Manipulated, Reconstituted and/or Injectable Amniotic and Placental Derived Products - Latest Update

Previously Processed Claims

At this time, Noridian will be re-evaluating claims previously denied regarding manipulated, reconstituted and/or injectable amniotic and placental derived products. Any claim already undergoing the appeals (redetermination) process will continue as such and NOT be-revisited.

What to Expect:

  • Noridian will issue an Additional Documentation Request (ADR) letter for any denied claim that has not been appealed. Letters are expected to be sent in May and/or early June.
  • Noridian will conduct a post-payment review on claims for those providers whose Part A or B claims are affected.
  • The ADR letter will be requesting documentation that supports the medical necessity in the form of medical records, as well as any publicly available evidence-based peer-reviewed literature demonstrating the safety and efficacy in the Medicare population regarding the use of the product for the condition(s) being treated.
  • If the individual claim in question is not part of the post-payment review, then you may exercise your appeal rights should you choose to do so.

Current or Future Claims

For current and future claims in which manipulated, reconstituted and/or injectable amniotic and placental derived products are billed, additional medical review may be performed. Providers will be notified via an ADR letter that will request similar supportive documentation as noted above.

  • Please note: Do not resubmit the same claim, as it may delay all claim reviews for that specific date of service.

What does this mean for you?

What if I have already appealed my claim?

If your claim is already undergoing the appeals process, please continue in that process and disregard the post-payment review letter should you receive one. Noridian encourages providers exercising their appeal rights to include medical records, as well as any evidence-based peer-reviewed literature including results from clinical trials, demonstrating the safety and efficacy in the Medicare population for the use of the product in the condition(s) being treated.

I have already appealed my claim and got a determination. What happens next?

If you are not in agreement with the first level of appeals determination, you may then exercise your rights to appeal at the next level (reconsideration).

How will I know if my previously denied claim is affected?

If your previously denied claim has been identified for individual review, Noridian will issue an ADR that will outline the time-frame to respond. If you are still uncertain whether your claim is affected, please access the Noridian Medicare Portal prior to contacting the PCC to confirm if your particular claim in question is affected; or you may choose to exercise your appeal rights.

Should I resubmit instead?

No. If you have already sent in a claim for that item/service and it is currently undergoing review, or you have exercised your appeal rights and it is currently undergoing the appeals process, do NOT resubmit as this will further delay any processing of the claim.

Should I proactively send my supportive documentation in?

Providers are encouraged to respond with documentation only after they receive the ADR letter within the timeframes outlined to avoid non-response denials.

What documentation should I provide?

Examples (not an all-inclusive list): Medical records (i.e., History and physical, documentation of trial and failure of conservative therapies, results of diagnostic testing, procedure note(s), plan of care), invoices, as well as any evidence-based peer-reviewed literature, including results from clinical trials that demonstrate the safety and efficacy in use of the product for the condition(s) being treated.

How long will it take to review my claim? And will this affect my appeals timeframe?

Timeframes for rendering a decision are outlined on the Internet Only Manual (IOM) 100-08 Chapter 3. When the documentation is received, the contractor has 30 calendar days to make a determination on a prepayment claim. For post-payment review, up to 60 days is allowed. Appeals timeframes per the Medicare Claims Processing Manual (MCPM), Chapter 29, Section 310.4 state, For appeals of a specific line item or service, the date of the first Medicare Summary Notice (MSN) or Remittance Advice (RA) that states the coverage and payment decision is the date of the initial determination. Adjustments to the initial claim or claim resubmissions for the same item/service on the same date of service that are included on subsequent MSNs or RAs, but do not revise the initial determination, do not extend/change the appeal rights on the initial determination.

Can I have a list of affected products?

Unfortunately, Noridian is not at liberty to provide a listing of amniotic and/or placental derived product Q codes. In addition, there are products still utilized that do not have a specific Q code assigned. Providers may refer to their product label to determine if their product is manipulated, reconstituted and/or injectable.

Will this affect current and future claims?

Yes, claims billed will be prioritized for review. If your claim is affected, you will receive or have received a letter requesting additional documentation that contains instructions on how to submit the information requested.

What if I have further general questions?

Noridian requests that providers and other external stakeholders check the Noridian Medicare website or Listserv for updates. General correspondences related to these issues may be emailed to amnion_placentalconcern@noridian.com. Please do not include any PHI or other confidential information. For a specific individual claim, you can check the Noridian Medicare Portal to see if a Request for Documentation letter has been sent.

What if I have an individual claim question?

If you are still uncertain whether your claim is affected, please access the Noridian Medicare Portal prior to contacting the PCC to confirm if your particular claim in question is affected. You may call the PCC if you need a response to a question and/or collaborate with other stakeholders to secure the information needed.

Last Updated May 18 , 2022