A Coordinated Assault to Stop Frequent Hemodialysis—Action Needed!

This blog post was made by Dr. Alan Collins on September 21, 2017.
A Coordinated Assault to Stop Frequent Hemodialysis—Action Needed!

Dear Home Dialysis Central Readers,

I write to you today deeply concerned about the health and welfare of dialysis patients under the care of United States nephrologists. In my 37 years in nephrology, as a past President of the National Kidney Foundation, as a past Director of the United States Renal Data System, and as Executive Director of the Peer Kidney Care Initiative, I have been striving to improve care and outcomes in chronic kidney disease patients generally and dialysis patients specifically. After I visited numerous centers that successfully utilize intensive hemodialysis in Canada, Asia, Australia, and Europe, Christopher Chan and I co-edited a literature review (published as a supplemental issue of the American Journal of Kidney Diseases) about the benefits and risks of intensive hemodialysis, with the aim that nephrologists should consider therapeutic alternatives to conventional hemodialysis.

One of the core challenges facing nephrology is the lack of progress in controlling hypertension, managing mineral and bone disorder, and improving the tolerability of hemodialysis, both during and after each session. Our country’s progress in reducing rates of death and cardiovascular hospitalization during the past 20 years does not mark complete victory. Hospitalizations for heart failure and volume overload together are unchanged. Sudden cardiac death is unchanged. Worryingly, the long-term downward trend in death among dialysis patients has flattened in the most recent years. And diminished quality of life on dialysis has certainly not been addressed. Given these challenges, physicians must be permitted to use their best judgement to deliver high-quality care and to advocate for the health of their patients. During my many years of caring for dialysis patients, I saw that there was a subset of patients that presented chronic fluid overload; persistent hypertension and/or hyperphosphatemia, despite use of multiple medications; and recurrent episodes of intradialytic hypotension, often due to aggressive ultrafiltration. Modest adjustments in session length rarely solved these problems.

Last week, four Medicare Administrative Contractors (MACs) released drafts of local coverage determinations (LCDs) that would effectively deny access to more frequent hemodialysis. These MACs–First Coast Service Options, Noridian Healthcare Solutions, Novitas Solutions, and WPS Government Health Administrators–process Medicare Parts A and B claims in 31 states, the District of Columbia, and 5 territories; those areas include over 60% of all dialysis patients in the United States. The drafts LCDs propose to limit provider reimbursement for additional hemodialysis sessions (i.e., beyond 3 sessions per week) to cases of acute clinical conditions that demand treatment outside of the documented plan of care. The draft LCDs include a reasonable list of diagnosis codes that could serve as medical justification for more frequent hemodialysis, but the draft LCDs would NOT permit provider reimbursement for an ongoing regimen of more frequent hemodialysis that a nephrologist judges to be a reasonable and necessary plan of care to meet the clinical needs of a patient.

Some people will complain that there are no large randomized clinical trials (RCTs) that show that increased hemodialysis frequency reduces risks of death and hospitalization. However, the Frequent Hemodialysis Network (FHN) investigators clearly stated that their trials were far too small to assess these outcomes, as recruitment proved to be an enormous challenge! The stark truth of the matter is that we also lack RCTs that show that aspirin, beta blockers, bypass grafts, and stents improve outcomes after myocardial infarction in dialysis patients. We lack RCTs supporting the efficacy of ACE inhibitors and ARBs in heart failure. And we lack RCTs that show that phosphate binders, on which Medicare Part D spends over $1.5 billion annually, reduce risks of death and hospitalization. However, we physicians use our best judgement to address all medical conditions that dialysis patients present.

The timeless principle of “do no harm” requires physicians to use their clinical judgement when they lack comprehensive evidence of efficacy and safety. There is evidence supporting most of the procedures and medications that I listed above, but that evidence arises from RCTs in the general population, observational studies of dialysis patients, and our understanding of human pathophysiology. More frequent hemodialysis is a reasonable and necessary therapy because we understand many of its clinical effects: regressing left ventricular hypertrophy; lowering blood pressure and reducing the need for antihypertensive medications; lowering serum phosphorus; and reducing ultrafiltration intensity, thereby resulting in lower risk of intradialytic hypotension and shorter post-dialysis recovery times. Clinical practice guidelines in the United States, Japan, the United Kingdom, Europe, and Canada suggest that more frequent hemodialysis should be considered as treatment for several specific conditions, including left ventricular hypertrophy, uncontrolled hypertension, hyperphosphatemia, and hemodynamic instability. The evidence base that supports these guidelines includes studies of long regimens of more frequent hemodialysis, with treatment for months or even years.

