By Mark E. Neumann

The final rule for the dialysis payment bundle is out, and most would agree that the Centers for Medicare & Medicaid Services did spend some time reading those 1,500 comments sent in after the first draft was released last September.

Some major victories for the renal community are noted in the final rule, released by CMS yesterday, but some concerns still remain about how this 'budget neutral' payment plan will work.
Some important changes from the draft include:

• Clinics will be able to charge the agency for home training sessions (rate is $33.38/session) "when clinically appropriate," giving dialysis clinics the flexibility to train patients at the time they elect a home therapy as a modality choice. Previously, a payment adjuster for training was available only in the first 120 days of treatment.
• The bundle will only include lab tests specifically associated with end-stage renal disease care; a list of those tests is in the final rule. Other tests ordered by a nephrologist that are not ESRD-related can be billed separately to CMS.
• Oral medications without an IV equivalent are part of the bundle---but not until Jan. 1, 2014, when all dialysis providers must be fully opted into the new payment system. Keeping oral medications outside the bundle for now was a major issue for providers, who said CMS underestimated the cost for these drugs based on limited Part D data. Putting new pharmacy services in place would also be a hardship for small- and mid-sized providers. The Government Accountability Office is expected to release a report next summer on the ability of dialysis clinics to provide these drugs.
  

The decision was good news for drug companies like Amgen (Sensipar) and Genzyme and Fresenius (Renvela and Phos Lo). In a press release, senior vice president and general manager of Genzyme's renal business Dan Regan said, "Genzyme is encouraged by CMS's final decision, as we believe it will put the needs of the patients first by providing the time needed to collect data to document the current standard of care, enabling assessment in the future of any unintended negative consequences that the new bundled payment system may have on the management and outcomes of dialysis patients."

• For the first time, the ESRD base rate will be updated annually by a market basket index. That review begins in 2012, starting with the 2011 rate.
  
• The number of case-mix adjusters has been reduced from an unwieldy 18 to just nine, including the three original (age, body mass index, and body surface area). The others, with payment multiplier, include:
  

Comorbidity adjuster                                                       Multiplier

Pericarditis (acute)                                                         1.114
Bacterial pneumonia (acute)                                            1.135
Gastrointestinal tract bleeding with hemorrhage (acute)     1.183
Hemolytic anemia with sickle cell anemia (chronic)            1.072
Myelodysplastic syndrome (chronic)                                 1.099
Monoclonal gammopathy (chronic)                                   1.024

A case mix adjusters based on gender (some data pointed to the idea that women were more expensive to dialyze) was dropped, and an adjuster under consideration that was based on a patient's race or ethnicity was not included. In that regard, CMS said it has been "reviewing and updating its processes for collecting and validating patient-level race and ethnicity data from dialysis facilities ... as this work continues, CMS will assess whether this effort will position the Agency to incorporate such an adjuster for payment in the future. CMS plans to continue studying the issue to ensure that all beneficiaries with ESRD have access to quality care, and in the meantime, plans to implement an active monitoring program to respond to concerns about disparities in access to care."

As a result of the drop in case mix adjusters, the base rate per patient went up slightly, to  $229.63 per treatment. Separate case-mix adjustments will apply to pediatric patients. CMS also kept facility level adjustments, including a geographic wage index and an adjustment for low-volume facilities, contained in the draft document.  Facilities that furnish fewer than 4,000 dialysis treatments (this is a change from 3,000 treatments in the draft) and meet other criteria can receive a 10% increase in payment at least through Jan. 1, 2014.

The final rule also includes an outlier payment policy that will pay facilities extra for patients whose care is more costly than the Medicare payment amount.

The new payment system fulfills a requirement in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). That Act also required CMS to develop a quality incentive program (QIP) that links a facility's payments to performance standards. The QIP, released as a proposed rule along with the bundle, is the first pay-for-performance program in a Medicare fee-for-service payment system.

