# 84 FR 70628: Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2019-27418

## Section

- **Citation:** 84 FR 70628
- **Heading:** Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 84 / 84 FR 70628

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 486 [CMS-3380-P] RIN 0938-AU02 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization AGENCY:
Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:
Proposed rule.

SUMMARY:
This proposed rule would revise the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current measures with new transparent, reliable, and objective measures.

DATES:
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. EST on February 21, 2020.

ADDRESSES:
In commenting, please refer to file code CMS-3380-P when commenting on the issues in this proposed rule. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the “submit a comment” tab.
2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3380-P, P.O. Box 8010, Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3380-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
b
ow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3380-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Diane Corning (410) 786-8486, Eric Laib (410) 786-9759, Jesse Roach (410) 786-1000, Alpha-Banu Wilson (410) 786-8687, or CAPT Hui-Hsing Wong (410) 786-9007.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.
I. Background
A. The Importance of Organ Procurement Organizations and the Need To Reform the Organ Procurement System
Organ procurement organizations (OPOs) are vital partners in the procurement, distribution, and transplantation of human organs in a safe and equitable manner for all potential transplant recipients. The role of OPOs is critical to ensuring that the maximum possible number of transplantable human organs is available to seriously ill people who are on a waiting list for an organ transplant
System
Organ procurement organizations (OPOs) are vital partners in the procurement, distribution, and transplantation of human organs in a safe and equitable manner for all potential transplant recipients. The role of OPOs is critical to ensuring that the maximum possible number of transplantable human organs is available to seriously ill people who are on a waiting list for an organ transplant. There are currently 58 OPOs that are responsible for identifying eligible donors and recovering organs from deceased donors in the United States (U.S.). Therefore, OPO performance is a critical element of the organ transplantation system in the U.S.
As of September 2019, a total of 112,846 people were on the waiting lists for a lifesaving organ transplant. 1 Many people face tremendous quality of life burdens or even death while on the waiting list. An OPO that is efficient in procuring organs and delivering them to recipients will help more people on the waiting list receive lifesaving organ transplants, which could ultimately save more lives.
1 Organ Procurement and Transplantation Network (OPTN) Data. https://optn.transplant.hrsa.gov/data/.
Given OPOs' important role in the organ donation system in the U.S., some stakeholders have argued that underperformers have faced few consequences for poor performance. These stakeholders, mainly from advocacy organizations, have noted that “Performance varies across the OPO network, with many persistent underperformers failing to improve over the last decade.” 2 They further note that there are serious negative impacts to both organ transplantation and donation when OPOs are underperforming, in that “[w]hen OPOs are inefficient or ineffective, donor hospitals are reluctant to refer potential donors, and transplant centers have fewer organ offers for patients on the waiting list. The end result is a bottleneck within the system that leads to avoidable deaths and increased national health care spending.” 3
2 The Bridgespan Group. Reforming Organ Donation in America
re underperforming, in that “[w]hen OPOs are inefficient or ineffective, donor hospitals are reluctant to refer potential donors, and transplant centers have fewer organ offers for patients on the waiting list. The end result is a bottleneck within the system that leads to avoidable deaths and increased national health care spending.” 3
2 The Bridgespan Group. Reforming Organ Donation in America. https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf .
3 ORGANIZE. Organ Donation Reform Report. 2019.
Some stakeholders, including members of the OPO industry, agree that the OPO outcome measures should be reformed. Some of these stakeholders note that “[e]xisting regulations need dramatic improvement to remove perverse incentives to organ procurement (for example, OPOs are evaluated on the number of organs procured per donor, which leads to older single-organ donors being overlooked) and increase continuous performance accountability.” 4 Reforming the outcome measures can be achieved, they indicated, through metrics that improve accountability and “by replacing current ineffective metrics for OPO performance with a simplified transparent metric that enables independent performance measurement.” 5
4 The Bridgespan Group. Reforming Organ Donation in America. https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
5 The Bridgespan Group. Reforming Organ Donation in America. https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
Based on public feedback and our own internal analysis of organ donation and transplantation rates, we agree that the current OPO outcome measures are not sufficiently objective and transparent to ensure public trust in assessing OPO performance, nor do they properly incentivize the adoption of
B
ages/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
Based on public feedback and our own internal analysis of organ donation and transplantation rates, we agree that the current OPO outcome measures are not sufficiently objective and transparent to ensure public trust in assessing OPO performance, nor do they properly incentivize the adoption of
B. Statutory and Regulatory Provisions
To be an OPO, an entity must meet the applicable requirements of both the Social Security Act (the Act) and the Public Health Service Act (the PHS Act). Section 1138(b) of the Act provides the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be paid under the Medicare program or the Medicaid program. Section 1138(b)(1)(A) of the Act specifies that payment may be made for organ procurement costs only if the agency is a qualified OPO operating under a grant made under section 371(a) of the PHS Act or has been certified or re-certified by the Secretary of the Department of Health and Human Services (the Secretary) as meeting the standards to be a qualified OPO within a certain time period. Section 1138(b)(1)(C) of the Act provides that payment may be made for organ procurement costs “only if” the OPO meets the performance-related standards prescribed by the Secretary. Section 1138(b)(1)(F) of the Act requires that to receive payment under the Medicare program or the Medicaid program for organ procurement costs, the entity must be designated by the Secretary. The requirements for such designation are set forth in 42 CFR 486.304 and include being certified as a qualified OPO by CMS.
Pursuant to section 371(b)(1)(D)(ii)(II) of the PHS Act, the Secretary is required to establish outcome and process performance measures for OPOs to meet based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of the qualified OPO
re set forth in 42 CFR 486.304 and include being certified as a qualified OPO by CMS.
Pursuant to section 371(b)(1)(D)(ii)(II) of the PHS Act, the Secretary is required to establish outcome and process performance measures for OPOs to meet based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of the qualified OPO. Section 1138(b)(1)(D) of the Act requires an OPO to be a member of, and abide by the rules and requirements of, the Organ Procurement and Transplantation Network (OPTN). OPOs must also comply with the regulations governing the operation of the OPTN (42 CFR part 121). The Department has explained that only those policies approved by the Secretary will be considered “rules and requirements” of the OPTN for purposes of section 1138 of the Act. The OPTN is a membership organization that links all professionals in the U.S. organ donation and transplantation system. Currently, the United Network for Organ Sharing (UNOS) serves as the OPTN under contract. OPOs are required under the OPTN final rule (42 CFR 121.11(b)(2)) and 42 CFR 486.328 of the OPO Conditions for Coverage (CfCs) to report specific information to the OPTN, including the data used to calculate the outcome measures for OPOs.
In addition, OPOs are required to comply with Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, and section 1557 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18116, which protects qualified individuals with a disability, including prospective organ recipients with a disability and prospective organ donors with a disability, from unlawful discrimination in the administration of organ transplant programs. Under these laws, OPOs must ensure that qualified individuals with a disability are afforded opportunities to participate in or benefit from the organ transplant program that are equal to opportunities afforded others
luding prospective organ recipients with a disability and prospective organ donors with a disability, from unlawful discrimination in the administration of organ transplant programs. Under these laws, OPOs must ensure that qualified individuals with a disability are afforded opportunities to participate in or benefit from the organ transplant program that are equal to opportunities afforded others. Decisions to approve or deny organ transplants must be made based on objective facts related to the individual in question. “Individuals with disabilities are also entitled to reasonable accommodations needed to participate in and benefit from a program, and auxiliary aids and services needed for effective communication. These rights extend in some circumstances to family members of a prospective organ donor or recipient. For example, health care providers and organ donation programs are required to provide auxiliary aids and services (including sign language interpreters) when necessary for effective communication between a relative involved in a prospective donor or recipient's care and a health care provider or donation program.”
We established CfCs for OPOs at 42 CFR part 486, subpart G, and OPOs must meet these requirements in order to be able to receive payments from the Medicare and Medicaid programs. These regulations set forth the certification and re-certification processes, outcome requirements, and process performance measures for OPOs and became effective on July 31, 2006 (71 FR 30982).
Section 486.322 requires that an OPO must have a written agreement with 95 percent of the Medicare- and Medicaid-participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room, and have not been granted a waiver by CMS to work with another OPO
nd process performance measures for OPOs and became effective on July 31, 2006 (71 FR 30982).
Section 486.322 requires that an OPO must have a written agreement with 95 percent of the Medicare- and Medicaid-participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room, and have not been granted a waiver by CMS to work with another OPO. Meanwhile, 42 CFR 482.45 requires a hospital have written protocols that incorporate an agreement with an OPO under which it must notify, in a timely manner, the OPO or a third party designated by the OPO, of individuals whose death is imminent or who have died in the hospital. Potential organ donors may encounter Medicare- and Medicaid-certified providers prior to an emergency department visit or hospital admission to a critical care unit. Therefore, we expect that each OPO's responsibilities and work began long before a hospital notified the OPO of an impending death—through, but not limited to, extensive training and education of all Medicare and Medicaid-certified providers along the continuum of care and by fostering a collaborative relationship among them.
C. HHS Initiatives Related to OPO Services and Executive Order 13879
In 2000, the Secretary's Advisory Committee on Organ Transplantation (ACOT) was established under the general authority of section 222 of the PHS Act, as amended, and implementing regulations under 42 CFR 121.12
Medicaid-certified providers along the continuum of care and by fostering a collaborative relationship among them.
C. HHS Initiatives Related to OPO Services and Executive Order 13879
In 2000, the Secretary's Advisory Committee on Organ Transplantation (ACOT) was established under the general authority of section 222 of the PHS Act, as amended, and implementing regulations under 42 CFR 121.12. ACOT is charged to (1) advise the Secretary, acting through the Administrator, Health Resources and Services Administration (HRSA) on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed OPTN policies submitted for the Secretary's approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating and ensuring the validity, accuracy, timeliness and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation. 6
6 https://www.organdonor.gov/about-dot/acot/charter.html.
A 2012 recommendation by ACOT stated: “The ACOT recognizes that the current CMS and HRSA/OPTN structure creates unnecessary burdens and inconsistent requirements on transplant centers (TCs) and OPOs and that the current system lacks responsiveness to advances in TCs and OPO performance metrics
ues that are relevant to transplantation. 6
6 https://www.organdonor.gov/about-dot/acot/charter.html.
