CMS Pub. 100-02, ch. 15, § 40.19

Because Medicare’s rules do not apply to items or services that are categorically not covered by Medicare, a

private contract is not needed to furnish such items or services to Medicare beneficiaries, and Medicare’s

claims filing rules and limits on charges do not apply to such items or services. For example, because

Medicare does not cover hearing aids, a physician or practitioner, or other supplier may furnish a hearing aid

to a Medicare beneficiary and would not be required to file a claim with Medicare; further, the physician,

practitioner, or other supplier would not be subject to any Medicare limit on the amount they could collect

for the hearing aid.

If the item or service is one that is not categorically excluded from coverage by Medicare, but may be

noncovered in a given case (for example, it is covered only where certain clinical criteria are met and there

is a question as to whether the criteria are met), a non-opt-out physician/practitioner or other supplier is not

relieved of his or her obligation to file a claim with Medicare. If the physician or practitioner or other

supplier has given a proper Advance Beneficiary Notice (ABN), he or she may collect from the beneficiary

the full charge if Medicare does deny the claim.

Where a physician or practitioner has opted out of Medicare, he or she must provide covered services only

through private contracts that meet the criteria specified in §40.8 (including items and services that are not

categorically excluded from coverage but may be excluded in a given case). An opt-out physician or

practitioner is prohibited from submitting claims to Medicare (except for emergency or urgent care services

furnished to a beneficiary with whom the physician or practitioner did not have a private contract). (See

§40.12.)