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.

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.

Dr. Robin Eady to receive the Clyde Shields Distinguished Service Award

By Bill Peckham

Dr. Robin Eady,the "World's longest-surviving kidney patient" is going to be in Seattle next week to receive from the Northwest Kidney Centers the "Clyde Shields Distinguished Service Award, given to people who make significant contributions to the welfare of kidney patients through advocacy, clinical care or research." Dr. Eady is a great selection to receive the award. He knew Clyde Shields; Eady's first hemodialysis treatment in 1963 was in the bed next to Shields.

Eady went on to be one of Canada's first dialyzors and then one of the first to use hemodialysis in England. I think this means that he was one of the first few dialyzors in three different countries. After 24 years of using hemodialysis, he has lived with a transplant for the last 23 years - 47 years of renal replacement!

The article (it's a good article, read the whole thing) mentions Eady will be at two public events - I'll be at both:

• Tuesday June 22, 2:30 to 3:30 p.m.
  SeaTac Kidney Center, across from the airport on International Boulevard
  Dr. Eady will receive the Shields Award


• Sunday June 27, 1:30 to 3:30 p.m.
  Seattle Kidney Center, just east of downtown Seattle on the corner of 15th & Cherry
  Dr. Eady will be featured in a presentation entitled "Home Dialysis and Transplant made it possible to live 47 years--A conversation with Dr. Robin Eady."

The Sunday event will be attended by special guest Congressman Jay Inslee, a Congressional champion and long time advocate for kidney patients.

Who killed the immunosuppressant drug extension?

By Bill Peckham

Via email I've been asked, what/who in my view, killed the immunosuppressant drug extension? Fate.

My historical narrative of the immunosuppressant drug extension begins in 2009 with the 111th Congress (though I think I first heard of the issue in 2001). In March the Senate introduced S. 565: the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 and the House introduced twin legislation H.R. 1458. The bills attract bipartisan support; at this point the goal is to get these bills incorporated into the various pieces of healthcare legislation that are working their way through committee.

This happens in July when the House health insurance reform bill HR3200, includes language that would extend immunosuppressant drug coverage. In September the Senate Finance Committee passes a bill that does not include immunosuppressant drug extension. Note that this happens in September, and despite unanimous support from all corners of the CKD advocacy community.

Meanwhile, while Congress works on healthcare reform, CMS is working to implement legislation that was passed in 2008. Medicare Improvements for Patients and Providers Act of 2008 requires CMS to expand the dialysis payment bundle but leaves it to CMS exactly how and on September 15th CMS released their proposed rule. DSEN tracks all public comments on the proposed rule and offers comments at a CMS town hall meeting in October. The most commented on issue is CMS's proposal to include "binders in the bundle", the overwhelming majority of comments express concern with that one element of the proposal. My official comments on the proposed PPS include my objections to including binders.

In November the House combines their various healthcare reform bills into HR 3962 which in addition to extending immunosuppressant drug coverage mandates the inclusion of binders in the dialysis payment bundle as a pay for. This is the first time that these two issue get linked but there is very little comment on this provision in the advocacy community. The thinking is that when the House and Senate healthcare reform bills get merged in committee the binder language will be stripped out.

The goal is to have immunosuppressant coverage in the final bill; to get there you need only to have it in the House or the Senate version, the language is in the House bill so things are looking good. In December the Senate passes their version of healthcare reform without immunosuppressant drug coverage. The Senate bill does have a provision directing the GAO to study including binders in the bundle.

Here is where my narrative and the narrative presented by Dr. Cohen diverge. It's here that the NKF/KCP is said to have killed the immunosuppressant drug provision by objecting to the binder language in the House bill. I disagree. The Senate never linked the issues and I think looking ahead there is every reason to believe that in the conference that is expected to happen, the conference that is required to merge the House and Senate bills together, Senator Durbin, an immunosuppressant coverage supporter, will be in the room. By not including immunosuppressant drug coverage in the Senate Managers amendment, Durbin avoids having to come up with any pay fors. In conference the projected cost of immunosuppressant drug coverage will amount to a rounding error when considered against the total cost of the final healthcare reform bill.

That was the expectation I expressed in December when Congress breaked for the Christmas recess. I didn't read any commentary at the time from the transplant community saying that hope was lost or calling on anyone to support the House's specific language. Things were looking good that Christmas. Then Scott Brown won the Massachusetts Senate race. No one saw that coming. Fate had intervened.

By flipping the Senate seat from Democrat to Republican, the Massachusetts election made it impossible for the Senate to bring a post conference bill to a vote. The only way for healthcare reform to proceed was for the House to vote for the Senate bill, which as it happened did not have the immunosuppressant drug provision. How could this result be the fault of KCP lobbying?

The kidney transplant community's stabbed in the back narrative

By Bill Peckham

On Friday RenalWEB linked to an American Society of Nephrology podcast that is deeply frustrating.

Expansion of Immunosuppressive Drug Coverage - An Imperative Reform, presents the National Kidney Foundation's and the American Society of Transplantation's explanation of how the transplant advocacy community failed to achieve their objective of extending immunosuppressant drug coverage, under Medicare Part B, to certain kidney transplant recipients. The podcast is a companion to editorials published in the Clinical Journal of the American Society of Nephrology (ASN hopefully will make the CJASN editorials freely available).

The story according to the podcast set-up (the fist minute) is that there is "bipartisan support for extending immunosuppressant benefits for the life time of the transplant", that such an extension makes "good clinical and economic sense" however, the narrative continues, in the process of passing healthcare reform "the Senate removed" from the House's healthcare bill a provision that would have extended immunosuppressant coverage.

Given that starting point, the editorials and podcasts present two explanations for events. Bryan N. Becker, MD, the President of the National Kidney Foundation, describes events as manifesting "A Conflict of Responsibility": the NKF couldn't support the House's approach to extending benefits because the pay for would disadvantage people on dialysis. David J. Cohen, MD, American Society of Transplantation Board member, gives what I take to the be the transplant community's explanation of events: the NKF's objection to the legislation is baseless and the root motivation was profits. Cohen's charge is that the dialysis industry (aka Kidney Care Partners), sacrificed a clear benefit for transplant patients on the altar of financial gain.

Where to begin. This is wrong on so many levels. First and foremost, there is no acknowledgment that immunosuppressant drug coverage under Medicare Part B has ALWAYS been a suboptimal solution to the problem. People need more than a few medications to successfully live with a transplant. The AST and NKF are continuing to advocate for legislation that would not even cover the doctor visits needed to maintain those prescriptions. This isn't what people need.

