evekhm/cms_iom_500 huggingface dataset:
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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
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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,
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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
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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 itself as the government. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00118 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222237 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations A top CMS priority, consistent with sections 1851(h)(2) and 1860D 01(b)(1)(B)(vi) of the Act and CMSs implementing regulations at  422.2262 and 423.2262, is to ensure that MA organizations and Part D sponsors, and their first tier and downstream entities, disseminate information to beneficiaries that is accurate and not misleading. We are therefore concerned that the use of the term Medicare in situations like those, as previously described, erroneously leads beneficiaries to believe that Medicare-related communications or advertising are disseminated or endorsed by Medicare or the Federal Government, when in actuality such communications are being disseminated by the MA organizations/Part D sponsors themselves, or by entities operating on behalf of the MA organizations or Part D sponsors. Although the types of plan communications, previously described, that feature the word Medicare typically include disclaimers that state the information presented is not connected to or
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or by entities operating on behalf of the MA organizations or Part D sponsors. Although the types of plan communications, previously described, that feature the word Medicare typically include disclaimers that state the information presented is not connected to or endorsed by the Federal Government or the Medicare program, these disclaimers are often tiny, difficult to read, and are mixed in with other CMS-required disclaimers as well as plan-developed, non-required, disclaimers. While CMS already prohibits inaccurate or misleading information under  422.2262(a)(1)(i) and 423.2262(a)(1)(i), we believe it is important to specifically prohibit the misleading use of the Medicare name, CMS logo, and products or information issued by the Federal Government, as well as prohibiting the use of the Medicare card unless previously approved by CMS in  422.2262(a)(1) and 423.2262(a)(1). We are not including the Medicare Part D mark, as CMS gives Part D sponsors contractual permission to use the mark. With these proposals, we intended to firmly and clearly prohibit the improper use of these terms and logos. Therefore, we proposed adding a new paragraph (xix) to  422.2262(a)(1) and a new (xviii) to  423.2262(a)(1), which specifically prohibits the use of the Medicare name, CMS logo, or products or information issued by the Federal Government, including the Medicare card, in a misleading manner. We acknowledge that reasons exist to use the Medicare card image, which we will permit with authorization from CMS. Since CMS contracts with MA organizations and Part D sponsors and those contracts incorporate requirements to comply with part 422 and part 423 regulations, CMS holds these organizations accountable for the actions of their first tier, downstream and related entities (FDR), per  422.504(i) and 423.505(i); in addition, CMS requires MA organizations and Part D sponsors to include in their contracts with first tier, downstream and related entities that any services or activities conducted by the first tier, downstream or related entity are performed in accordance with the MA organizations or Part D sponsors obligations under its contract with CMS. If CMS determines that the Medicare name,
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related entities that any services or activities conducted by the first tier, downstream or related entity are performed in accordance with the MA organizations or Part D sponsors obligations under its contract with CMS. If CMS determines that the Medicare name, CMS logo, or official products like the Medicare card, have been used in a misleading manner by an FDR, CMS would address the issue with the MA organization or Part D sponsor on whose behalf the FDR was operating and hold the sponsoring organization accountable for the misleading information. Comment: We received numerous comments supporting our proposal limiting the use of the Medicare name, logo, and products. Some commenters supporting our proposal did request that we provide additional guidance on ways the Medicare name or Medicare card image could be used. Commenters stated specific circumstances such as using the image of the Medicare card to help beneficiaries recognize their card when needed. Response: We appreciate the support for this proposal. We agree with the commenters that there are instances where the use of the word Medicare or the image of the Medicare card are both necessary and not misleading. Situations such as identifying the difference between a MA organizations or Part D sponsors card from the Medicare card, displaying a picture of the Medicare card to remind beneficiaries that they do need to keep the card safe, even though they are in a Medicare Advantage plan, and showing the card so a beneficiary knows where to find their Medicare Beneficiary Identification number serve legitimate and important purposes. To ensure that the Medicare card image is not being used inappropriately, we are requiring organizations, including first tier, downstream, and related entities to receive authorization from CMS prior to the use of the image. This will ensure that the card is only being used in educational ways and not for marketing purposes. Comment: We received one comment opposing this proposal. The commenter stated that as long as the website clearly states it is not Medicare, then the use of the word Medicare is not misleading. Response: Ensuring that beneficiaries can recognize and trust that materials are from Medicare or the federal government is important. Specifically prohibiting the misleading use of the Medicare name, CMS logo, and products or information issued by the Federal Government, as well as prohibiting the use of the Medicare card unless previously approved by CMS in  422.2262(a)(1) and 423.2262(a)(1),
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or information issued by the Federal Government, as well as prohibiting the use of the Medicare card unless previously approved by CMS in  422.2262(a)(1) and 423.2262(a)(1), will protect beneficiaries. Website names containing Medicare such as medicare.com may easily be confused with Medicare.gov. Although sites may have a disclaimer stating they are not a governmental agency, the disclaimer may be small, at the bottom of a very long page, or hidden in another page, all of which can make the disclaimer difficult for a beneficiary to notice on the website. Disclaimers or taglines that are prominently placed, in a font size and color to be readily noticed, and that clearly explain that an entity or website is not affiliated with, endorsed by, or otherwise somehow related to the federal government, CMS, HHS, and/or Medicare are essential. Additional information or factors may contribute to, or alternatively, actually eliminate the potential for use of the Medicare name, CMS logo, and products and information issued by the federal government to be confusing or misleading to enrollees or potential enrollees. It is necessary to consider and evaluate the facts, when using the Medicare name, CMS logo, and products or information issued by the Federal Government to determine whether the use of them violates this provision we are finalizing. Plans and their TPMOs need to take the necessary steps to ensure that their marketing and communication materials and activities comply. Based on the comments, CMS is finalizing the proposal, with a minor modification, to prohibit the use of the Medicare name, logo, or products in a misleading manner when used in marketing of MA and Part D plans. The modification is to permit use of the Medicare card image with CMS authorization. 3. Prohibiting the Use of Unsubstantiated Statements Without Supporting Data In our January 2021 final rule, we prohibited plan use of unsubstantiated statements except those used in taglines and logos in 42 CFR 422.2262(a)(1)(ii) and 423.2262(a)(1)(ii). Prior to the January 2021 final rule, we had prohibited the use of unsubstantiated superlatives and pejoratives, except when used in logos and taglines, through our
