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Federal Register / Vol. 86, No. 221 / Friday, November 19, 2021 / Rules and Regulations the timeframe established in this delay rule, and we may consider further delays in future rulemaking if systems are not ready.
Comment: Several commenters provided input as to how CMS, states, and manufacturers should utilize the time associated with the proposed 6
month delay in effective date. One commenter encouraged CMS to utilize the proposed 6 month delay to issue subregulatory guidance regarding whether an arrangement would qualify as a VBP arrangement if a State Medicaid Agency is not able to access the same type of patient and outcomes data utilized in the commercial contract that resulted in the multiple best price.
In other words, the commenter questioned if the state and the manufacturer will be allowed to modify the commercial sector agreement to better fit the Medicaid population, and how manufacturers will report multiple best prices when multiple commercial and/or state agencies enter into similar contracts but have different outcomes, resulting in different rebates and multiple best prices.
Response: We appreciate the commenters recommendations for how CMS, states, and manufacturers should utilize the time associated with the proposed 6 month delay in effective date; however, these comments and recommendations are outside of the scope of this rulemaking. We note, however, that CMS plans to provide further operational guidance for states and manufacturers in the near future regarding the implementation of the multiple best price reporting.
Comment: A few commenters requested that CMS take this additional time to consult with Medicaid agencies and other stakeholders to ensure the necessary systems and technology needed to facilitate the collection and reporting of patient clinical outcomes are in place. The commenters further commented that CMS should encourage and incentivize consistency for example, standard data reporting requirements in these systems across states.
Response: We agree with the commenters, and as noted in the December 31, 2020 final rule, we plan to develop operational guidance regarding the final policy permitting multiple best price reporting. To that end, we have been available to manufacturers, states, and other stakeholders to discuss what is needed in MDP systems to effectuate the reporting of multiple best prices and intend to issue operational guidance associated with the MDP system changes. We expect to also provide
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states with guidance regarding existing Medicaid access and beneficiary protections when engaging in VBP
arrangements.
With respect to the standardization of reporting systems across states, we understand that such systems would benefit states, patients, and manufacturers, as it would facilitate implementation of VBP programs, and avoid duplication of efforts. Since the MDP systems operated by CMS will not be collecting patient-specific or outcomes data associated with VBP
arrangements, we will not be encouraging or providing incentives to standardized data collection reporting associated with VBP arrangements as part of the MDP system. However, we expect that states, working with their supplemental rebate contractors or other VBP vendors, as well as manufacturers, will attempt to create standardized reporting templates and formats that may become industry standards over time.
Comment: A few commenters indicated their appreciation of CMS
December 31, 2020 final rule to enhance flexibility in creating VBP arrangements;
however, the commenters do not believe a 6 month delay in the effective date allows CMS sufficient time to adequately address the operational complexities and other legal hurdles giving examples such as the federal Anti-Kickback Statute or Medicare Part B requirements that impede adoption of VBP arrangements in a timely fashion.
Therefore, the commenters stated that to leverage the full benefit of VBP
arrangements, additional flexibilities and clarity are needed that cannot be provided via subregulatory guidance and urged CMS to withdraw the December 31, 2020 final rule and issue a revised proposed rule, or reopen the December 31, 2020 final rule for further public comment. A commenter indicated that while they appreciate CMS interest in and effort to modernize the MDRP to support innovation that advances high value, patient-centered care through VBP arrangements, the final VBP multiple best price policy lacks clarity and does not consider a full range of operational hurdles. The commenter also indicated that the changes to the MDRP alone are not sufficient to reduce current barriers to VBP arrangements in the commercial market, and therefore, CMS must address the Anti-Kickback Statute AKS, impact to Average Sales Price ASP, and other government price reporting barriers to realize the full potential of VBP arrangements.
Another commenter expressed concerns regarding how the final rule on
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VBP arrangements could be gamed by manufacturers. The commenter suggested and encouraged CMS
withdraw the December 31, 2020 final regulation, prohibit manufacturers from reporting multiple best prices, limit outcomes-based arrangements under a bundled approach, and clarify requirements regarding stacking discounts. The commenter expressed concern that CMS VBP regulations, as finalized in the December 31, 2020 final rule, are not related to the Medicaid program and instead are designed to encourage specific types of contracting in the commercial market. This commenter suggested that the VBP
regulations change Medicaid program requirements to achieve a goal outside of the Medicaid program and asserted that it is not appropriate to harm the Medicaid program to promote commercial contracting flexibility.
Response: The proposed rule only proposed a delay in effective date related to the VBP multiple best price reporting policy finalized in the December 31, 2020 final rule. The underlying policy itself was not a subject of the proposed rule open to public comment. Thus, comments related to the underlying policy are outside the scope of this rulemaking. At this time, we believe the 6 month delay beyond the initial delay in inclusion date from the COD final rule will be adequate for manufacturers to provide the data necessary to report multiple best prices in MDP system. Any other legal requirements that manufacturers may be subject to, such as the federal anti-kickback statute or Medicare Part B
requirements, are outside of the scope of this rulemaking. However, we do intend to issue additional guidance on the interaction between VBP and Medicare Part B ASP calculations.
Comment: Some commenters continue to request additional clarity on whether, and to what extent, new VBP
arrangements run afoul of the federal anti-kickback statute. The commenters indicate that CMS should work to remove barriers imposed by AKS that limit or prevent adoption of VBP
arrangements.
Response: While we appreciate the comments received, these issues are outside the scope of this rulemaking. As noted above, the underlying policy regarding VBP arrangements was not a subject of the proposed rule open to public comment. Rather, the proposed rule specifically proposed a 6 month delay to the effective date for the policy permitting manufacturers to report multiple best prices related to a VBP
arrangement. Questions regarding these
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