§410.78. Telehealth services. — Inbound Citations

(a) services. Medicare Part B pays for MNT services provided by a registered dietitian or nutrition professional as defined in § 410.134 when the beneficiary is referred for the service by a physician.

(ii) If it is a telehealth encounter, the requirements of §§ 410.78 and 414.65 of this chapter must be met.

(e) MNT and DSMT services may be provided as telehealth services (meeting the requirements in § 410.78) when registered dietitians or nutrition professionals act as distant site practitioners.

(A) The facility practice expense RVUs apply to services furnished to patients in a hospital, a skilled nursing facility, a community mental health center, a hospice, or an ambulatory surgical center, or in a wholly owned or wholly operated entity providing preadmission services under § 412.2(c)(5) of this chapter, or via telehealth under § 410.78 of this chapter.

(a) The Medicare payment amount for telehealth services described under § 410.78 of this chapter is equal to the current fee schedule amount applicable for the service of the physician or practitioner, subject to paragraphs (a)(1) and (2) of this section, but must be made in accordance with the following limitations:

(1) Only the physician or practitioner at the distant site may bill and receive payment for the professional service via an interactive telecommunications system.

(2) Payments made to the physician or practitioner at the distant site, including deductible and coinsurance, for the professional service may not be shared with the referring practitioner or telepresenter.

(A) (1) 99421, 99422, and 99423 (codes for online digital evaluation and management services).

(2) 99441, 99442, and 99443 (codes for telephone evaluation and management services). These codes are used in determining beneficiary assignment as specified in paragraphs (c)(2)(i) and (ii) of this section and until they are no longer payable under Medicare fee-for-service payment policies as specified under section 1834(m) of the Act and §§ 410.78 and 414.65 of this subchapter.

(j) Prior to January 15, 2010, or as otherwise specified by regulation prior to that date, instead of the definition in paragraph (i), the term practice of telemedicine means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (as that term is defined in section 102 of the Act (21 U.S.C. 802)) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommunications system that satisfies the requirements of section 410.78(a)(3) of title 42, Code of Federal Regulations.

(b) A practitioner may issue a prescription for schedule III-V controlled substances listed in 42 CFR 8.12(h)(2) as approved by the Food and Drug Administration (FDA) for use in the treatment of Opioid Use Disorder (OUD), defined as the use of an effective medication such as buprenorphine to treat OUD, pursuant to a communication between the prescribing practitioner and the patient using an interactive telecommunications system, including an audio-only telecommunications system, as described in 42 CFR 410.78(a)(3), if the following conditions are met:

(1) The prescribing practitioner must be authorized to access the applicable prescription drug monitoring program (PDMP) data of the state in which the patient is located at the time of the telemedicine encounter. The prescribing practitioner shall review such data regarding any controlled substance prescriptions issued to the patient in the last year, or, if less than one year of data is available, in the entire available period. The prescribing practitioner shall ensure the date and time of such a review is annotated in the patient's electronic health record (EHR) or paper record. This review, or attempted review, must be conducted prior to issuing a prescription in a manner authorized under this section.

(2) The practitioner may issue prescriptions to the patient pursuant to this section for a period not to exceed six calendar months beginning on the date the first prescription is issued. The practitioner may issue additional prescriptions to the patient for schedule III-V controlled substances approved by the FDA for use in the treatment of OUD either:

(i) After the prescribing practitioner has conducted at least one in-person medical evaluation of the patient, as defined in 21 U.S.C. 829(e)(2)(B); or

(ii) As otherwise authorized by 21 U.S.C. 829(e), including pursuant to any other form of telemedicine as defined in 21 U.S.C. 802(54) or pursuant to practices as determined by regulation issued pursuant to 21 U.S.C. 829(e)(3)(B).

(3) If the PDMP data is inaccessible or unavailable for any reason, the prescribing practitioner shall annotate in the patient's EHR or paper record the date and time that an attempt to view the PDMP data was made and the reason the data could not be reviewed. A practitioner may prescribe a seven-day supply of medication and must perform another PDMP review before prescribing another seven-day supply. Each time the PDMP is reviewed or attempted to be reviewed, the date and time must be annotated in the patient's EHR. A seven-day supply prescribed pursuant to this paragraph (b)(3) counts toward the time limit described in paragraph (b)(2) of this section.

(4) The pharmacist shall verify the identity of the patient prior to filling a controlled substance prescription issued under the authority of this section. The pharmacist shall verify the identity of the patient with a state or Federal Government-issued photographic identification card or other form of identification. For the purposes of verifying the identity of the patient, the pharmacist may accept identification in the manner described herein from any qualifying “ultimate user” as defined in 21 U.S.C. 802(27) prior to filling the prescription.

(5) Controlled substance prescriptions issued pursuant to this section may only be issued for the treatment of OUD, and subject to the requirements of this section.

