---
kind: "section"
citation: "42 U.S.C. § 1396w–3a"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1396w–3a"
heading: "Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1396w-3a"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XIX — Grants to States for Medical Assistance Programs"
---

# §1396w–3a. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

- (a) **In general—** Subject to [subsection (d)](#d), beginning October 1, 2021, a [State](/usc/42/619.md?p=5)—
  - (1) shall require each covered provider to check, in accordance with such timing, manner, and form as specified by the [State](/usc/42/619.md?p=5), the prescription [drug](/usc/42/11851.md?p=4) history of a covered individual being treated by the covered provider through a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in [subsection (b)](#b) before prescribing to such individual a [controlled substance](/usc/42/11851.md?p=2); and
  - (2) in the case that such a provider is not able to conduct such a check despite a good faith effort by such provider—
    - (A) shall require the provider to document such good faith effort, [including](/usc/42/1301.md?p=b) the reasons why the provider was not able to conduct the check; and
    - (B) may require the provider to submit, upon request, such documentation to the [State](/usc/42/619.md?p=5).
- (b) **Qualified prescription drug monitoring program described—** A qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in this subsection is, with respect to a [State](/usc/42/619.md?p=5), a prescription [drug](/usc/42/11851.md?p=4) monitoring program administered by the [State](/usc/42/619.md?p=5) that, at a minimum, satisfies each of the following criteria:
  - (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible:
    - (A) Information regarding the prescription [drug](/usc/42/11851.md?p=4) history of a covered individual with respect to [controlled substances](/usc/42/11851.md?p=2).
    - (B) The number and type of [controlled substances](/usc/42/11851.md?p=2) prescribed to and filled for the covered individual during at least the most recent 12-month period.
    - (C) The name, location, and contact information (or other identifying number selected by the [State](/usc/42/619.md?p=5), such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a [controlled substance](/usc/42/11851.md?p=2) to the covered individual during at least the most recent 12-month period.
  - (2) The program facilitates the integration of information described in [paragraph (1)](#b-1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe [controlled substances](/usc/42/11851.md?p=2).

  A qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in this subsection, with respect to a [State](/usc/42/619.md?p=5), may have in place, in accordance with applicable [State](/usc/42/619.md?p=5) and Federal law, a data-sharing agreement with the [State](/usc/42/619.md?p=5) Medicaid program that allows the medical [director](/usc/42/11851.md?p=5) and pharmacy [director](/usc/42/11851.md?p=5) of such program (and any designee of such a [director](/usc/42/11851.md?p=5) who reports directly to such [director](/usc/42/11851.md?p=5)) to access the information described in [paragraph (1)](#b-1) in an electronic format. The [State](/usc/42/619.md?p=5) Medicaid program under this subchapter may facilitate reasonable and limited access, as determined by the [State](/usc/42/619.md?p=5) and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program for the medical [director](/usc/42/11851.md?p=5) or pharmacy [director](/usc/42/11851.md?p=5) of any managed care entity (as defined under [section 1396u–2(a)(1)(B) of this title](/usc/42/1396u–2.md?p=a-1-B)) that has a contract with the [State](/usc/42/619.md?p=5) under [section 1396b(m) of this title](/usc/42/1396b.md?p=m) or under [section 1396d(t)(3) of this title](/usc/42/1396d.md?p=t-3), or the medical [director](/usc/42/11851.md?p=5) or pharmacy [director](/usc/42/11851.md?p=5) of any entity that has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the [State](/usc/42/619.md?p=5) plan (or under a waiver of the [State](/usc/42/619.md?p=5) plan). All applicable [State](/usc/42/619.md?p=5) and Federal security and privacy laws shall apply to the [directors](/usc/42/11851.md?p=5) or designees of such [directors](/usc/42/11851.md?p=5) of any [State](/usc/42/619.md?p=5) Medicaid program or entity accessing a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program under this section.

