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:
To: Ms. Charlene Frizzera, Acting Administrator, Centers for Medicare and Medicaid Services
RE: CMS-1418-P: Medicare Programs; End-Stage Renal Disease Prospective Payment System; Proposed Rule
My name is Bill Peckham. I was the first speaker at the October 23rd Town Hall on the Proposed Prospective Payment System (PPS) and I have previously submitted formal comments on the PPS via Word document submission CMS-2009-0083-0350.1, in which I support CMS's decision to forgo the use of a Race/Ethnicity case mix adjuster, and via PDF document submission CMS-2009-0083-0769.1 (as a member of the Home Hemodialysis Work Group) in which I support PPS improvements of particular interest to beneficiaries that dialyze at home. In addition to those comments, I am now grateful for the opportunity to submit my complete comments regarding the PPS.
I live with stage 5 chronic kidney disease (CKD5)(I acknowledge that CMS use the ESRD appellation to mean CKD5 but I do not), and have been a Medicare beneficiary due to my CKD5 since 1988. I went straight to transplant in 1988, however, my underlying condition - FSGS - recurred after just 26 months. Since 1990 I have treated my CKD5 with hemodialysis (HD): initially conventionally incenter but since 2001 I have enjoy a healthier, more frequent dose of HD in the comfort of my home. For the last two years I have been dialyzing overnight using the NxStage System One which is in my judgment the best dialysis option, both clinically and logistically.
Since 1997 I have been a very active volunteer in the CKD advocacy community with provider, industry and patient organizations. I am dedicated to the support of my dialysis provider the community based, not for profit Northwest Kidney Centers, volunteering as a trustee for many years. I have helped to establish and I continue to volunteer my support to the Kidney Research Institute which conducts research with the high potential to tangibly improve the lives of people with kidney disease.
I am very hopeful that in the years to come CKD will be made to be less of a burden for the individuals and families that are afflicted with this devastating disease. I know HD works; my comments are grounded in my belief that all Medicare beneficiaries with CKD5 should be able to live the lives they were meant to live but for their bum kidneys. As I read through and thought about the PPS I asked myself:
Will this change in reimbursement increase or decrease the burden of dialysis on those who are ill?After much thought and discussion I conclude that the PPS, as presented, will increase the burden of dialysis upon those who are ill.
The PPS will increase the burden of dialysis by: decreasing access to important medications; complicating access to needed laboratory tests; decreasing access to home dialysis; increasing patient copays and accelerating provider consolidation. In addition I believe the PPS misses an opportunity, in regards to the proposed QIP, to reward outcomes important to patients that also promote the global economic efficiency of the Medicare ESRD program. Finally the PPS does not provide safeguards to limit possible involuntary beneficiary dismissals resulting from the expansion of the bundle.
Only with significant changes will the PPS, required under the Medicare Improvements for Patients and Providers Act (MIPPA), improve clinical outcomes AND economic efficiencies.
I urge CMS to improve the PPS by making the following changes:
- Do not include oral drugs
- Use a defined list of dialysis related laboratory tests
- Reimburse Home Dialysis training treatments fairly
- Limit case mix adjusters to those required under MIPPA
- Support small dialysis organizations with a low volume adjuster
- Prepare to include bone health measures, hospitalizations and infections in the QIP
- Redirect, to support innovation, reimbursement withheld under the QIP
- Motivate beneficiaries with financial incentives
- Mitigate the financial impact of patients who receive fewer than three treatments a week
Oral Drugs without an Injectable Equivalent (Oral Drugs)
Including reimbursement for oral drugs in the PPS could improve care and lessen the overall burden of dialysis but doing so now, under MIPPA, is a mistake and would increase beneficiary's dialysis burden. CMS should remove oral drugs from the PPS under MIPPA, and wait until Congress acts to explicitly mandate their inclusion.
In the published oral drug analysis, CMS did not look at the inclusion of oral drugs impact on specific beneficiaries. If CMS had looked at 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) CMS would have identified problems with the approach they used in determining the value of oral drugs included in the PPS. I believe such an analysis would show that beneficiaries with drug coverage outside of Part D would have less access to oral drugs under CMS's proposed PPS.
In addition case studies of current Part B beneficiaries with drug coverage under Part D 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.
Providing Medicare ESRD beneficiaries medically appropriate, universal access to these oral drugs would come at a cost not reflected in current use and therefor current reimbursement. Fairness and prudence should restrain CMS from including oral drugs in the PPS required by MIPPA. When future legislation passes through Congress directing CMS to include oral drugs, CMS should evaluate how to include the drugs in the PPS by evaluating the impact on specific individuals who are representative of the many ways beneficiaries today access these drugs or in some cases do not have access. For now, the final PPS should not include binders and calcimimetics.
Laboratory Testing (labs)
Including Medicare reimbursement for labs in the PPS increases the dialysis burden on beneficiaries, however, that increase can be kept to a minimum by limiting the included PPS lab tests to a defined list.
Because labs are currently 100% reimbursed by Medicare their inclusion in the PPS necessarily means that beneficiary copays will increase. This seems unavoidable given that MIPPA does seem to anticipate their inclusion but the PPS exacerbates the problem by defining the labs in question as those ordered by the beneficiary's nephrologist – the MCP physician. Defining labs in this way will complicate the doctor patient partnership that is at the heart of successful disease management and increase the burden of managing chronic illness(es).
Limiting the included labs to a defined list of labs that are dialysis related, Conditions for Coverage required, will allow MCP nephrologists to continue as primary care physicians and promote the medical best practice of avoiding additional needle sticks. People with CKD5 should protect their vascular system to preserve sites for future fistula creation, a PPS that supports all blood draws through the dialysis unit will support medical best practices.
Labs required by units to accommodate patient travel should be specifically excluded from the defined list. Travel is an important feature of a life well lived – if the labs required by a destination unit are not separately billable it will complicate and perhaps compromise the ability of beneficiaries to travel for work, family and pleasure. Support your beneficiaries in the pursuit of normalcy by keeping travel labs outside of the bundle.
Home Dialysis Training
Including Medicare reimbursement for home dialysis training in the PPS's routine dialysis treatment payment increases the overall burden of dialysis by limiting beneficiary access to healthier at home options. The PPS would be improved if it included additional payment for home dialysis training treatments.
I participated in the Home Hemodialysis Work Group, a coalition made up of patients, patient organizations, providers, physicians, and renal organizations which submitted an extensive, thoughtful and actionable comment via PDF document CMS-2009-0083-0769.1. In addition to those comments which I fully support, I want to say on a personal level how important frequent home dialysis has been to me. I may be your beneficiary with the most frequent home HD experience.
Last September I marked 8 years at home doing more frequent HD. I first went home using the B Braun Dialog machine (a device that is commonly used incenter) with a separate dedicated water treatment system in September 2001. After a year I switched to a brand new machine designed especially for frequent HD at home. A little more than four years after that, in January 2007, I switched again, this time to the NxStage System One, a new device especially designed to provide frequent HD at home. The NxStage allows me to really thrive despite my CKD5. I'm attaching with this submission a photo of me in Washington State 's San Juan Islands in 2007, dialyzing aboard a 36' power boat.
Home dialysis, particularly home HD done frequently, for eight hours over night, is the healthiest least burdensome form of dialysis. Unfortunately right now some people do not have access to frequent home dialysis at all. CMS and Congress have acted to support home dialysis – the PPS supports home dialysis by setting the payment frequency at per treatment and by allowing additional payments for medically justified treatments above three a week (thank you for that) – but if CMS chooses to not fairly reimburse for training it will inappropriately limit beneficiary access. Access to this life changing option, this key component to thriving with CKD5, should not be based on ones zip code. All Medicare beneficiaries should have the chance to take dialysis out of the dialysis center. We all deserve this chance.
