Balancing Safety and Innovation: Key Takeaways From The FDA’s Latest Stem Cell Reports

fda stem cell businessBy: Matthew Fischer

Through two public channels this month, the FDA further solidified its stance on the innovative field of regenerative medicine.  First, in an article published in the New England Journal of Medicine (NEJM), Dr. Scott Gottlieb, FDA Commissioner, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), co-wrote a new paper entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine.”  On the same day of this publication, the FDA hosted a “Grand Rounds” webcast with Dr. Steven Bauer, Chief of the Cellular and Tissues Therapy Branch within CBER.  Taken together, these actions suggest a continued effort by the FDA to take a strong position against predatory clinics touting unapproved therapies while extending an open invitation to industry developers for expedited treatment to encourage innovation.Continue reading

Chiropractic Practice Expansion: The DMEPOS Licensure Process

florida physician self-referral statute

DMEPOS LicenseBy: Michael Silverman

Adding Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to a Chiropractic Practice is a great way to not only increase revenues, but most importantly it is a great way to increase overall patient satisfaction and care.

Providing patients with easy access to DMEPOS allows for more comprehensive care, enabling providers to help further stabilize injuries, maximize patient recoveries, and minimize patient down time. Many existing patients are already buying and utilizing DMEPOS such as back braces, so there is an opportunity to provide that additional supervision and care through an existing practice.

Examples of DMEPOS that would complement a Chiropractic Practice and which patients are likely already using:Continue reading

Level 2 Background Screening – Your License Depends on It!

level 2 background screening

level 2 background screeningBy: Susan St. John

Providers licensed or regulated by the Agency for Health Care Administration must make certain that their employees and/or contracted personnel have had Level 2 Background Screening (criminal history background check) pursuant to Florida Statutes and Administrative Code within 10 business days of being hired. Also, if a potential employee or contractor has not been employed within the previous 90 days, even if that individual previously had level 2 background screening, the individual will need to go through submitting fingerprints again. Further, each employee or contracted individual that is subject to Level 2 Background Screening must renew the background screening every 5 years to be eligible for employment or continued employment with an AHCA licensed or regulated provider.

Fingerprint Retention Period

The 5 year expiration from the date of retention of fingerprints is the date that the Florida Department of Law Enforcement (“FDLE”) will purge fingerprints from storage, meaning if fingerprint retention renewal has not occurred prior to this date, the whole screening process, that is fingerprinting, etc., starts over. There is no “grace period” if fingerprints have been purged, which means the individual is no longer “technically” eligible for employment with an AHCA licensed provider (and perhaps other providers licensed and regulated by other state agencies such as Department of Health, Department of Children and Families, or Department of Elder Affairs). Further if the provider is in the process of an AHCA survey, accreditation survey, or renewal licensure application, not having a current Level 2 Background Screening for an employee or contractor might subject the provider to a statement of deficiency, assessment of administrative fines or fees, or denial of a licensure renewal application.Continue reading