evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
40.2.1 - Other Written Notice Standards  (Rev.: 4197; Issued: 01- 11-19; Effective: 04 -15-19; Implementation: 04 -15-19)  A.  Timeliness   Written notice delivery:    Must be issued far enough in advance of an event (e.g., receiving a medical service) so that the beneficiary can make a rational, informed decision without undue pressure; or   Should take place before a procedure is initiated and before physical preparation of the patient (e.g., disrobing, placement in or attachment of diagnostic or treatment equipment) begins. Written notice is permissible:   If a situation arises when a notifier sees a need for a previously unforeseen item or service and expects that Medicare will not pay for it only in certain specific denial reasons, provided that the beneficiary is capable of receiving notice and has a mean ingful opportunity to act on it (e.g., the beneficiary is not under general anesthesia); or    Where it is foreseeable that the need for service for which Medicare likely would not pay may arise during the course of an encounter, and the beneficiary is either certain or likely not to be capable of receiving notice during the initial service (e.g., t he beneficiary will be under anesthesia).   NOTE:   Last minute notification can be coercive, and a coercive notice is an invalid notice.   B.  Written Notice Delivery   A written notice:    Should be delivered in person to the beneficiary or authorized representative whenever possible.  Delivery is the notifiers responsibility;    Must be prepared with an original and at least two copies.  The notifier should retain the original and give the copy to the beneficiary or authorized representative.  Legible duplicates (carbons, etc.), fax copies, electronically scanned copies, or photocopies will suffice;      Copy should be given to the beneficiary (or authorized representative) immediately after the beneficiary (or authorized representative) signs it.
(Medicare Claims Processing Manual)
 Copy should be given to the beneficiary (or authorized representative) immediately after the beneficiary (or authorized representative) signs it.    If a beneficiary is not given a copy of the written notice and if the beneficiary later alleges that the written notice presented to the Medicare contractor by the notifier is different in any material respect from the written notice s/he signed, the Medic are contractor will give credence to the beneficiarys allegations.  If the notifier is unable to deliver the notice to the beneficiary, the Medicare contractor will hold that the beneficiary did not receive proper written notice and will hold the notifier  liable.   In a case where the notifier that gives a written notice is not the entity which ultimately bills Medicare for the item(s) and/or service(s), (e.g., when a physician draws a test specimen and sends it to a laboratory for testing) the notifier should give a  copy of the signed written notice to the billing entity as well as the beneficiary.     C.  Reason for Predicting Denial   The written notice must give the beneficiary a reasonable idea of why the notifier is predicting the likelihood of Medicare denial so that the beneficiary can make an informed decision whether or not to receive the item or service and pay for it.  Statements of reasons for predicting Medicare denial of  payment at a level of detail similar to the approved Medical Necessity messages for Medicare Summary Notices are acceptable for written notice purposes.  If more than one reason for denial could apply (e.g., exceeding a frequency limit and same day du plication; cases where the reason for denial could depend upon the result of a test; etc.), the Medicare contractor will not invalidate a written notice on the basis of citing more than one reason for denial.  The following could result in an invalid written notice:   Simply stating medically unnecessary or the equivalent is not an acceptable reason, as it does not explain why the healthcare provider or supplier believes the item and/or service will be denied as not reasonable and necessary.    Listing several reasons which apply in different situations without indicating which reason is applicable in the beneficiarys particular situation generally is not an acceptable practice.
(Medicare Claims Processing Manual)
 Listing several reasons which apply in different situations without indicating which reason is applicable in the beneficiarys particular situation generally is not an acceptable practice.   40.2.2 - Written Notice Special Considerations  (Rev.: 4197; Issued: 01- 11-19; Effective: 04 -15-19; Implementation: 04 -15-19)  A.  Responsiveness to Inquiries    A notifier must answer any questions from a beneficiary regarding the written notice.  This includes requests for further information and/or assistance in understanding and responding to a notice.  The Medicare contractor will hold that a beneficiary did not receive proper written notice in any case where it finds that the notifier refused to answer inquiries.    B.  Dealing With Beneficiary Refusals   A beneficiary who has been given a written notice may decide to receive the item(s) and/or service(s).  In this case, the beneficiary should indicate that s/he is willing to be personally and fully responsible for payment.  When a beneficiary decides to de cline an item or service, s/he should so indicate.  If a beneficiary refuses to sign a valid written notice, the notifier should consider not furnishing the item or service, unless the consequences (health and safety of the patient, or civil liability in c ase of harm) are such that this is not an option.  Additionally, the notifier may annotate the written notice indicating the circumstances and persons involved.  The notifier should have the annotation witnessed.
