---
kind: "section"
citation: "42 U.S.C. § 1395w–104"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1395w–104"
heading: "Beneficiary protections for qualified prescription drug coverage"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1395w-104"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XVIII — Health Insurance for Aged and Disabled"
  - "Part D — Voluntary Prescription Drug Benefit Program"
  - "Subpart 1 — part d eligible individuals and prescription drug benefits"
---

# §1395w–104. Beneficiary protections for qualified prescription drug coverage

- (a) **Dissemination of information—**
  - (1) **General information—**
    - (A) **Application of MA information—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall disclose, in a clear, accurate, and standardized form to each enrollee with a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by the sponsor under this part at the time of enrollment and at least annually thereafter, the information described in [section 1395w–22(c)(1) of this title](/usc/42/1395w–22.md?p=c-1) relating to such plan, insofar as the [Secretary](/usc/42/1301.md?p=a-6) determines appropriate with respect to benefits provided under this part, and, subject to [subparagraph (C)](#a-1-C), [including](/usc/42/1301.md?p=b) the information described in [subparagraph (B)](#a-1-B).
    - (B) **Drug specific information—** The information described in this subparagraph is information concerning the following:
      - (i) Access to specific [covered part D drugs](/usc/42/1395w–151.md?p=a-2), [including](/usc/42/1301.md?p=b) access through pharmacy networks.
      - (ii) How any formulary ([including](/usc/42/1301.md?p=b) any tiered formulary structure) used by the sponsor functions, [including](/usc/42/1301.md?p=b) a description of how a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) may obtain information on the formulary consistent with [paragraph (3)](#a-3).
      - (iii) Beneficiary cost-sharing requirements and how a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) may obtain information on such requirements, [including](/usc/42/1301.md?p=b) tiered or other copayment level applicable to each [drug](/usc/42/11851.md?p=4) (or class of [drugs](/usc/42/11851.md?p=4)), consistent with [paragraph (3)](#a-3).
      - (iv) The medication therapy management program required under [subsection (c)](#c).
      - (v) The [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries under [subsection (c)(5)](#c-5).
      - (vi) For plan year 2021 and each subsequent plan year, subject to [subparagraph (C)](#a-1-C), with respect to the [treatment](/usc/42/11851.md?p=11) of pain—
        - (I) the risks associated with prolonged opioid use; and
        - (II) coverage of nonpharmacological therapies, devices, and nonopioid medications—
          - (aa) in the case of an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under part C, under such plan; and
          - (bb) in the case of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14), under such plan and under parts A and B.
    - (C) **Targeted provision of information—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) may, in lieu of disclosing the information described in [subparagraph (B)(vi)](#a-1-B-vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period.
  - (2) **Disclosure upon request of general coverage, utilization, and grievance information—** Upon request of a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) who is eligible to enroll in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14), the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering such plan shall provide information similar (as determined by the [Secretary](/usc/42/1301.md?p=a-6)) to the information described in subparagraphs (A), (B), and (C) of [section 1395w–22(c)(2) of this title](/usc/42/1395w–22.md?p=c-2) to such individual.
  - (3) **Provision of specific information—**
    - (A) **Response to beneficiary questions—** Each [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall have a mechanism for providing specific information on a timely basis to enrollees upon request. Such mechanism shall include access to information through the use of a toll-free telephone number and, upon request, the provision of such information in writing.
    - (B) **Availability of information on changes in formulary through the Internet—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall make available on a timely basis through an Internet website information on specific changes in the formulary under the plan ([including](/usc/42/1301.md?p=b) changes to tiered or preferred status of [covered part D drugs](/usc/42/1395w–151.md?p=a-2)).
  - (4) **Claims information—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) must furnish to each enrollee in a form easily understandable to such enrollees—
    - (A) an explanation of benefits (in accordance with [section 1395b–7(a) of this title](/usc/42/1395b–7.md?p=a) or in a comparable manner); and
    - (B) when prescription [drug](/usc/42/11851.md?p=4) benefits are provided under this part, a notice of the benefits in relation to—
      - (i) for a year preceding 2025, the [initial coverage limit](/usc/42/1395w–151.md?p=a-6) for the current year; and
      - (ii) the annual out-of-pocket threshold for the current year.

      Notices under [subparagraph (B)](#a-4-B) need not be provided more often than as specified by the [Secretary](/usc/42/1301.md?p=a-6) and notices under [subparagraph (B)(ii)](#a-4-B-ii) shall take into account the application of [section 1395w–102(b)(4)(C) of this title](/usc/42/1395w–102.md?p=b-4-C) to the extent practicable, as specified by the [Secretary](/usc/42/1301.md?p=a-6).

