evekhm/cms_iom_500 huggingface dataset:
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and 423.2274(g)(2)(ii). However, following the May 2022 final rule, CMS heard from trade organizations and plans, as well as individual agents, regarding the obligation to record all calls. Many of these post-final rule questions and comments centered around whether smaller agent companies had to record conversations. Some of the comments received after the final rule requested clarification on whether all calls really needed to be recorded. In the December 2022 proposed rule, CMS did not propose to change the requirement that TPMOs, including agents and brokers, regardless of their size, must record calls. However, we proposed to limit calls that must be recorded from all calls to only those calls regarding sales, marketing, and enrollment by amending  422.2274(g)(2)(ii) and 423.2274(g)(2)(ii). We explained in the proposed rule a concern that current requirement is too broad because calls placed to merely set up an in-person meeting, or to confirm a beneficiary received a plan welcome packet, or calls to provide a beneficiary the opportunity to ask non-marketing questions, such as when the plan will be effective, must all be recorded. We believe requiring the recording of these types of calls is an unnecessary burden and not aligned with our goal to obtain call recordings to ensure the marketing, sales, and enrollment activities conducted by agents, brokers and TPMOs meet the applicable regulatory requirements. Therefore, we proposed to modify  422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to limit the calls that must be recorded in their entirety to marketing, sales, and enrollment calls. We explained that the definition of marketing in  422.2260 and 423.2260 would apply to the use of the term in new paragraph (g)(2)(ii) and that we intended the words sales and enrollment to include the plain meaning of those terms. Comment: CMS received numerous comments supporting this proposal. Response: CMS thanks the commenters for their support. Comment: One commenter was concerned that they would have to go back and delete all non-marketing, sales, and enrollment calls. Response: This provision does not require adjustments to be made
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CMS thanks the commenters for their support. Comment: One commenter was concerned that they would have to go back and delete all non-marketing, sales, and enrollment calls. Response: This provision does not require adjustments to be made to recordings of past calls. The commenter will not need to delete non-marketing, sales, or enrollment calls. Comment: CMS received a few comments opposing the requirement to record calls in any case. Commenters focused on two main points: that beneficiaries may not want to be recorded, but the TPMO has no choice and that marketing issues and potential non-compliance are tied to large call centers and not independent agents or smaller offices. Response: We appreciate the comments about call recordings. However, our proposal addressed limiting the recording requirements, not eliminating CMS recording requirements, including the longstanding requirement to record enrollments. Beneficiaries have the right to refuse to be recorded and have alternative methods to enroll, such as in-person or online. Finally, as previously discussed, CMSs reviews of telephone call between agents and beneficiaries strongly indicate that call centers, independent agents, and smaller offices face similar compliance challenges and training needs. Furthermore, all agents must be trained, tested, and licensed in the same manner regardless of location or operational size. After consideration of the comments and for the reasons outlined in the proposed rule, we are finalizing the amendments to  422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) as proposed. 22. Require Web-Based Technology Meetings To Be Recorded In addition to modifying  422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to only require marketing, sales, and enrollment calls to be recorded, we also proposed to add language to clarify that web-based technology is included in the call recording requirements. Since the May 2022 final rule, we have received questions asking whether technology- based meetings (for example, Zoom meetings between an agent and a beneficiary) need to be recorded. CMS considers meetings taking place on Zoom, Facetime, Skype, or other technology-based platforms to be the same as telephonic calls that present the same concerns about inappropriate marketing as has been found during telephonic calls. Technology is changing the
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taking place on Zoom, Facetime, Skype, or other technology-based platforms to be the same as telephonic calls that present the same concerns about inappropriate marketing as has been found during telephonic calls. Technology is changing the way people interact, and Medicare beneficiaries aging into the program are more likely to have experience with newer technologies and may be more comfortable using such VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00137 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222256 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations technology. In addition, during the COVID19 pandemic, many beneficiaries learned to use different technologies to keep in touch with people and to conduct business. Moreover, because of the pandemic, many agents and brokers have moved to using these newer technologies, holding both sales and educational meetings using web-based technologies. And unlike in-person or online documentation, the