(Medicare Claims Processing Manual)
 Claims to Which LOL Provisions Apply -  If the beneficiary demands the item or service and refuses to pay, the notifier should have a second person witness the provision of the written notice and the beneficiarys refusal to sign.  Where there is only one person on site (e.g., in a draw station), the second witness may be contacted by telephone to witness the beneficiarys refusal to sign the written notice by telephone and may sign the written notice annotation at a later time.  An unused patient signatur e line on the written notice form may be used for such an annotation; writing in the margins of the form is also permissible.  The notifier should file its claim as having given the written notice.  The beneficiary will be held liable in case of a denial.    Claims to Which RR Provisions Apply -  if the physician or supplier does furnish the item or service, the beneficiarys signature is meant to attest both to receipt of the written notice and to the beneficiarys agreement to pay.  The beneficiary must receive a valid written notice so that s /he is on notice (that is, the beneficiary knew, or could reasonably have been expected to know, that payment could not be made) and  must agree to pay.  The beneficiary has the same two legitimate choices as the cases  of claims to which LOL provisions apply.  If the beneficiary demands the item or service and refuses to pay (will not sign or else marks out the agreement to pay language), the physician or supplier must take into account the fact that it will not be able  to collect from the beneficiary in deciding whether or not to furnish the items or services.  Although there would be little point in having a second person witness the provision of the written notice and the beneficiarys refusal to agree to pay (because the requirement that the beneficiary agree to pay still would not be fulfilled), the physician or supplier may annotate the written notice.  If the items or services are furnished despite the beneficiarys refusal to pay, the physician or supplier should file the claim as not having obtained a signed written notice.  The Medicare contracto r will not hold the beneficiary liable and will hold the physician or supplier liable.
(Medicare Claims Processing Manual)
NOTE:   In either case, the beneficiary who does receive an item or service, of course, always  has the right to a Medicare determination and the claim must be filed with Medicare.    C.  Routine Notice Prohibition   In general, the routine use of written notices is not effective and therefore is not an acceptable practice.  By routine use, CMS means giving written notice to beneficiaries where there is no specific, identifiable reason to believe Medicare will not pay.  Notifiers should only give written notices to beneficiaries when there is some genuine doubt that Medicare will make payment.  If the Medicare contractor identifies a pattern of routine notices in situations where such notices clearly are not valid, it will write to the notifier and remind it of these standards.  While in general, routine written notices are invalid and will not protect the notifier from liability, there are some exceptions.    Generic Written Notices  Generic written notices are routine written notices to beneficiaries which do no more than state that Medicare denial of payment is possible , or that the notifier never knows whether Medicare will deny payment.  Such generic written notices are not considered to be acceptable evidence of written notice and will not protect the notifier from liability.  The written notice must specify the ite m and/or service and a genuine reason that denial by Medicare is expected.  Written noti ce standards likewise are not satisfied by a generic document that is little more than a signed statement by the beneficiary to the effect that, should Medicare deny payment for anything, the beneficiary agrees to pay for the item and/or service.     Blanket Written Notices  - Giving written notices for all claims or items or services (i.e., blanket written notices) is not an acceptable practice.  Notice must be given to a beneficiary on the basis of a genuine judgment about the likelihood of Medicare payment for that individuals claim.    Signed Blank Written Notices  - A notifier is prohibited from obtaining beneficiary signatures on blank written notices and then completing the written notices later.  In order for a written notice to be effective, it must be completed before delivery to the beneficiary.  The Medicare contractor will hold any written notice that was blank when it was signed to be an invalid notice that will not protect the notifier from liability.
