1
So in original. Probably means first par. (6).
2
So in original. Two subpars. (E) have been enacted.
3
So in original. Two pars. (6) have been enacted.
4
So in original. Probably should be followed by a period.
References in Text
Section 6052 of the SUPPORT for Patients and Communities Act, referred to in subsec. (c)(4)(D)(v)(I), is [section 6052 of title VI of Pub. L. 115–271], which is set out as a note under this section.
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsecs. (c)(5)(J) and (e)(2)(C), is [section 264(c) of Pub. L. 104–191], which is set out as a note under section 1320d–2 of this title.
Section 119 of the Medicare Improvements for Patients and Providers Act of 2008, referred to in subsec. (c)(5)(K)(ii), is [section 119 of Pub. L. 110–275], which is set out as a note under section 1395b–3 of this title.
Amendments
2022—Subsec. (a)(4)(B)(i). [Pub. L. 117–169, § 11201(e)(2)], substituted “for a year preceding 2025, the initial” for “the initial”.
Subsec. (b)(3)(I). [Pub. L. 117–169, § 11001(b)(1)(E)], added subpar. (I).
2020—Subsec. (b)(4). [Pub. L. 116–136] added par. (4).
Subsecs. (m), (n). [Pub. L. 116–260, § 119(a)(1)], redesignated subsec. (m), relating to program integrity transparency measures, as (n).
Subsec. (o). [Pub. L. 116–260, § 119(a)(2)], added subsec. (o).
2018—Subsec. (a)(1)(A). [Pub. L. 115–271, § 6102(1)], inserted “, subject to subparagraph (C),” before “including”.
Subsec. (a)(1)(B)(vi). [Pub. L. 115–271, § 6102(2)], added cl. (vi).
Subsec. (a)(1)(C). [Pub. L. 115–271, § 6102(3)], added subpar. (C).
Subsec. (c)(1)(F). [Pub. L. 115–271, § 2004(1)], added subpar. (F).
Subsec. (c)(2)(A)(ii). [Pub. L. 115–271, § 6064], substituted “are the following:” for “are part D eligible individuals who—” in introductory provisions, added subcls. (I) and (II), redesignated former subcls. (I) to (III) as items (aa) to (cc), respectively, of subcl. (I), and realigned margins.
Subsec. (c)(2)(B). [Pub. L. 115–271, § 6103(b)], struck out “may include elements that promote” after “program” in introductory provisions, added cls. (i) and (ii), redesignated former cls. (i) to (iii) as subcls. (I) to (III), respectively, of cl. (i), and realigned margins.
Subsec. (c)(4)(D). [Pub. L. 115–271, § 6065], added subpar. (D).
Subsec. (c)(5)(A). [Pub. L. 115–271, § 2004(2)], inserted “(and for plan years beginning on or after January 1, 2022, a PDP sponsor shall)” after “A PDP sponsor may”.
Subsec. (c)(5)(B)(ii)(III), (iii)(IV). [Pub. L. 115–271, § 2007(a)(1)], substituted “, including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution” for “and the option of an automatic escalation to external review”.
Subsec. (c)(5)(C)(i). [Pub. L. 115–271, § 2006(1)], substituted “Except as provided in clause (v), for purposes” for “For purposes”.
Subsec. (c)(5)(C)(v). [Pub. L. 115–271, § 2006(2)], added cl. (v).
Subsec. (c)(5)(E). [Pub. L. 115–271, § 2007(a)(2)], substituted “and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution.” for “and the option of an automatic escalation to external review to the extent provided by the Secretary.”
Subsec. (c)(6). [Pub. L. 115–123] added par. (6) relating to providing prescription drug plans with parts A and B claims data to promote the appropriate use of medications and improve health outcomes.
Subsec. (e)(2)(E). [Pub. L. 115–271, § 6062], added subpar. (E).
Subsec. (e)(7). [Pub. L. 115–271, § 2003(a)], added par. (7).
Subsec. (m). [Pub. L. 115–271, § 6063(c)], added subsec. (m) relating to program integrity transparency measures.
[Pub. L. 115–262] added subsec. (m) relating to prohibition on limiting certain information on drug prices.
2016—Subsec. (a)(1)(B)(v). [Pub. L. 114–198, § 704(a)(2)], added cl. (v).
Subsec. (c)(1)(E). [Pub. L. 114–198, § 704(b)(1)], added subpar. (E).
