ORLANDO--A nurse at the session on quality measures during the American Nephrology Nurses Association annual conference, held here last week, had a dilemma, and shared it with the audience. Her home dialysis patient was enjoying the benefits of a hemoglobin of 12.5 g/dL. But the clinic knew that maintaining that high range would get them "dinged" by CMS' new Quality Incentive Program. So the clinic wanted to ratchet down the patient's ESA dose, and subsequently his hemoglobin below the allowable 12. The patient wanted nothing to do with it.

What next?

It's easy to imagine that many clinics may be facing the same problem. In fact, recent data presented by the Dialysis Outcomes Practice Pattern Study group suggests many already have: ESA use (based on dose) was down 23% in 2011, as was the number of doses delivered. Even more specific to the nurse's dilemma: from August 2010 through December 2011, the percentage of patients with hemoglobin greater than 12 g/dL declined from 32% to 22%--a 10% drop.

Patients have seen erythropoiesis-stimulating agents, like Amgen's Epogen and Affymax's new drug Omontys, as a means of helping them cope with dialysis. Think of being tired after a long day at work. Imagine that feeling after each treatment. ESAs help correct the problem. But now, patients are being told those 'good feelings' may change as clinics abide by the new QIP.

And there is some concern that the pendulum may be swinging too far the other way. The DOPPS data show that the percentage of patients with hemoglobin less than 10 g/dL has increased from 9% to 16%, and the percentage with hemoglobin less than 9 g/dL increased from 3.0% to 5.2%. To summarize: more patients are not only being pushed below their favored >12 g/dL, but below even 10.

The QIP is not necessarily the culprit; CMS had little choice but to follow the FDA changes to the ESA black box warnings (which now suggest the drug(s) only be used to "avoid transfusions"), and recent research suggesting that higher hemoglobins may be putting patients at risk. Not necessarily the high hemoglobins, but the heavy use of ESAs to get people to those high hemoglobins. Unfortunately, regulators –- and the nephrology speciality –- aren't quite sure yet how to separate the two.

So bringing this full circle: What do you tell patients? The ESA black box warning on both Omontys and Epogen says it all: "ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression orrecurrence."

Those are indeed risks. But well-being and quality of life is important too. How do we find the happy medium?

The transplant community erupted over an editorial published March 13 by The Wall Street Journal that questioned brain death protocols for organ donation. Now, a prominent physician quoted in the article is questioning author Dick Teresi's credibility.

Teresi wrote an opinion piece entitled, "What you lose when you sign that donor card," that was adopted from his new book, "The undead: Organ harvesting, the ice-water test, beating-heart cadavers—How medicine is blurring the line between life and death." In the column, Teresi suggests that the transplant community does an inadequate job ensuring that some one is functionally dead before harvesting their organs.

"The exam for brain death is simple. A doctor splashes ice water in your ears (to look for shivering in the eyes), pokes your eyes with a cotton swab and checks for any gag reflex, among other rudimentary tests. It takes less time than a standard eye exam. Finally, in what's called the apnea test, the ventilator is disconnected to see if you can breathe unassisted. If not, you are brain dead. (Some or all of the above tests are repeated hours later for confirmation.)," wrote Teresi. "Here's the weird part. If you fail the apnea test, your respirator is reconnected. You will begin to breathe again, your heart pumping blood, keeping the organs fresh. Doctors like to say that, at this point, the 'person' has departed the body. You will now be called a BHC, or beating-heart cadaver. Still, you will have more in common biologically with a living person than with a person whose heart has stopped. Your vital organs will function, you'll maintain your body temperature, and your wounds will continue to heal. You can still get bedsores, have heart attacks and get fever from infections."

The article resulted in a firestorm of comments (still posted on the WSJ website are 573 comments and more than 1,000 tweets), many from surgeons who said Teresi over-simplified describing the tests for brain death and that he quoted outdated research. Organ recipients also chimed in, saying that his words would hurt donation in a field where demand outstrips supply. National Public Radio interviewed him; Transplant News editor Jim Warren said in his letter to WSJ: "Dick Teresi's article … is the most malicious, potentially damaging and ill informed piece on the topics of organ and tissue donation I have seen in my 36 years in the field."