What people living with a transplant really need is access to health insurance. Affordable health insurance which would provide access to all the medical service they need including immunosuppressant drugs. Wouldn't that be nice - access to health insurance without having to find a way into a large Employer Group Health Plan.

The idea of providing access to health insurance, including access for people with preexisting conditions, should sound familiar because the bill under discussion, the one that didn't extend immunosuppressant drug coverage, that bill did extend health insurance access to people living with a transplant.

It's always disappointing to hear nefarious motives ascribed to those who advocate for optimal dialysis but what I find frustrating is the central complaint: that a redundant half measure wasn't passed. Get over it. On January 1, 2011 we will enter a new era.

After January 1 someone on dialysis, with Medicare primary, who gets a transplant - they will have full Medicare access for 36 months and then when that is up they will have access to insurance through the new public Exchanges (if they haven't found their way into a large employer group). That's a big change. That change represents a huge win for kidney patients. Advocates should now be working to make sure the Exchange policies, and the high risk pool policies during the 2011-1014 transition period, meet the needs of those with a transplant. January 1 is less than 7 months away, the NKF and AST should be working on new messaging to spread the good news that the future is bright.

CMS promises to monitor access and quality in wake of bundle implementation

By Bill Peckham

In bundling news RenalWEB links to a press release from Representative Stark and a GAO report (PDF link), that appears to be in response to questions from Representative Stark and Representative Lewis. The press release helpfully summarizes the GAO report:

• Populations of dialysis patients have varying costs. African-Americans, dually eligible and younger ESRD patients have higher-than-average costs, and Asian-Americans and elderly patients have lower-than-average costs;
• A majority of clinicians surveyed said that clinical factors, not demographics, drive variation in expenditures;
• GAO recommended that CMS monitor access to and quality of care for certain beneficiary groups as soon as possible after implementation of the new system;
• In response to the report, the Centers for Medicare and Medicaid Services (CMS) announced their intention to have a comprehensive system in place to monitor the quality of care once the bundled payment system is implemented next year.

I think the GAO report vindicates those of us who supported CMS's decision to not include a race/ethnicity patient level adjuster to the expanded bundle.

Representative Stark's press release also links to a letter from Jonathan Blum, Deputy Administrator and Director Center of Medicare (PDF link). The letter does not reference the variation in expenditures observed among race/ethnic groups, rather it promises to have a "comprehensive monitoring system" in place on January 1, 2011 because "CMS places its foremost concern on the impact of the change on beneficiary access and quality of care."

The questions unanswered are how does CMS define beneficiary access and quality of care? The letter does say that "CMS will soon issue a proposed rule on the QIP". The Quality Incentive Program will play an important role in encouraging quality care but no matter what is "soon" proposed, the QIP will not be able to do all that needs to be done. But at least quality has the QIP.

How to define and monitor beneficiary access remains an open question.

KCC/KCP anticipate that the final rule will leave oral drugs out of the bundle

By Bill Peckham

I learned something else while reading through the advocacy letters to the VA - KCC/KCP does not think oral drugs are going to be a part of the final expanded bundle.

The Kidney Care Partners/Kidney Care Council joint letter to the VA (PDF link) contends that the Veteran's Administration, in proposing to set their dialysis reimbursement at Medicare's allowed rate, is wrong because their "Proposed Rule’s Overly Simplistic Analysis of Medicare’s Payment Policy Fails To Accurately Anticipate or Capture Effects of Future Changes" as evidenced by the fact that the "Proposed Rule Fails To Consider Medicare’s ESRD Prospective Payment System “Bundle”." The letter then lays out the pending changes (my emphasis):

Beginning in 2011, the MIPPA statute mandates that Medicare payment for ESRD will be based on a bundled payment system (i.e., one “bundled” payment to the ESRD facility per-patient per-treatment) that includes:

(i) items and services included in the composite rate as of 2010;

(ii) injectable biologicals used to treat anemia – erythropoiesis stimulating agents – and any oral form of such agents;

(iii) other injectable medications that are furnished to individuals for the treatment of ESRD and are paid for separately under Part B, and any oral equivalent of such medications; and

(iv) laboratory tests and other items and services furnished to beneficiaries for the treatment of ESRD (excluding vaccines).²⁰

According to CMS’ proposed rule issued September 29, 2009, the costs for these items would form the basis for an unadjusted base rate per patient tied to utilization data from the lowest of three prior years (2007, 2008 or 2009).²¹

Actually those items and " Oral Drugs without an Injectable Equivalent" (i.e. binders) form the basis of the unadjusted base rate per patient as published in the Federal Register (footnote ²¹ is to the proposed rule as published September 29, 2010).

Oral drug's absence from the KCC/KCP summary is hard to explain unless they believe the final rule will exclude binders, which would be a very good result.

The VA should use Medicare reimbursement as a starting point

By Bill Peckham

On Thursday RenalWEB posted letters from KCP, DPC and two Senators, to the Veteran's Administration [note: all links are PDFs] :

Public Relations Firm for Kidney Care Partners Releases Three Letters on Proposed Rule To Use Medicare Rates for VA Dialysis Services 

• Kidney Care Partners-Kidney Care Council joint letter to the VA
• Letter from Senate Veterans Affairs Committee Chair Sen. Daniel Akaka and Committee Member Sen. Mark Begich to the VA
• DPC letter to the Department of Veterans Affairs

Reading through the letters was my first exposure to the issue but I think KCC/KCP/DPC  have a point.

To simplify ... the VA has about 10,000 beneficiaries dialyzing in non VA dialysis units all across the country. The VA wants to pay the Medicare allowed rate for dialysis, currently the VA pays a whole range of rates but often the VA reimburses at a much higher rate than Medicare. The letters advocate against the VA using Medicare's allowed rates. I agree. I don't think Medicare's allowed charges, as such, should be used by non Medicare payers. Medicare has hundreds of thousands of beneficiaries dialyzing; they get, the rate they get, based on that buying power. Medicare will always have the lowest rates because they have the most beneficiaries (Medicaid is a special case).

The VA is trying to piggy back onto Medicare's buying power but reading the KCC/KCP letter, by law the VA is suppose to negotiate their rates separately, which seems reasonable. Like any insurer with 10,000 dialyzors the VA should be able to negotiate better dialysis rates than the LDOs' list price but without a thumb on the scale the VA shouldn't expect rates as low as what Medicare allows. The letters suggest that the VA create a "a viable national rate" not tied to Medicare. However, the letters don't offer a reason why the VA should not use Medicare's allowed rate as their starting point. Why not set the VA's dialysis reimbursement at 200% of the Medicare allowed rate? Or 300%? Medicare's patient/facility adjusted payment would be the logical starting point to set rates.

