evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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 CMS. CMS appoints a Part D sponsor that meets the requirements at  423.2512 to serve as the LI NET sponsor. (b) Selection criteria. In appointing a LI NET sponsor, CMS evaluates the following: (1) Experience covering low-income beneficiaries, including but not limited to enrolling and providing coverage to low-income subsidy individuals as defined in  423.34; (2) Pharmacy access as outlined in  423.120; (3) Past performance, including Star Ratings (as detailed in  423.186), previous intermediate sanctions (as detailed in  423.750), and consistent with past performance in  423.503(b); and (4) Ability to meet the requirements listed in  423.505 that are not waived under  423.2536. (c) Term of appointment. The term of the appointment will be ongoing provided mutual agreement between CMS and the selected party, subject to an annual contracting and bid process (per  423.2524(b)) to determine payment rates for the upcoming year.  423.2518 Intermediate sanctions for the LI NET sponsor. In the event it is determined that the LI NET sponsor violated its contract, CMS may impose intermediate sanctions as outlined in subpart O of this part.  423.2520 Non-renewal or termination of appointment. (a) Notice of
2023-07115.pdf
the event it is determined that the LI NET sponsor violated its contract, CMS may impose intermediate sanctions as outlined in subpart O of this part.  423.2520 Non-renewal or termination of appointment. (a) Notice of non-renewal. If the LI NET sponsor decides for any reason to non-renew its existing contract, it must notify CMS by January 1 of the year before the next contract year. Except as provided in paragraph (c) of this section, if CMS decides for any reason to non-renew the existing contract with the incumbent LI NET sponsor, CMS notifies the LI NET sponsor by January 1 of the year before the next contract year. (b) Selection of successor and transition period. After a notice of non- renewal or termination, CMS selects a VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00225 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222344 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations successor for the LI NET contract from among potentially eligible entities (as detailed in  423.2516). The outgoing LI NET sponsor must coordinate with the successor for a period of no less than 3 months to ensure seamless transition of the LI NET program, including timely transfer of any data or files. (c) Immediate termination for cause. (1) Notwithstanding paragraph (a) of this section, CMS may immediately terminate the existing LI NET contract for any of the reasons specified at  423.509(a)(4)(i) and (xii) or  (b)(2)(i)(A) and (B). (2) CMS sends notice of an immediate termination as specified at  423.509(b)(2)(ii). (d) Appeal rights. Subpart N of this part applies to a termination under paragraph (c) of this section.  423.2524 Bidding and payments to LI NET sponsor. (a) Source of payments. CMS payments under this section are made from the Medicare Prescription Drug Account. (b) Submission of bids and related information.
2023-07115.pdf
of this section.  423.2524 Bidding and payments to LI NET sponsor. (a) Source of payments. CMS payments under this section are made from the Medicare Prescription Drug Account. (b) Submission of bids and related information. (1) The submission of LI NET bids and related information must follow the requirements and limitations in  423.265(b), (c), (d)(1), (d)(2)(i), (ii), (iv), and (v), (d)(4) and (6), and (e). (2) The review, negotiation, and approval of the LI NET bid would follow the provisions in  423.272(a) and (b)(1) and (4). (3) Basic rule for bid. The bid must reflect the LI NET sponsors estimate of its revenue needs for Payment Rates A and B per paragraph (c) of this section. (c) Monthly payments. CMS provides advance monthly LI NET payments equal to the sum of Payment Rates A and B as established in the LI NET sponsors approved bid, as outlined in paragraph (b) of this section. LI NET payments are made on a prospective per-member, per-month basis. (1) Payment Rate A is an annual rate of payment for projected administrative costs. An annual percentage-based cap on Payment Rate A limiting the year over year increase to Payment Rate A is set as part of the bid review and negotiation under  423.272(a). (i) For the 2024 plan year, the LI NET sponsor includes in its bid the assumption that Payment Rate A cannot exceed a 2% increase from the prior years Payment A, which is a figure CMS will provide to the LI NET sponsor. (ii) For the 2025 plan year and subsequent plan years, the LI NET sponsor will specify its assumption for any increase needed to the prior years Payment Rate A, submitting justification to CMS in their bid if the cap exceeds 2%. (2) Payment Rate B reflects the projected net costs of the Part D drugs dispensed to individuals who receive the LI NET benefit. (d) Payment reconciliation and risk corridors(1) Reconciliation. CMS conducts LI NET payment reconciliation each year for Payment Rates A and B after the annual PDE data submission deadline has passed
2023-07115.pdf
to individuals who receive the LI NET benefit. (d) Payment reconciliation and risk corridors(1) Reconciliation. CMS conducts LI NET payment reconciliation each year for Payment Rates A and B after the annual PDE data submission deadline has passed and makes the resulting payment adjustment consistent with  423.343(a). (2) Risk corridors. As part of LI NET payment reconciliation, CMS will apply risk corridors to Payment Rate B as follows: (i) There will be no risk sharing in the symmetrical 1% risk corridor around the target amount as defined in  423.308. (ii) There will be symmetrical risk sharing of 0.1% beyond the 1% risk corridor. (iii) To carry out this section,  423.336(c) applies to LI NET. (e) Reopening. The LI NET contract will be subject to payment reopenings per  423.346 as applicable. (f) Payment appeals. The LI NET sponsor can appeal under  423.350. (g) Overpayments. The overpayment provisions at  423.352 and 423.360 apply to LI NET.  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
