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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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Additionally, these commenters noted that compliance with 42 CFR 455.55(b)(1) and (d)(1) specifies that OASIS data submitted requires completion of the comprehensive assessment with OASIS within 5 days after the start of care and during the last 5 days of a prior episode for recertification. The commenter was concerned that the impact of the proposed change could preclude HHAs from receiving Medicare payment in all cases where OASIS was not completed within the 5-day timeframe. The commenters noted some exceptions to the 5-day timeframe, and that in the early years of HH PPS, CMS used Q&As and letters to express its intention to refrain from penalizing HHAs that failed to submit OASIS during the 5-day timeframe under certain circumstances. In these cases, the commenters wrote that CMS allowed HHAs to either conduct a comprehensive assessment as soon as possible in the 60 day episode, or to determine appropriate OASIS responses required for payment from the clinical record when Medicare is the payer. Also, when paymentonly items are collected, HHAs are not to submit these data to CMS. The commenters recommended that we amend any enforcement to consider that 100 percent compliance with the 5-day timeframe is not always achievable.

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require OASIS reporting as a condition for payment, noting the exceptions to the 5-day timeframe because of issues outside of the provider’s control. This commenter wrote that we should not include timeframes in any submission requirement related to payment and also asked that we change enforcement to recognize that 100 percent compliance with the 5-day timeframe is not always achievable.

Several commenters were concerned about the potential for reinstitution of collection of all OASIS items for one-visitonly cases; currently HHAs limit the OASIS collection to payment-only items for one-visit patients.

One commenter wrote that the current OASIS requirements are included only in the home health CoPs, and is concerned that the proposal would lead to the use of OASIS requirements by Regional Home Health Intermediaries (RHHIs), Payment Safeguard Contractors (PSCs), and Recovery Audit Contractors (RACs) to deny or adjust claims payment. The commenter wrote that HHAs are already inundated with State and Federal audits, and that this proposal would only exacerbate the problem. Another asked us to provide additional information in the implications and consequences of policy statements regarding OASIS being a

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agency failed to meet the requirement.

Response: We thank the writers for their comments. We assure commenters that we have no intention that this proposed requirement would have an effect on long-standing direction associated with submitting RAPS, OASIS completion timeframes, and instructions associated with one-visit episodes. Rather, we intend that in finalizing this policy, providers will ensure that prior to submitting a final HH PPS episode claim, a provider will have submitted an OASIS, and the HIPPS code on the final HH PPS episode claim will be consistent with the HIPPS on the OASIS validation report.

As such, we are implementing the provision to require the submission of OASIS, for final claims, as a condition of payment, and revising §484.210 “Data used for the calculation of the national prospective 60-day episode payment” to reflect this requirement.

E. Qualifications for Coverage as They Relate to Skilled Services Requirements In the proposed rule, for CY 2010, we proposed to clarify what constitutes skilled services in the home health setting

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qualifying instruction to §409.42(c)(1) to explain that intermittent skilled nursing services meeting the criteria for skilled services and the need for skilled services found in §409.32 (with examples in §409.33 (a) and (b)) are subject to certain limitations in the home health setting.

Proposed new paragraph §409.42(c)(1)(i) We proposed to describe the limitations in two new paragraphs, §409.42(c)(1)(i) and §409.42(c)(1)(ii). In §409.42(c)(1)(i) we proposed that in the home health setting, management and evaluation of a patient care plan is considered a reasonable and necessary skilled service only when underlying conditions or complications are such that only a registered nurse can ensure that essential non-skilled care is achieving its purpose.

Further, in §409.42(c)(1)(i) we also proposed to clarify that to be considered a skilled service, the complexity of the necessary unskilled services that are a necessary part of the medical treatment must require the involvement of licensed nurses to promote the patient’s recovery and medical safety in view of the overall condition. Where nursing visits are not needed to observe and assess the effects of the nonskilled services being provided to treat the illness or injury, skilled

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and the management and evaluation of the care plan would not be considered a skilled service.

Additionally, we proposed to further clarify in §409.42(c)(1)(i) that in some cases, the condition of the patient may require that a service that would normally be considered unskilled be classified as a skilled nursing service given a patient’s unique circumstances. This would occur when the patient’s underlying condition or complication required that only a registered nurse could ensure that essential non-skilled care was achieving its purpose. However, any individual service would not be deemed a skilled nursing service merely because it was performed by or under the supervision of a licensed nurse.

Where a service could be safely and effectively performed (or self administered) by the average non-medical person without the direct supervision of a nurse, the service could not be regarded as a skilled service, although a nurse may have actually provided the service.

Proposed new paragraph §409.42(c)(1)(ii) Additionally, we also proposed a new §409.42(c)(1)(ii), which would clarify when patient education services as described in §409.33(a)(3) constituted skilled services in the home health

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services are skilled services if the use of technical or professional personnel is necessary to teach patient selfmaintenance. However, to address the concerns and lack of clarity surrounding when educational services are skilled services as described above, we proposed to add a new paragraph, §409.42(c)(1)(ii). In the home health setting, skilled education services would be deemed to no longer be needed when it became apparent, after a reasonable period of time, that the patient, family, or caregiver could not or would not be trained.