We must resist all attempts to limit the practice of medicine and the application of therapies that are within reasonable bounds. Alternative hemodialysis schedules could be utilized in novel ways—in dialysis facilities (where nocturnal hemodialysis could be utilized more widely), self-care dialysis facilities, rehabilitation centers, skilled nursing facilities, and patient homes—to address the problems that many dialysis patients experience. The MACs’ blatant attempt to fix hemodialysis reimbursement at 3 sessions per week limits the practice of medicine and can ultimately do harm, as seen in unnecessary hospitalizations, diminished quality of life, and shortened lives. To ignore the MACs at this moment is tantamount to accepting that the menu of peritoneal dialysis and thrice-weekly hemodialysis is, practically speaking, the best that the United States can offer. We know that the United States can do better than this.

I urge all of you to act quickly. Those of you who live in states that are covered by one of these MACs can begin by submitting a comment:

Coverage Map

• If you reside in Florida, Puerto Rico, or the US Virgin Islands, you are affected by the proposed policy. Your MAC is First Coast Service Options. The comment period began on September 14 and will end on November 2. You can email your comment to Medical.Policy@FCSO.com.

• If you reside in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, or Wyoming, you are affected by the proposed policy. Your MAC is Noridian Healthcare Solutions. The comment period will begin on October 5 and end on December 15. You can email your comment to policydraft@noridian.com.

• If you reside in Arkansas, Colorado, Delaware, the District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Texas, or Pennsylvania, you are affected by the proposed policy. Your MAC is Novitas Solutions. The comment period began on September 14 and will end on November 2. You can email your comment to DraftLCDComments@novitas-solutions.com.

• If you reside in Indiana, Iowa, Kansas, Michigan, Missouri, or Nebraska, you are affected by the proposed policy. Your MAC is WPS Government Health Administrators. The comment period will begin on October 5 and end on November 19. You can email your comment to policycomments@wpsic.com.

• If you reside in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, or Wisconsin, you are affected by the proposed policy. Your MAC is National Government Services. The comment period will begin on October 17 and end on November 30. You can email your comment to PartBLCDComments@anthem.com.

• If you reside in North Carolina, South Carolina, Virginia, or West Virginia, you are affected by the proposed policy. Your MAC is Palmetto GBA. The comment period will begin on October 9 and end on November 27. You can email your comment to B.Policy@PalmettoGBA.com.

After you submit a comment, write to your representative and senators in Congress. Medicare policies play a role in shaping the landscape of dialysis for all patients in the United States, so whether you are currently enrolled in Medicare or merely plan to enroll in Medicare in the future is not so important. If you are currently enrolled in Medicare, tell your story about how more frequent hemodialysis has improved your health. MAC administrators and elected officials alike need to understand that more frequent hemodialysis is an important Medicare benefit to YOU.

Comments

  • NATHAN W LEVIN

    Sep 25, 2017 4:00 PM

    Regulators should understand that THREE TIMES A WEEK DIALYSIS can provide the rate and level of fluid removal appropriate to a fraction of the aging dialysis population for those with cardiac and autonomic dysfunction. Three times a week dialysis is invariably associated with significant, life altering reduction in cardiac output and peripheral resistance, singularly or together in a large fraction of patients The actual composition of which group continually changes due to other circumstances, both external and internal. Inability to remove fluid results in hypertension and heart enlargement while rapid removal reduces perfusion to heart, brain and other organs with loss of function and impairment in the quality of life and the survival of these often elderly patients. More frequent dialysis reverses both these deleterious effects since the rates of dialysis can be slower, and more fluid can be removed over 5 or 6 days.
    The literature supports these statements absolutely.

