42 CFR § 423.2536 - Waiver of Part D program requirements.

---
identifier: "/us/cfr/t42/s423.2536"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 423.2536 - Waiver of Part D program requirements."
title_number: 42
title_name: "Public Health"
section_number: "423.2536"
section_name: "Waiver of Part D program requirements."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "423"
part_name: "VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh."
regulatory_source: "70 FR 4525, Jan. 28, 2005, unless otherwise noted."
cfr_part: "423"
---


# 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) *Medicare Prescription Payment Plan.* Section 423.137.

(d) *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.

(e) *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.

(f) *Medicare contract determinations and appeals.* Subpart N, except for the provisions that apply to LI NET in § 423.2520(d).

(g) *Risk-sharing arrangements.* Section 423.336(a), (b), and (d).

(h) *Certification of accuracy of data for price comparison.* Section 423.505(k)(6).

(i) *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), (13), and (16);

(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), (33), and (45) through (51); and

(5) Section 423.2274.

(j) *Medicare Coverage Gap Discount Program.* Subpart W of this part.

(k) *Requirements for a minimum medical loss ratio.* Subpart X of this part.

(l) *Recovery audit contractor Part C appeals process.* Subpart Z of this part.

[88 FR 22342, Apr. 12, 2023; 88 FR 34780, May 31, 2023; 90 FR 15920, Apr. 15, 2025]