November 01, 2023
Senators Urge Administration To Drop Proposals That Put Prescription Drugs At Risk For Patients
Washington DC— Regarding preemption, the Centers for Medicare and Medicaid Services (CMS) has proposed new legislation to change the Medicaid Drug Reduction Program (MDRP) in ways that do not materially benefit patients. as if Letter For Gov. Chiquita Brooks-LaSure, Republican members of the US Senate Finance Committee, led by Ranking Member Mike Crapo (R-Idaho), urged the administration to withdraw problematic parts of the proposed legislation and work with Congress to make reforms to the Medicaid program. So patients have access to critical, life-saving prescription drugs.
Senators take note:
While we share some of the agency’s goals, including preventing some problematic practices in the drug supply chain, many [rule’s] The proposed changes would contradict longstanding legal understanding and impose costly new mandates, creating budget uncertainty for states and putting patients at risk for the most innovative treatments and cures.
They identified a number of problems with the proposal, including “overlapping” in calculating the “best value” measure, which creates technical complications and risks undermining the directive’s main objectives by missing out on large discounts.
The senators pointed out that there is insufficient justification for the proposed price-validation survey, which is focused on patient care, and that the proposed rule seeks to establish a survey process for certain “high-cost” covered outpatient drugs rather than addressing them. Barriers to access identified by regions, patients, and providers.
They finished the letter:
We urge CMS to maintain the MDRP’s legal balance by aligning it with the intent of Congress by addressing misguided ideas that could undermine patient care. We welcome the opportunity to work with you to improve the Medicaid program so that patients have access to effective, direct-to-prescription drugs.
In addition to Member Crapo’s rating, the letter was signed by Senators John Cornyn (R-Texas), John Tune (R-South Dakota), Tim Scott (R-South Carolina), James Lankford (R-Oklahoma), Steve Daines (R-R-Montana). , Todd Young (R-Indiana), John Barrasso (R-Wyoming), Ron Johnson (R-Wisconsin), Tom Tillis (R-North Carolina) and Marsha Blackburn (R-Tennessee).
Read the full letter over here or below:
Dear Administrator Brooks-Lasure,
We are writing to express concerns with several of the policies included in the proposed rule, which are included in the “Drug Discount Program for Medicaid, Program Administration, and Program Integrity Updates” (NPRM). While we share some of the agency’s goals, including preventing certain problematic practices in the prescription drug supply chain, many of the NPRM’s proposed changes contradict long-standing legal understanding and impose many costly new mandates, creating budget uncertainty for states and jeopardizing patient access to the very latest. They throw. Treatments and treatments. Instead of establishing new reporting requirements or changing basic definitions, we urge states, patients, providers, and policymakers to work with other new purchasing models that improve health outcomes and reduce costs.
As enacted by Congress, the Medicaid Drug Discount Program (MDRP) seeks to provide patients with greater access to life-sustaining and life-saving outpatient drugs through licensing partnerships with pharmaceutical manufacturers. The reductions required under this program, combined with expanded prescription drug coverage, are intended to contain costs to states while serving the needs of Medicaid recipients and maintaining incentives for medical discovery.
Unfortunately, the NPRM proposes to dramatically disrupt this approach, rewriting more than three decades of statutory understanding and practice for the MDRP mitigation calculation’s road rules. Specifically, the proposal calls for the aggregation of all manufacturer rebates and discounts to all supply chain participants to calculate the “best price” metric used as the basis for Medicaid rebates for many drugs. The Centers for Medicare and Medicaid Services’ (CMS) proposed “overlap” policy replaces the Act’s plain language with prior regulations and applicable statutory provisions, replacing the traditional definition of Medicaid’s best price with an approximate “best price” offered to an individual purchaser by combining any unrelated price discounts, for unrelated and complete discounts. Totally different entities.
Because neither CMS nor supply chain participants have a system to “stack” unrelated deals and offers from different transactions, the operational complexity involved in this broad shift makes the idea completely unworkable, even from a realistic perspective. Contracts, often involving proprietary information into a clear and verifiable figure. That said, technical difficulties and potential legal headwinds aside, any substantive policy change on the matter would risk undermining its core objectives by undermining rather than encouraging large price reductions. Tiering discounts and rebates will result in restricted rebates, smaller supplemental rebates for states, and a new set of hurdles for price reporting controls. Until then, patients will not benefit from this novel precursor.
The NPRM fails to provide patient-specific justification for the proposed cost-validation survey. Gene and cell therapies have the potential to transform healthcare delivery, providing treatment and cures for previously untreatable diseases. While the private sector has developed payment arrangements for these truly novel products, federal government programs have failed to provide a viable path to coverage for patients. Instead of addressing access barriers identified by states, patients, and providers, the NPRM seeks to establish a drug price validation survey process for certain “high-cost” covered outpatient drugs, including cell and gene therapies. The new cost-based list requires manufacturers to report information the agency plans to publish on research, development and production costs or costs incurred outside the United States. These new reporting requirements are inconsistent with the applicability of the MDRP and risk disclosing proprietary information without addressing fundamental legal and regulatory barriers to value-based coverage arrangements for gene and cell therapies under Medicaid.
We urge CMS to maintain the MDRP’s legal balance by aligning it with the intent of Congress by addressing misguided ideas that could undermine patient care. We welcome the opportunity to work with you to improve the Medicaid program so that patients have access to effective, direct-to-prescription drugs.
best regard