In the final rule for the bundle, CMS adopted the three quality measures that will be used in the initial implementation of the QIP.  Two of these measures deal with anemia management (controlled anemia, as shown by the percentage of patients at a facility whose hemoglobin levels were less than 10 g/dL and greater than 12 g/dL), and the third measure captures patients' urea reduction ratio (greater than or equal to 65%). Under the QIP, CMS can reduce the payment rates to a dialysis facility by up to 2% if that facility fails to meet or exceed the established performance scores from the clinical performance measure.

That QIP program begins on Jan. 1, 2012, but CMS will accept comments on the QIP proposed rule until Sept. 24, and will respond to them in a final rule to be issued later this year.

Other things worth noting in the final rule that differ from the draft version of the bundle, according to industry sources:

• The base (unadjusted) age group has changed from 45-59 years old in the current composite rate and the proposed bundling rule to 60-69 years old in the final bundling rule.
• The case mix adjuster for monoclonal gammopathy excludes myeloma despite the fact that myeloma patients are more likely to be EPO resistant than those with monoclonal gammopathy of uncertain significance.
• The case mix adjusters for pediatric patients include only age (less than 13 vs. 13-17) and modality.  Peritoneal dialysis is reimbursed at a substantially lower (about 20%) adjuster than hemodialysis,
  

Sticking points

Some issues remain of concern to providers, including:


The cost of the transition period: As required by the law, the final rule provides a four-year phase-in (transition) of the payments under the bundle, with the phase-in occurring in equal increments until 2014 when payments would be based entirely on the ESRD bundled payment system. For CY 2011, transition payments consist of 75% based on the payment rate under the current basic case-mix adjusted composite payment system and 25% based on the ESRD bundled payment amount.  Dialysis facilities have until Nov. 1 to take advantage of a one-time election to be excluded from the transition and paid entirely under the new ESRD payment bundle.


However, CMS is guessing that many facilities won't pick that option of 100% opt-in; most will keep the majority of the patients outside of the bundle in the first year. To compensate for that estimated higher cost for the ESRD program, CMS is shaving 3.1% off the payments to clinics (up from 3% in the draft) in the first year of the transition. CMS said in the final rule it is considering making an adjustment to correct for over or underestimating the number of dialysis facilities that opt out of the transition in 2012, but some have petitioned CMS to look at the opt-in results after the Nov. 1. deadline and alter the 3.1% cut before the Jan. 1 start-up of the new bundled payment rate.


Modality training: Advocates for home dialysis are pleased that CMS will pay for training sessions beyond just the first 120 days of dialysis therapy, but argue that the rate --- $33.38 per session --- is still too low. Likewise, if facilities do train a patient for home dialysis as their initial therapy, the clinic cannot collect both the training payments and the first 120-day home adjuster payment. (To incentivize providers to send more patients home, Medicare only pays for dialysis starting on the first day of treatment if the patient elects home therapy.) Clinics will have to decide which payment makes sense.

Outlier payments: These can help clinics that have patients that are more costly to treat and where therapies aren't covered by the case-mix adjusters. But to cover those anticipated expenses, CMS is taking another 1% off the payment rate to keep the program budget neutral.

Co-pays for patients: While CMS did agree to restrict the number of lab tests that providers have to cover under the bundle, patients will now be responsible for 20% of those costs, including applicable case-mix and facility-level adjustments and outlier payments.  For those beneficiaries served by facilities that are going through the four-year transition period, the coinsurance would be 20% of the blended payment amount.   Similarly, drugs being bundled that are currently payable under Medicare's prescription drug program and subject to a separate coinsurance structure, would be subject to the 20% coinsurance as part of the set of bundled renal dialysis services.

To view the ESRD PPS Final Rule and the QIP Proposed Rule, go to www.ofr.gov/OFRUpload/OFRData/2010-18466_PI.pdf.
 
Mr. Neumann has been editor of Nephrology News & Issues since 1989.