Medicare is the industry's most sophisticated payer. Medicare reimbursement rules try to match reimbursement to costs - there are case mix adjusters, geographic wage adjusters. But more importantly Medicare is on the verge of changing how they pay for dialysis, the final rule on the expanded bundle could come out any day. On January 1, 2011 the new payment method will go into effect (or start going into effect for providers who choose to phase into the new payment over the next three years), expanding the bundle is suppose to improve dialysis reimbursement's financial incentives, therefor why shouldn't we be advocating for all payers to use the new bundle?

I think paying separately for EPO resulted in the misuse of EPO. The dialysis industry should accept the expanded bundle as the new unit of service and change billing for all payers, in concert with Medicare's reimbursement change. The VA should be encouraged to use Medicare's methodology as a starting point in negotiating a fair rate.

Berwick likely to hear health care rationing questions from Republicans

By Bill Peckham

Donald Berwick looks to me to be the right person, at the right time, to run the Centers for Medicare and Medicaid Services (CMS). David covered the nomination announcement and he pulls together some recent press reports highlighting Berwick's impressive background, including quotes that suggest Berwick would be a strong advocate to improve healthcare provided through CMS. On Wednesday RenalWEB highlighted a quote from Berwick's press conference following his nomination:

Health care has no intrinsic value at all, none. Health does. Joy does. Peace does. . . The best health care is the very least health care we need to gain the long, full and joyous lives that we really want. The best hospital bed is empty, not full. The best CT scan is the one we don't need to take. The best doctor visit is the one we don't need to have.

That's a great mind set to bring to the job of running CMS.

However, yesterday Kaiser reported that Berwick May Face Difficult Confirmation In Senate; the Washington Post reports:

Democrats in the Senate said that, given Berwick's national stature and broad-based support, he would be easily confirmed under ordinary circumstances. But lingering partisan rancor over the health-care overhaul is almost certain to slow his confirmation, Senate sources in both parties said.

If only we were living under ordinary political circumstances.

Igor Volsky's reporting provides an idea of what might be the Republican focus during Berwick's confirmation process:

The Republican Policy Committee has already prepared a memo — which I’ve obtained — that links Berwick to the British health care system and presents him as someone who supports rationing and a government takeover of health care (Download the full memo HERE)

The Senate memo suggests that the Republican strategy will be to disparage the British National Health System (NHS) and by extension, Berwick.

The gist of the memo is that Berwick consulted with NHS and has said nice things about elements of the British health system (DSEN has been skeptical, the Renal Tsar helpfully looked at NICE through the CKD lens). Most of the Republican talking points seem designed to take issue with Berwick's characterization of NHS i.e. Berwick said NHS does a pretty good job, while the memo notes news reports with examples of people who didn't like an NHS decision or practice.

The memo makes clear that the Republican goal is to create the impression, in the minds of voters, of a potential "Medicare Administrator who explicitly advocates for rationing as indicative of Democrats’ government takeover of health care". The Republicans intend to use Berwick's confirmation to pursue political ends. That is a disservice.

Medicare is an important and popular government agency that needs to be well run. CMS isn't the Veterans Administration (an example of an American version of NHS); NHS has limited relevance to the job Berwick is being asked to do - lead CMS. And CMS needs a leader. Having a fully confirmed Administer makes a difference. CMS has not had a fully vested leader for four years. CMS has made do with an acting administrator but four years is too long for this important agency to be hobbled administratively.

I hope voters will ignore the smears, should they come, and instead engage with the issues faced by Medicare and Medicaid on a deeper, more sophisticated level. Berwick has thought deeply about health care including end of life care. As a country we need to talk about end of life care. We need to discuss the care we expect Medicare to provide and Berwick is an excellent person to lead that discussion. There is nothing to fear in this process.

Berwick is the right person for the job. Republicans should not obstruct his nomination through a divisive confirmation process. Mischaracterizing the choices the next CMS Administer faces, suggesting that the intention or that there is even the possibility to create death panels, is asinine and will harm Berwick's ability to lead CMS to achieve better health outcomes and ultimately lead CMS to provide their beneficiaries with long lives of health, joy and peace.

The Good Dialysis Index

By Bill Peckham

Dr. Agar has posted his Good Dialysis Index, which he presented during the morning session of Comprehensive Course in Hemodialysis on the Saturday of the Annual Dialysis Conference weekend last month in Seattle.

Answering yes to one of the 20 questions earns you a point; anything above 16 indicates Good Dialysis. This simplicity is a design feature. The idea is to create something usable, that matches clinical experience. 

The Good Dialysis Index is a survey across four categories of questions: Patient Directed; Process Directed; Laboratory Directed; Chart Directed. Agar acknowledges that any snap shot of dialysis quality will give an incomplete picture, but over time a good GDI score will mean more than a good Kt/V.

Dialysis & CKD Blog Report 3/30

By Bill Peckham

Here are the CKD related blogs updated since my last report on 3/20. One new blog added and two blogs fire up after lull.

As always if you have or know of a blog that should be on the list let me know. Comments in parentheses are my reactions or opinions. Feel free to nominate your own favorite post.