And, on April 5, WSJ had to run a correction, from the author, about how he quoted Robert Truog, a professor of medical ethics, anesthesia, and pediatrics at Harvard Medical School, who Teresi claimed compared pain in an organ donor to "whether it was OK to kick a rock." Aside from the change in the language, Truog denied even using the analogy. WSJ also had to run a correction on the article about the cost of organ transplants.

Many would say "any press is good press," and that the comments that the article generated from transplant professionals and organ donors actually shed a positive light on the value of transplantation. Teresi may sell more books because of it, but his credibility will no doubt be questioned.

Note: Teresi's original column can be found here, but a subscription to The Wall Street Journal is required.

The FDA's approval this week of Affymax's new ESA peginesatide will bring competition to the anemia treatment market for dialysis patients for the first time in more than 20 years. But with contracts signed by Fresenius and DaVita to use Epogen for many of their patients, what will be the strategy for Affymax––and other companies with ESAs in the pipeline?

In September 1989, NN&I devoted much of its monthly issue to Medicare's proposed payment policy for a new drug called Epogen (epoetin alfa), manufactured by a small California-based biotech company named Amgen, to treat anemia in individuals with end-stage renal disease. The renal industry had scored a win when Medicare approved reimbursement for the drug, but there was concern about the new $40-per-treatment payment. Physicians and clinic administrators said it was inadequate––less, in fact, than what Amgen would be charging clinics for the dose that would be needed to bring hematocrits to the desired level. "This policy decision demeans [the Health Care Financing Administration's, now the Centers for Medicare & Medicaid Services] understanding and commitment to beneficiaries," wrote John H. Sadler, MD, NN&I's then-Editorial Advisory Board chairman. "It also forces conscientious physicians to contrive means to evade it, in order to serve patients fairly."

Ultimately, Sadler's words have proven correct: Clinics used less drug than Amgen suggested, and hematocrits stagnated in the first year. Meanwhile, Congressional leaders complained to HCFA that the $1 billion a year estimated cost for the new wonder drug was too high. In one of his kinder words about Amgen, Congressman Fortney 'Pete' Stark, described the biotech company as "entrepreneurs who risked so much in the development of the product." As Medicare's cost of Epogen skyrocketed in years following––and Amgen fought off competitors in court to remain the sole manufacturer––Stark's view of the company was less complimentary, particularly since most of the company's huge profits were being paid for by Medicare.

We suspect he was feeling pretty good, however, on March 27, when the FDA approved drug maker Affymax's peginesatide, also known by the brand name Omontys, to treat anemia in adult dialysis patients. Omontys works by stimulating the bone marrow to produce more red blood cells ––a different approach than Amgen's Epogen. It also is administered as a once-a-month injection, versus dialysis clinic's usual three-times-a-week injection of Epogen.

Omontys is the first real competition for Amgen in the U.S. market for treating anemia in individuals on dialysis (Omontys has not been approved for pre-dialysis patients or any other medical applications). And many dialysis providers welcome having a new option. Talking with physicians and practice managers at the recent Renal Physicians Association meeting in Washington, D.C., it was clear they were ready for a change––including Sadler, who was quoted in a New York Times article on the day of the FDA approval: "We have suffered under a monopoly now for many years, and Amgen has done pretty much whatever they've pleased."

But it will be challenging for Affymax to claim a stake in the dialysis market: The days of using high doses of ESAs to raise hematocrit levels are now gone. Clinics are heeding research that shows high doses are dangerous, and Medicare's new bundled payment system no longer makes EPO a source of profit. It has hurt the bottom line of Amgen's flagship product.

Like any company threatened by competition, Amgen has made efforts to protect its turf by signing purchasing contracts with both Fresenius Medical Care North America and DaVita Inc. DaVita agreed to use Amgen's drugs for at least 90% of its needs through the end of 2018. Fresenius signed a three-year nonexclusive deal.

