Advance Beneficiary Notice of Noncoverage

Why RPh Labs may ask you to sign an ABN form

Medicare covers pharmacogenomic testing in defined circumstances, not for everyone. A national policy covers genetic testing for warfarin dosing, and most other pharmacogenomic testing is decided by regional Medicare contractors against local coverage policies, generally when you are taking or about to start a medication with FDA labeling or published guidance tied to a tested gene.

Because those decisions are made case by case, we cannot always know in advance whether Medicare will pay for your test. When there is a real chance it will not, Medicare rules say we must tell you before the sample is collected. The ABN form is how we do that: it tells you the test might not be covered, gives an estimated cost, and lets you decide what you want to do.

Signing the ABN form does not mean Medicare has refused the claim. Many tests are still paid. It simply means you know the risk before testing begins, rather than finding out from a bill later.

Why Medicare requires advance notice

Medicare protects beneficiaries from surprise bills. When a provider expects that Medicare may deny a service as not reasonable and necessary in a particular case, the provider has to say so in writing, before the service, using the standard notice. If the notice is given properly and Medicare then denies the claim, the beneficiary can be billed; if it is not, the provider generally has to absorb the cost.

The rule works in your favor either way. You get the information you need to decide before anything happens, and you keep the right to have Medicare make a formal decision that you can appeal.

How Medicare covers pharmacogenomic testing

Medicare Part B covers clinical laboratory tests that are reasonable and necessary for a beneficiary’s care. For pharmacogenomic testing, that is spelled out in two layers of policy. A national coverage determination (NCD 90.1) covers testing of CYP2C9 and VKORC1 for warfarin dosing. Everything else is decided by the regional Medicare Administrative Contractors through local coverage determinations, including the MolDX program used across much of the country.

Those local policies generally cover testing when a patient is taking, or is about to start, a medication whose FDA label or published CPIC guidance ties dosing or selection to a gene on the panel, and when the result is expected to change treatment. Your prescriber’s order and diagnosis codes show whether that applies to you.

When Medicare does cover a clinical laboratory test, there is usually no deductible or coinsurance for the test itself. That is why it is worth letting Medicare decide when there is a reasonable chance of coverage.

What the advance beneficiary notice is, and is not

The Advance Beneficiary Notice of Noncoverage is a standard Medicare notice, form CMS-R-131, published by the Centers for Medicare & Medicaid Services. Providers and suppliers give it to people with Original Medicare before an item or service that Medicare may not pay for in their case.

• It is a written warning that Medicare may not pay, with the reason and an estimated cost.
• It is your chance to choose whether to go ahead, and whether Medicare should be billed.
• It is not a denial. Only Medicare decides whether it pays.
• It is not used for Medicare Advantage plans, which have their own prior authorization process.
• It is not needed when you pay for the test yourself without involving Medicare.

If a provider should have given you an advance beneficiary notice and did not, you generally cannot be billed for a service Medicare denies. That is why we ask for it whenever coverage is uncertain.

What to have ready

• Your name exactly as it appears on your Medicare card.
• Details of the test your prescriber has ordered, if you have them.
• A few minutes to read each part before you choose an option.
• A device you can sign on with a finger, stylus or mouse.

The notice takes about seven minutes to complete, according to CMS.

Filling in the ABN form, part by part

The online ABN form above follows the CMS layout exactly, with lettered parts. This is what each one asks for:

1. A. Notifier: the laboratory giving the notice, RPh Labs, with our address and phone number.
2. B. Patient name: your full name as it appears on your Medicare card.
3. C. Identification number: optional; a reference number linking the notice to your records. Never enter your Medicare number here.
4. D. Item or service: the pharmacogenomic (PGx) test being ordered.
5. E. Reason Medicare may not pay: for example, that Medicare covers this test only when specific criteria are met.
6. F. Estimated cost: what you may be asked to pay if Medicare does not.
7. G. Options: choose one of three options (see below).
8. H. Additional information: any extra notes, if needed.
9. I. Signature and J. Date: sign and date the notice before your sample is collected.

Read every part before you choose. If anything is unclear, call us on (888) 383-2181, 9am to 5pm CT, Monday to Friday, before you sign.

Choosing an option in part G

Part G is the most important part of the ABN form. You choose only one option:

• Option 1: you want the test, and you want Medicare billed for an official decision. If Medicare does not pay, you are responsible for payment, but you can appeal using the Medicare Summary Notice you receive.
• Option 2: you want the test, but you do not want Medicare billed. You pay for it yourself, and because Medicare is not billed, there is nothing to appeal.
• Option 3: you do not want the test. You are not responsible for payment, and nothing is billed.

Most people who want Medicare to decide choose Option 1. If you are unsure, our team can explain what each option means for your situation, but the choice is always yours.

