CMS Pub. 100-04, ch. 30, § 40.2

The healthcare provider or supplier should issue a written notice each time, and as soon

as, it makes the assessment that Medicare payment certainly or probably will not be made

in order to transfer potential financial liability to the beneficiary. A healthcare provider

or supplier, should notify a beneficiary by means of timely and effective delivery of a

written notice document to a qualified recipient. Any written notice should meet the

following written notice standards as evidence of the beneficiary’s knowledge for the

purposes of the FLP provisions, except as otherwise explicitly specified. A notification

which does not meet the following written notice standards may be ruled invalid and may

not serve to protect the interests of the notifier.

A written notice will not be considered as acceptable evidence of knowledge if the

written notice is:

• Unreadable, illegible, or otherwise incomprehensible, or the individual

beneficiary is incapable of understanding the written notice due to the particular

circumstances (even if others may understand);

• Given during any emergency, or the beneficiary is under great duress, or the

beneficiary is, in any way, coerced or misled by the notifier, by the contents of the

written notice, and/or by the manner of delivery of the written notice;

• Routinely given to all beneficiaries for whom the notifier furnishes items and/or

services;

• No more than a statement to the effect that there is a possibility that Medicare

may not pay for the items or services; or

• Delivered to the beneficiary more than one year before the items and/or services

are furnished.

NOTE: A previously furnished written notice is acceptable evidence of written notice for

current items and/or services if the previous written notice cites similar or reasonably

comparable items and/or services for which denial is expected on the same basis in both

cases. A written denial (on the same basis in both cases) of payment from a Medicare

contractor for a claim for the same or similar item and/or service received by the

beneficiary is acceptable evidence of written notice for current item and/or service.

Written Notice Standard Description

Proper Written Notice Documents • An approved standard form (e.g.,

Form CMS-R-131); or

• A CMS approved model notice

language (e.g., Form CMS-10055)

Qualified Notifiers “Notifiers” are generally the healthcare

provider or supplier that furnished or

ordered the item(s) and/or service(s).

Capable Recipient The beneficiary must:

• Be able to read, understand, act on

his/her rights, and comprehend the

notice;

• Be issued the written notice in a

manner that allows her/him to

comprehend the contents of the

written notice. (e.g., when the

beneficiary (or authorized

representative) is unable to read the

notice due to a disability such as

blindness, visual impairment or

deafness) This can be done by a

verbal or electronic reading of the

notice, by providing the written

notice in Braille or large print, or by

the use of other assistive technology.

The notifier should document any

actions taken to assist with the

delivery of the written notice on the

notice; and

• Be afforded the verbal or written

assistance in other languages to assist

in understanding the notice. If a

translator who can speak the

beneficiary’s language is not

available, the notifier should assist by

calling 1-800-MEDICARE so a

customer service representative can

connect the beneficiary with the

Language Line for translation services.

Identification of Notifier The header of the written notice must

identify the notifier or notifier(s). In

situations where the notifier is not the

billing entity, it is permissible to enter the

names of more than one entity in the

header of the notice.

Written Notice Standard Description

If the header identifies the entity or person

that obtained the written notice, rather

than the entity or person that is billing for

the item and/or service, the Medicare

contractor will consider the written notice

form to be valid so long as it was

otherwise properly executed.