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Public Policy Newsletter Article

Pandemic Continues to Dominate Policy

  • 2020-07-30T15:00:00.000+0000
  • California
  • Author: Jimmy Jackson

A recurring discussion this year has been how to assist those who have been most adversely affected by the pandemic, from employees laid off to entire business sectors shut down as demand for services and goods disappear. On Monday, July 27, U.S. Senate Republicans released their proposal for a stimulus/assistance package, which has several provisions that could impact Biocom members. A summary can be found here. This proposal must now be reconciled with the one House Democrats passed in mid-May. Despite political pressure due to the expiration of the federal supplement to state unemployment benefits, it is not clear when or if an agreement can be reached and sent to the President for his signature.

Biocom continues to be the only life science state association that regularly files comments on proposed guidances from federal regulatory agencies such as the FDA and CMS, working closely with our member companies to ensure their concerns are heard. In the past month, Biocom has submitted three such comment letters on behalf of our members, one to the FDA on “Interpreting the Sameness of Gene Therapy Products” and two to CMS on its 2021 IPPS Proposed Rule regarding creation of a DRG for CAR-T therapy, and on Medicaid value-based agreements and copay accumulators.

Meanwhile, counties across the state are working to address the daily effects of the pandemic through local orders that balance the needs of health professionals with regulations for essential and reopened businesses. These orders often change with little or no notice; for instance, the most recent change to San Diego County’s emergency order was announced yesterday (July 29) at 2:30p and became effective at midnight July 30. A comprehensive review of new requirements and potential impacts on our member companies in each of Biocom’s service areas can be found here.

In the State Capitol, work has been disrupted greatly by the coronavirus. The Legislature was scheduled to return to work on July 13 after a brief post-budget enactment break, but the return was postponed when several employees of the Legislature and two members of the State Assembly tested positive for COVID-19. Having finally reconvened this past Monday, both houses of the Legislature have a daunting amount of work to complete before their (Constitutionally mandated) adjournment at midnight on August 31. We continue to engage on several bills covered in previous editions, and others of interest to the industry have surfaced in the past month. You can find a discussion of those bills here.