Regulatory and Reimbursement Newsletter | August 2022
The Latest in Regulatory and Reimbursement
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have had a busy summer with the release of multiple draft guidance documents and proposed rules. We are seeing a transition away from COVID-19 policies by the FDA while CMS is proposing payment adjustments for domestic NIOSH-approved N95 respirators. Regulatory and reimbursement policies are shifting with our evolving public health landscape.
FDA Withdraws COVID-19 Guidance for Medical Devices
Effective July 7, 2022, the FDA has withdrawn its guidance document, “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and Answers (Revised)”. As a result of the withdrawal, the agency’s 180-day extension for marketing submissions / applications is no longer applicable and the agency will generally consider a submission to be withdrawn if the applicant does not provide a complete response by the deadline as outlined in preexisting guidance. More information can be found here.
Zoe Bilis to Steer Regulatory Policy at Biocom California
Biocom California welcomed Zoe Bilis to the public policy team in June. Zoe’s focus is to respond to guidance documents, engage with federal agencies, lead Biocom California’s Regulatory Affairs Committee (RAC) and manage our Regulatory and Reimbursement Newsletter (R&R). Zoe’s experience is in biomedical engineering with a focus on product innovation and regulatory affairs, and she is based in our Washington, D.C. office. Zoe looks forward to engaging with our members to enhance, educate, and support their regulatory priorities. Click here to connect with Zoe Bilis.
FDA Proposes Rule for Amended IND Annual Reporting Requirement
If finalized, the rule would replace the Investigational New Drug (IND) annual reporting requirement with a new requirement for an FDA Development Safety Update Report (FDA DSUR). The FDA DSUR would be more comprehensive and informative than the current IND annual report. The proposed rule is currently under review by the White House Office of Management and Budget.
FDA Finalizes Guidance Document on Instructions for Use for Patient Labeling
On July 15, CMS released the CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Proposed Rule. In addition to updated payment rates, the proposed rule discusses OPPS payment for drugs acquired through the 340B Program and payment adjustments for additional costs of domestic NIOSH-approved N95 respirators.
CMS Proposes Rule to Improve Access to Care in Rural Communities
CMS is proposing policies, such as provider enrollment procedures and payment rates, for Rural Emergency Hospitals (REH). The proposed rule would allow rural hospitals to be designated as REHs and this designation would provide REHs with continued access to emergency services, observation care, and additional outpatient services. A CMS summary of the proposed rule can be found here.
In this brief draft guidance released in June 2022, the FDA outlines the considerations for rescinding a BTD and provides examples of circumstances where the agency may not rescind a BTD. The 3 main reasons why a BTD may be rescinded include:
“A different drug is approved to treat the unmet need that informed the rationale for granting BTD…”
Emerging data for the drug no longer supports a finding that the drug demonstrates substantial improvement over existing therapies
The drug’s sponsor is no longer pursuing the drug’s development program for the BTD use
This guidance may be of interest to drug and biologics sponsors who have been granted a BTD in the past or are considering applying for BTD.
This draft guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) and outlines the criteria that CBER will consider when evaluating a voluntary consensus standard for the SRP-RMT.
The agency acknowledges the regulatory challenges which are unique to RMTs due to their scientific and manufacturing novelty.
The release of this draft guidance demonstrates the FDA’s attempt to enhance regulatory predictability, decrease the burden of regulatory submissions, and facilitate product development by reducing the need to develop novel methods for individual products.
This guidance may be of interest to sponsors with CBER-regulated products and/or sponsors involved with regenerative medicine therapies, such as cell therapies, tissue-engineered products, human cell and tissue products, and combination products using any of these therapies.
Eli Lilly’s new drugwas approved by the FDA in May 2022. Mounjaro, is a “novel, dual-targeted treatment for Type 2 Diabetes” and it was found to improve blood sugar and was more effective than other diabetes therapies when compared in clinical trials.
For over 27 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over 1,600 companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.