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Federal Register / Vol. 86, No. 221 / Friday, November 19, 2021 / Rules and Regulations
2020, to continue giving CMS programs including Medicaid flexibility to support beneficiaries during the COVID19 pandemic. This PHE was most recently renewed on October 15, 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 Patient Protection and Affordable Care Act Pub. L. 111148, enacted March 23, 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
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infrastructure that will be able to implement VBP.
We also noted that we 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 states. We developed 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 2022.
However, because of other events that have transpired since the regulation was published on December 31, 2020, we explained in the proposed rule that we did not believe that certain aspects of the system necessary for states and manufacturers to operationalize the VBP
multiple best price program would be transitioned at that time, making a January 1, 2022 effective date infeasible.
We also noted that we believed that it is important to have a technically up-todate system that is ready to support the data requirements necessary for states and manufacturers to operationalize the VBP multiple best price program. When the proposed rule was issued, we were concerned we could have a delay with operationalizing that part of the MDP
system, which could mean we would not have the necessary CMS
components in place by later this year to implement the program by January 1, 2022, and believed July 1, 2022, to be a more realistic target date. As noted in the proposed rule, 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 also stated that in the proposed rule that we understand that there was interest among patient and consumer groups, states, and manufacturers in the new multiple best price policy, and that we were 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 remain concerned that there are several challenges the states, providers, and manufacturers are facing during the PHE. These included those resulting from the passage of the ARP, including those relating to implementing expanded eligibility and mandatory benefit requirements under Medicaid as described below. In summary, states, providers and manufacturers, as well as CMS, will need additional time to
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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 explained in the proposed rule that 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 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. We also 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. Therefore, we proposed a delay to the effective date for amendatory instruction 10.a. the multiple best price approach of 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. Again, by delaying the effective date of the amendment permitting multiple best price reporting for 6 months, the amendatory instruction 10.a would be effective beginning July 1, 2022. In the proposed rule, CMS also stated it expects to issue additional guidance before that time on operational and policy aspects of the new VBP program, including specifications relating to beneficiary protections.

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