A new FDA program might change the way we treat people with kidney failure.

The U.S. Food and Drug Administration announced last week that it has chosen three products for patients with end-stage renal disease to participate in the second phase of its new Innovation Pathway. The new project is designed to speed up the approval process of new devices by engaging with innovators much earlier.

"We found ESRD a natural fit given that patients have few options" for treatment, said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. The agency said it chose to focus the second phase of the project on ESRD because it is a growing public health concern, and it is expensive to treat. And because it is managed almost entirely by medical devices, ESRD patients would benefit greatly from technological advances.

And many in the renal community agree. "Basically I'm cheering, because this is a drastic change in the way the FDA does business," said Victor Gura, MD, the inventor of the artificial wearable kidney chosen for the FDA program, and an associate clinical professor at the David Geffen School of Medicine, University of California, Los Angeles. Gura told NN&I he had planned on getting the device approved in another country before applying for marketing approval from the FDA. The U.S. approval process is longer and more complex than most countries, he said. But the new Innovation Pathway "radically changes the whole picture," Gura said. "Now pathway to approval is much quicker."

The agency received 32 applications in response to a request for applications in January. "The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction," said Shuren.

The Winners
The FDA selected the following three products for the program.

Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
Gura said he has been working on this device for about 10 years. "More dialysis is better. I thought if we could miniaturize the big washing machines we use, we could implement more dialysis time," he told NN&I. It is  designed to be worn as a belt and uses sorbent technology to offer continuous renal replacement therapy.

The device has already successfully dialyzed pigs and passed two human trials. The first U.S. trial will be conducted in Seattle in collaboration with Larry Kessler, MD, professor and chair of the Department of Health Services in the University of Washington School of Public Health, and Jonathan Himmelfarb, MD, director of the Kidney Research Institute, a collaboration between the University of Washington and Northwest Kidney Centers. "Seattle is the birthplace of chronic dialysis therapy. Long-term dialysis began here in Seattle; what better place to test the device?" Himmelfarb told NN&I.

Both Himmelfarb and Gura, though cautious, said they hope that the device can someday be worn by all ESRD patients. Gura said he hopes to create a world where ESRD patients are no longer tethered to dialysis machines and dietary restrictions.

"I am absolutely excited to begin clinical trials," Gura said. "I'm like a kid in a candy shop."

An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
This device is being built and tested by 40 researchers in nine laboratories across the country under the guidance of Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy. It aims to combine nano-scale engineering with advances in cellular biology to create an implantable device that would enable patients with chronic kidney failure to lead healthier and more productive lives, without external dialysis or immunosuppressant medication.
The UCSF artificial kidney, or implantable Renal Assist Device would include thousands of microscopic filters as well as a bioreactor to mimic the metabolic and water-balancing roles of a real kidney. "The new Pathway program is a clear signal to researchers that innovations in how we treat disease are needed and supported by the FDA," said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy.
http://www.ucsf.edu/news/2012/04/11836/ucsf-artificial-kidney-project-tapped-accelerated-fda-program

A Hemoaccess Valve System (HVS) designed by Greenville, S.C.-based CreatiVasc Medical.
In development by CreatiVasc, the Hemoaccess Valve System is designed to limit the flow of blood through the implanted AV graft to only when the patient is in dialysis. According to CreatiVasc, the system does the following:

• Allows normal blood flow through the artery and vein at the AV graft site until dialysis is needed.
• A valve can be activated in a variety of ways to open the flow of blood through the AV graft tube, allowing the patient access to the dialysis process. 
• The valve system can then be flushed with saline and closed off when the dialysis session is completed, allowing for normal blood flow through the vein and artery.

"In an era where bundled payments for dialysis care has some believing that research and development may be stifled, this new 'pathway' may help to bring better technology to patients faster––and lead to improved quality of life.

Transplant experts have been advocating for an extension of Medicare immunosuppressive drug coverage for kidney transplant patients for a long time, yet the policy that ceases drug coverage for the majority of transplant recipients after three years remains in place. Despite overwhelming evidence that extending coverage would save lives, donated kidneys, and money, policymakers remain, according to a new perspective piece in The New England Journal of Medicine, penny wise and pound foolish. The failed bills that are introduced in Congress year after year are a sad side effect of the shortsightedness in our policymaking system.

The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 (H.R. 2969), currently before Congress, is a proposed amendment to the Social Security Act that would grant lifelong coverage for immunosuppressive medications to all kidney transplant recipients in the United States. As Congress seeks to slash spending, it is not necessarily popular to vote in favor of a bill that, on the surface, demands more money.

But extending coverage would, in fact, save money in the long run. “Premature transplant failure is the fifth leading cause of initiation of dialysis in the United States,” write the authors John S. Gill, MD, and Marcello Tonelli, MD. “Unfortunately, approximately 25% of patients whose transplants fail die within two years after returning to dialysis. This outcome is worse than the two-year mortality among patients with a functioning transplant from a deceased donor (6%) and still worse than that among age-matched dialysis patients who have never received a transplant (20%).”

The NEJM article notes that the intention of the coverage cut-off was to encourage transplant patients to go back to work and obtain private insurance. But although many patients go back to work, many have still not been able to obtain insurance that will cover the cost of the immunosuppressive drugs. This inevitably leads them back to organ failure, and likely a dialysis regimen that will leave them more dependent on government money. 

"The lack of funding for essential immunosuppressants for many Medicare patients also contrasts sharply with Medicare's provision of funding for lifelong dialysis," the authors write. "Although it is a lifesaving treatment for kidney failure, dialysis produces poorer outcomes than transplantation and is far more expensive on a yearly basis than immunosuppressant regimens. Yet patients must revert to this more costly and less effective treatment when their renal allografts fail."

As Congress continues to look for ways to decrease spending, this bill is an example of what steps must be taken. The long-term effects of policy decisions need to be considered.

Providing lifelong coverage to all kidney recipients would save Medicare money, save donated kidneys, which are precious and rare gifts, and save lives.

Download a copy of the House bill.

There is also a petition to extend Medicare coverage for transplant patients.

Although it has seen some serious profit decreases in the last year, it looks like Amgen will keep a large anemia market share.

Dialysis patient hemoglobin levels have dropped in the last year, as well as a subsequent drop in dosing of anemia drugs, according to data from the Dialysis Outcomes and Practice Patterns Study's Dialysis Practice Monitor. The DPM shows that from August 2011 to July 2011 the median hgb level declined .11 g/dl. and from July 2011 to August 2011 the median hgb level declined .14 g/dl.

From August 2010 to August 2011, the median EPO dose declined 15%. The decline was sharpest in patients who had been receiving the highest EPO doses; the 90th percentile declined 23%.

This is expected as a result of the new FDA prescribing information for ESAs, and it came as no surprise when Amgen announced that its fourth-quarter profit fell 8.5% because of decreased sales of their anemia drugs Epogen and Aranesp. The company's third-quarter profit had already dropped 63%.

In this sense, the bundle has already accomplished a major goal—a drop in EPO use means lower ESRD Program costs for CMS. But at a time when EPO use may be dwindling, the anemia market in the United States is heating up.

New players
Despite patent battles and government inquiries, Amgen has maintained a monopoly in the anemia market in the United States. Affymax, which is awaiting approval for its anemia drug peginesatide, said it plans to take a share of the dialysis patient market by offering its drug at a lower price. The drug is designed to be used once a month, compared to Amgen's Epogen, which is given druing each dialysis treatment. But during clinical trials, peginesatide proved to be dangerous for CKD non-dialysis patients. Affymax is only awaiting approval for dialysis patients. Amgen's Aranesp, along with Procrit, a version of Epogen sold by Johnson & Johnson in a marketing deal with Amgen, will remain the only ESA approved for patients not on dialysis.

Amgen has one other major advantage: the biotech company has contracts with the two largest dialysis providers in the country. In November 2011, Amgen signed a seven-year contract to provide dialysis provider DaVita with at least 90% of its anemia drug needs. Amgen also entered into a multiyear agreement to supply Epogen on a nonexclusive basis to Fresenius Medical Care.

Iron market grows
According to the Dialysis Practice Monitor, the mean use of IV iron from August 2010 to August 2011 increased 13% (the median increased 1%). The 90th percentile increased 19%. This is good news for Rockwell Medical, who is conducting phase 3 clinical studies for Soluble Ferric Pyrophosphate, and other companies that sell iron products, like Fresenius Medical Care, Watson Pharmaceuticals, and AMAG Pharmaceuticals. But the increase in iron use has stabilized, and it is still unknown whether it will grow more in the future.

A buyer’s market
Aside from Affymax, another EPO product, Fibrogen, is in clinical trials. Roche is also likely to come back with its on drug once Amgen’s patent on Epogen ends in 2014 (the company lost a patent battle against Amgen for its Mircera drug).

In a market where product use is dwindling, is there enough demand to meet the supply?

Nearly one in three dialysis clinics will receive a payment reduction under the new QIP. Is it the clinics, or the QIP, that need to improve?

CMS has announced the first QIP results and made the following payment reductions to dialysis facilities:
•    16.6% of dialysis facilities will receive a 0.5% reduction
•    6% will receive a 1% reduction
•    7.7% will receive a 1.5% reduction
•    0.6 % will receive a 2% reduction 

As a whole, dialysis facilities made out OK; most facilities that received reductions were penalized less than 1%. But even a small reduction in reimbursement is likely to bring about practice changes, and the gnawing question is whether these changes will be positive.

NN&I's upcoming January issue features a series of articles that review the program’s structure and look closely at how the QIP expects to improve quality. The measure that seems to concern clinics the most is the upper Hgb threshold of 12 g/dL.

In their upcoming article, "Perpetuating sub-optimal care: CMS, QIPs, and the hemoglobin myth," Stephen P. Pollak, PhD, Jonathan A. Lorch, MD, FACP , and   Victor E. Pollak, MD, FACP, FRCPE demonstrate how the measure could lead to worse patient care. The measure "reflects a flawed understanding of disease complexity, reinforced by three problematic randomized controlled trials." In their clinics, the authors have been exploring the "complex role of iron deficiency and other variables in anemia, and the merits of alternative therapeutic approaches."  Their practice-based studies have led to lower mortality and hospitalization rates, but sometimes patients have exceeded the Hgb threshold.

"We have been pioneering a new approach to anemia through a program of practice-based research, and continuous quality improvement," the authors write in NN&I. "Our databased, outcomes-oriented methods are patient, not population driven; achievement not target driven; and focused on addressing individual needs over time. The results so far include much-improved outcomes, with fewer drug inputs, than national and international norms. But the financial penalties under the QIP program give us little choice. We exceed the QIP upper threshold. Our work must stop; we must downgrade our care."

The anemia measure does not leave room for innovation or research. "The ability to innovate, to move the boundaries of knowledge forward, is essential to improve patient care, and to ensure our financial viability as a regional patient care organization," the authors wrote.

Although the QIP was enacted out of a desire to improve patient care, it could end up halting the improvements to patient care that some clinics have been working towards.

Of course, not all Hgb levels that exceed the measure do so as a result of carefully prescribed and monitored treatment methods, such as with the NN&I authors.  Is it possible to penalize clinics that offer sub-optimal care, while still leaving room for innovation and improved treatments?  Do the QIP measures have to remain one size fits all?

As CMS transforms how it reimburses for health care, it will need a leader to replace Berwick who can get the agency through the red tape.

Health care reform has become one of the most debated political topics this last year, and Donald Berwick, as the head of the Centers for Medicare & Medicaid Services, was often a face for the reform. Improving the nation's system of paying for the health care needs of millions of Americans is a complicated task that requires patience and a willingness and ability to compromise effectively. The issue itself is entangled in larger issues of budgetary spending and political philosophy, and a leader of reform should not be tied down by too many strong opinions about either. Although there is ample evidence of his pragmatism, Berwick's ideologies were his downfall.

The role of CMS
CMS is at the center of health care reform, and its role is changing. The Medicare ESRD Program is one of the best examples of CMS' evolving role in shaping American health care.

This was said best by two New York nephrologists, Premila Bhat MD, and J. Ganesh Bhat, MD, in the upcoming January issue of Nephrology News & Issues: "In its  'Roadmap for implementing value driven health care in the traditional Medicare Fee-for-Service program,' CMS states that a goal of value-based purchasing is to 'move Medicare away from being a passive purchaser of services to an active purchaser of high quality efficient care.'  In fact, the bundle itself can be considered a type of value-based purchasing, with the QIP representing a sort of checks and balances system to ensure that CMS' defined priorities for high quality care continue to be achieved in the bundled payment system. This represents a fundamental shift in the way that CMS views and pays for health care, and puts the ESRD program at the forefront in a new era." 

As CMS' role has changed, some say Berwick was responsible for a shift in the agency itself. "Berwick conducted the first-ever training to encourage continuous performance improvement throughout the 5,400-employee agency" according to an article from Kaiser Health News. "He sought to shift the agency culture toward teamwork, innovation, speed, and customer focus. Many staffers say they’ve been energized and are working to get information out faster to patients and to states, though some complain this work takes up too much of their time."

Berwick was a proponent of CMS' push towards pay-for-performance, and he helped draft one of the most ambitious plans to streamline health care and move towards value-based purchasing, the rules for accountable care organizations.

As Berwick moved forward with changing CMS, politicians cited his previous writings on his respect for the UK's National Health Service as reason for his removal from office.

"Government is more complex than I had realized," Berwick told The New York Times on his last day on the job. "Government decisions result from the interactions of many internal stakeholders — different agencies and parts of government that, in many cases, have their own world views.”


Navigating the red tape
Although Berwick is now a political casualty, CMS' reform policies are gaining momentum. But there is a lot of skepticism and distrust of CMS and its policies. Nephrologists have called the agency paternalistic and stifling.

"My pessimism revolves around the bureaucracy of CMS knowing what is best, their anti–free market approach to health care, and their paternalistic approach toward the providers of health care," said Robert Provenzano, MD, FACP, FASN in a guest blog post.

The agency might be well meaning, but its policies often have unintended consequences.

"Rather than promote a more relevant and effective care approach, one that provides more value for payers and dialysis patients alike, the QIP will stifle clinical understanding and innovation, raise care costs, and greatly harm patients," said Stephen P. Pollak, PhD, Jonathan A. Lorch, MD, FACP, and Victor E. Pollak, MD, FACP, FRCPE in the upcoming January issue of NN&I.

CMS needs a leader who can learn from mistakes and adjust policy to fit the growing health care system, who cares more about improving the delivery of health care more than any one political agenda or philosophy.

The third quarter reports for the renal industry are in, and while the profit picture is spotty,  some companies are moving forward with investments in R&D and new products.


Baxter

Baxter International Inc. has been improving since its fourth quarter drop of 26% last year. Baxter recently paid $380 million to acquire Baxa Corporation, a privately held company that develops pharmacy technology, and recently created Baxter Ventures to invest in early-stage therapies.

The company reported third quarter net income of $576 million, an increase of 10% from $525 million in the third quarter of 2010.  Earnings per diluted share of $1.01 grew 13% from $0.89 per diluted share reported last year.  Baxter's third quarter financial results included an after-tax special charge of $48 million (or $0.08 per diluted share) for the resolution of long-standing litigation.

Worldwide sales totaled $3.48 billion compared to sales of $3.22 billion in the third quarter of 2010, an increase of 8%. Sales within the United States of $1.40 billion grew 1%. International sales of $2.08 billion advanced 13%.


Rockwell Medical

Rockwell Medical has had struggling sales and stock these last two quarters but has invested heavily in research and development. The company spent $4.2 million in the third quarter on R&D compared to $0.7 million in the third quarter of 2010.

In July the company acquired an Abbreviated New Drug Application for injectable, active Vitamin-D, Calcitriol, for end stage renal disease patients on hemodialysis.

The company is conducting two Phase 3 clinical trials for Soluble Ferric Pyrophosphate, SFP, called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, double-blinded, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult chronic kidney disease patients requiring hemodialysis. Rockwell is also conducting a clinical study on SFP designed to investigate reduction in the need for erythropoietin stimulating agents in hemodialysis patients receiving SFP via dialysate. 


American Renal Associates

American Renal Associates Holdings Inc., and its subsidiary American Renal Holdings Inc. announced that revenue for the third quarter ended Sept. 30, 2011 grew 20% to $92.7 million compared to $77.2 million  for the same period in 2010. Adjusted EBITDA for the third quarter grew 30% to $17.3 million compared to $13.3 million the year before.

As of September 30, 2011, American Renal  provided services at 101 outpatient dialysis centers serving 7,070 patients. Total treatments for the third quarter of 2011 were 260,976 or 3,303 treatments per day, representing a per day increase of 19% over the third quarter of 2010. Non-acquired treatment growth was 16.5% in the third quarter.

DaVita and Amgen's stock have fallen on news of government inquiries and new ESA regulations, but some renal companies have seen rising prices.

DaVita Inc. (DVA)

Although DaVita Inc. continues to be one of the most profitable dialysis providers in the country, its stock has fallen on the news of two governement investigations and a whistleblower suit. DaVita was also downgraded by Citigroup analyst Gary Taylor. Taylor downgraded DaVita to "hold" from "buy" and said in a note to clients that DaVita's shares may be nearing full price.

DaVita receives subpoena for documents, announces estimate of third quarter 2011 results

DaVita downgrade sends shares reeling

DaVita Clinical Research announces new biorepository services

Colo. U.S. Attorney's office launches grand jury investigation into DaVita

Whistleblowers file suit against dialysis provider DaVita Inc.

Fresenius Medical Services (FMS)

Fresenius remains the largest provider of dialysis services in the country and the world. The company is facing some steep competition, and has begun offering minority stakes to physicians to remain competitive in the tough Chicago market.

Fresenius to sell minority stakes to physicians in Chicago dialysis clinics

Fresenius acquires Wisconsin dialysis clinic

Fresenius reopens high-yield bond market

Fresenius to buy Liberty Dialysis, American Access Care

Fresenius expects to buy more German hospitals

Amgen Inc. (AMGN)

Amgen Inc. has been losing money since the FDA began investigating reports of cardiac problems in patients taking ESAs. Implementation of the ESRD bundle and new Hgb guidelines have significantly reduce ESA use. Amgen has also been the subject of a N.Y. investigation since 2006.

Amgen Q3 profit falls 63%

Book claims Amgen, J&J sacrificed patient safety in push for EPO profits

Amgen 2Q profit falls 3%

Dialysis bundle leading to less ESA use

Court dismisses Amgen's motion for a protective order in ongoing investigation

NxStage Medical Inc. (NXTM)

NxStage Medical Inc. has steadily managed to cut into its net losses every year since 2007. The company has also spread distribution of the System One home dialysis machine across the globe.

NxStage reports Q2 revenues above its guidance range

NxStage signs distribution agreement in France

NxStage one of 500 fastest growing technology companies

Baxter International (BAX)

Baxter International has been steadily recovering since its fourth quarter profit shrank 26% last year because it took $227 million in charges related to business improvements, litigation, and acquisitions.

Baxter Q3 profit rises 10%

Baxter reports strong sales growth in Q2

Baxter to acquire Baxa Corporation

Baxter 4Q profit drops 26% on charges

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There were 3.5% more new ESRD patients in 2009 than in 2008, according to the 2011 United States Renal Data System report. Some of this rise in cases is due to overall population growth, and the USRDS tells us to view the increase in ESRD patients tentatively.

As the ESRD population grows, so do disparities in care among races. Early intervention, especially among those at risk for diabetes and hypertension is a viable solution. The USRDS gives us clear data on geographic locations particularly vulnerable to racial disparities, which should be good targets for intervention efforts. Younger people, too, are increasingly susceptible to ESRD. As diabetes and hypertension rates continue to rise across the country, this group will most likely also grow.

Here are some statistics about the growing ESRD population from the annual report:

• There were 116,395 new cases of ESRD reported in 2009, 3.5% more than in 2008, and the largest increase since 2000.

• 106,000 dialysis patients started ESRD treatment on hemodialysis, and 7,094 started on peritoneal dialysis.

• The rate of new ESRD cases per million population has been relatively stable since 2000, and rose just 1.1% in 2009, to 355.

• Since 2000, the adjusted incident rate of ESRD has grown 12% for patients 75 and older, to 1,762 per million population in 2009. Rates for those 19 and younger have increased 9.6% to 15.5. Rates for 20 to 44 year olds have increased 9.8% to 131. Rates for patients age 45 to 64 and 65 to 74 are now the same as in 2000, at 610 and 1,407.

• According to Dec. 31, 2009 data, the total treated ESRD population rose above 570,000, including 370,274 patients on hemodialysis, 27,522 on peritoneal dialysis, and 172,553 with a functioning kidney transplant. The rate of prevalent ESRD cases reached 1,738 per million population, an increase of 2.1% from 2008, and consistent with a similar rise per year since 2002.

• By primary diagnosis, the adjusted rate of new ESRD cases due to diabetes increased 0.5% in 2009, to 154.1 per million population. The rate of ESRD due to hypertension has grown 8.7% since 2000, to 101, while that of ESRD due to glomerulonephritis has fallen 23% to 23.8.

• The ESRD rate in African Americans were 3.5 times greater than in whites.

• The ESRD rate in Native Americans were 1.9 times greater than the rate among whites, and

• The ESRD rate in the Hispanic population was 1.5 times higher than that of non-Hispanics.

• The highest adjusted ESRD rates occurred in the Ohio Valley, portions of Texas and California, and the Southwestern United States.

• The rate for incident dialysis patients varied between Networks, from 236 in Network 16 (Alaska, Idaho, Montana, Oregon, Washington)  to 421 in Network 8( Alabama, Mississippi, Tennessee). The overall rate is 348 per million.

• The distribution of patients by race varies widely across the country. African Americans make up just 6.4% of the new dialysis population in Network 16, but 49 to 55% of patients in Networks 6 (Georgia, North Carolina and South Carolina) and 8.

According to the United States Renal Data System 2011 annual data report, hospital admissions for infections were 43% higher in 2009 than in 1993.

The report includes detailed analyses of hospitalization rates among dialysis patients, including comparisons between HD and PD, rehospitalization rates, and reasons for admissions.

Highlights include:

• The rate for vascular access procedures has fallen 48%.

• Mortality rates for ESRD patients are 2 to 2.5 times greater than for Medicare patients with cancer, diabetes, or congestive heart failure.

• There is a 36% all-cause rehospitalization rate among hemodialysis patients, and the highest rates occur among patients 20 to 44 years old. Rates of rehospitalizations have changed little over the last decade.

• Hospitalization rates for ESRD patients are twice as high as in the general population. Mortality rates are improving, but more slowly for the first year of treatment than for the years following.

• In the peritoneal dialysis population, there has been little change in the overall rate of hospitalization for infections, but admissions for peritonitis have fallen.

• Rates of hospitalization in HD patients for skin and lung infections have been rising since 1993. The same rates in peritoneal and transplant patients have been falling.

• Dialysis Clinic Inc. has the lowest standardized hospitalization rates among large providers, and hospital based units have the rates among small providers.

• The use of catheters continues to be the number one cause of hospitalizations due to infection.

• In HD patients, cardiovascular admission rates have fallen 12% since 2004. The same rated for PD and transplant patients have fallen 14 and 19%.

• Admissions for vascular access infections are highest among the youngest patients.

• Admissions are highest among women, African Americans, older patients, and patients whose ESRD is caused by diabetes.

These data provide more evidence for the need for infection control and patient education. Since a large percentage of the hospitalizations are due to infections, and catheters are still the number one cause of infection, there is a clear need to for patients to see nephrologists sooner, since patients that do are more likely to have a fistula or a graft. Disparities in care for women and African Americans also need to be addressed.

It is also noteworthy that among the three largest dialysis providers, Dialysis Clinic Inc. has the lowest mortality rate. In addition to being the only non-profit of the three, it also maintains the most stable patient population, with most of its patients remaining under their care for longer than five years.

Recent studies and surveys underscore need for better communication between doctors and kidney patients.

Nearly 50% of dialysis patients and their caregivers surveyed by the National Kidney Foundation said that their health care providers have less time for them now than in the past, and they would like to spend more time discussing their lab goals and progress with their health care team than they currently do. Although it is bad news that dialysis patients have less time with their health care providers, perhaps a result of changes in the way clinics are paid for their services, it is good to know that so many patients want to be more involved in their care. 

More and more studies have surfaced showing the risks associated with kidney failure and dialysis, and one of the best tools to combat these risks is patients' own knowledge of their disease and treatment. Patients should know how to interpret their lab values, and the steps they can take to reach lab goals. Of course there will always be some noncompliant patients, no matter how much education they are given about their disease and treatment. And lower reimbursement rates are not suddenly going to change. But it is unacceptable that patients who want to be involved in their care cannot get enough time with their health care team to properly do so. 

A New England Journal of Medicine study that shows the danger of the two-day dialysis break that goes along with conventional thrice-weekly sessions has gotten a lot of attention this week. Some patient advocates are calling for more frequent dialysis, but the response is generally the same: patients' preferences to dialyze less, and a strict payment system are barriers to more frequent care. CMS has made it clear that a randomized control trial is required to prove that more frequent dialysis is cost effective, so the payment barrier cannot be overcome easily, though it should not be ignored. But the patient barrier can be alleviated. And patients can take steps, like limiting fluids and following the proper diet, to make the two-day dialysis break less dangerous. Every dialysis clinic should make patient education a priority. If it was, we might see more patients adhering to their treatment protocol, wanting to stay in the chair longer, and maybe even want to start dialyzing at home.