(a) General rules. (1) Part D sponsors must establish and maintain an electronic prescription drug program that complies with the applicable standards in paragraph (b) of this section when transmitting, directly or through an intermediary, prescriptions and prescription-related information using electronic media for covered Part D drugs for Part D eligible individuals.

(2) Except as provided in paragraph (a)(3) of this section, prescribers and dispensers that transmit, directly or through an intermediary, prescriptions and prescription-related information using electronic media (including entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider, such as a nursing facility, that in turn forwards the prescription to a dispenser), must comply with the applicable standards in paragraph (b) of this section when e-prescribing for covered Part D drugs for Part D eligible individuals.

(3)(i) Entities transmitting prescriptions or prescription-related information must utilize the NCPDP SCRIPT standard, consistent with paragraph (b)(1) of this section, in all instances other than temporary/transient network transmission failures.

(ii) Electronic transmission of prescriptions or prescription-related information by means of computer-generated facsimile is only permitted in instances of temporary/transient transmission failure and communication problems that would preclude the use of the NCPDP SCRIPT standard adopted by this section.

(iii) Entities may use either HL7 messages or the NCPDP SCRIPT standard to transmit prescriptions or prescription-related information internally when the sender and the recipient are part of the same legal entity. If an entity sends prescriptions outside the entity (for example, from an HMO to a non-HMO pharmacy), it must use the adopted NCPDP SCRIPT standard or other applicable adopted standards. Any pharmacy within an entity must be able to receive electronic prescription transmittals for Medicare beneficiaries from outside the entity using the adopted NCPDP SCRIPT standard. This exemption does not supersede any HIPAA requirement that may require the use of a HIPAA transaction standard within an organization.

(4) In accordance with section 1860D-4(e)(5) of the Act, the standards under this paragraph (b) of this section supersede any State law or regulation that—

(i) Is contrary to the standards or restricts the ability to carry out Part D of Title XVIII of the Act; and

(ii) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered Part D drugs under Part D of Title XVIII of the Act.

(5) Beginning on January 1, 2021, prescribers must, except in the circumstances described in paragraphs (a)(5)(i) through (iii) of this section, conduct prescribing for at least 70 percent of their Schedule II, III, IV, and V controlled substances that are Part D drugs electronically using the applicable standards in paragraph (b) of this section, subject to the exemption in paragraph (a)(3)(iii) of this section. Prescriptions written for a beneficiary in a long-term care facility will not be included in determining compliance until January 1, 2025. Compliance actions against prescribers who do not meet the compliance threshold based on prescriptions written for a beneficiary in a long-term care facility will commence on or after January 1, 2025. Compliance actions against prescribers who do not meet the compliance threshold based on other prescriptions will commence on or after January 1, 2023. Prescribers will be exempt from this requirement in the following situations:

(i) Prescriber issues 100 or fewer controlled substance prescriptions for Part D drugs per calendar year as determined using CMS claims data with dates of service as of December 31st of the current year.

(ii) Prescriber has an address in PECOS in the geographic area of an emergency or disaster declared by a Federal, State, or local government entity. If a prescriber does not have an address in PECOS, prescriber has an address in NPPES in the geographic area of an emergency or disaster declared by a Federal, State, or local government entity. Starting in the 2024 measurement year, CMS will identify which emergencies or disasters qualify for this exception.

(iii) Prescriber has received a CMS-approved waiver because the prescriber is unable to conduct electronic prescribing of controlled substances (EPCS) due to circumstances beyond the prescriber's control.

(b) Standards—(1) Prescriptions, electronic prior authorization, and medication history. The communication of a prescription or prescription-related information must comply with a standard in 45 CFR 170.205(b) (incorporated by reference, see paragraph (c) of this section) for the following transactions, as applicable to the version of the standard in use:

(i)(A) GetMessage.

(B) Status.

(C) Error.

(D) RxChangeRequest and RxChangeResponse.