- (b) **Access to covered part D drugs—**
  - (1) **Assuring pharmacy access—**
    - (A) **In general—**
      - (i) **Participation of any willing pharmacy—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall permit any pharmacy that meets the [standard](/usc/42/1320d.md?p=7) contract terms and conditions under such plan to participate as a network pharmacy of such plan.
      - (ii) **Contract terms and conditions—**
        - (I) **In general—** Notwithstanding any other provision of law, for plan years beginning on or after January 1, 2029, in accordance with [clause (i)](#b-1-A-i), contract terms and conditions offered by such [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall be reasonable and relevant according to [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/1301.md?p=a-6) under [subclause (II)](#b-1-A-ii-II).
        - (II) **Standards—** Not later than the first Monday in April of 2028, the [Secretary](/usc/42/1301.md?p=a-6) shall establish [standards](/usc/42/1320d.md?p=7) for reasonable and relevant contract terms and conditions for purposes of this clause.
        - (III) **Request for information—** Not later than April 1, 2027, for purposes of establishing the [standards](/usc/42/1320d.md?p=7) under [subclause (II)](#b-1-A-ii-II), the [Secretary](/usc/42/1301.md?p=a-6) shall issue a request for information to seek input on trends in [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and network pharmacy contract terms and conditions, current [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and network pharmacy contracting [practices](/usc/42/17061.md?p=19), whether pharmacy reimbursement and dispensing fees paid by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) to network pharmacies sufficiently cover the ingredient and operational costs of such pharmacies, the use and application of pharmacy quality measures by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) for network pharmacies, [PDP sponsor](/usc/42/1395w–151.md?p=a-13) restrictions or limitations on the dispensing of [covered part D drugs](/usc/42/1395w–151.md?p=a-2) by network pharmacies (or any subsets of such pharmacies), [PDP sponsor](/usc/42/1395w–151.md?p=a-13) auditing [practices](/usc/42/17061.md?p=19) for network pharmacies, areas in current regulations or program guidance related to contracting between [prescription drug plans](/usc/42/1395w–151.md?p=a-14) and network pharmacies requiring clarification or additional specificity, factors for consideration in determining the reasonableness and relevance of contract terms and conditions between [prescription drug plans](/usc/42/1395w–151.md?p=a-14) and network pharmacies, and other issues as determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6).
    - (B) **Discounts allowed for network pharmacies—** For [covered part D drugs](/usc/42/1395w–151.md?p=a-2) dispensed through in-network pharmacies, a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) may, notwithstanding [subparagraph (A)](#b-1-A), reduce coinsurance or copayments for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) enrolled in the plan below the level otherwise required. In no case shall such a reduction result in an increase in payments made by the [Secretary](/usc/42/1301.md?p=a-6) under [section 1395w–115 of this title](/usc/42/1395w–115.md) to a plan.
    - (C) **Convenient access for network pharmacies—**
      - (i) **In general—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall secure the participation in its network of a sufficient number of pharmacies that dispense (other than by mail order) [drugs](/usc/42/11851.md?p=4) directly to patients to ensure convenient access (consistent with rules established by the [Secretary](/usc/42/1301.md?p=a-6)).
      - (ii) **Application of TRICARE standards—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish rules for convenient access to in-network pharmacies under this subparagraph that are no less favorable to enrollees than the rules for convenient access to pharmacies included in the statement of work of solicitation (#MDA906–03–R–0002) of the Department of Defense under the TRICARE Retail Pharmacy (TRRx) as of March 13, 2003.
      - (iii) **Adequate emergency access—** Such rules shall include adequate emergency access for enrollees.
      - (iv) **Convenient access in long-term care facilities—** Such rules may include [standards](/usc/42/1320d.md?p=7) with respect to access for enrollees who are residing in [long-term care facilities](/usc/42/1397j.md?p=15) and for pharmacies operated by the [Indian](/usc/42/619.md?p=4-A) Health Service, [Indian tribes](/usc/42/619.md?p=4-A) and [tribal organizations](/usc/42/619.md?p=4-A), and urban [Indian](/usc/42/619.md?p=4-A) organizations (as defined in [section 1603 of title 25](/usc/25/1603.md)).
    - (D) **Level playing field—** Such a sponsor shall permit enrollees to receive benefits (which may include a 90-day supply of [drugs](/usc/42/11851.md?p=4) or biologicals) through a pharmacy (other than a mail order pharmacy), with any differential in charge paid by such enrollees.
    - (E) **Not required to accept insurance risk—** The terms and conditions under [subparagraph (A)](#b-1-A) may not require participating pharmacies to accept [insurance risk](/usc/42/1395w–151.md?p=a-7) as a condition of participation.
    - (F) **Enforcement of standards for reasonable and relevant contract terms and conditions—**
      - (i) **Allegation submission process—**
        - (I) **In general—** Not later than January 1, 2029, the [Secretary](/usc/42/1301.md?p=a-6) shall establish a process through which a pharmacy may submit to the [Secretary](/usc/42/1301.md?p=a-6) an allegation of a [violation](/usc/42/2000e–16a.md?p=c) by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) of the [standards](/usc/42/1320d.md?p=7) for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), or of subclause (VIII) of this clause.
        - (II) **Frequency of submission—**
          - (aa) **In general—** Except as provided in [item (bb)](#b-1-F-i-II-bb), the allegation submission process under this clause shall allow pharmacies to submit any allegations of [violations](/usc/42/2000e–16a.md?p=c) described in [subclause (I)](#b-1-F-i-I) not more frequently than once per plan year per contract between a pharmacy and a [PDP sponsor](/usc/42/1395w–151.md?p=a-13).
          - (bb) **Allegations relating to contract modifications—** In the case where a contract between a pharmacy and a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) is modified following the submission of allegations by a pharmacy with respect to such contract and plan year, the allegation submission process under this clause shall allow such pharmacy to submit an additional allegation related to those modifications with respect to such contract and plan year.
        - (III) **Access to relevant documents and materials—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) subject to an allegation under this clause—
          - (aa) shall provide documents or materials, as specified by the [Secretary](/usc/42/1301.md?p=a-6), [including](/usc/42/1301.md?p=b) contract offers made by such sponsor to such pharmacy or correspondence related to such offers, to the [Secretary](/usc/42/1301.md?p=a-6) at a time, and in a form and manner, specified by the [Secretary](/usc/42/1301.md?p=a-6); and
          - (bb) shall not prohibit or otherwise limit the ability of a pharmacy to submit such documents or materials to the [Secretary](/usc/42/1301.md?p=a-6) for the purpose of submitting an allegation or providing evidence for such an allegation under this clause.
        - (IV) **Standardized template—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish a standardized template for pharmacies to use for the submission of allegations described in [subclause (I)](#b-1-F-i-I). Such template shall require that the submission include a certification by the pharmacy that the information included is accurate, complete, and true to the best of the knowledge, information, and belief of such pharmacy.
        - (V) **Preventing frivolous allegations—** In the case where the [Secretary](/usc/42/1301.md?p=a-6) determines that a pharmacy has submitted frivolous allegations under this clause on a routine basis, the [Secretary](/usc/42/1301.md?p=a-6) may temporarily prohibit such pharmacy from using the allegation submission process under this clause, as determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6).
        - (VI) **Exemption from Freedom of Information Act—** Allegations submitted under this clause shall be exempt from disclosure under [section 552 of title 5](/usc/5/552.md).
        - (VII) **Rule of construction—** Nothing in this clause shall be construed as limiting the ability of a pharmacy to pursue other legal actions or remedies, consistent with applicable Federal or [State](/usc/42/619.md?p=5) law, with respect to a potential [violation](/usc/42/2000e–16a.md?p=c) of a requirement described in this subparagraph.
        - (VIII) **Anti-retaliation and anti-coercion—** Consistent with applicable Federal or [State](/usc/42/619.md?p=5) law, a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall not—
          - (aa) retaliate against a pharmacy for submitting any allegations under this clause; or
          - (bb) coerce, intimidate, threaten, or interfere with the ability of a pharmacy to submit any such allegations.
      - (ii) **Investigation—** The [Secretary](/usc/42/1301.md?p=a-6) shall investigate, as determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6), allegations submitted pursuant to [clause (i)](#b-1-F-i).
      - (iii) **Enforcement—**
        - (I) **In general—** In the case where the [Secretary](/usc/42/1301.md?p=a-6) determines that a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) has violated the [standards](/usc/42/1320d.md?p=7) for reasonable and relevant contract terms and conditions under [subparagraph (A)(ii)](#b-1-A-ii) or the provisions of clause (i)(VIII) of this subparagraph, the [Secretary](/usc/42/1301.md?p=a-6) may use authorities under sections [1395w–27(g)](/usc/42/1395w–27.md?p=g) and [1395w–112(b)(3)(E)](/usc/42/1395w–112.md?p=b-3-E) of this title to impose civil monetary penalties or other intermediate sanctions.
        - (II) **Application of civil monetary penalties—** The provisions of [section 1320a–7a of this title](/usc/42/1320a–7a.md) (other than subsections [(a)](#a) and [(b)](#b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under [section 1320a–7a(a) of this title](/usc/42/1320a–7a.md?p=a).
  - (2) **Use of standardized technology—**
    - (A) **In general—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall issue (and reissue, as appropriate) such a card (or other technology) that may be used by an enrollee to assure access to negotiated prices under [section 1395w–102(d) of this title](/usc/42/1395w–102.md?p=d).
    - (B) **Standards—**
      - (i) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide for the development, adoption, or recognition of [standards](/usc/42/1320d.md?p=7) relating to a standardized format for the card or other technology required under [subparagraph (A)](#b-2-A). Such [standards](/usc/42/1320d.md?p=7) shall be compatible with part C of subchapter XI and may be based on [standards](/usc/42/1320d.md?p=7) developed by an appropriate [standard setting organization](/usc/42/1320d.md?p=8).
      - (ii) **Consultation—** In developing the [standards](/usc/42/1320d.md?p=7) under [clause (i)](#b-2-B-i), the [Secretary](/usc/42/1301.md?p=a-6) shall consult with the National Council for Prescription [Drug](/usc/42/11851.md?p=4) Programs and other [standard setting organizations](/usc/42/1320d.md?p=8) determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6).
      - (iii) **Implementation—** The [Secretary](/usc/42/1301.md?p=a-6) shall develop, adopt, or recognize the [standards](/usc/42/1320d.md?p=7) under [clause (i)](#b-2-B-i) by such date as the [Secretary](/usc/42/1301.md?p=a-6) determines shall be sufficient to ensure that [PDP sponsors](/usc/42/1395w–151.md?p=a-13) utilize such [standards](/usc/42/1320d.md?p=7) beginning January 1, 2006.
  - (3) **Requirements on development and application of formularies—** If a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) uses a formulary ([including](/usc/42/1301.md?p=b) the use of tiered cost-sharing), the following requirements must be met:
    - (A) **Development and revision by a pharmacy and therapeutic (P&T) committee—**
      - (i) **In general—** The formulary must be developed and reviewed by a pharmacy and therapeutic committee. A majority of the members of such committee shall consist of individuals who are practicing [physicians](/usc/42/1301.md?p=a-7) or practicing pharmacists (or both).
      - (ii) **Inclusion of independent experts—** Such committee shall include at least one practicing [physician](/usc/42/1301.md?p=a-7) and at least one practicing pharmacist, each of whom—
        - (I) is independent and free of conflict with respect to the sponsor and plan; and
        - (II) has expertise in the care of elderly or disabled [persons](/usc/42/1301.md?p=a-3).
    - (B) **Formulary development—** In developing and reviewing the formulary, the committee shall—
      - (i) base clinical decisions on the strength of scientific evidence and [standards](/usc/42/1320d.md?p=7) of practice, [including](/usc/42/1301.md?p=b) assessing peer-reviewed medical literature, such as randomized clinical trials, pharmacoeconomic studies, outcomes research data, and on such other information as the committee determines to be appropriate; and
      - (ii) take into account whether [including](/usc/42/1301.md?p=b) in the formulary (or in a tier in such formulary) particular [covered part D drugs](/usc/42/1395w–151.md?p=a-2) has therapeutic advantages in terms of safety and efficacy.
    - (C) **Inclusion of drugs in all therapeutic categories and classes—**
      - (i) **In general—** Subject to [subparagraph (G)](#b-3-G), the formulary must include [drugs](/usc/42/11851.md?p=4) within each therapeutic category and class of [covered part D drugs](/usc/42/1395w–151.md?p=a-2), although not necessarily all [drugs](/usc/42/11851.md?p=4) within such categories and classes.
      - (ii) **Model guidelines—** The [Secretary](/usc/42/1301.md?p=a-6) shall request the [United States](/usc/42/1301.md?p=a-2) Pharmacopeia to develop, in consultation with pharmaceutical benefit managers and other interested parties, a list of categories and classes that may be used by [prescription drug plans](/usc/42/1395w–151.md?p=a-14) under this paragraph and to revise such classification from time to time to reflect changes in therapeutic uses of [covered part D drugs](/usc/42/1395w–151.md?p=a-2) and the additions of new [covered part D drugs](/usc/42/1395w–151.md?p=a-2).
      - (iii) **Limitation on changes in therapeutic classification—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) may not change the therapeutic categories and classes in a formulary other than at the beginning of each plan year except as the [Secretary](/usc/42/1301.md?p=a-6) may permit to take into account new therapeutic uses and newly approved [covered part D drugs](/usc/42/1395w–151.md?p=a-2).
    - (D) **Provider and patient education—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall establish policies and procedures to educate and inform [health care providers](/usc/42/1320d.md?p=3) and enrollees concerning the formulary.
    - (E) **Notice before removing drug from formulary or changing preferred or tier status of drug—** Any removal of a [covered part D drug](/usc/42/1395w–151.md?p=a-2) from a formulary and any change in the preferred or tiered cost-sharing status of such a [drug](/usc/42/11851.md?p=4) shall take effect only after appropriate notice is made available (such as under [subsection (a)(3)](#a-3)) to the [Secretary](/usc/42/1301.md?p=a-6), affected enrollees, [physicians](/usc/42/1301.md?p=a-7), pharmacies, and pharmacists.
    - (F) **Periodic evaluation of protocols—** In connection with the formulary, the sponsor of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall provide for the periodic evaluation and analysis of [treatment](/usc/42/11851.md?p=11) protocols and procedures.
    - (G) **Required inclusion of drugs in certain categories and classes—**
      - (i) **Formulary requirements—**
        - (I) **In general—** Subject to [subclause (II)](#b-3-G-i-II), a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall be required to include all [covered part D drugs](/usc/42/1395w–151.md?p=a-2) in the categories and classes identified by the [Secretary](/usc/42/1301.md?p=a-6) under [clause (ii)(I)](#b-3-G-ii-I).
        - (II) **Exceptions—** The [Secretary](/usc/42/1301.md?p=a-6) may establish exceptions that permit a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) to exclude from its formulary a particular [covered part D drug](/usc/42/1395w–151.md?p=a-2) in a category or class that is otherwise required to be included in the formulary under [subclause (I)](#b-3-G-i-I) (or to otherwise limit access to such a [drug](/usc/42/11851.md?p=4), [including](/usc/42/1301.md?p=b) through prior authorization or utilization management).
      - (ii) **Identification of drugs in certain categories and classes—**
        - (I) **In general—** Subject to [clause (iv)](#b-3-G-iv), the [Secretary](/usc/42/1301.md?p=a-6) shall identify, as appropriate, categories and classes of [drugs](/usc/42/11851.md?p=4) for which the [Secretary](/usc/42/1301.md?p=a-6) determines are of clinical concern.
        - (II) **Criteria—** The [Secretary](/usc/42/1301.md?p=a-6) shall use criteria established by the [Secretary](/usc/42/1301.md?p=a-6) in making any determination under [subclause (I)](#b-3-G-ii-I).
      - (iii) **Implementation—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish the criteria under [clause (ii)(II)](#b-3-G-ii-II) and any exceptions under [clause (i)(II)](#b-3-G-i-II) through the promulgation of a regulation which [includes](/usc/42/1301.md?p=b) a public notice and comment period.
      - (iv) **Requirement for certain categories and classes until criteria established—** Until such time as the [Secretary](/usc/42/1301.md?p=a-6) establishes the criteria under [clause (ii)(II)](#b-3-G-ii-II) the following categories and classes of [drugs](/usc/42/11851.md?p=4) shall be identified under [clause (ii)(I)](#b-3-G-ii-I):
        - (I) Anticonvulsants.
        - (II) Antidepressants.
        - (III) Antineoplastics.
        - (IV) Antipsychotics.
        - (V) Antiretrovirals.
        - (VI) Immunosuppressants for the [treatment](/usc/42/11851.md?p=11) of transplant rejection.
    - (H) **Use of single, uniform exceptions and appeals process—** Notwithstanding any other provision of this part, each [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall—
      - (i) use a single, uniform exceptions and appeals process ([including](/usc/42/1301.md?p=b), to the extent the [Secretary](/usc/42/1301.md?p=a-6) determines feasible, a single, uniform model form for use under such process) with respect to the determination of prescription [drug](/usc/42/11851.md?p=4) coverage for an enrollee under the plan; and
      - (ii) provide instant access to such process by enrollees through a toll-free telephone number and an Internet website.
    - (I) **Required inclusion of selected drugs—**
      - (i) **In general—** For 2026 and each subsequent year, the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall include each [covered part D drug](/usc/42/1395w–151.md?p=a-2) that is a selected [drug](/usc/42/11851.md?p=4) under [section 1320f–1 of this title](/usc/42/1320f–1.md) for which a maximum fair price (as defined in [section 1320f(c)(3) of this title](/usc/42/1320f.md?p=c-3)) is in effect with respect to the year.
      - (ii) **Clarification—** Nothing in [clause (i)](#b-3-I-i) shall be construed as prohibiting a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) from removing such a selected [drug](/usc/42/11851.md?p=4) from a formulary if such removal would be permitted under section 423.120(b)(5)(iv) of title 42, Code of Federal Regulations (or any successor regulation).
  - (4) **Ensuring access during COVID–19 public health emergency period—**
    - (A) **In general—** During the emergency period described in [section 1320b–5(g)(1)(B) of this title](/usc/42/1320b–5.md?p=g-1-B), subject to [subparagraph (B)](#b-4-B), a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) or [MA–PD plan](/usc/42/1395w–151.md?p=a-9) shall, notwithstanding any cost and utilization management, medication therapy management, or other such programs under this part, permit a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) enrolled in such plan to obtain in a single fill or refill, at the option of such individual, the total day supply (not to exceed a 90-day supply) prescribed for such individual for a [covered part D drug](/usc/42/1395w–151.md?p=a-2).
    - (B) **Safety edit exception—** A [prescription drug plan](/usc/42/1395w–151.md?p=a-14) or [MA–PD plan](/usc/42/1395w–151.md?p=a-9) may not permit a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) to obtain a single fill or refill inconsistent with an applicable safety edit.
- (c) **Cost and utilization management; quality assurance; medication therapy management program—**
  - (1) **In general—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall have in place, directly or through appropriate arrangements, with respect to [covered part D drugs](/usc/42/1395w–151.md?p=a-2), the following:
    - (A) A cost-effective [drug](/usc/42/11851.md?p=4) utilization management program, [including](/usc/42/1301.md?p=b) incentives to reduce costs when medically appropriate, such as through the use of multiple source [drugs](/usc/42/11851.md?p=4) (as defined in [section 1396r–8(k)(7)(A)(i) of this title](/usc/42/1396r–8.md?p=k-7-A-i)).
    - (B) Quality assurance measures and systems to reduce medication errors and adverse [drug](/usc/42/11851.md?p=4) interactions and improve medication use.
    - (C) A medication therapy management program described in [paragraph (2)](#c-2).
    - (D) A program to control fraud, [abuse](/usc/42/1397j.md?p=1), and waste.
    - (E) A utilization management tool to prevent [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) (as described in [paragraph (6)(A)](#c-6-A)).[^1]
    - (F) With respect to plan years beginning on or after January 1, 2022, a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries described in [paragraph (5)](#c-5).