A 2012 recommendation by ACOT stated: “The ACOT recognizes that the current CMS and HRSA/OPTN structure creates unnecessary burdens and inconsistent requirements on transplant centers (TCs) and OPOs and that the current system lacks responsiveness to advances in TCs and OPO performance metrics. The ACOT recommends that the Secretary direct CMS and HRSA to confer with the OPTN, Scientific Registry of Transplant Recipients (SRTR), the OPO community, and TCs representatives to conduct a comprehensive review of regulatory and other requirements, and to promulgate regulatory and policy changes to requirements for OPOs and TCs that 7
7 Available at: https://www.organdonor.gov/about-dot/acot/acotrecs55.html.
On July 10, 2019, President Trump issued Executive Order 13879 titled Advancing American Kidney Health. The Executive Order 13879 states that it is the policy of the U.S. to “prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care; increase patient choice through affordable alternative treatments for ESRD by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys; and increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.”
Further, the Executive Order aims to increase the utilization of available organs by ordering that, within 90 days of the date of the order, the Secretary propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising OPO rules and evaluation metrics to establish more transparent, reliable, and enforceable objective measures for evaluating an OPO's performance
e Order aims to increase the utilization of available organs by ordering that, within 90 days of the date of the order, the Secretary propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising OPO rules and evaluation metrics to establish more transparent, reliable, and enforceable objective measures for evaluating an OPO's performance. In conjunction with the Executive Order, the Department set a goal to deliver more organs for transplantation and aims to double the number of kidneys available for transplant by 2030. 8
8 https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdf.
In accordance with the Executive Order and in response to ACOT's recommendations and stakeholder feedback, we are proposing to revise the OPO outcome and process measures so that they are more transparent, reliable, and objective measures of OPO performance. We believe that these changes will lead to increased procurement opportunities for transplantation, increased organ utilization, and as a result, more lives saved.
II. Provisions of the Proposed Regulations
A. Proposed Changes to Outcome Requirements (§ 486.318)
On May 31, 2006, CMS published the final rule, “Medicare and Medicaid Programs: Conditions for Coverage for Organ Procurement Organizations (OPOs)” in the Federal Register (71 FR 30982). That final rule established the CfCs that OPOs must comply with in order to receive Medicare and Medicaid reimbursement for organ procurement costs. It also set forth outcome measures at 42 CFR 486.318 and specifies the condition for reporting of data, 42 CFR 486.328. OPOs must report data to the OPTN in accordance with 42 CFR 121.11(b)(2) (describing data specified by the Secretary) and 42 CFR 486.328 (describing data required by the Secretary) for the operations of the OPTN and for CMS's assessment of OPO performance
organ procurement costs. It also set forth outcome measures at 42 CFR 486.318 and specifies the condition for reporting of data, 42 CFR 486.328. OPOs must report data to the OPTN in accordance with 42 CFR 121.11(b)(2) (describing data specified by the Secretary) and 42 CFR 486.328 (describing data required by the Secretary) for the operations of the OPTN and for CMS's assessment of OPO performance. Under these authorities, OPOs must report data to the OPTN or the SRTR specified by the Secretary (including on OMB-approved forms pursuant to the Paperwork Reduction Act of 1995). The CfCs for OPOs at 42 CFR 486.318(a) and (b) have required that an OPO must meet two of the three following outcome measures:
• The OPO's donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard deviations below the mean national donation rate of eligible donors as a percentage of eligible deaths, averaged over the 4 years of the re-certification cycle. Both the numerator and denominator of an individual OPO's donation rate ratio are adjusted by adding a 1 for each donation after cardiac death donor and each donor over the age of 70;
• The observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by SRTR;
• The OPO data reports, averaged over the 4 years of the re-certification cycle, must meet the rules and requirements of the most current OPTN aggregate donor yield measure.
For the 2022 re-certification cycle only however, under 42 CFR 486.316(a)(3), OPOs are not required to meet the second outcome measure (the observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by SRTR)
rules and requirements of the most current OPTN aggregate donor yield measure.
For the 2022 re-certification cycle only however, under 42 CFR 486.316(a)(3), OPOs are not required to meet the second outcome measure (the observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by SRTR). OPOs must instead meet one out of the two outcome measure requirements described in § 486.318(a)(1) and (3) for OPOs not operating exclusively in the noncontiguous States, Commonwealths, Territories, or possessions; or § 486.318(b)(1) and (3) for OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, and possessions (84 FR 61434 through 61436).
We have heard concerns from some stakeholders within the organ donation and transplantation community about these outcome measures since finalization in 2006. Some stakeholders contend that the current outcome measures are not reliable and transparent indicators of OPO performance. Most comments have centered on the self-defined and self-reported nature of the data on “eligible deaths” that are used for the evaluation of the outcome measures. Stakeholders increasingly have brought to our attention that the interpretation of “eligible deaths” appears to be inconsistent across donation service areas (DSAs), and that “all OPO data is unaudited and self-reported” and therefore, “the accuracy and consistency of that data cannot be assured.” 9
9 Letter from Helen Irving, President and CEO, New York Organ Donor Network, to Howard Shelanksi, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget. Oct. 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/oira_0938/0938_10292013b-1.pdf
In addition, there were concerns about the donor yield outcome measure
sured.” 9
9 Letter from Helen Irving, President and CEO, New York Organ Donor Network, to Howard Shelanksi, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget. Oct. 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/oira_0938/0938_10292013b-1.pdf
In addition, there were concerns about the donor yield outcome measure. According to stakeholders, there are “pressures from donor yield reporting” that “drives OPOs to walk away from cases in which the donor only has one organ viable for transplant (such as for older patients, where it is common that only the liver is medically viable), even in cases where next of kin consents to donation.” 10 As a result, some commenters have suggested that “the regulations may be causing OPOs to `game' the process of meeting [this] standard by only targeting `high-yield' organ candidates.” 11 Given these comments, we are concerned that potentially transplantable organs may be wasted, exacerbating the organ shortage problem.
10 ORGANIZE. Organ Donation Reform Report. 2019.
11 Letter from Helen Irving, President and CEO, New York Organ Donor Network, to Howard Shelanksi, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget. Oct. 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/oira_0938/0938_10292013b-1.pdf.
To address some of these stakeholder concerns, we made several changes to these outcome measures since we finalized the CfCs for OPOs in 2006. In 2012, we modified the definition of “donor document” (that is, the document that an individual can sign to authorize the procurement of their own
In addition, in November 2019, we finalized a proposal to reconcile the definition of “expected donation rate” in the OPO CfCs with the definition currently used by the SRTR. The rule also finalized a policy that requires OPOs to meet one out of the two outcome measures for the 2022 re-certification cycle only
is, the document that an individual can sign to authorize the procurement of their own
In addition, in November 2019, we finalized a proposal to reconcile the definition of “expected donation rate” in the OPO CfCs with the definition currently used by the SRTR. The rule also finalized a policy that requires OPOs to meet one out of the two outcome measures for the 2022 re-certification cycle only. OPOs therefore are not required to meet the second outcome measure (the observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by SRTR) for the 2022 re-certification cycle. Absent additional regulatory changes, an OPO would be required to meet 2 of the 3 regulatory requirements for future evaluation cycles (84 FR 61434 through 61436). We also published a Request for Information (RFI) in the CY 2020 OPPS/ASC proposed rule that solicited comments regarding what revisions may be appropriate for the current CfCs for OPOs that are set forth at 42 CFR 486.301 through 486.360 and the current Conditions of Participation (CoPs) for TCs that are set forth at 42 CFR 482.68 through 482.104 (84 FR 39595 through 39598). That RFI also requested comments on two potential outcome measures, which we now describe in more detail in this proposed rule.
In a continued effort to respond to these concerns and as required by Executive Order 13879 and controlling statutes, we are proposing to revise the outcome measures for re-certification at § 486.318 to replace the existing outcome measures with two new outcome measures that would be used to assess an OPO's performance: “donation rate” and “organ transplantation rate” effective for CY 2022
rule.
In a continued effort to respond to these concerns and as required by Executive Order 13879 and controlling statutes, we are proposing to revise the outcome measures for re-certification at § 486.318 to replace the existing outcome measures with two new outcome measures that would be used to assess an OPO's performance: “donation rate” and “organ transplantation rate” effective for CY 2022. The “donation rate” would be measured as the number of actual deceased donors as a percentage of total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an absolute contraindication to organ donation; and the “organ transplantation rate” would be measured as the number of organs procured within the DSA and transplanted as a percentage of total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an absolute contraindication to organ donation.
The first measure, “donation rate”, would demonstrate the OPO's percentage of possible deceased donors who become actual donors and the second measure, “organ transplantation rate”, would demonstrate the percentage of organs transplanted after procurement. We have chosen this combination of measures to reflect our view that OPOs should be expanding their efforts on both converting potential donors into actual donors and successfully placing all possible organs for transplantation. We chose to include actual organ donors who had at least one organ transplanted in our measure to encourage the pursuit of single-organ donors because we believe that these donors are the greatest opportunity for growth; it is our understanding that transplant centers have recently been willing to expand the definition of traditional organ donors and accept organs from these donors. We also chose the total number of organs transplanted to emphasize the role of the OPO in successful organ placement
urage the pursuit of single-organ donors because we believe that these donors are the greatest opportunity for growth; it is our understanding that transplant centers have recently been willing to expand the definition of traditional organ donors and accept organs from these donors. We also chose the total number of organs transplanted to emphasize the role of the OPO in successful organ placement. We acknowledge concerns that donation rate and transplant rate measures may seem redundant and highly correlated; however, we believe that evidence of the high level of correlation is due to our current outcome measures that include both donation rates and organ transplant yield. We selected both donation rates and transplantation rates in order to reduce the risk that resources would be diverted to focus on one measure rather than increasing overall efforts to address both types of measures, which we believe could result in more single-organ donors and minimize discarding of transplantable organs. We are cautious in creating outcome measures that inadvertently decrease one or the other type of measure. For example, if we choose measures based only on donation rates, we are concerned whether there would be sufficient incentives to place as many as possible organs from each donor, which can be time-consuming. Conversely, if we chose measures based solely on organ transplantation rates, we would be concerned that there would be fewer incentives to procure single organs from older donors or donors after cardiac death, as there would be to procure multiple organs from the younger, healthier donor after brain death.
For the first measure, donation rate, the numerator is defined as the number of actual deceased donors in the DSA who had at least one organ transplanted based on data reported to the OPTN
that there would be fewer incentives to procure single organs from older donors or donors after cardiac death, as there would be to procure multiple organs from the younger, healthier donor after brain death.
For the first measure, donation rate, the numerator is defined as the number of actual deceased donors in the DSA who had at least one organ transplanted based on data reported to the OPTN. In the current § 486.302 Definitions, we define “Donor” to mean a deceased individual from whom at least one vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) is recovered for the purpose of transplantation. We are proposing to change this definition to require that the organ be transplanted, not just recovered. There are three primary reasons for requiring that the organ be actually transplanted: (1) To discourage the discarding of procured organs, (2) to encourage transplantation of every organ, including those from single-organ donors, and (3) because it is easier to verify the existence of a donor who had at least one organ transplanted compared with donors who did not have an organ transplanted. We are seeking comments on the change in definition of “donor.”
For the second measure, organ transplantation rate, we are not changing the definition of “Organ,” but propose to provide clarification as to how the organs are counted (see Table 1) for purposes of determining the organ transplantation rate (as our current regulations do not provide the specificity that we now propose to more accurately track donations). We are excluding organs procured for research, but not transplanted, from our definition, except for pancreata that are procured for islet cell transplantation or research (transplanted or not transplanted), as this is required by section 371(c) of the PHS Act. The numerator is defined as the number of actual organs transplanted based on data obtained from the OPTN. We are seeking comments on this proposed change and clarification
or research, but not transplanted, from our definition, except for pancreata that are procured for islet cell transplantation or research (transplanted or not transplanted), as this is required by section 371(c) of the PHS Act. The numerator is defined as the number of actual organs transplanted based on data obtained from the OPTN. We are seeking comments on this proposed change and clarification.
Table 1—Organs Transplanted Count Organ type Number of organs transplanted Right or Left Kidney 1 Right and Left Kidney 2 Double/En-Bloc Kidney 2 Heart 1 Intestine 1 Intestine Segment 1 or Segment 2 1 Intestine Segment 1 and Segment 2 2 Liver 1 Liver Segment 1 or Segment 2 1 Liver Segments 1 and Segment 2 2 Right or Left Lung 1 Right and Left Lung 2 Double/En-bloc Lung 2 Pancreas (transplanted whole, research, islet transplant) 1 Pancreas Segment 1 or Segment 2 1 Pancreas Segment 1 and Segment 2 2 Some members of the OPO community have stated that the proposed measure, organ transplantation rate, reflects the transplant hospitals' acceptance practices and that OPOs should not be held accountable for the transplant hospitals' decisions. We understand the role of transplant hospitals in the organ transplantation rate measure; however, we also recognize the influence OPOs have on transplant hospital practice through OPO advisory boards (§ 486.324(a)(5)), which include a transplant surgeon from every transplant hospital in the DSA. Although the historical basis of this requirement was so that transplant hospitals could advise OPOs about transplant practices and have input into their policies, 12 we believe the relationship has evolved bilaterally, such that OPOs can educate transplant hospitals in the DSA about the performance of organs that were turned down by one hospital, but accepted by another
plant hospital in the DSA. Although the historical basis of this requirement was so that transplant hospitals could advise OPOs about transplant practices and have input into their policies, 12 we believe the relationship has evolved bilaterally, such that OPOs can educate transplant hospitals in the DSA about the performance of organs that were turned down by one hospital, but accepted by another. By serving on the OPO advisory board, transplant surgeons can learn more about the practices of the other transplant surgeons on the board, as well as about acceptance practices at transplant hospitals outside the DSA, and share that information with their own transplant hospitals. We also note that OPOs are often expected to place their organs outside of their DSA; our understanding of organ transplant practice is that there are numerous transplant hospitals throughout the country that successfully transplant “less than perfect” organs. It is our belief that given the unacceptable number of patients dying on the waiting list or on dialysis waiting for a transplant, there are transplant hospitals in the U.S. that will accept “less than perfect,” but still transplantable organs. As such, we believe it is the OPO's responsibility to ensure that those organs are transplanted, instead of discarded. Our goal for this rule and the organ transplantation rate measure is to incentivize the “system” to establish efficiencies that will result in substantial improvement of organ placement and transplantation.
12 Senate Report 104-256—Organ and Bone Marrow Transplant Program Reauthorization Act of 1995 and § 486.324.
The numerators for these measures will be based on the actual donors who had at least one organ transplanted and the number of organs procured and transplanted from those donors in the DSA
h efficiencies that will result in substantial improvement of organ placement and transplantation.
12 Senate Report 104-256—Organ and Bone Marrow Transplant Program Reauthorization Act of 1995 and § 486.324.
The numerators for these measures will be based on the actual donors who had at least one organ transplanted and the number of organs procured and transplanted from those donors in the DSA. Since the data for the numerators for both of these measures are already being submitted by the OPOs and verified by the transplant hospitals when they perform the transplant, we do not believe that these proposed changes create additional reporting burdens for the OPOs or the transplant hospitals. 13 Also, we are confident in the veracity of the information as it can be corroborated by the OPTN, which has a record of all organs in which a match is run for allocation, and requires reporting of the transplantation by the OPO, as well as the transplant program, and requires documentation of the disposition of the organ.
13 The data submitted to the OPTN has already been accounted for in the OPTN final rule's Paperwork Reduction Act analysis.
For both measures, the denominator (that is, donor potential) is defined as the number of total inpatient deaths within the DSA among patients 75 years of age or younger with a cause of death that would not be an absolute contraindication to organ donation. For calculating the denominator, we would use data obtained from state death certificates. Currently, this information can be obtained from the Center for Disease Controls' (CDC), National Center for Health Statistics' (NCHS's) Detailed Multiple Cause of Death (MCOD) as described in more detail in this section. The MCOD is published annually and is publicly available upon request. The MCOD meets NCHS data privacy and security requirements.
The MCOD comprises county-level national mortality data that include a record for every death of a U.S. resident recorded in the U.S
, National Center for Health Statistics' (NCHS's) Detailed Multiple Cause of Death (MCOD) as described in more detail in this section. The MCOD is published annually and is publicly available upon request. The MCOD meets NCHS data privacy and security requirements.
The MCOD comprises county-level national mortality data that include a record for every death of a U.S. resident recorded in the U.S. The MCOD files contain an extensive set of variables derived from the death certificates which are standardized across the 57 jurisdictions that provide CDC with the data (50 states, New York City, the District of Columbia and the five territories). The jurisdictions use the U.S. Standard Certificate of Death as a template for their forms. 14
14 https://www.cdc.gov/nchs/data/dvs/DEATH11-03final-acc.pdf .
Within the standard certificate of death are key variables relevant to our measures such as where the death occurred: Hospital (inpatient, emergency room/outpatient, and dead on arrival) or somewhere other than a hospital (hospice facility, nursing home/long-term care facility, decedent's home, other). In addition, there is information on the cause of death. The information on the cause of death is based on free text entered by the certifier, usually a physician, medical examiner, or coroner. Based on the causes of death on the certificate, NCHS assigns a code from the International Classification of Diseases, Tenth Revision (ICD-10) to each cause of death reported. This coding is done centrally at NCHS with software designed for this purpose or manually using expert coders; they have been using ICD-10 codes since 1999. In addition to the underlying cause of death, each record has space for up to 20 multiple cause codes. The ICD-10 codes that could be assigned are found in CDC's Instruction Manual, Part 2e, Volume 1: ICD-10, International Statistical Classification of Diseases and Related Health Statistical Classification of Diseases and Related Health Problems
oders; they have been using ICD-10 codes since 1999. In addition to the underlying cause of death, each record has space for up to 20 multiple cause codes. The ICD-10 codes that could be assigned are found in CDC's Instruction Manual, Part 2e, Volume 1: ICD-10, International Statistical Classification of Diseases and Related Health Statistical Classification of Diseases and Related Health Problems. Tabular List, 2017; modified by the National Center for Health Statistics for use in the classification and analysis of medical mortality data in the U.S. 15 Although there may be inaccuracies in the description of the causes of deaths in these death certificates, we have no evidence that there are differences in the rate of errors on inpatient death certificates based on the DSA and that any particular DSA would be disproportionately affected.
15 https://www.cdc.gov/nchs/data/dvs/2e_volume1_2017.pdf .
Deaths that are not an absolute contraindication to organ donation are calculated from those ICD-10 codes and would exclude clinical causes of death in which organs would never be used for transplantation. Our definition of “a death that is not an absolute contraindication to organ donation” means all deaths except those identified by the specific ICD-10 codes that would preclude donation under any circumstance. This information would be obtained from the state death certificates, and include both immediate cause of death and contributing causes of death. We have listed the three character categories of ICD-10 codes in Table 2 to be absolute contraindications to organ donation which was generated
Table 2—ICD-10 Codes Excluded From the Denominator Tuberculosis All. Other bacterial diseases A39 Meningococcal infection. A40 Streptococcal septicaemia. A41 Other septicaemia. Viral infections of the central nervous system A82 Rabies. Viral infections characterized by skin and mucous membrane lesions B03 Smallpox
in Table 2 to be absolute contraindications to organ donation which was generated
Table 2—ICD-10 Codes Excluded From the Denominator Tuberculosis All. Other bacterial diseases A39 Meningococcal infection. A40 Streptococcal septicaemia. A41 Other septicaemia. Viral infections of the central nervous system A82 Rabies. Viral infections characterized by skin and mucous membrane lesions B03 Smallpox. Human immunodeficiency virus [HIV] disease B20 Human immunodeficiency virus [HIV] disease with infectious and parasitic diseases. B21 Human immunodeficiency virus [HIV] disease with malignant neoplasms. Sequelae of infectious and parasitic diseases B90 Sequelae of tuberculosis. Malignant neoplasms of lip, oral cavity and pharynx All. Malignant neoplasms of digestive organs All. Malignant neoplasms of respiratory and intrathoracic organs All. Melanoma and other malignant neoplasms of skin C43 Malignant melanoma of skin. Malignant neoplasms of bone and articular cartilage All. Melanoma and other malignant neoplasms of skin All. Malignant neoplasms of methothelial and soft tissue All. Malignant neoplasm of breast All. Malignant neoplasms of female genital organs All. Malignant neoplasms of male genital organs All. Malignant neoplasms of thyroid and other endocrine glands All. Malignant neoplasms of ill-defined, secondary and unspecified sites All. Malignant neoplasms of lymphoid, haematopoietic and related tissue All. Malignant neoplasms of independent (primary) multiple sites All. Neoplasms of uncertain or unknown behavior D44 Neoplasm of uncertain or unknown behaviour of endocrine glands. D46 Meylodysplastic syndromes. D47 Other neoplasms of uncertain or unknown behavior of lymphoid, haematopietic and related tissue. D48 Neoplasms of uncertain or unknown behavior of other and unspecified sites. Coagulation defects, purpura and other haemorrhagic conditions D65 Disseminated intravascular coagulation [defibrination syndrome]. D69 Purpura and other haemorrhagic conditions. Metabolic disorders E84 Cystic fibrosis
s. D47 Other neoplasms of uncertain or unknown behavior of lymphoid, haematopietic and related tissue. D48 Neoplasms of uncertain or unknown behavior of other and unspecified sites. Coagulation defects, purpura and other haemorrhagic conditions D65 Disseminated intravascular coagulation [defibrination syndrome]. D69 Purpura and other haemorrhagic conditions. Metabolic disorders E84 Cystic fibrosis. Infections specific to the perinatal period P36 Bacterial sepsis of newborn. One of our current measures used to measure OPO performance relies upon measuring the donation rate based on eligible deaths. While the “eligible death” definition allows for a more narrow and definitive estimation of the organ donation potential, it also limits the pool of potential organ donors by which OPOs are evaluated and does not take into account the advances in medicine that could expand the pool of potential donors (such as, very effective treatments for hepatitis C allowing hepatitis C positive donors to donate to patients who do not have hepatitis C); 16 further, it is subject to bias in interpretation and reporting. By using inpatient deaths from this objective data source and eliminating causes of death that are absolute contraindications to organ donation, we are targeting a specific population that is more likely to be organ donors and mitigating concerns that the data could be manipulated based upon varying interpretations of an eligible death.
