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.

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.

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.

Price Comparison Shopping Enters the Medical Marketplace

By David L. Rosenbloom

A stent is a small, metal, cage-like tube which is used in angioplasty to widen an occluded artery. I had two such stents inserted into my renal artery six months after my kidney transplant because I had developed a stenosis, or narrowing of the artery, due to a buildup of scar tissue from the transplant. The procedure was done out-patient under a light sedative, and lasted about two hours. It’s a fairly common procedure, particularly for cardiac patients with an arterial stenosis.

My procedure was successful. Several months later I received an explanation of benefits (EOB) from Medicare outlining the hospital’s charges and the amounts approved and paid by Medicare and my secondary insurance. The difference was shocking, to say the least.  The hospital, a well-known university teaching hospital with an excellent reputation, billed Medicare $91,471 including the surgeon’s fee. The two stents, billed at $29,019 each, amounted to 64% of the total cost. Medicare allowed $5,801 for the hospital and $705 for the surgeon.  This was amazing considering that my entire transplant surgery and five days of hospitalization was billed at $212,000. Medicare allowed just under $24,000 for that much more involved surgery.

Another way of looking at this ludicrous pricing situation, over which I had no say, is to imagine that I had ordered a brand new Porsche Panamera but received a used Ford pickup instead. In reality I probably got the equivalent of Porsche stents, if there is such a thing, at a bargain-basement price. What was the “real” cost? Who knows. Hospital pricing is so opaque and Byzantine that price comparison shopping by patients is impossible. For decades, health insurers have privately negotiated reimbursement rates with hospitals and physicians, often agreeing not to reveal those numbers for competitive reasons. This practice, however, is about to change radically.

I was thinking of all this while reading an interesting New York Times article, Bringing Comparison Shopping to the Doctor’s Office. Several new companies are beginning to develop medical cost-comparison databases to help patients and employers estimate prices for the most common medical procedures like colonoscopies and other diagnostic tests. With the coming of health insurance exchanges built into the new reform legislation past earlier this year, upwards of 40 million formerly uninsured people will soon  be shopping for mandated health insurance. Coupled with many large employers seeking ways to reduce their outlays for healthcare benefits, cost-comparison firms may become a growth industry which finally introduces open competition into the healthcare market.

One such company is Castlight Health, a San Francisco-based startup founded by Dr. Giovanni Colella, former head of Relay Health, a web-based service connecting doctors and patients, and Todd Park, former co-founder of Athenahealth and now chief technology officer of Health and Human Services (HHS). Castlight has developed a way to pull data from millions of EOB forms supplied by employers seeking cost-comparison data. Safeway, the grocery chain with 200,000 employees, has signed on as Castlight’s first customer. Employers pay a fee by the employee by the month. A mobile version is being developed so employees can access the Castlight database right from the doctor’s office.  Eventually, they will offer the service to anyone via the internet. 

What makes Castlight unusual, is that it is being financed not only by private investors but also by the prestigious Cleveland Clinic. To date, Castlight has raised over $80 million. The Cleveland Clinic, headquartered in Cleveland, OH, with satellite clinics throughout Ohio, Florida, Nevada and the United Arab Emirites, would not reveal how much they have invested, but were eager to explain their interest in this new venture when I contacted them a few days ago. Spokesperson Eileen Sheil said that Cleveland Clinic “has established transparency as a high priority in recent years. We offer all in-patients 24-hour access to their medical records, which they can also retrieve from home on our web site, and we regularly share our financial and business relationships with physicians with the public.”

Recently Dr. Delos Cosgrove, chief executive of the Cleveland Clinic, was quoted in the N.Y. Times saying:

Ideally, transparency in health care pricing could lead to higher-quality, lower-cost health care, and more patient involvement in buying health care ... “Because they begin to realize that a trip to the doctor is not free, they might stay home and take the aspirin instead of getting the neurologic work-up.”

Ms. Sheil added that the Clinic wants to stay “ahead of the curve on trends” in patient-centered medicine, and remain a leader in quality healthcare in the U.S. and the world.  Currently, the Cleveland Clinic has 3.5 million patients worldwide.

Recent studies suggest that the more patients know about prices, the more money they save. Mercer, a research unit of Marsh & McLennan the internationally known business consultant, found that people on high-deductible health plans spent less when they had knowledge of the prices of doctor visits and diagnostic tests.

A point reinforced in the Times article. 

“I’m a big believer in trying to create market forces wherever you can and then let personal accountability really drive the result,” said Steven A. Burd, the chief executive of Safeway.

For instance, Safeway pays up to $1,200 for its employees’ colonoscopies, a preventative procedure to detect cancer. If employees wish to go to a doctor who charges more, they must pay the difference. According to Castlight, colonoscopies in the Bay Area, where Safeway is based, range from $500 to $3,000, and sometimes a doctor charges different rates at different hospitals.

While Castlight plans to add quality measurements to its price information, there is no universally accepted set of quality measurements in medicine. Also there are many procedures for which Castlight’s service is not applicable, like the delivery of a baby with complications or any type of extreme emergency such as a heart attack or serious injuries requiring immediate surgery. But it does seem like a sensible start to bringing more buying power into patients’ hands and has the potential to help control spiraling medical costs, which now account for 16% of our GNP, the highest in the world. 

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?

Cost Consciousness and Patient Care: Can they be compatible?

By David L. Rosenbloom

Cost effectiveness has been a byword in the business and manufacturing worlds for many decades. And we know it can be a double-edged sword, providing economic benefits while simultaneously causing unintended societal harm.  The same may be true today in our current efforts to reform medical practice in America by lowering costs while doing no harm to patients. The manner in which we educate the next generation of doctors and patients may determine the outcome.

A case in point was recently made by a commentary in the NEJM by Dr. Molly Cooke, professor of medicine at the University of California, San Francisco, and director of the school’s Academy of Medical Educators:

It is old news that the cost of medical care in the United States is unsupportable, yet we seem unable to grapple with the issue effectively. As current ideas for health care reform have percolated through Congress, cost-control mechanisms have generally been recognized as the weak component. Our country is remarkably generative in the development of new diagnostic tests, drugs, and procedures — and remarkably undisciplined in their deployment. New diagnostic and therapeutic procedures and the broadened application of established ones account for two thirds of the growth in health care expenditures. Since the importance of this problem has been recognized for nearly 40 years, one might imagine that medical educators have attempted to incorporate cost consciousness into their teaching, but such efforts have been remarkably few, and curricula remain largely silent on the role of cost in the planning of diagnostic and treatment strategies.

Dr. Cooke points to the length of a hospital stay as another important driver of the costs.

It unfortunately becomes a high priority to prepare patients for early discharge, which often serves as a rationale for preemptively ordering tests and consultations to avoid delaying discharge. Consequently, students and residents have scarce opportunity to practice cost-effective diagnostic strategies and explain their rationale to patients and families.

Dr. Michael Whitcomb, former senior vice president for medical education at the American Association of Medical Colleges, and former editor of the journal Academic Medicine, is quoted in the New York Times as saying:

“Medical schools have done a really terrible job over the years in educating students about the system that they’re going to encounter.”  According to a recent A.A.M.C. survey, about 60 percent of 102 American and Canadian medical schools include some material on health care costs, although the time they devote to it varies widely…  A separate survey of 155 large teaching hospitals, that together sponsor more than two-thirds of accredited residency programs in the U.S., found that only 41% had made sure that all their residencies included material on health care costs.

It’s not that medical students don’t have any idea of the cost of procedures.

The NY Times continues:

“You definitely try to think about it,” said Dr. Ian Warrington, a first-year resident at Beth Israel Deaconess Medical Center in Boston… All of us are aware that a CT scan is significantly more expensive than a chest X-ray, and an M.R.I. is significantly more than a CT scan”.  But resident doctors’ heavy workloads and the need to care efficiently for very sick people make it hard for them to consider the cost of tests and treatments.

I had a recent conversation with Dr. Donald W. Larsen, chief medical officer at the USC University Hospital and the USC Norris Cancer Hospital in Los Angeles. Dr. Larsen is clearly aware of this time/benefit constraint in medical education:

“Certainly teaching medical students, residents, and attending physicians these skills are a real challenge these days given the volume of skills they must acquire in a limited period of time in a rapidly changing environment. This is compounded by regulatory restrictions on work hours and tight control by the Accreditation Council for Graduate Medical Education (ACGME) on residency training programs that don’t leave much room for creativity.

Other important topics include professionalism, ethics, quality, patient safety, and risk management. Somehow they also have to learn how to manage their medical practice, as well as prepare and pass their medical boards.

