Response to Comments: Frequency of Hemodialysis

Comment Group 1

Comment A:

Novitas directly received numerous 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 JH and JL.

Comment B:

Novitas received an inquiry as to whether this draft LCD had any impact in physician billing.

Response to Comment A:

Novitas 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. 

Response to Comment B:

Monthly capitation payment (MCP) billing would still be the same and no changes would be indicated in the draft policy.

Comment Group 2

Novitas 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.

Comment A:

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 physicians.

Comment B:

Several commenters requested the removal of the term ‘planned inadequate dialysis’ as it implies the providers were not prescribing correctly and could be interpreted as a derogatory statement against the providers.

Comment C:

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.

Comment D:

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

Comment E:

A clinical diagnoses list shown below (not all inclusive) was submitted by several providers. Some included a related individual bibliography in the request but no printed literature was submitted for review. Some of the clinical conditions listed below are already 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: I51.7
• 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

Comment F:

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.

Response to Comment A:

Novitas disagrees with the commenters' 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 KX modifier, to signify additional treatments were needed (even with diagnoses not included in the LCD), the ESRD facilities will have a redetermination (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 ESRD facilities use modifiers frequently for dialysis services. Novitas recognizes the use of the word ‘acute’ may need to be altered to ‘acute/chronic’ in the text of the draft LCD. This would be an appropriate change. However, the list of diagnoses does include chronic conditions.

Response to Comment B:

Novitas disagrees with the premise of the comment. 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 patient's 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.

Response to Comment C:

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

Hemodialysis is typically furnished 3 times per week in sessions of 3 to 5 hours in duration. If the ESRD facility bills any treatments in excess of this frequency, medical justification is required to be furnished to the A/B MAC (A) and must be based upon an individual patient’s need. The A/B MAC (A) reviews the medical justification for EACH ADDITIONAL [emphasis added] treatment and is responsible for making the decision on the appropriateness of the extra treatment(s) and payments for these additional 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 direct changes in the draft policy are warranted, however it has been determined that additional avenues to communicate the dialysis prescription are acceptable. These include the appropriate Monthly Capitation (MCP) notes, history and physicals, and discharge summaries. With this documentation there needs to be evidence of a continuing need for the more frequent treatments.
 
Response to Comment D:

Novitas 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.

Response to Comment E:

The list of diagnoses included in the policy was chosen to reflect those clinical conditions that could cover acute or chronic conditions.

The requested diagnoses and any literature submitted were reviewed and it was determined that additional diagnoses are warranted. Novitas would like to point out that the policy includes a significant number of chronic diagnoses that would be allowable for additional payment.

Providers are reminded that they may follow the redetermination (appeals) process for diagnoses that are not included in the policy but that they feel support reasonable and necessary requirements.

Response to Comment F:

Novitas 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 on 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). The draft LCD was created, as noted in the LCD, in response to the 2015 Final Rule allowing MACs to define a list of clinical conditions considered to warrant payment for additional dialysis sessions above thrice weekly payments.

Comment Group 3

NxStage submitted comments and published literature for review. Most of the initial comments were similar to those above and have been addressed. All literature submitted was reviewed. A submitted 2016 supplement to the American Journal of Kidney Diseases was funded by NxStage. The various articles in the supplement outline the reasons to have more intensive hemodialysis for cardiac function addressing left ventricular hypertrophy (LVH), positive fluid balance, the reduction in use of drugs for mineral and bone disorders, and health-related quality of life (HRQOL) changes. Treatment complications such as infection, poor dialysis issues, hypotension, myocardial stunning, and post dialytic recovery times were addressed. However, it appears these review articles would be best directed to the national stage for a change in payment policy and is outside the focus of this draft LCD. Most of the literature was divided into categories based on clinical conditions felt to be needed as acceptable diagnoses 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 Mutinational Guidelines.

Comment A:

Cardiovascular

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% versus Daily Home Hemodialysis 19.2%.

Comment B:

Hypertension

Nine studies were submitted for review of which five were included in the Cardiovascular category. Of the four remaining studies, three 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.

Comment C:

Hyperphosphatemia

Six studies were submitted. Four 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 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 three were duplicates from above categories. The remainder included issues related to blood pressure (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 the United States, Japan, United Kingdom, Canada and European Best Practices. The National Kidney Foundation – Kidney Disease Outcomes Quality Initiative (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 are warranted as the studies need standardization of the treatment modalities and long term outcomes. New guidelines / literature with long term outcomes can be presented to local contractors through the LCD reconsideration process to request additional diagnoses be added 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 with controlled hypertension 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 request diagnoses be added to the policy.

Response to Comment C:

Novitas has 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:

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

Response to Comment E:

Novitas 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:

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

Response to Comment G:

Novitas appreciates the guidelines being forwarded from others. However, it appears the draft LCD addresses most of the 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.

A few commenters requested changes to the language suggesting the policy is contrary to the CMS payment process in place.

