It said the organization failed to meet two of the standards used to measure success at collecting organs that are often the last hope for people suffering from life-threatening diseases.
A CMS spokesman emphasized that it has procedures in place to ensure that organ collection and transplantation are not disrupted. “At no point in time will the service area be without an OPO or access to donated organs,” she said in a written statement, referring to organ procurement organizations.
The June 4 letter, which the CMS revised on June 7 to correct the expiration date of LiveOnNY’s contract, was written during a time of upheaval in the transplant industry, which faces a perennial shortage of donor organs.
Last month, a group of New York patients waiting for livers threatened to sue the CMS if the federal agency does not make changes in the way those organs are allocated nationwide. They claim organs should go to the patients who are sickest, with less emphasis on keeping the organs in the area where they are collected.
That approach worked last November, when a New York woman forced transplant officials to change the way they allocate lungs.
Nearly 115,000 people are on waiting lists for kidneys, livers, hearts, lungs and other organs. Many of them linger for years; about 22 die each day.
More than 33,400 organs from deceased donors, a record, were transplanted in 2017. Surgeons also are using increasing numbers of kidneys and livers from live donors to fill the demand for those organs.
The CMS regulates the 58 U.S. nonprofits that collect organs from deceased donors and transport them to recipients. It collects data regularly and conducts a fuller review every four years.
Since 2012, the agency has required LiveOnNY to submit at least three “corrective action plans.”
LiveOnNY said it has begun an appeal process that could take as long as seven months, according to the CMS. Ultimately, LiveOnNY could go to court if the appeal is denied.
For at least the last eight years, LiveOnNY has consistently registered one of the poorest performances in the nation, records show. It ranked as the country’s second-worst OPO, according to the last full year of data.
Helen Irving, chief executive and president of LiveOnNY, said in a statement that the organization “is deeply disappointed by CMS’s decision, a decision that is informed by inherently flawed metrics that CMS uses to evaluate organ procurement organization performance. Those metrics unfairly impact New York.”
Irving added that “LiveOnNY will continue its lifesaving work along with its hospital partners without interruption regardless of these CMS proceedings.”
A procurement organization was last closed in 1999, according to officials. The CMS has used other methods to encourage more organ collection, including demands that faltering organizations submit improvement plans.
Each group holds a federally approved monopoly over a swath of U.S. territory and the hospitals within those boundaries. That makes it difficult to shutter one without first identifying a replacement organization so that organ recovery can continue uninterrupted.
With jurisdiction over 13.5 million people in New York City, Westchester, Long Island and a tiny piece of Pennsylvania, LiveOnNY covers the second-largest area of the 58 OPOs by population. It has 215 employees, collects organs from donors in scores of hospitals and has nine transplant centers within its boundaries.
It is unclear which organization might take over LiveOnNY’s territory if the CMS carries out its plans. The letter says the area “will not be opened for competition until the appeals process is completed or LiveOnNY abandons its administrative appeal rights.”
Competition for LiveOnNY’s territory would be limited to the other 57 OPOs. The most likely candidates would be adjacent organizations in Philadelphia, Connecticut or New Jersey, according to people in the transplant network.