Compliance Today (February 2020)

On December 17, the U.S. Department of Health and Human Services (HHS) announced in a press release, “As directed by President Trump in his July 10 Executive Order on Advancing American Kidney Health, the Centers for Medicare & Medicaid Services (CMS) is issuing a proposed rule to change the way organ procurement organizations (OPOs) are held accountable for their performance, and the Health Resources and Services Administration (HRSA) is issuing a proposed rule to remove financial barriers to living organ donation.”

According to the press release, “This proposal could increase the number of transplant recipients receiving a better quality organ in a shorter time period from living donors. In general, recipients of kidney transplants from living organ donors have better clinical outcomes than those who continue on dialysis or those who receive a deceased donor kidney transplant. HRSA also is reviewing a notice that would increase the income threshold for living donors eligible for reimbursements.”

In addition, “The proposed rule would improve the current measures by using objective and reliable data, incentivize OPOs to ensure all viable organs are transplanted, and hold OPOs to greater oversight while driving higher OPO performance.”

Donation rate measure: The donation rate would be the number of actual deceased donors as a percentage of the donor potential, which would be defined as total inpatient deaths in the donor service area (DSA) among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.

Transplantation rate measure: The organ transplantation rate would be the number of organs transplanted as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.

Top 25 percent benchmark: CMS is proposing that all OPOs meet the donation and transplantation rates of the current top 25 percent of OPOs, which would be made public.

12-month reviews: At the end of each re-certification cycle (every four years), an OPO would have to meet the CMS requirements for both the donation rate and transplantation rate measures. CMS is proposing to review OPO performance every 12 months throughout the four-year re-certification cycle to more quickly identify OPOs that need improvement and ensure fewer viable organs are wasted and more timely transplants occur.

“Most of the proposed changes would not take effect until 2022.”

For more on the CMS proposed rule (CMS--P): https://bit.ly/2Sjmdf4

For more on the HRSA proposed rule: https://bit.ly/36WK3l7

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