    Nothing in this section shall be construed as impairing a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) from utilizing cost management tools ([including](/usc/42/1301.md?p=b) differential payments) under all methods of operation.

  - (2) **Medication therapy management program—**
    - (A) **Description—**
      - (i) **In general—** A medication therapy management program described in this paragraph is a program of [drug](/usc/42/11851.md?p=4) therapy management that may be furnished by a pharmacist and that is designed to assure, with respect to targeted beneficiaries described in [clause (ii)](#c-2-A-ii), that [covered part D drugs](/usc/42/1395w–151.md?p=a-2) under the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, [including](/usc/42/1301.md?p=b) adverse [drug](/usc/42/11851.md?p=4) interactions. Such a program may distinguish between services in ambulatory and institutional settings.
      - (ii) **Targeted beneficiaries described—** Targeted beneficiaries described in this clause are the following:
        - (I) [Part D eligible individuals](/usc/42/1395w–151.md?p=a-4) who—
          - (aa) have multiple chronic diseases (such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure);
          - (bb) are taking multiple [covered part D drugs](/usc/42/1395w–151.md?p=a-2); and
          - (cc) are identified as likely to incur annual costs for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) that exceed a level specified by the [Secretary](/usc/42/1301.md?p=a-6).
        - (II) Beginning January 1, 2021, at-risk beneficiaries for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) (as defined in [paragraph (5)(C)](#c-5-C)).
    - (B) **Elements—** Such program—
      - (i) may include elements that promote—
        - (I) enhanced enrollee understanding to promote the appropriate use of medications by enrollees and to reduce the risk of potential adverse events associated with medications, through beneficiary education, counseling, and other appropriate means;
        - (II) increased enrollee adherence with prescription medication regimens through medication refill reminders, special packaging, and other compliance programs and other appropriate means; and
        - (III) detection of adverse [drug](/usc/42/11851.md?p=4) events and patterns of overuse and underuse of prescription [drugs](/usc/42/11851.md?p=4); and
      - (ii) with respect to plan years beginning on or after January 1, 2021, shall provide for—
        - (I) the provision of information to the enrollee on the safe [disposal](/usc/42/2021b.md?p=7) of prescription [drugs](/usc/42/11851.md?p=4) that are [controlled substances](/usc/42/11851.md?p=2) that meets the criteria established under [section 1395w–22(n)(2) of this title](/usc/42/1395w–22.md?p=n-2), [including](/usc/42/1301.md?p=b) information on [drug](/usc/42/11851.md?p=4) takeback programs that meet such requirements determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6) and information on in-home [disposal](/usc/42/2021b.md?p=7); and
        - (II) cost-effective means by which an enrollee may so safely dispose of such [drugs](/usc/42/11851.md?p=4).
    - (C) **Required interventions—** For plan years beginning on or after the date that is 2 years after March 23, 2010, [prescription drug plan](/usc/42/1395w–151.md?p=a-14) sponsors shall offer medication therapy management services to targeted beneficiaries described in [subparagraph (A)(ii)](#c-2-A-ii) that include, at a minimum, the following to increase adherence to prescription medications or other goals deemed necessary by the [Secretary](/usc/42/1301.md?p=a-6):
      - (i) An annual comprehensive medication review furnished [person](/usc/42/1301.md?p=a-3)-to-[person](/usc/42/1301.md?p=a-3) or using telehealth technologies (as defined by the [Secretary](/usc/42/1301.md?p=a-6)) by a licensed pharmacist or other qualified provider. The comprehensive medication review—
        - (I) shall include a review of the individual’s medications and may result in the creation of a recommended medication action plan or other actions in consultation with the individual and with input from the prescriber to the extent necessary and practicable; and
        - (II) shall include providing the individual with a written or printed summary of the results of the review.

      The [Secretary](/usc/42/1301.md?p=a-6), in consultation with relevant stakeholders, shall develop a standardized format for the action plan under subclause (I) and the summary under subclause (II).