I think electronic medical records will be very helpful decision making tools in the future, not only with regard to benchmarking and best practices around clinical decisions, but also may help us make cost effective decisions. Though we have to be cautious that we don’t go too far and compromise care for the sake of saving money.

The crux of the dilemma goes to the very nature of how we as a society view our physicians and how they view their role in that society.  Dr. Cooke points out that physicians see themselves, and teach students accordingly, that doctors are advocates for each patient, “obligated to eschew all considerations other than benefit to that patient and his or her preferences.”

However, she warns that:

... we must abandon the myth of the physician as single-minded advocate for any amount of benefit for every patient. We make all kinds of choices in caring for patients; some involve denying care that patients perceive as — and that might actually be — beneficial. Given that we make value-based decisions about the deployment of other finite resources, such as our time and the use of beds in the intensive care unit, why not about costly treatments?

So where do we go from here? 

For awhile now, many in the medical field, like Dr. Donald Berwick of IHI, have been advocating that patient centered care must involve the patient in the process of diagnosing and strategizing treatment. The expanded access to detailed medical information, much of it on the internet, has transformed many patients from dependent and acquiescent to activated, informed, and sometimes insistent consumers of health care services.  And in the best instances, doctors recognize patients and caregivers who are educable, and make them an integral part of the healthcare team.

I know in my own long history with kidney disease, I have become less dependent on my doctors to make those decisions.  I am the ultimate consumer of those healthcare services and I seek to know the cost-benefit ratio, particularly if a procedure or test seems unwarranted or will do more harm than good. It is often the small things we do that alter our lives for the better. Grand plans for reform rarely work as we hope. Often the simplest changes make the biggest difference. And so it is with healthcare. Medical school education is only one part of the equation. Patient education is another. Until we do something about bring the two into the equation, costs will continue to escalate.

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.

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.

Our new man in Washington, Berwick nominated to head CMS

By David L. Rosenbloom

RenalWEB and NephOnline link to news that President Obama will soon name Dr. Donald M. Berwick to head the Centers of Medicare and Medicaid Services (CMS). Dr. Berwick is a brilliant, innovative and iconoclastic scholar and medical practitioner who has challenged doctors and hospitals for years to change their old, ineffective and costly ways and provide better care at lower costs.

On word of the announcement of Dr. Berwick’s appointment, Steven D. Findlay, a health policy analyst at Consumers Union, said:

This would be a spectacular appointment. Don has been an intellectual force in health care for decades. He helped forge many ideas incorporated in the new health care law. As examples, Mr. Findlay cited provisions of the law intended to reduce readmissions to hospitals, prevent hospital-acquired infections and hold doctors and hospitals more accountable”

CMS is no stranger to dialyzors. Their cryptic, nearly unintelligible payment advisories, are near constant reminders of how poorly the system serves the patient. Yet CMS policies affect nearly a third of all Americans and the agency “spends $800 billion a year, making it the largest purchaser of health care in the country. As administrator, Dr. Berwick would spend much of his time defending the health care overhaul, writing regulations to carry it out and fielding calls from members of Congress,” says the N.Y.Times article.

The article continues:

“Dr. Berwick has denounced ‘the insanity of health care that costs too much and achieves too little.’ But at the same time, he celebrates the work of hospitals that have reduced medical errors and deaths by the systematic application of proven techniques. And he wants to disseminate the secrets of communities that provide high-quality care at low cost.

Dr. Berwick could help shield the White House from Republican charges that Mr. Obama’s policies would lead to the rationing of care or even a government takeover.

At his institute’s annual conference in December, Dr. Berwick issued this challenge to health care providers: ‘Over the next three years, reduce the total resource consumption of your health care system, no matter where you start, by 10 percent. Do that without a single instance of harm, without rationing effective care, without excluding needed services for any population you serve.’

He said he had learned from his own medical problems, which include osteoarthritis in his right knee. ‘It comes from medical error, botched surgery when I was a medical student, aggravated by years of jogging,’ he said. Doctors urged him to have a knee replacement operation several years ago, but he decided instead to have just a “steroid injection,” and the outcome has been fine, he said”.

In an interview with Pauline W. Chen, MD Dr. Berwick spoke bluntly about the need for patient-centered healthcare. He insists that shared decision making should be mandatory, with the patient and family participating daily in the design and delivery of treatment, even occasionally allowing patient preference to override evidence-based care.

“If you are interested in quality, you have to be interested in patient-centeredness. Good doctors and nurses do try mostly to focus on every patient as an individual. But we have built a system around clinicians that makes it impossible to customize care the way it needs to be. We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Patients keep having to repeat their name because the system has no memory. We dress them in silly-looking gowns. We give them the food we make instead of the food they want. We don’t let them look into their medical records unless they have permission. Health care keeps telling patients the rules instead of asking patients about their individual needs. What is said is, “This is how we do things here,” not “How would you like things done?”

People get accustomed to this. They are trained to be passive, and passivity is not a good idea. Studies have shown that people who are trained to be proactive do better and feel stronger. They have more pride and trust in their own capabilities. When you make someone helpless, in a funny way you make them sicker, even if all you cared about was just the body”.

On the question of patient noncompliance nonaccommodation, Dr. Berwick’s position should be music to our ears:

“I think “noncompliance” is a control word, a power word, and we need a slightly different one. “Compliance” means I order and you either do it or not; you obey. Patients live in their bodies and may know more than the person who prescribes or does their procedure. They may know better about what is going on in their body and about the optimization of their own life. I think people who aren’t taking their own medicine are telling us valuable information about their medications and their life, and we need to listen to them.

When you are in a position of having to deny and exclude patients, it is draining on the spirit. I actually think the mode I am counseling would be more satisfying or joyous for caregivers. Not all of the time or always, but it would be a better place to be. You would be putting yourself at more of a level with the patient, as more of a peer. And you wouldn’t have to carry on as if you were mythical.

Medicine is imperfect and doctors know that. … It stuns me that people don’t know what medicine they are taking. Know the name of your medicine and what it does to you. If you are getting a procedure done, know the procedure. Medicine is not nuclear physics. Most adults and kids can basically understand. There can be uncertainty in medicine, but if there’s mystery, something is wrong. … From research we know that patients who write down questions do better. Bring your digital recorder into the meeting so you can listen to the conversation several times after. Bring a companion along to be your sentinel, your advisor.

In the end, if you are being cared for by a doctor or nurse who doesn’t give you what you feel is choice or control, find someone else”.

How refreshing and hopeful it is to hear a medical professional talk like an intelligent, caring human instead of an automaton. Like us, Dr. Berwick has been there and understands what if feels like to be a patient with little or no control over treatment decisions. You can image the influence he will have on CMS policies and regulations, which too often reinforce outmoded, bad practices in the name of cost control and protecting the status quo. His appointment to the CMS would give us a true champion for home dialysis preference and its financial support.

But first he must be confirmed by the U.S. Senate, a body not known for speed, objectivity or fairness. I urge everyone to contact their Senators today and voice unqualified support for his confirmation to head the CMS. It could be a game changer.

Note: Biography of Dr. Berwick on the IHI web site

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.

Renal Policy Changes: Do They Go Far Enough?

By Peter Laird, MD

CMS, as part of the process of developing new quality measures for Medciare beneficiaries who use dialysis, called for Technical Expert Panel (TEP). CMS certainly has the potential of improving dialysis related care in America if many of the known optimal dialysis techniques can be incorporated into routine practice.  In addition, other private groups and institutions are likewise looking at how dialysis care can be improved and in fact, there is much overlap between the government TEP and these private groups:

End-Stage Renal Disease (ESRD) Quality Measure Development and Maintenance
The Centers for Medicare & Medicaid Services (CMS) has contracted with the Arbor Research Collaborative for Health and the University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) to develop Quality Measures (QMs) for ESRD for the following six measure areas:

• Anemia Management (Target value for Serum Ferritin, Target value for Transferrin Saturation);
• Mineral Metabolism (Target value for Calcium, Target value for Phosphorus)
• Vascular Access Infection Rate (Catheter Infection Rate)
• Pediatric Adequacy (Hemodialysis [HD], Peritoneal Dialysis [PD])
• Pediatric Anemia (Anemia Management)
• Fluid Weight Management

Tom F. Parker, III MD is a very vocal advocate of reform in the dialysis industry and his views are a breath of fresh air compared to the stale accusations that dialysis patients cause their own demise through noncompliance issues and poor substrate caused by years of poor diabetes control and HTN.

