PROVIDER ALERT: Practices Providing Non-Surgical PRP Injections May Require Blood Bank Licensure to Avoid Significant Regulatory Penalties

Frier Levitt has recently become aware that the New Jersey Department of Health (NJDOH) has been issuing notices to medical practices and other facilities that may offer Platelet-Rich Plasma (PRP) injections to patients for non-surgical purposes – including for hair restoration or orthopedic therapies for joints, muscles, ligaments, etc. – warning that licensure as a blood bank under the New Jersey Blood Bank Statute is required to perform such procedures. In the absence of blood bank licensure, the notices warn, practices continuing to offer PRP may be liable for thousands of dollars in agency-imposed penalties.

New Jersey medical practices that provide PRP for cosmetic or therapeutic purposes are likely to be targets of what appears to be a new initiative within the NJDOH to further expand the scope of the Blood Bank Statute’s applicability. Such laws have been more traditionally applied to hospitals and other facilities who collect and store blood for transfusions, often in the surgical or perioperative context.  However, it appears that the scope of its application may be undergoing a significant expansion.

After having reviewed the agency notices and the Blood Bank Statute’s regulations, it appears the NJDOH’s efforts may be misguided, as the specific Blood Bank Statute regulations cited by the notices seem applicable only within the perioperative context. It is unclear how or why the agency has reached the conclusion that cosmetic or in-office therapeutic injections fall within the perioperative realm, but, by all appearances, this seems to be the case.

Ultimately, the question of whether the Blood Bank Statute requires that a practice obtain a Blood Bank license is a fact-specific and nuanced analysis that ought to be performed on a case-by-case basis by experienced healthcare counsel. Nevertheless, attention should be paid to this seemingly new regulatory trend, as NJDOH is clearly beginning to focus its attention on this widely-provided medical procedure (i.e., PRP) outside of the more traditional surgical or perioperative context.

Frier Levitt, a national healthcare boutique that regularly provides regulatory guidance and defense pertaining to all aspects of NJDOH and Board of Medical Examiner regulation and enforcement, is well-equipped to assist your practice or facility in addressing  this new trend and to mitigate the risks it may pose to your practice. Contact Frier Levitt for a consultation.