      - (ii) Follow-up [interventions](/usc/42/1397n–12.md?p=2) as warranted based on the findings of the annual medication review or the targeted medication enrollment and which may be provided [person](/usc/42/1301.md?p=a-3)-to-[person](/usc/42/1301.md?p=a-3) or using telehealth technologies (as defined by the [Secretary](/usc/42/1301.md?p=a-6)).
    - (D) **Assessment—** The [prescription drug plan](/usc/42/1395w–151.md?p=a-14) sponsor shall have in place a process to assess, at least on a quarterly basis, the medication use of individuals who are at risk but not enrolled in the medication therapy management program, [including](/usc/42/1301.md?p=b) individuals who have experienced a transition in care, if the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) sponsor has access to that information.
    - (E) **2 Automatic enrollment with ability to opt-out—** The [prescription drug plan](/usc/42/1395w–151.md?p=a-14) sponsor shall have in place a process to—
      - (i) subject to [clause (ii)](#c-2-E-ii), automatically enroll targeted beneficiaries described in [subparagraph (A)(ii)](#c-2-A-ii), [including](/usc/42/1301.md?p=b) beneficiaries identified under [subparagraph (D)](#c-2-D), in the medication therapy management program required under this subsection; and
      - (ii) permit such beneficiaries to opt-out of enrollment in such program.
    - (E) **2 Development of program in cooperation with licensed pharmacists—** Such program shall be developed in cooperation with licensed and practicing pharmacists and [physicians](/usc/42/1301.md?p=a-7).
    - (F) **Coordination with care management plans—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish guidelines for the coordination of any medication therapy management program under this paragraph with respect to a targeted beneficiary with any care management plan established with respect to such beneficiary under a chronic care improvement program under [section 1395b–8 of this title](/usc/42/1395b–8.md).
    - (G) **Considerations in pharmacy fees—** The [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall take into account, in establishing fees for pharmacists and others providing services under such plan, the resources used, and time required to, implement the medication therapy management program under this paragraph. Each such sponsor shall disclose to the [Secretary](/usc/42/1301.md?p=a-6) upon request the amount of any such management or dispensing fees. The provisions of [section 1396r–8(b)(3)(D) of this title](/usc/42/1396r–8.md?p=b-3-D) apply to information disclosed under this subparagraph.
  - (3) **Reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities—** The [Secretary](/usc/42/1301.md?p=a-6) shall require [PDP sponsors](/usc/42/1395w–151.md?p=a-13) of [prescription drug plans](/usc/42/1395w–151.md?p=a-14) to utilize specific, uniform dispensing techniques, as determined by the [Secretary](/usc/42/1301.md?p=a-6), in consultation with relevant stakeholders ([including](/usc/42/1301.md?p=b) representatives of [nursing facilities](/usc/42/1397j.md?p=17-A), residents of [nursing facilities](/usc/42/1397j.md?p=17-A), pharmacists, the pharmacy industry ([including](/usc/42/1301.md?p=b) retail and [long-term care](/usc/42/1397j.md?p=14-A) pharmacy), [prescription drug plans](/usc/42/1395w–151.md?p=a-14), [MA–PD plans](/usc/42/1395w–151.md?p=a-9), and any other stakeholders the [Secretary](/usc/42/1301.md?p=a-6) determines appropriate), such as weekly, daily, or automated dose dispensing, when dispensing [covered part D drugs](/usc/42/1395w–151.md?p=a-2) to enrollees who reside in a [long-term care facility](/usc/42/1397j.md?p=15) in order to reduce waste associated with 30-day fills.
  - (4) **Requiring valid prescriber National Provider Identifiers on pharmacy claims—**
    - (A) **In general—** For plan year 2016 and subsequent plan years, the [Secretary](/usc/42/1301.md?p=a-6) shall require a claim for a [covered part D drug](/usc/42/1395w–151.md?p=a-2) for a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) under this part or an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under part C to include a prescriber National Provider Identifier that is determined to be valid under the procedures established under [subparagraph (B)(i)](#c-4-B-i).
    - (B) **Procedures—**
      - (i) **Validity of prescriber National Provider Identifiers—** The [Secretary](/usc/42/1301.md?p=a-6), in consultation with appropriate stakeholders, shall establish procedures for determining the validity of prescriber National Provider Identifiers under [subparagraph (A)](#c-4-A).
      - (ii) **Informing beneficiaries of reason for denial—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish procedures to ensure that, in the case that a claim for a [covered part D drug](/usc/42/1395w–151.md?p=a-2) of an individual described in [subparagraph (A)](#c-4-A) is denied because the claim does not meet the requirements of this paragraph, the individual is properly informed at the point of service of the reason for the denial.
    - (C) **Report—** Not later than January 1, 2018, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on the effectiveness of the procedures established under [subparagraph (B)(i)](#c-4-B-i).
    - (D) **Notification and additional requirements with respect to outlier prescribers of opioids—**
      - (i) **Notification—** Not later than January 1, 2021, the [Secretary](/usc/42/1301.md?p=a-6) shall, in the case of a prescriber identified by the [Secretary](/usc/42/1301.md?p=a-6) under [clause (ii)](#c-4-D-ii) to be an outlier prescriber of opioids, provide, subject to [clause (iv)](#c-4-D-iv), an annual notification to such prescriber that such prescriber has been so identified and that [includes](/usc/42/1301.md?p=b) resources on proper prescribing methods and other information as specified in accordance with [clause (iii)](#c-4-D-iii).
      - (ii) **Identification of outlier prescribers of opioids—**
        - (I) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall, subject to [subclause (III)](#c-4-D-ii-III), using the valid prescriber National Provider Identifiers included pursuant to [subparagraph (A)](#c-4-A) on claims for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) enrolled in [prescription drug plans](/usc/42/1395w–151.md?p=a-14) under this part or [MA–PD plans](/usc/42/1395w–151.md?p=a-9) under part C and based on the thresholds established under [subclause (II)](#c-4-D-ii-II), identify prescribers that are outlier opioids prescribers for a period of time specified by the [Secretary](/usc/42/1301.md?p=a-6).
        - (II) **Establishment of thresholds—** For purposes of [subclause (I)](#c-4-D-ii-I) and subject to [subclause (III)](#c-4-D-ii-III), the [Secretary](/usc/42/1301.md?p=a-6) shall, after consultation with stakeholders, establish thresholds, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area.
        - (III) **Exclusions—** The following shall not be included in the analysis for identifying outlier prescribers of opioids under this clause:
          - (aa) Claims for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) who are receiving hospice care under this subchapter.
          - (bb) Claims for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) who are receiving oncology services under this subchapter.
          - (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Inspector General of the Department of Health and Human Services.
      - (iii) **Contents of notification—** The [Secretary](/usc/42/1301.md?p=a-6) shall include the following information in the notifications provided under [clause (i)](#c-4-D-i):
        - (I) Information on how such prescriber compares to other prescribers within the same specialty and geographic area.
        - (II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by [physician](/usc/42/1301.md?p=a-7) organizations.
        - (III) Other information determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6).
      - (iv) **Modifications and expansions—**
        - (I) **Frequency—** Beginning 5 years after October 24, 2018, the [Secretary](/usc/42/1301.md?p=a-6) may change the frequency of the notifications described in [clause (i)](#c-4-D-i) based on stakeholder input and changes in opioid prescribing utilization and trends.
        - (II) **Expansion to other prescriptions—** The [Secretary](/usc/42/1301.md?p=a-6) may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of [covered Part D drugs](/usc/42/1395w–151.md?p=a-2) used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the [Secretary](/usc/42/1301.md?p=a-6).
      - (v) **Additional requirements for persistent outlier prescribers—** In the case of a prescriber who the [Secretary](/usc/42/1301.md?p=a-6) determines is persistently identified under [clause (ii)](#c-4-D-ii) as an outlier prescriber of opioids, the following shall apply:
        - (I) Such prescriber may be required to enroll in the program under this subchapter under [section 1395cc(j) of this title](/usc/42/1395cc.md?p=j) if such prescriber is not otherwise required to enroll, but only after other appropriate remedies have been provided, such as the provision of education funded through section 6052 of the SUPPORT for Patients and Communities Act, for a period determined by the [Secretary](/usc/42/1301.md?p=a-6) as sufficient to correct the prescribing patterns that lead to identification of such prescriber as a persistent outlier prescriber of opioids. The [Secretary](/usc/42/1301.md?p=a-6) shall determine the length of the period for which such prescriber is required to maintain such enrollment, which shall be the minimum period necessary to correct such prescribing patterns.
        - (II) Not less frequently than annually (and in a form and manner determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6)), the [Secretary](/usc/42/1301.md?p=a-6), consistent with [clause(iv)(I)](#c-4-D-iv-I), shall communicate information on such prescribers to sponsors of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and Medicare Advantage organizations offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9).
      - (vi) **Public availability of information—** The [Secretary](/usc/42/1301.md?p=a-6) shall make aggregate information under this subparagraph available on the internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6) and shall not identify any specific prescriber. In carrying out this clause, the [Secretary](/usc/42/1301.md?p=a-6) shall consult with interested stakeholders.
      - (vii) **Opioids defined—** For purposes of this subparagraph, the term “opioids” has such meaning as specified by the [Secretary](/usc/42/1301.md?p=a-6).
      - (viii) **Other activities—** Nothing in this subparagraph shall preclude the [Secretary](/usc/42/1301.md?p=a-6) from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, [including](/usc/42/1301.md?p=b) activities that were being conducted as October 24, 2018.
  - (5) **Drug management program for at-risk beneficiaries—**
    - (A) **Authority to establish—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may (and for plan years beginning on or after January 1, 2022, a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall) establish a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries under which, subject to [subparagraph (B)](#c-5-B), the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may, in the case of an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) who is an enrollee in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) of such [PDP sponsor](/usc/42/1395w–151.md?p=a-13), limit such beneficiary’s access to coverage for frequently abused [drugs](/usc/42/11851.md?p=4) under such plan to frequently abused [drugs](/usc/42/11851.md?p=4) that are prescribed for such beneficiary by one or more prescribers selected under [subparagraph (D)](#c-5-D), and dispensed for such beneficiary by one or more pharmacies selected under such subparagraph.
    - (B) **Requirement for notices—**
      - (i) **In general—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may not limit the access of an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) to coverage for frequently abused [drugs](/usc/42/11851.md?p=4) under a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) until such sponsor—
        - (I) provides to the beneficiary an initial notice described in [clause (ii)](#c-5-B-ii) and a second notice described in [clause (iii)](#c-5-B-iii); and
        - (II) verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1).
      - (ii) **Initial notice—** An initial notice described in this clause is a notice that provides to the beneficiary—
        - (I) notice that the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) has identified the beneficiary as potentially being an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1);
        - (II) information describing all [State](/usc/42/619.md?p=5) and Federal public health resources that are designed to address prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) to which the beneficiary has access, [including](/usc/42/1301.md?p=b) mental health services and other counseling services;
        - (III) notice of, and information about, the right of the beneficiary to appeal such identification under [subsection (h)](#h), [including](/usc/42/1301.md?p=b) notice that if on reconsideration a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the [Secretary](/usc/42/1301.md?p=a-6) for review and resolution;
        - (IV) a request for the beneficiary to submit to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) preferences for which prescribers and pharmacies the beneficiary would prefer the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) to select under [subparagraph (D)](#c-5-D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) as described in [clause (iii)(I)](#c-5-B-iii-I);
        - (V) an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1), [including](/usc/42/1301.md?p=b) an explanation of the [drug](/usc/42/11851.md?p=4) management program established by the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) pursuant to [subparagraph (A)](#c-5-A);
        - (VI) clear instructions that explain how the beneficiary can contact the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) in order to submit to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) the preferences described in [subclause (IV)](#c-5-B-ii-IV) and any other communications relating to the [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries established by the [PDP sponsor](/usc/42/1395w–151.md?p=a-13); and
        - (VII) contact information for other organizations that can provide the beneficiary with assistance regarding such [drug](/usc/42/11851.md?p=4) management program (similar to the information provided by the [Secretary](/usc/42/1301.md?p=a-6) in other standardized notices provided to [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) enrolled in [prescription drug plans](/usc/42/1395w–151.md?p=a-14) under this part).
      - (iii) **Second notice—** A second notice described in this clause is a notice that provides to the beneficiary notice—
        - (I) that the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) has identified the beneficiary as an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1);
        - (II) that such beneficiary is subject to the requirements of the [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries established by such [PDP sponsor](/usc/42/1395w–151.md?p=a-13) for such plan;
        - (III) of the prescriber (or prescribers) and pharmacy (or pharmacies) selected for such individual under [subparagraph (D)](#c-5-D);
        - (IV) of, and information about, the beneficiary’s right to appeal such identification under [subsection (h)](#h), [including](/usc/42/1301.md?p=b) notice that if on reconsideration a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the [Secretary](/usc/42/1301.md?p=a-6) for review and resolution;
        - (V) that the beneficiary can, in the case that the beneficiary has not previously submitted to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) preferences for which prescribers and pharmacies the beneficiary would prefer the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) select under [subparagraph (D)](#c-5-D), submit such preferences to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13); and
        - (VI) that [includes](/usc/42/1301.md?p=b) clear instructions that explain how the beneficiary can contact the [PDP sponsor](/usc/42/1395w–151.md?p=a-13).
      - (iv) **Timing of notices—**
        - (I) **In general—** Subject to [subclause (II)](#c-5-B-iv-II), a second notice described in [clause (iii)](#c-5-B-iii) shall be provided to the beneficiary on a date that is not less than 30 days after an initial notice described in [clause (ii)](#c-5-B-ii) is provided to the beneficiary.
        - (II) **Exception—** In the case that the [PDP sponsor](/usc/42/1395w–151.md?p=a-13), in conjunction with the [Secretary](/usc/42/1301.md?p=a-6), determines that concerns identified through rulemaking by the [Secretary](/usc/42/1301.md?p=a-6) regarding the health or safety of the beneficiary or regarding significant [drug](/usc/42/11851.md?p=4) diversion activities require the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) to provide a second notice described in [clause (iii)](#c-5-B-iii) to the beneficiary on a date that is earlier than the date described in [subclause (I)](#c-5-B-iv-I), the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may provide such second notice on such earlier date.
    - (C) **At-risk beneficiary for prescription drug abuse—**
      - (i) **In general—** Except as provided in [clause (v)](#c-5-C-v), for purposes of this paragraph, the term “at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1)” means a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) who is not an exempted individual described in [clause (ii)](#c-5-C-ii) and—
        - (I) who is identified as such an at-risk beneficiary through the use of clinical guidelines that indicate misuse or [abuse](/usc/42/1397j.md?p=1) of prescription [drugs](/usc/42/11851.md?p=4) described in [subparagraph (G)](#c-5-G) and that are developed by the [Secretary](/usc/42/1301.md?p=a-6) in consultation with [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and other stakeholders, [including](/usc/42/1301.md?p=b) individuals entitled to benefits under part A or enrolled under part B, advocacy groups representing such individuals, [physicians](/usc/42/1301.md?p=a-7), pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers; or
        - (II) with respect to whom the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14), upon enrolling such individual in such plan, received notice from the [Secretary](/usc/42/1301.md?p=a-6) that such individual was identified under this paragraph to be an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) under the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) in which such individual was most recently previously enrolled and such identification has not been terminated under [subparagraph (F)](#c-5-F).
      - (ii) **Exempted individual described—** An exempted individual described in this clause is an individual who—
        - (I) receives hospice care under this subchapter;
        - (II) is a resident of a [long-term care facility](/usc/42/1397j.md?p=15), of a [facility](/usc/42/1320a–3.md?p=c-5-B) described in [section 1396d(d) of this title](/usc/42/1396d.md?p=d), or of another [facility](/usc/42/1320a–3.md?p=c-5-B) for which frequently abused [drugs](/usc/42/11851.md?p=4) are dispensed for residents through a contract with a single pharmacy; or
        - (III) the [Secretary](/usc/42/1301.md?p=a-6) elects to treat as an exempted individual for purposes of [clause (i)](#c-5-C-i).
      - (iii) **Program size—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish policies, [including](/usc/42/1301.md?p=b) the guidelines developed under [clause (i)(I)](#c-5-C-i-I) and the exemptions under [clause (ii)(III)](#c-5-C-ii-III), to ensure that the population of enrollees in a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries operated by a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) can be effectively managed by such plans.
      - (iv) **Clinical contact—** With respect to each at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13), the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall contact the beneficiary’s providers who have prescribed frequently abused [drugs](/usc/42/11851.md?p=4) regarding whether prescribed medications are appropriate for such beneficiary’s medical conditions.
      - (v) **Treatment of enrollees with a history of opioid-related overdose—**
        - (I) **In general—** For plan years beginning not later than January 1, 2021, a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) who is not an exempted individual described in [clause (ii)](#c-5-C-ii) and who is identified under this clause as a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) with a history of opioid-related overdose (as defined by the [Secretary](/usc/42/1301.md?p=a-6)) shall be included as a potentially at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) under the [drug](/usc/42/11851.md?p=4) management program under this paragraph.
        - (II) **Identification and notice—** For purposes of this clause, the [Secretary](/usc/42/1301.md?p=a-6) shall—
          - (aa) identify [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) with a history of opioid-related overdose (as so defined); and
          - (bb) notify the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) in which such an individual is enrolled of such identification.
    - (D) **Selection of prescribers and pharmacies—**
      - (i) **In general—** With respect to each at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by such sponsor, a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall, based on the preferences submitted to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) by the beneficiary pursuant to clauses [(ii)(IV)](#c-5-B-ii-IV) and [(iii)(V)](#c-5-B-iii-V) of subparagraph (B) (except as otherwise provided in this subparagraph) select—
        - (I) one, or, if the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) reasonably determines it necessary to provide the beneficiary with reasonable access under [clause (ii)](#c-5-D-ii), more than one, individual who is authorized to prescribe frequently abused [drugs](/usc/42/11851.md?p=4) (referred to in this paragraph as a “prescriber”) who may write prescriptions for such [drugs](/usc/42/11851.md?p=4) for such beneficiary; and
        - (II) one, or, if the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) reasonably determines it necessary to provide the beneficiary with reasonable access under [clause (ii)](#c-5-D-ii), more than one, pharmacy that may dispense such [drugs](/usc/42/11851.md?p=4) to such beneficiary.

      For purposes of subclause (II), in the case of a pharmacy that has multiple locations that share real-time electronic data, all such locations of the pharmacy shall collectively be treated as one pharmacy.

      - (ii) **Reasonable access—** In making the selections under this subparagraph—
        - (I) a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall ensure that the beneficiary continues to have reasonable access to frequently abused [drugs](/usc/42/11851.md?p=4) (as defined in [subparagraph (G)](#c-5-G)), taking into account geographic location, beneficiary preference, impact on costsharing, and reasonable travel time; and
        - (II) a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall ensure such access ([including](/usc/42/1301.md?p=b) access to prescribers and pharmacies with respect to frequently abused [drugs](/usc/42/11851.md?p=4)) in the case of individuals with multiple residences, in the case of natural [disasters](/usc/42/5204.md?p=2) and similar situations, and in the case of the provision of emergency services.
      - (iii) **Beneficiary preferences—** If an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) select in response to a notice under [subparagraph (B)](#c-5-B), the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall—
        - (I) review such preferences;
        - (II) select or change the selection of prescribers and pharmacies for the beneficiary based on such preferences; and
        - (III) inform the beneficiary of such selection or change of selection.
      - (iv) **Exception regarding beneficiary preferences—** In the case that the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) determines that a change to the selection of prescriber or pharmacy under [clause (iii)(II)](#c-5-D-iii-II) by the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) is contributing or would contribute to prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) or [drug](/usc/42/11851.md?p=4) diversion by the beneficiary, the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may change the selection of prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in [clause (iii)](#c-5-D-iii). If the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) changes the selection pursuant to the preceding sentence, the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall provide the beneficiary with—
        - (I) at least 30 days written notice of the change of selection; and
        - (II) a rationale for the change.
      - (v) **Confirmation—** Before selecting a prescriber or pharmacy under this subparagraph, a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in the [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries and that the prescriber and pharmacy has been selected as the beneficiary’s designated prescriber and pharmacy.
    - (E) **Terminations and appeals—** The identification of an individual as an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) under this paragraph, a coverage determination made under a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries, the selection of prescriber or pharmacy under [subparagraph (D)](#c-5-D), and information to be shared under [subparagraph (I)](#c-5-I), with respect to such individual, shall be subject to reconsideration and appeal under [subsection (h)](#h) and if on reconsideration a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the [Secretary](/usc/42/1301.md?p=a-6) for review and resolution.
    - (F) **Termination of identification—**
      - (i) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall develop [standards](/usc/42/1320d.md?p=7) for the termination of identification of an individual as an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) under this paragraph. Under such [standards](/usc/42/1320d.md?p=7) such identification shall terminate as of the earlier of—
        - (I) the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) described in [subparagraph (C)(i)](#c-5-C-i); and
        - (II) the end of such maximum period of identification as the [Secretary](/usc/42/1301.md?p=a-6) may specify.
      - (ii) **Rule of construction—** Nothing in [clause (i)](#c-5-F-i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) under [subparagraph (C)(i)](#c-5-C-i) after such termination on the basis of additional information on [drug](/usc/42/11851.md?p=4) use occurring after the date of notice of such termination.
    - (G) **Frequently abused drug—** For purposes of this subsection, the term “frequently abused [drug](/usc/42/11851.md?p=4)” means a [drug](/usc/42/11851.md?p=4) that is a [controlled substance](/usc/42/11851.md?p=2) that the [Secretary](/usc/42/1301.md?p=a-6) determines to be frequently abused or diverted.
    - (H) **Data disclosure—**
      - (i) **Data on decision to impose limitation—** In the case of an at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) (or an individual who is a potentially at-risk beneficiary for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1)) whose access to coverage for frequently abused [drugs](/usc/42/11851.md?p=4) under a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) has been limited by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) under this paragraph, the [Secretary](/usc/42/1301.md?p=a-6) shall establish rules and procedures to require the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) to disclose data, [including](/usc/42/1301.md?p=b) any necessary [individually identifiable health information](/usc/42/1320d.md?p=6), in a form and manner specified by the [Secretary](/usc/42/1301.md?p=a-6), about the decision to impose such limitations and the limitations imposed by the sponsor under this part.
      - (ii) **Data to reduce fraud, abuse, and waste—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish rules and procedures to require [PDP sponsors](/usc/42/1395w–151.md?p=a-13) operating a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries under this paragraph to provide the [Secretary](/usc/42/1301.md?p=a-6) with such data as the [Secretary](/usc/42/1301.md?p=a-6) determines appropriate for purposes of identifying patterns of prescription [drug](/usc/42/11851.md?p=4) utilization for plan enrollees that are outside normal patterns and that may indicate fraudulent, medically unnecessary, or unsafe use.
    - (I) **Sharing of information for subsequent plan enrollments—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish procedures under which [PDP sponsors](/usc/42/1395w–151.md?p=a-13) who offer [prescription drug plans](/usc/42/1395w–151.md?p=a-14) shall share information with respect to individuals who are at-risk beneficiaries for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1) (or individuals who are potentially at-risk beneficiaries for prescription [drug](/usc/42/11851.md?p=4) [abuse](/usc/42/1397j.md?p=1)) and enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and who subsequently disenroll from such plan and enroll in another [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by another [PDP sponsor](/usc/42/1395w–151.md?p=a-13).
    - (J) **Privacy issues—** Prior to the implementation of the rules and procedures under this paragraph, the [Secretary](/usc/42/1301.md?p=a-6) shall clarify privacy requirements, [including](/usc/42/1301.md?p=b) requirements under the regulations promulgated pursuant to [section 264(c)](/usc/42/264.md?p=c) of the Health Insurance Portability and Accountability Act of 1996 ([42 U.S.C. 1320d–2](/usc/42/1320d–2.md) note), related to the sharing of data under subparagraphs [(H)](#c-5-H) and [(I)](#c-5-I) by [PDP sponsors](/usc/42/1395w–151.md?p=a-13). Such clarification shall provide that the sharing of such data shall be considered to be protected [health information](/usc/42/1320d.md?p=4) in accordance with the requirements of the regulations promulgated pursuant to such [section 264(c)](/usc/42/264.md?p=c).
    - (K) **Education—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide education to enrollees in [prescription drug plans](/usc/42/1395w–151.md?p=a-14) of [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and providers regarding the [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries described in this paragraph, [including](/usc/42/1301.md?p=b) education—
      - (i) provided by Medicare administrative contractors through the improper payment outreach and education program described in [section 1395kk–1(h) of this title](/usc/42/1395kk–1.md?p=h); and
      - (ii) through current education efforts (such as [State](/usc/42/619.md?p=5) health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 ([42 U.S.C. 1395b–3](/usc/42/1395b–3.md) note)) and materials directed toward such enrollees.
    - (L) **Application under MA–PD plans—** Pursuant to [section 1395w–131(c)(1) of this title](/usc/42/1395w–131.md?p=c-1), the provisions of this paragraph apply under part D to MA organizations offering [MA–PD plans](/usc/42/1395w–151.md?p=a-9) to MA eligible individuals in the same manner as such provisions apply under this part to a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) to a [part D eligible individual](/usc/42/1395w–151.md?p=a-4).
    - (M) **CMS compliance review—** The [Secretary](/usc/42/1301.md?p=a-6) shall ensure that existing plan sponsor compliance reviews and audit processes include the [drug](/usc/42/11851.md?p=4) management programs for at-risk beneficiaries under this paragraph, [including](/usc/42/1301.md?p=b) appeals processes under such programs.
  - (6) **3 Utilization management tool to prevent drug abuse—**
    - (A) **In general—** A tool described in this paragraph is any of the following:
      - (i) A utilization tool designed to prevent the [abuse](/usc/42/1397j.md?p=1) of frequently abused [drugs](/usc/42/11851.md?p=4) by individuals and to prevent the diversion of such [drugs](/usc/42/11851.md?p=4) at pharmacies.
      - (ii) Retrospective utilization review to identify—
        - (I) individuals that receive frequently abused [drugs](/usc/42/11851.md?p=4) at a frequency or in amounts that are not clinically appropriate; and
        - (II) providers of services or suppliers that may facilitate the [abuse](/usc/42/1397j.md?p=1) or diversion of frequently abused [drugs](/usc/42/11851.md?p=4) by beneficiaries.
      - (iii) Consultation with the contractor described in [subparagraph (B)](#c-6-B) to verify if an individual enrolling in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) has been previously identified by another [PDP sponsor](/usc/42/1395w–151.md?p=a-13) as an individual described in [clause (ii)(I)](#c-6-A-ii-I).
    - (B) **Reporting—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) (and an MA organization offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9)) in a [State](/usc/42/619.md?p=5) shall submit to the [Secretary](/usc/42/1301.md?p=a-6) and the Medicare [drug](/usc/42/11851.md?p=4) integrity contractor with which the [Secretary](/usc/42/1301.md?p=a-6) has entered into a contract under [section 1395ddd of this title](/usc/42/1395ddd.md) with respect to such [State](/usc/42/619.md?p=5) a report, on a monthly basis, containing information on—
      - (i) any provider of services or supplier described in [subparagraph (A)(ii)(II)](#c-6-A-ii-II) that is identified by such plan sponsor (or organization) during the 30-day period before such report is submitted; and
      - (ii) the name and prescription records of individuals described in [paragraph (5)(C)](#c-5-C).
    - (C) **CMS compliance review—** The [Secretary](/usc/42/1301.md?p=a-6) shall ensure that plan sponsor compliance reviews and program audits biennially include a certification that utilization management tools under this paragraph are in compliance with the requirements for such tools.
  - (6) **3 Providing prescription drug plans with parts A and B claims data to promote the appropriate use of medications and improve health outcomes—**
    - (A) **Process—** Subject to [subparagraph (B)](#c-6-B), the [Secretary](/usc/42/1301.md?p=a-6) shall establish a process under which a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) may submit a request for the [Secretary](/usc/42/1301.md?p=a-6) to provide the sponsor, on a periodic basis and in an electronic format, beginning in plan year 2020, data described in [subparagraph (D)](#c-6-D) with respect to enrollees in such plan. Such data shall be provided without regard to whether such enrollees are described in [clause (ii)](#c-2-A-ii) of paragraph (2)(A).
    - (B) **Purposes—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may use the data provided to the sponsor pursuant to [subparagraph (A)](#c-6-A) for any of the following purposes:
      - (i) To optimize therapeutic outcomes through improved medication use, as such phrase is used in [clause (i)](#c-2-A-i) of paragraph (2)(A).
      - (ii) To improving care coordination so as to prevent adverse health outcomes, such as preventable emergency department visits and [hospital](/usc/42/300s–3.md?p=1) readmissions.
      - (iii) For any other purpose determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6).
    - (C) **Limitations on data use—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall not use data provided to the sponsor pursuant to [subparagraph (A)](#c-6-A) for any of the following purposes:
      - (i) To inform coverage determinations under this part.
      - (ii) To conduct retroactive reviews of medically accepted indications determinations.
      - (iii) To facilitate enrollment changes to a different [prescription drug plan](/usc/42/1395w–151.md?p=a-14) or an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) offered by the same parent organization.
      - (iv) To inform marketing of benefits.
      - (v) For any other purpose that the [Secretary](/usc/42/1301.md?p=a-6) determines is necessary to include in order to protect the identity of individuals entitled to, or enrolled for, benefits under this subchapter and to protect the security of personal [health information](/usc/42/1320d.md?p=4).
    - (D) **Data described—** The data described in this clause are standardized extracts (as determined by the [Secretary](/usc/42/1301.md?p=a-6)) of claims data under parts A and B for items and services furnished under such parts for time periods specified by the [Secretary](/usc/42/1301.md?p=a-6). Such data shall include data as current as practicable.
- (d) **Consumer satisfaction surveys—** In order to provide for comparative information under [section 1395w–101(c)(3)(A)(v) of this title](/usc/42/1395w–101.md?p=c-3-A-v), the [Secretary](/usc/42/1301.md?p=a-6) shall conduct consumer satisfaction surveys with respect to [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and [prescription drug plans](/usc/42/1395w–151.md?p=a-14) in a manner similar to the manner such surveys are conducted for MA organizations and [MA plans](/usc/42/1395w–151.md?p=a-8) under part C.
- (e) **Electronic prescription program—**
