Response to Comments: Frequency of Hemodialysis

Noridian directly received over 200 comments from patients, spouses, caretakers, nurses and other professionals who are, work with, or take care of dialysis patients. Most of these comments centered on home dialysis access. Although this level of evidence, i.e. anecdotal 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. None seemed to recognize an existing policy was in place by which the coverage they had been receiving was available. Some were from outside our Medicare Jurisdictions of JE and JF. 

Noridian 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.

Noridian received an inquiry as to whether this draft LCD had any impact in physician billing. MCP billing would still be the same and no changes would be indicated in the draft policy.

Noridian 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. The payment process, as outlined by CMS, has been in place for decades and is not the focus of this draft policy. 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 recognize acute and chronic conditions for additional coverage, and not to have undue administrative burden on physician.

Noridian 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 facilities use modifiers frequently by ESRD facilities. Noridian recognizes the use of the word ‘acute/chronic’ in the text of the draft LCD. However, the list of diagnoses does include chronic conditions. This would be an appropriate change.

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.

Noridian disagrees with the above. 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’, by definition, would not meet the needs of the patient 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.

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.

Noridian disagrees. 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 clinical conditions other than those listed in the LCD, there is a mechanism for additional payment not afforded at this time. Inclusion in the Plan of Care a higher number of treatments per week is not medical justification for the allowance of additional payments. Medical documentation should be available to support the additional treatments. (See Documentation Requirements in the LCD.) No changes in the draft policy are warranted.

One commenter stated that at this time weekly urea clearances are used which would be wstdKt/v and this should be recognized.

Noridian disagrees that any changes related to the clearance nomenclature is needed and would not be in the focus of this LCD. This would need to be addressed with CMS. No changes in the draft policy are warranted.

A list of clinical diagnoses listed below was submitted by several providers. Some with individual bibliography in the request but no printed literature was submitted for review. Some of the clinical conditions listed below are included in the draft and the others are included in the literature submitted by industry for review.

The list requests the following to be included in the policy (ICD-10 listed when given):

Congestive Heart Failure, ICD-10: I50.9—in the draft

Uncontrolled Hypertension, ICD-10: I12.1

Hypotension due to known cardiovascular disease ICD-10: I95.89

Hyperkalemia, ICD-10: E87.5 in the draft

Left ventricular hypertrophy, ICD-10: I 51.7

Fluid Overload (non-CHF) ICD-10: E87.79-in the draft

Hyperphosphatemia, ICD-10: E83.39—in the draft

Malnutrition, ICD-10: E46

Sleep Apnea, ICD-10: G47.30

Depression, ICD-10: F32.9

Restless Leg Syndrome: ICD-10: G25.81

Obesity, ICD-10: E66.9

High-risk Pregnancy, ICD-10: O09.899 and O26.839-O09.899 in draft

Amyloidosis, ICD-10: E85.9

Cardiomegaly

Silent myocardial ischemia (Cardiac Stunning)

Hyperoxalemia

Exposure to Disaster

Quality of Life issues, often not enumerated

These requested will be reviewed based on literature submitted if available.

One provider group submitted a large number of questions related to the intent of CMS to have the MACs create this list of clinical conditions.

Noridian does not have knowledge of any intent from CMS and would refer the group to CMS for a response. We refer providers to the Social Security Act, Section 2991 establishing the benefit to the various Code of Federal Regulations citations, starting in July 1, 1973, when the ESRD program became effective to the present. CMS webpage ‘ESRD Center’ is available for most recent rules and regulations (https://www.cms.gov/Center/Special-Topic/End-Stage-Renal-Disease-ESRD-Center.html).

A manufacturer 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.

Comment A

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%.

Comment B

Hypertension

Eight studies were submitted for review of which 5 were included in those above. Of the three new studies, 2 were small studies with no long term outcomes. One study was a restatement of 2 prior studies that showed a modest reduction in hypertension medications.      

Comment C

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.

Comment D

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.

Comment E

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’.

Comment F

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.

Comment G

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.

Response to comment A

No changes in the draft policy are warranted as the studies need standardization of the treatment modalities, and long tern outcomes. New guidelines / literature with long term outcomes can be presented to local contractors in the LCD reconsideration process to add additional diagnoses to the policy.

Response to comment B

No changes in the draft policy are warranted. However, studies or guidelines demonstrating long term outcomes associated with significant reduction in hypertension medications or hypertension controlled would be needed to be presented to CMS for consideration to change the overall payment plan or to local contractors in the reconsideration process to add diagnoses to the policy.

Response to comment C

Noridian has not included this diagnosis in the draft LCD for coverage based on other information in the KDOQI metabolic needs. We appreciate the information.

Response to comment D

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

Response to comment E

Noridian disagrees with adding other diagnoses to the draft LCD based on this information at this time, but would welcome new or updated literature to be submitted through the LCD reconsideration process as it becomes available.

Response to comment F

Noridian did not feel these studies added new information and changes in the draft LCD were not warranted

Response to comment G

Noridian 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.

Noridian, through this draft LCD, has expanded coverage from an existing LCD, offers an option for an automated process to facilitate payments, and offers an option for payment for those clinical conditions outside the list in the draft LCD. The focus of this draft LCD is narrow and does not change the CMS payment policy which would need to be addressed to and with CMS.