I still remember the excitement expressed by our company’s first client that purchased new, smaller home dialysis machines nearly 20 years ago. While the machines were expensive and would require patients to receive more frequent treatments, the patients’ quality of life would improve significantly, according to the company’s sales representative. Instead of being tied to a standard hemodialysis machine for 4 to 5 hours 3 days a week in an outpatient facility, the patient could dialyze at home in less than 2 hours and maintain a more normal and productive lifestyle. Medicare was promoting home dialysis and the new technology appeared to fit in perfectly with the government’s desires.
Today, the hopes and promises tied to that technology appear to have been crushed by a proposed Local Coverage Determination (LCD) about to be adopted by the seven companies that currently serve as Medicare contractors.
In a nutshell, the proposed LCDs state that facilities will not be paid for more than three treatments per week when more frequent treatments are part of the patient’s normal Plan of Care (POC). Thus, if the POC calls for five treatments for week on an ongoing basis, the Medicare contractors will only pay for three.
More frequent treatments are “likely” to be covered for acute conditions that fall into one of the following seven categories: metabolic acidosis; fluid positive status not controlled with routine dialysis; hyperkalemia; pregnancy; heart failure; pericarditis; or incomplete dialysis secondary to hypotension or access issues.
The LCDs indicate that the Medicare contractors will “monitor the frequency of additional sessions” and that billing for additional treatments could “trigger a Medical Review.” Thus, make sure your practitioners carefully and completely document the conditions that require the patient to receive one or more treatments on a temporary basis.
The reasoning behind these LCDs is revealing. Following are four of the factors presented by the contractors that guided their decisions. After each reason, I have added my own observations and comments.
The first item mentioned in the LCDs “Summary of Evidence” is that “conventional” hemodialysis at three times per week “remains the most common treatment modality for ESRD worldwide.”
While conventional hemodialysis may be the most common modality in the world, does that mean that it is the best modality for dialysis patients? What would be wrong with the US taking the lead in innovation and patient care when it comes to providing better care for hemodialysis patients?
A second factor cited in the LCD is that CMS’s reimbursement strategy is based on conventional hemodialysis treatments.
While that may be true, home hemodialysis with conventional machines was costly and impractical. The innovative portable home hemodialysis machines introduced about 20 years ago made it possible for many more facilities to offer home hemodialysis. The portables were more expensive than conventional machines and providers were encouraged to provide more than three treatments per week to help their patients get the maximum benefits of the machine. However, even though more providers began offering home hemodialysis, CMS never modified their reimbursement strategy. This mixed message of encouraging providers to offer more home treatments while failing to modify reimbursement has been confusing, at the very least.
A third factor upon which the contractors based their LCDs is listed in the “Limitations” section. It states that Medicare contractors consider a service to be “reasonable and necessary” if the service meets certain conditions. One of those conditions is that the service is, “one that meets, but does not exceed, the patient’s medical needs.”
While the statement may be well intended, it may also discourage innovation. “Reasonable and necessary” can be interpreted in a variety of ways. When the government determines that treatments only need to be “adequate” rather than being the best they can be, what financial incentive is there to promote innovation? Because more than 80% of patients with end-stage renal disease (ESRD) have some form of government or government-licensed managed care plans, the ESRD industry is dramatically affected by such policy.
A fourth reason for justifying the policies cited in the proposed LCD cites a finding by the Kidney Disease Outcomes Quality Initiative that states, “Efforts to increase the dose of dialysis administration above three times per week have not improved survival…”
While increased frequency of hemodialysis may not have improved survival” what about the patient’s quality of life? One of the biggest motivations behind switching patients to more frequent home hemodialysis was that the patient’s quality of life could be vastly improved. Patients who could not hold jobs when dialyzing in a facility three times per week for four to five hours at a time could have jobs because they could self-dialyze in the evenings. Patients would also not have to worry as much about their fluid intake and live a much more normal life overall. While Medicare and their contractors can calculate a dollar value on the provision of dialysis services, what is the value of leading a more normal life? What value would you place on this if your child or other loved one was the one affected? What value would you place on a better of quality of life if you were the one receiving dialysis? For Medicare and other payors to assign a lesser significance to this factor in their ESRD reimbursement policies is disturbing.