Subsec. (c)(5). [Pub. L. 114–198, § 704(a)(1)], added par. (5).
Subsec. (c)(6). [Pub. L. 114–198, § 704(b)(2)], added par. (6).
2015—Subsec. (c)(4). [Pub. L. 114–10] added par. (4).
2010—Subsec. (b)(3)(G). [Pub. L. 111–148, § 3307(a)], amended subpar. (G) generally. Prior to amendment, subpar. (G) related to required inclusion of drugs in certain categories and classes.
Subsec. (b)(3)(H). [Pub. L. 111–148, § 3312(a)], added subpar. (H).
Subsec. (c)(2)(C) to (G). [Pub. L. 111–148, § 10328(a)], added subpars. (C) to (E) and redesignated former subpars. (C) to(E) as (E) to (G), respectively.
Subsec. (c)(3). [Pub. L. 111–148, § 3310(a)], added par. (3).
2008—Subsec. (b)(3)(C)(i). [Pub. L. 110–275, § 176(1)], substituted “Subject to subparagraph (G), the formulary” for “The formulary”.
Subsec. (b)(3)(G). [Pub. L. 110–275, § 176(2)], added subpar. (G).
Subsec. (l). [Pub. L. 110–275, § 103(a)(2)], added subsec. (l).
Subsec. (l)(2). [Pub. L. 110–275, § 103(b)(2)], added par. (2).
Subsec. (l)(3). [Pub. L. 110–275, § 103(c)(2)], added par. (3).
Subsec. (l)(4). [Pub. L. 110–275, § 103(d)(2)], added par. (4).
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
[Pub. L. 115–271, title II, § 2003(b)], Oct. 24, 2018, [132 Stat. 3928], provided that: “The amendment made by subsection (a) [amending this section] shall apply to coverage of drugs prescribed on or after January 1, 2021.”
[Pub. L. 115–271, title II, § 2007(b)], Oct. 24, 2018, [132 Stat. 3931], provided that: “The amendments made by subsection (a) [amending this section] shall apply beginning not later [than] January 1, 2021.”
[Pub. L. 115–262, § 2(b)], Oct. 10, 2018, [132 Stat. 3671], provided that: “The amendment made by subsection (a) [amending this section] shall apply to plan years beginning on or after January 1, 2020.”
Effective Date of 2016 Amendment
Amendment by [Pub. L. 114–198] applicable to prescription drug plans (and MA–PD plans) for plan years beginning on or after Jan. 1, 2019, see [section 704(g)(1) of Pub. L. 114–198], set out as a note under section 1395w–101 of this title.
Effective Date of 2010 Amendment
[Pub. L. 111–148, title III, § 3307(b)], Mar. 23, 2010, [124 Stat. 472], provided that: “The amendments made by this section [amending this section] shall apply to plan year 2011 and subsequent plan years.”
[Pub. L. 111–148, title III, § 3310(b)], Mar. 23, 2010, [124 Stat. 475], provided that: “The amendment made by subsection (a) [amending this section] shall apply to plan years beginning on or after January 1, 2012.”
[Pub. L. 111–148, title III, § 3312(b)], Mar. 23, 2010, [124 Stat. 476], provided that: “The amendment made by subsection (a) [amending this section] shall apply to exceptions and appeals on or after January 1, 2012.”
Effective Date of 2008 Amendment
Amendment by [section 103(a)(2) of Pub. L. 110–275] applicable to plan years beginning on or after Jan. 1, 2009, see [section 103(a)(3) of Pub. L. 110–275], set out as a note under section 1395w–21 of this title.
Amendment by [section 103(b)(2) of Pub. L. 110–275] effective on a date specified by the Secretary (but in no case later than Nov. 15, 2008), see [section 103(b)(3) of Pub. L. 110–275], set out as a note under section 1395w–21 of this title.
Amendment by [section 103(d)(2) of Pub. L. 110–275] applicable to plan years beginning on or after Jan. 1, 2009, see [section 103(d)(3) of Pub. L. 110–275], set out as a note under section 1395w–21 of this title.
Rule of Construction
[Pub. L. 111–148, title X, § 10328(b)], Mar. 23, 2010, [124 Stat. 965], provided that: “Nothing in this section [amending this section] shall limit the authority of the Secretary of Health and Human Services to modify or broaden requirements for a medication therapy management program under part D of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq.] or to study new models for medication therapy management through the Center for Medicare and Medicaid Innovation under section 1115A of such Act [42 U.S.C. 1315a], as added by section 3021 [of [Pub. L. 111–148]].”
