2023-07115.pdf

NET sponsor assume in its 2024 plan year bid that Payment Rate A cannot exceed a 2 percent increase from the prior years Payment A, which is a figure CMS would provide to the LI NET sponsor. The commenter noted that under the demonstration program, CMS instituted a per-member, per-month cap on administrative expenses for plan year 2012 that has not been updated, and recommended reestablishing a baseline for Payment Rate A beginning in plan year 2024. The commenter recommended that the LI NET sponsor and CMS engage in a collaborative rate setting process, which the commenter suggested would contribute to the long- term stability of the LI NET program, and provide necessary flexibility to manage the program over the long term, particularly in light of factors like inflation or extreme or unpredictable circumstances like the COVID19 Public Health Emergency (PHE). Response: We thank the commenter for their general support of our LI NET payment provisions. As the commenter notes, under the demonstration we have long had a 2 percent cap on Payment Rate A, the portion of the LI NET payment comprised of two components: estimated administrative costs to run the LI NET program, which is inclusive of the LI NET sponsors profit, and the LI NET sponsors estimated costs to pay pharmacy claims for prescriptions filled by immediate need individuals, for which the LI NET sponsor might not be able to submit a prescription drug event (PDE) record to CMS due to the individuals unconfirmed LIS status. Over this time, the Part D sponsor administering the LI NET demonstration and CMS have had multiple discussions about the appropriateness of the 2 percent cap. To date, CMS has not received adequate justification to increase the cap, including for the past few years during an ongoing PHE. We note that  423.2524(c)(1)(i) fixes the cap at 2 percent cap for the 2024 plan year VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222150 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations only. This will maintain stability and continuity in Payment Rate A in this year of transition from LI NET as a demonstration to a permanent Part D program. The flexibility and collaboration the commenter seeks is provided from the 2025 plan year onward, in  423.2524(c)(1)(ii). Comment: One commenter expressed support for our proposal to enumerate those Part D requirements that will be explicitly waived under the LI NET program, concurring with the list of proposed waivers in  423.2536. The commenter encourages CMS to partner with the LI NET sponsor as new Part D program requirements are introduced, so there is clarity about whether new requirements apply to the LI NET program. Response: We thank the commenter for the support. With respect to new Part D program requirements that may be adopted in the future, we would consider at the time of their adoption whether they ought to apply to the LI NET program or be added to the list of waived requirements specified in  423.2536, as appropriate. We finalize as proposed  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 1860D4(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 1860D4(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(d)(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. Comment: One commenter raised concerns about CMS proposal to sunset the demonstration program on December 31, 2023 and start the permanent LI NET program on January 1, 2024. The commenter requested we begin the permanent program before sunsetting the demonstration program in case glitches arise in the transition, particularly recognizing that the start of a calendar year can be busy for pharmacists assisting beneficiaries with new coverage. The commenter recommended that CMS still begin the permanent program on January 1, 2024, but allow the demonstration program to continue until at least the second quarter of 2024 or until all potential unforeseen glitches are worked out, whichever is later. Response: We share the commenters desire to take precautions against any risk of disruptions in care or LI NET beneficiaries access to Part D drugs. If the current Part D sponsor administering LI NET under demonstration authority is selected to be the LI NET sponsor for the 2024 plan year, then the change from LI NET operating as a demonstration versus a permanent program is largely a matter of the authority under which LI NET is operated rather than significant operational differences. If there is a change in the Part D sponsor administering LI NET in 2024, the new sponsor would be vetted by CMS to confirm that the sponsor has the ability to administer the program. CMS would work closely with that sponsor during a transition period to ensure that there are no disruptions to beneficiaries who enroll in LI NET. We appreciate the feedback we received from the commenters. After consideration of all public comments, we are finalizing the LI NET largely as proposed, with modifications to  423.2504, 423.2508, and 423.2512, as previously discussed in our responses to comments. The revisions include:  423.2504: renumber proposed  423.2504(a)(2)(i) to  423.2504(a)(3) and add a heading that reads Documentation of LIS Eligibility; renumber the succeeding subsections under proposed  423.2504(a)(2)(i) accordingly; insert  423.2504(a)(4) to say CMS uses documentation submitted under paragraph (a)(3) of this section to confirm LIS eligibility; and renumber proposed  423.2504(a)(2)(ii) to  423.2504(a)(5) and revise to specify that If CMS cannot confirm an immediate need individuals eligibility during the period of LI NET coverage, the individual will not be auto-enrolled into a standalone Part D plan in accordance with  423.34(d) following their LI NET coverage; striking with an immediate need from the description of point-of-sale enrollment in  423.2504(b)(2); revise  423.2504(b)(2) to say, (2) Point-of-sale enrollment. An individual who is not automatically enrolled in accordance with paragraph (b)(1) of this section and whose claim is submitted at the point- of-sale and accepted by the LI NET sponsor will be enrolled into the LI NET program by the LI NET sponsor; finalize  423.2504(b)(3) as follows: (3) Direct reimbursement request. An individual described in paragraph (a)(1) of this section who is not automatically enrolled in accordance with paragraph (b)(1) or at the point-of-sale as provided in paragraph (b)(2) and who submits a direct reimbursement request form, receipts for reimbursement for eligible claims paid out of pocket (with and optional documentation of LIS eligibility listed in paragraph (a)(3)), will be retroactively enrolled into the LI NET program by the LI NET sponsor. The LI NET sponsor has 14 calendar days to reply with a coverage decision; and finalize  423.2504(b)(4) as follows: (4) LI NET application form. An individual who is not enrolled through one of the methods in paragraphs (b)(1) though (3) of this section may submit an LI NET application form to the LI NET sponsor (with optional documentation of LIS eligibility listed in paragraph VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222151 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations (a)(3)). If no documentation is submitted and accepted, the LI NET sponsor will periodically check for eligibility and enroll applicants once LIS eligibility is confirmed; add for clarity the term Extra Help to  423.2504(a)(3)(ii).  423.2508: removing CMS role in determining pharmacies good standing for LI NET and adding a reference to OIGs authority to exclude State health care programs; and  423.2512(c)(6): adding a cross reference to the good standing standard we are adopting in  423.2508(b). E. Expanding Eligibility for Low-Income Subsidies Under Part D of the Medicare Program ( 423.773 and 423.780) The Part D low income subsidy (LIS) helps people with Medicare who meet certain statutory income and resource criteria pay for prescription drugs and lowers the costs of prescription drug coverage. Individuals who qualify for the full LIS receive assistance to pay their full premiums and deductibles (in certain Part D plans) and have reduced cost sharing. Individuals who qualify for the partial LIS pay reduced premiums (on a sliding scale based on their income) and also have reduced deductibles and cost sharing. Section 11404 of the IRA (Pub. L. 117169), enacted on August 16, 2022, amended section 1860D14 of the Act to expand eligibility for the full LIS to individuals who are determined to have incomes below 150 percent of the FPL and who meet either the resource standard in paragraph (3)(D) or paragraph (3)(E) of section 1860D14(a) of the Act, with respect to plan years beginning on or after January 1, 2024. This change will provide the full LIS for individuals who currently qualify for the partial subsidy. To implement the changes to the LIS income requirements, we proposed to amend  423.773(b)(1) to add that to be eligible for the full subsidy for plan years beginning on or after January 1, 2024, an individual must have an income below 150 percent of the FPL. To coordinate with this change, we also proposed to amend  423.773(d) to specify that the requirement that an individual have an income below 150 percent of the FPL to be eligible for the partial subsidy applies only to plan years beginning before January 1, 2024. This latter change is consistent with the IRA effectively sunsetting the partial LIS after 2023. To implement the changes to the resource limits, we proposed to amend  423.773 to state that the current resource limits applicable for the full subsidy at paragraph (b)(2)(ii) apply to years 2007 through 2023. We also proposed to add a new  423.773(b)(2)(iii) to state that for years beginning on or after January 1, 2024, the resource limits at paragraph (d)(2) of  423.773the resource standards currently applicable for the partial subsidywould apply to full subsidy