• Dialysis from the sharp end of the needle Peter looks at unit policies and industry standards; David writes on the intersection between docs and dialyzors and Doc tapped to head CMS; I look for signs that the CKD advocacy community is changing advocacy strategies in light of the Affordable Care Act
• Kamal Shah's Blog announces the opening of what looks to be a very progressive and welcoming unit in Hyderabad (this provokes wanderdesire); takes more control of his own treatments (do what you can, while you can); skip Love, sex aur dhokha; work isn't all work
• Kaply, Inc. (I'm way behind on my Kaply, who was) sick; gets jewelry; showers; makes a tomato cry; is off food with a shelf life; moves her furniture around
• Toastiest polls suggest a disconnect; window to incenter nocturnal; cats through time; furniture through time; new couch
• NxStage Users Radi is home; Rich looks at PPS report; Katrena Lynn joins conversation with training diary
• Hasten down the wire Two multi-topic blotters and everyone can make TV
• Paddling on Dialysis for Kidney Health gets a corporate sponsor; a transaction at Sears leaves him reflective then recommitted to the 20K fund raising goal
• My Kidney Chronicles new DSEN CKD blog to date tracking the transition to incenter hemo
• The inner game of PKD set a goal; live in the moment; develop the habit of learning
• Joyful Mother window into living with PD
• CHRONIC POSITIVITY update - lights are all green
• Transplant, Tantrums, & Tiaras is too busy having fun to write it all down
• On the Road to a Lupus Cure advocacy day report; research; advocacy day video; more research
• Really, I'm as Old as I Feel? sparks up the grill; recounts past week's menu; anniversary #8
• I Am. Are you? mascots continue training - there's video, tribute song
• Dialyse This back from Duluth, it's cold up north
• Bud's Ramblings is left at home alone, spring is coming
• Linda Gromko MD kidneycare preparing for the next step after prolonged bed rest/hospitalization
• Precious Bodily Fluids running for 26 miles may not be all upside
• Renal Fellow Network is keeping busy with ten posts: the ACCORD study needs to be flagged - maintaining the peritoneum transport; low BP is more dangerous than high BP; Pancreas transplant info; nephrons are what matter; and more
• Uremic Frost Happy Doctor's Day; WKD; Nobel Prize; NKF²
• UKidney uncredited cross posting from Renal Fellows, aka plagiarism (tisk tisk tisk)
• Pediatric Nephrology nine posts including postive linking to Peter on DSEN; Kamal's PD experience; video, WKD and Grand Rounds
• Nephron Power  11 posts covering everything from horseshoe kidneys to Hollenhurst plaque and clinical cases
• pkdmom2five help; gratitude; courage
• Jean Louis Clemendot (Newest posts  at the bottom of the page) Daily reports as he gets under sail, heavy winds and rough seas on the way to the ABCs and then the Kuna nation and then the Panama Canal
• Kidney Notes twitter like blog activity
• Lemonade and Kidneys sets down to write - goes with latest kidney  news
• The Daily Dialysis gout; need to get to target BMI
• Joe Dialyzer steady posting covers FMC view on bundling and FMC patient stories; a video; NKF
• ....And Bells on Her Toes Easter is better this year; talking is fun; cats are tough; life
• Mushroom's Blog eponymous hat
• My Wife Has Lupus New drug offers some hope
• Biologically Safe Water Filters report from the ADC
• Encompass Network Partners foot screening poll
• Kidney Community Emergency Response FDA safety announcement
• Libre Clothing infusion clothes for sale
• NephrOnline Blogs 
• Renal BizBlog UNOS policy; unit data reporting changes
• Kidney Diet Tips salt is bad for people with CKD
• Renal PatientView Blog travel labs posted publicly? (couldn't do it in the US)
• My Kidney checks in, been busy away from personal blogs

NKF notes passage of Affordable Care Act, says it "will benefit Americans with kidney disease"

By Bill Peckham

I was glad to see the National Kidney Foundation take note of the new health insurance law:

With Senate approval of health care reform on March 25, 2010, we wanted to highlight some of the provisions contained in the underlying bill and in the corrections bill (or "reconciliation bill").  (The legislation signed by President Obama on March 23, 2010 was the underlying health reform bill and identical to what the Senate passed on December 24, 2009; the corrections bill made changes to the underlying bill, under agreement with House and Senate leaders.)

The National Kidney Foundation (NKF) did not advocate for or against a specific health care reform bill throughout the process.  However, we signed various letters of support on specific provisions (such as eliminating lifetime benefit caps) that were coordinate by coalitions and organizations. We believe that the legislation will benefit Americans with kidney disease or at risk of developing it. Here are some of the well-known features of the health care reform package that should have a positive impact on the population we serve.

The communication goes on to list some of the top line elements of the legislation.

The communication concludes by reaffirming the NKF's commitment to expanding Medicare to cover immunosuppressant drugs for the the life of the transplant. This has been a long standing organizational commitment, I believe a commitment approved at the board level. This means that it will take board action to change.

I think the NKF board and other advocates for better transplant outcomes need to act quickly by evaluating their public policy advocacy efforts in light of the new law. The law directs the Secretary of DHHS to make numerous decisions on how to implement the high risk pool insurance that is meant to bridge the period between January 2011 and January 2014. The immunosuppressant advocacy opportunity would be to push for a bridge extension of Medicare coverage.

A bridge extension of Medicare coverage for immunosuppressant drugs would cover the period between January 1, 2011 and January 1, 2014 when the expansion of Medicaid and the exchanges (with subsidized access) come into being. The bridge is needed to maintain immunosuppressant drug access for people who can not afford the high risk pool premiums.

You want people with transplants to have access to the high risk pool insurance but the program is designed to offer insurance at the rate you'd get, were you healthy. Even at this lower, "reasonable" rate, health insurance and thus immunosuppressant drugs, would be out of reach of many. This is where the bridge extension would come in: until subsidized health insurance access is available in 2014 the bridge would allow people limited Medicare coverage for immunosuppressant drugs.

Those advocating for lifetime immunosuppressant drug access through Medicare all these years may find it hard to retool their advocacy message but I would describe this as an opportunity. There should be celebration in the CKD community. Within our grasp is lifetime access to health care post transplant. Not just drugs but health care, for everyone living with a transplant. If advocates are nimble they can ensure that this problem of post transplant insurance access is finally comprehensively fixed in a way that improves the medical outcomes of people living with a transplant!. Through retooled advocacy this can be done sooner rather than later.

CKD Advocacy Community Needs to Take Their Binders

By Bill Peckham

The CKD advocacy community is calcified, they could really use some binders.

I spent some time this afternoon looking through the advocacy, professional and provider sites on DSEN's big link list. With two exceptions there is no mention of HR 3590 the Patient Protection and Affordable Care Act, the health insurance reform legislation signed into law last Sunday. When MIPPA passed there were numerous communications from all corners of the CKD advocacy world explaining the details of the legislation and its expected impact.

To date I have not seen a single communication from any advocacy group on the impact of the health insurance bill. Only the Lupus Foundation of America highlights some of the bill's provisions directly, while the American Society of Transplantation links to a pdf of the Bryan Cave Health Reform Update (March 24, 2010)(PDF link). That's it. No one else even mention the historic passage of reform that will unalterably change the CKD advocacy landscape. I didn't even see links to news articles let alone CKD specific analysis (I apologize in advance if I missed one - I looked).

