On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.
With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”
Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].
On January 31, Health and Human Services Secretary Alex Azar proposed a rule to remove safe harbor protections for drug rebates paid by manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations. Through the removal of these protections, HHS and the Trump Administration continue their attempts to lower prescription drug prices and out-of-pocket costs. The proposal would also create new safe harbor protection for fixed fee service arrangements between manufacturers and PBMs.
Read the proposed rule here. Read the HHS press release here and the HHS fact sheet here.
The Center for Medicare & Medicaid Innovation (CMS Innovation Center) is hosting a webinar to provide a basic overview of the Part D Payment Modernization Model. CMS will host two sessions including the same content, which will take place on Thursday, January 31, 2019 at 1:00 p.m. EST, and on Wednesday, February 6, 2019 at 1:00 p.m. EST.
If you previously registered for the Part D Payment Modernization Model webinar originally scheduled for Tuesday, January 29, 2019 please re-register for one of the new dates.
During the webinar, CMS subject matter experts will provide information about The Part D Payment Modernization model, which tests the impact of modernized Part D program design and improved incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs. The model is open to eligible standalone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans that are approved to participate, is voluntary, and will last 5 years, beginning with the 2020 plan year.
As part of the model, CMS will provide participants with additional programmatic tools, including Part D rewards and incentives programs, to increase engagement with enrollees, with the goal of promoting better enrollee understanding of: (1) their Part D benefit, including out-of-pocket and total drug costs; and (2) clinically equivalent therapeutic options.
Register for the Thursday, January 31, 2019 webinar here.
Register for the Wednesday, February 6, 2019 webinar here.