LCD Reference Article Response To Comments Article

Response to Comments: Frequency of Hemodialysis

A56235

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Source Article ID
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Article ID
A56235
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Article Title
Response to Comments: Frequency of Hemodialysis
Article Type
Response to Comments
Original Effective Date
02/16/2019
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Frequency of Hemodialysis (L37537). Thank you for the comments.

WPS GHA received numerous comments related to DL37537. This present draft form is an expansion of the coverage diagnoses, addition of the use of a modifier to identify those additional treatments needed, and establishes an appropriate way to have appeals available should a denial occur for those diagnoses not in the list. As noted in the document, the draft addresses a narrow issue for the ESRD program and does not change the base payment process issued by CMS. CMS charged Local Contractors (MACs) to develop a list of clinical conditions appropriate for payment beyond the thrice weekly payment by CMS. This list (included in the draft) is felt to be appropriate for such payments should medical documentation be supportive. All payment policies for ESRD program reside with CMS for other changes. MACs do not have the jurisdiction to change any basic payment policies related to this issue and is only defining a list of clinical conditions that up front in the submission of a claim could be felt to be appropriate for additional payment should medical documentation support use if reviewed. There will be other clinical situations that may require additional treatments. These lines in the claims, even though they do not have a diagnosis listed, can be noted by an appended KX modifier (see A55703). They would need additional review following an initial denial.

In the comment review, all submitted published literature was reviewed. WPS GHA does not do research based on bibliographies that may have been submitted along with comments. Many of the issues were similar and gathering of like comments was done for a response. A large number of literature articles were submitted by industry that encompasses the requests from others who did not submit literature.
In general, the comments address home dialysis and more frequent dialysis as a baseline for payment. This issue is outside the scope of the draft LCD and will need to be addressed by CMS. MACs do not have in their jurisdictions the mandate to change baselines payment strategies for CMS.
The comments can generally be divided into three categories:

  • Patient, caretakers, those who work with these patients
  • Providers and societies/organizations
  • Industry

Response To Comments

Number Comment Response
1

Numerous comments and testimonials (127 comments) have been received by beneficiaries, beneficiary family members, and constituents regarding the reimbursement for home hemodialysis sessions. Most were variations of 10 templated letters. Many discussed the health benefits and quality of life issues related to home hemodialysis. Most of these comments centered on home dialysis access. Although this level of evidence, i.e. antidotal information and testimonials, does not rise to the level needed for a change in the draft, the comments include fear about a change in coverage, access to home dialysis, and more frequency of dialysis improving heart health, stabilizing blood pressure, reduction in medications, ability to return to work or continuing to work, lowering overall healthcare cost and improvement in post dialysis recovery time. Many of these comments were duplicates or a version of a similar comment. None submitted literature to review. WPS GHA appreciates the comments and the passion related to ESRD patient care exhibited in the comments but no changes in the draft policy are warranted based on these comments.

WPS GHA appreciates the comments and the passion related to ESRD patient care exhibited in the comments but no changes in the draft policy are warranted based on these comments.

2

WPS GHA received multiple comments from physicians, facility providers, national associations and networks dealing with ESRD care. These comments included some historical information and a plea to increase the baseline frequency above thrice weekly. No comments were associated with submission of literature to review although selected bibliographies for review were submitted in comments.

  • Several comments mentioned potential interference with physician-patient relationship, included a request to encourage medically justified individualized care, to recognized acute and chronic conditions for additional coverage, not to have undue administrative burden on physician.
  • Several commenters requested the removal of the term ‘planned inadequate dialysis’ as it implies the providers were not prescribing correctly and could be derogatory statement against the providers.
  • Many commenters requested change to the language related to the Plan of Care and payment as thrice weekly. The statements imply that any prescription in the Plan of Care should be allowed as this would indicate medical justification.

WPS GHA disagrees with the above premises. Autonomy of the physician-patient relationship and the ability to have medically justified individualized care should not be impacted by this LCD. By use of the modifier to signify additional treatments were needed (even with diagnoses not included in the LCD), the ESRD facilities will have an appeals process for submission of medical records to justify the use compared to just frequency based denials. The additional use of the KX modifier is not considered an administrative burden as these modifiers are used frequently by ESRD facilities. WPS GHA recognizes the use of the word ‘acute’ may need to be altered to ‘acute/chronic’ in the text of the draft LCD. However, the list of diagnoses does include chronic conditions. This would be an appropriate change.

In the Medicare Program Integrity Manual (CMS IOM Publication 100-08) Chapter 13, Section 13.5.1 a list of criteria exists defining ‘reasonable and necessary’ for coverage of a service. One of the criteria states the service should meet or exceed the patients’ need. Inadequate dialysis would not meet the needs of the patients and therefore not be reasonable and necessary or allowable. Perhaps the conversation related to this would need to occur between the provider community and CMS to define parameters of dialysis. No changes in the draft policy are warranted.

