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«DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 409, 424, and 484 [CMS-1560-F] RIN 0938-AP55 Medicare ...»

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this scenario is negligible; that the physician relies solely on the home health nurse’s determination when certifying the need for the Medicare home health benefit. We remind commenters that the physician has always been responsible for certifying that the unique condition of the patient warrants eligibility for Medicare’s home health benefit. A home health agency’s recommendation alone is not sufficient for a physician to certify the need for the benefit. While our regulations have always required the physician to review the individual patient’s needs and unique clinical condition as part of the certification and recertification requirement, we believe the commenters are often correct that the physician may rely too heavily on the home health staff for the determination of skilled need for Medicare’s home health benefit.

We also would like to assure nurses that this requirement is not an attempt by CMS to diminish in any way the essential and important role that skilled nurses play in the assessment of a home health patient’s needs. While the home health nurse is responsible for initiating, managing and evaluating the resources needed to promote the Medicare home health patient’s optimal level of well-being, this does not diminish the

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condition of the patient warrants the need for Medicare’s home health benefit. The physician is currently responsible to carefully synthesize data regarding the patient’s condition and assess whether this patient’s unique condition requires Medicare’s home health services. The physician is accountable for the accuracy of the certification of need for home health services. We agree with the commenter that providing the physician with a list of patients’ home health services provided may be useful. Similarly, we agree with the commenter that inclusion of a clinical justification on the plan of care is a good idea, and that a clear physician order for this service should be present. We also agree that the OASIS process measures will more actively involve the physician in some aspects of patient care. Additional provider education associated with management and evaluation is something that CMS will consider providing. However, we do not believe that an NCD is appropriate in this scenario because skilled services are covered under the home health benefit, and appropriate use of management and evaluation management of the plan of care is a skilled service. Regardless, none of these suggestions would replace the physician’s accountability associated with the

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health benefit, nor would these suggestions address the program vulnerability associated with this specific category of home health patient. And, because the physician’s certification and recertification of the need for Medicare’s home health benefit is fundamental to eligibility, we disagree with the commenter that this provision would be more appropriately addressed in the physician fee schedule rule. Regarding the commenter’s suggestion that we hold the physician accountable for complying with this requirement, we continue to believe that each agency is responsible for ensuring that the certification and recertification requirements are met, but we also reiterate the physician’s accountability associated with the certification and recertification, as they are part of the medical record.

Therefore, we are finalizing the following policy: When a patient’s underlying condition or complication requires that a registered nurse ensures that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management and evaluation of a patient’s care plan, we will require that the physician include a written narrative on the certification and recertification

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Comment: Some commenters encouraged CMS to allow the narrative to be submitted as an attachment. These commenters believe that home health agencies and physicians which have electronic medical records should not be forced to include the narrative on the certification and recertification forms. Some commenters stated that CMS should provide examples to help home health agencies and physicians understand the scope of acceptable responses. Another commenter stated that the requirement would be meaningless since there are no specific guidelines for the content of the statement, and there would be no way to determine that the narrative is completed. Similarly, a commenter stated that if physicians were required to include a clinical justification narrative on the certification, the narrative would be simply a restatement of the nurse’s justification, or it would be a prefabricated statement.

Response: Our intent is for the physician to justify his or her certification of skilled need in the scenario where only unskilled services are being provided. We understand that many physicians would prefer to dictate rather than hand-write their

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we should take into account that some providers have electronic health record systems and may more easily produce an addendum containing the clinical justification. Therefore, we have decided that a typed addendum containing the narrative which is electronically or hand signed by the physician would be acceptable. We also appreciate the commenter’s concern that a home health nurse may compose the narrative for the physician and that we should clarify the criteria associated with the narrative requirement. We expect that the narrative must be composed by the physician performing the certification or recertification and not by other home health personnel.

Regarding the commenter’s concern associated with dual eligible patients, especially given that Medicaid is the payer of last resort, we would encourage agencies to ensure that all Medicare criteria are met if the agency believes that Medicare may be the appropriate payer for a patient.

We believe that these requirements regarding the certification and recertification are a first step in ensuring that only home-health eligible patients receive the benefit. We disagree with the commenter who suggested we include an illustrative example of narrative language, since the intent of

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patient’s unique conditions.

We are modifying our original proposal in that we will allow the narrative to either be part of the certification and recertification forms, or to be an addendum to the certification and recertification forms which is electronically or hand signed by the physician. If the narrative is part of the certification or recertification form, then the narrative must be located immediately prior to the physician’s signature. If the narrative exists as an addendum to the certification or recertification form, in addition to the physician’s signature on the certification or recertification form, the physician must also sign immediately following the narrative in the addendum.

The narrative must reflect the patient’s individual clinical circumstances.

Comment: A commenter stated that CMS should issue specific Medicare coverage guidelines that clearly differentiate noncovered custodial or medically unnecessary care under Medicare home health from covered rehabilitative, acute or curative care.