practical effect of using technology like Zoom, Facetime, or Skype is similar to a telephone call. We proposed to modify  422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to read Record all marketing, sales, and enrollment calls, including calls occurring via web-based technology, in their entirety. Comment: We received some comments supporting this proposed change. Response: We appreciate the support. Comment: A commenter opposed the proposed change stating that the change as written did not provide the beneficiary with the choice to not be recorded. The commenter pointed out that if the recording would be preserved for ten years, the beneficiary should have a say as to whether they wanted to be recorded. Response: The requirement to record calls does not prevent a beneficiary from declining to have the call recorded. CMS has always expected that if a beneficiary declines to be recorded, the call must end. The TPMO may engage with the beneficiary through an in- person meeting. Comment: One commenter stated that they opposed the requirement to record calls between
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if a beneficiary declines to be recorded, the call must end. The TPMO may engage with the beneficiary through an in- person meeting. Comment: One commenter stated that they opposed the requirement to record calls between beneficiaries and TPMOs. They indicated that they did not want their personal information disclosed, recorded during the phone call and then stored. Response: We appreciate this individuals desire to not have their information recorded on a phone call between a beneficiary and a TPMO, regardless whether the objection to the recording is from a beneficiary or a TPMO. If the commenter was a beneficiary, there are other enrollment mechanisms outside of phone calls that beneficiaries can use to enroll in a plan. Comment: One commenter indicated that they opposed the requirement to record calls between TPMOs and beneficiaries as it is an undue burden on independent agents. Some commenters indicated that they opposed the requirement to record calls altogether, regardless of CMS limiting the scope of the recording requirement to certain types of calls. One of these commenters indicated that there should be separate rules for independent agents and large call centers. Response: The requirement to record all calls is outside the scope of this regulation. The commenter also requested CMS distinguish between independent agents and large call centers with regard to the requirement. CMS did not address the definition of TPMO in the proposed rule and we decline to adopt a change of this scope in the regulation without a fuller opportunity for the public to understand and comment on it. In addition, CMS has anecdotal experience that marketing misrepresentation issues have occurred during calls with independent agents, as well as with the TPMO call centers. Finally, the premise that this requirement is an undue burden is based on the idea that independent agents do not have the capability to record calls and maintain the recordings of those calls and we fundamentally disagree. Independent agents have long been engaging in telephonic enrollment as detailed in the Medicare Managed Care Enrollment Manual and the Medicare Part D Enrollment Manual. Telephonic enrollment entails capturing enrollment requests over the phone. MA and Part D enrollment require the plan to maintain a copy of the enrollment request. In the medium of a telephonic enrollment this would be impossible without the ability to record the telephonic conversation that comprised the telephonic enrollment. As
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Part D enrollment require the plan to maintain a copy of the enrollment request. In the medium of a telephonic enrollment this would be impossible without the ability to record the telephonic conversation that comprised the telephonic enrollment. As such, independent agents should already have the capability available to capture telephonic conversations with the beneficiaries whom they serve. After considering the comments on the inclusion of web-based technology meetings, and for the reasons outlined in the proposed rule, we are finalizing this change largely as proposed but with the clarification that the requirement applies only to the audio portion of web-based calls. IV. Strengthening Current Medicare Advantage and Medicare Prescription Drug Benefit Program Policies K. Clinical Trial-Related Provisions ( 422.109) MA plans must cover Medicare Part A and Part B benefits, excluding hospice, kidney acquisitions for transplant, and certain changes in benefits due to a National Coverage Determination (NCD) or a legislative change. We proposed to adopt regulations regarding MA coverage of clinical trials covered by Medicare to ensure clarity on these coverage rules for MA plans. These coverage rules implement section 1852 of the Act and are within our rulemaking authority for the MA program. These proposals generally codify guidance currently specified in section 10.7 of Chapter 4 of the Medicare Managed Care Manual for clinical trials covered under National Coverage Determination (NCD) 310.1; A and B investigational device trials (AB IDE); and National Coverage Determinations with coverage with evidence development (NCDCED). We received several comments supporting our proposals in general. We address comments on specific proposals in the appropriate sections of this rule. 1. Clinical Trials Under National Coverage Determination 310.1 Clinical trials may include some items and services that would not be covered by Medicare, absent the trial. For clinical trials covered under the Clinical Trials National Coverage Determination 310.1 (NCD) (NCD manual, Pub. 10003, Part 4, section 310), long-standing CMS policy has been that traditional Medicare (that is, the Medicare FFS program) covers the routine costs of qualifying clinical trials for all Medicare enrollees who volunteer to participate in the approved trial, including those enrolled in MA plans. CMS has discussed this policy in several Advance Notices and Rate Announcements, including the advance notices of methodological changes in Part C payments issued for 2004, 2007, 2008, 2009, 2011, 2017, and 2019, and in
