Potentially curative cell and gene therapies are changing the face of medicine and providing hope to patients where there was once none. But how will they be paid for? This webinar discusses the implementation of value-based payment models for innovative therapies.
This webinar highlights potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients. Two therapeutic developers, Athersys and Pluristem Therapeutics, presented on their treatment approaches and plans for near term clinical trials.
ARM recommends that: (1) manufactures should be allowed to pay for travel and lodging expenses for the patient of a Medicaid Health Home and their immediate family; (2) CMS should eliminate reimbursement as an access barrier by requiring states to reimburse providers or facilities 100 percent of the applicable Medicare rate for that facility or provider; and (3) CMS should create one standardized process for all the states to use to simply verify that the patient meets the medically accepted indication of the physician prescribed gene, regenerative or immune therapies and to approve and credential a facility or provider to administer the therapy to out of state patients.
ARM recommends that the agency issue separate guidance specifically for rare and serious diseases with unmet medical needs and expressed concern “that the draft guidance does not acknowledge the regulatory flexibility for serious conditions.”
ARM and BIO submitted a joint letter to the Centers for Medicare and Medicaid Services (CMS) requesting that the agency issue guidance to hospitals regarding appropriate charges for CAR T-cell therapies. ARM and BIO are concerned that “some hospitals are reluctant to set charges for CAR T-cell therapies that are in line with the CCR (cost-to-charge ratio), and as a result, applying the standard CCR to their charges will underestimate the cost of CAR T therapies.”