Overview
- HHS posted a Request for Information to the Federal Register on Aug. 24 that asks whether the current three categories—routine, risk-based, and shared clinical decision-making—should be revised or expanded and sets a public comment deadline of Sept. 20.
- The RFI offers possible new labels such as “recommended, but not during infancy,” “recommended with qualification,” and “shared clinical decision-making with qualification,” but it does not assign specific vaccines to those labels or define how they would work.
- HHS notes that a shared clinical decision-making designation, once adopted by the CDC director, triggers the same coverage requirements as a routine recommendation under the Affordable Care Act and the Vaccines for Children program, while the proposed new categories carry no explicit coverage guarantee.
- The document asks for input on evidence standards, how to weigh individual versus population benefits, and a presumption favoring individual autonomy and religious freedom, and it flags clinician confusion about the SCDM category based on prior surveys.
- The RFI follows President Trump’s Aug. 10 executive order and a January overhaul of childhood recommendations that a federal judge blocked in March, major medical societies say they will comment, and it remains unclear how HHS will use public input or how courts will affect any policy changes.