    As someone who has been involved in dialysis for nearly 60 years I have seen and participated in many studies examining the issues mentioned above.Let me state unequivocally that attempts to limit dialysis to three times week ,as performed today ,is shortsighted and uncaring.It will shorten lives,increase hospitalization and promote misery for patients and families. I suggest a very complete review of all available information before hurting the sick and disabled by uninformed actions.
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  • sam

    Sep 25, 2017 1:31 AM

    ok, I wrote my congressman, with added request that the Congressional Black Caucus have one of their staff members develop expertise about this issue. I'm particularly distressed by this ruling because as I read it, /more frequent dialysis is optimal treatment for children with ESRD. I am appalled at the failure of our transplant system to address the racial differences in treatment for our African American and Latino children. Hope it is ok that I offered to connect Mr. Carson or his staff with those of you with much more understanding of the research and details.
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    • Dori

      Sep 25, 2017 2:44 PM

      Thank you, Sam. If they reach out to us, we will certainly do what we can.
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  • Beth Witten

    Sep 22, 2017 10:09 PM

    I downloaded all 5 of the local coverage determination (LCD) files on frequent hemodialysis to my computer. The WPS one lists the 6 states that are not colored red on the map (AL, GA, KY, OH, TN, WV). So if the other states are colored correctly, it looks like ALL of the MACs' draft LCDs say they will only cover >3 HD treatments/week if the doctor uses certain ICD-10 codes that indicate the diagnoses they'll accept. Skimming these LCDs for the number of acceptable diagnoses, here's what I found:
    • First Coast (DL37564) – 23
    • Noridian jurisdiction J-E (DL37502) - 53
    • Noridian jurisdiction J-F (DL37504) – 53
    • Novitas (DL35014) – 51
    • WPS (DL37537) - 51

    Determine your state and MAC from Dr. Collins' the article. Search by LCD number where it says "Document ID" using the LDC number starting with DL beside the MAC's name. Here's the website where you can search for that file: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

    This will open a page with the DL ID hyperlinked. Click on that link to open the draft document, including the acceptable diagnoses.

    Last December, Dr. Collins wrote an article about the MAC handling of extra treatments that includes a chart with the acceptable diagnoses at that time. I haven't compared, but it seems like one step to get MACs to accept other diagnoses (those without an asterisk) would be to submit results of studies that show those diagnoses are also treated/managed with >3 HD treatments/week. Here's a link to that article: https://www.nephrologynews.com/frequent-dialysis-role-medical-justification-mac-world/

    If you (or the patient) don't have any of those diagnoses, it's critically important that you comment to the MAC with the diagnoses you have, how >3 HD treatments a week has helped you (improved health, reduced hospitalizations, ability to live independently, ability to work, etc.).

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  • George Johnsen

    Sep 22, 2017 3:34 PM

    I have commented to both my MAC and my congressman.

    Thank you,

    George
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    • Dori

      Sep 22, 2017 9:04 PM

      Thank you for helping yourself and your fellow warriors, George!
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  • Belinda Jones

    Sep 22, 2017 2:30 PM

    My doctor and I should decide the course of treatment and frequency - not a politician - not an insurance company - not an administrative body (MAC).
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    • Dori

      Sep 22, 2017 9:03 PM

      We agree 100%, Belinda! Interestingly, so does Seema Verma, the new CMS lead--and she said so in a Wall Street Journal editorial just a couple of days ago. https://www.wsj.com/articles/medicare-and-medicaid-need-innovation-1505862017.
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  • Gary M. Thompson Mike

    Sep 22, 2017 1:51 PM

    I am presently on home hemodialysis 5 days a week. The amount of time I do dialysis is a major factor in how well I feel. My health is actually pretty good.
    Any reduction in the number of treatments that I do each week would be very detrimental to my health.
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  • Richard Gash

