Voglio sapere a riguardo di…

28744

Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Proposed Rules
inclusion date for the U.S. territories in the regulatory definitions of States and United States for purposes of the MDRP. The first, the Medicaid Program; Covered Outpatient Drug;
Delay in Change in Definitions of States and United States IFC, was issued on November 15, 2016, amending the regulatory definitions of States and United States to include the U.S.
territories beginning April 1, 2020, rather than to April 1, 2017 81 FR
80003. The second, the Medicaid Program; Covered Outpatient Drug;
Further Delay of Inclusion of Territories in Definitions of States and United States IFC, was published on November 25, 2019, and further delayed the inclusion date for the regulatory definitions of States and United States to include the U.S. territories beginning April 1, 2022, rather than April 1, 2020 84 FR 64783.
For similar reasons, in addition to ensuring continued beneficiary access and quality of care protections, we are proposing to amend 447.502 to delay the April 1, 2022 inclusion date for the amended regulatory definitions of States and United States to April 1, 2024, and are seeking public comment on the proposed delay as outlined in section I.A. of this proposed rule. As discussed in greater detail in section II.
of this proposed rule, we believe an additional delay of 2 years may be warranted because it would allow the territories to focus their human and financial resources on ensuring the health and well-being of their beneficiaries during this PHE, rather than having to divert those resources to the development of systems required to participate in the MDRP, which can take several years to implement from start to finish, and seek public comments on this proposal. However, if we determine based on public comments received from interested parties that the territories that want to participate in MDRP can do so sooner than April 1, 2024, and those that do not want to participate are able to complete the necessary waiver process, then we are proposing in the alternative to finalize a date that is sooner than April 1, 2024, but not earlier than January 1, 2023.
II. Proposed Delay in Effective and Inclusion Dates of Certain Regulation Provisions Due to Ongoing Public Health Emergency PHE
On April 21, 2021, the Secretary of Health and Human Services the Secretary renewed the PHE initially declared on January 31, 2020, to continue giving CMS programs including Medicaid flexibility to support beneficiaries during the
VerDate Sep<11>2014

16:44 May 27, 2021

Jkt 253001

COVID19 pandemic. This PHE is expected to last through 2021. In response to the PHE, CMS put in place its own pandemic plan https
www.cms.gov/files/document/covidpandemic-plan.pdf to address the needs of its stakeholders, as well as the beneficiaries of its various programs including Medicaid. As part of that plan, CMS provided that it may approve waivers, amendments, and flexibilities for U.S. states, including the District of Columbia, and U.S. territories to allow Medicaid and CHIP programs to adapt their operations as necessary to respond to the pandemic. The pandemic plan also provided that it may make adjustments to the agencys value-based payment initiatives to allow health providers, healthcare facilities, Medicare Advantage and Part D plans, and States to focus on providing needed care to beneficiaries. In addition to the flexibilities granted to states under the PHE, the President signed into law on March 11, 2021 the American Rescue Plan Act of 2021 ARP Pub. L. 1172
to address the health care and economic needs of the country during the pandemic. This law is one of the most significant expansions of Medicaid since enactment of the Affordable Care Act of 2010, and includes several new mandatory benefit requirements on states that will take time to implement.
We acknowledged in the December 31, 2020 final rule that the changes to the reporting of multiple best prices by manufacturers under the MDRP a VBP
policy adopted under the amendatory instruction 10.a would require additional time to provide operational guidance and complex system changes to implement. Thus, we delayed the effective date of the VBP provision until January 1, 2022. States that opt to participate in VBP models offered by manufacturers under the multiple best price approach must ensure that beneficiaries have appropriate access to care under such arrangements by developing systems and methods to track beneficiaries and their outcomes, retrieving and evaluating the patientspecific outcomes data, and securing the cooperation of providers and beneficiaries to enter into some of the more complex outcome-based arrangements offered by the manufacturers. Thus, there will be requirements on states to develop significant capabilities to build an infrastructure that will be able to implement VBP.
We also want to be sure that our own technology infrastructure will be ready to receive multiple VBP offers from manufacturers that will report them to CMS, and subsequently report them to
PO 00000

Frm 00031

Fmt 4702

Sfmt 4702

states. We are currently developing a new Medicaid Drug Program MDP
system. This MDP system will replace CMS current legacy system with certain aspects of the system expected to be transitioned in the summer of 2021.
However, because of other events that have transpired since the regulation was published in December 2020, we do not believe that certain aspects of the system necessary for states and manufacturers to operationalize the VBP
multiple best price program will be transitioned at that time, making a January 1, 2022 infeasible. We believe that it is important to have a technically up-to-date system that is ready to support the data requirements necessary for states and manufacturers to operationalize the VBP multiple best price program. However, we may have a delay with operationalizing that part of the MDP system by July 2021, which may mean we will not have the necessary CMS components in place by later this year to implement the program by January 1, 2022, and believe July 1, 2022, is a realistic target date.
Furthermore, the demands on researching, producing, and distributing COVID19 drug treatments and vaccines have likely diverted some manufacturer financial and human resources from developing and implementing system changes that would be required to enter multiple best price offers in the MDP
system.
We understand that there is interest among patient and consumer groups, states, and manufacturers in the new multiple best price policy, and we are committed to implementing the VBP
multiple best price policy in a manner that assures that Medicaid beneficiaries have access to medications and therapies that are appropriately administered and monitored. However, we are concerned that there are several challenges the states, providers, and manufacturers are facing during the PHE. These include, in addition to those resulting from the passage of the ARP, those relating to implementing expanded eligibility and mandatory benefit requirements under Medicaid as described below. In sum, states, providers and manufacturers, as well as CMS, will need additional time to operationalize the multiple best prices policy under amendatory instruction 10.a.
Therefore, given the possible delay in the MDP system and the recent developments around the PHE and ARP, we believe more time is critical to permit CMS and our partnersstates, providers, and manufacturersto successfully implement the multiple best prices approach so that Medicaid
E:FRFM28MYP1.SGM

28MYP1