Mark Neumann

Speculating on the near-term---and the future---of managing dialysis care, speakers at the 8th annual Business & Legal Issues in Dialysis and Nephrology symposium, sponsored by the McGuireWoods law firm, focused on legislative and regulatory issues impacting nephrology. While health care reform and the forthcoming payment bundle for dialysis services received the limelight, other important topics were covered during the day-long program, including electronic health records, access center development, and labor and employment issues.

An opening session by Prime Policy Group managing director Jerry Klepner outlined the details of the new health care reform law and its impact on the End-Stage Renal Disease Program (see box). Klepner also covered Congressional efforts on Medicare physician payment reform.

Perhaps the session that generated the most interest was a panel discussion, moderated by NN&I Legal Angle co-editor and McGuireWoods health care department partner Robert Pristave. Panelists for the session,  "Is the ESRD Program working well? Current problems and what the future holds," were well-rounded:  Ronald J. Kuerbitz, Executive Vice President of Marketing Development and Administration at Fresenius Medical Care North America; Robert Provenzano, MD, FACP, Chief of the Section of Nephrology, Hypertension & Transplantation, St. John Hospital & Medical Center, Detroit, and former president of the Renal Physicians Association; Robert J. Rubin, MD, former president of the Lewin Group consulting firm and former Assistant Secretary, Health and Human Services; and Chad Lennox, Executive Director, Dialysis Patient Citizens.

Pristave led the panelists through a range of topics, including the potential impact of health care reform on the ESRD program, potential changes to dialysis care under the bundle, and whether new forms of patient management, namely, accountable care organizations and the medical home concept, could benefit individuals with kidney disease.

Nephrology and  Congress On paper, the health care reform law, all 2,400 pages of it, only mentions the ESRD program in two areas: 1) a planned report by the General Accountability Office by March 2011 on the potential impact of including oral drugs (with no IV equivalent) into the bundled payment, and 2) a technical change in the market basket formula for adjusting the bundled rate each year that substitutes a 1% reduction with a productivity adjustment.   Other key issues: Additional funding under health care reform would help ease the pain imposed by the prescription drug "donut hole." Seniors slip into this dead zone of prescription drug reimbursement when their drug costs go too high --- but not high enough for Medicare to cover expenses. Klepner said the hole would disappear by 2020. For now, seniors get a  $250 rebate when they reach the end of Medicare coverage. The new Federal Coordinated Health Care Office will help manage development of new payment models, such as ACOs and medical homes.  Klepner said the renal community would not likely see the final rule for the bundled payment system until late June or early July. Sources indicate that the final language has yet to reach the Office of Management and Budget, which must review the economic impact of the plan. That process alone could take a number of weeks. The big concern about including oral drugs into the bundle with an inadequate payment to cover them--critics say the proposed $14/treatment by CMS is much too low---could be remedied by CMS agreeing to delay inclusion of the drugs until 2014, when all dialysis providers must be fully enrolled in the bundle. That time line could be influenced by the GAO report as well.  Or, CMS may compromise with the current plan and offer a higher payment for the oral drugs---somewhere around $40 per treatment. CMS sent details of the Quality Improvement Program, which is tied to the bundle and would take effect in 2012, to OMB for clearance on April 13. Expect to see that in the Federal Register soon. An important issue for physicians: developing a permanent fix to the sustained growth rate (what Medicare pays physicians). Congress is trying to beat the clock and finalize a five-year fix to avoid a 21% reduction in payments at the end of this month.  The tentative plan calls for no change in the Medicare payment rate (based on the 2009 fee schedule), but significant reductions--up to 30%--at the end of that five-year period.

During the panel discussion, speakers questioned the validity of the current dialysis prescription---thrice weekly for 90% of the dialysis patient population---but also suggested that improvements in indicators of care---fluid management, catheter infections, pre-ESRD education and treatment---could have an impact on the high mortality among dialysis patients.
"We can come up with new technical solutions within our current system," said Kuerbitz.  "[Renal Research Institute] research on fluid management shows we can get more dialysis within the traditional 3-4 hour limit."

But expanding the prescription, such as more frequent dialysis, to improve outcomes won't be cheap. "While its wonderful to dialysis patients longer ... in a payment system that is definitely broke, who is going to pay for it?" said Rubin.

The bundle, Kuerbitz said, makes sense in terms of providing more efficient care, and FMC has supported the idea for the past 10-12 years.

"[Dialysis] can be done, it can be done efficiently" at 98% of current treatment charges, he said---as long as CMS keeps oral drugs outside the bundle. "Beyond that it becomes a very difficult stretch," he said.

Rubin called the expanded case mix adjusters that are the center of the payment bundle "a fairy land" because they don't represent typical patient caseloads in dialysis clinics. He questioned whether CMS was "looking at a way to save money" when endorsing them, knowing dialysis clinics would find them of little value for billing patient care.

In addition to squeezing providers, the bundle offers little incentive for health care technology, Rubin said. "It's a real deficiency that not many people have put a bright light on ... The only technology that could be diffused back into the system is cost reducing technology." That might be of value in a fully capitated system, Rubin said, if systems were developed, for example, to reduce hospitalizations.

What might the future hold for physician relationships with providers? Some hospitals are buying nephrology practices, but the number of cases remains small. More such acquisitions are taking place in the oncology and cardiology specialties. FMC is not interested in buying practices, Kuerbitz said. "but providers and physicians will have to work together" in the new bundled payment era.

Mr. Neumann has been the editor of Nephrology News & Issues since 1989.

By Mark E. Neumann

A report released on Friday by the federal Office of Inspector General asserts that Spectra Laboratories, a subsidiary of Fresenius Medical Care North America, billed Medicare for medically unnecessary laboratory tests. But its not clear if the investigation is an effort to identify a problematic practice in the lab industry --- or just looking for new ways to keep Fresenius in line.

The audit was part of the OIG's scope of work in 2009 review  to determine "the extent to which the Medicare carriers have controls in place to detect and prevent inappropriate payments for laboratory tests." The audit was aimed specifically at labs that conduct tests for dialysis patients.

The audit, completed by National Government Services, a Medicare contractor, reviewed 2,771,777 claims filed by Spectra for tests provided to ESRD beneficiaries who received dialysis at FMCNA clinics from 2004-2006. The objective of the OIG was to determine whether the tests billed to Medicare were “reasonable and necessary."

The OIG gave Spectra a pat on the back for not filing any claims for composite rate-covered tests. And Spectra correctly billed for tests in 67 of the 100 quarters sampled by NGS --- almost 70%. But the audit did find claims that the NGS deemed were not reasonable and necessary based on Medicare requirements. Of the 37 quarters billed incorrectly, twelve of those quarters cited were in regard to tests not ordered by the treating physician. Those claims, Fresenius said, represented 3% of the claims in question.

"Spectra did not have sufficient procedures in place to ensure that the tests billed to Medicare were reasonable and necessary," the OIG wrote. "In addition, Fresenius facilities did not have sufficient controls to ensure that tests were ordered by the treating physician and were reasonable and necessary."

The OIG used the sample results to determine that Medicare overpaid Spectra by $5.4 million and, of course, suggested that FMCNA pay that back to Medicare.

With the Obama Administration looking for ways to cut fraud and abuse from the Medicare & Medicaid programs to help pay for health insurance for 32 million Americans, requiring Fresenius to pay over $5 million back to Medicare for unnecessary tests seems like a step in the right direction.

But the report raises some questions --- and provides few answers --- about how labs are supposed to respond to physician orders for a test.

