November 14, 2021

William N. Parham, III
Paperwork Reduction Staff
Office of Strategic Operations and Regulatory Affairs.

Submitted Electronically: 

RE: Information Collection Request Title: Organ Procurement Organization Histocompatibility Laboratory Cost Report; Form CMS-216-94; OMB Control number: 0938-0102

Dear Mr. Parkham:

Thank you for the opportunity to provide input to the Centers for Medicare & Medicaid Services information collection request, Organ Procurement Organization Histocompatibility Laboratory Cost Report on behalf of the Association of Organ Procurement Organizations (AOPO).

AOPO is the national representative of 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, who together serve millions of Americans. AOPO is dedicated to providing education, information sharing, research, and technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplant rates while consistently improving towards the singular goal of saving as many lives as possible.

Specifically, AOPO is commenting on the accuracy of the estimated burden.

The Centers for Medicaid & Medicare Services lists the following estimates for form CMS-216-94: number of respondents: 95; total annual responses: 95; total annual hours: 4,275.

CMS has set a benchmark of 41,000 annual transplants by 2026. AOPO has set its own ambitious goal to reach 50,000 organ transplants annually during the same period. AOPO recommends that the methodology to determine annualized burden hours for all forms account for anticipated increased staff hours spent on enhanced data collection and performance improvement initiatives related to achieving these goals of increasing the total number of donors.

A survey of OPO Finance Directors revealed that the actual time necessary to complete form CMS-216-94 is approximately 50 hours, resulting in 4,750 total annual hours. In addition, the amount of time it takes to complete the various schedules, which creates the data which is then entered on Form CMS-216-94, takes much longer. We encourage CMS to take into consideration the time necessary to collect and organize the data needed to complete CMS-216-94 in the total time burden calculation.

As the nation’s leading voice for OPOs, AOPO represents the thousands of dedicated OPO professionals working together with donor families, hospitals, and transplant programs, to ensure every donation opportunity results in a life saved. We appreciate this opportunity to provide feedback and welcome future opportunities to collaborate with CMS and other stakeholders toward our shared goal of improving the health of those in need of life-saving transplants. If you have any questions about the content of this letter, please contact Mark Cribben, Director of Government Affairs, at

Thank you,

j.finn signature

Jan Finn
President, AOPO