Implementation of 2020 Amendment
[Pub. L. 116–136, div. A, title III, § 3714(b)], Mar. 27, 2020, [134 Stat. 424], provided that: “Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendment made by this section [amending this section] by program instruction or otherwise.”
Update of Biometric Component of Multifactor Authentication
[Pub. L. 115–271, title II, § 2003(c)], Oct. 24, 2018, [132 Stat. 3928], provided that: “Not later than 1 year after the date of enactment of this Act [Oct. 24, 2018], the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances.”
Grants To Provide Technical Assistance to Outlier Prescribers of Opioids
[Pub. L. 115–271, title VI, § 6052], Oct. 24, 2018, [132 Stat. 3985], provided that:“(a)
Grants Authorized.—
The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b).
“(b)
Use of Funds.—
Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance—
“(1)
to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids;
“(2)
to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and
“(3)
to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids.
“(c)
Application.—
Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require.
“(d)
Geographic Distribution.—
In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State.
“(e)
Definitions.—
In this section:
“(1)
Eligible entity.—
The term ‘eligible entity’ means—
“(A)
an organization—
“(i)
that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and
“(ii)
that has at least—
“(I)
one individual who is a representative of consumers on its governing body; and
“(II)
one individual who is a representative of health care providers on its governing body; or
“(B)
an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act (
42 U.S.C. 1320c et seq.).
“(2)
Outlier prescriber of opioids.—
The term ‘outlier prescriber of opioids’ means, with respect to a period, a prescriber identified by the Secretary under subparagraph (D)(ii) of section 1860D–4(c)(4) of the Social Security Act (
42 U.S.C. 1395w–104(c)(4)), as added by section 6065 of this Act, to be an outlier prescriber of opioids for such period.
“(3)
Prescribers.—
The term ‘prescriber’ means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices.
“(f)
Funding.—
For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (
42 U.S.C. 1395t), to remain available until expended.”
Grants to Physicians To Implement Electronic Prescription Drug Programs
[Pub. L. 108–173, title I, § 108], Dec. 8, 2003, [117 Stat. 2172], provided that:“(a)
In General.—
The Secretary [of Health and Human Services] is authorized to make grants to physicians for the purpose of assisting such physicians to implement electronic prescription drug programs that comply with the standards promulgated or modified under section 1860D–4(e) of the Social Security Act [
42 U.S.C. 1395w–104(e)], as inserted by section 101(a).
“(b)
Awarding of Grants.—
“(1)
Application.—
No grant may be made under this section except pursuant to a grant application that is submitted and approved in a time, manner, and form specified by the Secretary.
“(2)
Considerations and preferences.—
In awarding grants under this section, the Secretary shall—
“(A)
give special consideration to physicians who serve a disproportionate number of medicare patients; and
“(B)
give preference to physicians who serve a rural or underserved area.
“(3)
Limitation on grants.—
Only 1 grant may be awarded under this section with respect to any physician or group practice of physicians.
“(c)
Terms and Conditions.—
“(1)
In general.—
Grants under this section shall be made under such terms and conditions as the Secretary specifies consistent with this section.
“(2)
Use of grant funds.—
Funds provided under grants under this section may be used for any of the following:
“(A)
For purchasing, leasing, and installing computer software and hardware, including handheld computer technologies.
“(B)
Making upgrades and other improvements to existing computer software and hardware to enable e-prescribing.
“(C)
Providing education and training to eligible physician staff on the use of technology to implement the electronic transmission of prescription and patient information.
“(3)
Provision of information.—
As a condition for the awarding of a grant under this section, an applicant shall provide to the Secretary such information as the Secretary may require in order to—
“(A)
evaluate the project for which the grant is made; and
“(B)
ensure that funding provided under the grant is expended only for the purposes for which it is made.
“(4)
Audit.—
The Secretary shall conduct appropriate audits of grants under this section.
“(5)
Matching requirement.—
The applicant for a grant under this section shall agree, with respect to the costs to be incurred by the applicant in implementing an electronic prescription drug program, to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 50 percent of such costs. Non-Federal contributions under the previous sentence may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions.
“(d)
Authorization of Appropriations.—
There are authorized to be appropriated to carry out this section $50,000,000 for fiscal year 2007 and such sums as may be necessary for each of fiscal years 2008 and 2009.”