But John A. Orwin, chief executive of Affymax, is optimistic that the rest of the midsize and small dialysis providers in the United States ––like Sadler's Baltimore-based Independent Dialysis Foundation group of clinics––will be ready to talk to a new supplier. The once-a-month injection can save clinics on staff nursing time and, if the price is lower than Amgen's Epogen, it will make it more attractive for maintaining the bundle. "We know we need to be part of the solution to lower costs," Orwin told The Times. 

As the Motley Fool's Brian Orelli said in a March 29th  editorial, "This drug battle will be anything but anemic."

At the Renal Physicians Association meeting this past weekend, attendees learned one reason why CMS has delayed implementation of the ICD-10 coding for medical procedures: there are thousands of new codes to become familiar with.

The Centers for Medicare & Medicaid Services announced on Feb. 14 that it would extend the implementation date for health care providers to begin using the new ICD-10 codes. CMS acting administrator Marilyn Tavernner said at the time that the agency would "re-examine the timeframe" for the planned Oct.13, 2013 launch. "There's concern that folks cannot get their work done around meaningful use, their work around ICD-10 implementation, and be ready for exchanges," Tavernner said, referring to health care insurance exchanges in the new health care reform law. "So we're trying to listen to that and be responsive."

There are two sets of codes that would be revised under ICD-10.

The ICD-10-CM
This set of codes identifies the diagnosis and will be used by physicians and other health care providers to report diagnoses in all settings. The total number of codes expands from about 13,000 to 68,000 codes.

The ICD-10-PCS
This is the code set that identifies inpatient hospital procedures only. There will be no change in the use of CPT and HCPCS in practice and ambulatory settings. The total number of codes expands from about 4,000 to 87,000.


Indeed, a review of the new codes lead by Nancy Spector, BSN, MSC, director of electronic medical systems for the American Medical Association, at the RPA meeting (download the slide here), showed what lies ahead: this increase in the number of codes will impact all specialties, including nephrology.

Those in renal care can empathize with the need for an update: similar to the recent makeover of the Conditions for Coverage after more than 40 years, the current ICD-9 coding system has been in place since 1979. Many of the codes are full; CMS has added sub codes (1.1, 1.2, etc.) as medicine has advanced and new procedures have been added for Medicare coverage. Spector said the current system has been unable to accurately reflect advances in medical knowledge or technology.

The ICD-10 has been around since 1989, originally developed by the World Health Organization. Aside from the expanded codes, it uses updated, current medical terminology and is more flexible in defining conditions while offering more specificity said AMA's Spector.  It offers payers and clinicians an improved ability to assess the severity of illnesses, she said. ICD-10 also supports better data for quality, research, and data analysis and supports improved public health surveillance.

Getting ready

Even with the delay in implementation, nephrology practices need to begin reviewing their coding procedures now and figure out how the new codes will apply. Identify the top 10-30 codes you use now in your practice; start looking at the expanded ICD-10 codes that will be applicable. Then, "cross-walk" the two sets and see how your billing will change for those diagnoses.

With more codes comes more documentation, said Spector. "With a higher level of detail in ICD-10 coding, [payers] may require more detailed documentation," said Spector. "There will be greater detail needed about the patient's condition if you choose that higher level of code."

More complexity, more costs
The more complex codes will also require updating billing systems, and training staff on those system will be necessary; forms will change, and there will be down time preparing for the new coding. Payments to the practice may lag if the wrong codes are used for billing. Spector said the AMA expects "financial neutrality," but "we are watching and waiting to see if this happens."

For conditions involving the renal patient, coding will expand for those patients with chronic kidney disease and those on dialysis. Glomerular disease will have expanded codes, as will hypertension and other co-morbidities.

Get help

The AMA offers resources to help you train your staff on the ICD-10 codes. Go to www.ama-assn.org/go/ICD-10. The site includes ICD-10 FAQs, an article entitled, "Preparing for the conversion from ICD-9 to ICD-10: What you need to be doing today;" and an ICD-10 Fact Sheets series and checklist.

March is National Kidney Month. What are we doing to improve treatment of kidney disease? Local organizers of the National Kidney Foundation's KEEP program are trying to make a difference.

KEEP stands for the Kidney Early Evaluation Program. Since 2000, volunteers at NKF chapters and affiliates around the country have screened more than 170,000 individuals for signs of kidney disease. It is a major financial commitment; the national organization covers the cost of each individual's blood tests, which can range from $150-$200. Renal care professionals volunteer to help run the screenings.

