LUGPA Policy Update: HHS Restricts Public Comment on Health Regulations

March 5, 2025 

The Department of Health and Human Services (HHS) has announced a significant policy change that restricts public input on certain regulatory actions. In a statement published in the Federal Register on March 3, HHS Secretary Robert F. Kennedy Jr. rescinded the long-standing Richardson Waiver, which had previously extended public comment requirements beyond legal mandates. Under the new policy, HHS agencies will no longer be required to solicit public input on regulations concerning agency management, public property, loans, grants, benefits, or contracts unless explicitly mandated by law.

The APA generally mandates notice-and-comment rulemaking for issuing regulations, with exceptions for matters related to agency management, public property, loans, grants, or contracts, or when public notice is impractical or contrary to the public interest. Since 1971, HHS has adhered to the Richardson Waiver, which extended public comment to exempted matters.  Critics argue that eliminating these established comment periods could reduce transparency and stakeholder engagement in federal health policy decisions. 

Despite the removal of the Richardson Waiver, the Centers for Medicare & Medicaid Services (CMS) must still adhere to other statutory notice-and-comment requirements, such as § 1871 of the Social Security Act, which mandates rulemaking for policies affecting Medicare benefits, payment, or eligibility. Notably, this does not apply to Medicaid, potentially affecting that program. Other HHS agencies, such as the FDA, NIH, HRSA, and SAMHSA, may also be affected, although the precise implications remain uncertain.

Concerns Over Transparency and Stakeholder Engagement

While the specific policies and programs affected by this requirement remain unclear, public comment periods are a vital part of the rulemaking process. They allow healthcare providers, industry stakeholders, and patient advocacy groups to offer feedback on proposed regulations, helping to refine rules, prevent unintended consequences, and ensure effective policymaking.

The potential elimination of these comment periods has raised concerns among healthcare organizations and policy experts, who warn it could lead to weaker, error-prone regulations. Critics argue that bypassing stakeholder input may negatively impact Medicaid, Medicare, reimbursement models, patient safety, and provider operations.

Removing public comment opportunities could also result in flawed regulations and insufficient preparation time for providers and patients. Many have called the move troubling, citing risks to payment systems, safety standards, and regulatory compliance.

LUGPA's Position

LUGPA is closely monitoring this policy change and evaluating its potential implications for independent physician practices. Public comment periods are an essential mechanism to ensure that regulatory decisions accurately reflect the realities of medical practice and patient care. The elimination of these opportunities for input could result in unintended consequences that adversely affect urologists and the broader healthcare community.

LUGPA remains committed to advocating for transparency, stakeholder engagement, and equitable regulatory processes. We will continue our efforts to ensure that the voices of physicians are heard in the policymaking process and that regulations foster high-quality, patient-centered care.

We are actively monitoring this issue and maintaining ongoing communication with legislators and regulators through all available channels. We will continue to advocate for the preservation of public comment periods in the rulemaking process.