Dialysis from the sharp end of the needle

The Dialysis Quality Incentive Program rule proposed - CMS calls for comments

By Bill Peckham 

On Monday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on the quality incentive program (QIP) required by Section 153 of MIPPA. Reading the 77 page PDF and the CMS Fact Sheet the proposal is about what was expected as a QIP starting point. 

The proposal is to use just three dialysis quality measures: Hemoglobin above 12; Hemoglobin below 10; URR above 65%, this represents no change from the QIP outline released in September. However, in response to comments received as part of the greater bundle comment process, CMS proposes to weight Hgb <10 as the most important of the three measures. Hgb <10 will count for 50% of your score, the other two measures will each count for 25%.

The PDF explains a pretty elaborate scoring system - it's a 10 point system for each of the three measures that together generates a Total Performance Score on a 30 point scale (30 is the highest score you can get), performance is measured against 2008 national averages (or 2007 unit performance, if it is lower) and the withhold is in .5% increments. 

CMS estimates that  3,205 units will see no payment reduction in 2012 because they will achieve a Total Performance Score (TPS) above 26. CMS estimates 709 units will see a 0.5% payment reduction due to TPS of 21 to 25; 183 units will see a 1.0% payment reduction for TPS between 16 and 20; 184 units will see a 1.5% payment reduction for TPS between 10 and 15; and only 30 units will see a 2.0% payment reduction for TPS 10 or below. In total CMS estimates that between 17 and 18 million dollars will be withheld in 2012.

Given the industry receives around 9 billion dollars a year in Medicare payments, 17 million dollars does not seem like very much but the basic framework of the QIP was created by Congress, not CMS. CMS does request comments on a number of specific points, page 48:

We are particularly interested in comments on how we can educate Medicare beneficiaries and their families about the presence of certificates in dialysis providers/facilities and how the information can be used to engage in meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care.

The certificates will report the facility's TPS.

Hmm ... "meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care" is a tall order from urea and hemoglobins under 10, but it is an invitation to give CMS your thoughts. I'd just turn the question around:

What would have to be reported by the TPS for it to inspire beneficiaries to have "meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care"?

Comments are due September 24th.

The Dialysis Payment Bundle - initial reaction

By Bill Peckham

The Centers for Medicare & Medicaid Services (CMS) issued the final rule creating a new bundled prospective payment system (PPS) for routine outpatient dialysis services. Skimming through the 900+ page PDF and the CMS Fact Sheet, I believe the new rule is an improvement on the initial proposal.

• It is gratifying that there is a Home Dialysis training add on which CMS included in response to comments, particularly comments from dialyzors.
• Oral-only drugs (binders) are not included initially but CMS will include them after 2014, following additional study.
• Covered lab tests will be those on a list, rather than all blood tests ordered by the MCP physician. 
• There are a lot fewer case mix adjusters - CMS at this time will not use a patient's sex or race/ethnicity to adjust payment.

Those are important changes that improved the final rule.

Trying to understand what happened to the actual payment amount is a little trickier. On page 256 of the final rule, CMS writes:

To summarize, the final base rate per treatment with an outlier adjustment & budget-neutrality is calculated to be $229.63. This amount includes a 5.93% reduction from $251.60 to account for standardization to the projected CY 2011 current system payment per treatment, a 1% reduction to account for outlier payments, and a 2% reduction for the required 98% budget neutrality.

This as compared to the the initial proposal in September as laid out in NN&I by Tracy J. Mayne:

The predicted 2011 mean bundled payment was $261.58. This number was then reduced 21.73% to adjust for "anticipated positive effects" of the impact of the case mix adjusters, or ways in which the new payment system might pay more than the current system. It was then reduced by 1% as a cost offset to pay for anticipated outlier payments, and by another 2% to meet the congressional requirement for a 2% reduction in ESRD spend in 2011, to equal $198.64.

Under the initial proposal the mean bundled payment was reduced by 21.73% to accommodate all the case mix adjusters, under the final rule with far fewer adjusters the mean bundled payment is reduced by 5.93% to get to the base payment. While it appears that there is a $30 increase in the base payment, it really is just an effect of having fewer case mix adjusters. However, it does appear that the payment amount was increased a few dollars in the final rule.