16 Woolley, AE, et al, “Heart and Lung Transplants from HCV-Infected Donors to Uninfected Recipients,” NEJM, 2019; 390:1606-1617.
The denominator will be the number of inpatient deaths of someone 75 years old or younger identified using the most recent prior 12 months of available data from the state death certificates from the DSA, and the numerators will be based on the number of donors and organs transplanted during the same corresponding time period
, discarded organs, or referral management.
In the regulatory impact analysis (RIA) section of this proposed rule, we present tables reflecting the results of our proposed measures using data from January 1, 2017 to December 31, 2017. We found a wide range of donation rates (1.65 to 6.45 donors/100 inpatient deaths) and organ transplantation rates (4.47 to 21.14 transplants/100 inpatient deaths). We did not find a correlation between the performance of OPOs and the number of deaths (reflecting experience with larger volumes of potential donors) or the number of patients on the waiting list (reflecting the demand for organs) in the DSA. 17 We examined the characteristics of the DSAs among the top 25 percent performing OPOs and found that they include geographic areas representative of all parts of the U.S. and diverse racial and ethnic populations. Despite this seemingly broader definition of potential organ donors, we did not notice any particular geographic patterns (including urban vs. rural) distinguishing the top performing OPOs from the rest of the cohort, leading us to conclude that our broad definition, inpatient deaths among those 75 and younger within the DSA, excluding causes of deaths that are an absolute contraindication for organ donation, appropriately describes the donor potential in a DSA and that the primary factors for differences in OPO performance using these measures are within the control of the OPOs to change. We are seeking comments as to the accuracy of our assessment and whether additional research is necessary to ensure that all DSAs will be impacted equally under the new measures. Specifically, we are requesting public comments that provide evidence-based support, such as peer-reviewed literature, that we should consider to inform our conclusion that our proposed definitions would not disadvantage any particular OPO as a result of population demographics or incidence of disease within a DSA
s necessary to ensure that all DSAs will be impacted equally under the new measures. Specifically, we are requesting public comments that provide evidence-based support, such as peer-reviewed literature, that we should consider to inform our conclusion that our proposed definitions would not disadvantage any particular OPO as a result of population demographics or incidence of disease within a DSA.
17 Cannon RM, Jones CM, et al, “Patterns of geographic variability in mortality and eligible deaths between organ procurement organizations,” AmJTransplant. 2019;00:4 (Fig. 2).
Since our criteria for the denominator takes into consideration many of the clinical characteristics associated with possible organ donation (the age of the potential donor, the inpatient hospitalization, and contraindication to donation), we believe all appropriate risk-adjustments to the clinical characteristics of the donor potential have been made. We are aware of literature identifying racial disparities among organ donors, specifically that African Americans were less willing to donate their own organs compared with whites (72.6% v. 88.3%). 18 However, we are concerned regarding the applicability of that study, given it was from 2000, and more recent evidence suggesting that the racial concordance of the OPO requester plays a role in the rate of authorization for organ donation. 19 Further, we are not aware of any validated coefficients that reflect the likelihood of a particular racial/ethnic group to donate organs and we are concerned that any current risk-adjustments factors being used include the historical poorer performances. Based on the most recent literature and our internal analyses, we have decided not to risk-adjust for race. We seek comments as to whether there is other literature or data regarding race or other demographics or other public health factors that warrant the consideration of further risk adjustment
rned that any current risk-adjustments factors being used include the historical poorer performances. Based on the most recent literature and our internal analyses, we have decided not to risk-adjust for race. We seek comments as to whether there is other literature or data regarding race or other demographics or other public health factors that warrant the consideration of further risk adjustment.
18 Siminoff, LA, et al, “Racial Disparities in Preferences and Perceptions Regarding Organ Donation,” JGIM, 2006; 21:995-100.
19 Bodenheimer, HC, et al, “The Impact of Race on Organ Donation Authorization Discussed in the Context of Liver Transplantation,” Transactions of the American Clinical and Climatological Association, Vol. 123, 2012.
Similarly, we are not proposing any additional risk-adjustments to our measures other than the exclusion of the ICD-10 codes that are absolute contraindications to organ donation, the age of 75 and younger, and the requirement that the death occurred as an inpatient in the hospital. However, we are seeking comments on whether other risk-adjustments are necessary and which ones, such as donor demographic characteristics (race, gender, age, disease condition) or DSA characteristics (number of ICU beds or level I and II trauma centers), would be significant and clinically appropriate in the context of our proposed approach to identifying OPOs in need of improved performance. If risk adjustment were to be implemented, it would likely be done retrospectively by identifying risk factors that have a statistically significant impact on transplantation rates using regression analysis. We are interested in comments on specific risk adjustment public health emergencies or other local activities (for example, legislative changes on presumed consent). We are also requesting that commenters provide evidence and data sources that would be necessary to calculate the risk-adjustments recommended
have a statistically significant impact on transplantation rates using regression analysis. We are interested in comments on specific risk adjustment public health emergencies or other local activities (for example, legislative changes on presumed consent). We are also requesting that commenters provide evidence and data sources that would be necessary to calculate the risk-adjustments recommended. Finally, we are seeking comments about any potential unintended consequence of using risk-adjustments to our measures. Depending on the substance of the public comments received, we could establish a risk adjustment methodology in the final rule.
In order to ensure that our measures adjust to changes in medical technology and causes of death and in order to achieve the goal of doubling the number of kidneys available for transplantation by 2030, we are proposing to use our measures in the context of a comparative donation rate and organ transplantation rate relative to the highest-performing OPOs. By using comparative rates, we assume that the highest performing OPOs are adjusting their practices to reflect medical technology and other factors that may impact the number of donors and organs transplanted. Our ultimate definition of success, however, is to encourage the performance of all OPOs to cluster around the highest performers. Therefore, our proposed definition of success will be based on how OPOs perform on the outcome measures of donation rate and organ transplantation rate compared with the top 25 percent of donation and transplantation rates for OPOs. We acknowledge that there may be other success factors for assessing performance of OPOs outside of the two outcome measures of donation rate and organ transplantation rate
fore, our proposed definition of success will be based on how OPOs perform on the outcome measures of donation rate and organ transplantation rate compared with the top 25 percent of donation and transplantation rates for OPOs. We acknowledge that there may be other success factors for assessing performance of OPOs outside of the two outcome measures of donation rate and organ transplantation rate. Thus, we are soliciting public comments on whether or not comparing OPO performance should be based solely on the performance of the top 25 percent of OPOs within these two outcome measures, whether a different percentile or calculation of OPO performance should be used, or whether additional outcome, structure, or process criteria could be used to inform stakeholders of OPO performance over time.
In determining our calculations, we will establish a threshold donation rate and organ transplantation rate based on the lowest rate among the top 25 percent of donation rates and organ transplantation rates during the 12-month period prior to the time period that is being evaluated. For example, if we are doing an assessment on December 31, 2024 and using data from January 1, 2023 to December 31, 2023, the threshold rates would be based on the lowest donation rate and organ transplantation rate of the top 25 percent donation and organ transplantation rates for the time period of January 1, 2022 to December 31, 2022. Since there are currently 58 OPOs, there are 15 OPO rates (rounded to the closest integer) in the top 25 percent
er 31, 2024 and using data from January 1, 2023 to December 31, 2023, the threshold rates would be based on the lowest donation rate and organ transplantation rate of the top 25 percent donation and organ transplantation rates for the time period of January 1, 2022 to December 31, 2022. Since there are currently 58 OPOs, there are 15 OPO rates (rounded to the closest integer) in the top 25 percent. There are two primary benefits for using this separate cohort to establish the threshold rates: (1) The predetermined threshold rate obtained from an external source would be known to OPOs before their evaluation cycle and (2) from a
Then, we will determine whether the donation rates and organ transplantation rates for each of the OPOs are statistically significantly lower than the predetermined threshold rate by calculating the 95 percent confidence interval (CI) for each OPO and flagging those OPOs whose upper limit of the one-sided 95 percent CI is lower than the threshold rate. By using this approach, we allow all OPOs the opportunity to re-certify as long as their performance is not statistically significantly different from the top 25 percent.