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Prior to the January 2021 final rule, we had prohibited the use of unsubstantiated superlatives and pejoratives, except when used in logos and taglines, through our Medicare Communications and Marketing Guidelines. In the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00119 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222238 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations December 2022 proposed rule, we proposed to further restrict the use of superlatives by prohibiting all superlatives unless substantiating supporting data is also provided with the material and essentially adopt a regulation that builds upon our prior guidance. We proposed this for all superlatives, including those used in logos and taglines. Previously, CMS generally required plans to provide substantiating data to support the use of a superlative. However, that substantiating information was only provided to CMS, resulting in the beneficiary seeing the superlative without any context. Currently, a beneficiary may have no knowledge of how the superlative is determined, potentially misleading the beneficiary to believe a statement that may be partially or mostly true, but is lacking context and important specificity. For example, an MA organization may advertise that it has the largest fitness network, which may be accurate if all fitness facilities in their national network are considered. However, when looking at a particular service area, the MA organization advertising the largest fitness network may only have two contracted facilities, but another organization may have eight contracted facilities. The advertisement of the largest fitness network would be mis-leading, potentially enticing a beneficiary to enroll in a plan based on inaccurate information. Permitting the use of superlatives without specific information explaining the basis or context that is relevant to the prospective enrollee is potentially misleading to beneficiaries so we have reconsidered the scope of  422.2262(a)(1)(ii) and 423.2262(a)(1)(ii) as previously finalized. CMS believes it is critical to provide current, reliable, and valid data or documentation,
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422.2262(a)(1)(ii) and 423.2262(a)(1)(ii) as previously finalized. CMS believes it is critical to provide current, reliable, and valid data or documentation, such as reports or studies, as the basis for a superlative statement in order for beneficiaries to review and understand the context and reference point for the superlative. This documentation and/or data can be referenced through footnotes explaining the basis, noting the source (with enough information for a beneficiary to locate), or providing the actual comparison done to determine the superlative. For example, if an organization stated that they have the lowest premiums, the organization must identify the specific MA or Part D plan and their premium and the premiums of other plans in the service area, or reference a study, review, or other documentation that supports the superlative and with which the beneficiary can make accurate comparisons between plans. We also proposed to add a requirement that the supportive documentation and/or data be based on current data. Our proposed regulation text requires that the supportive documentation or data must reflect data, reports, studies, or other documentation to have been published either in the existing contract year or the prior contract year. For example, a plan could not make the statement in CY 2022 that they have the largest provider network in an area using 2018 data. Rather, in CY 2022, the statement that a plan has the largest network (of providers or pharmacies) in an area must be supported by documentation and/or data published January 1, 2021 or thereafter. Data and the underlying situations can be dynamic and change over time, therefore, CMS proposed that recent data, meaning the current or the prior contract year data, are the only data that may be used to substantiate superlatives. We believe any data older than the prior contract year may be misleading, given the age of the data and the potential that the data has changed. Based on this, we proposed to modify paragraphs  422.2262(a)(1)(ii) and 423.2262(a)(1)(ii) to prohibit the use of superlatives, unless sources of documentation and/or data supportive of the superlative is also referenced in the material, and to provide that such supportive documentation and/or data must reflect data, reports, studies, or other
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to prohibit the use of superlatives, unless sources of documentation and/or data supportive of the superlative is also referenced in the material, and to provide that such supportive documentation and/or data must reflect data, reports, studies, or other documentation that has been published in either the current contract year or the prior contract year. Comment: CMS received numerous comments supporting the requirement to use current year or previous year data. Response: CMS thanks those supporting our proposal. Requiring that a superlative statement be based on data about current or recent circumstances will ensure that beneficiaries can make decisions informed by accurate information that best reflects the plan options at the time the beneficiary is choosing among MA and Part D plans. Comment: One commenter noted that the proposed regulation text stated published documentation. This commenter recommended replacing published documentation with documentation that is applicable, stating that published documentation could be based on significantly older data. Response: We thank that commenter for identifying the potential issue and providing a recommended solution. We agree that more precise language is necessary. It may be possible for a study published in 2023 to be based on data from 2018 and using that information would not be consistent with our goals and intent for this rule. Ensuring that superlative statements, which lack nuance, are supported by current and relevant data is at the heart of our goal for the proposed revision to  422.2262(a)(1)(ii) and 423.2262(a)(1)(ii). We are finalizing the proposed change with modifications from our proposal, including using the phrase that applies to instead of has been published. Information applying to the current or prior contract year means information that is about, from or based on the current or prior contract year. Comment: One commenter partially supported the proposal, stating that their support was contingent on permitting citations to be used as the documentation. Response: As proposed, the amendments to paragraphs (a)(1)(ii) required sources of documentation or data supportive when using superlatives. CMS considers footnotes explaining the basis, noting the source (with enough information for a beneficiary to locate), or providing the actual comparison sufficient documentation. Therefore, a citation referring the reader to the actual documentation, with a link to the documentation, to be