Common mistakes to avoid

• Signing after the sample is collected. The notice must be signed before the test, or it does not protect either of us.
• Choosing more than one option. Part G allows only one choice.
• Leaving part G blank. Without a choice, the notice is not valid and testing cannot proceed.
• Entering a Medicare number in part C. Part C is optional and must never contain your Medicare number.
• Using a name that does not match your Medicare card. Mismatched names can delay the claim.

Understanding the estimated cost

Part F shows a good-faith estimate of what you may be asked to pay if Medicare does not. It is an estimate, not a bill, and it is there so you can make an informed choice in part G.

For comparison, the self-pay price of the at-home test is $299, with free shipping both ways, a pharmacist consultation and lifetime report updates included. Self-pay can be split into four interest-free installments or paid with HSA or FSA funds.

Signing for someone else

If the person being tested cannot sign for themselves, an authorized representative, such as someone holding healthcare power of attorney or a legal guardian, can complete and sign the notice on their behalf. Enter the patient’s name in part B and sign in part I as their representative.

Each notice covers one person. If more than one family member with Medicare is being tested, complete a separate notice for each.

After you sign

• Your signed notice is sent securely to our team, together with a stamped PDF copy of the completed form for your records at the laboratory.
• We review it and follow up before testing proceeds.
• If you chose Option 1, we bill Medicare; you will receive a Medicare Summary Notice showing the decision.
• If you would like a copy of your signed notice, call or email us and we will send one.

Keep a note of the option you chose and the date you signed. If Medicare denies payment after you chose Option 1, the Medicare Summary Notice explains how to appeal.

Timeline: from order to results

1. Your prescriber orders the test and we check whether Medicare coverage is uncertain.
2. You complete and sign the notice online or on paper, choosing one option.
3. You collect your cheek swab at home and post it back in the prepaid envelope.
4. The laboratory processes the sample; results are ready 7 to 10 business days after it arrives.
5. A pharmacist reviews the report before it is released, and a free consultation is included.
6. If you chose Option 1, Medicare is billed and later sends you a Medicare Summary Notice.

Your Medicare Summary Notice and appeals

If Medicare is billed, it sends you a Medicare Summary Notice (MSN) listing the services billed, what Medicare paid, and what you may owe. It is a statement, not a bill.

If Medicare denies payment and you disagree, the MSN explains how to ask for a redetermination, the first level of appeal. You generally have 120 days from the date you receive the MSN to file. Your prescriber can support an appeal with a letter explaining why the test was needed and how the result affects your treatment.

We are happy to help you read the MSN and understand the reason given. Call us with it in front of you.

The CMS ABN form and this online version

This page reproduces the official CMS ABN form, CMS-R-131 (OMB control number 0938-0566), as an online form so you can complete and sign it without printing. The wording, parts and options match the CMS version; the answers you give are stamped onto the lab’s copy of the notice.

The official CMS ABN form and its instructions are published by the Centers for Medicare & Medicaid Services. The CMS ABN form is the same for every provider; only the notifier details and the service described change.

ABN form PDF

Prefer paper? Download the ABN form PDF, print it, complete every part, sign it and send it with your sample or give it to your provider. The ABN form PDF and the online version ask for exactly the same information, so use whichever is easier.

All of our patient paperwork, including the insurance billing form, is on the forms page.

Medicare Advantage and other insurance

The ABN form applies to Original Medicare. If you have a Medicare Advantage plan, the plan decides coverage itself and may require prior authorization instead. If you have commercial insurance or Medicaid, use the insurance billing form and see the insurances we accept.

You can also skip insurance altogether and pay for the at-home kit yourself, with four interest-free installments or HSA and FSA funds. No ABN form is needed in that case. Read more in our guide: Does Medicare cover pharmacogenomic testing?

Questions to ask before you sign

• Why do you think Medicare may not pay for this test in my case?
• What will I owe if Medicare denies the claim, and can I pay over time?
• Would my prescriber’s documentation make coverage more likely?
• If I choose Option 1 and Medicare denies payment, how do I appeal?

Our team will answer any of these before you choose. There is no pressure to sign on the spot.

Terms used on the notice

• Beneficiary: a person enrolled in Medicare.
• Notifier: the provider or supplier giving the notice, here the laboratory.
• Original Medicare: Medicare Parts A and B, as opposed to a Medicare Advantage plan.
• Reasonable and necessary: the Medicare standard a service must meet to be covered.
• Local coverage determination (LCD): a regional Medicare policy describing when a service is covered.
• Medicare Summary Notice (MSN): the statement Medicare sends showing what was billed and paid.
• Redetermination: the first level of a Medicare appeal.

Your privacy

The information on this form is protected health information and is handled under HIPAA. It travels over an encrypted connection, is stored securely, and is used only to process your test and any Medicare claim. Read our privacy policy for details.