42 U.S.C. § 1396w–3a — Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

(a) General rule. Subject to (d), beginning October 1, 2021, a State must (1) require each covered provider, at the State’s specified time, method, and form, to check through a qualified prescription-drug-monitoring program the prescription history of a covered individual being treated before prescribing that person a controlled substance; and (2) if the provider cannot check despite a good-faith effort, (A) require documentation of the effort and reasons for failure, and (B) optionally require the provider to submit it on request. (b) Qualified program. A State-administered program qualifies if, at minimum, it gives covered providers access, as close to real time as possible, to (1)(A) the covered person’s controlled-substance prescription history, (B) the number and types of controlled substances prescribed and filled during at least the latest 12 months, and (C) each prescribing covered provider’s name, location, contact information, or a State-selected identifier such as a CMS National Provider Identifier, for at least that period; and (2) integrates the information into the provider’s workflow, potentially including the electronic prescribing system. Subject to State and Federal law, the program may have a data-sharing agreement with the State Medicaid program allowing its medical and pharmacy directors, and direct-report designees, electronic access. The State Medicaid program may provide reasonable, limited access, as the State decides and with documented beneficiary protections, to the medical or pharmacy director of a contracted managed-care entity, or of an entity managing pharmaceutical benefits for people enrolled in the State plan or waiver. All applicable State and Federal security and privacy laws apply to those directors and designees. (c) Privacy clarification. The Secretary must clarify privacy requirements, including HIPAA-regulation requirements under section 264(c) of the 1996 Act, for sharing subsection (b) data in the same way required by section 1395w–104(c)(5)(J) for the data there. (d) Access exceptions. To preserve reasonable health-care access, the Secretary must waive subsection (a)’s State requirement for natural disasters and similar situations and for emergency services as defined in section 1395w–104(c)(5)(D)(ii)(II). (e) Reports. (1) Beginning with 2023 reports, each State’s annual report under section 1396r–8(g)(3)(D) must include, for the latest 12 months, at least (A) the percentage of covered providers, measured under a State process, who checked before prescribing; (B) aggregate controlled-substance prescribing trends, including (i) daily morphine-milligram-equivalent quantity, (ii) number and daily morphine-milligram-equivalent quantity per covered person, and (iii) types prescribed, prescription dates, authorized supplies and durations, and validity periods in different populations such as older people, disabled people, and people enrolled in both Medicaid and Medicare; (C) whether pharmacists must check before dispensing, with a detailed explanation why the State does or does not require it; and (D) each program data or privacy breach, affected-person count, and steps taken, including alerting affected people and law enforcement when required or otherwise appropriate. (2) By October 1, 2023, the CMS Administrator must publish on CMS’s public website a report containing State guidance for increasing provider use and best practices for States and providers to reduce controlled-substance abuse. (f) Temporary 100-percent matching. (1) For a State meeting (2), for a quarter in fiscal year 2019 or 2020, the FMAP or Federal matching rate otherwise applicable under section 1396b(a) is 100 percent for State-plan or waiver spending to design, develop, or implement a program, and connect to it, that meets (b)(1) and (2). (2) The condition is that the administering State has agreements with every contiguous State that together let providers in all contiguous States access through the program the (b)(1) information about the administering State’s covered people, while providers in the administering State can access it through the program. (g) Construction. A State may require pharmacists to check a covered person’s history before dispensing controlled substances. (h) Definitions. (1) “Controlled substance” means a drug in schedule II of section 812(c) of title 21 and, if the State chooses, a drug in schedule III or IV. (2) “Covered individual” means a person enrolled in the State plan or waiver, except a person (A) receiving (i) hospice or palliative care or (ii) cancer treatment; (B) living in a long-term-care facility, a section 1396d(d) facility, or another facility where frequently abused drugs are dispensed through a single-pharmacy contract; or (C) whom the State elects to exempt. (3)(A) “Covered provider,” subject to (B), means a State-plan or waiver health-care provider licensed, registered, or otherwise permitted by the State to prescribe a controlled substance, or that provider’s designee. (B)(i) Beginning October 1, 2021, it excludes a provider type the Secretary exempts under (ii). (ii) By October 1, 2020, after consulting the National Association of Medicaid Directors, national provider associations, Medicaid-beneficiary advocates, and rare-disease advocates, the Secretary must decide, based on those consultations, which provider types, if any, should be exempt.