In a recent editorial, Renal Policy: Changing the models and measurements of dialysis care, Dr. Parker and Dr. Steinman, made several recommended policy changes, which will have, if implemented, an immediate impact on our far too high dialysis related mortality in America:

The problem is in the left ventricle. Left ventricular hypertrophy (LVH) results from either pressure or volume overload. As the process continues, the increased oxygen demand by the hypertrophied heart will potentially exceed perfusion. Cardiomyopathy is the end consequence of this process because of cardiomyocyte death. Subsequently, LV fibrosis occurs. LV decompensation results in congestive heart failure (CHF) and fibrosis, the latter being highly arrythmogenic. About 70% to 90% of patients entering Stage 5 CKD have LVH. Approximately 60% of CVD deaths in dialysis patients can be linked to sudden death (presumed arrythmias) or CHF, originating in the left ventricle.

The only issue that I have with both the TEP and the editorial by Dr. Parker and Dr. Steinman is whether these recommended measures will directly address the issue of myocardial ischemia and myocardial stunning which have been shown to be independent of hypovolemia or anemia status and are present at the beginning of dialysis. 

To date, there are no proven causes of myocardial ischemia and myocardial stunning even though there are several likely areas of investigation.  LVH is an important marker of sudden cardiac death and should be addressed along with the other areas of policy change outlined above. However, you can have a dialysis patient with well compensated anemia without ESA usage, without LVH, who has minimal inflammation and normal nutritional parameters and excellent fluid and weight control without ever having intradialytic hypotension who still has myocardial ischemia and myocardial stunning during their dialysis sessions no matter how slow the blood pump speed is. 

If we are looking at quality measures, why has the nephrology community so boldly ignored myocardial ischemia which in every other setting is considered a medical emergency.  It appears that LVH may be in part due to myocardial ischemia and myocardial stunning, yet even with progressive dialysis policy making groups, their silence on this issue that may be the central cause of sudden cardiac death in hemodialysis remains puzzling to me personally. 

In a couple of hours, I will hook up to my NxStage System One machine, and if statistics are effectively related to my own case, I will experience four hours of silent myocardial ischemia due to my dialysis session.  In any other setting, I would be placed in the ICU/CCU with multiple specialty consultants and immediate evaluation of the causation of my myocardial ischemia.  Yet in the nephrology world, policy makers with the best interest of dialysis patients at heart don't address or acknowledge the issue of myocardial ischemia even with recommendations for future studies. It is likewise not addressed by any of the ongoing frequent hemodialysis studies. Yet in every other setting, myocardial ischemia is the single largest known contributor to sudden cardiac death. I believe that when this issue is finally addressed openly by the nephrology community, we will finally see a significant decline in dialysis associated mortality.

In the Dialysis Unit, Who is in Charge?

By Peter Laird, MD

Renal Fellow Network (RFN) is a great source of up to date information on renal issues at the level of a renal fellow.  In such, I have learned much since the late Nathan Hellman, MD started his blog.  However, there have been a couple of occasions where I believe that RFN needed to go deeper, especially on home dialysis issues. 

The Renal Fellow Network is now a joint venture with the fellows and attending physicians at Mass General Hospital which is considered one of the leaders of quality medical care in America.  In a recent post on the RFN, The Nephrologist as Team Leader, Dr. David Steele spoke about the new leadership role that a nephrologist is required to perform by the new CMS conditions of coverage:

In order to prepare for the eventuality of one of these surveys, I received a memo this week with a reminder of my responsibilities as the Hemodialysis Unit Medical Director:

"By virtue of the Medical Director's leadership of the facility's Governing Body, his/her responsibilities extend beyond the primary focus on improving quality of care delivered in the facility and extends to the general management and operations of the facility. As such, all condition level citations are linked to /and are the responsibility of the Medical Director according to CMS".

Dr Steele goes on to explain some of the newly mandated regulatory requirements, but in doing so, he freely points to the fact that the mentality of nephrology practice is that the dialysis unit runs itself with its nurses, techs and administrators. 

What does this all mean? At first glance these citations/conditions may seem to be out of the realm of the practicing clinician whose focus is elsewhere, but in actuality they are integral to the proper care of our patients and the infection control lapses certainly should raise a high level of concern. We all have a natural disinclination to being surveyed but maybe these surveys are useful if they encourage us to put into place processes which ensure these lapses do not occur and if we develop systems of self assessment and quality improvement within our domain of responsibility.

Which brings me to the point of this blog. It's all about the team, and as Physicians we assume a natural leadership role when we deliver care to our patients and some of us are eventually appointed to leadership positions as our career advances. The usual dialysis unit personnel resources include Nurses, Patient Care Technologists, Dieticians, Social Workers and Administrative Staff. CMS is telling us we are responsible for the performance of this team on multiple levels. Traditionally our training has not focused much attention on preparing us for such leadership. (Emphasis Added)

When I was a practicing physician in the Army, we had many extra duties serving as medical director of different services in our hospital.  In such, it was an excellent arena to develop leadership skills which were not only a requirement of being a physician in the hospital but it was also a requirement of an officer in the Army as well.  The titles that I held clearly indicated who had the final authority and responsibility for that department: "Medical Director." 

Yet somehow, the role of final authority as medical director of dialysis units has escaped this profession in many ways. This engenders several questions that need answers: Do American nephrologists traditionally focus on running a dialysis unit as a part of their nephrology training?  Do American nephrologists get directed training as a team leader? According to this post on Renal Fellow Network, it appears that the answer is that this is a new role brought upon nephrology by CMS regulations. If CMS must tell the nephrologist to take charge, then who has been running the show up until now?

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?

Taking Kidney Disease to the Hill: It Pays to be Organized

by Anna Bennett

I participated in the PKD Foundation's Annual United on the Hill Event on March 1st & 2nd. It was eyeopening to say the least, what a week to be in the Congressional buildings to discuss health care. Recently, the PKD foundation hired an amazing National Director for Government Relations, Kimberly Cantor. I was greeted on Monday with a slick, easy to read binder, a personalized appointment sheet (all meetings were set up by the PKD foundation in advance) and leave behind packets for the PKD Lobby, emphasizing the PKD issues (or in polispeak, the "asks"). The addition of Ms. Cantor brought the PKD Foundation to a new, professional level.  100 people from all over the United States, all affected by PKD rallied and took the call to the Hill, talking points in hand, having been prepped in the ballroom of the K Street Sheraton for a day on the issues, then on Hill day, given a kick-off breakfast before being bussed to the base of the Capital. Let the lobbying begin.

... government of the people, by the people, for the people, shall not perish from the earth.
The office buildings on Capitol Hill are buzzing with suited blackberry toting staffers, along with many lanyard wearing groups like the PKD Foundation, and others who are there to plead their cases to their elected officials and staffs (mostly their staff). News crews set up and break down on the steps of various buildings, waiting for a sound byte. The politicians and their staff can avoid being above ground totally by using a series of tunnels that join the buildings on the Hill.  The tunnels and the cafeteria is where it is at.  I met a friend for coffee before my first meeting on the House side of the Hill, and we listened as young staffers commiserated about being yelled at by constituents on the phone at one table, a defense contractor talking bids at another table, and the corn lobby preparing for a presentation. It was exciting and fascinating and I am no stranger to the Hill. At the forefront of my mind is that statistically all these people's lives will be touched in some way by CKD.

With Ms. Cantor at the helm, the Foundation can easily track their successes.  One goal was to get more co-sponsors for the immunosuppressive drug bill (H.R. 1458/S. 565) it worked, just the day after, there was a congratulations call from the sponsor's chambers.  By going in to their representatives and putting a face and a story on the impact of the issue, three Representatives have already signed on, bringing the total to 83 co-sponsors in the House.

What I learned by joining this group on the Hill?  Organization, focus and passion can work.  Personally, I don't agree with the niche marketing and "transplant or die" stance that I saw during prep.  I eventually started having a physical reaction each time I heard a person with a microphone (either from the audience or the podium) say "a person on dialysis can't work." The people at my table were worried I may explode. But I took a deep breath, and then on a one-to-one basis, I spoke with people about the options that are out there. I described myself as an "Advocate for dialysis reform with PKD". I told my story, I pulled up my sleeve and I showed off my fistula.  I recommended them to online sites Home Dialysis Central, Kidney School and IHD.  I was in a room with 100 socially charged advocates for a debilitating kidney disease, and I found myself correcting misinformation.  That was my real lobbying trip. Meeting with my Representatives and Senators, yeah, that is what they do for a living, they have a voter base to keep track of.  The PKD Lobby's voice was heard, language will stay in research programs, and PKD will keep its finger in the pie, thanks to the preparation, research and organization of the Foundation and the leg work and passion of the volunteers.

But, our health care system is failing fast.  Medicare and the sustainable growth rate (SGR) formula was poised to cut Part B physician payments 21% on March 1st.  There has been a 30 day delay as of the time that I write this, but I'll tell you, nephrologists across the country are sweating bullets, wondering how they will be able to keep their practices afloat. There are so many issues that affect our daily existence with CKD-5.  My advice, pick an issue, focus it, and let your voice be heard.

