As part of the U.S. Centers for Medicare and Medicaid Services (CMS) FY 2020 Inpatient Prospective Payment System (IPPS) final rule, CMS has finalized an alternative pathway for the New Technology Add-On Payment (NTAP) for drugs designated by the Food and Drug Administration as Qualified Infectious Disease Products (QIDPs), under which these drugs would not have to meet the substantial clinical improvement criterion. Additionally, CMS is increasing the NTAP for QIDPs from 50% to 75%. Limiting access to the current upper band of NTAP to only QIDP drugs reflects the agency’s awareness of the public health imperative for novel antibiotics.
The hope is that these new payment models will help address the urgent clinical and economic crisis of Antimicrobial resistance. According to CMS, each year, more than 2 million Americans are infected by bacteria that are resistant to existing antibiotic drugs, resulting in thousands of deaths annually. CMS is committed to removing regulatory restraints on innovators and modernizing payment systems to secure access to medications for Medicare beneficiaries and all Americans. By realigning payment pathways for inpatient cases with drug resistance, CMS is removing financial disincentives to antibiotic innovation and improving beneficiaries’ access to these drugs.
Additionally, within IPPS, CMS finalized a change in the severity level designation for 18 ICD-10 codes for antimicrobial drug resistance from ‘non-CC’ to ‘CC’ (complications or comorbidities). This change to CC recognizes the added clinical complexity and cost of treating patients with drug resistance, and ensures physicians are appropriately incentivized to use the correct (and sometimes, more expensive) drugs needed to manage patients with AMR.
CMS is also exploring implementing Centers for Disease Control and Prevention recommended guidelines for hospital-based Antibiotic Stewardship Programs into the regulations that govern hospitals’ Conditions of Participation in Medicare. According to CMS, proposed new requirements for infection prevention and control programs in Hospitals and Critical Access Hospitals are currently under development.
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