Further teaching and training would cease to be reasonable and necessary in this case, and would cease to be considered a skilled service. Notwithstanding that the teaching or training was unsuccessful, the services for teaching and training would be considered to be reasonable and necessary prior to the point that it became apparent that the teaching or training was unsuccessful, as long as such services were appropriate to the patient’s illness, functional loss, or injury.

Proposed change to §409.44(b) We proposed to revise the introductory material at §409.44(b)(1), to refer to the newly proposed limitations of skilled services in the home health benefit at §409.42(c)(1)(i)

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(i) through (iv) would remain unchanged.

Proposed revision to §424.22(a)(1)(i) and §424.22(b)(2) We also proposed to revise §424.22(a)(1)(i) and §424.22(b)(2) to require a written narrative of clinical justification on the physician certification and recertification for the targeted condition where the patient’s overall condition supported a finding that recovery and safety could be ensured only if the care was planned, managed, and evaluated by a registered nurse. To clarify for home health agencies what specific circumstances would necessitate the involvement of a registered nurse in the development, management, and evaluation of a patient’s care plan when only unskilled services were being provided, we proposed additions to the home health certification content requirements as described at §424.22(a)(i) and recertification content requirements at §424.22(b)(2).

Specifically, when a patient’s underlying condition or complication required exclusively that a registered nurse ensure that essential non-skilled care is achieving its purpose, and necessitated that a registered nurse be involved in the development, management, and evaluation of a patient’s care plan, we proposed to require the physician include a written

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the physician’s clinical justification of this need.

Comment: Many commenters appreciated CMS’ clarification of skilled services. However, many opposed CMS’ proposal that a physician include a clinical justification on the certification of need for Medicare’s home health services, in the scenario where a patient’s need for skilled services is met solely because skilled oversight of unskilled services is required.

Commenters urged CMS to reconsider this requirement, stating that such a requirement would be too burdensome for physicians to include on the certification, would be too burdensome for agencies to administer, and would result in fewer patients being referred to home health. Some commenters stated that the need for skilled oversight of unskilled services is a determination that the home health nurse makes at the initial eligibility assessment, and that this need is better understood by the nurse than it would be by the certifying physician. Further, commenters stated that this requirement would muddy issues of nursing practice by requiring more physician orders for established areas of nursing practice. Other commenters expanded on this concern, stating that by requiring the physician to clinically justify the need for skilled oversight

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responsibility of the home health nurse to makes such an assessment. Some commenters recommended that CMS instead provide education to providers regarding when evaluation and management of unskilled services is appropriate. Another commenter suggested that we develop a national coverage determination (NCD) to address our concerns. Commenters described the challenges that home health agencies currently face in getting the physician to sign orders and plans of care, fearing that this additional physician documentation requirement could result in physicians not certifying patients for Medicare’s home health benefit, ultimately resulting in access to care issues for patients. Other commenters stated that this requirement would have no positive effect; because so few patients meet the skilled requirement based solely on this need, the narrative requirement would not enhance program integrity efforts. Commenters contended that the requirement would increase HHA costs, since HHAs would need to track the physician’s compliance. One commenter suggested that we instead provide the patient’s certifying physician with a list of services provided to the patient to achieve more physician involvement with the home health patient. Another commenter

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scenario, we instead require that the plan of care contain a clinical justification for the skilled oversight. Other commenters stated that a narrative requirement is not the way to achieve more physician involvement and another commenter stated that a narrative requirement would take away from the time a physician spends with the patient. Instead, CMS should look to new OASIS-C process measures which would require the home health agency to contact the physician more frequently. Another commenter suggested that we instead require a clear order from the physician for management and evaluation of the plan of care.

Another commenter stated that this narrative requirement more appropriately belongs in the physician fee schedule rule, while another commenter stated that should CMS finalize this requirement, we place the burden of compliance on the physician.

Finally, a commenter stated this requirement is especially problematic for dual eligible home health patients. The commenter asserted that Medicaid does not have a comparable narrative requirement. Therefore, should an agency believe that the payer source for a patient is Medicaid, it would not obtain the narrative from the physician. If later the agency determines that Medicare should be the payer for the services

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satisfy this narrative requirement.

Response: We thank the writers for their comments.

However, we continue to believe that requiring a physician to complete a clinical justification on the certification in this targeted scenario addresses a specific program vulnerability which has been identified by our Medicare contractors, and is a first step in addressing vulnerabilities identified by the Office of Inspector General (OIG). We also believe that this requirement will result in a minimal burden on the physician, and minimal costs to the HHA, given that this requirement applies only to the small percentage of patients who require only skilled oversight of unskilled care. The brief narrative should be a simple task for the physician because of the physician’s responsibility for the clinical determination of the patient’s skilled need as part of the certification or recertification requirement.

We remind commenters that a physician must certify that home health services are required because the individual patient needs skilled nursing care on an intermittent basis, or physical or speech therapy, or continued occupational therapy in order for a patient to be eligible for the benefit. We are concerned

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