Importantly, Executive Order 13879 recognizes the problem of organ discards. In choosing the 25 percent cutoff, we hope to encourage OPOs to successfully place every organ they procure and to improve their donation rates. We analyzed the impact of these new outcome measures on data from January 1, 2017 to December 31, 2017 and determined that if all underperforming OPOs reached the threshold rate for that time period, we would have approximately 4,900 more organs transplanted. According to the OPTN data, from that same time period, there were a total of 4,905 organs discarded, of which 3,542 were kidneys. 20 A recent study showed that if U.S
hese new outcome measures on data from January 1, 2017 to December 31, 2017 and determined that if all underperforming OPOs reached the threshold rate for that time period, we would have approximately 4,900 more organs transplanted. According to the OPTN data, from that same time period, there were a total of 4,905 organs discarded, of which 3,542 were kidneys. 20 A recent study showed that if U.S. transplant centers expanded the type of deceased donor kidneys that they transplanted to include the lower quality kidneys, similar to those transplanted in France, there would be 17,435 more kidneys transplanted, resulting in 132,445 allograft years over an 11-year period. 21
20 OPTN databased accessed on August 28, 2019 ( https://optn.transplant.hrsa.gov/data/view-data-reports/build-advanced/ ).
21 Aubert, Reese, et al, “Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance, JAMA Intern Med. Published online August 26, 2019. Doi:10.1001/jamainternmed.2019.2322.
However, eliminating all inappropriate organ discards alone will not be enough to achieve the 4,900 more organs transplanted that we hope to achieve in setting the top 25 percent threshold. The reason we believe a top 25 percent threshold rate is appropriate is that we also found a wide variation in donation rates among OPOs, suggesting that there is significant opportunity, especially among the lower- performing OPOs, to increase their donation rates and subsequently, their organ transplantation rates. If we had not seen such a wide variation in donation rates, we would have aligned our expected increase in organs transplanted with the number of organs discarded that we believed could be transplantable and set a lower threshold rate, such as 30 percent or 40 percent. We are seeking comments on the threshold rate cutoffs for determining success and our methodology for calculating the threshold rates
we had not seen such a wide variation in donation rates, we would have aligned our expected increase in organs transplanted with the number of organs discarded that we believed could be transplantable and set a lower threshold rate, such as 30 percent or 40 percent. We are seeking comments on the threshold rate cutoffs for determining success and our methodology for calculating the threshold rates.
Our proposed measures are similar to the measures presented in the study, “Importance of incorporating standardized, verifiable, objective metrics of organ procurement organization performance into discussions about organ allocation.” 22 This study describes a similar approach using the NCHS data, but uses a cause, age, and location consistent (CALC) donation measure. We are actively considering this approach as well as other alternatives and have described them in greater detail in the RIA, Section G: Alternatives Considered.
22 Goldberg D, Karp S, et al, “Importance of incorporating standardized, verifiable, objective metrics of organ procurement organization performance into discussions about organ allocation,” Am J Transplant. 2019;00:1-6.
We believe that the consistency and quality of these proposed measures would be a significant improvement over the current measures because they would rely on independent data to measure donor potential. Stakeholders have increasingly brought to CMS' and HHS' attention that the self-reporting of data could inadvertently reward poor performance, suggesting that OPOs who are less proficient at identifying eligible deaths in their donation service area could have lower denominators, resulting in higher rates of donations. The current outcome measures also include potentially burdensome OPO self-defined and self-reported “eligible deaths” for evaluation purposes
ion that the self-reporting of data could inadvertently reward poor performance, suggesting that OPOs who are less proficient at identifying eligible deaths in their donation service area could have lower denominators, resulting in higher rates of donations. The current outcome measures also include potentially burdensome OPO self-defined and self-reported “eligible deaths” for evaluation purposes. We believe that using CDC data on inpatient deaths from the state death certificates as the denominator would greatly reduce reporting burdens on OPOs and allow them to more efficiently utilize their resources to improving donation rates and organ transplantation rates.
By establishing a definition of success that is compared with the top performing OPOs, we hope to increase the number of organs, particularly kidneys, to achieve the goal of doubling kidney transplantations by 2030. Therefore, we do not think it is appropriate for us to include a measure that assesses the OPO's actual donation or transplantation rates based on their expected donation or transplantation rates since that measure relies on average performances to assess OPOs. Our new measures are designed to drive OPOs to perform optimally by motivating them to pursue every organ, every time, rather than setting standards at or near the current average performance. For all the reasons stated above, we believe that the proposed changes to our outcome measures would standardize the assessment of OPO performance, reduce reporting burdens on OPOs, and increase the number of transplantable organs. We would expect OPOs to continue their quality improvement efforts through their Quality Assurance and Performance Improvement (QAPI) program, as required by our rules at § 486.348, and they would continue to seek and implement best practices for organ procurement
ould standardize the assessment of OPO performance, reduce reporting burdens on OPOs, and increase the number of transplantable organs. We would expect OPOs to continue their quality improvement efforts through their Quality Assurance and Performance Improvement (QAPI) program, as required by our rules at § 486.348, and they would continue to seek and implement best practices for organ procurement. We note that OPOs are already required to develop, implement, and maintain a comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all donation services, and we expect them to use the data provided as part of their QAPI program.
In the current regulations, we have specifically separated OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, or possessions from the other OPOs. In this proposed rule, we are not proposing different outcome measures for these OPOs because we believe the residents of those areas deserve every opportunity for organ transplantation and that OPOs servicing those areas should perform at the same level as the top 25 percent of OPOs. Although these OPOs may not be in a DSA with transplant hospitals capable of transplanting all organs that possibly could be procured, organs are frequently offered to hospitals outside of the DSAs in which they are procured. Further, we believe that geographical distances may not be as much of a hurdle as previously believed. For example, the OPO in Puerto Rico is geographically proximal to the continental U.S. where there are numerous transplant hospitals. The OPO in Hawaii may have more difficulty placing all organs given how long it takes to reach the continental
B. Proposed Changes to Definitions (§ 486.302) and Re-Certification and Competition Processes (§ 486.316)
In line with our proposal to change the outcome measures at § 486.318, as discussed in section II.A
proximal to the continental U.S. where there are numerous transplant hospitals. The OPO in Hawaii may have more difficulty placing all organs given how long it takes to reach the continental
B. Proposed Changes to Definitions (§ 486.302) and Re-Certification and Competition Processes (§ 486.316)
In line with our proposal to change the outcome measures at § 486.318, as discussed in section II.A. of this document, we are proposing to modify language in § 486.316(a)(1) that an OPO must meet two out of the three outcome measures at § 486.318 and at § 486.316 (a)(3) that for the 2022 re-certification cycle only that an OPO must meet one out of the two outcome measures described in § 486.318 (a)(1) and (3) and (b)(1) and (3). We are also proposing to remove several definitions from § 486.302, since these terms would no longer apply. Specifically, we are proposing to remove the definitions of “eligible death,” “eligible donor,” “expected donation rate,” “observed donation rate”, and “Standard criteria donor (SCD)”. Finally, we are proposing to modify the definition of “donor” as described in section II.A of this rule and are proposing to add the terms “death that is not an absolute contraindication to organ donation,” “donation rate,” “donor potential,” and “organ transplantation rate.” We are proposing to define these terms as follows:
• “Death that is not an absolute contraindication to organ donation”: All deaths from the state death certificates except those with any cause of death identified by the specific ICD-10 codes that would preclude donation under any circumstance.
• “Donor potential”: Is the number of inpatient deaths with in the DSA among patients 75 and younger with any cause of death that is not an absolute contraindication to organ donation.
• “Donation rate”: Is the number of donors as a percentage of the donor potential.
• “Organ transplantation rate”: The number of organs transplanted as a percentage of the donor potential
der any circumstance.
• “Donor potential”: Is the number of inpatient deaths with in the DSA among patients 75 and younger with any cause of death that is not an absolute contraindication to organ donation.
• “Donation rate”: Is the number of donors as a percentage of the donor potential.
• “Organ transplantation rate”: The number of organs transplanted as a percentage of the donor potential.
Accordingly, we are proposing to modify the reporting requirements in § 486.328 to eliminate the reporting of the “Number of eligible deaths” and modifying the reporting of “Number of eligible donors” to “Number of donors.” In addition, we are proposing to revise the language that incorrectly refers to the “Scientific Registry of Transplant Beneficiaries” and “DHHS” in this section. We would instead include the terms “Scientific Registry of Transplant Recipients” and “HHS.” We are requesting comments on these proposals.
Sections 486.316 (c) and (d) describe the criteria that an OPO must meet in order to compete for an open service area and the criteria for selection of an OPO for an open service area, respectively. Once an OPO is de-certified and their agreement is terminated, either voluntarily or involuntarily as described in § 486.312, the OPO's service area is open to competition from other OPOs. Under § 486.316(b), the OPO that has been de-certified is not permitted to compete for its service area or any other service area. If an OPO is interested in competing for an open service area, the OPO must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results. These current requirements for competition once an OPO is de-certified will continue to apply if we finalize the changes to the outcome measures described in this proposed rule
ed in competing for an open service area, the OPO must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results. These current requirements for competition once an OPO is de-certified will continue to apply if we finalize the changes to the outcome measures described in this proposed rule. If no OPO applies to compete for a de-certified OPO's open area, § 486.316 (e) allows for CMS to select a single OPO to take over the entire open area or adjust the service area boundaries of two or more contiguous OPOs to incorporate the open area. CMS would select the new OPO to take over the entire open area based on the criteria set out at § 486.316(d); however, our regulations do not require that the DSAs merge when a new OPO takes over. However, we acknowledge that decertification of multiple OPOs could require changes to OPTN policies. We are soliciting comments on our current regulations related to assigning an open DSA in the case where no OPO applies to compete for that open area or in the case where CMS selects an OPO to take over the entire open DSA, but the OPO refuses to do so.
Our goal is to ensure continuous coverage of an OPO service area in the event an OPO is decertified. Although we would attempt to minimize disruptions to organ procurement services in an open service area as much as possible, we acknowledge that there is the potential for disruption when one or multiple OPOs are decertified. We are therefore seeking comments on ways that we can reduce any potential disruptions when an OPO is decertified and their service area is open to competition. We are particularly interested in comments on such potential options including ways that we could improve or ease the process of transitioning an open service area from the decertified OPO to another OPO and other related factors that may impact organ donation or the OPO's ability to meet the outcome measures
ial disruptions when an OPO is decertified and their service area is open to competition. We are particularly interested in comments on such potential options including ways that we could improve or ease the process of transitioning an open service area from the decertified OPO to another OPO and other related factors that may impact organ donation or the OPO's ability to meet the outcome measures.
