Home and more frequent dialysis at the fore of Medicare dialysis rulemaking

Editor’s Note: The Centers for Medicare & Medicaid Services released its 2017 proposed rule for the Prospective Payment System and Quality Incentive Program on June 24. Part of the rule included new language regarding payments for training for home dialysis and payments for more frequent hemodialysis. We asked NxStage Medical president Joseph Turk to comment on the proposed changes. You can download the complete rule here. Formal comments are due by Aug. 23.

On June 30, Medicare released its proposed dialysis payment policies for 2017 in the Federal Register for public comment. In this year’s proposed rule, home and more frequent dialysis are at the fore. Specifically, Medicare seeks comments on proposals on payment for home/self-care dialysis training and for more frequent hemodialysis.

At the highest level, we commend Medicare for addressing these issues. Efforts to improve payment adequacy while removing process ambiguity represent a big win for patients and support continued advancement of care. Although we believe CMS largely succeeds in this goal with its plans for training, its proposals on payment for more frequent HD are confusing at best, and off the mark at worst, and must be refined.

Payment for home dialysis training moves in the right direction

For training, Medicare proposes to nearly double the add-on payment per session for peritoneal dialysis (PD) and home hemodialysis (HD) from $50.16 to $95.57 (intending to represent 2.66 hours of nursing time, a volume-weighted average assuming 2 hours for PD and 4 hours for HD), and for HD clarifies that all weekly training sessions are payment-eligible (as is already the case with PD). Also, Medicare will improve its cost data collection to refine the payment adequacy over time.

Turk

This is clearly a move in the right direction, responding to over 1,000 letters from patients and stakeholders over the last three years highlighting the issues and impact of the current dramatic training underpayment. But, we are puzzled by the budget neutrality adjustment -- this is not per se required by law, is inappropriate here given the de minimis cost and the continued leakage from the other payment adjustments, and given this we frankly don’t understand why the agency would knowingly sour providers on a positive change so obviously in line with resource requirements and the Congressional mandate to encourage home treatment.

Payment for more frequent therapies plan needlessly complex

On the subject of paying for more frequent HD therapy, Medicare reaffirms that it has supported payment for medically justified sessions in excess of three times per week since the 1980s, and has no intention of changing this long-standing policy. Where extra sessions are not medically justified, Medicare proposes to establish a payment equivalency for HD regimens where more than three treatments are furnished per week, similar to that for PD. This proposal seems to be in response to questioning by providers on billing and coverage of more frequent HD sessions, and to selected instances found in audits where additional sessions have been billed without supportive documentation of medical justification.

With more frequent HD payment, Medicare’s proposal is needlessly complex and its ambiguity could negatively interfere with the physician/patient relationship in determining the proper course of care. The per-treatment unit of payment for HD was thoroughly vetted with foresight, enabling individualization of care both in-center and at home. This payment structure, along with long-standing medical justification payment policies, has allowed modest growth of access to more frequent HD, a therapy repeatedly shown to have substantial clinical benefits for acute and chronic patient conditions.

Our experience is that physicians and providers are appropriately using this structure to make more frequent HD available to their patients who could medically benefit due to cardiovascular issues, blood pressure control, phosphorus control, poor tolerability of the dialysis treatment, and other issues such as sleep quality and depressive symptoms – all important domains with associations to morbidity and mortality. This therapy most often happens at home due largely to logistical and operational challenges of offering frequent HD in-center. There is no evidence of overutilization under this payment structure, as a very small percentage of patients (<2%) receive this therapy, nearly all of them at home.

Medicare’s suggestions in the proposed rule that more frequent hemodialysis regimens have evolved solely for the “convenience” of patients (patients typically take responsibility for their own care and may increase treatment time 30-40% per week) and that there are limitations of “evolving technology” (no such limitations exist) are completely incorrect and discount the critical decision making process between the patient and the physician. We are concerned that these faulty assumptions have led Medicare to the belief that a meaningful number of patients are prescribed extra sessions for reasons other than their own unique medical needs, and that this belief has led Medicare to introduce more complexity into the process of billing for extra sessions and has led to more confusing ambiguity into the very process Medicare is seeking to clarify.

We appreciate Medicare’s desire to clarify its position on more frequent HD payment. We believe the agency could be more effective by clarifying three items.

First, Medicare should again clearly stress its long-standing policy to pay for medically justified treatments in excess of three per week, as prescribed and documented by the physician for each patient. No justification, no payment.

Second, it should make clear that the agency is not determining or advising what constitutes appropriate medical justification (whether to address acute conditions or as part of an ongoing regimen to address chronic comorbidities), and reaffirm that is the purview of the Medical Administrative Contractor (MAC) based upon its review of the evidence and medical practice. If the MAC wants to limit coverage, it must do so with due process under a formal Local Coverage Determination subject to public comment consistent with Medicare requirements. The agency comes perilously close to losing its agnosticism in this proposed rule, calling out pregnancy and congestive heart failure as appropriate medical justification for additional sessions. This runs afoul of its policy of therapy neutrality and deference to the MACs. Notably, the agency could not establish a national coverage restriction without going through the National Coverage Determination process, and in our opinion this is not necessary at this time given the latitude and roles afforded to the MACs.

Third, Medicare should recognize that it already has a process where all treatments can be reported on UB-04 claim form and treatments without medical justification (either due to a lack of documentation or to be compliant with a formal LCD) would be indicated as non-billable through use of an appropriate modifier. By reaffirming this process, the whole equivalent treatment construct is rendered unnecessary.

More frequent HD has dramatically improved the lives of Medicare beneficiaries, arguably more than any therapeutic innovation introduced in the field of renal failure in decades. It is consistent with the Congressional mandate to encourage therapy at home and to promote rehabilitation. Allowing the continued exploration of this therapy through an agnostic national payment policy is consistent with Medicare policy allowing for the evolution of local medical practice and the development of new therapeutic alternatives. The final rule could either support continued modest adoption of home HD, or erect inadvertent barriers through ambiguity and complexity.

The community can make a real difference by submitting its comments on this proposal to Medicare, due by 5 PM on Aug. 23. -by Joseph E. Turk