The NKF estimates there are 26 million Americans with some level of kidney disease. KEEP offers the screenings to individuals with high blood pressure, diabetes, or who have a family history of kidney disease. Participants receive a comprehensive health risk appraisal, blood pressure measurement, blood and urine testing and the opportunity to discuss their health and review results with onsite clinicians.

Nearly 1,500 people go through a screening each month.

I recently heard KEEP results from my local chapter of the NKF, The National Kidney Foundation of Arizona, at the Southwest Nephrology Conference, an annual meeting sponsored by the organization. Arizona ranks 16th in the country among NKF chapters and affiliates in the number of screenings performed.

The presenters made it clear: KEEP has the greatest value among populations that are the most vulnerable to kidney disease, and those who have minimal or no health care coverage. "My view is, if we see a patient on dialysis, we have failed as a nephrologist," said Robert Cohen, DO, who helps direct the local effort. In addition to going into the poorer communities, the Arizona chapter is also targeting minority groups who traditionally have a higher risk of kidney disease, such as Asian Americans and Native-Americans.

Kidney disease can be a 'silent' illness until end-stage is reached. "Not too many people come to me and say, 'I have CKD,'" said Cohen. The NKF sets the criteria for screening individuals, but Cohen believes everyone should be accepted for testing.

The biggest problem is follow-up. By selecting patients who are the most vulnerable for testing, there is a stronger likelihood of identifying those who are hypertensive or pre-diabetic––two major factors that can lead to kidney failure. But what happens after the diagnosis of kidney disease is made is primarily in the hands of the individual. KEEP volunteers do ask about health insurance coverage, and encourage individuals to seek further attention based on the lab results. If an individual doesn't have any insurance, a community health center in their areas is recommended.
 
A more comprehensive approach
Many advocates in renal care––patient groups, nephrologists, and dialysis providers––say our national health care system needs to take a more global appraoch to managing patients with kidney disease. A continuum of care would start aggressive treatment and counseling at Stage 3 in efforts to slow the disease. Some physician practices and dialysis providers have started such programs, but Medicare thinks it is controlling costs by only covering individuals when 'end-stage' is reached. CKD patients with commercial health care coverage have the best chance of getting good care Maybe Medicare can learn something here: preventive measures rather than just reactive treatment.

If we spend money up front to control the disease and its causes and help individuals retain kidney function as long as possible; maintain quality of life and employment and allow time to make adjustments as needed; and help an individual prepare for kidney failure with good access management and good nutritional habits, that will save money for our nation's health care program. A healthier patient stays out of the hospital and is more cognizant of their disease and how to manage it.

Let's thank those who step forward and volunteer their time for programs like KEEP. They plant the seed of prevention; perhaps the ESRD Program can help provide the resources to make it grow.

Contact your local NKF chapter or affiliate to see how you can help with KEEP screenings. For more information on the national KEEP program, go to http://www.kidney.org.

It was the theme for a special event at the Annual Dialysis Conference in San Antonio this past weekend, but home dialysis really is about giving people the power to direct their own care.

The event, sponsored by NxStage Medical, added to the home dialysis focused program that the ADC offers each year at its annual meeting.   

The conference, which started more than 30 years ago with a primary focus on peritoneal dialysis, has expanded to include a separate program on pediatric care and, for the last 18 years, on hemodialysis.

But it's the focus on home care that makes the conference unique among the five or six nephrology-directed meetings in the United States each year. Renal providers tout their latest home dialysis programs, and manufacturers offer their best equipment.

Attention to home therapies is needed. Those who dialyze at home make up less than 10% of the ESRD patient population (about 1.6% for home hemodialysis and around 7% for peritoneal dialysis). Despite surveys that show nephrology professionals themselves would chose home therapy if they had renal failure, few of them actually send their own patients home.

PD remains a fledging modality choice, despite the fact that it has been available for more than 30 years.  It has become the 'hot' modality choice in countries like Thailand, where they have placed over 10,000 patients on PD in the last five years as part of their "PD First" approach to dialysis care. China boasts 80% on PD; Hong Kong is at 74%. Mexico is also a big user.