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enrolled in MA plans. CMS has discussed this policy in several Advance Notices and Rate Announcements, including the advance notices of methodological changes in Part C payments issued for 2004, 2007, 2008, 2009, 2011, 2017, and 2019, and in the announcements of capitation rates and payment policies for Part C in 2009, 2011, 2012, and 2017. NCD 310.1 is the current statement of the Medicare coverage of routine costs associated with clinical trial participation. As specified in the NCD, routine costs associated with a clinical trial include: Items or services that are typically provided by Medicare absent a clinical trial (for example, conventional care); Items or services required solely for the provision of the investigational item or service (for example, administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications. Although MA plans must follow all NCDs, section 1852(a)(5) of the Act, which CMS has implemented in  422.109(b), provides that if an NCD or new legislative benefit introduced in the middle of a plan year is considered a significant cost as determined by the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00138 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222257 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 132The Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter discusses the clinical trial coverage policy for the MA program on pages 2323 and is available at this link: https://www.cms.gov/Medicare/Health-Plans/ MedicareAdvtgSpecRateStats/Downloads/ Advance2019Part2.pdf. 133The Announcement of Calendar Year (CY) 2011 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter
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MedicareAdvtgSpecRateStats/Downloads/ Advance2019Part2.pdf. 133The Announcement of Calendar Year (CY) 2011 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter addresses this in a response to a comment on page 2021 and is available at the following link: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/ Downloads/Announcement2011.pdf. 134In addition, the See page 31 of the MA Payment Guide for Out of Network Payments, page 31, addresses this topic. The guide is available at the following link: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/ downloads/oonpayments.pdf. Office of the Actuary, MA plans are not responsible for coverage until the cost to provide the new benefit is calculated into the plans payment rate. CMS has previously determined, as discussed in the CY 2019 Advance Notice,132that the multiple clinical trials covered under NCD 310.1 trigger the significant cost threshold. Therefore, Traditional Medicare has covered the Medicare- covered routine costs of clinical trials that are covered under NCD 310.1 for MA enrollees. To ensure continued clarity and transparency for this longstanding policy, discussed in section 10.7.1 of Chapter 4 of the Medicare Managed Care Manual, we proposed to codify this policy by adding new  422.109(e). In  422.109(e)(1), we proposed to codify that traditional Medicare is responsible for coverage of routine costs of qualifying clinical trials for MA enrollees for clinical trials covered under the Clinical Trials National Coverage Determination 310.1 and all reasonable and necessary items and services used to diagnose and treat complications from participating in clinical trials. Deductibles and MA Responsibility for Differences in Cost-Sharing Traditional Medicare pays for all routine costs of clinical trials for MA enrollees and, as explained in the CY 2011 Rate Announcement,133MA enrollees do not pay the traditional Medicare Part A and B deductibles when Traditional Medicare pays the Medicare-covered costs associated with the clinical trial.134In  422.109(e)(2), we proposed to codify this policy that MA enrollees participating in clinical trials are not subject to Part A and B
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Traditional Medicare pays the Medicare-covered costs associated with the clinical trial.134In  422.109(e)(2), we proposed to codify this policy that MA enrollees participating in clinical trials are not subject to Part A and B deductibles. MA plans are responsible for paying the difference between traditional Medicare cost-sharing incurred for qualifying clinical trial items and services and the MA plans in-network cost-sharing for the same category of items and services. We proposed to codify this requirement for MA plans to pay the difference between traditional Medicare and plans cost sharing in  422.109(e)(3). We also proposed in  422.109(e)(4) to codify that the enrollees in-network cost-sharing portion must be included in the plans maximum out-of-pocket (MOOP) calculation. As the clinical trial costs within the scope of NCD 310.1 are covered by Part A and/or Part B, these are basic benefits within the scope of the MOOP requirements in  422.100(f)(4) and (5) and 422.101(d)(2) and (3), but for clarity we proposed to codify at  422.109(e)(4) the requirement that the enrollees in- network cost-sharing must be included in the plans MOOP calculation. In