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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
commercial insurers in the event that an item or service does not meet the appropriateness criteria that is long established policy. As part of CMS
consideration, if Medicare coverage is different than the majority of commercial insurers, CMS will include in the national or local coverage determination its reasoning for different coverage. To ensure there is adequate public input, CMS has committed not later than 12 months after the effective date of this rule, CMS will publish for public comment draft methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: Some commenters suggested that if CMS were to adopt a review of commercial insurer policies it should not be based on a single commercial policy, but a majority of commercial payers or use the most restrictive policy in the commercial market. Commenters also stated that commercial insurance policies vary widely and CMS could use any of the policies, including the most restrictive.
The commenters continued that CMS
should only adopt a commercial insurer policy if it expands coverage.
Response: To ensure there is adequate public input on which commercial insurers are appropriate and to what extent, CMS has committed not later than 12 months after the effective date of this rule, it will publish draft methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: A few commenters suggested that if CMS were to finalize the reasonable and necessary definition that includes consideration of commercial insurer policies, that CMS
should consider the model CMS
currently uses for compendia https
www.cms.gov/Medicare/Coverage/
CoverageGenInfo/compendia to determine which commercial insurers to include.
Response: We appreciate the idea and agree that more stakeholder engagement is needed. Therefore, CMS has committed not later than 12 months after the effective date of this rule, it will establish the methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: A commenter asked why the Agency would assess the appropriateness of a service, find it lacking, but then decide to move forward with affirmative coverage because somewhere out in the private
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insurance landscape the service is covered. This approach would create new areas of important conflicts of interest between manufacturers and payers that would be difficult to monitor.
Response: As the commenter stated, CMS will review commercial insurers only in the event it does not meet the appropriateness criteria. We believe it is important to ensure that we have evaluated all relevant evidence. To ensure we have full stakeholder engagement before we evaluate all commercial insurer policies, we will issue a sub-regulatory guidance for the public to comment. Further, CMS has committed to publish this no later than 12 months after the effective date of this rule. The guidance will establish the methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: Several commenters noted that commercial insurers typically consider other factors such as costeffectiveness of items or services in making coverage determinations;
whereas, CMS does not. There is no single standard for commercial payer coverage policies which could create significant challenges in applying a commercial payer analysis to an item or service to determine coverage, including some commercial insurers may use Medicare coverage policies as part of its coverage. Commenters wanted to know how CMS will weigh and use these commercial analyses to determine coverage. These same commenters wanted that methodology to be transparent and public.
Response: We agree. After further analyzing the definition along with the public comments it would be challenging to fully implement this part of the reasonable and necessary definition without further engagement with stakeholders. CMS has committed not later than 12 months after the effective date of this rule, it will establish the methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: Commenters noted that, rather than include commercial payer as a separate criteria in the reasonable and necessary definition, CMS should review commercial policies as part of the established NCD/LCD development process to ensure beneficiaries have access to items and services.
Response: We agree. CMS currently may consult commercial insurer policies as part of the NCD and LCD
process and we have further committed
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to establish the methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Comment: CMS received many comments that if we adopted commercial insurer policies as part of the reasonable and necessary definition that transparency would be extremely important in the policies we reviewed.
Many commenters stated that commercial insurers coverage policies are not public or transparent. The commenters stated that the public must have access to the scientific basis of commercial payers coverage decisions, including sources of data and the data itself.
Response: We agree transparency is an important aspect of the coverage process. After reviewing the public comments, we recognized that implementation of inclusion of commercial payers would be challenging. Therefore, a transparent analysis of commercial insurers will be part of the NCD and LCD process, which includes public comment period of at least 30 days.
Comment: If the reasonable and necessary definition is finalized with the commercial insurer policy provision, commenters were concerned it will cede essential government decisions to commercial insurers.
Response: We appreciate the comment. Based on comments, we are finalizing a definition that requires CMS
to explain why it would not follow a commercial insurer. This will be added to the NCD and LCD process to allow for a stakeholder engagement during the public comment period. In addition, as mentioned in previous responses, CMS
committed not later than 12 months after the effective date of this rule, to establish the methodology by which commercial insurers policies are determined to be relevant based on the measurement of majority of covered lives.
Commercial Insurer PolicyUniverse and Analysis Comment: CMS received a wide variety of comments regarding which commercial insurers we should review for consideration. The comments ranged from supporting any single plan to working with both national and local health care management groups who have a stake in the various regions to a plurality of plans to commercial insurance changes too rapidly and should not be considered. We also received a few comments to include government insurance plans. A few larger insurers stated that it used fully
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