The final rule uses $251.60 as a starting point. In September CMS used $261.58 but that $261.58 included the $12.48 CMS computed was necessary to pay for oral drugs. Given oral drugs are not in the final PPS I would expect CMS to use $249.10 as a starting point ($261.58 - $12.48). Therefor, I believe 251.60 represents a $2.50 increase per treatment over the September proposal.

I think my math is right but I might have missed a 1% adjuster somewhere that would have gotten the numbers to match. I'll follow up once I've had more time to read through the complete rule.

I appreciate the amount of work CMS must have put in to review all the comments and fashion the final rule. I feel the effort I put towards understanding the proposal and commenting was worthwhile and led to a better PPS. I thank CMS for all their hard work and in particular their commitment to us on the sharp end of the needle.

CMS releases final dialysis payment rule

By Bill Peckham

http://www.ofr.gov/OFRUpload/OFRData/2010-18466_PI.pdf

The rule has been released. Lots of reading to do.

Down the river with a cycler - NxStage conquers the Rogue

By Bill Peckham

The trip was a 100% success. The only disappointment was that one of the dialyzors, Jim, wasn't able to go due to illness in the days before the start. We were able to fill Jim's two spots at the last minute; Megan and Sasha didn't know they were going until three days before they found themselves running rapids on the Rogue. Dan and Connie drove in from Salt Lake City on Sunday, both he and I dialyzed the night before the trip so we could take the first night off (both our machines went down the river in their air travel cases).

The other seven members of our twelve person party (we had 19 total, three people just happened to have signed up for the trip before I picked the date, plus four guides) were a great mix: Doug, Kathy, Cheryl, Lauren and Kyle all came in from DCI. Kay from NxStage (previously working at DCI). And Gary who runs RenalWEB. Our group got along really well, no doubt assisted by the copious amounts of alcohol that also went down the river .... but, what happens on the Rogue, stays on the Rogue. In this post I'll just overview the logistics and dialysis component.

I drove down to Grants Pass on the 17th and dialyzed that night in the hotel for the forth night in a row (I dialyzed the fifth night too). On Sunday while everyone else arrived during the day and into the evening, I stopped by Rogue Wilderness Adventures (RWA) to meet up with Scott who would be leading our trip. Scott took one look at the NxStage's metal air travel case and knew exactly how he'd pack it to take it down the river. From that moment, until we were hauling the rafts out of the river at the end of the trip, the RWA staff were consummate professionals. If you're going to take a trip down the Rogue, with or without a dialysis machine, the guide service is no place to cut corners. Go with the best, most experienced service you can find; on the Rogue that's Rogue Wilderness Adventures.

Scott used some straps and the metal frame that's lashed to the large inflatable raft to create a cradle for the travel cases. In this way the frame could hold the two cyclers side by side, suspended about 3 or 4 inches above the actual raft floor. It was perfect. Aside from the NxStage cycler I had to keep dry the NxStage dialysate warmer. Scott had a solution for that too. I have the original foam packaging and together, the warmer and its packing foam, fit perfectly in a water tight ammo box Scott had on hand. It was as if the box was made to hold the warmer. The rest of the dialysis supplies (and personal gear) fit in various dry bags - waterproof duffel bags, able to hold about two carry on sized pieces of luggage.

We started down the river Monday morning with four inflatable kayaks and four rafts, one guide per raft. The guides: Scott, Gina, Keith and Mike are awesome. Mike's raft had a pile of dry bags and provisions. He stayed ahead most of the time getting to the lunch spot or to the lodges before us. Keith's raft had the cyclers and room for up to three people to ride down river, no paddling required. Kyle used the perch at the front of Keith's raft to shoot a lot of good action video of the rest of our group running the rapids in the two smaller rafts and four kayaks. We took turns between using the kayaks and paddling in the rafts. 

The inflatable, one person kayaks are a lot of fun. That said, I am a terrible kayaker. I fell in the water twice just trying to get into the things and I was the only one who wiped out twice in the white water ... I think there will be video of me going over backwards in the first rapid we came to, an easy rapid that I found a way to make a lot harder. Aside from the kayaks the other exciting way through the rapids was in Scott and Gina's rafts, which were propelled by the paddling of the passengers, up to six at a time. I'm sure Scott and Gina could have gotten through the rapids using their long oars at the back of the raft but we provided their turbo, paddling forward or back at their command.

