US Codex
Pub. L.
Notes

Title IV — Offsets

115th Congress · Approved Oct 24, 2018 · 132 Stat. 3894

TITLE IV Offsets

SEC. 4001. Promoting Value in Medicaid Managed Care.

Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by sections 1013 and 1016, is further amended by adding at the end the following new paragraph:

“(9)

(A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y).

“(B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State—

“(i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing—

“(I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or

“(II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and

“(ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio.

“(C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent.

“(D) For purposes of this paragraph:

“(i) The term ‘managed care entity’ means a medicaid managed care organization described in section 1932(a)(1)(B)(i).

“(ii) The term ‘minimum medical loss ratio’ means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan).

“(iii) The term ‘other specified entity’ means—

“(I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and

“(II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation).”

SEC. 4002. Requiring Reporting by Group Health Plans of Prescription Drug Coverage Information for Purposes of Identifying Primary Payer Situations under the Medicare Program.

Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42 U.S.C. 1395y(b)(7)(A)) is amended to read as follows:

“(i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been—

“(I) a primary plan to the program under this title; or

“(II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and”

SEC. 4003. Additional Religious Exemption from Health Coverage Responsibility Requirement.

(a)
In General.— Section 5000A(d)(2)(A) of the Internal Revenue Code of 1986 is amended to read as follows:

“(A) Religious conscience exemptions.—

“(i) In general.—Such term shall not include any individual for any month if such individual has in effect an exemption under section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act which certifies that—

“(I) such individual is a member of a recognized religious sect or division thereof which is described in section 1402(g)(1), and is adherent of established tenets or teachings of such sect or division as described in such section; or

“(II) such individual is a member of a religious sect or division thereof which is not described in section 1402(g)(1), who relies solely on a religious method of healing, and for whom the acceptance of medical health services would be inconsistent with the religious beliefs of the individual.

“(ii) Special rules.—

“(I) Medical health services defined.—For purposes of this subparagraph, the term ‘medical health services’ does not include routine dental, vision and hearing services, midwifery services, vaccinations, necessary medical services provided to children, services required by law or by a third party, and such other services as the Secretary of Health and Human Services may provide in implementing section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act.

“(II) Attestation required.—Clause (i)(II) shall apply to an individual for months in a taxable year only if the information provided by the individual under section 1411(b)(5)(A) of such Act includes an attestation that the individual has not received medical health services during the preceding taxable year.”

(b)
Effective Date.— The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2018.
(c)
Construction.— Nothing in the amendment made by subsection (a) shall preempt any State law requiring the provision of medical treatment for children, especially those who are seriously ill.

SEC. 4004. Modernizing the Reporting of Biological and Biosimilar Products.

Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) is amended—
(1)
in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act—
(A)
in the paragraph (3) inserted by such section 3(1), by striking “ an application” and inserting “ a biosimilar biological product application”;
(B)
in the paragraph (4) inserted by such section 3(1), by inserting “ application” before “ under section 351(k) of the Public Health Service Act”;
(C)
in the paragraph (5) inserted by such section 3(1), by striking “ for licensure of a biological product under section 351(k) of the Public Health Service Act” and inserting “ under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product”;
(D)
in paragraph (7), as redesignated and amended by such section 3(1), by striking “ or under section 351(a) of the Public Health Service Act” and inserting “ or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act”; and
(E)
in the paragraph (12) added by such section 3(1), by striking “ means a brand name drug for which a license is in effect under section 351(a)” and inserting “ has the meaning given such term in section 351(i)”; and
(2)
in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act—
(A)
in subsection (a)—
(i)
in paragraph (1), by striking “ for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided”;
(ii)
in paragraph (2)—
(I)
in subparagraph (C)(i), by striking “ brand name” and inserting “ listed”; and
(II)
by amending clause (ii) of subparagraph (C) to read as follows:

“(ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product.”

(B)
in subsection (b)—
(i)
in the subsection heading, by inserting “ or Biosimilar Biological Product Applicant” after “ Applicant”;
(ii)
in paragraph (1)(B), by striking the first sentence and inserting the following: “ A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c).”; and
(iii)
in paragraph (2)—
(I)
by striking “ 2 generic drug applicants” and inserting “ 2 or more generic drug applicants”; and
(II)
by striking “ or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned” and inserting “ , an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product”; and
(C)
in subsection (c)(2), by inserting “ were entered into within 30 days of,” after “ condition for,”.