But countries that expand their PD programs are doing so primarily because of cost (although outcomes have been good). In a country like the United States, where dialysis is offered to everyone and patients are given the option to choose their modality (more on that later), PD use remains scant. It also suffers from a lack of champions – yes, there are dedicated physicians to this modality, but patient endorsement seems limited. It is a modality choice that needs to find that power to reach the next level.

The Medicare program has offered some help. Facilities that put patients on PD from the start get incentivized: payment begins immediately (rather than the 90 day wait for in-center dialysis) and a 51% bonus payment for incident patients is added. It also helps a clinic reduce its reliance on catheters: PD patients don’t get temporary access for in-center hemodialysis.  PD also does a better job of preserving residual renal function. So there are lots of ways to jump-start PD.

But home hemodialysis, particularly in short daily or nocturnal form, has become the new kid on the block (although its history goes back to the early days of dialysis).  New studies and news about health plans offering their stamp of approval have given the modality a sense of 'what's old is new again." No less than four companies are working on home hemodialysis machines , and the current market leader – NxStatge – is making refinements to its System One.  Patients who go home and perform slower, longer hemodialysis say they feel better. They also use fewer medications, and tend to see a hospital bed less often than those who pick conventional in-center treatments.

Many are younger – and have commercial health plans. So providers get paid more. But the incentives offered by Medicare to providers for sending patients home should help level out the economic playing field.

Based on the presentations made at the meeting, there are several key components to making home the place to be for more dialysis patients.

• Modality education. Many patients are not being informed about choices beyond in-center hemodialysis therapy. New requirements set by Congress and CMS make modality options education mandatory.

• Building programs that will succeed. Whether it is PD or HHD, larger programs with a dedicated staff will have the best outcomes.

• Better medical education. Fellows are not being taught about modality options beyond conventional in-center hemodialysis and transplant. The renal community is doing a disservice to thousands of individuals diagnosed with kidney failure when they don’t make it clear what options are available.

• Respite care is needed to help with burnout. Patients who go home save providers and the Medicare system thousands of dollars by requiring less staffing, staying healthier, and staying employed. When they need a break, give them a place to go.

Power to the Patients means they need to be at the table when it comes to selecting the best therapy for them – for now. That means that their first choice might not be their last. A life plan of treatment choices means a patient may experience multiple therapies over time. That avoids burnout and keeps the patient focused on self-care.

Let's give them that power.

 

The renal community has argued for the last two decades that the Medicare dollar for dialysis services doesn’t go far enough. Last month, the state of Oregon told the two providers who control 90% of the patient population that it could no longer afford to pay $300,000 a year for dialysis care. Are we taking ‘cost shifting’ to excess?

In November 2010, an overwhelming majority of dialysis clinics told the Centers for Medicare & Medicaid Services that it would opt in 100% to the agency’s new Prospective Payment System rather then take a four-year phase in option. That decision shocked the agency, but the industry had a heavy role in shaping the payment plan.

While some concerns still linger about the ability for small providers to survive, the PPS was embraced by the country’s two largest providers – Fresenius Medical Care and DaVita Inc. – as a better approach to managing costs and improving outcomes. And, make money. Third quarter reports published by NN&I in our December issue showed Fresenius had an 8% growth in profit and DaVita showed an 11% increase in profit over the previous year. Fresenius has been on a buying spree this past year, acquiring providers in the U.S. and overseas and bringing in more companies to add to its integrated approach to dialysis care. With a year of bundling under their belt, it looks like providers see the payment system as workable – and profitable.

It’s not enough
But providers insist that Medicare, which covers over 90% of the patient population, still doesn’t pay enough. So it “cost shifts” and charges commercial health plans much higher rates for dialysis care. The insurers tend to pay it because their dialysis patient population is a thin slice of their beneficiary pie, and they may have little choice because of the dominance of one or two providers in that area. These may also be out-of-network patients who pay a higher premium to go the dialysis clinic near their home; the health plan is obligated to pay whatever price the clinic charges.

