Moving the Needle on Prescription Drug Costs: Using the Innovation Center and Other Demonstration Authority
Issue Brief
This authority also allows for demonstrations under Medicaid, though waivers have been more typically used in the Medicaid program. https://www.kff.org/medicaid/issue-brief/the-landscape-of-medicaid-demonstration-waivers-ahead-of-the-2020-election/
Medicaid requirements that can be waived include: that a Medicaid program must be operated statewide (Section 1902(a)(1)); that it must have a public process for determining payment rates for hospital services (1902(a)(13)); and a provision relating to prepaid payments under Medicaid managed care (1903(m)(2)(A)(iii)). The Program of All-Inclusive Care for the Elderly (PACE) is section 1934 and the Secretary can waive all provisions except subsections (b)(1)(A) and (c)(5).
The Medicare Payment and Advisory Commission, “Report to Congress - Chapter 1: Enhancing Medicare’s Ability to Innovate,” June 2010. http://www.medpac.gov/docs/default-source/reports/Jun10_Ch01.pdf?sfvrsn=0
Ibid.
Ibid.
Government Accountability Office, “CMS Innovation: Model Implementation and Center Performance,” March 2018. https://www.gao.gov/assets/700/690875.pdf
The Medicare Payment and Advisory Commission, “Report to Congress - Chapter 1: Enhancing Medicare’s Ability to Innovate,” June 2010. http://www.medpac.gov/docs/default-source/reports/Jun10_Ch01.pdf?sfvrsn=0
In another case, the U.S. District Court for the Southern District of New York temporarily prohibited the federal government from applying the rule to a single drug (EYLEA), manufactured by Regeneron Pharmaceuticals.
The Northern District of California case has been stayed until April 23, 2021, at which point the parties will update the court on whether to continue the stay, allow the lawsuit to proceed, or dismiss the case. In another case, the U.S. District Court for the District of Maryland entered a temporary restraining order prohibiting implementation of the rule until January 20, 2021. The parties agreed to stay the Maryland litigation until a final rule based on the interim final rule is published, provided that the federal government does not seek to have the California court’s preliminary injunction overturned on appeal. If the federal government decides to rescind the interim final rule or otherwise decides not to proceed with it, the parties must notify the court.