HHS Semiannual Regulatory Agenda for FY 2011
The Obama Administration has published its semiannual regulatory agenda outlining planned regulatory initiatives, including a number of major health policy rules. Specifically, the Administration identifies as key Department of Health and Human Services (HHS) priorities regulations addressing, among many other things: implementation of a variety of Affordable Care Act (ACA) insurance reform provisions (including rate review, uniform explanation of benefits, and appeal and external review process rules); notification requirements for long-term care facility closures; implementation of the ACA’s Community Living Assistance Services and Supports (CLASS) program; establishment of civil money penalties (CMPs) for noncompliant nursing homes; establishment of the ACA’s shared savings program for accountable care organizations (ACOs); revisions to HIPAA privacy and security enforcement regulations to comply with the provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH) Act; Food and Drug Administration (FDA) rules to standardize the electronic submission of registrations and listings for devices, data from studies evaluating drugs and biologics for humans, and data on adverse events involving medical devices; an FDA rule establishing a unique identification system for medical devices; a proposed rule addressing the Office of Inspector General’s (OIG’s) authority to impose CMPs and assessments; and annual updates to various Medicare payment systems.
