The Alliance

Spotlight Series

The Alliance Spotlight Series is a recurring one-page publication for front-line healthcare professionals, offering quick-takes on critical topics affecting the field of organ donation and transplantation. We encourage you to download these issues and share them with your front-line colleagues and partners.

Spotlight Series Past Issues

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Overview on Final Rules, Conditions for Coverage, Conditions of Participation, the State Operations Manual and Interpretive Guidelines

CMS Legislation: An Overview of Organ Donation and Transplantation Regulations

Introduction

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.

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:

Summary

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.

A Special Thanks to This Series’ Contributors

Deanna Fenton
About the Editor |
Deanna Fenton

Deanna is a knowledgeable and versatile professional with diverse experiences in healthcare, client relations, marketing, project management and demonstrated skills in leadership and advocacy. Prior to joining The Alliance, she worked in Hospital Development at her local OPO in the state of New Jersey where she served as the clinical liaison to a number of Level 1 Trauma & Neuroscience centers as well as community hospitals. Her personal connection as a donor family and friend fuels her passion to support her colleagues across the donation-transplantation continuum through the development of valuable educational resources that ultimately boost performance and improve outcome measures. Deanna holds a Bachelor of Arts in Psychology and a minor degree in Public Health from Montclair State University. In her spare time, Deanna enjoys visiting vineyards, spending time with her family, and traveling in hopes of visiting all seven wonders of the world.

Hedi Aguiar
About the Editor |
Hedi Aguiar

Hedi has been a critical care nurse for over 26 years, gathering experience in three different countries. She has a Bachelor of Arts Honors degree in intensive care nursing and a Masters of Science in Nursing as a Clinical Nurse Specialist. After working as an ICU Educator, she transitioned into the organ, eye, and tissue donation field. She worked for two different Organ Procurement Organizations (OPO), OneLegacy and Donor Network West, where in her last position she was the Donation Process Improvement Manager.

During her time in the OPO field, Hedi served as faculty for the North American Transplant Coordinator Organization (NATCO) and chaired the national Association of Organ Procurement Organization’s (AOPO) Hospital Development Council. After working for the OPO, she took a leadership role with the national organization the Organ Donation and Transplantation Alliance where she became the Senior Director of Programs, leading various national initiatives, councils and workgroups.

After many years of providing consultations, trainings and speaking engagements, she founded her own business in 2018, called Fundamental Roots. Fundamental Roots offers various customized soft skills trainings, including topics surrounding managing one’s sphere of control, general communication and collaboration skills, and physician communication and partnership. Leveraging her life-experiences in growing up internationally and having lived on four continents and in 7 different countries, Hedi also provides trainings on cross-cultural communication.

Advancing All.

The Alliance is not a membership organization and therefore relies on annual voluntary financial support from OPOs and transplant programs who find value in our programs and initiatives.

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