On December 28, 2007, the Department of Health and Human Services ("HHS") issued a proposed rule that, when finalized, will substantially increase the Secretary of Health and Human Services' role in the administrative review process for appeals involving the Departmental Appeals Board ("DAB"). The DAB is the body responsible for hearing a variety of issues, including grant disputes, review of certain ALJ decisions, the imposition of civil monetary penalties and exclusions under various fraud and abuse authorities, provider and supplier participation issues, enrollment and enforcement cases brought by the Centers for Medicare & Medicaid Services ("CMS"), Medicare coverage, payment, and entitlement issues, and enforcement remedies imposed on clinical laboratories under CLIA and Medicare rules. The proposed rule contains two general changes to the current appeals and review process: First, under the proposed rule, the DAB and its ALJs will be required to follow the Secretary's published guidance (e.g., manual provisions, State Medicaid Directors letters, CMS website postings), as long as the guidance is not inconsistent with applicable statutes and regulations. Currently, there is no requirement that the DAB adhere to mere policy interpretations by the Secretary. This rule will require the DAB to follow any publicly disseminated agency interpretation and vastly expands the impact of the Secretary's informal rulemaking powers. Second, the proposed rule creates an additional level of administrative review over DAB decisions. The rule grants the Secretary authority to review various DAB and ALJ decisions that are currently deemed "final administrative decisions," therefore effectively creating an additional level of review before an agency decision is deemed "final" and subject to judicial review. This additional layer of review makes the DAB review process similar to the current Provider Reimbursement Review Board process, which allows the CMS Administrator final review of PRRB decisions. In the PRRB realm, when the Secretary chooses to review a PRRB decision that is favorable to a provider, the PRRB decision is reversed the vast majority of the time. If the PRRB appeals process is any indication, the proposed rule will simply add an additional hurdle for parties appealing adverse agency findings. HHS stated that any final rule will be effective on a prospective basis; final deicisions issued by the DAB prior to the rule's effective date will not be affected, but any case still under DAB review will be subject to the new rules. The text of the proposed rule is located in the December 28, 2007 Federal Register at 72 Fed. Reg. 73,708. Comments to this proposed rule must be submitted by January 28, 2008.