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:
• 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 email@example.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 firstname.lastname@example.org.
• 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.