(Medicare Claims Processing Manual)
 Routine Written Notice Prohibition Exceptions  - In general, routine written notices will not be considered valid.  There are, however, a few limited circumstances when a routine notice can be given to a beneficiary and considered effective.    Exception  Description  Items or Services Which Are Always Denied for Medical Necessity  In any case where a national coverage decision provides that a particular item or service is never covered, under any circumstances, as not reasonable and necessary under 1862(a)(1)  of the Act (e.g., at present, all acupuncture services by physicians are denied as not reasonable and necessary), a written notice that gives as the reason for expecting denial that: Medicare never pays for this item/service may be routinely given to beneficiaries, and no claim need be submitted to Medicare.  If the beneficiary demands that a claim be submitted to Medicare, the notifier should submit the claim as a demand bill.  Experimental Items and Services  When any item or service which Medicare considers to be experimental (e.g., Research Use Only and Investigational Use Only laboratory tests) is to be furnished, since all such items or services are denied as not reasonable and necessary under 1862(a)(1)  of the Act because they are not proven safe and effective, the beneficiary may be given a written notice that gives as the reason for expecting denial that: Medicare does not pay for items or services which it considers to be experimental or for research  use. Language with respect to Medicare coverage for clinical trials may be substituted as the reason for expecting denial.  Frequency Limited Items and Services  When Medicare has established a frequency limit for any item or service, a routine written notice can be given.  This is applicable anytime a frequency limitation is made through statute or regulation, through medical national coverage determinations, or on the basis of the Medicare contractors local Exception  Description  coverage determinations.  In any such routine written notice, the notifier must state the frequency limitation as the reason for expecting denial (e.g., Medicare does not pay for this item or service more often than frequency limit ). Medical Equipment and Supplies Denied Because the Supplier Had No Supplier Number or the Supplier Made an Unsolicited Telephone Contact
(Medicare Claims Processing Manual)
Given that Medicare denials of payment under 1834(j)(1)  of the Act, and under 1834(a)(17)(B) of the Act, apply to all varieties of medical equipment and supplies and to all Medicare beneficiaries equally, the usual prohibition on routine notices to all beneficiaries does not apply in these cases.   NOTE:  A routine written notice, like any other written notice, is valid only for the denial reason specified on the notice.  A written notice will not be considered a valid notice in the case of any Medicare denial of the claim for any reason other than that specified on the notice.   40.3 - Medical Emergency or Otherwise Under Great Duress Situations  (Rev.: 4197; Issued: 01- 11-19; Effective: 04 -15-19; Implementation: 04 -15-19)  A written notice should not be obtained from a beneficiary in a medical emergency or otherwise under great duress (i.e., when circumstances are compelling and coercive) since that individual cannot be expected to make a reasoned informed decision.  A beneficiary (or authorized representative) cannot be expected to make an informed, rational decision when in an emergency situation and therefore cannot be considered a capable recipient.  If the beneficiary is not capable of receiving the notice, then the beneficiary has not received proper written notice and cannot be held liable  where the LOL or RR provisions apply, and the notifier may be held liable.   Examples:    Ambulance companies may not give written notices to beneficiaries (or authorized representatives) in any emergency transport because such beneficiaries are under great duress.     Skilled nursing facilities may not give written notices in the case of middle -of-the-night emergencies or in any other emergency circumstances, since the beneficiary clearly cannot make an informed decision.
(Medicare Claims Processing Manual)
 Skilled nursing facilities may not give written notices in the case of middle -of-the-night emergencies or in any other emergency circumstances, since the beneficiary clearly cannot make an informed decision.  NOTE:   The Medicare contractor will consider any written notice given in any kind of coercive circumstances, including medical emergencies, to be invalid.  The Medicare contractor will determine the healthcare providers or suppliers liability by the appropriate knowledge standards which are used in cases where written notices are not given and beneficiary agreements to pay are not obtained.  40.4 - Emergency Medical Treatment and Active Labor Act (EMTALA) Situations  (Rev.: 4197; Issued: 01- 11-19; Effective: 04 -15-19; Implementation: 04 -15-19)  A written notice should not be given to a beneficiary in any case in which EMTALA (1867 of the Act) applies, until the hospital has met its obligations under EMTALA.  These include completion of a medical screening examination (MSE) to determine the presence or absence of an emergency medical condition, or until an emergency medical condition has been stabilized.  The CMS published this policy in the November 10, 1999 OIG/HCFA Special Advisory Bulletin on the Patient Anti -Dumping Statute: A hospital would violate the patient anti -dumping statute if it delayed a medical screening examinat ion or necessary stabilizing treatment in order to prepare an ABN and obtain a beneficiary signature.  The best practice would be for a hospital not to give financial responsibility forms or notices to an individual, or otherwise attempt to obtain the individuals agreement to pay for services before the individual is stabilized.  This is because the circumstances surrounding the need for such services, and the individuals limited information about his or her medical condition, may not permit an individual  to make a rational, informed consumer decision. This policy applies in any case in which EMTALA applies, not only to EMTALA cases seen in emergency rooms (ERs).  This policy also includes times when a beneficiary does not appear to have a life threatening condition, rather, h/she is seeking primary care services at an ER, if EMTALA applies.
