Every year, the Centers for Medicare & Medicaid Services updates payment policies related to end-stage renal disease. CMS does this through rulemaking, which covers items such as how much Medicare will pay for dialysis treatments as well as other key program items (e.g., setting quality measures through the Quality Incentive Program).

This year, the proposed rule touches on cornerstone features of how the Medicare payment system fosters the percolation of innovation and allows the advancement of patient-centric care, specifically through the concepts of medical necessity and distributed coverage decision making by the Medicare Administrative Contractors (MACs).

Read also: Every other day nocturnal home hemodialysis: An alternative approach to reduce burden 

For clinicians and patients, it is essential to the advancement of dialysis care that these features are preserved with respect to home and more frequent hemodialysis (MFHD). In essence, the opportunity to offer medical justification for MFHD must be available for nephrologists who see the value of this therapy.

MFHD has value for some patients

Recognizing the clinical benefits of more frequent treatment relative to the needs of their kidney failure patients, physicians are prescribing more frequent home hemodialysis (currently less than 2% of all dialysis patients) to treat patients’ underlying chronic conditions. The major clinical benefits have been shown in patients with congestive heart failure/fluid overload, persistent hypertension, poor phosphorus control, pregnancy, frequent hypotension on dialysis resulting in poor tolerability of the dialysis treatment, sleep apnea, and depressive symptoms.

For patients with these chronic conditions, more frequent dialysis has been shown to improve clinical outcomes, including, cardiovascular death and hospitalization, 1,2,,7-11 lower blood pressure, 3, 7-11 reduced use of antihypertensive agents, 4,8 reduced Left Ventricular Mass Index, 5,7 and reduced serum phosphorus. 5,9  Table 1 includes ICD-10 diagnosis codes that are congruent with the noted clinical conditions.

Published clinical benefits of more frequent hemodialysis and illustrative ICD-10 conditions

Published clinical benefits of more frequent hemodialysis and illustrative ICD-10 conditions

Improved mental health is an additional area that should be considered on a case-by-case basis. Recent studies have shown that patients may have better mental health outcomes, including social function, which is vitally important for overall well-being. 6, 10,11 The sum of these clinical benefits results in improved health-related quality of life, which also correlates directly with morbidity and mortality. These noted positive effects on patient outcomes supported by the medical literature form the basis of medical justification for the use of more frequent hemodialysis and should be consistent across MACs based on local medical practices.

Defining medical justification

Medicare has a long standing policy, reiterated in this year’s proposed rule, of routinely paying for three dialysis sessions per week, and that it will pay for extra sessions when “medically justified” What does it mean to be medically justified? Does Medicare stipulate what will and will not be covered with respect to more frequent dialysis?

The answer to the second question is no, not specifically. And that is part of the design in the vast majority of payment decisions across the entire Medicare program, not just for ESRD. Since its initiation in 1965, Medicare has been guided by the principle that it will not pay for services that are not reasonable and necessary.

Reasonable and necessary is defined at a very high level, meaning that a service is safe and effective, not experimental or investigational, and appropriate (further defined as being furnished in accordance with accepted standards of medical practice, furnished in an appropriate setting, ordered by qualified personnel, meeting but not exceeding the patient’s medical need, and being at least as beneficial as an existing alternative).12

Recently, the standard was interpreted in the rehabilitation setting to include not only those services that improve an existing condition, but also those that may prevent further decline in health status.13

Medical Justification, therefore, is addressed by a medical necessity standard which is intentionally non-specific, as Medicare has long recognized that medical practice will continuously evolve and that physicians require the discretion to make individual clinical decisions based upon the unique circumstances of an individual patient.

This framework is consistent with the goals of patient-centered care, and helps to sustain a vibrant, responsive health care system. In our rapidly evolving medical environment, overly prescriptive centralized policies would at best limit physician discretion in dealing with the needs of their individual patients, and at worst become quickly obsolete.

Connecting therapy with payment

So how do these decisions on whether a specific service is covered for a specific patient get made? As clinicians that have routinely treated patients in our own practice, including those on home dialysis, we believe that the available clinical evidence generally supports the diagnoses outlined in Table 1 for more frequent dialysis sessions.