• Citing Medicare regulation, the OIG says "no payment may be made under Medicare Part A or B for any expenses incurred for items or services ... that are not reasonable and necessary for the diagnosis or treatment of illness or injury..." One of the examples cited by the OIG was a patient who received weekly calcium and phosphorus testing, as ordered by the physician, even though the composite rate only allows for one test per month. Were those additional tests needed to diagnose the patient's condition? The physician obviously thought they were reasonable and necessary. The NGS and the OIG did not.

Fresenius says in its response to the findings that the audit results suggest that labs should "second guess" physicians when they submit requests for a lab test.  There is a fine line between giving physicians the ability to request tests to treat an illness, and a payer scrutinizing those requests to determine their necessity.

In its response, the OIG said Fresenius "overstated" its position in asserting that the findings amount to unlawful second guessing of treating physicians "Furthermore, this report in no way attempts to recommend how physicians should treat patients," the OIG stated.

How does it not? The NCS determined the tests for the patient with weekly calcium and phosphorus tests were not reasonable or necessary. In essence, Spectra Laboratories should have a mechanism in place to monitor such lab requests and take on the job of determining whether such tests --- or any test requested by a nephrologist --- is reasonable and necessary.

• It's not clear how clinical laboratories would be able to scrutinize every test that is requested by a nephrologist. The OIG cites a 1998 OIG guidance document that a laboratory "should take all reasonable steps to ensure that it is not submitting claims for services that are not covered, reasonable, and necessary." But after Fresenius asked the OIG to identify specific steps --- or mis-steps --- that Spectra took in filing the claims, the OIG said "these issues are beyond the scope of this report ... we therefore continue to recommend that both Spectra and the Fresenius facilities strengthen their policies and procedures to ensure that all tests billed are reasonable and necessary, in compliance with Medicare requirements.'"

No doubt, lab tests without a physician order need to be questioned, and Fresenius acknowledges those missteps. But the OIG's implication that laboratories are to question any test request that comes from a physician to ensure it is medically necessary sounds nightmarish. Within the renal community, there are some logical safeguards: Spectra understands tests allowed under the composite rate, and can monitor tests that don't fit that panel. But how far should they go --- or any lab go --- in question a physician's request for a test?

Likewise, the OIG is of no help in fixing the problem, offering FMCNA and Spectra no advice on how to change its procedures. If fixes are not part of the "scope of work" then is the only purpose of the audit to give the OIG a monetary victory by sending money back to the Medicare coffers?

Of course, concern about excessive lab tests could be a moot point by January 1, when CMS's new bundled payment system will include all lab tests ordered by a nephrologist. Clinic administrators will be watching physicians carefully to make sure all tests are, in fact, "reasonable and necessary." Thus the OIG should complete its work soon while the potential "rewards" are still available.

 
Mr. Neumann has been the editor of Nephrology News & Issues since 1989.

27th annual symposium
Mark E. Neumann

Las Vegas -- The new Conditions for Coverage are placing demands on dialysis providers to change how they deliver care. That scenario presents some valuable opportunities for the dialysis technician to strengthen their role on the renal care team.

The presentations and discussions at this year's NANT symposium, which ends here today, offer patient care and biomed technicians a better understanding of their roles in the dialysis clinic. Equally important, organizers noted, was helping technicians become certified by the April 15 deadline. Dialysis providers continue to worry as technicians struggle to pass a certification exam before the April 15 deadline. Passing the test is key for technicians who want to advance.

Conditions important for both PCTs, biomed techs
Much of the focus at this year's conference is on the revised Conditions, which took effect in October 2008. The two days of talks and special sessions made it clear that PCTs and bio-med technicians will play a much larger role in helping renal providers meet the new regulations. Dozens of the requirements in the new Conditions fall into the hands of the clinic's patient care and technical operations; water and dialysate testing, in particular, have undergone a major overhaul.

The new Conditions, which replaced regulations that were more than 40 years old, have shifted the focus from processes of care to delivered outcomes.  For water and dialysis testing alone, the number of "tags" or inspection points that Medicare-funded surveyors are now reviewing has increased from 8 to more than 100.