(Medicare Claims Processing Manual)
A written notice that is otherwise appropriate may be given to a Medicare beneficiary who is seen in the ER after completion of an MSE, but a written notice should not be given unless there is a genuine reason to expect that Medicare will deny payment for the item and/or service.  EMTALA does not prohibit asking payment questions entirely, rather, only doing so before screening/stabilization.  After screening/stabilization, EMTALA no longer applies and written notices may be given, as applicable, to beneficiaries who come to emergency care settings after they have received a medical screening examination and are stabilized.    50 - Advance Beneficiary Notice of Non -coverage (ABN)                        (Rev. 10862; Issued: 07- 14-21; Effective: 10 -14-21; Implementation: 10 -14-21) A.  General Statutory Authority -  Applicability to Limitation on Liability  (LOL)
(Medicare Claims Processing Manual)
Section 1879 of the Act (where the LOL provisions are located) requires a healthcare provider or supplier (i.e. notifier) to notify a beneficiary in advance of furnishing an item or service when s/he believes that items or services will likely be denied by  Medicare for any of the reasons specified in the statutory provision in order to shift financial liability to the beneficiary for the denial.  For example, advance notice is required if the item or service may be denied as not reasonable and necessary und er 1862(a)(1) of the Act or because the item or service constitutes custodial care under 1862(a)(9) of the Act.  Notice (e.g., the ABN) is a way for healthcare providers or suppliers to establish beneficiary knowledge of non- coverage and therefore, shift financial liability for these items or services if Medicare denies the claim.    B.  Compliance with Limitation on Liability Provisions  A notifier who fails to comply with the ABN instructions risks financial liability and/or sanctions.  LOL provisions shall apply as required by law, regulations, rulings and program instructions.  Additionally, when authorized by law and regulations, sanct ions under the Conditions of Participation (COPs) may be imposed.  The Medicare contractor may hold any healthcare provider or supplier who either failed to give notice when required, or gave defective notice, financially liable.  A notifier who can demonstrate that s/he did not know and could not reasonably have been expected to know that Medicare would not make payment will not be held financially liable for failing to give notice.  However, a notifier who gave defective notice may not claim that s/he did not know or could not reasonably have been expected to know that M edicare would not make payment, as the issuance of the notice is clear evidence of knowledge.  A notifier who cannot demonstrate that adequate advance notice was furnished to the beneficiary will not be able to use the provisions in section 1879 of the Act  to transfer financial liability to the beneficiary.   ABN - Quick Glance Guide3  Notice Name: Advance Beneficiary Notice of Non -coverage (ABN)  Notice Number: Form CMS -R-131 Issued by: Healthcare providers and suppliers of Medicare Part B items and services;                      Hospice and Religious Non- medical HealthCare Institute (RNHCI) providing Medicare Part A items and services;
(Medicare Claims Processing Manual)
Hospice and Religious Non- medical HealthCare Institute (RNHCI) providing Medicare Part A items and services;                      and home health agencies(HHAs) for Part A and Part B items and services                       Recipient: Original Medicare FFS (fee for service) beneficiary;                                         Type of notice:  Must be issued:  Timing of notice:  Optional use:  Financial liability notice    Prior to providing an item or service that is usually paid for by Medicare under Part B (or under Part A for hospice, HHA, and RNHCI providers only) but may not be paid for in this particular case because it is not considered medically reasonable and necessary   Prior to providing custodial  care  For hospice providers, prior to caring for a patient who is not terminally  ill  For Durable Medicare Equipment (DME) suppliers   For HHA providers, prior to providing care when the individual is not confined to the home or does not need intermittent skilled nursing  care.  Prior to delivery of the item or service in question.  Provide enough time for the beneficiary to make an informed decision on whether or not to receive the service or item in question and accept potential financial liability.   Yes.  Prior to providing an item or service that is never covered by Medicare (i.e. not a Medicare benefit).  3 This is an abbreviated reference tool and is not meant to replace or supersede any of the directives contained in Section 50.  50.1 - ABN  Scope                                                                                       (Rev. 10862; Issued: 07- 14-21; Effective: 10 -14-21; Implementation: 10 -14-21)  The ABN is an Office of Management and Budget (OMB) -approved written notice issued by healthcare providers and suppliers for items and services provided under Medicare Part B.  With the exception of DME suppliers, only healthcare providers and suppliers who are enrolled in Medicare can issue the ABN to beneficiaries.   The ABN is given to beneficiaries enrolled in the Medicare FFS program.  It is not used for items or services provided under the Medicare Advantage (MA) Program or for prescription drugs provided under the Medicare Prescription Drug Program (Part D).