The Centers for Medicare & Medicaid Services’ (CMS) latest publication of a final rule updating the Conditions for Coverage for Organ Procurement Organizations (OPO) released on November 20, 2020, is generating many questions and discussions in the donation and transplantation community. To understand the impact of such a release, it is helpful to clarify the following questions: 1 – What exactly are final rules? 2 – How are Conditions for Coverage (CfCs) and Conditions of Participation (CoPs) related to final rules? 3 – How are final rules incorporated into the State Operations Manual and associated Interpretive Guidelines?
Final Rules Overview
Final rules are new or revised legislative requirements, executed and published by a Federal agency (e.g., CMS, FDA, etc.). It may also be a rescindment of an existing regulation. As final rules are Federal regulations, all identified parties in a given rule, e.g. hospitals, transplant centers, and OPOs, are held accountable to them. Final rules are rewritten and revised using a structured rulemaking process that elicits written public comments on proposed rules prior to the issuing of a specific final rule.(1)
Final Rules – The Federal Register and the Electronic Code of Federal Regulations
Final rules are published in the Federal Register after an agency has reviewed public comments and has concluded that its proposed solution will help accomplish established goals or solve problems that have been identified. Final rules are required to consider whether any alternative solutions would be more effective or cost less. Final rules must follow a specific format in order to be published in the Federal Register. (2) That format includes:
- A Preamble that provides a summary of the agency’s rationale for the rule.
- The Effective and Compliance Date(s) – effective dates are usually within 30 days after being published
in the Federal Register.
- Supplemental Information that provides the basis and purpose of the rule.
- Statement of Authority that identifies the Federal agency’s legal authority to issue the rule.
- A Full Text of the Final Rule and any Interim Final Rules.
The Federal Register is often referred to as (FR or Fed. Reg.) and it is the official daily legal publication for rules, proposed rules, and notices issued by Federal agencies and organizations, as well as executive orders issued by the President.(3) The Federal Register can be accessed via https://www.federalregister.gov/.
The Electronic Code of Federal Regulations (e-CFR) is a web version of the Code of Federal Regulations (CFR) and is updated daily. It is an editorial compilation of CFR material and Federal Register amendments and is not an official legal edition of the CFR. (4)
The eCFR related to the Organ Procurement & Transplantation Network (OPTN) are found under Title 42 – Public Health, Chapter 1 – Public Health Service (PHS), Department of Health and Human Services (DHHS), Subchapter K and Part 121 – Organ Procurement and Transplantation Network.
Conditions for Coverage (CfC) and Conditions of Participation (CoP)
Final rules may reflect changes in CfCs and CoPs . CfCs and CoPs are specific CMS standards health care organizations must meet in order to be able to participate in CMS programs and to receive CMS reimbursement. These requirements are intended to protect the health and safety of patients and to improve the quality of care. The CfCs are the provisions that State Survey Agencies (SA) use to determine an organization’s (e.g. hospital, OPO, transplant program, etc.) compliance with standards to obtain initial approval or re-approval status to receive reimbursement from CMS for services provided to patients. CoPs are Federal regulations associated with the provision of patient care 5 with which the CMS participating organizations must comply. The following links are the specific CfCs and CoPs related to hospitals, OPOs, and transplant centers.
- 42 CFR Parts 413, 441, et al. Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs); Final Rule – May 31, 2006
- Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs CMS – 3380-F – November 20, 2020 (This latest OPO final rule is specific to OPO CfCs related to OPO Outcome Measures)
- Transplant Centers
- 42 CFR Parts 405, 482, 488, and 498 Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants; Final Rule – March 30, 2007 (Note: This was originally published in 2007. Since then, there have been several revisions to different sections of the final rule. These can be viewed on the e-CFR link above. The dates of revisions are shown just below the relevant section and can be used to search the Federal Register for all of the public commentary, rationale and analyses of the changes.)
The State Operations Manual (SOM) and associated Interpretive Guidelines (IGs)
The SOM contains the CMS primary survey and certification rules and guidance for health care organizations. The IGs can be thought of as a blueprint for surveyors to use in determining whether an organization has met their required CoPs. IGs define or explain the relevant statute and regulations and do not impose any requirements that are not otherwise stipulated in CfCs or CoPs. Organization specific IGs are located in the SOM Appendixes and are updated whenever there is a new or updated hospital, OPO or transplant center final rule. SOM and IG links of interest for hospitals, OPOs, and transplant centers include:
- Complete State Operations Manual
- Complete list for the Medicare State Operations Manual
- Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals – Appendix A Rev. 200, Dated: 02-21-20 (see §482.45 Condition of Participation: Organ, Tissue and Eye Procurement)
- Guidance to Surveyors: Organ Transplant Programs – Appendix X Rev. 200, Dated: 02-21-20
- Organ Procurement Organization (OPO) Interpretive Guidance – Appendix Y Rev. 180, Dated: 08-24-18
- Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revision to Outcomes Measures for OPOS CMS – 3380-F
- Organ Procurement Organization Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations. Final Rule, Public Comment Period, and Delay of Effective Date: CMS – 3380-F and CMS 3380-F2 Dated: 03-20-21
- Emergency Preparedness for All Provider and Certified Supplier Types Interpretive Guidance Dated 03-04-19 – Appendix Z
To keep abreast of any regulatory changes that could potentially impact your organization’s compliance during a survey, it is valuable to periodically review the final rules published in the Federal Register or e-CFR. In addition, regular review of the CMS Transmittals will ensure that you have access to the latest version of the SOM and any associated IGs applicable to your organization. CMS Transmittals can be accessed via the following link: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals.