CMS Pub. 100-04, ch. 30, § 30.2.1

In accordance with regulations at 42 CFR 411.406, evidence that the healthcare provider

or supplier did, in fact, know or should have known that Medicare would not pay for an

item or service includes:

• A Medicare contractor’s prior written notice to the healthcare provider or supplier

of Medicare denial of payment for similar or reasonably comparable item or

service. This also includes notification of Quality Improvement Organization

(QIO) screening criteria specific to the condition of the beneficiary for whom the

furnished item and/or service are at issue and of medical procedures subject to

preadmission review by the QIO. Instructions for application of the LOL

provision to QIO determinations are in the QIO Manual;

• Medicare’s general notices to the medical community of Medicare payment denial

of item or service under all or certain circumstances (such notices include, but are not

limited to, manual instructions, bulletins, and Medicare contractors’ written guidance);

• Provision of the item and service being inconsistent with acceptable standards of

practice in the local medical community.

• Written notification from the healthcare provider or supplier’s utilization review

committee informing the healthcare provider or supplier that the item and/or

service was not covered;

• The healthcare provider or supplier issuing a written notice of the likelihood of

Medicare payment denial for an item and/or service to the beneficiary; or

• The healthcare provider or supplier being previously notified by telephone and/or

in writing that an item or service is not covered or that coverage has ended.

If any of the circumstances described above exists, a healthcare provider or supplier is

held to have knowledge.