2023-07115.pdf

enrollees targeted for its MTM program, as required under  423.153(d)(1)(vii)(E). 51. Section 423.2272 is amended by adding paragraph (e) to read as follows: VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00223 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222342 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations  423.2272 Licensing of marketing representatives and confirmation of marketing resources. * * * * * (e) Establish and implement an oversight plan that monitors agent and broker activities, identifies non- compliance with CMS requirements, and reports non-compliance to CMS. 52. Section 423.2274 is amended by adding paragraph (c)(12) and revising paragraph (g)(2)(ii):  423.2274 Required materials and content. * * * * * (c) * * * (12) Ensure that, prior to an enrollment CMS required questions and topics regarding beneficiary needs in a health plan choice are fully discussed. Topics include information regarding pharmacies (that is, whether or not the beneficiarys current pharmacy is in the plans network), prescription drug coverage and costs (including whether or not the beneficiarys current prescriptions are covered), premiums, and other services or incentives. * * * * * (g) * * * (2) * * * (ii) Record all marketing, sales, and enrollment calls, including the audio portion of calls occurring via web-based technology, in their entirety. * * * * * 53. Subpart Y is added to read as follows: Subpart YTransitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the Limited Income Newly Eligible Transition (LI NET) Program Sec. 423.2500 Basis and scope. 423.2504 LI NET eligibility and enrollment. 423.2508 LI NET benefits and beneficiary protections. 423.2512 LI NET sponsor requirements. 423.2516 Selection of LI NET sponsor and contracting provisions. 423.2518 Intermediate sanctions for the LI NET sponsor. 423.2520 Non-renewal or termination of appointment. 423.2524 Bidding and payments to LI NET sponsor. 423.2536 Waiver of Part D program requirements. Subpart YTransitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the Limited Income Newly Eligible Transition (LI NET) Program  423.2500 Basis and scope. (a) Basis. This subpart is based on section 1860D14 of the Social Security Act. (b) Scope. This subpart sets forth the requirements for the Limited Income Newly Eligible Transition (LI NET) program that begins no later than January 1, 2024. Under this program, eligible individuals are provided transitional coverage for Part D drugs.  423.2504 LI NET eligibility and enrollment. (a) Eligibility. An individual is eligible for LI NET coverage if they satisfy the criteria at paragraph (a)(1) or (2) of this section. (1) LIS-eligible. The individual is a low-income subsidy eligible individual as defined at  423.773 and (i) Has not yet enrolled in a prescription drug plan or an MAPD plan; or (ii) Has enrolled in a prescription drug plan or MAPD plan but their coverage has not yet taken effect. (2) Immediate need individuals. An individual who states their eligibility for LIS and immediate need for their prescription, but whose eligibility as defined at  423.773 cannot be confirmed at the point-of-sale, will be granted immediate need LI NET coverage. (3) Documentation of LIS eligibility. Individuals may provide documentation to the LI NET sponsor to demonstrate LIS eligibility. Documentation may include, but is not limited to: (i) A copy of the beneficiarys Medicaid card that includes their name and the eligibility date; (ii) A copy of a letter from the State or SSA showing LIS or Extra Help status; (iii) The date that a verification call was made to the State Medicaid Agency, the name and telephone number of the State staff person who verified the Medicaid period, and the Medicaid eligibility dates confirmed on the call; (iv) A copy of a State document that confirms active Medicaid status; (v) A screen-print from the States Medicaid systems showing Medicaid status; or (vi) Evidence at point-of-sale of recent Medicaid billing and payment in the pharmacys patient profile. (4) Confirmation of LIS eligibility. CMS uses documentation submitted under paragraph (a)(3) of this section to confirm LIS eligibility. (5) Inability to confirmation of eligibility. 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. (b) Enrollment. Individuals who are eligible for LI NET as defined in  423.2504 are enrolled into the LI NET program as follows: (1) Automatic enrollment. Beneficiaries who are LIS-eligible and whose auto-enrollment into a Part D plan (as outlined in  423.34(d)(1)) has not taken effect will be automatically enrolled by CMS into the LI NET program unless the beneficiary has affirmatively declined enrollment in Part D per  423.34(e); (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; or (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) of this section 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) of this section), 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; or (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 (a)(3) of this section). If no documentation is submitted and accepted, the LI NET sponsor will periodically check for eligibility and enroll applicants once LIS eligibility is confirmed. (c) Duration of LI NET enrollment. (1) Enrollment begins on the first day of the month an individual is identified as eligible under this section and ends after 2 months, with a longer LI NET enrollment for those with retroactive coverage per paragraph (c)(2) of this section. (2) Retroactive LI NET coverage begins on the date an individual is identified as eligible for a low-income subsidy as a full-benefit dual eligible or an SSI benefit recipient, or 36 months prior to the date such individual enrolls in (or opts out of) Part D coverage, whichever is later. LI NET coverage ends with enrollment into a Part D plan or opting out of Part D coverage. (d) Ending LI NET enrollment. An individuals enrollment in the LI NET program ends when: VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00224 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222343 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations (1) The individual is auto-enrolled into a standalone Part D plan in accordance with the guidelines at  423.34(d) and that coverage has taken effect. (2) The individual elects another Part D plan and that coverage has taken effect. (3) The individual voluntarily disenrolls from the LI NET program. (4) The individual is involuntarily disenrolled under  423.44(b). (5) LIS eligibility for an individual in LI NET due to an immediate need cannot be confirmed within the period of LI NET coverage.  423.2508 LI NET benefits and beneficiary protections. (a) Formulary. The LI NET program provides access to all Part D drugs under an open formulary. (b) Network. The LI NET sponsor must allow its network and out-of- network pharmacies that are in good standing to process claims under the program. Licensed pharmacies are considered to be in good standing for the LI NET program so long as they: are not revoked from Medicare under  424.535; do not appear on the Office of Inspector Generals list of entities excluded from Federally funded health care programs pursuant to section 1128 of the Act or from Medicare and State health care programs under section 1156 of the Act (unless waived by the OIG); do not appear on the preclusion list as defined at  423.100; and do not have a determination by the LI NET sponsor of a credible allegation of fraud as defined at  423.4. (c) Safety. The following provisions necessary to improve patient safety and ensure appropriate dispensing of medication apply to the LI NET program and LI NET sponsor, as applicable: (1) Sections 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) Cost sharing. (1) LI NET beneficiaries under  423.2504(a)(1) will pay the applicable cost sharing for their low-income category as established for each year in the Rate Announcement publication specified in  422.312 of this chapter. (2) LI NET beneficiaries under  423.2504(a)(2) will pay the cost sharing associated with the category of non-institutionalized full-benefit dual eligible individuals with incomes above 100% of the Federal poverty level and full-subsidy-non-FBDE individuals. If the beneficiary is later confirmed to belong to a different LIS category, the LI NET sponsor must reimburse the beneficiary for the difference between the cost sharing they paid versus what they would have paid in their LIS category. (e) Appeals. LI NET enrollees have rights with respect to Part D grievances, coverage determinations, and appeals processes set out in subpart M of this part.  423.2512 LI NET sponsor requirements. The LI NET program is administered by one or more Part D sponsor(s) that meet all of the requirements in paragraphs (a) through (c) of this section. (a) Pharmacies and access to Part D drugs. (1) The LI NET sponsor must be a PDP sponsor that has an established contracted pharmacy network in all geographic areas of the United States in which low-income subsidies are available. (2) The LI NET sponsor must meet the requirements for providing access to Part D drugs under  423.120(a), (c), and (d). (b) Experience. The LI NET sponsor must have a minimum of two consecutive years contracting with CMS as a Part D sponsor. (c) Other LI NET sponsor requirements. The LI NET sponsor must: (1) Have the technical capability and the infrastructure to provide immediate, current, and retroactive coverage for LI NET enrollees; (2) Have the technical capability to develop the infrastructure necessary for verifying Medicaid dual eligibility status for presumed eligible LI NET enrollees. (3) Identify, develop, and conduct outreach plans in consultation with CMS targeting key stakeholders to inform them about the LI NET program. (4) Establish and manage a toll-free customer call center per  423.128(d)(1) and fax line that can be accessed by pharmacy providers and beneficiaries, or others acting on their behalf, for purposes that include but are not limited to: handling inquiries about services under the LI NET program, providing the status of eligibility or claims, and having the ability to accept supporting documentation. (5) Timely respond to beneficiary requests for reimbursement of claims by issuing reimbursement for eligible claims submitted by beneficiaries no later than 30 days after receipt, or, if the drug is not covered, the LI NET sponsor has 14 days to send communication to the beneficiary with a reason for the denial. (6) Adjudicate claims from out-of- network pharmacies that are in good standing (as defined in  423.2508(b)) according to the LI NET sponsors standard reimbursement for their network pharmacies.  423.2516 Selection of LI NET sponsor and contracting provisions. (a) Appointment by