Quiero saber acerca de...

khammond on DSKJM1Z7X2PROD with RULES

64822

Federal Register / Vol. 86, No. 221 / Friday, November 19, 2021 / Rules and Regulations
prices, including prices paid by the U.S.
territory Medicaid programs, once the territories are included in the definitions of States and United States. This is because, as currently drafted, section 1927 of the Act requires that eligible sales of drugs within the United States be included in the drug manufacturers calculation of AMP and best price. The inclusion of these prices in AMP and best price could result in the territories that receive a waiver realizing an increase in their Medicaid drug costs without the offsetting benefit of receiving Medicaid rebates.
Furthermore, the increase in Medicaid costs could adversely affect territories because of their Medicaid funding cap.
As noted previously in the proposed rule, that could result in an increase in drug prices in the territories, making drugs less affordable, and making it more difficult for the territories to address their own public health needs during the PHE. We believe this provides further rationale for delaying the effective date of the inclusion of the territories in the regulatory definitions of States and United States. It will ensure that during this PHE, which has the potential to extend into 2022, those territories that opt to waive participation from the MDRP will not face the additional financial burdens associated with increased Medicaid drug costs from drug manufacturers increasing drug prices to the territories.
We proposed a new inclusion date of April 1, 2024, for the amended regulatory definitions of States and United States to include the U.S.
territories for purposes of the MDRP. In the alternative, we proposed to finalize an inclusion date that may be earlier than April 1, 2024, but before January 1, 2023, based on public comments received. We specifically requested comments on whether April 1, 2024, or an earlier inclusion date, but not earlier than January 1, 2023, would be more appropriate for the amended regulatory definitions. More specifically, we requested public comments that will assist us in understanding all relevant concerns related to establishing a new inclusion date, including whether territories are ready to participate in the MDRP, and whether CMS is able to execute appropriate and necessary waivers for territories that do not want to participate. In any case, manufacturers would be required to include their sales to the territories in their AMP and best price calculations based on the inclusion date finalized in a final rule, which we proposed to be April 1, 2024, or possibly earlier, but no
VerDate Sep<11>2014

21:40 Nov 18, 2021

Jkt 256001

earlier than January 1, 2023 based on public comments.
II. Response to Public Comments and Provisions of the Final Rule In response to the proposed rule, we received 29 public comments.
A. Delay of Effective Date of Amendatory Instruction 10.a.
447.505a The following is a summary of the comments received and our responses on proposed delay of effective date of amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to value based purchasing VBP arrangements.
Comment: Several commenters supported the proposal to delay for 6
months the January 1, 2022 effective date for amendatory instruction 10.a. of the December 31, 2020 final rule, which addresses the reporting by manufacturers of multiple best prices connected to a VBP arrangement. These commenters supported the proposed delay because of both the time as well as the state and federal resources that have been taken up by the emergence of the pandemic, implementation of Medicaid expansion under the ARP, and the focus on development, production, and distribution of vaccination efforts related to controlling the spread of the COVID19 virus. Some commenters indicated that they do not believe that states, providers, and CMS have the infrastructure in place at this time to be able to track the necessary data related to health outcomes to properly implement VBP arrangements. They believe that the proposed delay will allow for some of this work for example, work associated with pandemic efforts and infrastructure work to collect adequate patient data with appropriate privacy protections to be finished without compromising care for those who need it in the interim. The commenters also noted that the proposed delay will allow CMS, states, and manufacturers time to develop and test the new MDP system, and allow CMS to develop operational guidance to facilitate multiple best price reporting.
Response: We appreciate the support of the proposed delay of the effective date of amendatory instruction 10.a. to July 1, 2022, and continue to believe that the proposed delay is necessary for CMS, manufacturers, states, and providers to engage in the work necessary to facilitate the multiple best price reporting approach. As commenters noted, we are implementing a new MDP system and, as part of that new system, will include
PO 00000

Frm 00022

Fmt 4700

Sfmt 4700

the necessary changes to address multiple best price reporting. The additional 6 months will give us time to upgrade our new MDP system to collect multiple best prices, as well as explore and test these changes with the manufacturers and states that have been anxious to commit to the multiple best price approach. We will also use this time to issue operational guidance for states and manufacturers on reporting and accessing the multiple best price information in the MDP system.
For commenters concerns regarding infrastructure and data collection, while we plan to provide general operational guidance, we do not plan to issue guidance on how to operationalize, evaluate, or monitor specific VBP
arrangements as each arrangement will have its own set of specific facts and circumstances associated with the arrangement, such as the drug, the anticipated outcomes, and population included in the arrangement. A one size fits all approach to operationalizing a VBP arrangement is not possible because of the many different arrangements on the marketplace 85 FR 87018.
Comment: A few commenters urged CMS to effectuate the multiple best price reporting option as established in the final rule, but no later than the proposed delay in effective date of July 1, 2022. Several commenters, while agreeing with the proposed delay, continue to believe that the multiple best price reporting flexibility is essential to ensuring that patients benefit from VBP arrangements. One commenter in particular was disappointed that CMS was considering the proposed 6 month delay in effective date, but understood that putting in place the necessary systems and modifications for a seamless adoption of this new program is challenging. This commenter encouraged CMS to work diligently to ensure the proposed effective date of July 1, 2022 was achievable. Another commenter indicated that any further delay in effective date, beyond the 6 months proposed, will result in substantial negative repercussions for patient access to therapies that address significant unmet need, especially for Medicaid beneficiaries, and therefore, should be a one-time delay.
Response: This delay rule allows states additional time to ensure patient access by Medicaid beneficiaries to certain higher cost therapies. We will continue to assess system readiness for states, manufacturers and CMS to ensure the reporting by manufacturers of multiple best prices connected to a VBP arrangement can be effectuated in
E:FRFM19NOR1.SGM

19NOR1