Medicare states in the Medicare Benefit Policy Manual (CMS IOM Pub 100-02) Chapter 11, Section 50.A.1, the following:

Hemodialysis is typically furnished three times per week in sessions of 3-5 hours in duration. If the ESRD facility bills any treatment in excess of this frequency, medical justification is required to be furnished to the A/B MAC (A) and must be based on the individual patient’s need. The A/B MAC reviews the medical justification for EACH ADDITIONAL treatment and is responsible for making the decision on the appropriateness for the extra treatment(s) and payment for these added treatments.

By using the proposed list of clinical conditions and modifier, automation would occur and thereby facilitate payments. For those patients who had other diagnoses than listed in the LCD, there would be a mechanism for additional payment not afforded at this time. Inclusion in the Plan of Care a higher number of treatments per week does not justify the allowance of additional payments. Medical documentation should be available to support the additional treatments. No changes in the draft policy are warranted.

3

NxStage submitted comments and published literature for review. Most of the initial comments were similar to those above and have been addressed. The literature was divided into categories based on clinical conditions felt to be needed as acceptable diagnosis to be added to the draft LCD. Some literature was duplicated in several categories. The following categories were specifically submitted: Cardiovascular, Hypertension, Hyperphosphatemia, Quality of Life issues, Tolerance of Hemodialysis, New Research, and Multinational Guidelines.

  • Cardiovascular Issues.
    The company submitted 13 articles for review. The literature reviewed various aspects of cardiovascular disease including LVH, inflammatory cardiac markers, hypertension etc. Over half were of small number and of short duration. Some had larger patient population included over a longer period of time. Some of the larger studies over long period of time showed overall decrease in cardiovascular hospitalizations but one showed only a minimal change in survival with in-center treatment 21.7% vs Daily Home Hemodialysis 19.2%.
  • Hypertension
    Eight studies were submitted for review of which five were included in those above. Of the three new studies, two were small studies with no long term outcomes. One study was a restatement of two prior studies that showed a modest reduction in hypertension medications.
  • Hyperphosphatemia
    Four studies were submitted. Two were duplicates and one was a restatement of prior study. A study of new information followed a small number of patients for 12 months, stating the increase dialysis for this issue would decrease morbidity and mortality. However, they also concluded longer term studies were warranted.
  • Quality of Life Issues
    Fifteen studies were submitted for review. Many were reporting of issues from other studies. The issues included sleep disorders, restless leg syndrome, and depression. The studies were self-reported issues.
  • Tolerance of Hemodialysis
    Six studies were submitted of which 3 were duplicates from above. The remainder included issues related to BP control and need for antihypertensive medicine and cardiac stunning more appropriate to be considered in the cardiovascular area above. The studies not previously reviewed state ‘follow up studies underway’ and ‘long term effects unknown’.
  • New Research
    Fourteen articles were submitted for review. These articles represented various issues such as cardiovascular risk, dialysis schedule predicting hospitalizations, target weights, high ultrafiltration rates, sleep quality, pediatric populations, ambulatory BP monitoring, uremic solute concentrations, etc.
  • Multinational Guidelines
    Submitted were practice guidelines from US, Japan, UK, Canada and European Best Practices. The NKF-KDOQI is noted to have the following conditions lists: large weight gains, high ultrafiltration rates, poorly controlled blood pressure, difficulty achieving dry weight, or poor metabolic control (hyperphosphatemia, metabolic acidosis, and or hyperkalemia. Other guidelines are similar but include malnutrition (all), LVH (Canada), hemodynamic instability (Canada), refractory peripheral vascular disease (Canada). Most of the later were graded as opinions only.

No changes in the draft policy are warranted as the cardiovascular issues need standardization of the treatment modalities. However, long term outcomes with survival rates would be needed to be presented to CMS for consideration to change the overall payment plan.

No changes in the draft policy are warranted for hypertension issues. However, long term outcomes with significant reduction in hypertension medications or uncontrolled hypertension would be needed to be presented to CMS for consideration to change the overall payment plan.

WPS GHA has included the hyperphosphatemia diagnosis in the LCD for coverage based on other information. We appreciate the information.

WPS GHA disagrees with adding self-reported issues at this time. No changes related to these issues warrant change to the draft at this time.

WPS GHA disagrees with adding other diagnoses to the draft LCD based on this information for tolerance of hemodialysis.

WPS GHA did not feel these studies for new research topics added new information and a change in the draft LCD was not warranted.

WPS GHA appreciates the guidelines being forwarded from others. However, it appears the draft LCD addresses most of those issues in the NKF-KDOQI guidelines and no changes are warranted. Uncontrolled hypertension was not added to the draft LCD as the guidelines discussed longer dialysis treatments (rather than more frequent) and lower sodium dialysates to help with the issue. Much of the literature above focused on reduction of antihypertensive medications as an outcome within HRQOL outcomes. It appears this area would be addressed through other clinical conditions listed in the draft. Any additional conditions noted in the other guidelines would need to be incorporated in the NKF-KDOQI guidelines.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37537 - Frequency of Hemodialysis
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