Proposed MAC policy undermines value of more frequent dialysis

Seven Medicare Administrative Contractors (MACs) simultaneously released proposed Local Coverage Determinations (LCDs), or payment policy rules, on how they would be covering more frequent hemodialysis (defined as beyond the standard three times/week covered in the bundled payment rate).

MACs are hired by the Centers for Medicare & Medicaid Services to review all Medicare claims, including from dialysis providers, to insure the claims are in line with Medicare payment policy before the contractors pay for the services provided.

These seven MACs (there are 10 total) that are 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 country. As a result, these proposed rules are far reaching for nephrologists wanting to prescribing MFD and providers who get paid for the treatments.

What the proposed rules say

The proposed policy from the seven MACs is nearly identical in language. They 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 (POC). 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 do so in the proposed policies. “While there are no set frequency limitations for these services (author emphasis), [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,” wrote Novitas Solutions Inc., which covers Pennsylvania, New Jersey, Maryland, Delaware, and the Washington D.C. Metro area, in their proposed rule.

All of the LCDs have a comment period on the proposed rules (see table), so support is needed now to defend the right of physicians to prescribe MFD for patients who can benefit and for those who should be maintained presently on MFD.1, 2

MAC proposed policies on more frequent dialysis

Below are listed the seven MACs along with an email address to respond.

• Novitas Solutions Send comments to: DraftLCDComments@novitas-solutions.com

• First Coast Options Inc. Send comments to: Medical.Policy@FCSO.com

• WPS Government Help Administrators Send comments to: Policycomments@wpsic.com

• Palmetto GBA Send comments to: B.Policy@PalmettoGBA.com

• National Government Services Send comments to: PartBLCDComments@anthem.com

• Noridian Healthcare Solutions Send comments to: policydraft@noridian.com

• CGS Administrators Send comments to: cmd.inquiry@cgsadmin.com

Ignoring the benefits of more frequent dialysis

Patients who are given dialysis treatment more frequently show important clinical and quality-of -life benefits. According to the US Renal Data System, the adjusted 5-year survival of living and deceased donor transplants were 84% and 75% respectively in a 2011 cohort of ESRD patients. Meanwhile, adjusted 5-year survival rates on peritoneal dialysis and in-center hemodialysis were 51% and 42%, respectively.3

The negative results of the HEMO Study suggested that it would be difficult to improve quality of life and overall outcomes for patients on thrice-weekly, in-center hemodialysis.4 Hence, we have moved toward more frequent and longer hemodialysis to improve outcomes.

Because 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.

Patients can medically benefit from more frequent home hemodialysis (mfHHD) treatments because it:

• eliminates the two-day killer gap––the period when patients on standard three-times-a-week go two days straight without dialysis. Studies show that mortality drops by 45% on Monday and Tuesday when more frequent HHD is used versus thrice-weekly in-center hemodialysis. This cannot be done operationally in center and can only be done at home.5

• reduces post-dialysis recovery time, which markedly improves quality of life. This has been shown in both randomized and observational studies. 6,7,8

• 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. 9-11

• offers better control of phosphorus, with a large reduction in phosphate binder use on nocturnal HHD. 9-11

• allows for a slower rate of fluid removal and prevents myocardial stunning. This has been shown in observational studies. 12

• reduces left ventricular mass, which correlates directly with improving survival. This has been shown in two RCTs. 9,10

• improves quality of life, shown in two RCTs and observational studies. 8, 10,13,14

• improves the chance of normal pregnancy for dialysis patients, 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.15

• improves overall survival of the patient. A US Renal Data System analysis reviewed patients on nocturnal dialysis, short daily dialysis, and in-center dialysis and showed that nocturnal dialysis had an improved survival and reduced hospitalization.16 Database analysis in Canada of nocturnal HHD and matched USRDS transplant data show similar outcomes with deceased donor transplant and nocturnal dialysis.17

Nephrologists that read the literature concerning mfHHD believe if patients have medical indications they will benefit from mfHHD on a long-term chronic basis.

Conclusion

What these six 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.

References

1. Protect kidney patients and the right of doctors to help kidney patients

2. Palmetto Medicare Administrative Contractor, draft LCD “Frequency of Hemodialysis” DL34575, downloaded 10/15/17

3. United States Renal Data System. 2016 USRDS annual data report: Epidemiology of Kidney Disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2016.

4. Garabed Eknoyan for the Hemodialysis (HEMO) Study Group; Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis: N Engl J Med, Vol 347, No 25 December 19, 2002 (needs reference format)

5. Foley RN, Gilbertson DT, Murray T, Collins AJ. Long interdialytic interval and mortality among patients receiving hemodialysis. N Engl J Med. 2011;365(12):1099-1107 doi:10.1056/NEJMoa1103313.

6. Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R, Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol CJASN. 2006;1(5):952-959. doi:10.2215/CJN.00040106

7. Jaber BL, Lee Y, Collins AJ, et al. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis Off J Natl Kidney Found. 2010;56(3):531-539. doi:10.1053/j.ajkd.2010.04.019.

8. Garg AX, Suri RS, Eggers P, Finkelstein FO, Greene T, Kimmel PL, Kliger AS, Larive B, Lindsay RM, Pierratos A, Unruh M, Chertow GM. Frequent Hemodialysis Network Trial Investigators. Patients receiving frequent hemodialysis have better health-related quality of life compared to patients receiving conventional hemodialysis. Kidney Int. 2017 Mar;91(3):746-754.

9. Culleton BF, Walsh M, Klarenbach SW, et al. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007;298(11):1291-1299. doi:10.1001/jama.298.11.1291.

10. FHN Trial Group, Chertow GM, Levin NW, et al. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010;363(24):2287-2300. doi:10.1056/NEJMoa1001593.

11. Rocco MV, Lockridge RS, Beck GJ, et al. The effects of frequent nocturnal home hemodialysis: The Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011;80(10):1080-1091. doi:10.1038/ki.2011.213.

12. Jefferies HJ, Virk B, Schiller B, Moran J, McIntyre CW. Frequent hemodialysis schedules are associated with reduced levels of dialysis-induced cardiac injury (myocardial stunning). Clin J Am Soc Nephrol CJASN. 2011;6(6):1326-1332. doi:10.2215/CJN.05200610.

13. Finkelstein FO, Schiller B, Daoui R, et al. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012;82(5):561-569. doi:10.1038/ki.2012.168.

14. Jaber BL, Schiller B, Burkart JM, et al. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol CJASN. 2011;6(5):1049-1056. doi:10.2215/CJN.10451110.

15. JASN 2014 Intensive Hemodialysis Associates with Improved Pregnancy Outcomes A Canadian and United States Cohort Comparison (Need to put in reference format)

16. Johansen, K.L., Zhang, R., Huang, Y., Chen, S., Blagg, C., Goldfarb-Rumyantzev, A., Hoy, C., Lockridge, Jr., R.S., Miller, B., Eggers, P., Kutner, N.: Survival and Hospitalization Among Patients Using Nocturnal and Short Daily Compared to Conventional Hemodialysis: A USRDS Study. Kidney International 76: 984-990, 2009

17. Pauly RP, Gill JS, Rose CL, et al. Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant Off Publ Eur Dial Transpl Assoc – Eur Ren Assoc. 2009;24(9):2915-2919. doi:10.1093/ndt/gfp295.