Legislators recommend more pediatric ESRD research, review of transplant drug costs in HHS funding

A U.S. House and Senate conference report that is part of the 2019 appropriations spending package recently signed by President Donald J. Trump includes a push for more research in pediatric kidney disease and for a CMS-directed study on determining the cost of lifetime coverage for anti-rejection drugs for transplant patients.

Trump signed off on the $855.1 billion spending plan, known as H.R. 6157, that includes $178.1 billion for the Departments of Labor, Health and Human Services, and Education and Related Agencies for “investments in critical medical research, opioid abuse prevention and treatment, and education,” the Senate Appropriations Committee said in a press release. Funding includes $39.1 billion for the NIH, a $2 billion increase compared with 2018; $7.6 billion for the CDC; and $89.1 billion in funding for HHS, a $2.4 billion increase compared to fiscal year (FY) 2018. The Health Resources and Services Administration, which maintains the Organ Procurement and Transplant Network to distribute decreased donor kidneys and other organs as well as maintaining a national system for the recruitment of bone marrow donors, received $25.5 million for managing organ transplantation for FY 2019.

In recommending funding for CMS for fiscal year 2019, the Senate Appropriations Committee suggested in the conference report that the agency look at the cost of transplant drugs for Medicare patients with ESRD. Currently, Medicare only covers immunosuppressives 3 years after a kidney transplant for recipients younger than 65 years old.

“Recipients who cannot afford the high cost of the drugs sometimes resort to skipping doses and stretching medication, resulting in diminished kidney function and ultimately rejection, returning the patient to years of dialysis and another kidney transplant,” legislators wrote in the report. “The committee encourages CMS to commission a study to determine the cost of effectiveness of the current policy of restrictive coverage for these lifesaving immunosuppressive medications by analyzing the long-term cost of dialysis for patients who have received a kidney transplant and subsequent transplants due to the lack of access to anti-rejection medications.”

It also encouraged the National institutes of Diabetes and Digestive and Kidney Diseases, which received a boost in its budget to $2.144 billion for 2019, to continue research into pediatric kidney disease.

“The committee is encouraged by the research funded by NIDDK on pediatric kidney disease. However, the committee continues to urge the NIDDK to plan and work toward multicenter clinical trials and translational studies that will focus on the unique needs of children with kidney disease … The committee also encourages NIDDK to fund research aimed at establishing new prognostic indicators such as genomics and personalized medicine, novel diagnostics and therapeutics that may help further understanding in pediatric kidney disease that may also lead to breakthroughs and applications in adult kidney disease.”

The kidney care community had hoped the final version of the bill would have included a House proposal to extend the Medicare secondary payer provision for ESRD treatment from 30 months to 33 months, but that plan was not in the final bill. The extension meant patients with ESRD who had commercial health insurance would have stayed on those plans for at least another 3 months before Medicare became the primary payer for kidney care. The insurance industry voiced its opposition to Congress about the proposal; the dialysis community supported it because providers would be able to charge higher rates to insurers for treatment. – by Mark E. Neumann







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