Novitas appreciates the comments and yet disagrees based on CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 11, Section 50.A.1, where Medicare states the following:

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

Local MACs do not implement payment policies for these services. The draft LCD in question was created, as noted in the LCD, in response to the 2015 Final Rule allowing MACs to define a list of clinical conditions considered to warrant payment for additional dialysis sessions above thrice weekly payments. All payment questions and questions related to CMS motives/insights should be directed to CMS.

No changes in the draft policy are warranted.

A commenter inquired if nephrology consultants experienced in hemodialysis were consulted for development of the policy.

Selected nephrologists reviewed the list of clinical diagnoses prior to posting the LCD. These nephrologists were very experienced in home hemodialysis. During the CAC process, nephrologists were able to submit comments as well. Also other providers submitted comments in the open meetings.

The comments submitted during the CAC and open meeting processes were essentially the same as the comments discussed above and do not require further review.

One provider group stated documentation requirements would become so burdensome as to dissuade a physician from prescribing medically necessary care and should reasonably correspond with CMS plan of care review requirements.

Novitas disagrees. The current Novitas LCD (L35014) has a similar documentation requirement. Novitas disagrees physician burden is increased by medical record documentation of a physician order for a medically necessary additional treatment to ensure patient safety. The changes in the areas where the dialysis orders may be documented are all of the documents that are required for the care of dialysis patients and therefore do not represent an additional burden.

One provider group commented the policy restricts the ability of the treating physician to exercise medical judgement in treatment of their ESRD patients and undermines the patient-doctor relationship.

Novitas disagrees the policy places any restriction on a physician’s medical judgement. The draft LCD was created at the allowance of CMS to create a list of clinical conditions in which additional dialysis session(s) would be potentially payable. The list of diagnoses represents this thought process. Should a provider feel additional diagnoses would be appropriate for the patient population as a whole, reconsideration to the LCD to add such diagnoses is indicated. Should the provider feel a particular patient’s situation would necessitate additional treatments, the redetermination process would be used for such indication in order for clinical reviewers to review medical documentation. Novitas disagrees with the premise that this draft LCD undermines the patient-doctor relationship.

One provider group mentioned patient access to care considerations due to the policy.

Novitas has an existing LCD which has a more restricted list of clinical conditions. The present draft has an expanded list of diagnoses. Novitas disagrees that the draft is limiting access to care for these patients. We encourage the provider community to review the draft LCD as well as the companion article for coding changes.

One provider group submitted a large number of questions related to CMS decisions or CMS views related to ESRD and the policy.

The draft LCD in question was created, as noted in the LCD, in response to the 2015 Final Rule allowing MACs to define a list of clinical conditions considered to warrant payment for additional dialysis sessions above thrice weekly payments. All payment questions, questions related to CMS motives/insights should be directed to and discussed with CMS.

One provider group suggested development of the LCD in the broader context of the ESRD program. The commenter suggested while most patients would be appropriately treated with three times per week sessions, a subset of patients will need more, of which fluid overload is cited. They note this acute event may be a chronically occurring condition.

The request to develop the LCD in a broader context of the LCD is beyond the scope of this LCD which is to develop a list of clinical conditions which would indicate the need for additional treatment session(s). However through an Interagency Agreement with CMS, AHRQ has awarded a contract for a systematic review of the data concerning the frequency of dialysis and to define the needs for future studies concerning the frequency of dialysis and the clinical applicability of the various QOL metrics. The draft report is due on 8/12/2019 and the final report is due on 11/18/2019.

One provider group stated the proposed LCD may increase hospital sessions cost as well as hospitalizations for care.

Novitas disagrees with the comment about financial implication. The increase in facility based support may happen but is not known at this time.

A provider advocacy group submitted comments for additional dialysis session more than three times per week for various indications such as improved survival, reduced hospitalizations, decrease in left ventricular mass, better control of hypertension, reduction of antihypertensive medications, reduction of post dialysis recovery time, and improved quality of life. The commenter also mentioned a CMS initiative to have more patients on home dialysis modalities.

Novitas appreciates the comments which appear more suited to changes in the overall payment policy rather than adding to the list of conditions for this narrow focused policy.

Comments were received requesting removal of the statement that the plan of care including more than three treatments a week is not medically justified for additional payment.

After review, Limitation statement #1 was clarified to state planned number of sessions found in the plan of care (POC), or other documentation, of sessions above 3 times per week will be considered not reasonable and necessary unless fully supported in the medical documentation as detailed in the policy.

A provider group commented that Medicare beneficiaries with kidney disease have a disadvantage noting commercial insurers cover dialysis at higher frequencies and the change from private insurance to Medicare may be difficult for patients and discourage or keep patients from continuing to work.

Novitas disagrees this LCD will give Medicare beneficiaries a disadvantage and discourage them from continuing to work. Any issues related to this would need to be discussed with CMS related to the ESRD program as a whole and are not the narrow focus of this LCD.

A few commenters noted the KDOQI Clinical Practice Guidelines for Hemodialysis Adequacy was misquoted in the draft policy.

Novitas appreciates the information and will amend that statement in the final policy. It is noted that the intent of the guideline was not misinterpreted.