Would Medicare routinely reimburse EOD dialysis schedules?

By Bill Peckham

This is Part Three of a five part DSEN series making the case that incenter Every Other Day (EOD) dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three); EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

The question has to be asked - would EOD schedules receive routine reimbursement from Medicare, in the same way that conventional schedules receive routine reimbursement? My review of the documents online leaves me to conclude that Medicare support of EOD schedules is implied though not plainly expressed. It is possible that, short of a National Coverage Decision (that anyone can initiate) it may be necessary to fight for routine EOD dialysis reimbursement but that is a fight worth having and on this ground it is a fight dialysis unit administrators can win. 

Medicare Administrative Contractors (MACs) are entities, created by 2003 legislation, that are contracted to pay claims on behalf of Medicare. The country is divided into 15 regions and each region has a MAC (I think there will eventually be 5 MACs, possibly 10 but it is confusing; current list here (PDF LINK)). When a dialysis unit submits a claim, that claim is submitted to their MAC, who then rejects, or authorizes and pays, the claim.

The Medicare Benefit Policy Manual has little, but not nothing, to say about coverage related to hemodialysis treatment frequency, Chapter 11 - End Stage Renal Disease (ESRD), (PDF LINK):

30.1 - Frequency of Dialysis Sessions
(Rev. 1, 10-01-03) A3-3112.6, A3-3166.2
Hemodialysis and peritoneal dialysis are covered at the frequencies shown below under the composite rate. Additional composite rate payments may be made when they are medically justified.

A) Hemodialysis
The usual pattern of hemodialysis consists of three sessions weekly, and these may be covered routinely. If the ESRD facility bills for any sessions in excess of this frequency, the intermediary shall consider requiring medical justification 

MACs are guided by the Medicare Benefit Policy Manual when making claim decisions. According to the claims manual additional dialysis treatments can be reimbursed when they are medically justified but if additional hemodialysis treatments are provided it is up to the MAC whether medical justification is required.

One way MACs communicate their understanding of what is and is not covered or required for coverage, is through Local Coverage Determinations (LCD). As published in CMS IOM 100-08, Section 13.5.1 (PDF LINK), to be covered under Medicare, a service shall be reasonable and necessary. It is the MACs job to ensure LCDs for the service in question is considered reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. Basically, MACs will consider a service to be reasonable and necessary if the MAC determines that the service is (my emphasis):

• Safe and effective.
• Not experimental or investigational (with exception).
• Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
  • Furnished in a setting appropriate to the patient’s medical needs and condition.
  • Ordered and furnished by qualified personnel.
  • One that meets, but does not exceed, the patient’s medical need.
  • At least as beneficial as an existing and available medically appropriate alternative.

Two of the current MACs have LCDs regarding hemodialysis treatment frequency: First Coast (FL, PR, VI) and Trailblazer (CO, NM, OK, TX). First Choice directs that:

HEMODIALYSIS sessions which exceed the frequency of three sessions per week must be medically reasonable and necessary.

Trailblazer directs that:

Hemodialysis and peritoneal dialysis performed or billed more than three times per week is reasonable and medically necessary for hyperkalemia, pregnancy, fluid overload, acute pericarditis, congestive heart failure, pulmonary edema or severe catabolic state when these conditions are refractory to dialysis three times per week.

The Trailblazer LCD doesn't preclude payment under other circumstances, but it does suggest that payment for four or more treatments in a week would not be routinely granted. But what about three and half treatments a week? 

An EOD schedule (3.5 treatments per week) uniquely meets the directive that duration and frequency of service be "One that meets, but does not exceed, the patient’s medical need."

There is very good research, most recently a NEJM paper, but the data has been consistent since the 1960s: routinely taking two days off from dialysis increases the risk of mortality and hospitalization. The NEJM paper found that the incidence of death increased during two days off from dialysis vs during the remainder of the week when treatment is every other day :

all-cause mortality (22.1 vs. 18.0 deaths per 100 person-years, P<0.001), mortality from cardiac causes (10.2 vs. 7.5, P<0.001), infection-related mortality (2.5 vs. 2.1, P=0.007), mortality from cardiac arrest (1.3 vs. 1.0, P=0.004), mortality from myocardial infarction (6.3 vs. 4.4, P<0.001), and admissions for myocardial infarction (6.3 vs. 3.9, P<0.001), congestive heart failure (29.9 vs. 16.9, P<0.001), stroke (4.7 vs. 3.1, P<0.001), dysrhythmia (20.9 vs. 11.0, P<0.001), and any cardiovascular event (44.2 vs. 19.7, P<0.001).

In order to meet a patient's need, in order to have 18.0 deaths per 100 person-years, instead of 22.1, patients have to adhere to an EOD schedule. Dialysis on an EOD schedule is reasonable and necessary.

EOD schedules are implicitly supported by MAC/FIs.

Comments

[Peter Laird, MD]

Unfortunately, the provision of dialysis under the 1973 ESRD program has proven again and again it is not all about patient outcomes but maximizing LDO profits instead.

[Bill Peckham]

I think if the LDOs wanted to maximize profits they would offer EOD schedules.

The sticking point in my view is that the current system works well for a lot of the stakeholder on the dull end of the needle. And for people on the sharp end it mostly works well enough.

There is tremendous inertia to overcome.