All Politics is local
My final leave behind to all of the people that I met on the Hill on Tuesday was the closing paragraph of my thank you e-mails, and that's how I'll close this post:

On a personal note, please, if you got anything from our meeting, just know that should anyone in your life be stricken with any form of kidney disease, it is not an immediate death sentence.  Even though just a small percentage are eligible for transplant, and kidneys are scarce, there are GREAT therapies today and people are able to thrive rather than just survive on dialysis. My own personal mission is to let as many people out there know that they need not accept minimum treatment for kidney disease.

How are ESRD Program issues faring in the health insurance reform process?

By Bill Peckham

Tomorrow is the big bipartisan meeting at Blair House which may open a path to passage of a health insurance reform bill. My understanding is if health insurance reform legislation were to pass, that the bulk of the legislative language would come from the Senate bill, which is the Senate's HR 3590, the relevant ESRD Program language was voted through initially in November and then revised with a Managers Amendment in December. For that language to go to the Presidents desk to be signed, all that would have to happen would be for the House of Representatives to vote on the amended Senate bill; this has been true since December.

The problem is that the House passed a health insurance reform bill significantly different from the Senate's and there needs to be a second bill with a package of changes to the Senate Bill, for the House to be willing to pass the Senate's bill. This package of changes will be the subject of tomorrow's meeting. One can imagine that anything could be added to the package but I would think that extending immunosuppressant drug coverage and/or mandating that the dialysis payment include oral drugs (as the House's health insurance reform bill, HR 3962, did) are not big enough issues to enter the discussion. Meaning extending immunosuppressant drug coverage is out.

The a package of changes will be about big things; the ESRD pieces are small in comparison. However, things get slipped into legislation all the time. Illinois Senator Durban, a supporter of extending immunosuppressant drug coverage, is attending tomorrow's meeting. Representative Stark, a proponent of including oral drugs in the dialysis payment bundle to pay for immunosuppressant drug coverage will not be in attendance.

Until changes to the Senate legislation are written into a bill and voted on by both Houses of Congress we can't be sure of the final ESRD provisions, except to say that in the absence of additional language, the Senates HR 3590 ESRD language will become law.

ASN podcast: Harvard conference & the difficulty of implementing clinical performance measures

By Bill Peckham 

The American Society of Nephrology has a great podcast available, it's a 32 minute discussion among Jonathan Himmelfarb, MD; Thomas F. Parker III, MD; Theodore I. Steinman, MD, FACP; William M. Bennett, MD. You can listen to it online or download an MP3.

Three of the participants signed a letter to CMS last year that RenalWEB judged was "era-changing", the forth participant is Dr. Himmelfarb the director of the Kidney Research Institute, who is an expert on public policy and kidney research. Last July DSEN joined a chorus of complaints about the lack of response from CMS, to the letter. Now I think it is fair to say CMS has responded. I would say that CMS, by convening Technical Expert Panels (TEPs) for the development of new quality measures for those using dialysis, is doing so, in part, as a response to the letter. Certainly the scope of the TEPs is broader because of the letter and subsequent discussions between CMS and the letter's authors. 

The discussion between Himmelfarb, Parker, Steinman, and Bennett looks at the questions from a higher altitude then the TEPs, but ultimately they're talking about the same things. What can CMS measure that will correlate to an improved mortality rate (the standard mortality rate among people treating their CKD with dialysis as calculated by KECC) and/or an improved hospitalization rate (again as calculated by KECC). I think it is fair to say that Parker, Steinman and Bennett are in favor of moving forward with new measures faster than Himmelfarb councils.

I nominated myself and was invited to join the Fluid Weight Management TEP, the meeting is in about two weeks; the TEP is a daunting task to prepare for. The podcast voices the vague internal dialog I have been  having. Take cramping - it is without a doubt a very negative outcome. In a perfect world there wouldn't be cramps during dialysis and not having cramps relates to proper fluid weight management. My experience says I only cramp when I'm not managing my fluids correctly. So should cramping be something we measure? And should there be cramping outcome targets that impact reimbursement? I'm not sure I'm ready to say that - which gets to Himmelfarb's position. Where's the data? Where's the randomized controlled trial (RCT) to support a cramping target?

An RCT is always welcome is the retort but we can't wait years for the result. People are needlessly dying today, couldn't we proceed but verify? That seems to be the consensus that they coalesces around but I'm not sure how that will look in practice. Hopefully all will become clear during the TEP process. However, this consensus is not the most interesting part of the podcast, at about the 26:15 minute mark a remarkable brain storming session breaks out.

I think it starts with Bennett who speaks to the government motivating clinical practice research to improve the provision of dialysis, particularly the need to engage the LDOs. Then at 28:30 again Bennett (I think) remarks that just off the top of his head, it could be a role of CMS to create incentives to participate in research (a QIP measure: percent of patients enrolled in NIH/NIDDK funded clinical trials?). Himmelfarb then suggests looking at what's been done in cancer, with cooperative oncology research groups, organized through a clinical trials network. This is an exciting idea.

Imagine if such a thing was in place 30 years ago? or 20? or 10? Dialyzors would be much better off today if patients had been systematically enrolled in clinical trials to identify and improve best practices. As is brought up during the podcast, had there been some basic clinical research done on EPO the unfolding fiasco could have been avoided.

I am very much in favor of high quality research, research that is meaningful to those who need dialysis, but I also think that within the current reimbursement that the important outcomes of mortality and hospitalizations could be improved and that new measures, perhaps fluid management measures, could help achieve that ultimate goal. However, it may be that if CMS made participation in research a payment metric that would have the biggest positive impact of all.

Sex in the bundle - good or bad?

By Bill Peckham

Jack Ahern has an article up on Renal Business Today reviewing one element of the PPS. Ahern asks Do Women Really Cost More to Dialyze? (Bundling Sex). The PPS included a sex adjustment, Ahern includes some of the relevant text concluding with:

As would be expected, CMS treads softly on the idea of differentiating payment by sex and solicited your comments regarding “unintended consequences of providing a payment adjustment for female patients that may lead to admission practices favoring female patients.”

Does this adjustment, which will impact ESRD payment possibly for the next 20 years, make sense to you?

No, it doesn't make sense, not yet anyway.

There is no evidence that this EPO disparity between the sexes will persist after the bundle is expanded, after EPO becomes a pure expense. For the most part all the new case mix adjusters proposed by CMS were based on current correlations to EPO use. The entire premise of expanding the bundle is that making EPO a pure expense means less will be used; this also means it is fair to say that the premise of the bundle is that EPO is currently being overused. It seems we are to assume that this EPO overuse is layered over the system like a tax - everyone is using 10% too much but that is a big assumption.

It is more likely that this EPO overuse is clustered and skewed. Is this overuse skewed towards woman? We don't know. What are the demographic/clinical characteristics of those that are non-responsive to EPO therapy? I don't think we know, or at least CMS makes no note of it. Given that, CMS should not include any of their proposed EPO based adjusters (adjusters meant to accommodate the observed historic differences in EPO use). They should go forward with a minimum number of case mix adjusters and monitor the use of injectable drugs and other measurable dialysis cost centers.

If there are usage disparities after the bundle is in effect, then that is the time to devise case mix adjusters. Which case mix adjusters will be included in the final rule is a situation ripe for wagering. I hope for simplicity's sake, if nothing else, the clinical case mix adjusters are few: today's adjusters (age, BMI, BSA) along with a scaled back first four month adjuster. We'll see when the final is published, but with the snow and federal office closures, the final rule release date probably just got pushed back a week.

Reading the tea leaves: does CMS transmittal signal oral drugs are not in the bundle?

By Bill Peckham

I was interested to read The CMS's Program Transmittal on Dialysis Adequacy, Infection and Vascular Access Reporting (PDF link) that was linked to by RenalWEB and NephrOnline. The transmittal relates to the Quality Improvement Program (QIP) that is a feature of the Prospective Payment System (PPS) required by the Medicare Improvements for Patients and Providers Act (MIPPA). After providing background the transmittal lays out new reporting requirements:

B. Policy: The CMS will require the reporting of the Kt/V reading and date of the reading, vascular access and infection data on ESRD claims with dates of service on or after July 1, 2010. This new data reporting requirement will allow CMS to implement an accurate quality incentive payment for dialysis providers by January 1, 2012, as required by MIPPA §153c. CMS is requesting a July 2010 implementation date because the quality incentive payment must be in part based on provider improvement over time, thus, CMS requires an accurate measurement of baseline provider performance. The CMS will require that providers continue to report the existing G1 through G6 modifiers for URR at this time.