How can it be, with all the highly paid analysts at the various DC lobbying firms, that no one seems to have looked at this bill through the CKD public policy lens? I believe that this bill makes obsolete many of the positions held by the dialysis and transplant community, does it? Does making insurance widely available obviate the need to extend Medicare immunosuppressant drug coverage? I think it does. Why hasn't any of the many organizations advocating for expanded access to immunosuppressants come forward with definitive analysis one way or the other?

I think that the legislation, by adding some 20,000,000 previously uninsured adults to the insurance roles, means that thousands of people who previously would have started dialysis without any health insurance will now start dialysis with private insurance primary. If those 20 million adults are average how many would be expected to start dialysis in a given year? According to the USRDS ADR the number of people who start dialysis each year is about 350 per million - so in that group of 20,000,000 you could expect 7,000 to start dialysis.

What would have happened before this health insurance reform? Here's renal social worker extraordinaire Beth Witten on what happens today:

I get calls and emails all the time from pateints, family members, social workers, Networks, etc. trying to find ways to help uninsured or underinsured people who are US citizens or permanent legal residents pay for dialysis when dialysis clinics refuse to accept them unless they have coverage for dialysis. I've heard my social worker colleagues lament the time they have to spend on teleconferences explaining situations that can't be fixed in the current health insurance system which denies coverage or charges premiums that are too high for people to pay. I've heard of providers donating money to AKF to get their patients premiums paid for EGHP (including COBRA) premiums so those providers can recoup many times what they've donated for as long as possible.

Does the new legislation address this issue as I think it does?

Where is the analysis from the KCP? From the KCC? I hear that maybe those with insurance through the exchanges would not be subject to MSP. One, if that is true it would be a good thing to advocate about but two, how could that be true? Many of the people in the new exchange could be expected to have not paid into Medicare - a self employed landscaper, for instance. Without any work quarters to qualify under the ESRD program it makes no sense to think that the exchange insurance would drop him due to illness. That would be a news worthy exception to how the bill has been described. 

Right now the number one advocacy issue in the dialysis world is KCP's call to push Congress to push CMS to pay more for oral meds if they're going to be included in the expanded bundle. DPC, AKF and ANNA have versions of the Capwiz letter on their sites. DPC, NKF, RSN and AKF sent a letter cosigned by the four groups last week. None of the organizations acknowledge the language signed into law that directs the GAO to conduct a study. None of the organizations acknowledge the changes to Medicare Part D that will likely increase appropriate use of the oral drugs in question.

Together, these elements of the bill the President signed into law will make it much less risky for CMS to add oral meds at a later date. It'll be less risky because CMS will be better able to judge the appropriate level of use and the cost of that level of use, if all Part B beneficiaries had access via dialysis. If it is less risky in the future, than it is riskier to proceed now. That is a very powerful message. Why isn't that the suggested message?

Why are the CKD advocates proceeding with the messages they developed pre passage of HR 3590 the Patient Protection and Affordable Care Act? Why is there no analysis of the impact on CKD policy issues available from any of the CKD organizations interested in public policy?

It is ironic that as CMS works to address the calcium balance among people who use dialysis, that it is the organizations that advocate on our behalf that could really use the oral drugs without injectable equivalents.

Drug And Device Companies Will Now Have To Report Payments

By Bill Peckham

Merrill Goozner has a post that highlights a small piece of the health insurance reform legislation that will mean:

Drug and device companies will soon have to report payments to physicians in a national database, thanks to a little noted section of the health care reform bill called the Physician Payments Sunshine Act.

Too bad it won't be able to publish retrospective data.

Reading the text of S. 301*, the Physician Payments Sunshine Act of 2009 it applies to:

‘(1) APPLICABLE GROUP PURCHASING ORGANIZATION- The term ‘applicable group purchasing organization’ means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply.

I'm not sure if that would include dialysis providers. It seems like it would, they negotiate the purchase of covered drugs, but it is the Secretary of DHHS's call. There will probably be a letter writing campaign any day now.

* it looks to me this went into the health insurance reform bill in it's entirety as Section 6002, the language as signed by the President is here but be warned it is a large file, viewing options at link.

Kidney Community silent on legislation that massively benefits people with CKD and those that provide our care

By Bill Peckham

I don't usually pay attention to renal industry stock prices and I am suspect of arguments that rely too much on a stock price or the market generally, but I was curious about DaVita's stock price on news that the House passed the Senate health insurance reform bill and thus, no matter the fate of the reconciliation sidecar, health insurance reform. DaVita's stock was up 1.29% today, not a big move but still a 52 week high.

I think this in part reflects a sophisticated understanding of how HR 3590, the Patient Protection and Affordable Care Act, will benefit DaVita and all dialysis providers. On the operations side, millions more people will have private health insurance (health insurance companies are also trading at new highs), that means thousands more people will have private insurance paying for their dialysis for the first 33 months that they require treatment. On the care side, people will now be more likely to start dialysis with a fistula because those identified with advanced CKD will be able to buy into high risk pools at the state level starting in 2011; once the insurance exchanges are established in 2014 people will transition off the state high risk pools(PDF).

When I was first diagnosed with CKD I was looking for my first job after college. Those four months between graduation and hearing the CKD diagnosis were the only four months of my life that I did not have insurance. After President Obama signs this bill today's Bill Peckhams will be able to stay on their parent's insurance as they transition from school to a career(PDF).

There are many great things for those that are fighting the dull advance of CKD in our society but for those using dialysis, with Medicare Part D, this bill, post reconciliation, acts to close the donut hole and makes other improvements in Part D coverage(PDF). This is in addition to language specific to the reimbursement of dialysis, calling for the GAO to study the inclusion of oral drugs under the PPS.

This legislation does all of this for the kidney community - increases future profits, improves patient health, provides helpful action that will make adding oral drugs to the PPS in the future less risky for CMS and beneficiaries - I thought there must be a big banner of gratitude and thanks on the Kidney Care Partner's website. Best. Legislation. Ever! Maybe? Nope.

KCP has not a word to say about the biggest victory for the provision of dialysis since passage of the original Medicare entitlement in 1973. The nation's premier coalition of patient advocates, dialysis professionals, care providers and manufacturers dedicated to working together to improve quality of care for individuals with Chronic Kidney Disease is silent on the most important CKD advocacy win in a generation.

Instead of elaborately thanking Congress for this huge win for better CKD care they'd like you to send Congress a form letter echoing the letter I commented on last week. People have to follow their own heart but in my book thanking people should come before asking for more.

Dialysis & CKD Blog Report 3/20

By Bill Peckham

Here are the CKD related blogs updated since my last report on 3/16. One new blog added - see if you can find it - and PD dialyzor Jean Louis is setting sail with real time English translations so you have no excuse and should follow his trip as he heads from the Caribbean to Tahiti, while using PD.