Health plans with large ESRD patient populations have caught on and negotiate for bundled rates (some get lower-than-Medicare pricing). And some fight back. A federal court in Georgia in 2009 upheld the right of Blue Cross Blue Shield to cut its payment rates to dialysis provider National Renal Alliance by 88% to treat out-of-network non-Medicare patients after claiming the $2,000-per-treatment charges were ‘excessive.’ The court said  “commercial insurers are not obligated to pay more for treatments to help dialysis providers make up for lower Medicare payments” the provider was getting for rural and underserved areas. Even with the revised rates, the court noted, the Blue Cross payments were higher than Medicare rates.

Cost-shifting doesn’t just occur in the dialysis industry – we all pay more for a hospital visit to help subsidize the cost of free care provided to the uninsured (federal law says hospitals cannot turn someone away if they need care, even if they do not have the ability to pay).

How much is reasonable?
Last month, Oregon told Fresenius Medical Care and DaVita Inc. that their price was equally ‘excessive,’ saying it was breaking the bank of the state’s high-risk insurance pool. The providers’ control of the market gave them the ability to charge the state upwards of $300,000 a year for dialysis patients – close to 15 times the Medicare rate, state officials said. As a result, the state has racked up bills in the last three years that have increased from $7 million to more than $20 million for dialysis care and payments have already exhausted the $2 million coverage limit for some patients, leaving them without health insurance. "That rate structure needs to be reexamined as to what the community reasonably can be expected to bear," said Robert Gluckman, a Portland physician who sits on the board of the Oregon Medical Insurance Pool, at a meeting with dialysis providers on Jan. 4.

The role of the AKF
Individuals who are in the Oregon risk pool because of kidney failure are lucky. Their premiums are paid for by the American Kidney Fund. Since dialysis providers can’t legally pay the premiums directly, the AKF takes in donations – the majority of which come from Fresenius and DaVita -- and then pays the premiums to health plans for patients who don’t quality for Medicare or Medicaid and can’t get insurance because of their pre-existing condition. Federal regulators have approved the arrangement, and both the providers and the AKF say the practice is a way to help cover patients who might otherwise not get insurance (read AKF CEO LaVarne Burton’s view of the program's value to the renal community).

The tipping point
Ultimately, DaVita’s and Fresenius’ approach will hurt their bottom line; when the risk pool exhausts its funds, the AKF premiums will have little value. Patients will lose access to care. With the ProPublica series of investigative stories on the profits and high mortality rate of the dialysis industry still lingering, a story about Big Dialysis overcharging for care of vulnerable patients is the last thing the renal community needs. And it tarnishes the reputation of the American Kidney Fund, which has created a program blessed by federal regulators that gets insurance coverage for dialysis patients who need it.

Dialysis providers, in essence, cover the premiums with their donations; both patients and other health care providers benefit. But exploiting the system does little for the industry’s image. Both Fresenius and DaVita have agreed to sit down with Oregon officials and look at what they charge. That's a positive step. Make a profit, but make it a reasonable one.

New data out last week pinpoints inflammation as a mortality risk among African Americans with ESRD. It is one more identifier presented recently in the literature that helps explain what influences survival among African Americans.

In the new paper published in the Journal of the American Society of Nephrology, "Inflammation and the paradox of racial differences in dialysis survival," principal investigator Deidra C. Crews, MD, and colleagues from Johns Hopkins University, Wake Forest University, and the University of California San Francisco, looked at the issue as to why African Americans on dialysis typically survive longer than Caucasians, but experience a higher mortality rate compared with Caucasians in the general population. A recent study by Kucirka et al. and published in the Journal of the American Medical Association in August, took a retrospective look at survivability among blacks on dialysis and found a survival advantage only among older blacks; those below 50 years of age showed a much poorly survival advantage compared to Caucasians (read a commentary on this study in NN&I's December issue).

There was some belief by researchers prior to the Kucirka study that the survivability edge among blacks was not as significant as once thought (although the data had been strong enough for the Centers for Medicare & Medicaid Services to consider a case-mix adjuster for the new bundled payment system for dialysis based on the understanding that blacks do enjoy higher survival benefits and use more anemia drugs). Some suggested there were non-clinical factors that might lead to a lower survivability among young blacks with ESRD, including social-economic issues and limited access to pre-dialysis care.

