Tuesday, March 24, 2020

FDA Loosens Restrictions on REMS for Medications, CMS Grants Exceptions on Quality Reporting

In response to the unfolding COVID-19 public health crisis, federal agencies have announced new changes intended to lighten the burden on health care systems and professionals working to respond to the crisis. These include separate announcements by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).

The FDA has released new guidance regarding Risk Evaluation and Mitigation Strategy (REMS) requirements for certain medications, including clozapine. According to the notice, the FDA does not intend to take action against health care professionals for failing to adhere to certain REMS requirements for these medications for the duration of the COVID-19 public health emergency. Clozapine is considered one of the most effective antipsychotics for serious mental illness, especially treatment of refractory schizophrenia.

The FDA guidance is posted along with other COVID-related items on the APA website.

According to the guidance, health care professionals prescribing and/or dispensing medications subject to REMS with laboratory testing (or imaging) requirements should consider whether there are compelling reasons not to complete or delay lab tests during this public health emergency. Health care professionals should discuss the benefits and risks of continuing treatment in the absence of laboratory testing with their patients.

The FDA guidance followed a separate and distinct announcement by CMS on granting exceptions for health care professionals enrolled in Medicare quality reporting programs. For those programs with data submission deadlines in April and May, submission of those data will be optional. In addition, no data reflecting services provided from January 1, 2020, through June 30, 2020, will be used in CMS’s calculations for the Medicare quality reporting and value-based purchasing programs.

(Image: iStock/Wavebreakmedia)

APA’s COVID-19 Resource Center Keeps You Updated

APA’s COVID-19 Resource Center brings together a number of useful resources from APA and other authoritative sources to help you deal with the COVID-19 crisis.


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