Response: We thank the commenter for the suggestion. We believe that the commenter is asking CMS to expand our skilled services clarification to better clarify CMS’ definition of

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that which we solicited comments, which was to clarify CMS’ regulations concerning skilled services in the home health setting. However, we will briefly address this as it is a related topic. Custodial care is not considered skilled care.

We suggest the commenter refer to regulations at 42 CFR 409.45(b) and 42 CFR 409.49(d) for some clarification regarding custodial care in the home health setting. We suggest the commenter refer to regulations at 42 CFR 409.49(d) where we specifically stipulate the exclusion of housekeeping services from home health services, and also stipulate that services whose sole purpose is to enable the beneficiary to continue residing in his or her home (for example, cooking shopping, Meals on Wheels, cleaning, laundry) are excluded from home health coverage. We also note that personal care and some incidental services can be provided in the course of a covered Medicare home health visit. 42 CFR 409.45(b) defines what constitutes a home health aide visit. This section explains that the reason for the aide visit must be to provide hands-on personal care to the beneficiary or services that are needed to facilitate treatment of the beneficiary’s illness or injury.

Please note 42 CFR 409.45(b)(1)(i) provides examples of covered

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services incidental to a covered visit. These incidental services may include changing bed linens, personal laundry, or preparing a light meal. Therefore, a home health aide may perform some incidental services which do not meet the definition of a home health aide service (light cleaning, preparation of a meal, taking out the trash, shopping, etc.).

However, the purpose of a home health aide visit may not be to provide these incidental services since they are not healthrelated services, but rather are necessary household tasks that must be performed by anyone to maintain a home. It is important to note that to be considered a covered Medicare home health visit, the purpose of the home health visit cannot be to provide the “incidental or custodial” services.

Comment: A few commenters supported the proposed narrative requirement. One commenter recommended that we require the narrative for ALL home health episodes, regardless of services ordered, stating that this would be encourage more physician involvement with the home health patient.

Response: The commenter has correctly interpreted our interest in enhancing physician accountability and involvement with the home health patient. However, at this time we are

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service. Program vulnerability has been identified in this scenario, because the patient is receiving only unskilled services, which would normally not result in eligibility to Medicare’s home health benefit. Therefore, we believe it is prudent to require the physician to provide this clinical justification of why a patient’s condition would require skilled nursing management and evaluation (M&E) of the patient’s care plan.

Comment: A commenter recommended that CMS reconsider the restrictive interpretation of skilled oversight of the plan of care (POC). Providers are often compelled to discharge patients from Medicare based on a very limited interpretation of skilled oversight when it is apparent that the patient is in advanced stages of chronic illness and will likely relapse once nursing oversight is discontinued. Such patients may become stable for several weeks and under the policy above would be considered non-covered and discharged from Medicare home health. Patient outcomes could be improved if such patients were offered continuing care coordination during periods of stability. The commenter suggested we modify coverage guidelines to allow home

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of care through periods of relative stability if the patient is in advanced stages of chronic illness and likely to deteriorate without skilled care.

Response: We thank the writer for this perspective.

However, we are not excluding beneficiaries in advanced stages of chronic illness from qualifying for this service. When a chronically ill patient with an underlying condition or complication requires skilled nursing personnel to manage the plan of care then this service is indeed indicated until the treatment regimen has essentially stabilized. If the combination of the patient’s underlying condition, age and immobility creates a high potential for serious complications which require that only a registered nurse can ensure that essential non-skilled care is achieving its purpose then the patient is indeed eligible for this service. However when the patient’s treatment regimen is essentially stabilized and skilled nursing visits are not necessary to manage and supervise the home health aide the patient will not require this type of care and does not meet the definition of needing a skilled service for purposes of Medicare home health eligibility, per sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Social Security

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Comment: A commenter urged CMS to undertake a similar initiative to set out coverage conditions for therapy services in the home health regulations.

Response: In response to a commenter’s request for CMS to provide clarification of coverage of therapy services we are referring the commenter to the following existing section of the Code of Federal Regulation, 42 CFR 409.44(c). We believe that this section adequately sets out the circumstances under which therapy services are covered. However, we thank the commenter for this opportunity to remind HHAs of their ongoing responsibility to evaluate the patient’s need for therapy and provide all covered home health services (except durable medical equipment) either directly or under arrangement while a patient is under a home health plan of care.

Comment: A commenter stated that the revisions proposed by CMS will make it more difficult for Medicare patients to obtain skilled nursing management and evaluation of the care plan. The commenter also stated that the requirement places an unrealistic expectation on a patient or caregiver to gauge effectively whether non-skilled care is achieving its purpose, that CMS wrongly hinges coverage on the complexity of unskilled services,

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The commenter further states that the proposed clarifications add confusion to the current standard.

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