Editorial Note on Part 410
Editorial Note: Nomenclature changes to part 410 appear at 62 FR 46037, Aug. 29, 1997.

§ 410.141 Outpatient diabetes self-management training. ( a ) *General rule.* Medicare Part B covers training defined in § 410.140 if all of the conditions and requirements of this subpart are met.
( b ) *Conditions for coverage.* The training must meet the following conditions: ( 1 ) *Training orders.* Following an evaluation of the beneficiary's need for the training, the training is ordered by the physician (or qualified nonphysician practitioner) (as defined in § 410.32(a)(2)) treating the beneficiary's diabetes.
( 2 ) *Plan of care.* It is included in a comprehensive plan of care established by the physician (or qualified nonphysician practitioner) treating the beneficiary for diabetes that meets the following requirements: ( i ) Describes the content, number of sessions, frequency, and duration of the training as written by the physician (or qualified nonphysician practitioner) treating the beneficiary.
( ii ) Contains a statement specified by CMS and signed by the physician (or qualified nonphysician practitioner) managing the beneficiary's diabetic condition. By signing this statement, the physician (or qualified nonphysician practitioner) certifies that he or she is managing the beneficiary's diabetic condition and the training described in the plan of care is needed to ensure therapy compliance or to provide the beneficiary with the skills and knowledge to help manage the beneficiary's diabetes. The physician's (or qualified nonphysician practitioner's) statement must identify the beneficiary's specific medical conditions (described in paragraph (d) of this section) that the training will address.
( iii ) Provides that any changes to the plan of care are signed by the physician (or qualified nonphysician practitioner) treating the beneficiary.
( iv ) Is incorporated into the approved entity's medical record for the beneficiary and is made available, upon request, to CMS.
( 3 ) *Reasonable and necessary.* It is reasonable and necessary for treating or monitoring the condition of a beneficiary who meets the conditions described in paragraph (d) of this section.
( c ) Types and frequency of training— ( 1 ) Initial training— *General rule.* ( i ) Medicare Part B covers initial training that meets the following conditions: ( A ) Is furnished to a beneficiary who has not previously received initial training under this benefit.
( B ) Is furnished within a continuous 12-month period.
( C ) Does not exceed a total of 10 hours.
( D ) Except as permitted under paragraph (c)(1)(ii) of this section, 9 hours of the training are furnished in a group setting consisting of 2 to 20 individuals who need not all be Medicare beneficiaries.
( E ) Is furnished in increments of no less than one-half hour.
( F ) May include 1 hour of individual training for an assessment of the beneficiary's training needs.
( ii ) *Exception.* Medicare covers training on an individual basis for a Medicare beneficiary who meets any of the following conditions: ( A ) No group session is available within 2 months of the date the training is ordered.
( B ) The beneficiary's physician (or qualified nonphysician practitioner) documents in the beneficiary's medical record that the beneficiary has special needs resulting from conditions, such as severe vision, hearing, or language limitations that will hinder effective participation in a group training session.
( 2 ) *Follow-up training.* After receiving the initial training described in paragraph (c)(1) of this section, Medicare covers follow-up training that meets the following conditions: ( i ) Consists of no more than 2 hours individual or group training for a beneficiary each year.
( ii ) Group training consists of 2 to 20 individuals who need not all be Medicare beneficiaries.
( iii ) Is furnished any time in a calendar year following the year in which the beneficiary completes the initial training.
( iv ) Is furnished in increments of no less than one-half hour.
( v ) The physician (or qualified nonphysician practitioner) treating the beneficiary must document, in the referral for training and the beneficiary's medical record, the specific medical condition (described in paragraph (d) of this section) that the follow-up training must address.
( d ) *Beneficiaries who may be covered.* Medicare Part B covers outpatient diabetes self-management training for a beneficiary who has been diagnosed with diabetes.
( e ) *Who may furnish services.* Training may be furnished by a physician, individual, or entity that meets the following conditions: ( 1 ) Furnishes other services for which direct Medicare payment may be made.
( 2 ) May properly receive Medicare payment under § 424.73 or § 424.80 of this chapter, which set forth prohibitions on assignment and reassignment of benefits.
( 3 ) Submits necessary documentation to, and is accredited by, an accreditation organization approved by CMS under § 410.142 to meet one of the sets of quality standards described in § 410.144.
( 4 ) Provides documentation to CMS, as requested, including diabetes outcome measurements set forth at § 410.146.
[65 FR 83148, Dec. 29, 2000, as amended at 68 FR 63261, Nov. 7, 2003; 76 FR 73471, Nov. 28, 2011]