We continue to receive questions from podiatry practices regarding the use of and billing for amniotic fluid injections for musculoskeletal purposes. We recently published an article, “Caveat Emptor Vendor: Skin Substitutes & Injectable Amniotic Fluid” that details some real-life examples of the risk providers incur if they fail to do proper due diligence in these situations. In the article below, we continue the conversation around amniotic fluid injections by answering three of the most asked questions so you can make informed decisions at your practice.
Question #1: Can amniotic fluid injections be billed on a cash basis to Medicare patients?
Answer: The answer to this question depends on whether amniotic fluid injections are statutorily non-covered under the Medicare program. While the FDA has expressed disapproval about the use of these injections, neither Congress nor CMS have enacted a statute or rule excluding amniotic fluid injections from Medicare coverage. Accordingly, the injections are a potentially covered benefit and doctors therefore must bill Medicare and may not charge cash to patients. That being said, because of FDA disapproval of the use of amniotic fluid for musculoskeletal purposes, many Medicare contractors consider such usage to be experimental and investigational and thus not meeting the definition of “medical necessity.” As a result, doctors can and should ask patients to sign an Advanced Beneficiary Notice (ABN), and bill Medicare with a GA modifier. In that way, if Medicare denies payment, the patient will bear financial responsibility for the injection.
Question #2: Can amniotic fluid injections be used for off-label purposes?
Answer: Yes if there is adequate medical literature supporting that off-label use. Regulations issued by CMS state as follows (CMS Pub. 100-02, Chap. 15, Section 50.4.2):
An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the A/B MAC (B) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.
Per the above, it should be noted that a doctor’s Medicare Administrative Contractor (MAC) must determine if the off-label use is “medically accepted.”
It should also be noted that most amniotic fluid products were initially submitted for approval with “intended use” language stating that they were intended for purposes of wound care. Thus, using amniotic fluid for musculoskeletal purposes would be an off-label use. There are, however, some amniotic fluid products with intended use statements for musculoskeletal purposes and here there is no off-label issue.
Question #3: When using amniotic fluid injections for musculoskeletal purposes, should a doctor have the patient sign a properly drafted consent form?
Answer: Yes. When doctors use amniotic fluid injections for musculoskeletal purposes, the consent form must contain special language. This language must explain the risks of the injection and the fact that such treatment is considered off-label.
We hope this information provides you with the answers you need related to amniotic fluid injections for musculoskeletal purposes.
If you aren’t currently insured with PICA, take a moment to reevaluate your decision. Fill out our online form to get a no-obligation quote.
The information contained on the PICA Blog does not establish a standard of care, nor does it constitute legal advice. The information is for general informational purposes only. We encourage all blog visitors to consult with their personal attorneys for legal advice, as specific legal requirements may vary from state to state. Links or references to organizations, websites, or other information is for reference use only and do not constitute the rendering of legal, financial, or other professional advice or recommendations. All information contained on the blog is subject to change.