evekhm/cms_iom_500 huggingface dataset:
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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. Comment: One commenter suggested expanding the definition of pharmacies that are in good standing in LI NET to also prohibit out-of-network pharmacies from submitting claims to the LI NET sponsor if they are under a current payment suspension by any Part D sponsor pursuant to  423.504(b)(4)(vi)(G)(4) or have been terminated from the LI NET sponsors network based on credible allegations of fraud. The commenter recommends this change to avoid a situation in which a pharmacy has been suspended or terminated from participation in a Part D plans network but can still serve LI NET beneficiaries. Response: We agree with the commenter that we do not want to consider pharmacies against which there are credible allegations of fraud to be in good standing for purposes of participating in LI NET. Currently, each Part D sponsor performs its own investigation to determine whether a credible allegation of fraud against a pharmacy exists, which may result in implementation of a payment suspension or termination. CMS encourages Part D sponsors to use the information CMS provides through Health Plan Management Systems (HPMS) Program Integrity (PI) Portal for FWA Reporting module regarding other plan sponsors payment suspensions, as well as information provided on referrals of providers and suppliers by plan sponsors, to conduct their own investigations of pharmacies. We remind sponsors that they should not take any administrative action based solely on information within CMS HPMS PI Portal for FWA Reporting. Plan sponsors should perform their own investigations and conduct oversight efforts to substantiate information regarding potential pharmacy FWA. It makes sense to similarly require the LI NET sponsor to make its own determination of what is credible instead of adopting a standard that any Part D sponsors determination controls, as the commenter suggests. Thus, we finalize the definition of good standing in  423.2508(b) to also include pharmacies against which the LI NET sponsor does not have a credible allegation of fraud as defined at  423.4. With the addition of this element relying on the LI NET sponsors determination, and noting that there are specific, objective standards comprising the definition of
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NET sponsor does not have a credible allegation of fraud as defined at  423.4. With the addition of this element relying on the LI NET sponsors determination, and noting that there are specific, objective standards comprising the definition of pharmacies that are in good standing for LI NET, it is unnecessary for CMS to make a determination about pharmacies standings in this regard. Thus, we also strike the phrase as determined by CMS from  423.2508(b). Additionally, we noted an omission in  423.2508(b) of the description of OIGs exclusion authority. OIG has the authority to exclude individuals and entities from Medicare and State health care programs under section 1156 of the Act. We omitted reference to State Health care programs in proposed  423.2508(b), and take this opportunity to fully cite the OIGs list of excluded entities under section 1156 of the Act. Thus, we finalize section 423.2508(b) to read, (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. Comment: One commenter raised a concern about an LI NET sponsors ability to audit and recover overpayments from out-of-network pharmacies, which would not be contracted with the LI NET sponsor. The commenter suggested modifying proposed  423.2512(c)(6) to incorporate the good standing standard proposed in  423.2508(b) and to state that pharmacies that submit claims to the LI NET sponsor would be subject to the LI
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 423.2512(c)(6) to incorporate the good standing standard proposed in  423.2508(b) and to state that pharmacies that submit claims to the LI NET sponsor would be subject to the LI NET sponsors standard pharmacy audit and overpayment recovery processes. Response: We agree with the commenter that the requirement to adjudicate out-of-network claims would apply only to pharmacies in good standing and have modified  423.2512(c)(6) to include a cross reference to the good standing standard we are adopting in  423.2508(b). We note that  423.504(b)(4)(vi)(G) is not waived for LI NET and requires the LI NET sponsor to establish and implement procedures and a system for promptly responding to compliance issues as they are raised, investigating potential compliance problems as identified in the course of self- evaluations and audits, correcting such problems promptly and thoroughly to reduce the potential for recurrence, and ensure ongoing compliance with CMS requirements. Further,  423.504(b)(4)(vi)(G)(2) says that the Part D sponsor must conduct appropriate corrective actions (for example, repayment of overpayments and disciplinary actions against responsible individuals) in response to the potential violation, as previously referenced. We believe the commenter is requesting that the LI NET regulations VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222149 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations expressly state that the LI NET sponsor has the ability to audit out-of-network pharmacies and subject them to overpayment recovery processes. The commenter does not suggest what a standard pharmacy audit and overpayment recovery process could mean. One possibility is for it to be the same as is used for network pharmacies, similar to how we require the LI NET sponsor to adjudicate claims from out- of-network