Having to paddle also meant that you had to perch on the raft's outer pontoon, exposed to the rapids breaking from all sides, but those riding in the front saw the most water. With temperatures in the high 80s/low 90s the water felt refreshing. During a few stretches we floated the river in our life jackets. Three people swam (on purpose (not me)) a rapid, but for the most part we only swam on the flat sections. RWA does not condone jumping off of rocks into swimming holes but if I did jump off any rocks into a swimming hole it would have been at a little swimming hole on a creek just up river from Paradise Lodge.

The lodges were outstanding. The first lodge Black Bar, is rustic with about 10 cabins and a main building strung along a forest path above the river. There is an upper and lower Black Bar lodge, we were at the lower, but I believe they have about the same amenities - hot showers, hard beds and lights off between 10PM and 7AM. The main cabin had a deck that we dragged a couch onto and from there we recounted the day's adventures while being refreshed by cold beverages. Inside two large tables could seat the whole group for dinner and breakfast.

As nice as Black Bar is, Paradise Lodge is a whole other level. Paradise has over 50 beds in five or six structures. We had the Garden House that is across the cow pasture/landing strip from the main lodge. It has an assortment of rooms with four, two or one bed. I don't know what I expected but this was ideal. In addition to being able to sleep 14 or 15 people the Garden House has a large conference room with couches, a long table and recliners! Dan and I set up our dialysis right there, I couldn't have been more comfortable.

I admit to some nervous excitement as I set up my machine for my treatment Tuesday night. We had run Blossom the big rapid of the trip, just before arriving at Paradise. To keep the cycler dry I had taped the seam of the travel case; between the tape, the slings Scott rigged and Keith's expert handling of the raft I really had nothing to worry about, the machine worked without a single hitch. I dialyzed Tuesday night and took Wednesday completely off. Dan dialyzed both Tuesday night and Wednesday afternoon.

Wednesday was a free day - we stayed at Paradise all day. I hiked up to the top of Deak's peak over looking the ranch and the Rogue River valley. It was a treat to have a day just to relax and hang out without any electronic communication. I wondered if our highly connected group would miss 24/7 email access but after the first rapid I don't think anyone gave email or the "Bundle" another thought (well maybe a few thoughts).

Dinner is family style in the main lodge. Wednesday night after we had finished eating we took turns giving our personal highs and lows of the trip. No one had any lows to speak of, the mosquitoes got an (dis)honorable mention but even they weren't that bad. It was a fantastic trip that proved you could take the NxStage cycler down a river on a raft, this trip was a proof of concept. With planning, a little ingenuity, and electricity there is a world of travel opportunities. If it could be done in 1983, we ought to be able to do it in 2011.

A few additional notes on the logistics of traveling down the Rogue with the NxStage cycler. 

• Selecting a great guide service is critical - rely on people with experience. 
• I had dialysate delivered to the guide service a few weeks before the trip so they could take it down river a little at a time. 
• Consider worst case scenarios. While the Rogue is remote we did know that we could come out early if something happened disrupting our ability to dialyze. 
• I planned ahead for "what ifs?" by noting my cycler's serial number and figuring out how to initiate a cycler swap from the river. 

Just as with the cruise the cyclers preformed flawlessly but a little planning brings piece of mind.

Still waiting for CMS to release the final dialysis PPS rule

Here it is a week later than my "best guess", just after 5PM on a Friday, and still the final dialysis payment rule is unreleased. It'll probably come out (just to spite me) when I am on the river and beyond the reach of the internet. I haven't heard anything - rumor, gossip or otherwise - about why there has been a delay. I last heard that the financial community was expecting the rule this week; the dialysis community was said to be expecting the release last week.

Google has DSEN pretty high up as a search result for people searching for news; if that's how you got here let me give you the links I've been checking:

• CMS's End Stage Renal Disease (ESRD) Center
• CMS End Stage Renal Disease (ESRD) Payment - Overview
• CMS End Stage Renal Disease (ESRD) Payment - Spotlight
• CMS End Stage Renal Disease (ESRD) Payment - Payment Regulations & Notices

One of these sites (or all of them) should announce and link to the final rule when it is released. If the rule is released between 7/19 & 7/23 you'll have to wait until I return, for the POV from this sharp end of the needle.

