinical practice guideline

The term clinical practice guideline means an evidence-based guideline developed by an independent organization or medical professional society that uses a transparent methodology and reporting structure and includes a conflict-of-interest policy.

(2)

Effective date

The amendment made by this subsection shall apply with respect to plan years beginning on or after the date that is 1 year after the date of the enactment of this Act. (b)

Medicaid

(1)

Inclusion as medical assistance

Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended— (A)in paragraph (31), by striking and at the end; (B)by redesignating paragraph (32) as paragraph (33); and (C)by inserting after paragraph (31) the following new paragraph:

(32)biomarker testing (as defined in section 2730(c) of the Public Health Service Act); and

(2)

Mandatory coverage

Section 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 1395a(a)(10)(A)) is amended, in the matter preceding clause (i), by striking and (30) and inserting (30), and (32). (3)

Manner of coverage

Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended— (A)in paragraph (89), by striking and at the end; (B)in paragraph (90), by striking the period at the end and inserting ; and; and (C)by inserting after paragraph (90) the following new paragraph:

(91)provide, in the case of biomarker testing (as defined in subsection (c) of section 2730 of the Public Health Service Act), for coverage of such testing in the same manner as such testing is required to be covered by a group health plan or health insurance issuer offering group or individual health insurance coverage under subsection (b) of such section.

(4)

Effective date

The amendments made by this subsection shall apply with respect to calendar quarters beginning on or after the date that is 1 year after the date of the enactment of this Act. (c)

Report

Not later than 1 year after the date of the enactment of this Act, and on an annual basis for the 2 succeeding years, the Director of the National Institutes of Health shall, through contract with the National Academies of Sciences, Engineering, and Medicine, conduct a study and submit to Congress a report on the value of biomarker testing in detecting and treating Alzheimer’s disease.