Chiropractors should be barred from subjecting patients to injection-based investigational care and be subject to disciplinary action should they facilitate these activities, wrote CMS President Debra Parsons, MD, FACP, in a letter to the Colorado Department of Regulatory Agencies.
In comments related to the sunset reviews of the State Board of Chiropractic Examiners and State Board of Nursing, Parsons wrote that it has come to CMS’ attention that “some chiropractors are utilizing nurse practitioners to perform injection therapies that are not standard of care and not part of an IRB-approved clinical trial such as ‘stem cell therapy’ or the use of amniotic or umbilical cord tissue, platelet rich plasma, or autologous or allogenic serum or plasma with or without vesicles to treat chronic pain or disease.”
She requested that the sunset reports include recommendations that the relevant acts be amended to address the issues more explicitly and in a manner that subjects individuals to disciplinary action.
- Providers administering injections must be appropriately trained.
- Any therapeutic products provided/administered must be FDA-approved or exempt from regulation.
- Informed consent must always be obtained, including an accurate assessment of the risks vs. benefits of any treatment, accurate information about the content of any therapeutic products (e.g. providers must not make inaccurate claims that allogeneic products contain “live stem cells” or “viable stem cells”), and accurate information about the efficacy of any treatment according to the current scientific literature.
- All advertising and sales activities and materials must be accurate and supported by the current scientific literature.
The recommendations are in line with current CMS policy on stem cells. Click here to read the full letter.