    Sep 22, 2017 1:16 PM

    I feel the need to comment even though as of yet I am not on any dialysis. I'm looking at all types so that if and when the time comes to choose what is best for me, I will be able to make an informed choice.
    Everything I have read so far makes a strong case for more frequent dialysis. The best seems to be shorter, daily home hemodialysis. Once my spouse and I decide what method will work for me (read as us) and my doctors can offer no sound medical reason to oppose it then a bureaucrat sitting in an office should not have any say about my personal choice.
    Why is this even up for discussion?
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    • Amy Staples

      Sep 22, 2017 10:30 PM

      Actually nocturnal hemodialysis (most often done at home) has been considered the "platinum" of dialysis care, i.e., the very best outcomes etc. I've been on home hemodialysis for nearly 15 years and *most* of that has been on nocturnal/extended dialysis. More is always better and longer time equals better clearance of middle molecules like phosphorus. I've actually only taken binders for a total of less than 1 year in my 15 1/2 years on dialysis. That speaks volumes in longer times (i.e. 5+hours) per treatment at removing the most damaging molecules to the body. I've stuck to 6-8 hours 4-6 days per week and feel the best and have the very best lab results when I get a minimum of 30 hours per week. Conventional dialysis of 12 hrs per week is the "bare" minimum of survival. I don't want to just survive, I want to thrive!! With shorter daily dialysis that still only works out to about 15 hrs. per week just slightly over the bare minimum. Longer, slower, gentler equals longevity in the long run. Blessings
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    • Dori

      Sep 22, 2017 9:05 PM

      Excellent question. It should not be.
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  • Tami Ramsey

    Sep 22, 2017 12:55 PM

    I live in Georgia and Palmetto DBA is my MAC as well. Why aren't we listed and should I make a comment or call my Representative anyway?
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    • Eric Weinhandl

      Sep 22, 2017 2:31 PM

      Tami, Palmetto recently won the contract for the MAC jurisdiction of Tennessee, Alabama, and Georgia. It is not clear when Cahaba ends and Palmetto begins, but your sense is correct: the draft LCD will be applicable to you in the near future, if it is not already.
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  • Debra Maynor

    Sep 22, 2017 10:09 AM

    I have kept my job and have been well for ten years doing home hemo more than three times. I hope this will not happen.
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  • Stewart Purchase

    Sep 22, 2017 6:10 AM

    In centre treatment: 3 years of high blood pressure despite 3 lots of tablets a day, slow recovery times post-treatment, diet restrictions & a general state of health which meant I was refused access to the transplant list. Nocturnal home haemo: almost immediately blood pressure perfect with no tablets, no recovery time, no diet restrictions, and after 2 years i'm now 6 months on from a kidney transplant donated by my wife. We'd never have been in this position with just 3 short treatments a week. It's brutal. And, thankfully, I live in the U.K so I know I can return to a regime which is comfortable for me if I ever lose the kidney.
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  • james Harris

    Sep 22, 2017 1:11 AM

    My health is MUCH better when I do it every day. Medicine needs to be individualized, not doled out assembly line style.
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  • John Agar

    Sep 21, 2017 11:47 PM

    Thank you, Al, for your clear description of further sorrow and hardship for US dialysis patient in the making. While not a US nephrologist, nor a US citizen, I doubt I can do anything to materially help, but, to limit more frequent treatments to brief and likely mainly in-hospital rescue therapy ... which, as I understand it from your description of planned changes, this does ... is madness. It flies in the face of common sense, common decency, and common humanity. More strength to your bow. We, from down under, stand by your side.
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  • Jeanne Dillon

    Sep 21, 2017 9:41 PM

    Will this affect home hemodialysis or just in center?
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    • Dori

      Sep 21, 2017 9:55 PM

      ALL dialysis, home AND in-center.
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  • Dori

    Sep 21, 2017 8:50 PM

    Thank you for commenting, Elizabeth. Will you be calling your MAC and your Congress person and Senators?
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  • Elizabeth Pagnani

    Sep 21, 2017 8:26 PM

    My husband has had much improved health both in blood work and quality of life by having dialysis 4 days a week. If funding was cut for dialysis, he would be back to the 3 day schedule that made him feel much worse. Medicine needs to be individualized not doled out assembly line style. Real actual people will be adversely affected if this terrible change takes place.

    Thank you
    Elizabeth Pagnani
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