I 116th CONGRESS 1st Session H. R. 5438 IN THE HOUSE OF REPRESENTATIVES December 16, 2019 Mr. Cox of California (for himself, Mr. Harder of California , Mr. Costa , Mr. Gallego , Mr. O'Halleran , Mrs. Kirkpatrick , Mr. Panetta , and Mr. Grijalva ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to award grants to develop programs to increase health care providers’ awareness of Valley fever, and for other purposes.

1. Short title This Act may be cited as the End Valley Fever Now Act . 2. Grants to develop programs to increase health care providers’ awareness of Valley fever Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following: 399V–7. Grants to develop programs to increase health care providers’ awareness of Valley fever (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration and in consultation with the Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to eligible entities to establish and carry out programs— (1) to increase health care providers’ awareness of Valley fever; and (2) to educate and train health care providers on the diagnosis and treatment of Valley fever. (b) Use of funds An eligible entity selected to receive a grant or contract under this section shall use amounts awarded under such a grant or contract to provide innovative supportive activities (which may include activities that do not rely on the use of broadband services) to enhance education through distance learning, continuing educational activities, collaborative conferences, and electronic and telelearning activities. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section $1,000,000 for the period of fiscal years 2021 through 2023, to remain available until expended. (d) Condition A recipient of a grant under this section shall, as a condition on receipt of the grant, agree to develop curricula for the purposes specified in subsection (a) in coordination with local providers at hospitals and clinics. (e) Definitions In this section: (1) The term eligible entity means— (A) a State department of health (or similar State authority); (B) an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )), including a medical school or continuing medical education program at such institution; (C) an entity operating a graduate medical residency training program under section 340E or under section 340H; or (D) a teaching hospital (as defined in section 415.152 of title 42, Code of Federal Regulations) that has physicians and other medical providers with specialized knowledge in diagnosing and treating Valley fever. (2) The term Valley fever means the condition caused by Coccidioidomycosis. . 3. Study comparing different case definitions used to identify valley fever (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention shall conduct a study comparing different case definitions used to identify valley fever. Such study shall include the efficacy of the methods being used to establish such case definitions and the cost effectiveness of such methods, including using the case definition for valley fever established by the Council of State and Territorial Epidemiologist. (b) Valley fever defined In this Act, the term Valley fever has the meaning given the term in section 399V–7 of the Public Health Service Act. 4. Allowing States to provide coverage under the Medicaid program for items and services furnished in connection with qualifying Valley fever clinical trials (a) In general Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (1) in paragraph (29), by striking and at the end; (2) by redesignating paragraph (30) as paragraph (31); and (3) by inserting after paragraph (29) the following new paragraph: (30) items and services furnished in connection with participation in a qualifying Valley fever clinical trial (as defined in section 2709A(b)(4) of the Public Health Service Act), including travel and incidental expenses, regardless of whether such items and services are furnished by a participating provider under the Medicaid program (other than a provider excluded from participation in such program under section 1128) or whether such items and services are furnished in another State; and . (b) Reduction in FMAP for States that do not provide coverage Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended— (1) in subsection (b), by striking and (ff) and inserting (ff), and (gg) ; and (2) by adding at the end the following new subsection: (gg) Reduction in FMAP for States that do not provide coverage for certain items and services With respect to a calendar quarter beginning on or after January 1, 2021, the Federal medical assistance percentage otherwise determined under subsection (b) for a State that does not provide coverage for items and services described in subsection (a)(30) that are furnished during such quarter shall be reduced by 5 percentage points. . (c) Ensuring access for Medicaid expansion population Section 1937(b)(5) of such Act is amended by inserting before the period at the end the following: , and beginning January 1, 2021, coverage of items and services described in section 1905(a)(30) . (d) Prohibition on imposition of costsharing requirements Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended— (1) in section 1916(a)(2)— (A) in subparagraph (D), by striking or at the end; (B) in subparagraph (E), by striking ; and at the end and inserting , or ; and (C) by adding at the end the following new subparagraph: (F) items and services described in section 1905(a)(30); and ; and (2) in section 1916A(b)(3)(B), by adding at the end the following new clause: (xi) Items and services described in section 1905(a)(30). . (e) Continuous coverage for individuals who lose Medicaid eligibility based on income Section 1902(e) of the Social Security Act ( 42 U.S.C. 1396a(e) ) is amended by adding at the end the following new paragraph: (16) Continuous coverage for items and services furnished in connection with qualifying Valley fever clinical trials In the case of an individual who is eligible for medical assistance under the State plan (or a waiver of such plan) based on the application of modified adjusted gross income under paragraph (14)(A), who while so eligible is furnished items and services described in section 1905(a)(30) in connection with participation in a qualifying Valley fever clinical trial (as defined in section 2709A(b)(4) of the Public Health Service Act), and who while so furnished such items and services loses eligibility for such medical assistance due to a change in income of the family of which such individual is a member, such individual shall be deemed to continue to be an individual eligible for such medical assistance, without regard to such change in income, only with respect to such items and services through the end of the month in which such qualifying Valley fever clinical trial ends. . (f) Effective date (1) In general The amendments made by this section shall apply with respect to items and services furnished, and eligibility determinations made, on or after January 1, 2021. (2) Exception for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. 