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Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Proposed Rules patients benefit from these programs to full extent possible. Specifically, CMS
and all the parties involved with the multiple best prices policies will want to make sure Medicaid patients receive the drug therapies under the VBP
approach that are prescribed for them in a timely manner; that the VBP program does not create unnecessary barriers or requirements on the patient to access the drug; that they receive appropriately scheduled doses of a therapy if the patient treatment under the VBP
arrangement is based on multiple doses;
and that patient outcomes are tracked so that optimal patient care is provided;
and, the states can obtain any additional discounts due to them from manufacturers under the VBP
arrangement. At this time, we believe it is in the best interest of the Medicaid program and Medicaid beneficiaries, in particular, that states prioritize the Medicaid eligibility and benefit requirements under the ARP for example, expanded optional Medicaid coverage for postpartum women, expansion of COVID19 testing and treatment services, and expansion of vaccine administration to limited benefit groups, resulting from enactment of the ARP to address beneficiary needs during the COVID19
pandemic, and therefore, propose a delay to the effective date for amendatory instruction 10.a. the multiple best price approach by 6
months effective July 1, 2022. By allowing more time to address the needs of Medicaid beneficiaries during the PHE, states, CMS, providers, and manufacturers will also have more time to put in place appropriate beneficiary protections as part of the multiple best price approach.
Therefore, we propose to delay the amendment associated with multiple best price requirements for 6 months, which if finalized, would make amendatory instruction 10.a effective beginning July 1, 2022. We also expect to issue additional guidance before that time on operational and policy aspects of the new VBP program, including specifications relating to beneficiary protections.
For the same reasons discussed above, we believe that in light of the pandemic and the resource demands stemming from the PHE including those established under the ARP on the Medicaid program and its beneficiaries, it is imperative that the territories prioritize the Medicaid eligibility and mandatory benefit requirements brought about by the ARP to address beneficiary needs during the COVID19. Therefore, we believe that a further delay in the inclusion date of the U.S. territories in
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the regulatory definitions of States and United States is warranted and are proposing that they be included in those definitions beginning April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received.
By delaying the inclusion date to April 1, 2024, or in the alternative, a date earlier than April 1, 2024, but not before January 1, 2023, we are allowing the territories additional time to develop needed systems and policy changes, in order to avoid unintended increases in drug costs and access concerns. The needed systems must be capable of collecting, reporting, validating, and tracking drug utilization on an ongoing basis. In addition, they require extensive advance planning and budgeting.
The delay in inclusion date would also benefit those territories that choose not to participate in the MDRP, and therefore, would be required to use human and financial resources to complete the section 1115 and section 1902j waiver applications that are required to waive out of MDRP
participation should the current April 1, 2022 date remain in effect.
Moreover, should the amended regulatory definitions of States and United States go into effect on April 1, 2022, all manufacturers sales to the territories and prices paid would be included in the AMP and best price calculations at that time, regardless of whether the territory is participating in the MDRP. As discussed in the COD
final rule 81 FR 5224, we heard from various stakeholders who expressed concerns that drug manufacturers would likely be prompted to increase drug 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 Average Manufacturer Price AMP and best price. The inclusion of these prices in AMP and best price would 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 above, 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
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health needs during the PHE. We believe this provides further rationale for delaying the inclusion date of 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 are proposing 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 are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. Thus, we are specifically requesting comments from all interested parties 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 are requesting 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 are proposing to be April 1, 2024, or possibly earlier, but no earlier than January 1, 2023 based on public comments.
Therefore, we are requesting comment on our proposal to amend 447.502 to delay the inclusion date for the the U.S.
territories into the regulatory definitions of States and United States until April 1, 2024. We are also requesting comments on an alternative proposal, which is to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received.
III. Response to Comments Because of the significant number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble for each applicable comment period, and, if and when we
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