As always if you have or know of a blog that should be on the list let me know. Comments in parentheses are my reactions or opinions. Feel free to nominate your own favorite post.

• Dialysis from the sharp end of the needle looks at the national advocacy scene, tries to offer constructive advise; Peter follows the K data back to 1974
• Kamal Shah's Blog cheers on medical oversight
• Kaply, Inc. Tracy's hair is great, Amy is great and there was walking. And birthday lasagna, also.
• Toastiest  checks where the Google places his flickrs; cats; posts the text of the President's speech to the Democratic caucus (I haven't had much luck making sense of the outrage either)
• NxStage Users Radi4music keeps up the training diary with nice things to say about the Northwest Kidney Centers (without NKC there would be no DSEN)
• Hasten down the wire judging criticism requires considering the source
• The inner game of PKD continuing the QoL blogging - passion
• The Life of a 20-Something With Lupus ROs are just another thing that can break
• On the Road to a Lupus Cure support the Lupus Foundation's advocacy efforts from home
• Really, I'm as Old as I Feel? a new rain coat; classroom report - parent teacher conference night
• I Am. Are you? yes there are mascots aplenty and results! 5.1 million registered donors; and you could have won tickets to a concert
• Chronic Chick Talk the dog has a cape
• Bud's Ramblings had a nice day starting with breakfast, gnomes need paint
• Linda Gromko MD kidneycare in the midst of going day to day while her loved one is in the hospital, is able to take a step far enough back to describe the stages of the journey for care partner and care subject
• Precious Bodily Fluids (another thing I will never understand that nephrologists understand)
• Renal Fellow Network is keeping busy with posts from docs covering grand rounds, case reports and identifying the nephrologist as team leader (ideally a patient/nephrologist partnership is at the center of care)
• Uremic Frost thought statins would preform better in people with CKD
• UKidney links to RenalWEB RPA report
• Pediatric Nephrology case reports and slides; links to the excellent nephrology history post on Kt/V
• Nephron Power links to nephrology history Kt/V post; presents case study
• pkdmom2five nephrologist visit is less than ideal
• Jean Louis Clemendot (Newest posts are at the bottom of the page) ready to set sail, now the news is live translated into English and Spanish (DSEN will update the link I haven't seen where the Spanish is)
• Kidney Notes guide to the Google; twitter feed to follow
• Lemonade and Kidneys sometimes you need the godfather of soul to say what you feel
• Joe Dialyzer new DSEN CKD blog with NKF links and video (so are we the dialyzee?)
• ....And Bells on Her Toes should be given a vacation - husband is home
• My Wife Has Lupus connects the random
• Encompass Network Partners prevent amputations
• Chronicals of the PD Warrior new blog - went HHD
• Kidney in the News is back with FDA news

The letter I would write to Congress to solicit their help to get the best PPS

By Bill Peckham

I think it is fair to ask what letter I would support, as is often said, it's easy to be a critic. This is the letter I would like to read from four of the leading CKD advocacy groups. I changed the date and the approach:

March 25, 2010

Dear Members of Congress:

We congratulate Congress on the historic vote and the passage of legislation to reform the health system, HR 3590 the Patient Protection and Affordable Care Act. These reforms will benefit people with chronic kidney disease, particularly by ending the practice of excluding people with preexisting conditions from participation in the health insurance market and action to close the so called "Part D donut hole". Thank you.

The dialysis community has been working to implement previously legislated reforms, we are writing to ask your help with that process.

The Centers for Medicare and Medicaid Services (CMS) is in the midst of finalizing its End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Rule.  The rule implements provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) that require the Agency to establish a bundled payment system for dialysis services. CMS published the proposed rule last September 16th; the comment period closed December 17.

One measure in HR 3590 that is specific to the ESRD program, Section 10336, directs that:

The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system ...

We believe that this provision brings helpful clarity to the choices CMS must make as it prepares the PPS final rule.

In September CMS proposed to shift all oral drugs without injectable equivalents, including calcimimetics and phosphate binders (oral drugs), into the bundle. This proposed policy was the subject of the most public comments during the PPS's comment period. The vast majority of these comments, including the vast majority of comments from people who use dialysis, spoke against the idea of including oral drugs at this time. We feel this consensus position should be supported and we urge Congress to make clear that the GAO report is meant to be a prospective study, that this study should inform the future process of including oral drugs in the PPS.

We believe that CMS can implement the PPS program MIPPA requires in a way that improves care for individuals who need dialysis services and does not endanger the progress in quality of care made in recent years. However, for that to happen CMS must wait for the GAO to study including oral drugs, and allow the implementation of MIPPA to proceed without their inclusion.

We ask that you contact CMS to underscore the intent of your recent legislation. It should be made clear that the study required by Section 10336 should be completed before CMS acts to include oral drugs under the dialysis PPS. By clarifying the intent of the GAO report, you will be supporting the concerns of Medicare beneficiaries.

We asked the beneficiary community, the people who use dialysis, and their loved ones, to engage with the PPS comment process, and they came through with scores of thoughtful, actionable comments. Reading through these many comments it is clear that aside from the inclusion of oral drugs, beneficiaries are most concerned about CMS's method for including laboratory services (labs) and the inclusion of home dialysis training under the routine PPS payment. The comments not only identified the problems they offered solutions. These comments should be acted upon.

We request that you encourage CMS to take seriously the thoughtful comments of beneficiaries, and the thoughtful and actionable comments of the organizations who represent individuals who need life-saving dialysis care, including the undersigned.  The issues are complex and there is limited time to act, but CMS must get the policies right.  At stake is the health and well being of hundreds of thousands of Medicare beneficiaries.

Warm regards,

Maybe the idea is that members of Congress don't have to meet the various comment period deadlines but it seems to me that the place to advocate now is where legislation has created an opening.

The approach of getting Congress to challenge CMS's results could have unintended consequences. Assuming HR 3590 the Patient Protection and Affordable Care Act passes, advocates would be wise to build on the language to study the inclusion of oral drugs and hope that they made their case sufficiently on other issues while the comment period was open.

CKD Advocacy Groups Write Congress a Curious Letter. Why now? Why this?