- (c) **Application of privacy rules clarification—** 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 [subsection (b)](#b) in the same manner as the [Secretary](/usc/42/1301.md?p=a-6) is required under subparagraph (J) of [section 1395w–104(c)(5) of this title](/usc/42/1395w–104.md?p=c-5) to clarify privacy requirements related to the sharing of data described in such subparagraph.
- (d) **Ensuring access—** In order to ensure reasonable access to health care, the [Secretary](/usc/42/1301.md?p=a-6) shall waive the application of the requirement under [subsection (a)](#a), with respect to a [State](/usc/42/619.md?p=5), 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 (as defined for purposes of [section 1395w–104(c)(5)(D)(ii)(II) of this title](/usc/42/1395w–104.md?p=c-5-D-ii-II)).
- (e) **Reports—**
  - (1) **State reports—** Each [State](/usc/42/619.md?p=5) shall include in the annual report submitted to the [Secretary](/usc/42/1301.md?p=a-6) under [section 1396r–8(g)(3)(D) of this title](/usc/42/1396r–8.md?p=g-3-D), beginning with such reports submitted for 2023, information [including](/usc/42/1301.md?p=b), at a minimum, the following information for the most recent 12-month period:
    - (A) The percentage of covered providers (as determined pursuant to a process established by the [State](/usc/42/619.md?p=5)) who checked the prescription [drug](/usc/42/11851.md?p=4) history of a covered individual through a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in [subsection (b)](#b) before prescribing to such individual a [controlled substance](/usc/42/11851.md?p=2).
    - (B) Aggregate trends with respect to prescribing [controlled substances](/usc/42/11851.md?p=2) such as—
      - (i) the quantity of daily morphine milligram equivalents prescribed for [controlled substances](/usc/42/11851.md?p=2);
      - (ii) the number and quantity of daily morphine milligram equivalents prescribed for [controlled substances](/usc/42/11851.md?p=2) per covered individual; and
      - (iii) the types of [controlled substances](/usc/42/11851.md?p=2) prescribed, [including](/usc/42/1301.md?p=b) the dates of such prescriptions, the supplies authorized ([including](/usc/42/1301.md?p=b) the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this subchapter and subchapter XVIII).
    - (C) Whether or not the [State](/usc/42/619.md?p=5) requires (and a detailed explanation as to why the [State](/usc/42/619.md?p=5) does or does not require) pharmacists to check the prescription [drug](/usc/42/11851.md?p=4) history of a covered individual through a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in [subsection (b)](#b) before dispensing a [controlled substance](/usc/42/11851.md?p=2) to such individual.
    - (D) An accounting of any data or privacy breach of a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program described in [subsection (b)](#b), the number of covered individuals impacted by each such breach, and a description of the steps the [State](/usc/42/619.md?p=5) has taken to address each such breach, [including](/usc/42/1301.md?p=b), to the extent required by [State](/usc/42/619.md?p=5) or Federal law or otherwise determined appropriate by the [State](/usc/42/619.md?p=5), alerting any such impacted individual and [law enforcement](/usc/42/1397j.md?p=13) of the breach.
  - (2) **Report by CMS—** Not later than October 1, 2023, the [Administrator](/usc/42/4005.md?p=1) of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report [including](/usc/42/1301.md?p=b) the following information:
    - (A) Guidance for [States](/usc/42/619.md?p=5) on how [States](/usc/42/619.md?p=5) can increase the percentage of covered providers who use qualified prescription [drug](/usc/42/11851.md?p=4) monitoring programs described in [subsection (b)](#b).
    - (B) Best [practices](/usc/42/17061.md?p=19) for how [States](/usc/42/619.md?p=5) and covered providers should use such qualified prescription [drug](/usc/42/11851.md?p=4) monitoring programs to reduce the occurrence of [abuse](/usc/42/1397j.md?p=1) of [controlled substances](/usc/42/11851.md?p=2).
- (f) **Increase to FMAP and Federal matching rates for certain expenditures relating to qualified prescription drug monitoring programs—**
  - (1) **In general—** With respect to a [State](/usc/42/619.md?p=5) that meets the condition described in [paragraph (2)](#f-2) and any quarter occurring during [fiscal year](/usc/42/619.md?p=3) 2019 or [fiscal year](/usc/42/619.md?p=3) 2020, the [Federal medical assistance percentage](/usc/42/1396d.md?p=b) or Federal matching rate that would otherwise apply to such [State](/usc/42/619.md?p=5) under [section 1396b(a) of this title](/usc/42/1396b.md?p=a) for such quarter, with respect to expenditures by the [State](/usc/42/619.md?p=5) for activities under the [State](/usc/42/619.md?p=5) plan (or a waiver of such plan) to design, develop, or implement a prescription [drug](/usc/42/11851.md?p=4) monitoring program (and to make connections to such program) that satisfies the criteria described in paragraphs [(1)](#b-1) and [(2)](#b-2) of subsection (b), shall be equal to 100 percent.
  - (2) **Condition—** The condition described in this paragraph, with respect to a [State](/usc/42/619.md?p=5), is that the [State](/usc/42/619.md?p=5) (in this paragraph referred to as the “administering [State](/usc/42/619.md?p=5)”) has in place agreements with all [States](/usc/42/619.md?p=5) that are contiguous to such administering [State](/usc/42/619.md?p=5) that, when combined, enable covered providers in all such contiguous [States](/usc/42/619.md?p=5) to access, through the prescription [drug](/usc/42/11851.md?p=4) monitoring program, the information that is described in [subsection (b)(1)](#b-1) of covered individuals of such administering [State](/usc/42/619.md?p=5) and that covered providers in such administering [State](/usc/42/619.md?p=5) are able to access through such program.
- (g) **Rule of construction—** Nothing in this section prevents a [State](/usc/42/619.md?p=5) from requiring pharmacists to check the prescription [drug](/usc/42/11851.md?p=4) history of covered individuals through a qualified prescription [drug](/usc/42/11851.md?p=4) monitoring program before dispensing [controlled substances](/usc/42/11851.md?p=2) to such individuals.
- (h) **Definitions—** In this section:
  - (1) **Controlled substance—** The term “[controlled substance](/usc/42/11851.md?p=2)” means a [drug](/usc/42/11851.md?p=4) that is included in schedule II of [section 812(c) of title 21](/usc/21/812.md?p=c) and, at the option of the [State](/usc/42/619.md?p=5) involved, a [drug](/usc/42/11851.md?p=4) included in schedule III or IV of such section.
  - (2) **Covered individual—** The term “covered individual” means, with respect to a [State](/usc/42/619.md?p=5), an individual who is enrolled in the [State](/usc/42/619.md?p=5) plan (or under a waiver of such plan). Such term does not include an individual who—
    - (A) is receiving—
      - (i) hospice or palliative care; or
      - (ii) [treatment](/usc/42/11851.md?p=11) for cancer;
    - (B) 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
    - (C) the [State](/usc/42/619.md?p=5) elects to treat as exempted from such term.
  - (3) **Covered provider—**
    - (A) **In general—** The term “covered provider” means, subject to [subparagraph (B)](#h-3-B), with respect to a [State](/usc/42/619.md?p=5), a [health care provider](/usc/42/1320d.md?p=3) who is participating under the [State](/usc/42/619.md?p=5) plan (or waiver of the [State](/usc/42/619.md?p=5) plan) and licensed, registered, or otherwise permitted by the [State](/usc/42/619.md?p=5) to prescribe a [controlled substance](/usc/42/11851.md?p=2) (or the designee of such provider).
    - (B) **Exceptions—**
      - (i) **In general—** Beginning October 1, 2021, for purposes of this section, such term does not include a [health care provider](/usc/42/1320d.md?p=3) included in any type of [health care provider](/usc/42/1320d.md?p=3) determined by the [Secretary](/usc/42/1301.md?p=a-6) to be exempt from application of this section under [clause (ii)](#h-3-B-ii).
      - (ii) **Exceptions process—** Not later than October 1, 2020, the [Secretary](/usc/42/1301.md?p=a-6), after consultation with the National Association of Medicaid [Directors](/usc/42/11851.md?p=5), national [health care provider](/usc/42/1320d.md?p=3) associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of [health care providers](/usc/42/1320d.md?p=3) (if any) that should be exempted from the definition of the term “covered provider” for purposes of this section.