Inspectors have broadened their scope to make sure process and results are in sync. For bio-med technicians, it isn't just about the water testing---it is about the consistency in how the test is done, the cleanliness of the environment in which it is done, how well the equipment is maintained, and the steps associated with keeping the quality of the water and dialysate at required levels.

A great emphasis has also been placed on infection control measures, which the Centers for Medicare & Medicaid Services says remains the number one violation cited by surveyors when inspecting dialysis clinics. Equipment sanitizing and upkeep will have a higher priority for bio-med technicians.

Direct patient care
While bio-med technicians will need to improve equipment and product delivery during the treatment, patient care technicians will need to do their part. The new regulations place patient assessment and care---even patient comfort in the clinic-- at a much higher priority than in the past. Infection control---using protective wear and doing proper hand hygiene---must become routine, speakers said. Patients with infectious disease, like Hepatitis B, must have a dedicated space, equipment, and caregiver.

Speakers also emphasized throughout the program the importance of documenting practices and procedures. "If it hasn't been documented, it hasn't been done," one speaker said.

The meeting's theme this year, "Where do you fit in the game?" makes it clear that changes in the regulatory and economic landscape for dialysis care create some new opportunities for dialysis technicians to strengthen their role in the dialysis clinic.

Don't miss out.

Mr. Neumann has been the editor of Nephrology News & Issues since 1989.

By Mark E. Neumann and Rebecca Zumoff


Economic catastrophe or more control over managing the dialysis prescription?

These are two interpretations presented last week in the release of six articles published in the American Journal of Kidney Diseases that looked at the potential impact of the proposed bundled payment system for the end-stage renal disease program. AJKD editors collected a variety of viewpoints on how the bundle would impact current ESRD practice: small-, mid- and large providers, a non-profit provider, and the perspective from the ESRD Networks.

Here is a summary of the points made.

An historical perspective
This opening article by nephrologists Daniel E. Weiner and Suzanne G. Watnick traces the history of payment policies for the ESRD program, outlines the currently proposed bundled payment formula, and looks at potential advantages and disadvantages. They define some of the common concerns echoed in remarks to CMS during the bundle's review by the renal community late last year (more than 1,000 comments were received). But they also touch on a larger issue: fear of change. "As with any system that has remained largely unchanged in its reimbursement structure for 37 years, technological advances will eventually demand administrative changes, and these changes are associated with both inherent opportunities and risks." They also suggest that the ESRD program is serving as a "test bed" for further health care reform. "Establishment of a new model for health care reimbursement is a massive undertaking, and the forthcoming dialysis experience may provide the lessons necessary to implement a more widespread, federally-funded capitated payment policy throughout the U.S. health care system."


An LDO perspective
As Weiner and Watnick state in their editorial, bundling brings with it both opportunities and risks. Large dialysis organizations, or LDOs, have the advantage of patient volume and price negotiating that smaller providers do not. So, does that mean a bundled payment system will make the strong even stronger? LDOs do offer certain advantages, authors Allen R. Nissenson, MD, Tracy J. Mayne, PhD, and Mahesh Krishnan, MD.MPH, representing DaVita Inc., wrote in their contribution. "We believe that large dialysis organizations are uniquely positioned to nurture quality improvements by using extensive databases to test what practices are best. But they also state that adequate funding of the ESRD program, regardless the size of the provider, is key. "With adequate funding, there will be opportunity not just for innovation, but to leapfrog improvements in care and outcomes," they wrote, citing an increase in the use of peritoneal dialysis, improvements in anemia management, and better treatment of bone and mineral disorders as potential winners.  If the bundle is underfunded, patients in rural areas and African-Americans in particular will be the most vulnerable, they said, and drug and device companies will shy away from developing new products and therapies.