OPOs are also required to meet certain criteria in order to compete for an open service area. In general, OPOs must meet two out of the three outcome measures requirements at § 486.318 (with the exception of the 2022 re-certification cycle where OPOs are required to meet one out of two outcome measures) and the OPO must be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360. The OPO that is applying to compete for the open service area must also meet additional criteria, including that the OPO's:
• Performance on the donation rate outcome measure and yield outcome measure is at or above 100 percent of the mean national rate averaged over the 4 years of the re-certification cycle; and
• Donation rate is at least 15 percentage points higher than the donation rate of the OPO currently designated for the service area.
• The OPO must also compete for the entire service area.
These existing requirements, however, are not consistent with our proposed method of assessing an OPO's performance, which would compare OPOs to an established threshold rate (using the lowest rate among the top 25 percent of donation rates and organ transplantation rates during the 12-month period prior to the time period that is being evaluated)
O must also compete for the entire service area.
These existing requirements, however, are not consistent with our proposed method of assessing an OPO's performance, which would compare OPOs to an established threshold rate (using the lowest rate among the top 25 percent of donation rates and organ transplantation rates during the 12-month period prior to the time period that is being evaluated). We therefore are proposing to remove the additional requirement for an OPO's performance on the donation rate outcome measure and yield outcome measure (is at or above 100 percent of the mean national rate averaged over the 4 years of the re-certification cycle) and the requirement that an OPO's donation rate be at least 15 percentage points higher than the donation rate of the OPO currently designated for the service area. We believe that OPOs will be held to a high standard of performance under the new proposed outcome measures. This would ensure that any OPO that is seeking to compete for an open service
Finally, the current requirements list certain criteria for selection of an OPO for designation of an open service area including:
• Performance on the outcome measures at § 486.318;
• Relative success in meeting the process performance measures and other conditions at §§ 486.320 through 486.360;
• Contiguity to the open service area; and
• Success in identifying and overcoming barriers to donation within its own service area and the relevance of those barriers to barriers in the open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.
We are proposing to make a clarifying change to these requirements to emphasize that CMS will consider the current criteria when determining which OPO to designate for an open service area
competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.
We are proposing to make a clarifying change to these requirements to emphasize that CMS will consider the current criteria when determining which OPO to designate for an open service area. Our original intent was to list these criteria as guidelines as opposed to requirements that an OPO must meet in order to be selected. For example, we could select a high performing OPO that meets the outcome measures and other CfC requirements, but may not be contiguous to the open service area. This change would provide clarity to the circumstances under which CMS would select an OPO to take over an open service area.
We are soliciting comments on all of our proposed changes to § 486.316. We are especially interested in comments on whether the contiguity of an OPO to the open service area is still an important factor to consider when selecting an OPO to take over an open service area. Since we implemented the OPO CfCs in 2006, there have been advances in technology that have improved organ procurement and transplantation and that have changed the way and the speed, in which OPOs and transplant centers communicate with each other. It may be the case that an OPO that is taking over an open service area may no longer need to be contiguous to the open service, especially if that OPO is a high performer that could increase the number of organs procured and eventually transplanted in an open service area. We are seeking comments on whether this specific criterion is still applicable.
We are also soliciting comments on whether we should reconsider opening the service area of every OPO for competition at the conclusion of every re-certification cycle, regardless of whether the OPO met the outcome performance standards for the prior re-certification cycle
tually transplanted in an open service area. We are seeking comments on whether this specific criterion is still applicable.
We are also soliciting comments on whether we should reconsider opening the service area of every OPO for competition at the conclusion of every re-certification cycle, regardless of whether the OPO met the outcome performance standards for the prior re-certification cycle. Under our current regulations, OPOs that successfully pass the outcome and process performance measures and comply with our CfCs are automatically renewed. Only OPOs that are unsuccessful in meeting these regulatory requirements could be de-certified. We are seeking comments on an alternative approach where all OPO service areas would be open for competition at the end of each agreement cycle. Any OPO seeking to renew the agreement could face competition from another OPO that wanted to take over that DSA.
In 2005, we proposed opening every OPO's service area for competition at the end of every re-certification cycle. Specifically, we proposed that once we determined that an OPO met the outcome measures at proposed § 486.318 for the previous re-certification cycle and was found to be in compliance with the process performance measures at §§ 486.320 through 486.360, that we would open the OPO's service area for competition from other OPOs. Some of the comments we received at the time included concerns that such a proposal would threaten cooperation and collaboration between OPOs, and would impact the sharing of best practices and change strategies between OPOs (71 FR 30996). In response to this feedback, we finalized a modified version of this proposal whereby this process would only occur in the service areas of OPOs that have been de-certified. We are seeking comments as to whether circumstances in the past 15 years have changed that would warrant our reconsidering our policy of limiting the competition to just open service areas
rategies between OPOs (71 FR 30996). In response to this feedback, we finalized a modified version of this proposal whereby this process would only occur in the service areas of OPOs that have been de-certified. We are seeking comments as to whether circumstances in the past 15 years have changed that would warrant our reconsidering our policy of limiting the competition to just open service areas. If we were to consider a policy to open the service areas of all OPOs, we seek comment on how much effort it would take to prepare a bid for the open service area, how this type of competition may affect organ donation, and how it would affect cooperation when transplant centers are receiving organs from outside the service area.
C. Proposed Changes to the Re-Certification Cycle (§ 486.302 and § 486.318)
In accordance with our rules at § 486.308(b)(1), OPOs are re-certified on a four-year cycle. Currently, OPOs are assessed based on 36 months of data analysis. This data period begins six months after the certification period starts and ends six months prior to the end of the certification cycle. CMS analyzes these data and determines if the OPO is out of compliance with outcomes prior to the end of the current cycle and prior to the start of the next cycle. OPOs are given interim reports every six months during the certification period to gauge performance. The survey and certification administrative enforcement actions begin six months before the end of the certification period. For instance, the data collection period for the previous re-certification cycle ended on December 31, 2017. Re-certification surveys were conducted January 1, 2018 through July 31, 2018 and outcomes measures were assessed for the 36 month period beginning January 1, 2015 through December 31, 2017, with the next certification cycle beginning on August 1, 2018
e the end of the certification period. For instance, the data collection period for the previous re-certification cycle ended on December 31, 2017. Re-certification surveys were conducted January 1, 2018 through July 31, 2018 and outcomes measures were assessed for the 36 month period beginning January 1, 2015 through December 31, 2017, with the next certification cycle beginning on August 1, 2018. We recognize that waiting a full 36 months to assess and take actions to improve OPO performance would result in numerous lost opportunities to procure and transplant potentially viable organs. Therefore, we propose that the outcome measures assessment occur at least every year and be based on data from the most recent 12 months of data from the state death certificates. OPOs that are flagged as having donation rates or organ transplantation rates that are statistically significantly less than the threshold rates established by the top 25 percent of OPOs are expected to take actions to improve their performance and include the specific actions that they will undertake to improve their outcome measures in their QAPI program. Currently, OPOs receive data on their performance from the SRTR every six months, so our proposed methodology would not provide assessments as frequently. But, this approach could provide for a continuous assessment of OPO performance and allow for more responsive performance improvement actions from low performers because of
Although the assessments would occur at least once every 12 months, no OPO may be de-certified until the end of the re-certification cycle, except in cases of urgent need. 23 We are proposing to use the most recent prior 12 months of data at the last assessment cycle before re-certification to be the basis for de-certification
onsive performance improvement actions from low performers because of
Although the assessments would occur at least once every 12 months, no OPO may be de-certified until the end of the re-certification cycle, except in cases of urgent need. 23 We are proposing to use the most recent prior 12 months of data at the last assessment cycle before re-certification to be the basis for de-certification. The reason we are proposing to use only the prior 12 months of data is that we do not want to penalize an OPO who has made legitimate and successful efforts to improve their performance by including the older data, nor do we want to reward an OPO whose recent performance has fallen to be able to rely on past performance as the basis for a subsequent four-year re-certification. In the past, we have used 36 months of data to determine re-certification, so we are seeking comments on the use of the shorter length of data as opposed to all the data during the re-certification cycle. Although using the longer period of time would include data that does not reflect the OPO's current status, it would allow OPOs who had been performing adequately through most of the four-year cycle to remain certified even if they had a lapse in performance at the last cycle. We are also seeking comments on other approaches to use the data to identify high-performing OPOs for re-certification.
23 The Organ Procurement Organization Certification Act of 2000 changed the re-certification cycle from every 2 years to every 4 years; § 486.312(d) and § 486.302 states that CMS can give written notice of de-certification in cases of urgent need and defines urgent need as occurring when an OPO's noncompliance with one or more conditions for coverage has caused, or is likely to cause, serious injury, harm, impairment, or death to a potential or actual donor or an organ beneficiary
ication cycle from every 2 years to every 4 years; § 486.312(d) and § 486.302 states that CMS can give written notice of de-certification in cases of urgent need and defines urgent need as occurring when an OPO's noncompliance with one or more conditions for coverage has caused, or is likely to cause, serious injury, harm, impairment, or death to a potential or actual donor or an organ beneficiary.
After considering public comments and finalizing this rule, we expect to begin calculations of the outcomes measures before the beginning of the next re-certification cycle in 2022. We are requesting comments on this proposed change to the applicability of the outcome measure requirements for the cycle beginning in 2022 and ending in 2026.
D. Proposed Change to the Quality Assessment and Performance Improvement Requirement (§ 486.348)
QAPI requirements for OPOs were first established in 2006 (71 FR 31054). OPOs are required to develop, implement, and maintain a comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all donation services, including services provided under contract or arrangement under § 486.348. In addition, an OPO's QAPI program must include objective measures to evaluate and demonstrate improved performance with regard to certain OPO activities, and the OPO must take actions that result in performance improvements and track performance to ensure that improvements are sustained.
A QAPI program is an important, data driven process that allows health care entities to assess their functioning continuously and make changes to improve their quality and efficiency over time. Since we are proposing to revise the outcome measure requirements at § 486.318 and the re-certification process at § 486.316, we believe that OPOs should also be required to include a process to address and improve poor performance on their outcome measures as part of their QAPI program
ies to assess their functioning continuously and make changes to improve their quality and efficiency over time. Since we are proposing to revise the outcome measure requirements at § 486.318 and the re-certification process at § 486.316, we believe that OPOs should also be required to include a process to address and improve poor performance on their outcome measures as part of their QAPI program. We currently do not have such a requirement for an OPO's QAPI program, but because OPOs are re-certified every 4 years, it is important that OPOs continuously strive to improve outcomes over the course of the re-certification cycle. An OPO's QAPI program provides a process to achieve these improvements. We, therefore, are proposing to require that OPOs include a process to evaluate and address their outcome measures in their QAPI program if their rates are statistically significantly lower than the top 25 percent at each assessment, for each assessment period except the final assessment. Failure to meet the outcome measure in the final assessment period would result in de-certification. For all other assessment periods, if the OPO does not meet the outcome measures, the OPO must identify opportunities for improvement and implement changes that lead to improvement in these measures.
