HHS Adds Four Final Rules in 2024
August 16, 2024
The year 2024 has already witnessed a flurry of new final rules from the U.S. Department of Health and Human Services (HHS) through its Office for Civil Rights (OCR). To assist clients and others in the health care industry to understand the basic requirements of these new rules and bring themselves into compliance in a timely manner, this summary highlights the following final rules, actions and deadlines:
1. Confidentiality of Substance Use Disorder (SUD) Patient Records.
On February 8, 2024, HHS, through the Substance Abuse and Mental Health Services Administration (SAMSHA) and the OCR, announced a final rule aligning certain aspects of 42 C.F.R. Part 2 (Part 2) with HIPAA. The rule became effective on April 16, 2024, and Part 2 Programs are required to be in compliance with the rule by February 16, 2026. The final rule’s modifications of Part 2 include:
• Allowing a single consent for all future uses and disclosures for treatment, payment and health care operations to cover the use and disclosure of Part 2 records, with certain exceptions for SUD notes and legal proceedings;
• Permitting redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions for legal proceedings;
• Treating SUD counseling notes similar to how HIPAA treats psychotherapy notes;
• Aligning Part 2 patient notices with HIPAA notices or allowing notices to be combined provided all of the required elements are included; and
• Outlining breach notification requirements aligning with HIPAA.
The full language of the rule may be found HERE, and the HHS Fact Sheet may be found HERE. Prior to the compliance deadline, Part 2 programs need to take the following actions:
• Update patient consent forms to include the required elements;
• Update the notice of privacy practices to include the required elements;
• Update disclosure notices to include the required elements; and
• Update policies and train staff on policy updates.
2. Privacy of Reproductive Health Care.
On April 22, 2024, OCR issued a final rule aimed at strengthening HIPAA protections for patients receiving lawful reproductive health care. The rule became effective on June 25, 2024, and covered entities (and business associates) are required to be in compliance with the rule by December 23, 2024, with the exception of the notice of privacy practices requirements, which must be implemented by February 16, 2026. The new rule:
• Prohibits the use or disclosure of protected health information (PHI) when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities;
• Requires covered entities (and business associates) to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes; and
• Requires covered entities (and business associates) to modify their notice of privacy practices to support reproductive health care privacy.
The full language of the rule may be found HERE, and the HHS Fact Sheet may be found HERE. Prior to the compliance deadline, covered entities (and business associates) need to take the following actions:
• Update the notice of privacy practices to include the required elements; and
• Update policies and train staff on policy updates.
3. Protections against Discrimination in Health Care.
On April 26, 2024, OCR issued a final rule under Section 1557 of the Affordable Care Act (ACA) strengthening protections against discrimination in health care and broadening its application to all providers, insurers and HHS-administered programs. The new rule became effective on July 5, 2024, and various parts of the rule must be implemented pursuant to the schedule set forth below:
• A Section 1557 Coordinator must be appointed by November 2, 2024;
• Notices of nondiscrimination to patients must be updated by November 2, 2024;
• A procedure to ensure nondiscrimination in health programs or activities through the use of patient care decisions tools must be implemented by May 1, 2025;
• Written policies and procedures relating to nondiscrimination, grievances, language access, effective communication and reasonable access must be written and adopted by July 5, 2025;
• Training relating to the new policies and procedures must be conducted within 30 days of adoption but no later than July 5, 2025; and
• Notices of availability for language assistance services and auxiliary aids and services must be updated by July 5, 2025.
All policies, procedures and notices must recognize an enhancement of what constitutes protected classes, including race, color, national origin (including limited English proficiency), sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), age, or disability. At the same time, the rule prohibits any application of the rule that violates federal protections for religious freedom and conscious.
The full language of the rule may be found HERE, and the HHS Fact Sheet may be found HERE.
4. Protections against Disability Discrimination.
On May 1, 2024, OCR issued a final rule strengthening protections against disability discrimination and advancing equity for people with disabilities under Section 504 of the Rehabilitation Act. This rule was adopted in furtherance of Executive Order 14091 relating to advancing racial equity and supporting underserved communities. The rule became effective on July 8, 2024. The rule:
• Prohibits discrimination on the basis of disability in medical treatment, including the allocation or withdrawal of any good, benefit, or service, or taking or withholding care based on bias, stereotypes or judgment or belief that a disabled person will be a burden or has lesser value than a person without a disability, unless the person’s disability impacts or effects such treatment;
• Prohibits the use of any measure, assessment, or tool that discounts the value of life extension on the basis of a person’s disability;
• Prohibits discrimination based on disability under any child welfare program or activity that receives federal financial assistance and requires that individual assessments be made on the basis of objective evidence or research and fully accessible to persons with disabilities;
• Requires delivery of web content, mobile applications, and kiosks to be readily accessible to and usable by individuals with disabilities and compliant with the technical criteria and requirements as provided in the Web Content Accessibility Guidelines (WCAG) 2.1 (employers with 15 or more employees must comply by May 11, 2026, and employers with less than 15 employees must comply by May 10, 2027);
• Requires that (i) facilities provide accessible medical diagnostic equipment (MDE) to people with disabilities, (ii) that at least 10% of newly purchased, leased, or otherwise acquired MDE meet the US Access Board’s Standards for Accessible MDE, (iii) that facilities that specialize in treating conditions that affect mobility must ensure that at least 20% of equipment complies with the standards, and (iv) that facilities acquire at least one examination table and one weight scale that meets the standards by July 8, 2026, if applicable; and
• Requires a facility to administer a program or activity in the most integrated setting appropriate to the needs of a qualified person with a disability, such as providing a setting to individuals with disabilities to fully interact with non-disabled persons.
The full language of the rule may be found HERE, and the HHS Fact Sheet may be found HERE.
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This summary does not provide an exhaustive and comprehensive analysis of all of the updates provided in these final rules, nor does it constitute legal advice or establish an attorney-client relationship. If you would like assistance complying with the final rule, please reach out to attorneys Joseph Miller or Tricia Hoffman-Simanek.
We would like to thank associate attorneys Cary Parle and Allison Richter, and summer associate Laney Miller, for their assistance in preparing this summary.