Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information**

According to the Kidney Disease Outcomes Quality Initiative (KDOQI) Practice
Guideline for Hemodialysis Adequacy: 2015 update,1 over 400,000 patients are
currently treated with hemodialysis (HD) in the United States, with Medicare
spending approaching $90,000 per year of care in 2012. They note mortality
rates remain higher than age-matched individuals in the general population.
They also experience an average of 2 hospitalizations per year.

The KDOQI 2015 Update1 states the following: Attempts to improve outcomes have
included initiating dialysis at higher glomerular filtration rates (GFRs),
increasing dialysis frequency and/or duration, using newer membranes, and
employing supplemental or alternative hemofiltration. Efforts to increase the
dose of dialysis administered 3 times weekly have not improved survival,
indicating that something else needs to be addressed.

This guideline was also cited in the most recent CMS Final Rule CMS-1651-F
published November 4, 2016.

**Covered Indications**

  1. Metabolic conditions (acidosis, hyperkalemia, hyperphosphatemia)
  2. Fluid positive status not controlled with routine dialysis
  3. Pregnancy
  4. Heart Failure
  5. Pericarditis
  6. Incomplete dialysis secondary to hypotension or access issues

**Limitations** The following are considered not reasonable and necessary and
therefore will be denied as not medically justified for payments.

  1. Sessions furnished in excess of 3 sessions per week are not considered reasonable and necessary unless fully supported in the medical documentation as detailed in this policy
  2. Planned inadequate or short dialysis
  3. Sessions performed for convenience of patient or staff

There are documentation requirements in this LCD which if not followed will
generate denials. Please refer to the Documentation Requirements section
below.

While there are no set frequency limitations for these services, continued use
of additional sessions by a given provider or for a given beneficiary or
unusual patterns of billing, verification of need for services may generate
reviews. Please refer to the Utilization Guidelines section below.

**For coding guidelines, please refer to the companion, A55676-Billing and
Coding: Frequency  of Hemodialysis**.

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy and associated A55676,
Coding for Hemodialysis Sessions; the general requirements for medical
necessity as stated in CMS payment policy manuals; any and all existing CMS
National Coverage Determinations; and all Medicare payment rules.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.

HD at 3 times (3X) per week is noted to be 'conventional' treatment.
Conventional HD remains the most common treatment modality for end stage renal
disease (ESRD) worldwide and is usually performed for 3 to 5 hours, 3 days per
week. CMS established payment for hemodialysis based on conventional
treatment.

Hence, Medicare reimburses HD treatments 3 times per week (13/14 sessions per
month depending on length of month). In CMS-1651-F (November 4, 2016), CMS
outlines the process for medical justification aspect of the overall
requirements of being reasonable and necessary for additional treatment
payments.

This LCD sets out medical conditions likely to meet reasonable and necessary
requirements for additional payments.

ESRD Facilities establish parameters for treatment of any given patient
through a Patient Plan of Care (POC). It is defined in the Conditions of
Coverage for ESRD Services 42 CFR 494.90. Among other items, the POC developed
by the Interdisciplinary Team must provide the necessary care and services to
manage the patient's volume status; and achieve and sustain the prescribed
dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal
dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent
professionally-accepted clinical practice standard for adequacy of dialysis.

The prescription for chronic hemodialysis therapies includes the type of
dialysis access, the type and amount of anticoagulant to be employed, blood
flow rates, dialysate flow rate, ultrafiltration rate, dialysate temperature,
type of dialysate (acetate versus bicarbonate) and composition of the
electrolytes in the dialysate, size of hemodialyzer (surface area) and
composition of the dialyzer membrane (conventional versus high flux), duration
and _frequency of treatments_ , the type and frequency of measuring indices of
clearance, and intradialytic medications to be administered.

Those treatment sessions furnished to the beneficiary are paid by Medicare as
3X per week. If more than three sessions per week are furnished, such as 4-6
sessions per week, Medicare will pay the 3X per week amount unless there is a
covered indication, appropriate use of the KX modifier occurs, and it is
supported by medical documentation. Refer to the Local Coverage Article
A55676, Billing and Coding: Frequency of Hemodialysis for more information on
appropriate use of the KX modifier.

However, on occasion, acute, and occasionally chronic, conditions may require
additional sessions during the month. These may be considered for additional
payment. The associated Local Coverage Article A55676, Billing and Coding:
Frequency of Hemodialysis, provides a list of diagnoses felt to be consistent
with such clinical conditions that could establish reasonable and necessary
requirements for payment. Use of these diagnoses should be verified in the
medical records to support any payment made.

Clinical conditions not seen listed in this policy may still be appropriate to
allow payment. However, these claims may require additional review through the
appeals process.

Medicare will monitor the frequency of additional sessions which may trigger
Medical Review.

The POC reassessment is noted in 42 CFR 494.80(d).

Please note the Plan of Care does not establish medical necessity by itself
and will need to be supported by other medical documentation as outlined in
the documentation requirements below.

Repeated need for additional dialysis sessions is expected to be addressed in
the medical documentation and addressed in the subsequent POC, including
attempts to correct any issues, (See medical documentation requirements
below).

This LCD establishes documentation requirements as listed in the appropriate
section below.

KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 Update,1
Guideline 4.1.1 states to "Consider additional hemodialysis sessions or longer
hemodialysis treatment times for patients with large weight gains, high
ultrafiltration rates, poorly controlled blood pressure, difficulty achieving
dry weight, or poor metabolic control (such as hyperphosphatemia, metabolic
acidosis, and/or hyperkalemia)." This specific recommendation was 'Not Graded'
in the Guidelines but based on expert opinions. However, these guidelines are
determined by a panel of experts and are felt to have a STRONG level of
evidence to follow.

While uncontrolled hypertension is noted to be an indication for additional
dialysis frequency, the included diagnoses are felt to be adequate for the
condition in lieu of an available ICD-10 diagnosis.

The Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines2 for the
evaluation and management of chronic kidney disease (CKD) address the many
facets of CKD. The guidelines discuss the management variables that may affect
CKD. Indications are supportive of guidelines above.

The 2018 Seminars in Dialysis article, "When is more frequent hemodialysis
beneficial?", Suri and Kliger3 discuss the unresolved issue pertaining to
frequency of dialysis. They review 3 randomized trials, 15 comparative cohort
studies and some case series for recommendations and adverse events related to
increased frequency of dialysis. They note effect on mortality remains
controversial with conflicting results. More frequent dialysis is noted as
being associated with vascular access site problems. Recommendations for
increased frequency of dialysis include pregnant women, patients who are
unable to obtain a dry weight on 3X per week regimen and for minimal urine
output patients with left ventricular hypertrophy.

National experts were also contacted for input during development of this
policy.

Based on KDOQI Practice Guidelines as well as KDIGO Guidelines, and the Suri
and Kliger article, the listed conditions in the LCD may meet reasonable and
necessary requirements for additional payments.

Based on local collaborative data, Medicare contractors expect the list of
diagnoses in the associated Article A55676: Billing and Coding: Frequency of
Hemodialysis would represent the great majority of claims for which additional
payments may occur.

Facilities with sites in multiple states should be able to submit claims in a
unified approach.

**However, this LCD would not be the appropriate approach to change the
payment methodology by CMS and reconsiderations to this LCD to potentially try
to change the CMS payment process will be denied as invalid reconsideration to
this LCD.**