There is no mention of bone measures. Does this mean that oral drugs will not be included in the PPS required by MIPPA? Like the dog that did not bark, it is suggestive.

As the transmittal notes for a measure to be included in the QIP, CMS has to establish a baseline. As it stands, there isn't data for the sorts of reporting you would want to have in place if oral drugs were going to be part of the PPS. If CMS was planning to include oral drugs I would expect them to measure bone health outcomes e.g. PTH, calcium, phosphorus. If the transmittal included phosphorus or PTH, their inclusion would signal that CMS is preparing to include oral drugs (in the foreseeable future). However, you can't be sure their absence signals oral drugs are out. There could be another transmittal on the way!

We'll have to keep watching, and reading the tea leaves until the final rule is released in the next several months. When, exactly, is that going to be? I'd say April if it is an interim rule (another comment period!); June if the rule is released in final form. These are just a wild eyed guesses on my part, however, pushing the QIP implementation into 2012 (I think this transmittal means 2012 will be the first year payment is at risk/2011 would be the base year) signals that the expected round of proposed rule making focusing on the QIP is going to be held off until the final PPS rule is released.

The final rule does have to be released sometime this year. In enough time to allow providers time to get ready. If I had to guess one date, I'd take June 30 ... right before the long July 4 weekend.

Using dialysis for healthcare fear mongering is tricky if facts matter

By Bill Peckham

Last week Renal Business Today linked uncritically to Dr. Richard Amerling's Medicare Rationing Begins in January, 2011, an article that manages to shoehorn in a greatest hits of healthcare political bogeymen while presenting the provision of dialysis as an early example of the heathcare dystopia that is just around the corner.  It's all here: private insurance disappearing, death panels, arbitrary reimbursement cuts, rationing, federal micromanagement,  congressional mismanagement, and nationalization of healthcare! Oh my.

Let's go through doctor Amerling's article from its start to its penultimate paragraph of doom. He begins:

House and Senate Democrat leaders, and President Obama, argue that they can "pay for" health insurance "reform" by cutting $500 billion from Medicare spending over the next decade—largely through arbitrary reimbursement cuts,— without reducing the quality of care delivered to beneficiaries.

Actually it is the Congressional Budget Office that scored the Senate's healthcare legislation as saving billions of dollars over 10 years (and even more in the 10 years after that). The cuts have a name, Medicare Advantage, but since talking about Medicare Part C causes people's eyes to glaze over why not call them arbitrary reimbursement cuts? That aside Amerling's question is: Can Medicare be cut while maintaining or improving clinical outcomes? Amerling doubts it is possible. He continues:

Yet, in January, 2011, Medicare will implement a new payment system for patients receiving dialysis for end stage kidney disease that will severely ration care to this vulnerable (and largely minority) population based on equally arbitrary payment reductions. These patients will be the unfortunate canary in the Medicare coal mine: "reform" legislation will expose millions of Medicare patients to rationing and reduced quality of care.

Armerling is saying that the expanded payment bundle, the PPS required under MIPPA, will arbitrarily cut reimbursement and ration care to people who need dialysis, and this change in how dialysis is reimbursed is a model that will be applied to the detriment of other parts of Medicare, leaving bad quality and rationing in its wake.

Politically this bogeyman has never made sense, Medicare is a Made Man in the federal budget - it wont get hurt. Amerling then goes into a weird history of dialysis reimbursement:

In 1972, Congress passed legislation creating an entitlement to Medicare for patients diagnosed with end stage renal disease. The bill allocated about $140 per treatment (or $1820 per month) per patient. This facility fee was large enough to incentivize the creation of dialysis centers, the expansion of dialysis treatment to all patients, and an end to what were very real "death panels." The ESRD program became a model for what good government could accomplish. There was broad consensus that payment for this catastrophic illness was a legitimate federal function and use of taxpayer funds. Unfortunately, Congress neglected to index the payment for inflation, leading the constant-dollar value to dwindle to around $14 per treatment. Dialysis units were able to survive, and even prosper, by aggressive cost-cutting (substituting technicians for nurses), consolidation into ever-larger chains, boosting efficiency (sometimes by cutting treatment times with a negative impact on outcomes), and by generating revenue from sales of drugs used during dialysis.

The panels that selected people for dialysis were choosing who would live not who would die but beyond that the numbers are a mess (for an authoritative review of early dialysis payments policies and amounts see this 2000 paper by Eggar (PDF link)).

The history ignores that for comparative purposes, the dialysis payment rate was set in 1983 at $127, which you can discount into today's dollars but what is really curious is that when describing how units managed to survive under stagnant payments Amerling leaves out the most important piece - accepting Medicare gives providers license to vastly inflate prices charged private insurers. This dialysis provider feast period known as MSP is the main net income engine for the industry. How could private payers be missing from this history? In the next paragraph Amerling identifies injectable drug margins as "the major source of profit for dialysis units". That's not true, commercial payers are the major source of profit for dialysis units.

The next two paragraphs are taken up with a discussion of EPO's separate payment history and how studies published in the last two years caused Congress to act in 2003 to bundle EPO. The key point Amerling makes about EPO is that:

the payment model that had evolved led to incentives to prescribe that were potentially hazardous, and needed reform.

It is nice to see someone from the Manhattan Institute for Policy Research acknowledge fee for service medicine results in overuse without clinical benefit but remember Amerling's premise is that the Obama administration's promise that Medciare spending can be cut while improving outcomes is false. This statement says the Obama administration is right.

The current payment model causes units to overuse EPO. Which is a financial problem but even more importantly is a cause for clinical concern. Therefor if you change the incentives to motivate doctors to use the right amount of EPO you could spend less and get better care. Now there is a lot to be said about how the  details of the PPS came out and whether it would be truly budget neutral but there was a comment period, CMS could listen and improve the bill, so Amerling's next five paragraphs are premature. They require the PPS to go into effect unchanged.

If that were to happen it would not be as good a payment system as Medicare could devise. I spent 4,000 words saying what I thought could be improved and I have bet knowledgeable renal insiders that the final rule will not include oral drugs - but the insiders think oral drugs are going to be in, so I maybe I'm wrong. However, Amerling's analysis is off no matter the shape of the PPS in the final rule. In evaluating the value of the proposed bundle Amerling compares the $235 UMKECC came up with against the $198 base rate CMS used in the PPS. That's apples and oranges.

There is no doubt the PPS payment rate is confusing but Tracey Mayne did an impressive job breaking it down for Nephrology News & Issues:

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.

The base rate before case mix, the number comparable to UMKECC's $235, is $261.58 less $13 (the 1%, 2%, 2%) or $248 compared to UMKECC's $235. But wait, don't forget the $14 for oral meds that CMS included in the payment. UMKECC didn't imagine Part D meds in the bundle so they are not reflected in the $235. Take away the $14 and you have $234 vs $235. Given rounding the CMS's PPS payment rate is what UMKECC suggested.

In the second to last paragraph Amerling warns that:

Even the large dialysis chains will struggle to remain afloat. Their situation will worsen dramatically if private insurance (which covers dialysis at rates well above Medicare) disappears as a result of the added costs and regulatory burdens imposed on them by ObamaCare. In effect, this legislation sets the stage for an eventual nationalization of the dialysis industry.

Where to begin?

The article is full of dissonance but to suggest the large providers are at risk in all this is not credible. A lot depends on what the PPS looks like in the final rule but since the payment is based on historic overuse of EPO there should be some room for all units to improve outcomes and cut costs by using less of the expensive drug. The large dialysis organizations have shown they want nothing more then to expand, they want more of the healthcare pie not less.

But finally, here there is mention of private insurers. Until now you would not know they had a role in financing dialysis. Amerling's apparently believes that covering people who are uninsured will decrease provider profits - this doesn't make sense. Looking at insurance industry equity prices in response to the Senate bill suggests that insurers are set to benefit under Obamacare. Far from disappearing to produce Hollywood blockbusters the insurance industry looks to be entering a growth phase.  Amerling imagines all this somehow culminating in nationalization of the dialysis industry.

Really? Nationalization. In other words Medicare would own the dialysis units, pay the staff, buy the equipment. Amerling is imagining that somehow the federal government will be the only entity willing to provide dialysis after insurers and dialysis providers leave their industries to do other things. That's farcical but today some people consider this sort of hackery thoughtful commentary. 

There is an interesting free market take on the provision of dialysis but Amerling actually dismisses it early in his piece by writing that "there was broad consensus that payment for this catastrophic illness was a legitimate federal function and use of taxpayer funds." At least there we agree.

PPS Comments to Medicare show the way forward: higher dialysis doses for better health

By Bill Peckham

I noted in my PPS comment to CMS the level of distrust that I heard as I read them in mass. Reading them one after another, as they were posted started making me feel cynical. However, there is another narrative in those nearly 1,200 comments, another story. A story of hope.