MDO perspective
Among the hundreds of comments to CMS about the proposed payment bundle, the increase in the number of case-mix adjustments is perhaps the strongest. Moving from three basic adjusters to over a dozen will make for a complicated payment structure for medium-sized dialysis organizations, wrote John Moran, MB, BS, Senior Vice President of Clinical Affairs at Satellite Healthcare. Likewise, the choice of the adjusters appears at best to be "both arbitrary and perverse."

In reading the explanation of how they were determined by the University of Michigan Kidney Epidemiology and Cost Center, "nowhere in this list is clinical plausibility or relevance taken into account," he notes. In fact, he states, some of the modifiers may in fact reward poor patient care. "Pericarditis is especially bothersome as a modifier, since the most common cause of this in the dialysis population is inadequate dialysis."
 

SDO perspective
The Medicare Payment Advisory Commission has shown that smaller dialysis organizations operate on thinner margins compared to the LDOs, and J. Ganesh Bhat and Premila Bhat, nephrologists with Atlantic Dialysis Management Services, fear that smaller independent dialysis organizations will not be able to survive. They updated data first published in NN&I last year in their AJKD article on an SDO perspective, and concluded that the clinic they evaluated with about 125 patients "will be at substantial financial risk under the proposed payment system." Administrative burdens are "substantial."

"A small number of very high-cost patients could have an enormous impact on the DSO's bottom line; furthermore, DSOs are disadvantaged in negotiating with vendors, including pharmacies and laboratories," the authors wrote. The end result, the nephrologists say, may be facilities that are closed or bought out, decreasing competition and reducing options for patients.


The Forum of ESRD Networks' perspective
The Forum of ESRD Networks said it supports CMS' s goal to "provide more cost-effective care, eliminate waste, and create a culture of value-based purchasing." However, nephrologists Cynthia Kristensen and Jay Wish, who authored the Forum response in the series, said that the organization is concerned that the provisions of the PPS do not support the goals of the ESRD Network Program or the goals of the Institute of Medicine.

"It is the opinion of the Forum that implementation of the PPS in its current form will unintentionally degrade ESRD care," the editorial said.

The forum takes issue with the inclusion of lab tests in the bundle, which they say can lead to a lowered access to care for some, and provides incentives for clinics to not run necessary tests; the elimination of Method 2, which can decrease a clinic's desire to provide home training; the thrice weekly payment system which the forum calls outdated; the inclusion of IV and oral drugs in the bundle, which can lead to patients not receiving the medication they need; and the quality incentive program that is set to begin in 2012 based on 2010 data, which the forum said "will have the effect of punishing facilities which have made advancements in quality between 2010 and 2012." The forum also said that not giving the Networks access to the data or the data collection system, which the Forum called flawed, will make the data even less valid.

In conclusion, the forum said it "appeal[s] to CMS to reassess the proposed rule for PPS to focus on the establishment of a dialysis care system that is more patient-centered, less fragmented, and more comprehensive."


Not-for-profit SDO perspective
Independent Dialysis Foundation CEO and nephrologist John Sadler says that he agrees with the concept of a single payment system, but not with the many elements at play in CMS's current proposal.

Sadler begins by providing the history of cost cuts within the dialysis community, and said "we still remain unsure about the quality of care we provide." The bundle includes too many things out of the control of the nephrologists, like lab tests and oral drugs, which will lead to less access to medications and treatments. Further, Sadler says the data used to create the reimbursement rates for drugs are based too much on non-ESRD populations.

Sadler says that, although CMS said the rule intends to promote home dialysis, it actually does the opposite. And the additional requirement that small organizations enter data in CROWNWeb individually gives an unfair advantage to the large providers. "It appears CMS has concluded it is better off if all dialysis is done by large organizations; these rules will help produce that," Sadler wrote.

In conclusion, he writes, "if this policy remains as proposed, it well may drive small dialysis organizations out of business. When there are only two or three very large organizations remaining, some may consider that desirable. Those large organizations may be able to provide care at lower cost, but then it will be on their terms."