  - (1) **Application of standards—** As of such date as the [Secretary](/usc/42/1301.md?p=a-6) may specify, but not later than 1 year after the date of promulgation of final [standards](/usc/42/1320d.md?p=7) under [paragraph (4)(D)](#e-4-D), prescriptions and other information described in [paragraph (2)(A)](#e-2-A) for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) prescribed for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) that are transmitted electronically shall be transmitted only in accordance with such [standards](/usc/42/1320d.md?p=7) under an electronic prescription [drug](/usc/42/11851.md?p=4) program that meets the requirements of [paragraph (2)](#e-2).
  - (2) **Program requirements—** Consistent with uniform [standards](/usc/42/1320d.md?p=7) established under [paragraph (3)](#e-3)—
    - (A) **Provision of information to prescribing health care professional and dispensing pharmacies and pharmacists—** An electronic prescription [drug](/usc/42/11851.md?p=4) program shall provide for the electronic transmittal to the prescribing health care professional and to the dispensing pharmacy and pharmacist of the prescription and information on eligibility and benefits ([including](/usc/42/1301.md?p=b) the [drugs](/usc/42/11851.md?p=4) included in the applicable formulary, any tiered formulary structure, and any requirements for prior authorization) and of the following information with respect to the prescribing and dispensing of a [covered part D drug](/usc/42/1395w–151.md?p=a-2):
      - (i) Information on the [drug](/usc/42/11851.md?p=4) being prescribed or dispensed and other [drugs](/usc/42/11851.md?p=4) listed on the medication history, [including](/usc/42/1301.md?p=b) information on [drug](/usc/42/11851.md?p=4)-[drug](/usc/42/11851.md?p=4) interactions, warnings or cautions, and, when indicated, dosage adjustments.
      - (ii) Information on the availability of lower cost, therapeutically appropriate alternatives (if any) for the [drug](/usc/42/11851.md?p=4) prescribed.
    - (B) **Application to medical history information—** Effective on and after such date as the [Secretary](/usc/42/1301.md?p=a-6) specifies and after the establishment of appropriate [standards](/usc/42/1320d.md?p=7) to carry out this subparagraph, the program shall provide for the electronic transmittal in a manner similar to the manner under [subparagraph (A)](#e-2-A) of information that relates to the medical history concerning the individual and related to a [covered part D drug](/usc/42/1395w–151.md?p=a-2) being prescribed or dispensed, upon request of the professional or pharmacist involved.
    - (C) **Limitations—** Information shall only be disclosed under subparagraph [(A)](#e-2-A) or [(B)](#e-2-B) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of [individually identifiable health information](/usc/42/1320d.md?p=6)) promulgated under [section 264(c)](/usc/42/264.md?p=c) of the Health Insurance Portability and Accountability Act of 1996.
    - (D) **Timing—** To the extent feasible, the information exchanged under this paragraph shall be on an interactive, real-time basis.
    - (E) **Electronic prior authorization—**
      - (i) **In general—** Not later than January 1, 2021, the program shall provide for the secure electronic transmission of—
        - (I) a prior authorization request from the prescribing health care professional for coverage of a [covered part D drug](/usc/42/1395w–151.md?p=a-2) for a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) enrolled in a part D plan (as defined in [section 1395w–133(a)(5) of this title](/usc/42/1395w–133.md?p=a-5)) to the [PDP sponsor](/usc/42/1395w–151.md?p=a-13) or Medicare Advantage organization offering such plan; and
        - (II) a response, in accordance with this subparagraph, from such [PDP sponsor](/usc/42/1395w–151.md?p=a-13) or Medicare Advantage organization, respectively, to such professional.
      - (ii) **Electronic transmission—**
        - (I) **Exclusions—** For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet [standards](/usc/42/1320d.md?p=7) specified by the [Secretary](/usc/42/1301.md?p=a-6), or an electronic form shall not be treated as an electronic transmission described in [clause (i)](#e-2-E-i).
        - (II) **Standards—** In order to be treated, for purposes of this subparagraph, as an electronic transmission described in [clause (i)](#e-2-E-i), such transmission shall comply with technical [standards](/usc/42/1320d.md?p=7) adopted by the [Secretary](/usc/42/1301.md?p=a-6) in consultation with the National Council for Prescription [Drug](/usc/42/11851.md?p=4) Programs, other [standard setting organizations](/usc/42/1320d.md?p=8) determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6), and stakeholders [including](/usc/42/1301.md?p=b) [PDP sponsors](/usc/42/1395w–151.md?p=a-13), Medicare Advantage organizations, health care professionals, and [health information](/usc/42/1320d.md?p=4) technology software vendors.
        - (III) **Application—** Notwithstanding any other provision of law, for purposes of this subparagraph, the [Secretary](/usc/42/1301.md?p=a-6) may require the use of such [standards](/usc/42/1320d.md?p=7) adopted under [subclause (II)](#e-2-E-ii-II) in lieu of any other applicable [standards](/usc/42/1320d.md?p=7) for an electronic transmission described in [clause (i)](#e-2-E-i) for a [covered part D drug](/usc/42/1395w–151.md?p=a-2) for a [part D eligible individual](/usc/42/1395w–151.md?p=a-4).
  - (3) **Standards—**
    - (A) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide consistent with this subsection for the promulgation of uniform [standards](/usc/42/1320d.md?p=7) relating to the requirements for electronic prescription [drug](/usc/42/11851.md?p=4) programs under [paragraph (2)](#e-2).
    - (B) **Objectives—** Such [standards](/usc/42/1320d.md?p=7) shall be consistent with the objectives of improving—
      - (i) patient safety;
      - (ii) the quality of care provided to patients; and
      - (iii) efficiencies, [including](/usc/42/1301.md?p=b) cost savings, in the delivery of care.
    - (C) **Design criteria—** Such [standards](/usc/42/1320d.md?p=7) shall—
      - (i) be designed so that, to the extent practicable, the [standards](/usc/42/1320d.md?p=7) do not impose an undue administrative burden on prescribing health care professionals and dispensing pharmacies and pharmacists;
      - (ii) be compatible with [standards](/usc/42/1320d.md?p=7) established under part C of subchapter XI, [standards](/usc/42/1320d.md?p=7) established under [subsection (b)(2)(B)(i)](#b-2-B-i), and with general [health information](/usc/42/1320d.md?p=4) technology [standards](/usc/42/1320d.md?p=7); and
      - (iii) be designed so that they permit electronic exchange of [drug](/usc/42/11851.md?p=4) labeling and [drug](/usc/42/11851.md?p=4) listing information maintained by the Food and [Drug](/usc/42/11851.md?p=4) [Administration](/usc/42/1301.md?p=a-10) and the National Library of Medicine.
    - (D) **Permitting use of appropriate messaging—** Such [standards](/usc/42/1320d.md?p=7) shall allow for the messaging of information only if it relates to the appropriate prescribing of [drugs](/usc/42/11851.md?p=4), [including](/usc/42/1301.md?p=b) quality assurance measures and systems referred to in [subsection (c)(1)(B)](#c-1-B).
    - (E) **Permitting patient designation of dispensing pharmacy—**
      - (i) **In general—** Consistent with [clause (ii)](#e-3-E-ii), such [standards](/usc/42/1320d.md?p=7) shall permit a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) to designate a particular pharmacy to dispense a prescribed [drug](/usc/42/11851.md?p=4).
      - (ii) **No change in benefits—** [Clause (i)](#e-3-E-i) shall not be construed as affecting—
        - (I) the access required to be provided to pharmacies by a [prescription drug plan](/usc/42/1395w–151.md?p=a-14); or
        - (II) the application of any differences in benefits or payments under such a plan based on the pharmacy dispensing a [covered part D drug](/usc/42/1395w–151.md?p=a-2).
  - (4) **Development, promulgation, and modification of standards—**
    - (A) **Initial standards—** Not later than September 1, 2005, the [Secretary](/usc/42/1301.md?p=a-6) shall develop, adopt, recognize, or modify initial uniform [standards](/usc/42/1320d.md?p=7) relating to the requirements for electronic prescription [drug](/usc/42/11851.md?p=4) programs described in [paragraph (2)](#e-2) taking into consideration the recommendations (if any) from the National Committee on Vital and Health Statistics (as established under [section 242k(k) of this title](/usc/42/242k.md?p=k)) under [subparagraph (B)](#e-4-B).
    - (B) **Role of NCVHS—** The National Committee on Vital and Health Statistics shall develop recommendations for uniform [standards](/usc/42/1320d.md?p=7) relating to such requirements in consultation with the following:
      - (i) [Standard setting organizations](/usc/42/1320d.md?p=8) (as defined in [section 1320d(8) of this title](/usc/42/1320d.md?p=8))[^4]
      - (ii) Practicing [physicians](/usc/42/1301.md?p=a-7).
      - (iii) [Hospitals](/usc/42/300s–3.md?p=1).
      - (iv) Pharmacies.
      - (v) Practicing pharmacists.
      - (vi) Pharmacy benefit managers.
      - (vii) [State](/usc/42/619.md?p=5) boards of pharmacy.
      - (viii) [State](/usc/42/619.md?p=5) boards of medicine.
      - (ix) Experts on electronic prescribing.
      - (x) Other appropriate Federal [agencies](/usc/42/1397n–12.md?p=1).
    - (C) **Pilot project to test initial standards—**
      - (i) **In general—** During the 1-year period that begins on January 1, 2006, the [Secretary](/usc/42/1301.md?p=a-6) shall conduct a pilot [project](/usc/42/13641.md?p=2) to test the initial [standards](/usc/42/1320d.md?p=7) developed under [subparagraph (A)](#e-4-A) prior to the promulgation of the final uniform [standards](/usc/42/1320d.md?p=7) under [subparagraph (D)](#e-4-D) in order to provide for the efficient implementation of the requirements described in [paragraph (2)](#e-2).
      - (ii) **Exception—** Pilot testing of [standards](/usc/42/1320d.md?p=7) is not required under [clause (i)](#e-4-C-i) where there already is adequate industry experience with such [standards](/usc/42/1320d.md?p=7), as determined by the [Secretary](/usc/42/1301.md?p=a-6) after consultation with effected [standard setting organizations](/usc/42/1320d.md?p=8) and industry users.
      - (iii) **Voluntary participation of physicians and pharmacies—** In order to conduct the pilot [project](/usc/42/13641.md?p=2) under [clause (i)](#e-4-C-i), the [Secretary](/usc/42/1301.md?p=a-6) shall enter into agreements with [physicians](/usc/42/1301.md?p=a-7), [physician](/usc/42/1301.md?p=a-7) groups, pharmacies, [hospitals](/usc/42/300s–3.md?p=1), [PDP sponsors](/usc/42/1395w–151.md?p=a-13), MA organizations, and other appropriate entities under which health care professionals electronically transmit prescriptions to dispensing pharmacies and pharmacists in accordance with such [standards](/usc/42/1320d.md?p=7).
      - (iv) **Evaluation and report—**
        - (I) **Evaluation—** The [Secretary](/usc/42/1301.md?p=a-6) shall conduct an evaluation of the pilot [project](/usc/42/13641.md?p=2) conducted under [clause (i)](#e-4-C-i).
        - (II) **Report to Congress—** Not later than April 1, 2007, the [Secretary](/usc/42/1301.md?p=a-6) shall submit to Congress a report on the evaluation conducted under [subclause (I)](#e-4-C-iv-I).
    - (D) **Final standards—** Based upon the evaluation of the pilot [project](/usc/42/13641.md?p=2) under [subparagraph (C)(iv)(I)](#e-4-C-iv-I) and not later than April 1, 2008, the [Secretary](/usc/42/1301.md?p=a-6) shall promulgate uniform [standards](/usc/42/1320d.md?p=7) relating to the requirements described in [paragraph (2)](#e-2).
  - (5) **Relation to State laws—** The [standards](/usc/42/1320d.md?p=7) promulgated under this subsection shall supersede any [State](/usc/42/619.md?p=5) law or regulation that—
    - (A) is contrary to the [standards](/usc/42/1320d.md?p=7) or restricts the ability to carry out this part; and
    - (B) pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to [covered part D drugs](/usc/42/1395w–151.md?p=a-2) under this part.
  - (6) **Establishment of safe harbor—** The [Secretary](/usc/42/1301.md?p=a-6), in consultation with the Attorney General, shall promulgate regulations that provide for a safe harbor from sanctions under paragraphs (1) and (2) of [section 1320a–7b(b) of this title](/usc/42/1320a–7b.md?p=b) and an exception to the prohibition under subsection (a)(1) of [section 1395nn of this title](/usc/42/1395nn.md) with respect to the provision of nonmonetary remuneration (in the form of hardware, software, or information technology and training services) necessary and used solely to receive and transmit electronic prescription information in accordance with the [standards](/usc/42/1320d.md?p=7) promulgated under this subsection—
    - (A) in the case of a [hospital](/usc/42/300s–3.md?p=1), by the [hospital](/usc/42/300s–3.md?p=1) to members of its medical staff;
    - (B) in the case of a group practice (as defined in [section 1395nn(h)(4) of this title](/usc/42/1395nn.md?p=h-4)), by the practice to prescribing health care professionals who are members of such practice; and
    - (C) in the case of a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) or MA organization, by the sponsor or organization to pharmacists and pharmacies participating in the network of such sponsor or organization, and to prescribing health care professionals.
  - (7) **Requirement of e-prescribing for controlled substances—**
    - (A) **In general—** Subject to [subparagraph (B)](#e-7-B), a prescription for a [covered part D drug](/usc/42/1395w–151.md?p=a-2) under a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) (or under an [MA–PD plan](/usc/42/1395w–151.md?p=a-9)) for a schedule II, III, IV, or V [controlled substance](/usc/42/11851.md?p=2) shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription [drug](/usc/42/11851.md?p=4) program that meets the requirements of [paragraph (2)](#e-2).
    - (B) **Exception for certain circumstances—** The [Secretary](/usc/42/1301.md?p=a-6) shall, through rulemaking, specify circumstances and processes by which the [Secretary](/usc/42/1301.md?p=a-6) may waive the requirement under [subparagraph (A)](#e-7-A), with respect to a [covered part D drug](/usc/42/1395w–151.md?p=a-2), [including](/usc/42/1301.md?p=b) in the case of—
      - (i) a prescription issued when the practitioner and dispensing pharmacy are the same entity;
      - (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription [Drug](/usc/42/11851.md?p=4) Programs SCRIPT [Standard](/usc/42/1320d.md?p=7);
      - (iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the [Secretary](/usc/42/1301.md?p=a-6), not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;