AJKD requesting essay submissions from CKD community

By Bill Peckham

Back in November the American Journal of Kidney Disease launched a new monthly feature: In a Few Words. These are essays of fewer than 1,600 words that illustrate some facet of kidney disease through a personal story. So far they have been quite good - I particularly liked Feeding the Hungry Ghost. The call for submissions (PDF link) indicates that "footnotes or references are discouraged".

I think this is an effort to be inviting to people who might not normally consider submitting something to what can be a pretty data driven journal. For instance dialyzors, care partners and those living with a transplant (cough, cough, Anna, cough) should feel encouraged to submit something. Your submission will be reviewed by an editorial board. If it's accepted your essay will be published online and in the AJKD print journal which is sent to a large National Kidney Foundation member readership.

Paddling for Dialysis set to launch

By Bill Peckham

I haven't been posting blog reports, hopefully they'll return soon ... until then be sure to check in on Erich at Paddling on Dialysis for Kidney Health. Tomorrow Erich will embark on a 250 mile canoe adventure, in part to mark his 10th year of using dialysis, and in part to raise money for the NKF of Michigan. On Erich's blog you'll find links to recent news articles and updates from the river.

AEI publishes another kidney-centric call for an organ market

By Bill Peckham

The American Enterprise Institute is out with another call for an organ market. Our Deeply Unethical National Organ Policy by Harold Gershowitz (recipient) and Amy Gershowitz Lask (donor) is a full throated call for kidney donor reimbursement. They even suggest a figure, $20,000.

The piece is aggravating for a number of reasons but the most aggravating part is that the authors view the issue as exclusively a kidney issue.

Kidney transplantation is not walled off from the rest of medicine. Change the structure of the kidney acquisition/transplant process, and you change the structure of medicine. Most particularly by paying for kidneys you change the system that has developed for the acquisition/transplant of other organs and tissues.

If a kidney from a living donor is worth $20,000, what's a postmortem kidney worth? How much for a postmortem liver? Postmortem donation of hearts, livers, lungs and all manner of other useful tissues rely on altruistic donation. If body parts become commodities what will it mean for all the people waiting for postmortem donations? I think the needs of people waiting for irreplaceable body parts (e.g. hearts, lungs, liver (mostly)) should be considered before the needs of those waiting for a kidney.

Have the authors spoken to the relatives of postmortem donors, the ones who had to make the decision to donate, and asked how compensation would have effected their decision? I have. The ones I've spoken to were repulsed by the idea. An altruistic donor system can't coexist with a paid donor system, it's one or the other. We will lose more than we'll gain if we allow kidneys to be sold.

I'm going Rogue, and taking dialysis along for the ride

By Bill Peckham

The current NxStage newsletter just came in the mail; it's the Special Freedom Cruise 2010 Issue (PDF link). The main article gives a great overview of last January's cruise and provides a little information on each of the  NxStagers who participated (for DSEN's cruise coverage go here and scroll down). Meeting NxStagers, people from all over the country who use the NxStage cycler to treat their CKD, was a highlight of the cruise.

One thing to come out of the cruise, due to demand from NxStagers who didn't get to go, was the idea for a land based NxStage meetup. This has evolved into a Las Vegas Meetup and Conference for anyone with CKD or who cares for people with CKD. Dialyzors, care partners, doctors, nurses and techs ... all are invited to meetup in Vegas October 10 - 15th. Check out NxStageUsers for all the details.

The other thing to come out of the cruise is an adventure that will begin in just about a week. One night as we plied the Western Caribbean, I was sitting around with a few fellow dialyzors talking about travel and trips we'd like to take. As someone with a wanderlust comorbidity the list of trips I'd like to take is pretty long but there was one trip in particular that I had wanted to do. A trip that I thought had been made possible for a dialyzor by the NxStage System One: a three night Rogue River whitewater rafting trip.

Next Monday, July 19th, I and two other dialyzors from the cruise (Jim and Dan), will depart on a three night, 4-Day Wilderness Lodge Trip organized through Rogue Wilderness Adventures. We'll be bringing two cyclers with us down the Rogue, along with supplies for five hemodialysis treatments. At night we'll be staying at lodges accessible only by river - we've sent some of our supplies ahead. The generators only run until 10PM so I'll be switching to 3 hour runs while I'm on the river.

