While the COVID emergency bill is still in flux, one thing is certain: It’s changing healthcare for decades to come.
In late March, a $2 trillion emergency relief bill was signed by the President to elevate businesses that are being economically-impacted during the COVID-19 pandemic. Legislation also provided $80 million to the U.S. Food and Drug Administration (FDA) to invest towards developing vaccines and medical products in the fight against Coronavirus.
In understanding the impact of the funding and how it can help medical practitioners, here are three things HCP’s and organizations must know:
Big changes are coming to over-the-counter (OTC) medications
The President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act (also known as H.R.3443) into law. Both modernizing the process and way FDA regulates OTC medications and innovating new medications by shortening the pathway to approval, this important act is slated to improve standards of safety and allow better access to OTC medicines for Americans.
The bill has three important elements:
- Speed up the approval process for OTC drugs, creating an 18-month exclusivity period that incentivizes companies to innovate more quickly
- Updates important language that hasn’t been touched in health care bills since 1970
- Proposed user fees the FDA would receive from facility registrations in a 2-tier fee structure for OTC monograph order requests ($500k for Tier 1 and $100k for Tier 2)
The bill mandates new leave policies
For hospitals and clinics, the bill may have an impact on H.R. best practices as it mandates employer-paid leave for workers affected by coronavirus — especially those on the front lines. Employers in the private sector are eligible for tax credits as well.
The CARES Act clarifies the paid emergency leave and FMLA-based longer-term family and medical leave sections from the Families First Coronavirus Response Act. It directs the Office of Management and Budget (OMB) that certain categories of Federal employees can be exempt from both the emergency paid leave provision (80 hours paid leave) and FMLA-based paid family and medical leave for parents of children whose schools have been closed.
The Act also clarifies that workers cannot access paid emergency leave unless they have been employed for 30 days. Furthermore, it limits paid leave for workers who were laid off before March 1 from accessing the emergency paid leave benefit.
Vaccines and testing are at the forefront
Not only does the bill provide for fully-covered testing for individuals with health insurance, the insurer must pay one of two ways: either the rate specified in the contract between provider and insurer or the cash price posted by the laboratory.
Additionally, once a vaccine is green-lit with an A or B rating, those with private insurance are allowed any preventative service for vaccine to be covered at no cost.
While the COVID emergency bill is still in flux, with new items being added, along with funding, one thing is certain: It’s changing healthcare for decades to come.