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The proposed rule would establish culturally competent and person-centered requirements for all provider and supplier types that participate in Medicare and Medicaid programs. These requirements revise the Conditions of Participations/Conditions for Coverage (CoPss/CfCs) pertaining to governance, patient/resident/client rights (such as nondiscrimination and accessibility), clinical quality standards, quality assessment and performance improvement, staff training, discharge planning, and care planning in an effort to increase quality and improve access to health care. These proposals also include additional requirements for transplant programs, organ procurement organizations, and end-stage renal disease facilities that would advance equity and reduce disparities in organ transplantation and organ donation.

Statement of Need:

This rule would advance health equity, increase access to care, improve quality of care, and reduce health disparities for all individuals.  The proposals are in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively. Despite the existence of Federal civil rights laws, disparities in care still persist. Revising the CoPs/CfCs by adding culturally competent and person-centered requirements will incentivize providers to address disparities that exist within their facilities by requiring specific actions or face a noncompliance determination that may affect their participation status in the Medicare and Medicaid programs.  Discrimination, or even the fear of discriminatory behavior by healthcare providers, negatively impacts a patient’s health and safety and health outcomes, and presents barriers to accessing quality health care.  The establishment of culturally competent and person-centered requirements are a necessary step to protect an individual’s health and safety. The provisions of this rule would help ensure that everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.  Further, culturally competent and person-centered focused health and safety requirements could lead to improved access to care, improved quality of care, and better health outcomes for all.  

Summary of the Legal Basis:

The statutory authority to revise the health and safety standards for Medicare and Medicaid participating providers and suppliers is contained within Section 1102 (42 U.S.C. 1302) of the Social Security Act. In addition, this rule revises the health and safety regulations to advance health equity and reduce disparities for all individuals in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively.

Alternatives:

In developing the policies contained in this rule, we considered numerous alternatives to the presented proposal.  These alternatives will be included in the proposed rule.  

Anticipated Costs and Benefits:

The provisions in this rule aim to advance health equity, increase access to care, improve quality of care, and reduce health disparities for all individuals.  This regulation will ultimately remove barriers to access health care, ensure that all individuals have equitable care, and improve quality of care for all.  As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks:

This action furthers the goals of the Executive Orders on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985), Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988), Executive Order on Ensuring an Equitable Pandemic Response and Recovery (E.O. 13995), and Executive Order on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders (E.O.14301). While there may be some risks associated with an increased burden on providers as a result of these regulations, we believe benefits related to addressing the challenges that historically underserved populations (those that have been subject to racism, discrimination, or systemic disadvantage) face when accessing and receiving care from a health care organization, would far outweigh any risks.