Two companies, Fresenius and DaVita, control over 80% of the US in-center Hemodialysis market, and Fresenius further has "monopolistic" control of the US Home Hemodialysis market since it's acquisition of NxStage Medical in 2019.
FMCNA COMPLETES ACQUISITION OF NXSTAGE MEDICAL
WALTHAM, MASS. – Feb. 26, 2019 – Fresenius Medical Care, the world’s largest provider of dialysis products and services, has successfully completed the acquisition of NxStage Medical, Inc. (NxStage), following approval by antitrust authorities in the United States. . .
. . . “The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality,” said Rice Powell, Chief Executive Officer of Fresenius Medical Care. “By combining NxStage’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”
However, I strongly protest Fresenius CEO Rice Powell's assertion that the acquistion of NxStage Medical Home Hemodialysis program "enhances" patient's choices of treatment modality. Since this acquisition, other Home Hemodialysis machines vying to enter this promising market such as Outset Medical Tablo and Quanta have met stiff competition not only from Fresenius, but also paradoxically, with the joint efforts of Fresenius and DaVita together trying to establish another duopolistic control of this market as well.
DaVita Kidney Care Expands Use of NxStage Home Hemodialysis Machines from Fresenius Medical Care
New Agreement Supports Efforts to Empower More People Living with Kidney Failure to Choose Home Dialysis
WALTHAM, Mass. and DENVER – March 23, 2021 – Fresenius Medical Care North America (FMCNA) and DaVita Kidney Care today announced an expanded agreement to provide home dialysis technology—including NxStage home hemodialysis (HHD) machines, dialysis supplies, and a connected health platform—to DaVita patients across the United States. The agreement supports both companies’ goals to empower more patients to choose home dialysis, which can provide a higher quality of life for people living with chronic kidney failure*1.
“For patients choosing home dialysis, it can mean more freedom and also active participation in their care, which is why we’re always looking for new solutions that ease the burden on our patients,” said Keith Hartman, group vice president for DaVita home modalities. “We’re expanding our use of NxStage home hemodialysis machines that have invaluable remote capabilities and connectivity for our patients. By transmitting treatment information, we hope to help identify irregularities and prevent avoidable complications, thus supporting patients’ desire to stay on their treatment of choice longer.”
Empowering patients to develop "independent" control of their own treatments is always a step in the right direction, but is NxStage the best machine available today to provide for that independence? Certainly, for myself, the NxStage System One or the new NxStage VersiHD, while granting it is the only portable dialysis machine widely available in the US today, does have limitations such as a fixed sodium of 140 mmol/L. In my case, this caused sodium loading for which I no longer tolerate the fixed sodium of 140 mmol/L There came a point that I had to change to the Fresenius K@Home Dialysis system which has flexible sodium, bicarb and other settings allowing individual adjustments.
Today, we have the Outset Medical Tablo Home Hemodialysis machine which has flexible settings of sodium (130 mmol/L to 145 mmol/L), bicarb and TIME that, in my opinion, will accommodate more patients than the NxStage machine . This provides a better match of sodium levels, which, also in my opinion, is a key to help reduce HTN and LVH in longstanding dialysis patients. Reducing dialysate sodium levels helps decrease the sodium gradients during dialysis. NxStage, with its fixed sodium levels is relatively contraindicated in my case with the loss of residual renal function over the last 5 years and the development of high output cardiac failure from my high flow, brachiocephalic fistula. This one issue ended my 6 years of treatment with the NxStage System One in 2015 due to their fixed sodium levels in all their dialysate products available. (Note: Fortunately, plication of my fistula anastomosis in 2022 of the first 3 cm has completely reversed my High Output Cardiac failure and "right-sized" my fistula, but I still remain very sodium sensitive.)
Scribner showed in his first patient, Clyde Shields, that HTN was related to an expanded extracellular space size and controlled BP with sodium reduction and sufficient UF. There are, however, clinical situations where cardiac ejection fractions result in low pre-dialysis BP and metabolic effects of high, intracellular sodium levels contributes to hyponatremia in the plasma. Many approach this combined low EF, low BP and low sodium with a positive sodium gradient to prevent intradialytic hypotension. In reality, that only perpetuates the expanded extracellular space volume, thus continuing the cycle of hyponatremia and low BP with poor outcomes from excessive intradialytic UF.
Scribner warned about this many times being caused by not only expansion of the extracellular space but also the for-profit motivated short TIME of dialysis in the US. Scribner further believed and showed that TIME was a necessary component of controlling HTN. Bernard Charra in Tassin, France, reproduced Scribner's long and slow dialysis protocol for over 30 years with excellent BP control using the Drug Free Dry Weight method.
However, despite the clinical benefits of the flexibility of the Outset Medical Tablo over the NxStage, it has found poor market penetration which, in my opinion, is in large part due to the "undue" influence of the Home Hemodialysis "monopoly" reigned over by Fresenius through NxStage ownership.
Contrary to the Home Hemodialysis and In-center Hemodialysis market controlled by monopolies and duopolies, is the truly remarkable free market competition of the Acute Kidney Injury market in hospital based ICU's. Here, we see not only market competition, but all innovative dialysis strategies giving providers full access to all possible combinations of TIME, Frequency, Convection modalities and high flux artificial kidneys. It is a market that is not controlled entirely by Nephrology alone, nor large dialysis organizations. Here Outset Medical with their Tablo dialysis machine is making popular headway in the acute renal treatment market.
In fact, other new dialysis machines such as Quanta are entering the US market through the ICU acute care market to gain acceptance. Although Tablo has had FDA warnings on marketing info that included unapproved 24 hour data to challenge the CRRT market, Tablo is well poised to dominate the market of SLED, SLEDD, SLEDD-f and CRRT with its quick, simple set up and small size compared to the RO systems. But for patients, economic competition leading to provider freedom in the ICU is giving patients the best choices, the best options and the best outcomes possible that dialysis can offer. In the ICU, there are many US and international companies providing doctors true choice in dialysis modality and a very interesting competition between critical care doctors and nephrologists on who controls this market.
This same free market competition is completely lacking in both the in-center and home hemodialysis markets. We find here instead, a monopoly in Home Hemodialysis and a Duopoly with in-center dialysis, that stifles physician and patient control over treatment paradigms. Today, Fresenius and DaVita have overt control over dialysis prescriptions, machines, supplies and protocols. Fortunately, in the Acute Kidney Dialysis Market, freedom is still a word you can use truthfully and appropriately, when we consider the freedom that critical care doctors, ICU nurses and nephrologists have because of economic competition in the Acute Kidney care realm of dialysis in the ICU.
While it may be too late to positively impact free market competition in the chronic dialysis population short of anti-trade actions by the FTC and the DOJ, we should cherish the freedom found in the ICU for dialysis care. It is easy to recognize the cognitive dissonance between the hundreds of academic articles debating dialysis protocols that deny TIME as an independent factor of ESRD, dialysis mortality in chronic kidney care ICU dialysis protocols. The ICU docs understand well that longer, slower and more frequent is the winning dialysis protocol for patient survival. Perhaps, some of the nephrologists advocating that TIME and Frequency do not impact mortality will one day carry over what they learn in the ICU to their chronic patients suffering the effects of "for-profit greed" that leads to Death and Deficiency in Kidney Treatment across this nation.
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