RISE summarizes recent regulatory news.

CDC plans to revamp structure, become more responsive during health emergencies

The Centers for Disease Control and Prevention (CDC) will go through a reorganization to better respond to public health emergencies in the wake of criticism of how the agency’s responded to COVID-19 and the recent monkeypox outbreak.

CDC Director Rochelle Walensky M.D., MPH, met with senior staff this week and laid out her plans to overhaul how the agency works so it can respond faster to a public health crisis and simplify and streamline public health guidance, CNN reports.

"My goal is a new, public health action-oriented culture at CDC that emphasizes accountability, collaboration, communication, and timeliness.  I look forward to working with the incredible people at CDC and our partners to realize the agency's fullest potential to benefit the health and well-being of all Americans," Walensky said in a statement to CNN.

HHS Deputy Secretary Mary Wakefield will oversee the reorganization, according to the media outlet. Other key changes include:

  • The Division of Laboratory Science and the Office of Sciences will report directly to Walensky
  • The establishment of a new office of intergovernmental affairs where state health departments and federal agencies can interact with the CDC
  • The creation of an equity office to increase diversity in CDC staff
  • The establishment of an executive council to help Walensky determine agency priorities, track its progress, and weigh in on budget decisions

FDA finalizes rule to improve access to over-the-counter hearing aids

The U.S. Food and Drug Administration this week issued a final rule to improve access to hearing aids by creating s a new category of over-the-counter (OTC) hearing aids. The action will allow millions of Americans with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. 

The rule is expected to lower the cost of hearings aids and is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace, the FDA said in an announcement.

The announcement follows President Biden's Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action. Consumers could see OTC hearing ais in retail and drug stories by mid-October.

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices. 

NCQA releases 2023 HEDIS® update

NCQA has published its update to the Healthcare Effectiveness Data and Information Set for 2023. Among the changes for next year, HEDIS has added five new measures and retired five measures.

The newest additions address pediatric dental care, safety and appropriateness, diabetic care and social needs screenings and interventions. Retired measures include the annual dental visit, frequency of selected procedures, flu vaccinations for adults ages 18-64 and those ages 65 and older, and pneumococcal vaccination status for older adults.

For the complete list of changes, including cross-cutting topics and electronic clinical data systems (ECDS) reporting, click here.