2023-07115.pdf

that they can opt out of plan business calls; prohibiting the distribution of Scope of Appointment and Business Reply Card forms at educational events; prohibiting sales events to directly follow educational events; requiring 48 hours between the Scope of Appointment and an agent meeting with a beneficiary; limiting Scope of Appointments and Business Reply Cards to a six month timeframe from the submission of a Scope of Appointment (SOA) or Business Reply Card (BRC); requiring website provider directories be searchable by all required elements (for example, name, phone number, address); adding effect on current coverage to the Pre-enrollment Checklist (PECL), as well as requiring agents to review the PECL with enrollees; requiring plans to list benefits at the beginning of the Summary of Benefits (SB) and in a specified order; labeling the non-renewal notice as standardized rather than a model, consistent with CMSs guidance instructions; modifying the TPMO disclaimer to add State Health Insurance Programs (SHIPs) as an option for beneficiaries to obtain additional help; requiring MA organizations and Part D sponsors to have an oversight plan that monitors agent/broker activities and reports agent/broker non-compliance to CMS; requiring agents and brokers to go over a CMS list of required elements with an enrollee prior to enrollment; limiting the requirement to record calls between third-party marketing organizations (TPMOs) and beneficiaries to marketing (sales) and enrollment calls; clarifying the requirement to record calls between TPMOs and beneficiaries such that it is clear that the requirement to record applies only to calls that result in an enrollment and includes virtual connections such as Zoom and FaceTime; and, prohibiting the distribution of data by TPMOs. We are finalizing, in some cases with modifications, the majority of the proposed policies in this final rule. We are not addressing our proposal to prohibit the distribution of data by TPMOs in this final rule but, may address it in a future final rule. The regulatory changes for Subpart V of Parts 422 and 423 are applicable for the 2024 Contract Year and beyond; thus applying to marketing and communications materials and activities beginning for the 2024 Contract Year; current regulations require the distribution of 2024 materials beginning September 30, 2023. Sections 1851(h) and 1851(j) of the Act, which address MA, provide CMS the authority to review marketing materials, develop marketing standards, and ensure that marketing materials are accurate and not misleading. These provisions also provide CMS with the authority to prohibit certain marketing activities. Section 1856(b)(1) of the Act authorizes CMS to adopt standards, through rulemaking, standards that are consistent with, implement and carry out the Medicare Advantage statutory provisions. In addition, sections 1876(i)(3)(D), 1857(e)(1) and 1860D 12(b)(3)(D) of the Act provide CMS the authority to adopt additional contract terms for cost plans, MA plans, and Part D plans when necessary and appropriate. Likewise, section 1860D 1(b)(1)(B)(vi) of the Act directs that the Secretary use rules similar to and coordinated with the MA rules at section 1851(h) of the Act for approval of marketing materials and application forms for Part D plan sponsors. Section 1860D4(l) of the Act applies certain prohibitions under section 1851(h) of the Act to Part D sponsors in the same manner as such provisions apply to MA organizations. In addition, sections 1852(c) and 1860D4(a) of the Act require organizations to provide certain materials to Medicare beneficiaries concerning MA and Part D plan choices, benefits coverage, and other information to make informed enrollment decisions. These statutory provisions help ensure Medicare beneficiaries are informed, and thus have sufficient knowledge to assist in protecting them when making an election to enroll in an MA (including MAPD) or Part D plan. We believe the changes proposed and adopted in this rulemaking strengthen CMS ability to ensure MA and Part D marketing to beneficiaries is not misleading, inaccurate, and/or confusing. Additionally, under 42 CFR 417.428, most marketing requirements in subpart V of part 422 apply to section 1876 cost plans as well. (75 FR 19783 through 19785) 1. Requirement for TPMOs To Submit Materials Into the Health Plan Management System (HPMS) In accordance with regulations at  422.2261(a) and 423.2261(a), MA organizations and Part D sponsors (MA organizations/Part D sponsors) must submit all marketing materials, all election forms, and certain designated communications materials for CMS review. The HPMS is CMS system of record for marketing materials.128In the past,  422.2261(a)(3) and 423.2261(a)(3) prohibited third-party and downstream entities from submitting materials directly to CMS, unless specified by CMS. In the January 2021 final rule, we modified  422.2261(a)(3) and 423.2261(a)(3) to provide CMS the flexibility to allow third parties to submit materials directly to CMS in the future (86 FR 5998). CMS made this modification in anticipation of operational changes to HPMS, which occurred in May 2021. Prior to the HPMS changes, third-party materials were submitted into HPMS, but the TPMO was required to send materials to an MA organization or Part D sponsor and have the MA organization or Part D sponsor submit the materials on the TPMOs behalf. These system changes permitted third parties and downstream entities, such as TPMOs, to submit materials directly to CMS following the receipt of prior approval from at least one MA organization or Part D sponsor. In cases where a TPMO document only markets one MA organization/Part D sponsor, there would be no change for the TPMO, meaning they would still send the document in through the MA organization/Part D sponsor who would submit it into HPMS. For TPMOs that develop materials for more than one MA organization/Part D sponsor, the TPMO would submit the material directly to CMS. Based on CMS operational change, we proposed to require TPMOs, as defined at  422.2260 and 423.2260, to submit their marketing materials developed for multiple MA organizations and Part D sponsors (and their specific plans) to CMS through HPMS. Specifically, we proposed to remove  422.2261(a)(3) and 423.2261(a)(3), which as implemented prohibited TPMOs from submitting materials the TPMO alone developed, and modify  422.2261(a)(2) and 423.2261(a)(2) to require that marketing materials developed by a TPMO for multiple plans must be submitted into HPMS by the TPMO. In addition, submission may only occur after the TPMO receives the prior approval of VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00117 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222236 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations each of the MA organizations or Part D sponsors on whose behalf the materials were designed and developed by the TPMO. CMS believes these changes are beneficial to the MA and Part D programs, for CMS, and plans. By having the TPMO submit materials directly to CMS and MA organizations and Part D sponsors opting into the piece, CMS will know exactly which organizations the piece is being used to market. This will allow CMS to hold only those MA organizations and Part D sponsors accountable for inappropriate marketing. This also allows organizations to decide whether they want to be represented by the TPMO on a specific material. Prior to this change, if the marketing material was sent in by the one lead organization, the non- lead organizations were automatically included in the marketing piece. Comment: The vast majority of commenters supported our proposal to require TPMOs to submit marketing materials to CMS through the HPMS. One commenter supported the proposal but was concerned about the burden if all plans did not opt into the marketing piece. Response: CMS thanks the commenters for supporting our proposal to require TPMOs to submit marketing materials into HPMS. Regarding the concern about plans that may not have opted in, a TPMO may not use the marketing piece for any plan that does not opt into the piece. Comment: We received a few comments opposing our proposal. Commenters generally stated that the current process is cumbersome and inefficient, requiring a TPMO to receive approval from every plan prior to submission into HPMS. One of the commenters suggested that a single plan serve as the reviewer for multi- marketing plan materials submitted by the TPMO while another commenter suggested CMS return to the former process where one plan submitted on behalf of the TPMO. Response: We appreciate the comments. Our proposal does not change our current process. Currently, marketing materials are required to be submitted to CMS, with HPMS being the method of submitting materials. The current regulation was written, stating that TPMOs may submit materials into HPMS, in preparation for a major HPMS marketing module change. The marketing module change took place in May 2021, which changed the way third party materials were submitted. We proposed to modify the regulation to make the submission of multi-plan marketing materials in HPMS a requirement, instead of a may, which, as previously stated, was in preparation for our systems change. This change to require TPMOs to submit the materials they develop ensures that all plans on whose behalf the TPMO is marketing, know what material is being submitted and that CMS knows which materials will be used by which plans. This process also allows for MA organizations and Part D sponsors to either opt into or opt out of each material, which allows CMS to see which organizations the TPMO material is being used for. With this new process CMS can better hold MA organizations and Part D sponsors responsible for the actions of their first tier, downstream, and related entities and, therefore, we believe that MA organizations and Part D sponsors should know and approve of the materials being used to market their products. Comment: We received one comment opposing requiring TMPOs to submit materials on behalf of employer group waiver plans (EGWPs). Response: Currently, our Medicare Communication and Marketing Guidelines (MCMG) do not require EGWPs to submit communication or marketing materials in HPMS, provided the materials are specific to the EGWP(s). The HPMS material submission requirement is waived (for TPMOs and EGWPs) when the materials are only applicable to and used for EGWPs. After review of the comments and for the reasons outlined in the proposed and our responses to comments, we are finalizing the provision to require TPMOs to submit marketing materials into HPMS as proposed. The benefits of ensuring that TPMO marketing materials are submitted into HPMS and are approved by each plan to permit the TPMO to use the material far outweigh any additional effort made by TPMOs. 2. Prohibit the Use of the Medicare Name, CMS Logo, and Products or Information Issued by the Federal Government in a Misleading Way CMS proposed to add a new sub- subparagraph (xix) to  422.2262(a)(1) and a new sub-subparagraph (xviii) to  423.2262(a)(1) to address the use of the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card. CMS is aware of concerns from external stakeholders about marketing activities and documents that appear to be from Medicare, CMS, or the Federal Government. Through beneficiary complaints and CMS surveillance activities over the years, we have seen the word Medicare in names of store fronts, on notices or postcards where Medicare is in large font while disclaimers are miniscule, and in television advertisements where a beneficiary could assume that the advertising is coming from CMS or the Medicare program in general. We have also seen logos that are very similar to the Health and Human Services (HHS) logo, on websites and print materials. These logos have featured circles with writing around the circle and a bird, wings, or other images that appear to be the same image used by the Federal Government. There are also numerous third-party internet sites with Medicare in the URL or a logo similar to the HHS logo, potentially causing a beneficiary to click on a private site when they intend to go to Medicare.gov or are seeking official Medicare information or access. Often, it appears as if the materials urging the beneficiary to take action are from Medicare, or that these third parties represent Medicare or the Federal Government. With the increase of third parties in the marketplace, based on CMS surveillance and complaints received (especially through 1800MEDICARE), we are concerned that an increasing number of beneficiaries are being misled into believing the entity they are contacting is Medicare or the Federal Government. One specific example, provided by a Medicare beneficiary, is a postcard with the beneficiary-named address with Medicare Notice in large, bold letters at the top along with Personal & Confidential and Important Medicare Information. This postcard also had a Medicare Information box listing a Customer ID, formatted to look like an official Medicare beneficiary number. This misleading postcard appeared to be an official document disseminated by the Federal Government. In our review of complaints received through 1800 MEDICARE, CMS discovered other examples of beneficiaries who mistakenly believed they were calling Medicare rather than a private MA or Part D plan or its agent or broker, likely based on the receipt of a flyer using the word Medicare in a way that conveyed to the beneficiary that they must call the telephone number on the mailer. These complaints illustrate that the use of the Medicare name is at times confusing and misleading to Medicare beneficiaries. CMS can see no value or purpose in a non-governmental entitys use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting