Years come and years go, but 2008 will long be remembered as the year that shaped the renal community for the 21st century. It was the year that the End-Stage Renal Disease Program saw some of its biggest changes in three decades, from the updated Conditions for Coverage as well as dialysis reimbursement reform. Of course, there was also the presidential election, as well the economic crisis that has gripped the country. So, to recap the year, RBT has compiled a list on the top 10 stories in 2008.
1. Dialysis gets an annual update, bundled payment
In July, after a protracted political battle on Capitol Hill, Congress overwhelmingly overrode President Bush’s veto of Medicare legislation that halted a 10.6 percent physician fee cut and reformed the End-Stage Renal Disease Program with a long-awaited annual update, kidney disease education and prevention programs and a bundled payment system. The fully bundled payment system goes into effect Jan. 1, 2011, and will include an annual reimbursement update. The bundled payment will include the services covered under the composite rate as well as drugs, biologics and lab tests that are currently billed separately. All this, of course, means big changes for dialysis providers, and the renal community is sure to spend the next two years delving into the details of bundling and how it could affect the financial health of dialysis clinics.
2. Dialysis rules revised for first time in three decades
In April, after years of delay, the Centers for Medicare & Medicaid Services released new rules to modernize the rules that set minimum requirements dialysis centers must meet in order to operate and be Medicare certified. It was the first time since 1976 that the ESRD Conditions for Coverage had been updated. After more than 30 years of no rule changes, dialysis centers around the United States were left scrambling to ensure compliance by mid-October when Medicare surveyors started using the new rules to inspect clinics. CMS said the new regulations reflect clinical and scientific advances that have been made in the last three decades. CMS said it focused the new rule on patient rights, patient safety and patient participation in developing a plan of care. Under the new rule, each facility is required to develop a quality assessment and performance improvement program (QAPI), which would track a facilities performance in a patient’s health outcomes.
3. Tainted heparin wreaks havoc in U.S. healthcare
In late February, Baxter International announced that it was recalling all lots of the blood-thinning drug heparin, which is widely used in dialysis centers, after more than 350 adverse events were reported to the U.S. Food and Drug Administration in the first two months of 2008. There had only been 100 such events reported in all of 2007. But the plot thickened as the FDA and the media dug deeper. Regulators found that the tainted heparin’s source came from China where its base ingredients were being manipulated for economic reasons. Part of the problem was that the FDA never inspected the Chinese plant that sent the ingredients into the United States. As a result of the recall, APP Pharmaceuticals took control of the heparin market, which caused the price of the drug to double for dialysis providers. The recall, however, cost more than just money. More than 1,000 adverse events have been reported and 80 people died as a result of the contamination.