Evaluating this on a local level is the role of the MAC in the Medicare system. MACs are entities contracted by Medicare to administer the program locally. Currently there are 12 MAC jurisdictions and nine individual MACs across the country that manage dialysis claims (three MACs cover more than one jurisdiction). It is the purview of the local MAC to determine what constitutes appropriate medical justification based upon the review of the evidence and medical practice. The steps include:

  • The dialysis provider indicates the medical justification for more that 13 (14 in a 31-day month) treatments on its monthly claim, and support for that diagnosis would be located in the physician’s records.
  • The MAC ordinarily would evaluate coverage on a case-by-case basis; however, if the MAC wants to define coverage systematically, it must do so under a formal Local Coverage Determination (LCD) subject to public comment consistent with Medicare requirements.

With respect to more frequent hemodialysis, this system has generally worked, allowing modest adoption of more frequent home hemodialysis to address the clinical benefits described. Currently, five MACs review claims on a case-by-case basis and three have implemented formal coverage guidelines under LCDs.

How policy can change…and impact MFHD

The use of more frequent home hemodialysis has dropped notably in one geographic area (by an annualized rate of 6%) after the MAC’s medical director implemented a policy change that lead to restrictive guidelines for MFHD.14 Use of the therapy had been growing 7% in the year prior to implementation of the policy.

What was the basis for the policy change? Based on our review, the MAC did not follow Medicare’s required processes in the Program Integrity Manual that outline how local policy must be developed and applied. Rather than creating a formal local coverage determination, which requires public input and a review of literature, it implemented a “billing article” to be used as a guideline for payment. The MAC has refused to allow review of claims that are for well documented issues, but not defined in their billing article.

This approach circumvents Medicare’s clearly articulated due process, and a formal LCD process should be undertaken if it is the MACs intention to define coverage in that jurisdiction. The power of the review and comment rulemaking process at the local level is that it allows the LCD to reflect the practice patterns and understanding of the medical evidence base in a collegial and open manner.

Should CMS be more specific when paying for dialysis services?

We have heard over the years our colleagues express discomfort with the MAC-centric system, wondering why such important discretion is left to the medical director at the local MAC and why the ambiguity is necessary. We can’t stress enough––this is good for you and good for your patients.

The discretion is important, and should be preserved because it allows for clinicians to advocate for the appropriate care for their patients based upon their own judgement and the individual needs of their patients, and it allows clinical practice to evolve as the evidence base continuously develops.

 

MAC-worldfigure-1.png

Moreover, the assignment of decision-making authority to the MAC is also appropriate as it is closest to the clinical standard of care in the community, and should be preserved. Similar to our legal system, Medicare’s coverage system allows for due process and a robust appeals sequence (see Figure 1). At the lowest level, a case-by-case coverage decision can be appealed.

If a MAC decides to limit coverage systematically and/or stipulate documentation requirements, it may do so only after a public comment period as required in the LCD process. LCDs may also be appealed and physicians, beneficiaries and other stakeholders can ask MACs to reconsider LCDs if there is a belief that the LCD is flawed, including if it does not reflect the current state of clinical evidence or evolving standards of care.

Ultimately, if the community remains dissatisfied with access to care or with disparities in geographic access to care due to differing MAC policies, a National Coverage Decision (NCD) process may be initiated by Medicare.

It is important to note that NCDs are few and far between in all of Medicare, and generally unnecessary when the system is functioning as intended. Having an NCD be a path of last resort allows for the fullest development of the clinical evidence base, to minimize the probability of an unfavorable, restrictive ruling.

Across all of the Medicare system, there were only 213 NCDs from 1999-2012. Importantly, Chambers et al. found that CMS’s coverage of medical interventions in national coverage determinations has become increasingly restrictive, with over one third of NCDs resulting in non-coverage.15

We are witnessing a gradual evolution of how we care for dialysis patients. We know there are opportunities to improve, and more frequent and home hemodialysis each address clinical areas known to be vexing in practice and should be preserved to advance beneficiaries outcomes. Over the last decade, thousands of patients’ lives have changed for the better through Medicare’s payment policies, and the clinical data has simultaneously evolved. This has been enabled, in significant part, through the supportive payment policy with medical justification and engagement with MACs.

