(b) Any communication required by the terms and provisions of this Agreement shall be permitted in writing or electronically. The rebate periods correspond to a quarter of the financial year, which makes it possible to adjust the amount of the rebate up to four times a year. As with most health programs, the MDRP has countless conditions and rules. Program requirements, particularly the minimum discount, have changed over the years, including by the Affordable Care Act (ACA) in 2010. While the commenter understood that CMS has modified these forms in the past through the Paperwork Reduction Act, without formally modifying the reduction agreement, the commenter recommended that CMS modify all forms associated with this NDRA in the same way that CMS modifies the NDRA itself. The commentator indicated that section VIII. (h) of the proposed NDRA, it is stated: „with the exception of the conditions referred to in Section II. (g) and VIII. a). (concerning changes to the status of rebates or to the implementing rules) this Agreement shall be amended only by a written amendment signed by both Parties. .
. . “ which means that, with the exception of legislative and regulatory amendments, all amendments to the NDRA, including its annexes, must be made in writing and signed by both parties. Start Printed Page 12782The commenter recommended that CMS extend the same requirements to all forms that CMS includes by reference, to ensure that the content of the NDRA cannot be altered by changes to standard CMS forms that are not technically considered part of the NDRA itself. Starting in October 2019, six states will have permission to introduce alternative payment models through additional discounts54, including Louisiana and Washington, both of which are implementing a subscription model (also known as the „Netflix model“) to pay for hepatitis C drugs. Some legislative proposals would give states increased powers to enter into risk- and value-based contracts with manufacturers of ambulatory drugs, which are potentially curative treatments.55,56 These agreements would be treated as additional discounts for the purposes of calculating MPAs and the best price. Answer: As already said, this type of information is usually disseminated through operational instructions. In this case, we publish information about our role in dispute resolution, the dispute resolution request process and our contacts on our website under www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/dispute-resolution/index.html.
(y) „State Medicaid Agency“, the agency for the management or oversight of the management of the Medicaid program designated by a state in accordance with sections 1902 (a) (5) and 1927 (k) (9) of the Act. Comment: Some commentators have recommended that CMS clarify that a discount under the NDRA is only due for covered outpatient drugs paid for by the state „under a Medicaid State plan or approved waiver program“ or „under Medicaid,“ as some states have multiple non-Medicaid programs under which they pay for covered outpatient drugs. . . .
