Home / Newsletters / Regulatory and Reimbursement Newsletter | September 2022
Regulatory and Reimbursement Newsletter | September 2022
The Latest in Regulatory and Reimbursement
Biocom California’s advocacy efforts are in full swing with the submission of two new comment letters to federal agencies and with the opposition of drug pricing provisions in the Inflation Reduction Act. Updated COVID vaccine booster doses will be available this fall while N95 respirators are no longer in short supply. The FDA has had a busy month issuing a historic final rule and releasing data on pharmaceutical drug and site quality.
Biocom California Submits Comments on FDA Draft Guidance & CMS Proposed Rule
Biocom California submitted comments on the FDA draft guidance document, Risk Management Plans to Mitigate the Potential for Drug Shortages, and on the CMS CY 2023 Physician Fee Schedule(PFS) proposed rule. With regards to the PFS, we commented on reimbursement issues related to telehealth services, skin substitute policies, and more.
Thank you to our members for engaging on these important topics and providing their feedback.
CMS Hosts National Stakeholder Call on Inflation Reduction Act
On August 25, CMS Administrator Brooks-LaSure hosted a national stakeholder call to discuss CMS’s implementation of the Inflation Reduction Act (IRA). The sweeping tax and climate measure, signed into law on August 16, also allows Medicare to set prices for certain drugs and this was a main discussion point during the stakeholder call. Biocom California opposes the drug pricing provisions in the IRA as it will hurt innovation for the life science industry.
FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines
Updated vaccines, which have been authorized for use as a single booster dose, contain two mRNA components of the virus and are expected to provide increased protection against the omicron variant. Boosters are now available for people ages 12-plus (Pfizer) and 18-plus (Moderna).
N95 Respirators Removed from FDA’s Medical Device Shortage List
In late August, the FDA removed N95 respirators from the medical device shortage list. Removal of the N95 respirators, one of the first devices listed on the agency’s shortage list at the beginning of the public health emergency, is attributed to increased domestic manufacturing.
FDA Finalizes Rule Enabling Access to Over-the-Counter Hearing Aids
By establishing this final rule, Establishing Over-the-Counter Hearing Aids, the FDA has created a new category of over-the-counter hearing aids available to adult consumers with mild to moderate hearing loss. These OTC products improve access to safe, effective, and affordable hearing aids for the estimated 30 million Americans who suffer from hearing loss.
FDA Issues FY2021 Report on the State of Pharmaceutical Quality
Last month, the Office of Pharmaceutical Quality within FDA’s Center for Drug Evaluation and Research published the fiscal year 2021 Report on the State of Pharmaceutical Quality. This report, which is used to inform research and regulatory decision-making, summarizes the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers.
Request for Comments
Biocom California welcomes feedback from members on the following draft guidance documents.Click here to submit comments via email.
Remote regulatory assessments (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements.
The guidance outlines which establishments are subject to voluntary and mandatory RRAs, how the agency will request a RRA, and the consequences for a sponsor who declines a RRA.
While RRAs are not inspections, RRAs could “precede, prompt, or be a follow-up to an inspection.” FDA may conduct an inspection or take other appropriate actions, including enforcement action, when significant issues are discovered during a RRA.
This guidance may be of interest to drug and medical device manufacturers.
The draft guidance provides recommendations to help sponsors identify, modify, develop, and validate clinical outcome assessments (COA) to “measure outcomes of importance” for clinical trial patients.
The draft guidance provides a “roadmap” outlining different COA options and discusses how evidence should be developed to support the appropriate use of a COA in a particular context.
Four noteworthy appendices discuss conceptual frameworks and provide examples of patient-reported, observer-reported, clinician-reported, and performance outcome measures.
This guidance may be of interest to drug, biologic, and device sponsors and clinical trial investigators.
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.
