Medicare administrative contractors are responsible for reviewing claims from health care providers, including dialysis companies, and paying Medicare rates for provided patient services. Seven of these MACs simultaneously released proposed LCDs, or payment policy rules, last September on how these contractors would cover more frequent hemodialysis, defined as beyond the standard three times per week covered in the bundled payment rate.
These seven MACs (there are 10 total) proposing new rules on more frequent dialysis represent 11 of the 12 jurisdictions, and cover 45 states and nearly 90% of dialysis patients in the United States. As a result, these proposed rules are far reaching for nephrologists who want to prescribe more frequent dialysis (MFD) and providers who get paid for the treatments.
The MACs offered public hearings on the proposed rules in November and December.
What the proposed rules say
The proposed policies from the seven MACs are nearly identical in language. The policies propose to restrict coverage of dialysis to three treatments per week unless a nephrologist and the care team can document acute events that medically justified more treatments. That documentation and the request for more frequent dialysis needs to be in the patient’s monthly plan of care. Once the acute event is resolved, however, the MAC will terminate coverage for additional treatments.
The MACs have recognized that these additional treatments can result in important clinical patient benefits and say so in the proposed policies. “While there are no set frequency limitations for these services, [if] continued use of additional sessions by a given provider or for a given beneficiary or unusual patterns of billing [occurs], verification of need for services will generate reviews,” Novitas Solutions Inc., which covers Pennsylvania, New Jersey, Maryland, Delaware and the Washington D.C. metro area, wrote in the proposed rule.
The renal community needs to defend the right of physicians to prescribe MFD for patients who can benefit and for those who should be maintained presently on MFD.
Ignoring the benefits
Patients who are given dialysis treatment more frequently show important clinical and quality-of-life benefits. According to the U.S. Renal Data System (USRDS), the adjusted 5-year survival of living and deceased donor transplants was 84% and 75%, respectively, in a 2011 cohort of patients with early stage renal disease. Meanwhile, adjusted 5-year survival rates on peritoneal dialysis and in-center hemodialysis were 51% and 42%, respectively.
The negative results of the HEMO study suggested it would be difficult to improve quality of life and overall outcomes for patients on thrice-weekly, in-center hemodialysis. Hence, we have moved toward more frequent and longer hemodialysis to improve outcomes.
As this cannot be done in-center due to financial and physical restraints, the renal community has utilized more frequent dialysis in the home setting to improve outcomes.
Home hemodialysis treatments
Patients can medically benefit from more frequent home hemodialysis treatments in a number of ways.
- It eliminates the 2-day killer gap — the period when protocol patients on standard three-times-a-week protocol go 2 days straight without dialysis. Studies show mortality drops by 45% on Monday and Tuesday when more frequent home hemodialysis is used vs. thrice-weekly in-center hemodialysis. This cannot be done operationally in center and can only be done at home.
- It reduces post-dialysis recovery time, which markedly improves quality of life. This has been shown in both randomized and observational studies.
- It provides better, more consistent control of fluid volume, which leads to a concurrent reduction in antihypertensive medication use. This has been proven in three randomized controlled trials (RCTs).
- It offers better control of phosphorus, with a large reduction in phosphate binder use on nocturnal home hemodialysis.
- More frequent dialysis allows for a slower rate of fluid removal and prevents myocardial stunning. This has been shown in observational studies.
- In two RCTs, left ventricular mass, which correlates directly with improving survival, has diminished in patients using more frequent dialysis.
- More frequent dialysis improves the chance of normal pregnancy for patients on dialysis, directly correlating with increased frequency and increased time, because it results in the best fetal outcomes. This normalizing of the mother’s metabolic milieu results in a normal pregnancy.
Lastly, it improves overall survival of the patient. A USRDS analysis reviewed patients on nocturnal dialysis, short daily dialysis and in-center dialysis, and showed nocturnal dialysis had an improved survival and reduced hospitalization. Database analysis in Canada of nocturnal home hemodialysis and matched USRDS transplant data show similar outcomes with deceased donor transplant and nocturnal dialysis.
Nephrologists who read the literature concerning more frequent home hemodialysis believe that if patients have medical indications, they will benefit from more frequent home hemodialysis on a long-term chronic basis.
What these seven MACs are trying to do is eliminate this option of MFD for our patients through the LCD process. We, as physicians, feel if there are clear medical benefits for the patient, we should be able to prescribe MFD and the treatments should be covered. The MACs with these proposed LCDs are preventing nephrologists from practicing medicine in the best interest of their patients.
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