Year in Review 2024

April 04, 2024

Key Healthcare Regulatory Updates From 2023 and What to Expect in 2024

In the healthcare and environmental landscapes, regulations are constantly changing—and 2023 was no exception. From health and safety to waste management, it is important to keep your organization up-to-date on the most recent regulatory changes to help ensure you and your employees comply with the latest requirements.

Below are some key updates from last year and a look ahead at what may be expected in 2024.

Federal Regulatory Updates

In 2023, three U.S. Environmental Protection Agency (EPA) regulations were adopted by more states, and the U.S. Drug Enforcement Administration (DEA) issued a proposed rule focused on controlled substance destruction.

  • Hazardous Waste Generator Improvements Rule: The Hazardous Waste Generator Improvements Rule took effect in May 30, 2017, and aimed to strengthen requirements, increase flexibility, and improve environmental protection as related to the management of hazardous waste. Washington, D.C., was the latest adoptee of the rule in 2023. The total number of state adoptees is now 39 states plus Washington, D.C., and Puerto Rico. This rule is in reference to the generation of chemical waste that is regulated as hazardous waste, not regulated medical waste (RMW). States with authorized programs must adopt regulations that are equally as stringent as, or more stringent than, the federal regulations.
  • Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine: This rule became effective on August 21, 2019. The EPA gave states until July 2021 or 2022 to adopt the Hazardous Waste Pharmaceutical Rule, which includes a mandate that no hazardous waste pharmaceuticals, including controlled substances, can be disposed of into a sewer system. The EPA did not give a timeline for the Nicotine Exclusion rule because it is less stringent than current regulation and thus does not have to be adopted by the States. In 2023, Washington, D.C. adopted both rules.
  • Universal Waste - Aerosol Cans: Effective February of 2020, the EPA added aerosol cans to the universal waste program under the federal Resource Conservation and Recovery Act (RCRA) regulations, seeking to reduce regulatory burdens on stores and other businesses that discard hazardous waste aerosol cans, while promoting their collection and recycling. In 2023, New York became the latest state to adopt this rule.
  • Controlled Substance Destruction Alternatives to Incineration: The U.S. Drug Enforcement Administration (DEA) published an advance notice of proposed rulemaking in October 2023. The proposed rulemaking seeks industry input related to alternatives to incineration as methods for rendering controlled substances non-retrievable.  

State Regulatory Updates

Stericycle saw activity in the following states as further described below:

  • Alabama: In August 2022, the Alabama Department of Environmental Management (ADEM) proposed amendments to its Medical Waste Program rules related to requirements for storage, transportation, treatment, and disposal of medical waste. Comments were due in October 2022 and again in April 2023, but a final rule is not yet published.
  • Florida: In June 2023, Florida published draft rules updating its current biomedical waste program. The draft does not contain major impacts for generators at this time, however, we encourage interested parties to keep an eye on the Florida rulemaking page for updates.
  • New York: Updates to New York’s medical waste rule were finalized in July 2023 and include eliminating the 60-day regulated medical waste (RMW) time limit for small quantity generator storage areas. New York also revised storage limits for RMW and sharps containers in patient care areas.
  • Ohio: Ohio began the stakeholder engagement process for potential changes to its medical waste/infectious waste rule. Ohio EPA is looking to move these rules into its own chapter to make them easier to find and more user friendly. In addition, Ohio is looking at storage timelines for both generators of waste and those who treat and dispose of the waste. Regulators have not indicated what the timelines are, but they indicated that they are trying to prevent long-term storage and or illegal disposal of infectious waste. The comment period ended in October 2023, however more opportunities to comment on the rule will come up as they develop a draft, which we should see sometime in March 2024.
  • Texas: Texas opened and reviewed its RMW rules earlier in 2023 but did not make any changes. Current medical waste rules were readopted without change.

OSHA Updates

The Occupational Safety and Health Administration (OSHA) made key changes in 2023 that help workplaces improve safety, reduce violence, and report incidents.

Federal Updates:

  • Electronic Submission of Injury and Illness Records (29 CFR 1904.41): This regulation aims to enable OSHA to focus its enforcement and compliance assistance efforts on individual workplaces with ongoing serious safety and health problems.
  • What is changing? The regulation updated the standard to include a new requirement for establishments with 100 or more employees in certain designated high-hazard industries to electronically submit to OSHA their injury and illness information from forms 300 and 301, in addition to 300A, once a year. These high-hazard industries are listed in the newly created Appendix B to Subpart E of Part 1904. Additionally, all establishments must include their legal company name, not just their Employer Identification Number (EIN), when making electronic submissions to OSHA from their injury and illness records.
  • When does it go into effect? The updates went into effect on January 1, 2024.
  • The Hazard Communication Standard (HCS): The HCS was finalized in 1983 and applied to the manufacturing sector. In January 1989, expanded coverage became effective for all industries where employees are exposed to hazardous chemicals. It provides a standardized approach to workplace hazard communications associated with exposure to hazardous chemicals.
  • What is changing? The proposed updates to HCS will increase worker protection and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on labels and safety data sheets (SDS) for hazardous chemicals.
  • When does it go into effect? The proposed updates were expected by mid-January 2024; however, OSHA has not yet released a final rule.
  • Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings: OSHA concluded the Small Business Regulatory Enforcement Fairness Act (SBREFA) process on November 3, 2023. This step in the rulemaking process included the convening of a Small Business Advocacy Review (SBAR) panel to gain input from small entity representatives (SERs) on the potential impacts of a heat-specific standard. The stated goal is to create regulations and establish a standard for heat injury and illness prevention in outdoor and indoor work settings.
  • Prevention of Workplace Violence in Healthcare and Social Assistance: In March 2023, OSHA took a major step toward developing its anticipated standard regarding violence in the healthcare setting. The Small Business Advocacy Review (SBAR) panel that OSHA convened is considering workplace violence hazard assessments and control measures, preventative training, violent incident investigations and recordkeeping, and more.

State Updates:

  • Senate Bill (SB) 553: Preventing Workplace Violence: In September 2023, the California Governor signed into law a bill that aims to prevent workplace violence. The bill requires employers not already following Cal OSHA’s Safety Order 8 CCR 3342 to adopt comprehensive workplace violence prevention plans and meet additional requirements of the new law.
  • What is changing? This bill requires employers to develop their own plans to address and prevent workplace violence. This includes requiring employers to maintain a log of violent incidents and post-incident investigations, laying out procedures for responding to violent emergencies, requiring employers to communicate to employees how to report incidents, and more.
  • When does it go into effect? The new state law goes into effect on July 1, 2024.

HIPAA Updates

Health Insurance Portability and Accountability Act (HIPAA) is essential for patient health privacy, security of electronic records and insurance portability. Last year saw some changes that are relevant to the healthcare industry:

  • HIPAA: HIPAA Privacy Rule updates that are expected to be finalized by the end of 2024 include:
  • COVID-19 Enforcement Discretion: The Public Health Emergency and certain HIPAA enforcement discretions issued during the COVID-19 emergency expired in May 2023.
  •  405(d) Cybersecurity Practices: The 2023 edition of Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients outlines the top threats facing the healthcare and public health (HPH) Sector. It provides organizations of all sizes with the resources and best practices needed to fight against cybersecurity threats, which can put patients’ private information at risk.
  • The Cures Act: Effective December 31, 2023, electronic health information (EHI) exports must be done in compliance with required application interface technology (APIs).  Not complying could be seen as information blocking unless an organization has one or more documented exceptions.  Information blocking has not been enforced to date; however, the department of health and human services (HHS) along with the centers for Medicare and Medicaid services (CMS), issued a final rule on June 27, 2023, to establish statutory penalties for committing information blocking.  On November 1, 2023, HHS published a proposed rule that would establish disincentives for information blocking.  

What to Expect in 2024

What you and your organization should look out for in 2024:

  • State adoption of EPA rules: Keep an eye out for additional states to adopt the EPA rules discussed above.
  • State RMW regulation updates: Over the course of this year, states may update or change existing rules. To stay updated, check your state’s registers and/or relevant agency websites.
  • Potential updates to HIPAA Privacy Rule: HIPAA Privacy Rules are subject to change to account for new situations and resources, so keep an eye out for potential updates.

With the regulatory landscape always evolving, healthcare facilities need to be prepared. Learn how Stericycle can help with your compliance efforts in 2024.

 

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