Here are excerpts from 23 comments submitted by those using frequent home hemodialysis (these comments were mostly submitted through regulations.gov, which limited text box submissions to 2,000 characters (not even 15 twitter messages). The process also stripped away paragraph formatting. I, for the sake of readability, added paragraph breaks to the messages and let my spell check correct some obvious typos. You can read these and all comments in their posted form here or download a continuously updated Excel file). The stories excepted below offer a glimpse of a brighter dialysis future. A future that can be achieved today, without waiting for a scientific breakthrough or the FDA approval process.

Read these and hear what they are saying. Taken together these comments offer as strong an endorsement of more frequent dialysis as I've ever seen. Story, after story of being cured of the symptoms of too little dialysis. All of the symptoms that people mistakenly attribute to dialysis, are reported cured. And not one of these commentators talk of urea.

Read through these personal testimonies, and then look around a dialysis unit. Should those people, those individuals really be there?  People with CKD5 don't have to feel that sick - there is an alternative to conventional incenter dialysis.

CA Dialyzor
Dear Sir/madam, I am a 42 year old home hemo patient of 5 years, I work 9 hours every day and exercise regularly.

I am also extremely grateful to be able to dialyse 6 times per week for 6 hours every night as a result I have no pressing need for a transplant, and climbed Mt Witney in August.

I used to have in center dialysis 3x per week and was not able to work a full day or keep myself fit. I feel that others may not be able to enjoy a productive life if sufficient encouragement to move patients home is not created by the new payment system. ...

GA Dialysis Mom
Thank you for the opportunity to share my thoughts on the Proposed ESRD Rule. While I am a healthcare professional, I never thought I would have an interest in dialysis- but that changed when my daughter developed kidney failure.

She was transplanted at age 11, but the new kidney did not last. After that, she tried peritoneal dialysis, but had many infections. Incenter dialysis was the only other option we were given, and it did keep her alive- but it put our whole family in survival mode. I had to quit working to take her to all her treatments and be here when she slept afterwards. We thought that was the only way. But, in 2007 I heard about home hemodialysis. This therapy has given us back our daughter and given our family back a life. ...

CA Care Partner
My husband returned to dialysis in 2006 when his kidney transplant failed. While dialysis was much improved since his experiences 1990-91, the most marked improvement was what we experienced when we began home hemodialysis in 2007.

His general health and quality of life increased enormously. It was more than worth the effort, even considering the fact that home hemo includes a lot of work for the patient and caregiver, particularly when compared to clinic hemodialysis. ...

CA Dialyzor
I am a kidney dialysis patient for almost 20 years & a home dialysis patient for the last 3 years. As a result of home dialysis I am off many of the medicines I had to take when going in center for treatment because doing dialysis at home is almost like having my kidneys function again. ...

MN Dialyzor
I am a 22 year old home dialysis patient, and "going home" when I do treatments has changed my life dramatically, in only the best ways. I want to first thank everyone for still supporting this treatment option, because it has been in integral piece to my continued health and life satisfaction. I was diagnosed when I was 7 with MPGN type two, and have been on some form of dialysis since 1997.

I remember the days when I had to go into a center to do dialysis, and having to do my treatments on their schedule and how it fit into their day, actually worked against my ultimate goal of living as "normal" a life as possible. When I learned that I would be starting to do it at home, both me and my family were very excited. We had some amazing nurses who trained us, and who were there for us in a one on one fashion to learn how to be independent, and because the training is one of the most important pieces to the puzzle, I think that making it "part of the package" would only be detrimental to the program. I want all of those people out there that are just as scared and nervous as I was when I began to have the same experience that I did with amazing trainers who will help them feel comfortable enough to take it home, and live an amazing fulfilled life just as I am!

UT Dialyzor
I have been on NxStage home hemodialysis for 3 1/2 years. My health has improved remarkably. I live 90 miles from a dialysis center and I made that trip 3 times a week for one year and the trip itself almost killed me. I did it or 4 years in Montana and had to drive nearly the same distance. Home Hemo gives us the patient freedom and better health.

My health is remarkable as if have been fighting ESRD for 22 years. Had I not been enabled to do NxStage home hemo I would have certainly met my demise by this juncture. In center is good but home hemo is so much better. The care one gets from their loved one as the service provider is unfounded anywhere. The peace and saftey from infection is also reflected in my health with home hemo. I just cannot say enough that Home Hemo has saved my life! If I had to go back to in center and drive 180 miles 3 times a week I would soon be dead in body and spirit.

Home hemo renews one's spirit and the ability to stay at home and not make that awful trip cannot be traded for anything. If you were to take a photo of me now and 4 years ago before I started NxStage home hemo you would not know it was the same person. My health has been renewed. ...

OH Dialyzor
i have been on dialysis since 2002. in 2006, i started going downhill. my wife drove me to dialysis and got a wheel chair to take me into dialysis. we found out about nextstage on the internet and looked into it. we began training in January of 2007. after just a week of the training i felt good enough to drive and my wife and i stopped for lunch for the first time in over 2 years. NxStage dialysis has given me and my wife a much fuller life.

UT Care Partner
To whom it may concern, My husband Brad has Alport's Syndrome which is ESRD, he was diagnosed when he was only 34. We have 4 children and have spent the last 9 years learning how to best deal with this disease. It was life altering as you can imagine.

First I would like to say without Medicare we would have less than we have now. It has enabled our family to continue moving forward. We heard of the changes that will be taking place and want to make sure our voices are heard. Brad has been a Home hemodialysis patient for the last 7 years, 2 which have been on the NX stage Nocturnal program, meaning he dialyzes at night for 8 hours.

This has enabled Brad to hold down a full time job, go off of his high blood pressure meds, and forgo Aranesp shots because his body is functioning on a more normal level. ...

KS Dialyzor
To Whom It May Concern' As a current home dialysis patient and a past in-center patient I want to thank you for the availability of home dialysis. The difference in how I feel on HD as opposed to in-center is remarkable.

My high blood pressure which was at the stroke levels previous to HD is now completely under control allowing me to take less medications. The frequency of dialysis has also helped me to feel better, sleep better and eat better resulting in an overall improvement of my health.

My lab values particularly phosphorus and potassium have lowered significantly. I can only assume this is due to the frequent dialysis treatments I receive which HD. My only concern is with the possible bundling of treatment which would eliminate training sessions for some units. I ask you to think carefully about the change in this rule as it may keep others from reaping the many healthful benefits from this type of dialysis.

NE Dialyzor
I have done all forms of dialysis: PD and hemo. Over 8 years of surviving this way at 42 years old. I struggled along for a very long time until it was suggested that I try home hemo and overcoming the fear of poking myself I tried.

I have since avoided being in the hospital every year around July for quiet some time. I feel better and can function at a higher degree due to my fluid being removed more often. I walk and ride my bike and love it. I don't just survive, but I live!!!! Trust me living and enjoying life is huge when you have kidney failure. The windows of how often you feel good is small and even smaller when you are required to go to in clinic dialysis.

There is great freedom given when you allow me to stay home and hook up and not go by the clinics clock, but mine. I get to attend meetings and family fatherings and church functions because I choose when I do dialysis. I love this freedom. Please do not take this from me. I can travel and visit friends and not have to worry about setting up chair times so far in advance. I am an active person and am so pleased to have better health and am able to participate with gatherings and groups where as before I was very limited. ...

CA Dialyzor
I am a home dialysis patient. Home dialysis has made my life bearable. The more frequent and gentle treatments have done wonders.

Before with dialysis in the Dialysis Center four times a week, I had a tremor that made it difficult to even use a computer and I had small seizures several times a minute. These symptoms of subtle uremic poisoning did not go away with regular in center dialysis but did with daily home dialysis. Please support daily home dialysis. ...

WI Care Partner
CMS, THANK YOU FOR PAST SUPPORT. BECAUSE OF HOME DIALYSIS I HAVE BEEN ABLE TO TREAT MY HUSBAND AND STILL WORK MYSELF.OUR DR. ENCOURAGED US AND THE NURSES TRAINED ME( I'M NOT A NURSE) AND ARE AVAILABLE 24/7. HIS HEALTH HAS IMPROVED BECAUSE OF DIALYSIS 6 NIGHTS A WEEK. HIS CARDIOLOGIST SAYS HIS HEART IS EVEN STRONGER. SOME MEDICATION DOSES HAVE BEEN ELIMINATED OR LESSENED. THERE IS NO FEAR OF CATCHING FLU OR COLDS FROM OTHERS BECAUSE WE ARE HOME IT'S BEEN WONDERFUL HE IS 82 AND SAFE AT HOME. ...

CA Dialyzor
I live in a remote area near Willits and about 30 to 40 miles from a HD treatment center. With out HHD I would not be able to live where I do for many reasons.

When I was in a Treatment Center with treatment 3 times/week I never really felt good (It was like a light bulb being on but not giving off as much light as it was designed to). I got sick more often and not able to do anything else that day due to travel, treatment time, and fatigue.

I have been doing HHD 6 days/wk for the past 5 years. For the past year + I have been doing NOCTURNAL which frees up my days. I love it, I FEEL GREAT! My check ups and blood workups are always very good. So, thank you CMS for supporting HHD treatment. ...

AR Dialyzor
I would like to thank CMS for the continued support of home hemodialysis. I completed my training in June 2009 and have been utilizing HHD since that time.

I am 40 years old, married, and have two (2) young children. My wife went through the training with me and is my care giver. Being able to perform my dialysis on my schedule has allowed me much greater flexibility and time with my family. I utilized in-center hemodialysis for approximately six (6) months prior to HHD training and I feel much better on HHD.

HHD also allows me to travel - we have taken two (2) trips where I simply take my machine with me. This has been incredibly important for my job as a work 40+ hours/ week. ...

KS Dialyzor
Dear CMS, I am a home Hemo Dialysis patient. I am on the NxStage system. I have been on dialysis since 10/08 and started home dialysis in 6/09. I must say the initial training for this services was quite extensive, lasting over two weeks but it was very worthwhile and highly effective.

Being on home dialysis has allowed me to return to work full time, 8 hrs a day, 5 days a week. I also have been able to resume normal activities on my 22 acre farm. ...

MA Dialyzor
I have been a HHD paitent for the past 3 years and I feel that anyone who can do it at home should do it .

It gives you more freedom and helps keep your life as close to normal as possible. ...

FL Care Partner
A year ago my husband and I were barely familiar with Dialysis nor did we even consider the ramifications of kidney failure. The funding of the programs via Medicare and terms e.g. bundling, composite rates, etc. were furthest from our minds. However, fast forwarding to the present, we have learned in the last eight months that without dialysis my husband would cease to exist.

While our medical bills were piling up we were introduced to a home hemodialysis program that provides him with life saving dialysis at home with me as his caretaker. Do you have any idea how valuable it was to have an excellent training nurse instructing us for home hemodialysis? I am close to 70 yrs. old with no medical background and with our excellent training from a dedicated dialysis nurse we were able to start his dialysis in our home.

We have been able to keep my husband out of the hospital and gave him back the gift of living. The difference in his health is amazing, he has reduced his blood pressure meds and the daily home hemodialysis training is priceless. ...

NC Family/Care Partner
I am writing to share my concerns about your proposed changes to the way dialysis is covered and paid.
...
2. Home Hemodialysis training- thank you for being aware of home hemodialysis. It is the real thing and has totally changed our lives. Seriously, my brother was in a wheelchair and slept most of the time when he was treated in the unit. He was in the hospital regularly.

Since going home on hemodialysis, he has not been in the hospital a single time! He even volunteers at the hospital now!!! It has been life changing for our whole family. I have returned to teaching, after having stopped to care for my brother when he was in the unit. ...

TX Dialyzor
I am on hemodialysis in a home administered plan. Because of the individualized training my wife and I received we are able to successfully perform my dialysis in the comfort and privacy of my own home.

I went to the center for treatment for two months. During that time I was washed out every other day after in center dialysis. At home, I have dialysis 6 days a week and feel wonderful the minute I'm finished. I can travel any time and at almost a moment's notice. I've taken 3 to 4 week vacations across the country to visit family members that can no longer travel, and I went with my whole family on a cruise. I would not have been able to do that without the home hemodialysis.

Because we were well trained on an individual basis, we feel comfortable and capable of performing the treatment no matter where we are. Because we can set our own schedule, we are able to participate in community, church, and family events. We do not feel like we are missing out on life.

I had my yearly evaluation last week and it was wonderful. My health is good and I'm living my life to the fullest. I pick up my grandson every day after school and recently got a new granddaughter. As quickly as children grow I could not have had this time to spend with my children, grandchildren and siblings.

Spouse of above Dialyzor
My husband is on home hemodialysis. I am not a medical professional and when I first heard about home hemodialysis I thought it would be impossible for us to do that. I received individual training and because of that I was able to learn what I needed to be comfortable enough to perform hemodialysis in my home.

My husband went to in center dialysis for a couple of months. During that time he was terribly depressed. He would drive himself to the center but was unable to drive home (It was a 40 minute drive and we were at the center approximately 5 to 6 hours). I was unable to work during that time because I had to drive him home from the clinic. When he finished his treatment he was barely able to walk to the car.

He had no appetite and was losing weight. His blood counts were going down because of his lack of appetite. Now when he finishes his treatment (6 days a week instead of 3) he has plenty of energy. He can get dressed and be ready for anything. We vacation, spend time with family and friends, and participate in church activities.

My husband also belongs to the local Exchange Club and the Lions Club. He was not able to do that when he went to the in center dialysis unit. Please don't change anything. This has allowed my husband to live a fuller life and to feel so much better than he did in center.

MA Dialyzor
Response for Proposed Medicare Bundling Rule Thank you CMS for making all options available I agree per treatment payment is best way to support frequent hemodialysis.

Since being on frequent home hemodialysis I have noticed a tremendous change in how I feel physically and emotionally. Physically I have more energy, my diet is more liberal and I have more time to enjoy life. My life has changed significantly since starting on frequent home hemodialysis, instead of dialysis being my whole life it know is a part of my life.

I ask that you not punish clinics that offer more frequent hemodialysis but make it more available and financially acceptable. Since being on frequent home hemodialysis I have noticed decreased illness which brings down any potential hospital stays that I might have had. Since being on frequent home hemodialysis I have decreased my B/P meds significantly. ...

AK Dialyzor
To whom it may concern, Thank you for allowing me the opportunity to comment. My name is Stan and I have been on dialysis since May 2009.

I was initially on in-center for the first 3 months and have been on home hemo since. I lead a very active lifestyle with my children. I also continue to work full time. I really appreciate the rules allowing for home hemodialysis and short daily treatments.
...
I hope it will be possible to make modifications to ensure that every dialysis patients is able to receive the optimum treatment, and not just the minimum required to keep them alive. It is important to many of us to remain healthy enough to continue to be a contributing member of society

VA Dialyzor
Making all dialysis options available in the bundle rule certainly makes sense. I am very appreciative of the many different types of dialysis that is offered in this setting.

Seven years ago, my kidneys began to fail & my doctor advised dialysis. One of the options was home dialysis. Choosing this, I signed up for the class. However, before I could start the training, I suffered a heart attack & congestive heart failure. My dialysis then became an urgent necessity & I began dialysis in the hospital setting.

After my release from the hospital, I continued my dialysis treatments at the center, 3 days/week, and 4 hours/day. I did not feel very well after treatments; I itched, was cold, had cramping all the time & felt very weak. I have an IJ catheter. In the center they would run 500 speed to get a good clearance, but my machine's alarm would constantly go off. The motor speed was reduced, resulting in the poisons not taken off, as they should be.

I was 81 when I started dialysis & my wife (helper) was 74. Although skeptical of home training, we completed the training & all went well. I have been on home dialysis for 7 years and feel great. I am able to cut 4 acres of grass, visit with family, tend a garden, can vegetables and keep up with and order supplies. I eat what I want & my lab results are normally great.

I dialyze 5 nights/week, 8 hrs/night. Because each person is different, I believe CMS's per treatment plan options are best suited for everyone. Dialyzing this slow, long way is much better for my catheter & my well being.

I am now retired, but I know w/ home dialysis, my quality of life is much improved. This is reflected in my activities, my diet & my lack of hospitalizations.

I feel better all around & have been taken off blood pressure medication. I have only been hospitalized once in 7 yrs. for anything other than catheter problems.

These selected comments are in addition to the long home dialyzor submissions via Word or PDF document.

There are over 90 times as many people on conventional incenter dialysis as are on frequent home hemo, yet I can think of very few who, by any stretch, wrote to endorse their care. Only those at home, dialyzing more frequently, were moved to do so.  They know the truth, their stories tell of a better way.

Senate's Health Reform Manager Amendment: No Immunosuppressant Drug Coverage, GAO to Study Including Oral Drugs in PPS

By Bill Peckham

Ezra Klein reports that today Senate majority leader:

Reid released "the Manager's amendment (pdf)," a single piece of legislation that contains hundreds of amendments within it. This way, there is one big vote changing the bill rather than dozens, or even hundreds, of smaller votes.