Next steps

So, this brings us to what we think CMS should do as it finalizes its rules for 2017.

1). We commend, and urge CMS to maintain, its reiteration of the long standing medical justification policy for additional weekly dialysis sessions, and the role of the MAC in evaluating the medical justification for these extra sessions.

2). We think that CMS should remain proactively agnostic as to what constitutes medical justification, while explicitly confirming justification is not limited to either acute or chronic patient conditions. CMS should use specific examples (such as pregnancy or heart failure) with caution, explicitly noting, if used, that these are used for illustrative purposes only and do not imply a limitation to avoid any risk that MAC’s inappropriately interpret illustrative rulemaking language as guidance.

3). CMS’ implication that more frequent therapy is prescribed by physicians solely for the convenience of their patients or because of limitations of prevalent technology is simply not true and should be removed from the rule.

4). CMS should reinforce its formal procedures for local coverage decisions, to ensure that due process is followed and appropriate appeals pathways remain available. In parallel, physicians and professional groups should endorse core indications for medical justification as noted above, and, using ICD-10 codes, work with MACs to ensure patient and physician appropriate prescribing of more frequent hemodialysis on an acute and chronic basis.

Addressing each of these will help preserve clinicians’ ability to deliver the therapy best-suited for their Medicare patients and ensure that the carefully designed due process built into our evolving health care system continues to thrive.

References

  1. Weinhandl ED, Liu J, Gilbertson DT, Arneson TJ, Collins AJ: Survival in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. J. Am. Soc. Nephrol JASN 23: 895-904, 2012
  2. Weinhandl ED, Nieman KM, Gilbertston DT, Collins AJ: Hospitalization in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. Am. J. Kidney Dis. Office. J, Natl Kidney Found. 65: 98-108, 2015.
  3. Kotanko P, Garg AX, Depner T, et al. Effects of frequent hemodialysis on blood pressure: Results from the randomized frequent hemodialysis network trials. Hemodial Int. Int. Symp. Home Hemodial. 19: 386-401, 2015.
  4. Jaber BL, Collins AJ, Finkelstein FO, Glickman JD, Hull AR, Kraus MA, McCarthy J, Miller BW, Spry LA.; FREEDOM Study Group: Daily hemodialysis (DHD) reduces the need for anti-hypertensive medications [Abstract] J Am Soc Nephrol 20: SA-PO2461, 2009.
  5. FHN Trial Group, et al: In-center hemodialysis six times per week versus three times per week. N. Engl J Med, 363: 2287-2300, 2010.
  6. Finkelstein FO, Schiller B, Daoui R et al: At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 82: 561-569, 2012.
  7. Intensive Hemodialysis, LVD and CVD AJKD Supplement Oct 2016 (in press)
  8. Intensive Hemodialysis, Blood Pressure and Medications AJKD Supplement Oct 2016 (in Press)
  9. Intensive Hemodialysis, Mineral and Bone Disorder and Phosphate binder use AJKD Supplement Oct 2016 (in Press)
  10. Intensive Hemodialysis and Health Related Quality of Life AJKD Supplement Oct 2016 (In press)
  11. Intensive Hemodialysis and treatment complications and Tolerability AJKD Supplement Oct 2016 (in Press)
  12. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf
  13. immo vs. Sebelius Settlement Agreement Factsheet (www.cms.gov/medicare/medicare-fee-for-service-payment/SNFPPS/downloads/jimmo-factsheet.pdf)
  14. Network 16 web data quarterly dialysis report
  15. James D. Chambers, Matthew Chenoweth, Michael J. Cangelosi, Junhee Pyo, Joshua T. Cohen and Peter J. Neumann, Medicare IsS crutinizing Evidence More Tightly For National Coverage Determinations, Health Affairs, 34, no.2 (2015):253-260