The adventure begins in Oregon, about 60 mile north of the California state line (note West is up on the map). Monday night, at the first lodge, will be a night off of dialysis because we all plan to dialyze each day leading up to departure. Tuesday night we'll arrive at Paradise Lodge for a two night stay. We all plan to dialyze during our stay at Paradise, I think I'll do one run Tuesday night or on Wednesday - our free day. I should be able to fit in a three hour treatment between hikes, fishing and just hanging out in the secluded splendor of the wild and scenic Rogue. Thursday we raft out of the wilderness and return to civilization.

While we're on the river there will be no internet access, no cell service, no TV - we'll be unplugged! Four days without electronic communication will probably be more of a novelty than dialyzing on a generator in the woods. There will be pictures and video once I return to the Internet's electronic embrace. And if you go to Vegas in October you'll be able to hear more about the raft adventure, and the cruise, from those who were there.

Nocturnal Hemodialysis: Promising or Proven?

By Peter Laird, MD

I continue to marvel at the dialysis medical literature that in many instances completely ignores the history of dialysis. This is especially true when it comes to the subject of "alternative" dialysis strategies, such as daily dialysis or nocturnal dialysis. It is sad indeed when the pioneers of such life saving modalities are not even remembered. 

Dr. Stanley Shaldon has been overlooked for years as the original investigator of home nocturnal hemodialysis. He not only initiated the first overnight or nocturnal home dialysis treatments, but also published his results extensively in the early 1960's. We've all had access to his results for nearly fifty years!

Dr. Shaldon has reminded readers of his early work through letters to the editor in Kidney International and Blood Purification, Origin of Nocturnal Home Haemodialysis:

Dear Sir,

Precedent claims are rarely correct, thus the statement by Drs Schlapper and Diaz-Buxo in the January issue of Blood and Purification ^[1], that Uldall et al. ^[2] established the first nightly home haemodialysis program in 1993, cannot go unchallenged.  I believe that my group was the first to develop this technique 30 years earlier and that we published extensively in the period of 1963-1968 on this subject ^[3-7]. In addition, visual proof of my claim can be seen in a video of self unattended overnight home haemodialysis in 1968 by any of your readers at http://www.youtube.com/user/stanleyshaldon ^[8].

(Ed: I have updated Dr Shaldon's video link with his YouTube page URL.)

I recently read with interest another article that speaks of the promise of nocturnal dialysis, yet why is it referred to as a promising therapy nearly fifty years after its first use?

CMS submits dialysis "Bundled" Payment Rule to OMB

By Bill Peckham

UPDATE 7/16/2010:
Here it is a week later than my "best guess", just about 2PM in DC. The rule could come out in the next three hours but if it doesn't then it'll probably come out  (just to spite me) when I am on the river and beyond the reach of the internet. Google has DSEN (this post in particular) pretty high up as a search result relating to people searching for news about CMS's final Dialysis Bundle rule, so if that's how you got here let me give you the links I've been checking for news:

• CMS's End Stage Renal Disease (ESRD) Center
• CMS End Stage Renal Disease (ESRD) Payment - Overview
• CMS End Stage Renal Disease (ESRD) Payment - Spotlight
• CMS End Stage Renal Disease (ESRD) Payment - Payment Regulations & Notices

One of these sites (or all of them) should announce and link to the final rule when it is released. If the rule is released between 7/19 & 7/23 you'll have to wait until I return for the POV from this sharp end of the needle.

>>>>>>>>>>>>>----------------<<<<<<<<<<<<<

ORIGINAL POST FROM 7/1/2010:
The Centers for Medicare and Medicaid Services (CMS) has submitted the End Stage Renal Disease Bundled Payment System final rule to the Office of Management and Budget (OMB) for final evaluation. This is the final step in a process that began last September.

Typically OMB review takes about a week and often these rules are released to the public on a Friday, therefore, the best guess is that CMS will publish the final PPS rule on Friday July 9th. A caveat is that OMB could request additional data, resulting in the rule ping ponging between the two federal departments for a few days, but the end is in sight. 

There have been rumors and hints of what will be in the final rule. I think the CKD advocacy community is expecting that oral meds will not be in the bundle (which means certain people owe me dinner). Of greater interest to DSEN, and the community of dialyzors that submitted comments, I hear that the final rule will include a separate payment accommodation for home training. If true, a meaningful home training payment mechanism will be the most important element of the new dialysis payment scheme.