(E) RxRenewalRequest and RxRenewalResponse.

(F) Resupply.

(G) Verify.

(H) CancelRx and CancelRxResponse.

(I) RxFill.

(J) DrugAdministration.

(K) NewRxRequest.

(L) NewRx.

(M) NewRxResponseDenied.

(N) RxTransferInitiationRequest.

(O) RxTransfer.

(P) RxTransferConfirm.

(Q) RxFillIndicatorChange.

(R) Recertification.

(S) REMSInitiationRequest and REMSInitiationResponse.

(T) REMSRequest and REMSResponse.

(U) RxHistoryRequest and RxHistoryResponse.

(V) PAInitiationRequest and PAInitiationResponse.

(W) PARequest and PAResponse.

(X) PAAppealRequest and PAAppealResponse.

(Y) PACancelRequest and PACancelResponse.

(Z) PANotification.

(ii) [Reserved]

(2) Eligibility. Eligibility inquiries and responses between the Part D sponsor and prescribers and between the Part D sponsor and dispensers must comply with 45 CFR 162.1202.

(3) Formulary and benefits. The National Council for Prescription Drug Programs Formulary and Benefits Standard, Implementation Guide, Version 3, Release 0 (Version 3.0), (incorporated by reference, see paragraph (c)) of this section) or comply with a standard in 45 CFR 170.205(u) (incorporated by reference, see paragraph (c) of this section) for transmitting formulary and benefits information between prescribers and Part D sponsors. Beginning January 1, 2027, transmission of formulary and benefit information between prescribers and Part D sponsors must comply with a standard in 45 CFR 170.205(u) (incorporated by reference, see paragraph (c) of this section).

(4) Provider identifier. The National Provider Identifier (NPI), as defined at 45 CFR 162.406, to identify an individual health care provider to Medicare Part D sponsors, prescribers and dispensers, in electronically transmitted prescriptions or prescription-related materials for Medicare Part D covered drugs for Medicare Part D eligible individuals.

(5) Real-time benefit tools. Part D sponsors must implement one or more electronic real-time benefit tools (RTBT) that are capable of integrating with at least one prescriber's e-Prescribing (eRx) system or electronic health record (EHR) to provide complete, accurate, timely, clinically appropriate, patient-specific formulary and benefit information to the prescriber in real time for assessing coverage under the Part D plan. Such information must include enrollee cost-sharing information, clinically appropriate formulary alternatives, when available, and the formulary status of each drug presented including any utilization management requirements applicable to each alternative drug. Beginning January 1, 2027, Part D sponsors' RTBT must comply with a standard in 45 CFR 170.205(c) (incorporated by reference, see paragraph (c) of this section).

(c) Incorporation by reference. The material listed in this paragraph (c) is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Centers for Medicare & Medicaid Services (CMS) and at the National Archives and Records Administration (NARA). Contact CMS at: CMS 7500 Security Boulevard, Baltimore, Maryland 21244; phone: (410) 786-4132 or (877) 267-2323; email: [email protected]. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be obtained from National Council for Prescription Drug Programs (NCPDP), Incorporated, 9240 E Raintree Drive, Scottsdale, AZ 85260-7518; phone: (480) 477-1000; email: [email protected]; website: www.ncpdp.org.

(1) NCPDP Formulary and Benefit Standard, Implementation Guide, Version 3, Release 0 (Version 3.0), ANSI-approved January 28, 2011.

(2) NCPDP SCRIPT Standard, Implementation Guide Version 2017071, ANSI-approved July 28, 2017.

(3) NCPDP SCRIPT Standard, Implementation Guide Version 2023011, ANSI-approved January 17, 2023.

(4) NCPDP Real-Time Prescription Benefit Standard, Implementation Guide Version 13, ANSI-approved May 19, 2022.

(5) NCPDP Formulary and Benefit Standard, Implementation Guide Version 60, ANSI-approved April 12, 2023.