§423.2536. Waiver of Part D program requirements.
42 C.F.R. § 423.2536
CMS waives the following Part D program requirements for the LI NET program:
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).
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).
Medicare Prescription Payment Plan. Section 423.137.
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).
Section 423.153(b) and (c) for dispensing and point-of-sale safety edits;
Section 423.154 for appropriate dispensing of prescription drugs in long-term care facilities;
Sections 423.159 and 423.160 for electronic prescribing, excepting the requirements pertaining to formulary standards in § 423.160(b)(5);
Section 423.162 for QIO activities; and
Section 423.165 for compliance deemed on the basis of accreditation.
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.
Medicare contract determinations and appeals. Subpart N, except for the provisions that apply to LI NET in § 423.2520(d).
Certification of accuracy of data for price comparison. Section 423.505(k)(6).
Part D communication requirements. Portions of subpart V of this part related to Part D communication requirements that are inapplicable to LI NET, including:
Section 423.2267(e)(3) through (5), (9) through (12), (14) through (17), (25), (29), (33), and (45) through (51); and
Medicare Coverage Gap Discount Program. Subpart W of this part.
Requirements for a minimum medical loss ratio. Subpart X of this part.
Recovery audit contractor Part C appeals process. Subpart Z of this part.
Provision of specific information. Section 423.128(d)(1)(i)(A).
Notes, amendments, and revision history
Amendments
[88 FR 22342, Apr. 12, 2023; 88 FR 34780, May 31, 2023; 90 FR 15920, Apr. 15, 2025; 91 FR 17593, Apr. 6, 2026]
Source
Source: 88 FR 22342, Apr. 12, 2023, unless otherwise noted.
Authority
Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
Source
Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.
Amendments
[88 FR 22342, Apr. 12, 2023; 88 FR 34780, May 31, 2023; 90 FR 15920, Apr. 15, 2025; 91 FR 17593, Apr. 6, 2026]