2023-07115.pdf
(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. 54. The heading for subpart Z is revised to read as follows: Subpart ZRecovery Audit Contractor
2023-07115.pdf
X of this part. (k) Recovery audit contractor Part C appeals process. Subpart Z of this part. 54. The heading for subpart Z is revised to read as follows: Subpart ZRecovery Audit Contractor Part D Appeals Process PART 460PROGRAMS OF ALL- INCLUSIVE CARE FOR THE ELDERLY (PACE) 55. The authority citation for part 460 continues to read as follows: Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u4(f). 56. Section 460.6 is amended by revising the definition of contract year to read as follows:  460.6 Definitions. * * * * * Contract year means the term of a PACE program agreement, which is a calendar year, except that a PACE organizations initial contract year may be from 19 to 30 months, as determined by CMS, but in any event will end on December 31. * * * * * VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00226 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222345 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 57. Section 460.40 is amended by revising paragraph (b) to read as follow:  460.40 Violations for which CMS may impose sanctions. * * * * * (b) If CMS or the State administering agency makes a determination under  460.50 that could lead to termination of a PACE program agreement, CMS may impose any of the sanctions specified at  460.42 and 460.46. If CMS or the State administering agency determines that the circumstances in  460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in  460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension. 58. Section 460.70 is amended by revising paragraph (a) to read as follows:  460.70 Contracted services. (a) General rule. The PACE organization must have
2023-07115.pdf
a CMP or enrollment and/or payment suspension. 58. Section 460.70 is amended by revising paragraph (a) to read as follows:  460.70 Contracted services. (a) General rule. The PACE organization must have a written contract with each outside organization, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE organization, including, at a minimum, the medical specialties identified in paragraph (a)(1) of this section. The PACE organization does not need to have a written contract with entities that provide emergency services as described in  460.100. (1) At a minimum, except as noted in paragraph (a)(4) of this section, PACE organizations must have contracts in place for the following medical specialties: (i) Anesthesiology. (ii) Audiology. (iii) Cardiology. (iv) Dentistry. (v) Dermatology. (vi) Gastroenterology. (vii) Gynecology. (viii) Internal Medicine. (ix) Nephrology. (x) Neurosurgery. (xi) Oncology. (xii) Ophthalmology. (xiii) Oral surgery. (xiv) Orthopedic surgery. (xv) Otorhinolaryngology. (xvi) Palliative Medicine. (xvii) Plastic surgery. (xviii) Pharmacy consulting services. (xviv) Podiatry. (xx) Psychiatry. (xxi) Pulmonology. (xxii) Radiology. (xxiii) Rheumatology. (xxiv) General Surgery. (xxv) Thoracic and vascular surgery. (xxvi) Urology. (2) Contracts with medical specialists must be executed prior to enrollment of participants and must be maintained on an ongoing basis to ensure participants receive appropriate and timely access to all medically necessary care and services. (3) A PACE organization is responsible for making all reasonable and timely attempts to contract with medical specialists. If at any time a PACE organization is unable to directly contract or maintain a contract with a specific specialty, the PACE organization must (i) Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participants needs are met through a different mechanism to include hospitalization; and (ii) Promptly report the contracting issue to CMS and the
2023-07115.pdf
Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participants needs are met through a different mechanism to include hospitalization; and (ii) Promptly report the contracting issue to CMS and the SAA, including the attempts made to contract, the reason why the contract was not effectuated, and the PACE organizations plan to provide access to the necessary services. (4) A PACE organization is not required to have a contract with a particular medical specialty if the PACE organization directly employs one or more individuals prior to contracting who are legally authorized, and if applicable, board certified in the participant medical specialty. * * * * *  460.121 [Amended] 59. Section 460.121 is amended in paragraph (i)(2) by adding the phrase either orally or after the phrase their designated representative. 60. Section 460.200 is amended by revising paragraph (d)(2) to read as follows:  460.200 Maintenance of records and reporting of data. * * * * * (d) * * * (2) Maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participants care, health, or safety including, but not limited to the following: (i) Communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participants, care, health, or safety. (ii) Communications from an advocacy or governmental agency such as Adult Protective Services. * * * * * 61. Section 460.210 is amended by revising paragraph (b)(6) to read as follows:  460.210 Medical records. * * * * * (b) * * * (6) Original documentation, or an unaltered electronic copy, of any written communication as described in  460.200(d)(2) must be maintained in the participants medical record unless the following requirements are met: (i) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication, (ii) Original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and
2023-07115.pdf
The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication, (ii) Original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and in accordance with  460.200(e), and (iii) Original documentation of the communication is available to CMS and the SAA upon request. * * * * * Dated: March 31, 2023 Xavier Becerra, Secretary, Department of Health and Human. [FR Doc. 202307115 Filed 4523; 4:15 pm] BILLING CODE 412001P VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00227 Fmt 4701 Sfmt 9990 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES2