On June 12, 2020, the Department of Health and Human Services’ (HHS’) Office for Civil Rights (OCR) published a prepublication version of a final rule on nondiscrimination in health programs and activities under Section 1557 of the Affordable Care Act (ACA). Section 1557 serves protected classes of individuals whose health coverage may not be denied, canceled, limited or refused on the basis of race, color, national origin, sex, age, or disability. Originally proposed in May 2019, this new final rule replaces the original final rule from 2016 and repeals or revises key provisions of that 2016 rule. The rule is effective Aug. 18, 2020, though legal challenges, particularly regarding gender identity and discrimination “on the basis of sex” following recent high court decisions, are expected that could impact when the rule takes effect.

Key provisions and updates from the 2016 rule include:

Repeal of prior regulation’s definition of discrimination on the “basis of sex”: The final rule repeals the 2016 rule’s expanded definition of “basis of sex” that included pregnancy termination, sex stereotyping, and gender identity. The new final rule continues to prohibit discrimination on the “basis of sex,” but under the prior interpretation of the word “sex” (i.e., as defined by gender assignment at birth). The final rule also amends regulations issued by the Centers for Medicare & Medicaid Services to ensure nondiscrimination on the “basis of sex” is consistently applied.

As it relates to how health benefits coverage may have been changed to comply with the 2016 rule, HHS clarifies that “nothing in this final rule prohibits a healthcare provider from offering or performing sex-reassignment treatments and surgeries, or an insurer from covering such treatments and procedures, either as a general matter or on a case-by-case basis.”

Narrowed scope of application: The final rule narrows the scope of application of Section 1557 so it only applies to health programs or activities, any part of which receives federal financial assistance, and any program or activity under Title I of the ACA (i.e., Exchanges) or entities established under that Title. In comparison, the 2016 final rule interpreted the regulation as applying to all operations of the covered entity, even if it is not “principally engaged” in health care.

This means that under the new rule, Section 1557 will generally not apply to self-funded group health plans under ERISA or short-term limited duration plans because the entities offering them are typically not principally engaged in the business of providing health care, nor do they receive federal financial assistance.

Removal of notice and tagline requirements: The final rule eliminates the notice and tagline provision that required covered entities to distribute nondiscrimination notices and taglines in at least fifteen languages with all “significant communications” to patients and customers.

Addition of a “four-factor analysis” for providing limited-English proficiency (LEP) individuals meaningful access: To ensure covered entities offer meaningful access for individuals with LEP, the final rule establishes a new four-factor analysis. The four factors include: 1) the number or proportion of LEP individuals eligible to be served, or likely to be encountered, in the eligible service population; 2) the frequency with which LEP individuals come in contact with the entity’s health program, activity, or service; 3) the nature and importance of the entity’s health program, activity, or service; and 4) the resources available to the entity and costs.

For more details on the final rule, review the information at these links:

Read the final rule [PDF]
Read the HHS fact sheet [PDF]

On Oct. 24, 2018 the SUPPORT for Patients and Communities Act (SUPPORT Act) was signed into law. This comprehensive legislation addresses the U.S. opioid crisis and takes steps to augment and enhance the nationwide system for preventing and treating opioid addiction. The SUPPORT Act enjoyed tremendous bipartisan support, with a vote of 393-8 in the House and 98-1 in the Senate.

The SUPPORT Act makes changes to a variety of public health and law enforcement policies. Here’s an overview of some of the health care-related policy changes included in the law.

• Medicaid Institutions for Mental Diseases (IMD) Exclusion: Amends the IMD exclusion to allow state Medicaid programs to receive federal reimbursement for covering certain IMD services up to a total of 30 days annually.
• Telehealth: Expands coverage of telehealth services under Medicare for the treatment of substance use disorders and co-occurring mental health disorders beginning July 1, 2019. Also directs the Secretary of Health and Human Services (HHS) to issue guidance regarding federal reimbursement for telehealth services and treatment for substance use disorders under Medicaid.
• Medicare and Medicare Advantage: 
  • Requires e-prescribing for coverage of Part D controlled substances starting in 2021.
  • Requires HHS to establish prior authorization standards for electronic submissions starting in 2021.
  • Requires physicians to screen for opioid use disorders during initial Medicare physical and annual wellness visits.
  • Expands Medicare coverage and bundled payment for opioid addiction treatments.
  • Requires drug management programs for at-risk beneficiaries be implemented by 2022 (currently voluntary).
• Addiction Treatment: Lifts restrictions on maintenance medications used to treat opioid addiction, allowing more types of health care providers to prescribe the drugs.
• Opioid Alternatives: Provides funding for research and development of non-addictive painkillers and allows the Food and Drug Administration to require that certain opioids be dispensed in packaging that encourages safe use (e.g., small blister packs).
• Prescription Drug Monitoring Programs (PDMPs): Gives authority to the HHS Secretary to issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information for PDMPs. It also gives States the ability to share PDMP data with Medicaid managed care entities under certain parameters. 
• Grant Funding: Includes new and reauthorized grant funding for a number of initiatives to address the crisis, including funding for Comprehensive Opioid Recovery Centers and reauthorizing funding from the 21st Century Cures Act to provide $500 million annually, in fiscal years 2019-2021, for State Opioid Response Grants. The following may also be of interest to employers and other community stakeholders:
  • Career Act: Helps treatment or recovery services that partner with local employers, community organizations, and/or workforce development boards to support recovery, independent living, and participation in the workforce.
  • Addressing Economic Impacts Pilot Program: Supports local workforce boards in areas with a high rate of substance use disorders to engage and assist employers in establishing job-training/transition services for those in recovery.
  • Peer Support Communities: Supports recovery community organizations to develop, expand, and enhance services including fostering connections between such organizations and employers, behavioral care providers, primary care providers, schools, housing services, and child welfare agencies.

Medical record privacy rules update
Notably, after bipartisan negotiations between both chambers of Congress, a key provision aimed at changing medical record privacy rules did not make it into the final law. Under existing federal regulations (42 CFR Part 2), health care providers operating a Part 2 covered program are prohibited from disclosing a patient’s history with a substance use disorder unless they have the patient’s consent. The House’s opioid bill included a provision to align 42 CFR with existing Health Insurance Portability and Accountability Act (HIPAA) privacy requirements, but it is not included in the SUPPORT Act.