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CMS agreed with the GAO's conclusions, according to the report; nevertheless, the GAO wrote that “CMS does not know whether or the extent to which the bundled payment rate will be adequate when, beginning in 2014, CMS includes oral-only ESRD drugs in the bundled payment for dialysis care.”
The March report also contained a few pieces of other noteworthy news: CROWNWeb’s full, national rollout will be February 2012; CMS plans to include measures related to mineral and bone disorder in the ESRD Quality Incentive Program (QIP); and there will be a public comment period when the proposed rule regarding oral-only ESRD drugs is released.
The GAO cited three main reasons why oral-only ESRD drugs are going to be part of the dialysis bundle: including the drugs could promote more efficient dialysis care, promote clinically appropriate care, and improve access to these drugs for patients.
However, “GAO and others have stated that inadequate payments could lead to access and quality of care issues for beneficiaries on dialysis,” according to the report.
The current bundle, which started in January, covers the following under Medicare Part B: dialysis treatment and associated routine services, such as nursing, equipment, supplies, and ESRD-related laboratory tests; injectable drugs used to treat complications related to ESRD; and oral ESRD drugs that have injectable equivalents.
However, the bundle does not include oral ESRD drugs that do not have injectable equivalents. These include calcimimetics and phosphate binders that are used to treat mineral and bone disorder, which can result in a variety of negative clinical conditions, including weak and brittle bones and cardiovascular disease.
CMS plans to include these oral-only ESRD drugs in the bundled payment for dialysis care beginning in 2014.
Right now, dialysis providers may operate or contract with a community or mail-order pharmacy to provide these drugs to beneficiaries, according to the GAO. In addition, beneficiaries may have coverage for these drugs through other sources, such as Medicare Part D prescription drug plans and employer- or union-sponsored drug plans. However, approximately 17 percent of all Medicare beneficiaries on dialysis did not have any prescription drug coverage in 2007.
Some patients at three of the four large dialysis organizations interviewed by GAO received oral-only ESRD drugs in 2010. However, all of the 16 small dialysis organization interviewed did not provide these drugs last year. Despite the current differences, most of the organizations told the GAO they were concerned whether the bundled payment could adequately cover the cost of these oral-only drugs.
Three of the four LDOs interviewed have started plans to provide these drugs in 2014. However, only one of the 16 small dialysis organizations reported that they have plans for providing oral-only ESRD drugs to beneficiaries in 2014. “Specifically, representatives from a small hospital-based dialysis organization reported that their organization planned to use the hospital's pharmacy to provide oral-only ESRD drugs to beneficiaries,” the GAO wrote.
One major issue is whether the all-inclusive bundle can adequately cover oral drug costs, and determining payment could be limited by the fact that CMS will be using payment data under Medicare Part D. According to the GAO, these data could understate the costs that dialysis providers pay because “Medicare currently pays for these drugs primarily for those beneficiaries with Part D coverage.”
Part D data for 2007 through 2009 accounted for only about two-thirds of beneficiaries on dialysis, according to the report. “In 2007, for example, Part D payments for oral-only ESRD drugs for beneficiaries on dialysis with Part D coverage totaled about $445 million; however, this amount did not include payments for oral-only ESRD drugs for the approximately one-third of beneficiaries on dialysis who lacked Part D coverage,” according to the GAO.
On the other hand, one potential benefit for oral drugs in the bundle for patients is avoiding the Part D doughnut hole, in which patients are required to cover prescription drugs when the costs fall between $2,840 and $6,448. “When oral-only ESRD drugs are included in the bundled payment, all beneficiaries on dialysis will be eligible for coverage for these drugs under Medicare Part B, and will not be subject to the Medicare Part D coverage gap for these drugs,” the GAO wrote.
Small dialysis organization’s weaker purchasing power is also a concern and could make it difficult for them to negotiate competitive prices for oral-only ESRD drugs with drug manufacturers and pharmacies, according to the analysis.
In addition, state pharmacy licensure requirements might make dispensing these drugs troublesome. The GAO said these requirements generally pertain to staffing, drug storage, security, and delivery. “For example, officials from the Board of Pharmacy in two states—Georgia and Ohio—told us that their states generally prohibited pharmacies in their states from mailing drugs to beneficiaries at dialysis facilities,” the GAO wrote.
Data collection is another roadblock cited by the GAO report. CROWNWeb has been designed as a major component for compiling data to analyze the bundle. “Due in part to repeated implementation delays, it is uncertain when CMS will be able to rely on CROWNWeb to collect the data it needs to support its quality measures related to treatment of mineral and bone disorder, as well as other aspects of dialysis care,” the GAO wrote.
Because of continued implementation challenges, CMS recently delayed the full, national rollout of CROWNWeb until February 2012, according to the report. CMS told the GAO that one delay was because a contractor tasked with designing and implementing CROWNWeb performed poorly. The system was further delayed because CMS needed to update the system to address security requirements for federal data systems.
“The substantial and repeated delays associated with CROWNWeb, in addition to potential problems with data reliability associated with that system, raise questions about when CMS will be able to rely on the data collected in CROWNWeb to monitor the quality of dialysis care,” the GAO wrote. “Due to significant recent changes in CMS's method for paying for dialysis care, it is imperative that CMS identify an alternate source of data for quality monitoring until CROWNWeb is fully operational.”
CMS told the GAO that data from 2008 through 2010 for quality measures related to mineral and bone disorder and other aspects of dialysis care were collected through a project—referred to as the Elab Project— administered by the ESRD Network Program. CMS plans to continue funding the Elab Project in 2011 and said that it may be necessary to continue this initiative in the future.
According to the GAO, CMS is developing new quality measures related to treatment of mineral and bone disorder in order to identify measures for which a consensus target level can be proposed based on the clinical evidence available. CMS's current quality measures use target levels for serum calcium and serum phosphorus that are based on clinical guidelines recommended by the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease.
In addition, CMS told the GAO that it plans to include measures related to mineral and bone disorder in the ESRD Quality Incentive Program (QIP), which can take up to 2 percent off each payment to clinics that do not meet certain quality standards.
“To help ensure that Medicare beneficiaries have access to high-quality dialysis care, we recommend that the Administrator of CMS assess the extent to which the bundled payment for dialysis care will be sufficient to cover an efficient dialysis organization's costs to provide such care when the bundled payment expands to cover oral-only ESRD drugs. The Administrator should conduct this assessment before implementing this expanded bundled payment,” the GAO wrote.
In addition, the GAO said, “In order to ensure effective monitoring of treatment of mineral and bone disorder, we recommend that the Administrator of CMS continue collecting data for quality measures related to this condition from sources such as the Elab Project until CROWNWeb is fully implemented and concerns about its data reliability have been adequately addressed.”
In response to these recommendations, CMS said that it would “carefully analyze data on the utilization of these drugs before including them under the bundled payment.” CMS also said that before implementing this payment change, it would allow for public comment through the rulemaking process and would carefully examine any concerns expressed by the public to ensure that beneficiaries continue to have access to needed medications.