This is the final amendment to HR 3590 the Patient Protection and Affordable Care Act, the Senate's version of health reform slowly working its way to a vote. The hope was that Senator Durbin would get immunosuppressant drug coverage into the Manager's amendment without a "pay for" mandating the inclusion of oral drugs in the dialysis payment bundle, which is the choice the House made a little over a month ago.

Unfortunately, the Manager's Amendment does not include any language relating to immunosuppressant drug coverage. There is, however, Section 10336 which calls for a GAO study of including in the dialysis payment, payment for dialysis related oral drugs (Page 249 - 250 PDF link):

SEC. 10336. GAO STUDY AND REPORT ON MEDICARE BENEFICIARY ACCESS TO HIGH-QUALITY DIALYSIS SERVICES.

(a) STUDY.—

(1) IN GENERAL.—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 under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) (pursuant to the proposed rule published by the Secretary of Health and Human Services in the Federal Register on September 29, 2009 (74 Fed. Reg. 16 49922 et seq.)). Such study shall include an analysis of—

(A) the ability of providers of services and renal dialysis facilities to furnish specified oral drugs or arrange for the provision of such drugs;

(B) the ability of providers of services and renal dialysis facilities to comply, if necessary, with applicable State laws (such as State pharmacy licensure requirements) in order to furnish specified oral drugs;

(C) whether appropriate quality measures exist to safeguard care for Medicare beneficiaries being furnished specified oral drugs by providers of services and renal dialysis facilities; and

(D) other areas determined appropriate by the Comptroller General.

(2) SPECIFIED ORAL DRUG DEFINED.—For purposes of paragraph (1), the term ‘‘specified oral drug’’ means a drug or biological for which there is no injectable equivalent (or other non-oral form of administration).

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

I have to believe this means oral drugs will not be included in the PPS required by MIPPA.

As to the immunosuppressant coverage piece, the hope now is that when they bring the House's HR 3962 and the Senate's HR 3590 bills to conference, the immunosuppressant coverage from the House Bill will pass through to the final bill and in the process the House's oral drug pay for will be replaced by the Senate's oral drug GAO study. That would be a great outcome.

The Congressional Budget Office thinks that adding oral drugs to the bundle will save money - $100 million over 10 years - but I can now say, after evaluating the idea in the context of commenting on the PPS, I'm confident that isn't true. Providing Medicare Part B beneficiaries medically appropriate, universal access to these oral drugs would come at a cost not reflected in current use and therefor current reimbursement. You can't save money you're not spending.

I hope that "other areas determined appropriate by the Comptroller General" will include evaluation of specific examples, from categories of current Part B beneficiaries (e.g. those with drug coverage through work, those with drug coverage through a retirement plan, those with drug coverage through low income plans, those without any drug coverage) to determine how the proposal would impact each group. How would adding binders to the bundle change their access to these drugs?

The Comptroller General should conduct case studies of current Part B beneficiaries with drug coverage under Part D to evaluate the appropriateness of their current use. I believe such an analysis would reveal that current coverage inappropriately limits the use of these effective and important medications. Current Part D copays and the “donut hole” have a profound impact on beneficiary's behavior. Evaluating future reimbursement based on current usage understates the need because under today's reimbursement nephrologists working closely with their patients will forgo prescribing medically appropriate drugs due to their financial cost and the patient's lack of adequate insurance coverage.

I didn't know all that two months ago, but after hours and hours spent thinking about and discussing the idea with scores of people I now have a well informed opinion. I adapted those last two paragraphs directly from the comment I filed last Tuesday. CMS did the dialysis community a great favor by including oral drug under the PPS. There is no way, as a community, we CKD advocates could have come to understand the implications of the seemingly simple idea of adding "specified oral drugs" to Medicare's dialysis treatment payment. We now know that the problems are much deeper than the questions of logistics specified for study under Section 10336.

Thanks to CMS's PPS oral drug trial balloon the entire CKD advocacy community can enumerate numerous challenges that arise from paying for binders and calcimimetics through Part B. From Congress's point of view the big problem will be it doesn't save money. Unless ... the CBO evaluates their inclusion assuming the drug prices are directly negotiated by Medicare. Nothing bars Medicare from negotiating Part B drugs directly with pharmaceutical companies. And that approach might end up saving money, even while expanding access and improving care.

Best PPS comment, nonDialyzor catergory

By Bill Peckham

No new PPS comments were posted today (you can view the comments here or download the continuously updated Excel file), but I am expecting at least a few more. I haven't seen one from KCC or from FMC, I expect they'll be posted early next week.

So far I have 1,115 comment on my PPS spreadsheet. They run the gamut from the actionable to those that can be summarily dismissed. I'll have a more in depth analysis once I think all the comments are posted. There were a lot of great comments from dialyzors. Dialyzors using the NxStage are vastly over represented. I can't wait to count up the comments from people using the NxStage (and NxStage family members). I think home dialyzors really came through to improve this rule for everyone. If CMS really listens to their beneficiaries they'll get rid of medical justification and pay fairly for home training.

I'll compile and post from the best dialyzor comments soon, until then here is my favorite comment out of all that were submitted, in the non-dialyzor category.

It's the 1,112^th comment I read. Maybe I'm just loopy from all the previous multipage entries, but I thought this one broke through in an engaging way, to tell a story that made the author's point, in fewer than 2,000 characters. (The submission was through the website interface so it was limited to 2,000 characters (the web interface also strips paragraph breaks, I've made a guess where to add them to improve the comment's readability.)):

I will never forget the first time a dialysis patient was upset with me. It was 15 years ago. I was an undergraduate Dietetic Student at the University of Vermont. I was interviewing dialysis pts on their calcium/phosphorus intake. One Saturday morning 2 pts absolutely refused to participate.

I had interviewed each of them 15 times before, but today, interviews were not going to happen. Why? The pts refused, saying; "we're trapped here in a chair. we're prisoners. We're going to sit here for 4-5 hours on a Saturday, and then spend most of our weekend trying to recover. You're going to ask a bunch of questions and then run off to enjoy your day. We don't want to help you".

What they were really saying is that they wanted to be free. They wanted to recover faster and feel better. They wanted a more "normal life". Why do i remember these 2 pts? Having now worked with many home hemodialysis pts, I know that these 2 pts should NOT have been in that center, not these 2.

They should have been treating at home, they should have been enjoying the benefits of daily home hemodialysis. Clinical evidence tells us that pts performing more frequent, home hemodialysis, realize faster recovery times post-treatment, a reduction in BP meds, increased levels of energy, less depressive symptoms, improved mental and physical capabilities, etc...

I applaud CMS for including in the proposed rule a stated goal of encouraging more home dialysis, and for allowing providers the opportunity to bill for more frequent therapy, which has been proven to improve the lives of patients. Unfortunately, because the stated rule fails to appropriately capture the costs associated with providing the essential HHD training required for home patients, I fear you are working against your stated goal.

Please reconsider the elimination of separate payments for home hemodialysis training. You are so close to hitting the mark, improving cost of care and quality of life. Help keep pts home and free.

That's a great comment. If you're the renal dietitian from CA congratulations, you won the best comment nonDialyzor award.

In your honor I went through and corrected the spelling of "Dietitian" in Column P across all 19 page of the spreadsheet.

My comments to CMS on the ESRD Prospective Payment System Proposed Rule

By Bill Peckham

My comment on CMS's proposed payment rule is now submitted. You have until 5PM Eastern Wednesday December 16th to get your comments submitted. This has been a challenging process. Exhausting.

Over 850 comments have been posted (you can view the comments here or download the continuously updated Excel file). The comments run the gamut from unactionable complaints about MIPPA to the 126 page opus submitted by the Kidney Care Partners (PDF link). After reading the KCP comments I would be shocked if oral drugs make it into the final rule. CMS seems to have clearly misread MIPPA to find statutory authority to include oral drugs. You get what you pay for and the KCP comments must have cost a lot of money to produce: they are very good, very compelling.

Reading through all the public comments reveals a deep distrust among all parties involved in the provision of dialysis. Patients don't trust providers who don't trust physicians and the feelings are mutual. And Medicare? Well Medicare doesn't trust us and we don't trust them, times ten. Sigh.

I don't know where this lack of trust will lead. Maybe somewhere on the other side of this seismic change is a reimbursement system that controls cost by promoting optimal dialysis. I think that is possible but it will take a concerted effort.

I don't think it is within the power of humankind to devise an optimal payment system for dialysis in one massive effort. Success will mean revisiting the questions raised by the PPS again and again; ongoing evaluation and improvement should be a routine feature of the payment system. This is an historic change that will guide and constrain the provision of dialysis for a generation. It's critical to get this right.

My over 4,000 word comment follows: