WPS MAC
Claim Denials for Manipulated Amniotic
and/or Placental Tissue Biologics for Injections
Editor’s note: We updated this article on February 24, 2022, to add “drug” to the last sentence of the first paragraph, and to change “We refer you to” to “Please refer to” in the third paragraph.
Manipulated amniotic and/or placental tissue biologics for injections to treat illness are experimental exosome biologic products that have not been proven to be safe and effective for any medical use. All claims for dates of service on or after December 6, 2019, shall be denied. Under Section 1862(a)(1)(E) of the Social Security Act, per the Food and Drug Administration (FDA), these products may only be provided within approved investigational new drug (IND) trials.
Many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, present potential, significant safety concerns that put patients at risk.
Please refer to the FDA’s Tissue Reference Group (TRG) or the FDA’s Office of Combination Products to obtain written feedback regarding how the product is appropriately regulated.
You may find additional information from the FDA at the following:
Public Safety Notification on Exosome Products
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
Important Patient and Consumer Information About Regenerative Medicine Therapies
Medicare Provider Information:
Medicare payment of a service requires for it to be compliant with all applicable regulation. Providers at enrollment agree to abide by the Medicare laws, regulations, and program instructions and at enrollment they certify that they understand that payment of a claim by Medicare is conditioned upon the claim and the underlying transaction complying with such laws.
The CMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15 
, Section 50.4.1 states:
The A/B MAC (A), (B), or (HHH), or DME MAC will deny coverage for drugs and biologicals, which have not received final marketing approval by the FDA unless it receives instructions from CMS to the contrary.
If there is reason to question whether the FDA has approved a drug or biological for marketing, the MAC must obtain satisfactory evidence of FDA’s approval. Acceptable evidence includes:
- A copy of the FDA’s letter to the drug’s manufacturer approving the new drug application (NDA);
- A listing of the drug or biological in the FDA’s “Approved Drug Products” or “FDA Drug and Device Product Approvals”;
- A copy of the manufacturer’s package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it; or
- Information from the FDA’s Web site.
Any claims processed and paid for dates of service on or after Dec. 6, 2019, will be adjusted and payment will be recouped. Impacted providers will receive an overpayment demand letter identifying the amount of the overpayment.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.