As we have previously described in this proposed rule, we are proposing that an OPO's performance on the outcome measures be assessed at least every 12 months, based on the most recent prior 12 months of data. We would expect OPOs to use the data that are obtained from each assessment to drive changes to their QAPI program in order to improve their performance on the outcome measures. If proactive changes are made early in the re-certification cycle, an OPO would be able to begin to address poor performance on the outcome measures early in the re-certification cycle and prior to the re-certification determination
xpect OPOs to use the data that are obtained from each assessment to drive changes to their QAPI program in order to improve their performance on the outcome measures. If proactive changes are made early in the re-certification cycle, an OPO would be able to begin to address poor performance on the outcome measures early in the re-certification cycle and prior to the re-certification determination. We are additionally interested in whether the QAPI process is sufficiently robust to capture year over year improvements, as well as other quantitative factors that may not be captured in our proposed outcome metrics. As such, we encourage commenters to consider ways the QAPI process may be modified or enhanced to better assess OPO performance relative to past performance and to other OPOs. As proposed in this rule, an OPO that was deemed compliant on its QAPI, but did not meet one or both of the proposed outcome measures would be subject to decertification.
E. Solicitation of Comments
In addition to our requests for comments throughout the preamble, we are specifically seeking the public's input on the following questions:
• Should OPO outcome measures also include an assessment of organ transplantation rates by type of organ transplanted?
• We are proposing to use a performance measure that is based on the OPO's performance relative to the top 25 percent of donation rates and organ transplantation rates. Should CMS use a static level or a different criterion from what is being proposed? What statistical approach to the data or incentives can we use to encourage all OPOs to strive to be high performers? Can the current performance parameter, which requires that the donation rate be no more than 1.5 standard deviations below the mean national donation rate, be appropriately applied to achieve this goal? We are requesting that commenters explain and include any evidence or data they have to support their comments
e data or incentives can we use to encourage all OPOs to strive to be high performers? Can the current performance parameter, which requires that the donation rate be no more than 1.5 standard deviations below the mean national donation rate, be appropriately applied to achieve this goal? We are requesting that commenters explain and include any evidence or data they have to support their comments.
• What are the benefits, consequences, or unintended consequences, of using these two proposed measures and what are their potential impact on OPOs, transplant centers, organ donation, patient access, and transplant recipients?
• Are there potential additional compliance burdens on OPOs or transplant centers if the two proposed measures were finalized? Please explain.
In § 486.316(c)(3), we require an OPO to compete for an entire service area as a criterion to compete for an open service area. At this time, we are not proposing to change this requirement but would like comments as to whether we should consider revising this subsection and redefining the open service area for competition. Although we have proposed eliminating the definition of “eligible deaths,” we have not proposed to remove the requirement that OPOs conduct monthly death record reviews. We are seeking comments as to whether § 486.348(b)
We encourage detailed comments that answer all of the aforementioned questions. Additionally, in the RIA, Section G: Alternatives considered, we discuss a number of different alternatives that we are actively considering. These alternatives examine different type of denominators, different statistical confidence intervals for calculations, and different threshold rates for assessment. We are actively considering these policy alternatives and are seeking comments on them.
III
dditionally, in the RIA, Section G: Alternatives considered, we discuss a number of different alternatives that we are actively considering. These alternatives examine different type of denominators, different statistical confidence intervals for calculations, and different threshold rates for assessment. We are actively considering these policy alternatives and are seeking comments on them.
III. Collection of Information Requirements
Under the Paperwork Reduction Act (PRA) of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
A. ICRs Regarding Re-Certification and Competition Processes (§ 486.316)
At § 486.316(b), we are proposing to modify language that refers to the current outcome measure requirements that states that an OPO must meet two out of the three outcome measures at § 486.318. They would instead be required to meet both newly proposed outcome measures, or face de-certification which may then be appealed by the OPO
egarding Re-Certification and Competition Processes (§ 486.316)
At § 486.316(b), we are proposing to modify language that refers to the current outcome measure requirements that states that an OPO must meet two out of the three outcome measures at § 486.318. They would instead be required to meet both newly proposed outcome measures, or face de-certification which may then be appealed by the OPO. If the OPO does not appeal or the OPO appeals and the reconsideration official and CMS hearing officer uphold the de-certification, the OPO's service area would be opened for competition by other OPOs.
The current information collection request for the OPO CfC (OMB Control Number 0938-0688, Exp. February 2021) estimates that one OPO would face de-certification per year, and under the proposed outcome measures, this number would have potential to increase. We do not know exactly how many would be de-certified under these new measures; however, based on the improvement required to meet the proposed measures it is possible that approximately 7 to 33 OPOs could be de-certified. Assuming some number of these de-certifications are upheld, their respective service areas would be opened for competition.
Under § 486.316(b), an OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results. In addition, § 486.316(c) states that to compete for an open service area, an OPO must meet the performance requirements of the outcome measures at § 486.318 and the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.348. The OPO must also compete for the entire service area
nation, what steps the OPO took to overcome them, and the results. In addition, § 486.316(c) states that to compete for an open service area, an OPO must meet the performance requirements of the outcome measures at § 486.318 and the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.348. The OPO must also compete for the entire service area.
The burden associated with this requirement is the time it would take to create a document that contains the required information and data related to the OPO's success in identifying and addressing the barriers in its own service area and how they relate to the open service area. We will refer to this documentation as a plan.
Based on historical data and our previous experience with the OPOs, we would expect a total of nine OPOs will want to compete for a new service area and three of those OPOs may want to compete for more than one service area. Thus, we believe there will be a total of 12 plans that will need to be developed for the competition process.
We believe that developing each plan would require the collective efforts of a QAPI director (Registered Nurse, $71/hour), organ procurement coordinator (RN or social worker, $71/hour), medical director ($107/hour), OPO director ($107/hour), and a medical secretary ($35/hour). All wages are adjusted upwards by 100 percent to account for the cost of fringe benefits and overhead. Assuming, consistent with past rulemaking, that it would take these professionals 104 hours to develop such a plan, we estimate each competition would require 1,248 burden hours for all 9 OPOs to complete 12 plans and would cost all 9 OPOs $79,416 (($71 RN × 30 hours × 9 OPOs) + ($71 organ procurement coordinator × 30 hours × 9 OPOs) + ($107 medical director × 12 hours × 9 OPOs) + ($107 OPO director × 30 × 9 OPOs) + ($35 medical secretary × 2 hours × 9 OPOs))
hese professionals 104 hours to develop such a plan, we estimate each competition would require 1,248 burden hours for all 9 OPOs to complete 12 plans and would cost all 9 OPOs $79,416 (($71 RN × 30 hours × 9 OPOs) + ($71 organ procurement coordinator × 30 hours × 9 OPOs) + ($107 medical director × 12 hours × 9 OPOs) + ($107 OPO director × 30 × 9 OPOs) + ($35 medical secretary × 2 hours × 9 OPOs)). For the annual burden, each of these figures needs to be divided by 4, since competition for open service areas will typically occur every 4 years. Thus, the annual burden hours for all 9 OPOs to prepare 12 plans would be 312 (1,248/4) and the annual cost estimate would be $19,854 ($79,416/4).
B. ICRs Regarding Condition: Reporting of Data (§ 486.328)
We are proposing to revise § 486.318 to eliminate the reporting of the “Number of eligible deaths” and modify the reporting of “Number of eligible donors” to “Number of donors.” Although the current outcome measures include the potentially burdensome OPO self-defined and self-reported “eligible deaths” for evaluation purposes, the current information collection request for the OPO requirements (OMB Control Number 0938-0688, Exp. February 2021) does not attribute any burden to this requirement. This is because the type of data and how it is reported to the OPTN is already covered by the information collection requirements associated with the OPTN final rule (42 CFR 121). Thus, we are not attributing any quantifiable burden reduction to this proposed change.
C. ICRs Regarding Quality Assessment and Performance Improvement (§ 486.348)
At § 486.348(d) we are proposing to require that OPOs include a process to evaluate and address their outcome measures in their QAPI program if their rates are statistically significantly lower than the top 25 percent at each assessment
we are not attributing any quantifiable burden reduction to this proposed change.
C. ICRs Regarding Quality Assessment and Performance Improvement (§ 486.348)
At § 486.348(d) we are proposing to require that OPOs include a process to evaluate and address their outcome measures in their QAPI program if their rates are statistically significantly lower than the top 25 percent at each assessment. Assessments would occur at least every 12 months with the most recent prior 12 months of available data, meaning there would be 3 assessments in each 4 year re-certification cycle that might require modifications to an OPO's QAPI program.
As stated in the information collection request for the OPO requirements (OMB Control Number 0938-0688, Exp. February 2021), we believe the information collection requirements associated with maintaining a QAPI program are exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with this collection of information would be incurred by persons in the normal course of their activities. Accordingly, we do not believe this proposed change would
If you comment on these information collection, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule.
Comments must be received on/by February 21, 2020.
IV. Response to Comments
Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
V. Regulatory Impact Analysis
A
mber of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
All major government regulations should undergo periodic review to ensure that they do not unduly burden regulated entities or the American people, and that they accomplish their goals effectively and efficiently. It has been apparent for a number of years that the current system for organ donation and the rules under which OPO performance is measured do not create the necessary incentives to optimize organ donation and transplantation as evidenced by performance discrepancies among OPOs, the wide geographic and population diversity among both higher- and lower-performing OPOs, and the significant gap between the number of potential organ donors and the number of actual donors (see the following Tables 3 and 4). Recent article titles tell the story as well: “Reforms to Organ Donation System Would Save Thousands of Lives, Millions of Taxpayer Dollars Annually,” “Lives Lost, Organs Wasted,” and “A Simple Bureaucratic Organ Donation Fix Will Save Thousands of Lives.” 24 All three of these articles include, or reference, in-depth studies of the current organ donation system's problems and discuss reforms that could increase its performance
story as well: “Reforms to Organ Donation System Would Save Thousands of Lives, Millions of Taxpayer Dollars Annually,” “Lives Lost, Organs Wasted,” and “A Simple Bureaucratic Organ Donation Fix Will Save Thousands of Lives.” 24 All three of these articles include, or reference, in-depth studies of the current organ donation system's problems and discuss reforms that could increase its performance. These problems and the reforms needed to improve organ donation and transplantation have multiple dimensions, including the underperformance of many OPOs to procure and place organs at the levels of the best-performing OPOs and is the basis for President Trump's July 10, 2019 Executive Order on Advancing American Kidney Health, to “increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.”