By Bill Peckham

I'm happy to post this letter, as asked, from four leading CKD advocacy groups to members of Congress concerning the proposed Prospective Payment System for dialysis (PPS). These groups all represent themselves as speaking for those who use dialysis: Dialysis Patient Citizens, Renal Support Network, National Kidney Foundation, and the American Kidney Fund. However, I have to say that I find the letter's reasoning to be internally inconsistent, and I find their choice of issues do not reflect the priorities expressed in the public comments filled by commenters who self identified as dialyzors. 

DPC, RSN, NKF, AKF Letter

I would say that the top beneficiary issue is access to home dialysis; indeed sometime during the next several months would be a good time to ask Congress to voice support for home hemodialysis (HHD) and to ask CMS to encourage HHD in the final PPS but this issue goes unmentioned in the letter.

All four of the signers expressed support for fair home hemodialysis training reimbursement in their public comments to CMS (view all public comments, or download as an Excel file), yet in the letter to Congress this issue is conspicuously absent. The letter chooses to discuss: oral drugs, lab tests, an adjuster for African Americans, and ... a technical issue around a withhold due to the expected cost of providers who choose to phase into the bundle over three years. Come on.

First of all, how can you write a letter to Congress yesterday, this week, and not mention the health insurance reform bill? This signals obliviousness on the part of these advocates. In the left column of DSEN there is a link to The Hunger Site - you should click it. That's there to acknowledge that the provision of dialysis is not the most important issue facing society. The provision of dialysis is not the most important issue facing Congress. Or CMS.

This blog is focused on the provision of dialysis because it's important to me and people read DSEN because the provision of dialysis is important to them but let's not pretend it's the only thing that matters. The timing of this letter makes no sense to me; the content makes less sense.

The health bill that may well be signed by the President and go into law , in the next two weeks, contains the Senate language calling for the GAO to study the inclusion of oral drugs under the PPS. Why continue to bang on about CMS's lack of diligence in proposing oral drugs' inclusion when there is an obvious way for everyone to save face. Study the issue. Get it right. Support the concept of seamless care. These are not difficult positions to take. Additionally, the letter complains about the dollar amount being added to the proposed payment rate, that the amount is not enough to cover the cost of these oral drugs.

I don't think that is appropriate. No one has the full picture of what prices the providers could negotiate for these drugs. It is tempting to say it's not enough but how can you take a position when you don't have access to cost data? Part of my comment about including the oral drugs is that CMS doesn't have access to the cost data because it isn't being done. No one knows what it would cost to provide universal access to these important and useful drugs, so how can these advocacy groups take a position? Because of what they've heard? They should stay away from the numbers.

In general, I agree that the way CMS proposes to include labs is a problem but the way this letter makes the case raises questions. I don't think the primary issue is the copay - MIPPA clearly imagines labs are going to be included. The copay isn't that much and to the extent it is, the letter writers' complaint is with Congress not CMS. The letter is asking Congress to lobby against their own legislation. Tactically the problem is that that this letter raises the copay issue as an important consideration. This undercuts their next concern.

If lab copays are an important consideration. And if singling out ESRD beneficiaries to be the only beneficiaries responsible for lab copays is a problem. Why wouldn't those problems be problems with including a race adjuster? The race adjuster would mean higher copays too. ESRD beneficiaries would be the only Medicare beneficiaries subject to higher copays due to race.

Including a race adjuster could be said to levy a tax on people who self identify as African American. The additional copay due to the race adjuster could be $3 a treatment or more. Ten times the additional copay due to labs tests. The letter asks that "The final rule should not increase the financial burden of care on dialysis patients" but copays will necessarily increase for some people, while for others copays will be less.

This dynamic is in the nature of expanding the bundle and is due largely to the inclusion of EPO. The letter, after raising the copay issue, ignores the varying copay impact of the race adjuster as well as the numerous adjusters that the PPS did propose, in favor of bringing up an obscure provision having to do with paying for providers who opt to phase into the bundle over three years.

That is an odd choice. That is an odd choice for patient centered organizations. I think there is a far more important issue to ask Congress to support.

I believe that at least 10% of Medicare beneficiaries would be happier and better cared for, if they were dialyzing at home. I think the leadership of the four organizations that signed this letter believe that at least 10% of Medicare beneficiaries who use dialysis would be happier and have better clinical outcomes if they were using HHD. That's 40,000 people. The current home hemodialysis training capacity in the United States is less than 4,000 people per year.

When you consider the training needs to replace those who get a transplant or go back incenter we will never meet the true demand for HHD without a magnitude increase in the number of HHD training slots. For every current training slot we need ten. For that to happen CMS will have to create a fair home hemodialysis training payment under the expanded bundle.

Reading the public comments submitted by people who use dialysis, creating a home hemodialysis training rate is the most important change CMS could make to the PPS, yet it isn't even mentioned in this letter. I find that curious.

Passage of Health Overhaul Bill will unalterably change the CKD advocacy landscape

By Bill Peckham

I take there to be at least three foundational policy positions in the CKD advocacy community. Not that everyone has the same position but that everyone has a position on: extending immunosuppressant drug coverage for the life of the graft, include/exclude oral drugs in the final dialysis PPS rule, and the length of the Medicare Secondary Payer provision. In the first case everyone in the CKD advocacy community seems to be on the same page, in favor of extending coverage. Positions on including oral drugs are less clear cut, and in the case of MSP, CKD advocates disagree, but generally CKD advocates have positions on these three issues. 

The passage of the Health Overhaul Bill, without specifically addressing it, will take the immunosuppressant issue off the table by providing routine access to insurance. The question of whether to include oral drugs in the final PPS will be moot since the final Health Overhaul Bill will include a call for the GAO to study the issue. And by eliminating the preexisting condition issue, and life time insurance caps, the Health Overhaul Bill leaves me without a strong objection to extending MSP and I agree that there is an opportunity to create an important incentive by extending the MSP period only for those dialyzors who are working or actively seeking paid work.

Am I missing something or will the CKD advocacy landscape unalterably change with the passage of this bill?

Dialysis & CKD Blog Report 3/16

By Bill Peckham

Here are the CKD related blogs updated since my last report on 3/2 TWO WEEKS AGO. This will be the most epic blog update to date ... a lot of posts were made in the last two weeks. As always if you have or know of a blog that should be on the list let me know. Comments in parentheses are my reactions or opinions. Feel free to nominate your own favorite post of the last two weeks ... I dare you to read them all.