(6) The practitioner must be:

(i) Authorized under §§ 1301.11, 1301.12(a), and 1301.13(e)(1)(iv) of this chapter to prescribe the basic class of controlled substance specified on the prescription; or

(ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d).

(7) The issuance of the controlled substance prescription otherwise complies with the requirements set forth in this part.

(2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3);

(2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3);

(b) A practitioner may issue a prescription for schedule III-V controlled substances listed in 42 CFR 8.12(h)(2) as approved by the Food and Drug Administration (FDA) for use in the treatment of Opioid Use Disorder (OUD), defined as the use of an effective medication such as buprenorphine to treat OUD, pursuant to a communication between the prescribing practitioner and the patient using an interactive telecommunications system, including an audio-only telecommunications system, as described in 42 CFR 410.78(a)(3), if the following conditions are met:

(1) The prescribing practitioner must be authorized to access the applicable prescription drug monitoring program (PDMP) data of the state in which the patient is located at the time of the telemedicine encounter. The prescribing practitioner shall review such data regarding any controlled medication prescriptions issued to the patient in the last year, or, if less than one year of data is available, in the entire available period. The prescribing practitioner shall ensure the date and time of such a review is annotated in the patient's electronic health record (EHR) or paper record. This review, or attempted review, must be conducted prior to issuing a prescription in a manner authorized under this section.

(2) The practitioner may issue prescriptions to the patient pursuant to this section for a period not to exceed six calendar months beginning on the date the first prescription is issued. The practitioner may issue additional prescriptions to the patient for schedule III-V controlled substances approved by the FDA for use in the treatment of OUD either:

(i) As authorized by 21 U.S.C. 829(e), including pursuant to any other form of telemedicine as defined in 21 U.S.C. 802(54) or pursuant to practices as determined by regulation issued pursuant to 21 U.S.C. 829(e)(3)(B); or

(ii) After the prescribing practitioner has conducted at least one in-person medical evaluation of the patient, as defined in 21 U.S.C. 829(e)(2)(B).

(3) If the PDMP data is inaccessible or unavailable for any reason, the prescribing practitioner shall annotate in the patient's EHR or paper record the date and time that an attempt to view the PDMP data was made and the reason the data could not be reviewed. A practitioner may prescribe a seven-day supply of medication and must perform another PDMP review before prescribing another seven-day supply. Each time the PDMP is reviewed or attempted to be reviewed, the date and time must be annotated in the patient's EHR. A seven-day supply prescribed pursuant to this paragraph (b)(3) counts toward the time limit described in paragraph (b)(2) of this section.

(4) The pharmacist shall verify the identity of the patient prior to filling a controlled medication prescription issued under the authority of this section. The pharmacist shall verify the identity of the patient with a state or Federal Government-issued photographic identification card or other form of identification. For the purposes of verifying the identity of the patient, the pharmacist may accept identification in the manner described herein from any qualifying “ultimate user” as defined in 21 U.S.C. 802(27) prior to filling the prescription.

(5) Controlled medication prescriptions issued pursuant to this section may only be issued for the treatment of OUD.

(6) The practitioner must be:

(i) Authorized under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled medication specified on the prescription; or

(ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d).

(7) The issuance of the controlled substance prescription otherwise complies with the requirements set forth in 21 CFR part 1306.

(5) Beginning the upon the expiration of the Public Health Emergency (PHE) for the COVID-19 pandemic, CMS waives the geographic and site of service originating site requirements in sections 1834(m)(4)(B) and 1834(m)(4)(C) of the Act and § 410.78(b)(3) and (4) of this chapter for purposes of kidney disease patient education services furnished by qualified staff via telehealth in accordance with this section, regardless of the location of the beneficiary or qualified staff. Beginning the upon the expiration of the Public Health Emergency (PHE) for the COVID-19 pandemic, CMS also waives the requirement in section 1834(m)(2)(B) of the Act and § 414.65(b) of this chapter that CMS pay a facility fee to the originating site with respect to telehealth services furnished to a beneficiary in accordance with this section at an originating site that is not one of the locations specified in § 410.78(b)(3) of this chapter.

(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.

(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.

(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.

(5) Beginning the upon the expiration of the Public Health Emergency (PHE) for the COVID-19 pandemic, CMS waives the geographic and site of service originating site requirements in sections 1834(m)(4)(B) and 1834(m)(4)(C) of the Act and § 410.78(b)(3) and (4) of this chapter for purposes of kidney disease patient education services furnished by qualified staff via telehealth in accordance with this section, regardless of the location of the beneficiary or qualified staff. Beginning the upon the expiration of the Public Health Emergency (PHE) for the COVID-19 pandemic, CMS also waives the requirement in section 1834(m)(2)(B) of the Act and § 414.65(b) of this chapter that CMS pay a facility fee to the originating site with respect to telehealth services furnished to a beneficiary in accordance with this section at an originating site that is not one of the locations specified in § 410.78(b)(3) of this chapter.

(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.

(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.