Response to Comments: Frequency of Hemodialysis

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL35014 Frequency of
Hemodialysis which was posted for comment on September 14, 2017, and presented
at the October 2017 Contractor Advisory Committee (CAC) Meeting. All comments
were reviewed and incorporated into the final LCD where applicable.

Novitas received numerous comments related to DL35014, Frequency of
Hemodialysis. Novitas has an existing Local Coverage Determination (LCD) for
this subject and this present draft form is a revision of the existing LCD. In
this revision there is expansion of the coverage diagnoses, addition of the
use of a modifier to identify those additional treatments needed, and
establishment of an appropriate way for redetermination (appeals) should a
denial occur for those diagnoses not in the list. As noted in the document,
the draft addresses a narrow issue for the End Stage Renal Disease (ESRD)
program and does not change the base payment process issued by The Centers for
Medicare and Medicaid Services (CMS). CMS charged Local Contractors (Medicare
Administrative Contractors [MACs]) to develop a list of clinical conditions
appropriate for payment beyond the standard thrice weekly payment. This list
(included in the draft) is felt to be appropriate for such payments should
medical documentation be supportive. All payment policies for the ESRD program
reside with CMS for other changes. MACs do not have the discretion to change
any basic payment policies related to this issue and are 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 may be other clinical situations that require
additional treatments. These services, even though they do not have a
diagnosis listed, can be noted by an appended KX modifier (see A55723-Coding
for Hemodialysis Sessions for more billing and coding information). Additional
review following an initial denial would be available through the
redetermination process. Additional review may result in the addition of
diagnosis codes to the Local Coverage Determination.

In the comment review period, all submitted published literature was reviewed.
Novitas does not do research based on bibliographies that may have been
submitted along with comments. Many of the issues submitted were similar and
gathering of like-comments was done for a response. A large number of
literature articles were submitted by industry that encompassed 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 to, and by CMS. MACs do not have discretion to
change payment strategies for CMS.

The comments can generally be divided into three comment groups:

  1. Patient, caretakers, those who work with these patients
  2. Providers
  3. Industry

_As noted below, through an Interagency Agreement with CMS, the Agency for
Healthcare Research and Quality (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 Quality of Life (QOL) metrics. The draft report
is due on 8/12/2019 and the final report is due on 11/18/2019._

Novitas, 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.