New State Stem Cell Laws: A Brief Overview

stem cell law

By: Matthew Fischer

Amid the growing focus on stem cell products by the Federal Food and Drug Administration (FDA), multiple states have proposed and passed some form of stem cell law or clinic regulation.  While some center the regulation on informing prospective customers of the risks associated with these treatments others seek to protect the availability of these treatments in the form of a “right-to-try” law.  Here are a few examples:

California

Effective January of this year, California implemented a new regulation in its Business and Professions Code aimed at clinics offering non-FDA approved stem cell treatments.  The regulation requires a notice to be posted at the clinic entrance along with the requirement to provide a separate written notice to the patient prior to initiating treatment.  However, this requirement does not apply if a licensed health care practitioner has obtained approval for an investigational new drug from the FDA. 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

Protecting Your License Against Adverse Action

election of rightsBy: Susan St. John

If you have ever been the recipient of a Florida state agency’s (i.e. Department of Health, AHCA, etc.) notice regarding an adverse action, such as a Notice of Intent to Deny, licensure application, renewal or change of ownership, you probably received an Election of Rights form along with the agency’s notice. The Election of Rights form must be completed and returned to the agency within 21 days of receiving the agency’s notice. In completing the Election of Rights form, you are given three options to choose from in deciding how you want to respond to the agency’s notice.

Under Option One you admit to the allegations of facts and law contained in the agency’s notice of intended action and waive the right to object and have a hearing. This is akin to an admission of guilt, that the agency is right in its decision, and you agree to a final order that supports the agency’s actions, including imposition of fines and punishment against you. Option One is generally not in your best interest.Continue reading