## Source credit

(Aug. 14, 1935, ch. 531, title XIX, § 1944, as added Pub. L. 115–271, title V, § 5042(a), Oct. 24, 2018, 132 Stat. 3967.)

## Notes

### Editorial Notes

### References in Text

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (c), is section 264(c) of Pub. L. 104–191, title II, Aug. 21, 1996, 110 Stat. 2033, which is set out as a note under section 1320d–2 of this title.

### Statutory Notes and Related Subsidiaries

### Guidance

Pub. L. 115–271, title V, § 5042(b), Oct. 24, 2018, 132 Stat. 3970, provided that: “Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs.”

### Development of Model State Practices

Pub. L. 115–271, title V, § 5042(c), Oct. 24, 2018, 132 Stat. 3970, provided that: In general.—Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data-sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act [42 U.S.C. 1396w–3a(b)], as added by subsection (a), for the following purposes: Monitoring and preventing fraud, waste, and abuse. Improving health care for individuals enrolled in a State plan under title XIX of such Act [42 U.S.C. 1396 et seq.] (or under a waiver of such plan) who— transition in and out of coverage under such title; may have sources of health care coverage in addition to coverage under such title; or pay for prescription drugs with cash. Any other purposes specified by the Secretary. Elements of model practices.—The model practices described in paragraph (1)— shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and shall include any appropriate beneficiary protections and privacy guidelines. Consultation.—In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act [42 U.S.C. 1396u–2(a)(1)(B)]) with contracts with States pursuant to section 1903(m) of such Act [42 U.S.C. 1396b(m)], pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records.”