Home is where CMS reimbursement should aim the provision of dialysis. Not every beneficiary will choose to dialyze at home more frequently but every beneficiary should have that option. I can think of few things worse than to be overburdened by the rigors of conventional incenter HD, especially if I was without any option or choice. People who are now experiencing frequent home dialysis are telling CMS and the world what they have experienced. It is a very compelling story.
Demand is going to increase for this healthier dose of dialysis, people want to live the lives they were meant to live but for their CKD, for many this is how it can happen. But for use to grow, access must grow and for that Medicare reimbursement must support the gateway – Medicare must fairly reimburse for the intensive one on one training that prepares beneficiaries to safely go home.
Each time I switched machines I need to go into the Northwest Kidney Centers specialty home training facility to receive intensive one on one training in how to operate the new device. When I switched to frequent over night dialysis I went in for training to ensure I could safely dialyze overnight, something I have been doing now for two years. My initial training to go home was about four weeks in duration, the subsequent sessions have been a week or less; some trainings last just a day in the case of a new secondary piece of equipment e.g. heparin pump, water treatment. This training is what has kept me safely dialyzing at home for over eight years. These training treatments should be fairly reimbursed.
It is wise to evaluate all payment adjustments for their potential misuse. A home training adjuster is unlikely to be misused. Training to dialyze at home can only occur in facilities certified for home training. The new Conditions for Coverage (I participated in the CMS Community Forum for Interpretive Guidelines in December 2007) outline extensive requirements for home training including specialized staff, policies, facility requirements, etc. It is a big deal to train for home dialysis, a beneficiary would not take the decision lightly.
In order to train patients would have to change their dialysis routine, change the time and place of treatments, even the frequency of care. This makes a home training adjuster unlikely to game. Of more importance is ensuring that beneficiaries get enough timely training to manage their treatments safely. The reimbursement system should support safety, fairly paying for home dialysis training separately or with an adjuster.
CMS may be tempted to propose a pilot or some other half measure, instead of implementing full support of home training. This would not be in keeping with CMS's and Congress's stated support of home treatments. A limit on the availability of fair reimbursement will limit the use of home dialysis. Without adequate funding some units will scale back or discontinue their home training programs, while others will wait before launching new training centers. The costs involved in one on one training are not a mystery. They are obvious and necessary; the growth of optimal dialysis hinges on fair reimbursement of home dialysis training.
Case mix adjusters
The number and complexity of case mix adjusters will increase the burden experienced by beneficiaries by creating an inequity for patients, in that some will have much higher bundled payments per treatment than others—and will subsequently have higher coinsurance payments. CMS should limit the case mix adjusters to those specifically required by MIPPA.
Given that the proposed adjusters poorly predict the variation costs, less than 40% of the measured variability, many patients find the treatment case-mix adjusters confusing, and unjustified. I am concerned how this will be implemented. The proposed case-mix adjusters system seems to open the door to errors and possible manipulation, for instance in the case of alcohol dependency. In the case of sex it is not clear why women would be more resource intensive and so I urge CMS to forgo a sex adjuster. The marginal gain from increasing payments for half the beneficiary population does not outweigh the sense of inequity from the higher copays that come with each adjuster.
Much of the cost difference meant to be addressed by the adjusters are due to historic differences in EPO use (the expanded bundle is meant to inspire less EPO use – this is what is suppose to fund the 2% decrease mandated by MIPPA). Adjusting payment, ahead of the medical practice changes driven by the bundle, may have the perverse effect of slowing the adoption of medical best practices. Once EPO is a pure cost the bundle will promote medical best practices that result in lower EPO use – higher eKt/Vs, higher quality water/dialysate, aggressive iron store maintenance - will be seen as decreasing costs and will be widely implimented. Units will have an incentive to provide the care that is better for the patient on its own merits and because it results in less EPO use, i.e. lower costs. CMS should wait until the bundle is in place and reevaluate the need for more than the minimum number of adjusters. Adjusters that are used should be based on scientifically understandable correlations to costs.
The adjuster for the first 120 days of treatment is understandable. As people transition to dialysis they should receive additional nursing, social work, nutrition support, etc.. However, 47% is a very large adjustment and will carry with it a large copay right during the period when beneficiary's coinsurance is the least settled.
Halving the first 120 day adjustment, setting it at 25% instead of 47%, would be good policy. It would still be a significant adjustment but it would not be so large that it creates incentives for gaming. Splitting the cost of new patients with providers will align incentives – money formerly in the adjuster would be returned to the base rate; providers could make up the cost of new patients over time by keeping the patients alive and well dialyzed.
Low Volume Facility Adjuster
A diverse provider community drives improvements in the provision of dialysis thereby decreasing the dialysis burden faced by beneficiaries. In general, the complexity of the new rule will drive further dialysis provider consolidation, in an already consolidated industry. Ownership diversity is healthy and in the interest of beneficiaries. I don't understand CMS's choice to define small volume facilities in terms of treatments provided rather than in terms of the size, and therefor the purchasing power, of the provider.
I believe Congress’ intent with MIPPA's low volume provision was to support dialysis choice and access. Congress recognizes in the US that the provision of dialysis is an oligopoly. An oligopoly mostly funded by Medicare, an unprecedented situation. CMS should define “small volume” as units owned by providers who serve fewer than 1% of the total dialysis census so as to allow beneficiary choice, encourage competition, and support the industry's engines of innovation. A low volume adjuster so defined will help balance the oligopoly by giving truly small providers additional resources to operate under the new payment rule.
There is no catching up to the purchasing power of the two large dialysis organizations. They will only get larger and more powerful. The PPS can only maintain provider ownership neutrality if it includes an adjustment for the nation's small dialysis providers. With out an adjuster for small dialysis providers the PPS massively favors large dialysis organizations. Neutrality requires the adjuster.
Quality Incentive Program
Given the financial incentives inherent in the expanded bundle there is no need to include a measure for Hgb >13. I wish I could suggest a magic measure that would convey the quality and appropriateness of the dialysis delivered. A weekly eKt/V would do a better job than URR, especially for those dialyzing longer or more frequently than conventional HD. However, these blood measures have little meaning to those of us on dialysis. Improving ones URR does not sound very important.
The most important measures to beneficiaries reported on the annual Dialysis Facility reports from KECC are hospitalizations and infections. The quality of ones dialysis has a lot to do with staying out of hospitals and avoiding dangerous and costly infections. CMS should establish baseline measures for hospitalizations and infections so that in the future, QIP can include outcomes of importance to beneficiaries.
Eventually Congress will require that the PPS include dialysis related oral drugs so while I do not think oral drugs should be included under MIPPA, I do think the QIP program should establish measures for bone health – including phosphorus, calcium and PTh. I hope that when Congress legislates the inclusion of oral drugs the PPS is ready with appropriate measures of bone health and a program that allows beneficiaries the opportunity to pay less for performance.
Missing from the PPS
No healthcare worker - doctors, nurse, etc. - can compel people to do what would be in their own best interests if they choose to ignore the healthcare worker. Frowney faces on lab reports aren't going to change an adult's behavior. Cash. Cash changes an adult's behavior. Achieved your clinical goals for bone health? You get $200 off your quarterly Medicare Part B premiums. Beneficiaries pay less for performance.
If you the beneficiary perform, you pay less. Saving money on Medicare premiums will motivate beneficiaries to make good choices during the 90% of time that they are not in a unit, good choices that will save payers and providers money.
The beneficiary has far more control over phosphorus levels then either the nephrologist or the unit. The beneficiary is in control of their diet and remembering to take their binders. Phosphorus control is important but units can't take a beneficiary's binders for them and it is in Medicare’s financial interest to see better phosphorus control among their CKD5 beneficiaries. This is where Pay Less for Performance will help. We all (society) will benefit if beneficiaries are motivated to properly manage their bone health and if financial incentives work for doctors and clinic administrators then they should work for any human, even those who need dialysis.
I propose CMS pool money withheld in the QIP to fund innovation. Innovations cost money and it is not at all clear how innovations in the provision of dialysis will happen under the PPS. Under the PPS only innovations that replace existing services are funded (when replacing a service an innovation can capture the associated funds). Under the PPS up to 2% withheld from under preforming units is unaccounted for! … that is not budget neutral. The QIP funds should be pooled for use in future years so that funding innovation is budget neutral. Access to the funds could be controlled by an advisory council tasked with the job of funding innovation and improvements in the provision of renal replacement.
Also missing from the PPS is a way to ensure that this reimbursement change does not result in an increase in involuntary dismissals. I worry that beneficiaries that skip treatments will be denied care. Dialysis is a tough row to hoe. It can be hard to learn to accommodate the demands of regular HD. Providers need their patients to dialyze three times a week in order to be fairly reimbursed for services provided less frequently than every treatment. EPO missed one day during the month will eventually need to be made up one way or another, skipping will now represent a very large cost for the units.
I don't write in defense of skipping but I do write to ask that skipping not equate to dismissal. I ask that CMS acknowledge the challenge, and work to find solutions. Networks should be tasked with monitoring and reporting involuntary dismissals. Beneficiaries who need only two treatments a week should not be compelled to fit the three day a week mold. Beneficiaries should not be denied readmittance to the unit when they return from hospitalizations. Renal networks should track and count cases of beneficiaries not being readmitted as an involuntary discharge. CMS must work through all available channels to prevent involuntary discharge and denial of readmittance. CMS should monitor closely what happens once under the final PPS.
On the other end of the continuum are beneficiaries who wish to work, they should be specifically supported. A case mix adjuster for those who work would align incentives in ways that are important to beneficiaries. CMS should evaluate options that support and reward optimal dialysis for those who wish to work.
I've read most of the public comments that have been posted on the Regulations.gov website. The comments reveal 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. My suggestions in the above letter represent a starting point.
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.
Great comments, Bill. I hope they listen and implement your well reasoned and actionable suggestions.
Miriam
Posted by: Miriam Lippel Blum | December 15, 2009 at 09:39 PM
Bill, as always you have articulated important aspects that will be in the best interest of patients.
Thank you for your continued devoted energy towards improving our delivery of care
Roberta Mikles, RN BA
Advocates4QualitySafeCare
Posted by: roberta mikles | December 16, 2009 at 09:14 AM
Bill,
An excellent and eloquent statement of the position that many patients espouse.
Hopefully, the powers that be will heed your passionate call.
Posted by: Richie Perl | December 17, 2009 at 10:44 AM
Well written!
Posted by: Kjellstrand fan club | December 18, 2009 at 06:28 AM
Thanks every one - it was a long process. Now we wait for CMS to release the final rule.
BTW I'd join the Kjellstrand fan club - where do I send my application?
Posted by: Bill Peckham | December 18, 2009 at 06:23 PM
I truly wish that each person at CMS who is reviewing comments places themselves, or a loved one, in the shoes of a dialzyor. As a family member I know what my loved one has experienced as well as observing many patients in many units....however, I will never truly feel that which the dialyzor experiences.
So, again, we hope and pray that CMS thinks, "What if this was me?" Personally, I am disgusted at the entire oversight and enforcement system, or lack thereof, as I have stated for years, with little improvements as I see it. Hopefully, this final rule will add some needed-protections for dialyzors and avail more home dialysis.
As I review more surveys I realize more and more the increased need for dialyzors to do their own treatments at home -- for their own safety. Recently, I had the opportunity to speak with an Education Coordinator from a LDO. I was shocked at the lack of understanding about infection control which supports my thinking, even more, that if staff are not adequately trained how can we expect a decrease in infection rates.
Roberta Mikles
Patient Safety Advocate
Advocates4QualitySafeCare
Posted by: roberta mikles | December 19, 2009 at 08:01 AM