The work by Crews et al. in  the JASN study took a different direction—instead of just examining survivability data, they looked at potential causes for longer life among blacks, honing in on the influence of inflammation. They followed a national cohort of incident dialysis patients in 81 clinics for a median of three years. Among 554 Caucasians and 262 African Americans, they confirmed a 34% lower mortality among blacks after adjusting for demographics and several other covariates. However, a risk differential was noted across different subgroups delineated by inflammatory markers.  An even higher survival advantage of African Americans was noted among those with a worse inflammatory profile, whereas no survival differential existed in the lowest CRP or Interlukin-6 group, which influences inflammation. "Differences in inflammation may explain, in part, the racial paradox of ESRD survival," the researchers noted.

Despite some limitations of the study, the findings are important for nephrologists, giving them a marker to explain mortality risk among blacks, who have an incident rate of ESRD that is 3.5 times greater than non-Hispanic whites. But it also becomes a discovery that can be added to other indicators that might help reduce mortality among all dialysis patients.

Nephrologists Keith Norris and Kamyar Kalantar-Zadeh, who wrote the commentary for NN&I on the Kucirka study and also wrote an editorial on the Crews study, published in JASN this month, said "Examining these unusual disparities and paradoxes may be the key to discovering factors that can improve longevity in all CKD patients and probably in other populations with chronic disease and will be a major step to improving outcomes for all patients.  

"CRP levels can be added to a list of characteristics that may be linked to mortality, including racial/ethnic differences in nutritional and inflammatory profile and diet; differences in mineral-bone disorders, including higher parathyroid hormone levels in African-American patients leading to higher likelihood of receiving active vitamin D agents; differences in psychosocial status and coping mechanisms, including perception of quality of life; differences in dialysis treatment and techniques; and genetic or other inherent differences related to CKD and cardiovascular disease progression," they said.

With reducing risk of mortality, particularly in the first year of dialysis, being a high priority for the renal community, more studies like that of Crew et al. and Kucirka et al. can provide much needed help in reducing that risk.

But those who take care of their kidney disease at home do so much more. Ask the NxStageUsers, who held their second meetup and conference this past week in New Orleans.

The conference objectives were to make the gathering "a celebration of life. The life that home dialysis has afforded us … in the coming days, let’s share our stories and what we’ve learned along the way."

Indeed, the two-day conference was a platform for the 100+ home hemodialysis patients and their care partners to learn and discuss their experiences with short daily home hemodialysis. Topics ranged from cannulation techniques to anemia management to understanding health care reform to being an advocate for home dialysis. Breakout sessions covered topics like the pros and cons of transplantation, traveling with the NxStage System One machine, balancing work and dialysis, and help for care partners. One of the breakouts sessions was presented by Terry Waldon, who manages the NxStageUsers Buddy System. Waldon, who has been a care partner for his wife Sharon for 16 years, including the last five doing home hemodialysis, matches dialyzors nationwide to help with the rigors of daily dialysis.

Those at the conference understood the benefits of home hemodialysis, and many expressed gratitude for having access to the machine. Joseph Turk, head of NxStage Medical’s North America operations, said updates are coming: a lighter machine for ease of travel, and the company is working on getting FDA approval for nocturnal dialysis.
Patients who want to go home with a NxStage machine face special challenges: NxStage looks for centers that are committed to expanding (about 1,000 clinics around the country have NxStage’s System One available). Home hemodialysis requires more patient training than those who choose peritoneal dialysis. And, in many cases, a patient partner is needed. Those elements are key to a successful program; Turk says the drop out rate among patients choosing the System One machine tends to occur in the first three months.

In her blog about the meeting, Sharon Whipkey, who wrote about her first year on dialysis for NN&I’s October issue and traveled with her NxStage machine to New Orleans, said, "What an amazing group of people. We had such a good time meeting everyone, putting faces to names, sharing experiences and marveling at how fortunate we are for discovering the benefits of home hemodialysis." The connection NxStageUsers patients feel, said Whipkey, is "so wonderful and affirming. The fact that we face the same challenges and issues and we will receive support, information, and empathy is invaluable to me.

"Yet, for all the meeting, greeting and learning the best part for me was listening to and sharing our stories. Whether listening to a caregiver story or a dialyzor story I was moved so many times. For each and every one of them/us are committed to leading wonderful and fulfilling lives, not allowing kidney failure to define them/us. So many caring and courageous individuals in one place with one goal: to live life to the fullest. Truly humbling."

Note: at the meeting, the NxStageUsers agreed to change the name of their organization to Home Dialyzors United, opening up membership to all individuals who dialyze at home. More information is available at www.NxStageUsers.com.

The investigation by ProPublica earlier this year of the dialysis industry pointed to federal health officials holding back on releasing outcomes data. But can it be used to 'cherry pick' the best patients to treat?

A recent editorial published on Sept. 20 in The Wall Street Journal entitled "More transparency, better health care," suggested that the health care industry needs to open its medical records for scrutiny, not only for physicians but for patients who deserve to know who provides the best care.

Written by a trio of authors led by George Schultz, former secretary of labor (1969-70), secretary of the Treasury (1972-74) and secretary of state (1982-89), the editorial argues that "fantasy baseball managers have far more data to evaluate players for their teams than patients and referring doctors have in matters affecting life and death." They suggest that one easy step to reform the U.S. health care system is for federal officials to release claims data from the Medicare program. "Controlling costs without compromising quality will require multiple scalpels rather than one blunt instrument," the authors wrote. "Public reporting of performance measures could provide those scalpels by allowing the public to compare doctors and hospitals based on cost and clinical results."

The Affordable Care Act includes a provision that requires that Medicare release claims data—with full protection of patient privacy—to qualified organizations that can analyze the data and publicly report on hospital and doctor performance, the authors say. "This one step could greatly motivate doctors and hospitals to improve the quality and affordability of their care and substantially lower health-insurance premium growth from its current ruinous trajectory."

It’s also an argument made by the reporters at ProPublica, an investigative news group that did a three-part series earlier this year in The Atlantic about poor outcomes in the End-Stage Renal Disease Program. One part of the series discussed the lack of openness by CMS in releasing complete data on how dialysis clinics performed. CMS acknowledged it had the data but said it was reluctant to release it in raw form because it might be misinterpreted.

Some of the 19 online comments on the Journal article echoed the same concern. And the authors said they understood that. "Some physician leaders worry that public reporting based on health-insurance claims data may be inaccurate, inconsistent and misunderstood by the public. To be sure, there is great need in the measurement process for integrity and fairness to physicians." But, they added, "the legislation has provisions to give doctors ample time to review their records and correct errors before the results are released. It also requires full disclosure of, and opportunities to critique, measurement methods."

Among the commentators on the article was nephrologist Richard Amerling. He said, "Assuming health outcomes can be accurately assessed (and this is a huge assumption), the greatest factor affecting them is the underlying health status of the patient. Outcome reporting, and ultimately "pay-for-performance" will inevitably lead to cherry picking of healthier patients by doctors, hospitals and all the new Accountable Care Organizations created by the administration." Amerling is the Director of the Association of American Physicians and Surgeons, which has sued the Department of Health and Human Services over the health care reform law.

Another letter writer also worried about cherry picking: "…what the proposed system fails to make clear is that if physicians are going to be graded, they will alter their behavior. This means they will be more selective in the patients they treat. The obese, hypertensive, diabetic patient who has a higher risk of complications based on pre-existing problems, and who also is less likely to be compliant, will be left out in the cold."

If that writer, Claudio Vincenty, is right, patients with kidney failure, many who have those comorbid conditions, could be the victims of too much data. The ESRD Program entitles all individuals with kidney failure with access to dialysis treatment and transplantation. What if the pressures of pay-for-performance and the new clinical performance measures on their way in the Quality Incentive Program paved the way for dialysis providers to ‘select’ the best patients who generated the most profits?

Like any profession, physicians need to be held accountable for the way they practice. Data on performance – how well patients do under their care – should be made public, particularly in a publically funded program. But let’s use that data to improve outcomes for all patients. That’s the key.