24 These articles were written by and published in: Goran Klintman, RealClearHealth, March 4, 2019; Kimberly Kindy, Lenny Bernstein, and Dan Keating, Washington Post, December 20, 2018; and Laura and John Arnold, STAT, July 24, 2019.
We note that the Secretary recently issued a final rule to reduce regulatory burden on several types of health care providers (“Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care,” 84 FR 51732, September 30, 2019) that directly addresses the same policy concern. Under that final rule, performance standards for transplant hospitals were revised to reduce the practice of transplanting only the best organs in the healthiest patients and allowing transplantable organs to be discarded and sicker patients to die without a transplant
, Flexibility, and Improvement in Patient Care,” 84 FR 51732, September 30, 2019) that directly addresses the same policy concern. Under that final rule, performance standards for transplant hospitals were revised to reduce the practice of transplanting only the best organs in the healthiest patients and allowing transplantable organs to be discarded and sicker patients to die without a transplant. Those performance standards rewarded very high one-year organ and patient survival rates by threatening program closure to hospitals that did not achieve such rates. In so doing, those performance standards gave no weight to maximizing treating the many patients on the waiting lists whose lives would be saved, even at a higher risk of failure. As discussed in the regulatory impact analysis (RIA) for CMS-3346-F, there is the potential for regulatory reform to reduce the number of “transplant quality” discarded organs, and through transplantation of those organs, save the lives of many patients each year.
Finally, the Executive Order directs the Secretary of HHS as follows: “Within 90 days of the date of this order, the Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO's performance.” That directive applies directly to this proposed rule.
B. Scope of Review
We have examined the impacts of this proposed rule as required by E.O. 12866 on Regulatory Planning and Review (September 30, 1993), E.O. 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), E.O. 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and E.O
tember 30, 1993), E.O. 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), E.O. 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and E.O. 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
E.O. 13771 states that it is essential to manage the costs associated with the government imposition of private expenditures required to comply with federal regulations and establishes policies and procedures to reduce the costs of both new and existing federal regulations. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of E.O. 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O
creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.
An RIA must be prepared for major rules with economically significant effects ($100 million or more in any one year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared an RIA that to the best of our ability presents the costs and benefits of this rulemaking.
C. Effects on OPO Performance
We are proposing two new outcome measures that would be used to assess an OPO's performance: A measure of an OPO's donation rate and organ
In the tables that follow, the first two digits of the letters in parentheses are, in most cases, the primary state of the OPO. Some OPOs serve more than one state, and some states have more than one OPO. We are also including, in the Appendix, a map for each proposed measure that depicts geographic trends in performance. In a few cases in the tables below, we have abbreviated an OPO name to improve simplicity of presentation. For a complete OPO listing and additional information, see the following link: https://optn.transplant.hrsa.gov/members/member-directory/?memberType=Organ%20Procurement%20Organizations. 25 These tables show the performance required of each OPO to reach the proposed performance standard, including an allowance for statistical “confidence” (one-tailed test), for the OPOs that fell below the standard. Confidence intervals are calculated based on test statistics derived from the assumed binomial and Poisson distribution for the donation rate and transplant rate, respectively
zations. 25 These tables show the performance required of each OPO to reach the proposed performance standard, including an allowance for statistical “confidence” (one-tailed test), for the OPOs that fell below the standard. Confidence intervals are calculated based on test statistics derived from the assumed binomial and Poisson distribution for the donation rate and transplant rate, respectively. Specifically, the Wilson score interval with continuity correction (Newcombe 1998) is used to calculate the confidence interval for the donation rate of each OPO. The Wilson and Hilferty formula (Wilson and Hilferty 1931, Breslow and Day 1987, Kulkarni and Hemangi 2012) is used to calculate the confidence interval for the transplant rate of each OPO.
25 Some of these OPOs have changed names in recent years, so some other published lists may be out of date. However, the codes shown in parentheses in our tables have not changed.
We are committed to using all available data to continue our analysis of OPO performance, including, where possible, historical trends in OPO performance; a range of potential outcomes, including a scenario where high performers remain at steady state; and year over year OPO performance and distribution of scores and improvements within the past two certification cycles, using the proposed metrics.
BILLING CODE 4120-01-P EP23DE19.022
EP23DE19.023
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Table 4 shows the current range of organ transplantation performance, using the new proposed standard of measuring the total number of organs transplanted from deceased donors (including all transplanted organs from each donor) as a percentage of the same donor potential used for the donation rate. 26 According to the NCHS, there are about 2.8 million deaths each year in the U.S., but the potential donor pool is far lower because it only includes those who die in hospitals, who are age 75 or less, and who have no contraindications to donation (such as metastatic cancers)
including all transplanted organs from each donor) as a percentage of the same donor potential used for the donation rate. 26 According to the NCHS, there are about 2.8 million deaths each year in the U.S., but the potential donor pool is far lower because it only includes those who die in hospitals, who are age 75 or less, and who have no contraindications to donation (such as metastatic cancers). Table 4 shows that organ transplantation rates range from 19.44 at the highest levels to 4.47 (using data from calendar year 2017), a range of about four to one from highest to lowest. The top one-fourth of OPOs achieve rates above 12 donors/100 inpatient deaths, more than double the rates of many lower performing OPOs. The top-performing OPOs are geographically and demographically diverse, with potential donor pools ranging from about 2,000 deaths a year to almost 10,000 a year. We recognize that some OPOs have fewer transplant programs within their service areas than others, but allocation policies allow OPOs to place organs outside their DSA. The organ match run, which lists all potential recipients for a donated organ, includes eligible patients on the waiting list for that particular organ and organs are often offered to hospitals outside of the DSAs in which the organs were procured.
26 These results would look similar if we used the current estimates of “eligible” deaths but would be an imperfect comparison since that is not a standardized measure
n, which lists all potential recipients for a donated organ, includes eligible patients on the waiting list for that particular organ and organs are often offered to hospitals outside of the DSAs in which the organs were procured.
26 These results would look similar if we used the current estimates of “eligible” deaths but would be an imperfect comparison since that is not a standardized measure.
EP23DE19.025
EP23DE19.026
EP23DE19.027
BILLING CODE 4120-01-C Both proposed outcome measures address multiple goals not met by the current requirements: (1) They can be uniformly applied across all OPOs; (2) they capture not only success in obtaining donors but also success in placing as many organs as possible; (3) they capture the entire pool of possible donors (not the pool as determined separately by each OPO); (4) they adjust for the geographic differences in the number and causes of death; and (5) they meet central necessities for a workable performance standard that exhibits uniformity, timeliness, and stability year-to-year. Of particular importance, these measures would replace the non-standardized criteria for “eligible” donors as determined by each OPO. The existing denominator standard allows OPOs to exclude from the calculated potential donor pool those cases where the next-of-kin did not authorize donation, a crucial task we believe all OPOs should be effective and continually improving at. For an extensive discussion of these and related issues, see “Changing Metrics of Organ Procurement Organization Performance in Order to Increase Organ Donation Rates in the United States.” 27 The proposed measures do not control for every variable that can affect OPO performance for reasons beyond its control. For example, states without motorcycle helmet laws have higher rates of accidents that create potential donors. Some DSAs have greater transplant hospital competition than others, and more competition for transplantable organs is associated with greater use of organs that might otherwise be discarded
do not control for every variable that can affect OPO performance for reasons beyond its control. For example, states without motorcycle helmet laws have higher rates of accidents that create potential donors. Some DSAs have greater transplant hospital competition than others, and more competition for transplantable organs is associated with greater use of organs that might otherwise be discarded. 28 Regardless, it is our belief that the untapped donor and organ potential is sufficiently large in every DSA so that every OPO has
27 Goldberg D, et al, “Changing Metrics of Organ Procurement Organization Performance in Order to Increase Organ Donation Rates in the United States,” AmJTransplant 2017; 17:3183-3192.
28 Adler, et al “Is Donor Service Area Market Competition Associated with Organ Procurement Organization Performance?” Transplantation 2016; 100; 1349-1355.
Tables 3 and 4 also show a very important quantitative result: At present, there are about 10,000 deceased donors a year, which is only about three percent of the 272,000 potential donors in 2017. Importantly, the proposed criteria for potential donors already exclude many deaths, and focus on decedents with greater potential to provide transplantable organs. Hence, all OPOs will have a pool of potential donors many times higher than the number of donors and organs needed to meet the proposed performance standards.
If the number of donors at the lower-performing OPOs were to reach what is now the 75th percentile of achievement, the number of donors would increase by over one thousand by the end of the four-year performance period. Both through this increase, and greater success in maximizing the number of organs actually transplanted from each donor, achieving the 75th percentile for the transplant rate would increase the number of such transplants from about 32,000 by as many as 6,000 by 2024, and by as many as 10,000 by 2026, for a total of about 42,000 in that year (see Table 12)
end of the four-year performance period. Both through this increase, and greater success in maximizing the number of organs actually transplanted from each donor, achieving the 75th percentile for the transplant rate would increase the number of such transplants from about 32,000 by as many as 6,000 by 2024, and by as many as 10,000 by 2026, for a total of about 42,000 in that year (see Table 12). Achieving higher success rates would be unlikely to occur in just the lower performers, and these estimates assume improvements at all current levels of performance as better techniques and methods are identified and widely adopted. For example, there have been major recent improvements in perfusion techniques used to preserve kidneys and extend the time period allowed between donation and transplantation. This technology rewards focusing efforts on extending the placement of organs beyond local areas for appropriate transplant candidates on waiting lists. These techniques are available to all OPOs, but have not been adopted by all OPOs. There may be future improvements as well, but our estimates do not assume any major breakthroughs will be routinely available in the near term. In September 2019, the National Institutes of Health reported that a new method of preserving livers for transplantation would potentially increase the viability of livers from nine to 27 hours, but this is still in a

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2019-27418. Check the current official text before relying on it. Not legal advice.