• Dialysis from the sharp end of the needle has had 18 posts since the last blog report (my favorite is the Hats Off to Scribner post). Anna stopped by (Yay!); DSEN welcomed two new writers - Jim and David - and the Annual Dialysis Conference came to Seattle which generated a number of posts; Peter has been tracking down research on stunning and now myocardial ischemia in a call for more research (truly an urgent need)
• Kamal Shah's Blog has six posts since the last update - they are a good representation of his blog's topics: the blood tests arrived; iPhone is never the source of the problem; a vignette of India: a film; personal advocacy efforts expand; news on the provision of dialysis (if you haven't read Kamal's blog, check it out; if you have ... cheers)
• Kaply, Inc. is in with ten posts since we last checked and, ah um ... really just go read her blog, if you don't think it's funny, well fine but it is
• Toastiest comes in with eight posts - I really like the top flickr photos but the post asking for a donor is the important one to read; along with his strategy to get some sleep during his nocturnal incenter runs; for you March Madness sorts ... pool up
• NxStage Users has seven new posts by five people including usual suspect Harvey, Dan and Rich and now two new writers Willowtreewren and Radi4Music. Harvey is on the road; Dan reveals he is Dialysis Dan; Rich went to ADC; WTW shares experience gained; R4M is providing a well written training diary as she transitions directly from PD to HHD
• Hasten down the wire with five posts covering digital privacy, internet search and limits to growth; newish blotter feature with short post under various categories (I like the Blotter, I might steal it)
• Paddling on Dialysis for Kidney Health makes up for number of posts (2) by posting entire PPT presentation from the ADC (I think he was planning to sing at one point during his talk - it would be worth flying him in to speak to your group just for the singing!)
• The inner game of PKD has four posts focusing on PKD
• The Life of a 20-Something With Lupus five posts, gets some recognition for her writing; friends have a video; dealing with the doctor's never ending hoops
• The Adventures of Stacy Without An E two posts - gives out awards (you don't want to win one of these); posts a CKD musical
• Joyful Mother keeps us updated
• CHRONIC POSITIVITY February post Tx labs
• Jack's Kidney Adventure it's soccer season already (sure sign of spring)
• Transplant, Tantrums, & Tiaras gets settled into work, a new title and a friend gets the call
• On the Road to a Lupus Cure has six posts promoting ways to get involved with the lupus community and advocacy
• Really, I'm as Old as I Feel? six posts keeping up with life
• I Am. Are you? four posts: embedded videos, ambulatory plush creatures (shiver)
• Chronic Chick Talk video (drummer for Talking Heads did original version); chronic pain is real
• Lupus and Humor five posts including a vent
• Dialyse This heading south of the boarder - to Duluth
• Bud's Ramblings quick update
• Linda Gromko MD kidneycare five posts: tracking Steve's hospital stay (Sending good thoughts); fitting into the home
• Precious Bodily Fluids seven posts including on hypokalemia; irony; kayexalate; RCT; unmatch
  
• Renal Fellow Network has twelve posts as it continues on with a large group of new contributors
• Uremic Frost ten posts covering the latest nephrology news
• UKidney eight posts including DSEN reposts
• Renal tsar's blog eight posts covering NHS reports and news
• Pediatric Nephrology and the winner is ... Pediatric Nephrology with 31 posts
• Nephron Power 13 posts covering news of the kidney
• Kidney Doc Talk vitamin D for CKD
• Jean Louis Clemendot (Newest posts are in French at the bottom of the page, copy and paste into Google Translate) The adventure begins! (Bon Voyage!!)
• Diario de diálisis Crónicas (en Español)  Journal dialysis - Chronicles (Google translated from Spanish) World Kidney Day
• Kidney Notes four posts linking to news for the wired physician
• Lemonade and Kidneys four posts covering life with kids
• OH Positive: Rob needs a Kidney Transplant nice account of kidney walk with writer of other DSEN tracked blog
• The Daily Dialysis working to get listed
• ....And Bells on Her Toes seven post the last three share the heart wrenching experience of having a kid in the hospital (I can not begin to imagine)
• Kidney Dialysis News Baxter recall; new show on the Beeb
• Jenna Franks WKD
• PKD World reposts from the WWW
• Living with PKD YouTube has exercises
• My Wife Has Lupus looks at research; how do you keep track of all this?
• Michael W. Newman example letter when dealing with doctor office billing mistakes
• Life on Dialysis recounts efforts at forging connections; plans go awry; toughs it out
• I'm-u-no-logic a poem
• Berns on Nephrology has new video up
• Encompass Network Partners keeping your feet healthy
• NephrOnline Blogs scattered posts on MedPAC; donors could reap mortality benefits
• Renal BizBlog WKD; C-TEP; ER Tx
• Kidney Diet Tips WKD
• Nathan's PKD guest blogs
• History of Nephrology nice post on the first RCT to look at conventional dialysis

Monday at the Annual Dialysis Conference - the debate

By Bill Peckham

I attended a great session this afternoon at the Annual Dialysis Conference:

Challenges to and Defenses of Dr. Kjellstrand’s Keynote Address at the 2009 ADC: Clinical Observations vs. Randomized Controlled Trials (RCTs) in Dialysis Research
Richard Amerling, MD, Presiding

• RCT Is Redundant if Observational Studies Consistently Show that Daily HD Is Superior- Zbylut Twardowski, MD
• Observational Studies Are Not Always Reliable Due to Lack of Randomization and Biases - Marcelo Tonelli, MD
• There Is Not Enough Observational Evidence to Support Funding and Widespread Application of Daily HD - James Sloand, MD
• The Waste of Life, Time, and Money Waiting for the Results of RCT in Daily HD - Carl Kjellstrand, MD

I really enjoyed the exchange; I'm looking forward to writing about it but not tonight.

Maybe I'll be able to write something  while I'm traveling to Baltimore tomorrow for the TEP (the full roster of all six TEPs is posted). Once the meeting starts DSEN may go quiet for a few days.

Hats off to Scribner

The Northwest Kidney Centers, with this full page ad in the Seattle Times (on page A5 today) is celebrating Scrib's achievement and honoring the physician who's insights and understanding of dialysis echoed through all the Annual Dialysis Conference sessions that I attended. His most noteworthy achievement happened 50 years ago, tomorrow.

March 9th, 1960 was a Wednesday, the second Wednesday of the month. On that day Scribner began what today we realize was the first chronic hemodialysis treatment. That treatment lasted over 70 hours. Clyde Shields dialyzed the entire day on what would have been World Kidney Day in 1960, the second Thursday of March. The whole day. That was the first World Kidney Day.

The first World Kidney Day was March 10, 1960. The day Clyde Shields dialyzed all day. The day, I imagine, Scribner first understood that ongoing dialysis might really work.