2023-07115.pdf

stand- alone Part D contracts. (A) For contracts with service areas wholly located in Puerto Rico, the percentage of enrollees that are LIS/DE or disabled is calculated by adding the number of DE/disabled enrollees to the estimated LIS percentage calculated by taking the percentage LIS/DE as calculated at  422.166(f)(2)(vi) and (vii) and 423.186(f)(2)(vi) and (vii) and subtracting the percentage of DE enrollees. (B) Contracts with service areas wholly located in Puerto Rico are excluded from the calculation of one- half of the contract-level median and the contract-level median. (viii) For contracts that have percentages of enrollees with SRFs greater than or equal to the contract- level median enrollment percentage, the HEI reward added to the contracts summary and overall ratings will vary from 0 to 0.4 on a linear scale, with a contract receiving 0 if the contract receives a score of 0 or less on the HEI and 0.4 if the contract receives a score VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00215 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222334 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations of 1 on the HEI. For contracts that have percentages of enrollees with SRFs greater than or equal to one-half the median percentage of enrollees with SRFs up to, but not including, the contract-level median percentage of enrollees with SRFs, the HEI reward added to the contracts summary and overall ratings will vary from 0 to 0.2 on a linear scale, with a contract receiving 0 if the contract receives a score of 0 or less on the HEI and 0.2 if the contract receives a score of 1 on the HEI. The HEI reward is rounded and displayed with 6 decimal places. Contracts that cannot have an HEI score calculated (that is, contracts that are not scored on at least half of the measures included in the index) will not receive an HEI reward. (ix) The HEI reward is calculated separately for, and then added to, the overall rating, Part C rating for MAPDs and MA-only contracts (and cost contracts), Part D rating for MAPDs (and cost contracts), and Part D rating for PDPs after the addition of the CAI as specified in paragraph (f)(2) of this section and application of the improvement measures as specified in paragraph (g) of this section and before the final overall and Part C and D summary ratings are calculated by rounding to the nearest half star. (g) * * * (1) CMS runs the calculations twice for the highest level rating for each contract-type (overall rating for MAPD contracts and Part C summary rating for MA-only contracts), with the reward factor adjustment if applicable and the CAI adjustment, once including the improvement measure(s) and once without including the improvement measure(s). In deciding whether to include the improvement measures in a contracts final highest rating, CMS applies the following rules: * * * * * (i) * * * (3) * * * (iv) For an affected contract with at least 25 percent of enrollees in FEMA- designated Individual Assistance areas at the time of the extreme and uncontrollable circumstance, the affected contract receives the higher of the previous years Star Rating or the current years Star Rating (and corresponding measure score) for each HOS and HEDISHOS measure. The adjustment is for 3 years after the extreme and uncontrollable circumstance. * * * * * (9) * * * (i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA- designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the clustering algorithms described in paragraph (a)(2) of this section. * * * * * (10) * * * (i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA- designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the determination of the performance summary and variance thresholds for the reward factor described in paragraph (f)(1) of this section. * * * * * 18. Section 422.202 is amended by revising paragraph (b)(1)(i) to read as follows:  422.202 Participation procedures. (b) * * * (1) * * * (i) Are based on current evidence in widely used treatment guidelines or clinical literature; * * * * * 19. Section 422.503 is amended by revising paragraphs (e)(1) and (2) to read as follows:  422.503 General provisions. * * * * * (e) * * * (1) The contract will be amended to exclude any MA plan, MA plan segment, or State-licensed entity specified by CMS; and (2) A separate contract for any such excluded plan, segment, or entity will be deemed to be in place when such a request is made. 20. Section 422.504 is amended by adding paragraph (a)(19) to read as follows:  422.504 Contract provisions. * * * * * (a) * * * (19) Not to establish a segment of an MA plan that meets the criteria in  422.514(d), as determined in the procedures described in  422.514(e)(3), with the addition of the newly enrolled individuals. * * * * * 21. Section 422.510 is amended by adding paragraph (a)(4)(xvi) to read as follows:  422.510 Termination of contract by CMS. * * * * * (a) * * * (4) * * * (xvi) Meets the criteria in  422.514(d)(1) or (2). * * * * * 22. Section 422.514 is amended by revising paragraph (d)(1) and adding paragraph (g) to read as follows:  422.514 Enrollment requirements. * * * * * (d) * * * (1) Enter into or renew a contract under this subpart, for plan year 2024 and subsequent years, for a MA plan that (i) Is not a specialized MA plan for special needs individuals as defined in  422.2; and (ii) Projects enrollment in its bid submitted under  422.254 that 80 percent or more enrollees of the plans total enrollment are enrollees entitled to medical assistance under a State plan under title XIX. * * * * * (g) Applicability to segments. The rules under paragraphs (d) through (f) of this section also apply to segments of the MA plan as provided for local MA plans under  422.262(c)(2). 23. Section 422.566 is amended by revising paragraph (d) to read as follows:  422.566 Organization determinations. * * * * * (d) Who must review organization determinations. If the MA organization expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the organization determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision. The physician or health care professional reviewing the request need not, in all cases, be of the same specialty or subspecialty as the treating physician or other health care provider. The physician or other health care professional must have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. 24. Section 422.590 is amended by revising paragraph (b)(1) to read as follows: VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00216 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222335 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations  422.590 Timeframes and responsibility for reconsiderations. * * * * * (b) * * * (1) If the MA organization makes a reconsidered determination that is completely favorable to the enrollee, the MA organization must issue its reconsidered determination to the enrollee (and effectuate it in accordance with  422.618(a)(2)) no later than 60 calendar days from the date it receives the request for a standard reconsideration. * * * * * 25. Section 422.629 is amended by revising paragraph (k)(3) to read as follows:  422.629 General requirements for applicable integrated plans. * * * * * (k) * * * (3) Integrated organization determinations. If the applicable integrated plan expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the integrated organization determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare and Medicaid coverage criteria, before the applicable integrated plan issues the integrated organization determination decision. The physician or health care professional reviewing the request need not, in all cases, be of the same specialty or subspecialty as the treating physician or other health care provider. The physician or other health care professional must have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. * * * * * 26. Section 422.2261 is amended by revising paragraph (a)(2) and removing paragraph (a)(3). The revision reads as follows:  422.2261 Submission, review, and distribution of materials. (a) * * * (2) Materials must be submitted to the HPMS Marketing Module by the MA organization or, where materials have been developed by a Third Party Marketing Organization for multiple MA organizations or plans, by a Third Party Marketing Organization with prior review of each MA organization on whose behalf the materials were created or will be used. * * * * * 27. Section 422.2262 is amended by revising paragraph (a)(1)(ii) and adding paragraph (a)(1)(xix) to read as follows:  422.2262 General communications materials and activity requirements. * * * * * (a) * * * (1) * * * (ii) Use of superlatives, unless sources of documentation or data supportive of the superlative is also referenced in the material. Such supportive documentation or data must reflect data, reports, studies, or other documentation that applies to the current or prior contract year. (A) Including data older than the prior contract year is permitted provided the current and prior contract year data are specifically identified. (B) [Reserved] * * * * * (xix) Use the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card, in a misleading way. Use of the Medicare card image is permitted only with authorization from CMS. * * * * * 28. Section 422.2263 is amended by adding paragraphs (b)(8) through (10) to read as follows:  422.2263 General marketing requirements. * * * * * (b) * * * (8) Advertise benefits that are not available to beneficiaries in the service area(s) where the marketing appears, unless the advertisement is in local media that serves the service area(s) where the benefits are available and reaching beneficiaries who reside in other service areas is unavoidable. (9) Market any products or plans, benefits, or costs, unless the MA organization or marketing name(s) as listed in HPMS of the entities offering the referenced products or plans, benefits, or costs are identified in the marketing material. (i) MA organization or marketing names must be in 12-point font in print and may not be in the form of a disclaimer or fine print. (ii) For television, online, or social media, the MA organization or marketing name(s) must be either read at the same pace as the phone number or must be displayed throughout the entire advertisement in a font size equivalent to the advertised phone number, contact information, or benefits. (iii) For radio or other voice-based advertisements, MA organization or marketing names must be read at the same pace as the advertised phone numbers or other contact information. (10) MA organizations may not include