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pharmacy audit and overpayment recovery process could mean. One possibility is for it to be the same as is used for network pharmacies, similar to how we require the LI NET sponsor to adjudicate claims from out- of-network pharmacies according to the LI NET sponsors standard reimbursement for its network pharmacies. However, given that out-of- network pharmacies that are in good standing under  423.2508(b) must be permitted to process claims under LI NETa distinguishing feature of LI NETwe believe that defining a standard pharmacy audit and overpayment recovery process would not provide the LI NET sponsor the level of flexibility that is already provided under  423.504(b)(4)(vi)(G). Thus, we take this opportunity to state that the LI NET sponsor must meet the requirements in  423.504(b)(4)(vi)(G), including for out-of-network pharmacies, without incorporating these concepts into  423.2512(c)(6). Thus, we finalize these concepts as proposed in  423.2512(c)(6), and add the cross-reference to the good reference standard in  423.2508(b) to say that the LI NET sponsor must [a]djudicate 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. Comment: One commenter recommended that we require the LI NET sponsor to maintain telephone and fax lines 24 hours a day, 7 days a week, and every day of the year, as well as setting customer service standards that include limits on average hold times and disconnect rates, and availability of interpreters. Response: The LI NET sponsor will be held to the same customer service requirements as other Part D sponsors under  423.128(d). Under  423.128(d)(1)(i)(B), any call center serving pharmacists must be open so long as any network pharmacy in the region is open. Given that the LI NET sponsors region is nationwide because of
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any call center serving pharmacists must be open so long as any network pharmacy in the region is open. Given that the LI NET sponsors region is nationwide because of the requirement in  423.2512(a)(1) to have a contracted pharmacy network in all geographic areas of the United States in which low- income subsidies are available, practically speaking we would expect some network pharmacies to be open 24 hours a day and therefore, by extension, the call center serving pharmacists would also need to be open 24 hours a day. Section 423.128(d) also sets forth requirements for interactive voice response systems, timeframes for return calls, average wait times, disconnect rates, provision of interpreters (including how quickly the interpreters are made available), and provision of effective real-time communication with individuals using auxiliary aids and services like TTY. We note that the requirement to maintain a fax line is not separately discussed in  423.128(d), but we believe as a practical matter that it will be necessary for the LI NET sponsor to maintain a fax line in order to conduct point-of-sale enrollments in accordance with  423.2504(b)(2). Comment: One commenter encouraged CMS and our contractors to regularly educate and communicate with pharmacists about LI NET. The same commenter called for consistent outreach to LI NET eligible beneficiaries to make them aware of the program. Response: We agree with the importance of making stakeholders as well as beneficiaries who are likely eligible for LI NET aware of the program. In  423.2512(c)(3), we require the LI NET sponsor to identify, develop, and conduct outreach plans in consultation with CMS targeting key stakeholders to inform them about the LI NET program. Under the demonstration, CMS enrolls over 90 percent of LI NET beneficiaries into the LI NET plan, and we expect CMS would continue to be responsible for most enrollments in the permanent LI NET program. For beneficiaries who are not auto-enrolled, we agree that outreach is important so that stakeholders such as states, SHIPs, and pharmacies have awareness and knowledge about the LI NET program. Beneficiary education and outreach is also important, though it has been our experience that pharmacists and SHIP counselors
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important so that stakeholders such as states, SHIPs, and pharmacies have awareness and knowledge about the LI NET program. Beneficiary education and outreach is also important, though it has been our experience that pharmacists and SHIP counselors are the most effective at connecting eligible beneficiaries with LI NET. We finalize  423.2512(c)(3) as proposed, except for an editorial change to more concisely say conduct outreach plans instead of carry out outreach plans. Comment: One commenter expressed support for our proposal to define the LI NET sponsor as a Part D sponsor selected by CMS to administer the LI NET program. Response: We thank the commenter for the support. Comment: One commenter noted that the LI NET demonstration is sometimes referred to by its full name of (Limited Income Newly Eligible Transition program), in addition to abbreviated forms, such as LI NET or LINET. The commenter encourages us to use program nomenclature consistently to avoid beneficiary confusion. Response: We agree that using consistent nomenclature for the LI NET program can minimize confusion. We take this opportunity to state that the proper, full name of the program in this provision is the Limited Income Newly Eligible Transition program, which may also be referred to as the LI NET program. Comment: One commenter expressed support for the proposed LI NET payment policies under  423.2524 with the exception of  423.2524(c)(1)(i), which proposed to require that the LI 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
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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
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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
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(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
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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
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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,