42 C.F.R. § 423.2536

Current through September 30, 2024
Section 423.2536 - Waiver of Part D program requirements

CMS waives the following Part D program requirements for the LI NET program:

(a)General information. Paragraphs (1) and (3)(B) of section 1860D-4(a) of the Act (relating to dissemination of general information; availability of information on changes in formulary through the internet).
(b)Formularies. Subparagraphs (A) and (B) of section 1860D-4(b)(3) of the Act (relating to requirements on development and application of formularies; formulary development) and formulary requirements in §§ 423.120(b) and 423.128(e)(5) and (6) .
(c)Cost control and quality improvement requirements. Provisions under subpart D of this part, including requirements about medication therapy management, are waived except for the provisions in § 423.2508(c)(1) through (5) .
(1) Section 423.153(b) and (c) for dispensing and point-of-sale safety edits;
(2) Section 423.154 for appropriate dispensing of prescription drugs in long-term care facilities;
(3) Sections 423.159 and 423.160 for electronic prescribing, excepting the requirements pertaining to formulary standards in § 423.160(b)(5) ;
(4) Section 423.162 for QIO activities; and
(5) Section 423.165 for compliance deemed on the basis of accreditation.
(d)Out-of-network access. Section 423.124 Special rules for out-of-network access to Part D drugs at out-of-network pharmacies, except for § 423.124(a)(2) , which applies to LI NET.
(e)Medicare contract determinations and appeals. Subpart N, except for the provisions that apply to LI NET in § 423.2520(d) .
(f)Risk-sharing arrangements. Section 423.336(a), (b), and (d) .
(g)Certification of accuracy of data for price comparison. Section 423.505(k)(6) .
(h)Part D communication requirements. Portions of subpart V of this part related to Part D communication requirements that are inapplicable to LI NET, including:
(1) Section 423.2265(b)(4), (5), (11), and (13) ;
(2) Section 423.2265(c) ;
(3) Section 423.2266(a) ;
(4) Section 423.2267(e)(3) through (5), (9) through (12), (14) through (17), (25), (29), and (33) ; and
(5) Section 423.2274 .
(i)Medicare Coverage Gap Discount Program. Subpart W of this part.
(j)Requirements for a minimum medical loss ratio. Subpart X of this part.
(k)Recovery audit contractor Part C appeals process. Subpart Z of this part.

42 C.F.R. §423.2536

88 FR 22342, Apr. 12, 2023; 88 FR 34780, May 31, 2023
88 FR 22342, 6/5/2023; 88 FR 34780, 6/5/2023