5. Requirement for group health plans and health insurance issuers to provide coverage for items and services furnished in connection with qualifying Valley fever clinical trials (a) In general Subpart I of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg et seq.) is amended— (1) by redesignating the second section 2709 as section 2710; and (2) by inserting after the first section 2709 the following new section: 2709A. Coverage for individuals participating in qualifying Valley fever clinical trials (a) In general Notwithstanding section 2709, a group health plan or health insurance issuer offering group or individual health insurance coverage shall, with respect to an enrollee of such plan or coverage, respectively, provide coverage for any item or service furnished to such enrollee in connection with such enrollee’s participation in a qualifying Valley fever clinical trial, including travel and incidental expenses— (1) without regard to whether such item or service is furnished by a participating provider or participating facility with respect to such item or service; and (2) in a manner so that, if such item or service is furnished to such enrollee by a nonparticipating provider or nonparticipating facility, the cost-sharing requirement (expressed as a copayment amount or coinsurance rate) is not greater than the requirement that would apply if such item or service were furnished by a participating provider or participating facility. (b) Definitions In this section: (1) Nonparticipating facility; participating facility (A) Nonparticipating facility The term nonparticipating facility means, with respect to an item or service and a group health plan or group or individual health insurance coverage, a health care facility that does not have a contractual relationship with the sponsor of such plan or issuer of such coverage for furnishing such item or service under the plan or coverage. (B) Participating facility The term participating facility means, with respect to an item or service and a group health plan or group or individual health insurance coverage, a health care facility that has a contractual relationship with the sponsor of such plan or issuer of such coverage for furnishing such item or service under the plan or coverage. (2) Nonparticipating provider; participating provider (A) Nonparticipating provider The term nonparticipating provider means, with respect to an item or service and a group health plan or group or individual health insurance coverage, a physician or other health care provider who is acting within the scope of practice of that provider’s license or certification under applicable State law and who does not have a contractual relationship with the sponsor of such plan or issuer of such coverage for furnishing such item or service under the plan or coverage. (B) Participating provider The term participating provider means, with respect to an item or service and a group health plan or group or individual health insurance coverage, a physician or other health care provider who is acting within the scope of practice of that provider’s license or certification under applicable State law and who has a contractual relationship with the sponsor of such plan or issuer of such coverage for furnishing such item or service under the plan or coverage. (3) Qualifying Valley fever clinical trial (A) In general The term qualifying Valley fever clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of Valley fever (as defined in section 399V–7) and is described in any of the following clauses: (i) The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following: (I) The National Institutes of Health. (II) The Centers for Disease Control and Prevention. (III) The Agency for Healthcare Research and Quality. (IV) The Centers for Medicare & Medicaid Services. (V) A cooperative group or center of any of the entities described in subclauses (I) through (IV) or the Department of Defense or the Department of Veterans Affairs. (VI) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. (VII) Any of the following if the conditions described in subparagraph (B) are met: (aa) The Department of Veterans Affairs. (bb) The Department of Defense. (cc) The Department of Energy. (ii) The clinical trial is conducted under an investigational new drug application reviewed by the Food and Drug Administration. (iii) The clinical trial is a drug trial that is exempt from having such an investigational new drug application. (B) Conditions For purposes of subparagraph (A)(i)(VII), the conditions described in this subparagraph, with respect to a clinical trial approved or funded by an entity described in such subparagraph (A)(i)(VII), are that the clinical trial has been reviewed and approved through a system of peer review that the Secretary determines— (i) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health; and (ii) assures unbiased review of the highest scientific standards by qualified individuals with no interest in the outcome of the review. . (b) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2021. 6. Medicare coverage of items and services furnished in connection with qualifying Valley fever clinical trials (a) Coverage Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (GG), by striking and at the end; (2) in subparagraph (HH), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new subparagraph: (II) items and services furnished in connection with participation in a qualifying Valley fever clinical trial (as defined in section 2709A(b)(4) of the Public Health Service Act), including travel and incidental expenses; . (b) Payment Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (1) by striking and (CC) and inserting (CC) ; and (2) by inserting before the semicolon at the end the following: , and (DD) with respect to items and services described in section 1861(s)(2)(II), the amount paid shall be 100 percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848 .