The U.S. House of Representatives unanimously passed a bipartisan bill on Tuesday that would allow private accreditation organizations to certify dialysis facilities. But experts are concerned that the change could threaten patient safety.
The CMS and states currently certify dialysis facilities, but patient advocacy groups and dialysis centers claim that process is too slow to meet demand. The House reform proposal is part of the larger Medicare Part B Improvement Act.
The proposed law mandates that the CMS review and approve the accreditation process of private organizations such as the Joint Commission so they can begin to certify dialysis centers for operation. Roughly 90% of providers including hospitals are already certified by private accreditors instead of the CMS, but dialysis centers have been excluded from this.
Rep. Lynn Jenkins (R-Kan.), the lead sponsor of the initial legislation, claims that new dialysis centers in her state have to wait more than two years before they can open to patients because they have not yet received CMS certification.
The CMS provides funding to state agencies to survey, certify and inspect a variety of Medicare-funded providers, including hospitals, nursing homes and dialysis centers. But new dialysis centers are a lower priority on the certification tier system established by the CMS. Overseeing nursing homes and facilities identified as at-risk of providing poor care takes precedence.
Jenkins and patient advocacy groups such as the Dialysis Patient Citizens argue this tier system prevents new dialysis centers from opening fast enough because state agencies are overwhelmed by other priorities that take precedence.
Dialysis Patient Citizens' CEO told the House Ways and Means Committee in a letter that "long delays for the approval of new dialysis facilities as well as extremely high startup costs discourage new centers from being opened, especially in rural communities where there may be fewer patients making it more difficult to recoup initial costs."
DaVita, a large dialysis provider, supports the law as the need for treatment of end-stage renal disease continues to increase, said LeAnne Zumwalt, group vice president of DaVita.
More than 600,000 Americans are being treated for kidney failure and 468,000 patients are on dialysis, according to the latest data from the National Kidney Foundation. Modern Healthcare reported that the number of dialysis facilities increased by 6% annually over a five-year period to meet the rising need for services.
"It's really no surprise that we are seeing the demand for dialysis treatment balloon," said Michael Abrams, co-founder of healthcare consultancy Numerof & Associates, as age and chronic disease contributes to kidney disease. He said the CMS and state agencies "should have seen this coming" and better prepared for the expected rise in demand.
Abrams said that the use of third-party accreditation companies isn't a sufficient solution given their controversy. Patient safety experts and the CMS have questioned how effective accreditation organizations are at finding problems. The CMS recently proposed a rule requiring private accreditors to publicly release reports of facilities in part because of some of these concerns.
"If I were a dialysis patient, I wouldn't be inspired by that kind of track record," Abrams said.
Instead of allowing third-party accreditors to survey new dialysis centers, Abrams advocates for dialysis providers to pay user fees to the CMS so the agency can afford to better staff state agencies and prioritize certification of new centers.
The Food and Drug Administration charges drug companies user fees so they can expedite the drug approval process. The use of these fees has allowed the FDA to maintain oversight of the drug industry instead of private companies, which is much better for patients' safety, Abrams argued.
"The responsibility lies with the CMS, and we shouldn't do things that compromise that," he said.