requiring MA organizations to provide in-network cost sharing for clinical trial services, CMS is requiring that MA plan enrollees have coverage for clinical trial services that is consistent with coverage they have for all other Medicare Part A and Part B services. In paragraph (e)(5), consistent with our guidance in section 10.7.1 of Chapter 4 of the Medicare Managed Care Manual, we proposed that MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollees participation in a non-plan-sponsored clinical trial under NCD 310.1. This protection is necessary in order to ensure that MA enrollees have access to and coverage of clinical trials within the scope of NCD 310.1 to the same extent as Medicare beneficiaries enrolled in the traditional Medicare program. While MA plans are responsible for covering any differences in cost-sharing between traditional Medicare and MA plan in- network
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clinical trials within the scope of NCD 310.1 to the same extent as Medicare beneficiaries enrolled in the traditional Medicare program. While MA plans are responsible for covering any differences in cost-sharing between traditional Medicare and MA plan in- network costs for services in the same category, traditional Medicare, through the MACs, is responsible for all other costs included in clinical trials within the scope of NCD 310.1. Finally, in accordance with  422.109(c)(2), CMS requires MA organizations to provide coverage for: (1) services to diagnose conditions covered by clinical trial services; (2) most services furnished as follow-up care to clinical trial services; and (3) services already covered by the MA organization. Because  422.109(c) adequately addresses how MA organizations are required to cover certain benefits and costs even when the traditional Medicare program pays for changes in benefits as a result of an NCD or legislative change, we do not believe that additional regulation text is necessary to apply those rules in the context of NCD 310.1. Comment: A commenter supported the proposal to codify clinical trial- related policies under NCD 310.1 and stated it believes there is sufficient information on expectations of MA organizations with respect to clinical trial coverage. The commenter also suggested that CMS continue to provide MA organizations with information about coverage responsibilities for Medicare-covered trials to include information in the final decision memo for the NCD regarding significant cost as well as information on policy implications for Part D, dually eligible, and Medicaid. Response: We thank the commenter for its support of our proposal. We note that, for clinical trials that are outside the scope of NCD 310.1 and are conducted under a separate NDC, coverage of items and services under that separate NCD is addressed by the existing regulation at  422.109(a) through (d). We also appreciate the commenters suggestion that significant cost information be included with the decision memo for the NCD and will work with our colleagues in Traditional Medicare about including this information in future decision memos. With respect to information about other programs, unless the NCD has specific information relevant to other programs, we believe that each program can best explain through its guidance for the program any issues in implementation or coverage. Comment: A commenter recommended that CMS reconsider its proposal to permit MA enrollees to participate in clinical trials without
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to other programs, we believe that each program can best explain through its guidance for the program any issues in implementation or coverage. Comment: A commenter recommended that CMS reconsider its proposal to permit MA enrollees to participate in clinical trials without prior authorization from an enrollees MA plan. The commenter expressed concern that the enrollee or the MA organization would have no control over whether the enrollee would, for example, receive a placebo, or the treatment being tested in the trial which could put the enrollees health and quality of care at risk while also undermining the MA organizations care coordination efforts for the enrollee. Response: Under the current policy that we proposed to codify, Traditional Medicare pays for MA enrollees for clinical trials under 310.1. MA organizations do not cover these trials for MA enrollees and the costs of what is covered is paid by the Traditional Medicare program; therefore, MA organizations cannot require prior authorization. MA organizations may, however, require prior authorization for A and BIDE trials and NCDCEDs. Although MA organizations may not require prior authorization for clinical VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00139 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222258 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations trials under 310.1, enrollees, if they choose, may notify plans of their participation in clinical trials and MA organizations may help facilitate communication with the trial leaders and enrollee. MA enrollees in clinical trials also receive the same protections as those in Traditional Medicare, including informed consent requirements and discussion of the trials features, such as, whether a placebo will be used. After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing  422.109(e) as proposed with a minor modification to the heading for paragraph (e) to clarify the scope of the paragraph is limited to NCD 310.1. 2. AB Investigational Device Exemption Trials The regulation at  405.211 specifies Medicare coverage of Category A and B investigational device exemption (IDE)