      - (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved;
      - (v) a prescription issued by a practitioner prescribing a [drug](/usc/42/11851.md?p=4) under a research protocol;
      - (vi) a prescription issued by a practitioner for a [drug](/usc/42/11851.md?p=4) for which the Food and [Drug](/usc/42/11851.md?p=4) [Administration](/usc/42/1301.md?p=a-10) requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a [drug](/usc/42/11851.md?p=4) with risk evaluation and mitigation strategies that include elements to assure safe use;
      - (vii) a prescription issued by a practitioner—
        - (I) for an individual who receives hospice care under this subchapter; and
        - (II) that is not covered under the hospice benefit under this subchapter; and
      - (viii) a prescription issued by a practitioner for an individual who is—
        - (I) a resident of a [nursing facility](/usc/42/1397j.md?p=17-A) (as defined in [section 1396r(a) of this title](/usc/42/1396r.md?p=a)); and
        - (II) dually eligible for benefits under this subchapter and subchapter XIX.
    - (C) **Dispensing—**
      - (i) Nothing in this paragraph shall be construed as requiring a sponsor of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) under this part, MA organization offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a [covered part D drug](/usc/42/1395w–151.md?p=a-2), has a waiver (or is otherwise exempt) under [subparagraph (B)](#e-7-B) from the requirement under [subparagraph (A)](#e-7-A).
      - (ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense [covered part D drugs](/usc/42/1395w–151.md?p=a-2) from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations.
      - (iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a [covered part D drug](/usc/42/1395w–151.md?p=a-2) to designate a particular pharmacy to dispense the [covered part D drug](/usc/42/1395w–151.md?p=a-2) to the extent consistent with the requirements under [subsection (b)(1)](#b-1) and under this paragraph.
    - (D) **Enforcement—** The [Secretary](/usc/42/1301.md?p=a-6) shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under [subparagraph (A)](#e-7-A).
- (f) **Grievance mechanism—** Each [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall provide meaningful procedures for hearing and resolving grievances between the sponsor ([including](/usc/42/1301.md?p=b) any entity or individual through which the sponsor provides covered benefits) and enrollees with [prescription drug plans](/usc/42/1395w–151.md?p=a-14) of the sponsor under this part in accordance with [section 1395w–22(f) of this title](/usc/42/1395w–22.md?p=f).
- (g) **Coverage determinations and reconsiderations—**
  - (1) **Application of coverage determination and reconsideration provisions—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall meet the requirements of paragraphs (1) through (3) of [section 1395w–22(g) of this title](/usc/42/1395w–22.md?p=g) with respect to covered benefits under the [prescription drug plan](/usc/42/1395w–151.md?p=a-14) it offers under this part in the same manner as such requirements apply to an MA organization with respect to benefits it offers under an [MA plan](/usc/42/1395w–151.md?p=a-8) under part C.
  - (2) **Request for a determination for the treatment of tiered formulary drug—** In the case of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) that provides for tiered cost-sharing for [drugs](/usc/42/11851.md?p=4) included within a formulary and provides lower cost-sharing for preferred [drugs](/usc/42/11851.md?p=4) included within the formulary, a [part D eligible individual](/usc/42/1395w–151.md?p=a-4) who is enrolled in the plan may request an exception to the tiered cost-sharing structure. Under such an exception, a nonpreferred [drug](/usc/42/11851.md?p=4) could be covered under the terms applicable for preferred [drugs](/usc/42/11851.md?p=4) if the prescribing [physician](/usc/42/1301.md?p=a-7) determines that the preferred [drug](/usc/42/11851.md?p=4) for [treatment](/usc/42/11851.md?p=11) of the same condition either would not be as effective for the individual or would have adverse effects for the individual or both. A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall have an exceptions process under this paragraph consistent with guidelines established by the [Secretary](/usc/42/1301.md?p=a-6) for making a determination with respect to such a request. Denial of such an exception shall be treated as a coverage denial for purposes of applying [subsection (h)](#h).
- (h) **Appeals—**
  - (1) **In general—** Subject to [paragraph (2)](#h-2), a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) shall meet the requirements of paragraphs (4) and (5) of [section 1395w–22(g) of this title](/usc/42/1395w–22.md?p=g) with respect to benefits ([including](/usc/42/1301.md?p=b) a determination related to the application of tiered cost-sharing described in [subsection (g)(2)](#g-2)) in a manner similar (as determined by the [Secretary](/usc/42/1301.md?p=a-6)) to the manner such requirements apply to an MA organization with respect to benefits under the original medicare fee-for-service program option it offers under an [MA plan](/usc/42/1395w–151.md?p=a-8) under part C. In applying this paragraph only the [part D eligible individual](/usc/42/1395w–151.md?p=a-4) shall be entitled to bring such an appeal.
  - (2) **Limitation in cases on nonformulary determinations—** A [part D eligible individual](/usc/42/1395w–151.md?p=a-4) who is enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) may appeal under [paragraph (1)](#h-1) a determination not to provide for coverage of a [covered part D drug](/usc/42/1395w–151.md?p=a-2) that is not on the formulary under the plan only if the prescribing [physician](/usc/42/1301.md?p=a-7) determines that all [covered part D drugs](/usc/42/1395w–151.md?p=a-2) on any tier of the formulary for [treatment](/usc/42/11851.md?p=11) of the same condition would not be as effective for the individual as the nonformulary [drug](/usc/42/11851.md?p=4), would have adverse effects for the individual, or both.
  - (3) **Treatment of nonformulary determinations—** If a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) determines that a plan provides coverage for a [covered part D drug](/usc/42/1395w–151.md?p=a-2) that is not on the formulary of the plan, the [drug](/usc/42/11851.md?p=4) shall be treated as being included on the formulary for purposes of [section 1395w–102(b)(4)(C)(i) of this title](/usc/42/1395w–102.md?p=b-4-C-i).
- (i) **Privacy, confidentiality, and accuracy of enrollee records—** The provisions of [section 1395w–22(h) of this title](/usc/42/1395w–22.md?p=h) shall apply to a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) and [prescription drug plan](/usc/42/1395w–151.md?p=a-14) in the same manner as it applies to an MA organization and an [MA plan](/usc/42/1395w–151.md?p=a-8).
- (j) **Treatment of accreditation—** Subparagraph (A) of [section 1395w–22(e)(4) of this title](/usc/42/1395w–22.md?p=e-4) (relating to [treatment](/usc/42/11851.md?p=11) of accreditation) shall apply to a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) under this part with respect to the following requirements, in the same manner as it applies to an MA organization with respect to the requirements in subparagraph (B) (other than clause (vii) thereof) of such section:
  - (1) [Subsection (b)](#b) of this section (relating to access to [covered part D drugs](/usc/42/1395w–151.md?p=a-2)).
  - (2) [Subsection (c)](#c) of this section ([including](/usc/42/1301.md?p=b) quality assurance and medication therapy management).
  - (3) [Subsection (i)](#i) of this section (relating to confidentiality and accuracy of enrollee records).
- (k) **Public disclosure of pharmaceutical prices for equivalent drugs—**
  - (1) **In general—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall provide that each pharmacy that dispenses a [covered part D drug](/usc/42/1395w–151.md?p=a-2) shall inform an enrollee of any differential between the price of the [drug](/usc/42/11851.md?p=4) to the enrollee and the price of the lowest priced generic [covered part D drug](/usc/42/1395w–151.md?p=a-2) under the plan that is therapeutically equivalent and bioequivalent and available at such pharmacy.
  - (2) **Timing of notice—**
    - (A) **In general—** Subject to [subparagraph (B)](#k-2-B), the information under [paragraph (1)](#k-1) shall be provided at the time of purchase of the [drug](/usc/42/11851.md?p=4) involved, or, in the case of dispensing by mail order, at the time of delivery of such [drug](/usc/42/11851.md?p=4).
    - (B) **Waiver—** The [Secretary](/usc/42/1301.md?p=a-6) may waive [subparagraph (A)](#k-2-A) in such circumstances as the [Secretary](/usc/42/1301.md?p=a-6) may specify.
- (l) **Requirements with respect to sales and marketing activities—** The following provisions shall apply to a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) (and the agents, brokers, and other third parties representing such sponsor) in the same manner as such provisions apply to a Medicare Advantage organization (and the agents, brokers, and other third parties representing such organization):
  - (1) The prohibition under [section 1395w–21(h)(4)(C) of this title](/usc/42/1395w–21.md?p=h-4-C) on conducting activities described in [section 1395w–21(j)(1) of this title](/usc/42/1395w–21.md?p=j-1).
  - (2) The requirement under [section 1395w–21(h)(4)(D) of this title](/usc/42/1395w–21.md?p=h-4-D) to conduct activities described in [section 1395w–21(j)(2) of this title](/usc/42/1395w–21.md?p=j-2) in accordance with the limitations established under such subsection.
  - (3) The inclusion of the plan type in the plan name under [section 1395w–21(h)(6) of this title](/usc/42/1395w–21.md?p=h-6).
  - (4) The requirements regarding the appointment of agents and brokers and compliance with [State](/usc/42/619.md?p=5) information requests under subparagraphs (A) and (B), respectively, of [section 1395w–21(h)(7) of this title](/usc/42/1395w–21.md?p=h-7).
- (m) **Prohibition on limiting certain information on drug prices—** A [PDP sponsor](/usc/42/1395w–151.md?p=a-13) and a Medicare Advantage organization shall ensure that each [prescription drug plan](/usc/42/1395w–151.md?p=a-14) or [MA–PD plan](/usc/42/1395w–151.md?p=a-9) offered by the sponsor or organization does not restrict a pharmacy that dispenses a prescription [drug](/usc/42/11851.md?p=4) or biological from informing, nor penalize such pharmacy for informing, an enrollee in such plan of any differential between the negotiated price of, or copayment or coinsurance for, the [drug](/usc/42/11851.md?p=4) or biological to the enrollee under the plan and a lower price the individual would pay for the [drug](/usc/42/11851.md?p=4) or biological if the enrollee obtained the [drug](/usc/42/11851.md?p=4) without using any [health insurance coverage](/usc/42/1397jj.md?p=c-3).
- (n) **Program integrity transparency measures—** For program integrity transparency measures applied with respect to [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and [MA plans](/usc/42/1395w–151.md?p=a-8), see [section 1395w–28(i) of this title](/usc/42/1395w–28.md?p=i).
- (o) **Real-time benefit information—**
  - (1) **In general—** After the [Secretary](/usc/42/1301.md?p=a-6) has adopted a [standard](/usc/42/1320d.md?p=7) under [paragraph (3)](#o-3) for electronic real-time benefit tools, and at a time determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6), a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) of a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) shall implement one or more of such tools that meet the requirements described in [paragraph (2)](#o-2).
  - (2) **Requirements—** For purposes of [paragraph (1)](#o-1), the requirements described in this paragraph, with respect to an electronic real-time benefit tool, are that the tool is capable of—
    - (A) integrating with electronic prescribing and electronic health record systems of prescribing health care professionals for the transmission of formulary and benefit information in real time to such professionals; and
    - (B) with respect to a [covered part D drug](/usc/42/1395w–151.md?p=a-2), transmitting such information specific to an individual enrolled in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14), [including](/usc/42/1301.md?p=b) the following:
      - (i) A list of any clinically-appropriate alternatives to such [drug](/usc/42/11851.md?p=4) included in the formulary of such plan.
      - (ii) Cost-sharing information and the negotiated price for such [drug](/usc/42/11851.md?p=4) and such alternatives at multiple pharmacy options, [including](/usc/42/1301.md?p=b) the individual’s preferred pharmacy and, as applicable, other retail pharmacies and a mail order pharmacy.
      - (iii) The formulary status of such [drug](/usc/42/11851.md?p=4) and such alternatives and any prior authorization or other utilization management requirements applicable to such [drug](/usc/42/11851.md?p=4) and such alternatives included in the formulary of such plan.
  - (3) **Standards—** In order to be treated (for purposes of this subsection) as an electronic real-time benefit tool described in [paragraph (1)](#o-1), such tool shall comply with technical [standards](/usc/42/1320d.md?p=7) adopted by the [Secretary](/usc/42/1301.md?p=a-6) in consultation with the National Coordinator for [Health Information](/usc/42/1320d.md?p=4) Technology through notice and comment rulemaking. Such technical [standards](/usc/42/1320d.md?p=7) adopted by the [Secretary](/usc/42/1301.md?p=a-6) shall be developed by a [standards](/usc/42/1320d.md?p=7) development organization, such as the National Council for Prescription [Drug](/usc/42/11851.md?p=4) Programs, that consults with stakeholders such as [PDP sponsors](/usc/42/1395w–151.md?p=a-13), Medicare Advantage organizations, beneficiary advocates, health care professionals, and [health information](/usc/42/1320d.md?p=4) technology software vendors.
  - (4) **Rules of construction—** Nothing in this subsection shall be construed—
    - (A) to prohibit the application of paragraph (b)(7) of section 423.160 of title 42, Code of Federal Regulations, as is to be added to such section pursuant to the final rule published in the Federal Register on May 23, 2019, and titled “Modernizing Part D and Medicare Advantage To Lower [Drug](/usc/42/11851.md?p=4) Prices and Reduce Out-of-Pocket Expenses” (84 Fed. Reg. 23832 through 23884); or
    - (B) to allow a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) to use a real-time benefit tool to steer an individual, without the consent of the individual, to a particular pharmacy or pharmacy type over their preferred pharmacy or pharmacy type nor prohibit the designation of an individual’s preferred pharmacy under such tool.

## Footnotes

[^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.

## Source credit

(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–4, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2082; amended Pub. L. 110–275, title I, §§ 103(a)(2), (b)(2), (c)(2), (d)(2), 176, July 15, 2008, 122 Stat. 2499–2501, 2581; Pub. L. 111–148, title III, §§ 3307(a), 3310(a), 3312(a), title X, § 10328(a), Mar. 23, 2010, 124 Stat. 471, 475, 476, 964; Pub. L. 114–10, title V, § 507, Apr. 16, 2015, 129 Stat. 168; Pub. L. 114–198, title VII, § 704(a)(1), (2), (b), July 22, 2016, 130 Stat. 742–748; Pub. L. 115–123, div. E, title III, § 50354, Feb. 9, 2018, 132 Stat. 213; Pub. L. 115–262, § 2(a), Oct. 10, 2018, 132 Stat. 3670; Pub. L. 115–271, title II, §§ 2003(a), 2004, 2006, 2007(a), title VI, §§ 6062, 6063(c)–6065, 6102, 6103(b), Oct. 24, 2018, 132 Stat. 3926, 3928, 3930, 3986, 3989, 4004, 4005; Pub. L. 116–136, div. A, title III, § 3714(a), Mar. 27, 2020, 134 Stat. 424; Pub. L. 116–260, div. CC, title I, § 119(a), Dec. 27, 2020, 134 Stat. 2951; Pub. L. 117–169, title I, §§ 11001(b)(1)(E), 11201(e)(2), Aug. 16, 2022, 136 Stat. 1852, 1891; Pub. L. 119–75, div. J, title II, § 6223(a), (c)(1), Feb. 3, 2026, 140 Stat. 664, 667.)

## Notes

### Editorial Notes

### 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

2026—Subsec. (b)(1)(A). Pub. L. 119–75, § 6223(a), added subpar. (A) and struck out former subpar. (A). Prior to amendment, text read as follows: “A prescription drug plan shall permit the participation of any pharmacy that meets the terms and conditions under the plan.”

Subsec. (b)(1)(F). Pub. L. 119–75, § 6223(c)(1), added subpar. (F).

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: 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). Use of Funds.—Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance— to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids; to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids. 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. Geographic Distribution.—In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State. Definitions.—In this section: Eligible entity.—The term ‘eligible entity’ means— an organization— that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and that has at least— one individual who is a representative of consumers on its governing body; and one individual who is a representative of health care providers on its governing body; or 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.). 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. 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. 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: 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).Awarding of Grants.— 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. Considerations and preferences.—In awarding grants under this section, the Secretary shall— give special consideration to physicians who serve a disproportionate number of medicare patients; and give preference to physicians who serve a rural or underserved area. Limitation on grants.—Only 1 grant may be awarded under this section with respect to any physician or group practice of physicians.Terms and Conditions.— In general.—Grants under this section shall be made under such terms and conditions as the Secretary specifies consistent with this section. Use of grant funds.—Funds provided under grants under this section may be used for any of the following: For purchasing, leasing, and installing computer software and hardware, including handheld computer technologies. Making upgrades and other improvements to existing computer software and hardware to enable e-prescribing. Providing education and training to eligible physician staff on the use of technology to implement the electronic transmission of prescription and patient information. 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— evaluate the project for which the grant is made; and ensure that funding provided under the grant is expended only for the purposes for which it is made. Audit.—The Secretary shall conduct appropriate audits of grants under this section. 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. 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.”