On May 26, 2011, the Department of Health and Human Services (HHS) released its Preliminary Plan for Retrospective Review of Existing Rules (the Plan) as required by Executive Order 13563, "Improving Regulation and Regulatory Review."1 In order to identify potentially inefficient and ineffective regulations, the Executive Order requires federal agencies to submit a preliminary plan describing how each agency will perform retrospective reviews of the significant regulations it administers. Specifically, the agency plan must contain a process for determining which regulations should be "modified, streamlined, expanded, or repealed" to decrease unnecessary regulatory burdens. For HHS, the Plan contains a preliminary list of the regulations HHS intends to review over the next two years and describes the process by which it will perform retrospective analysis on significant final regulations, pending proposed regulations, and interim final regulations. HHS seeks public comment on the contents of its plan, which must be submitted by June 30, 2011.
The Plan describes a number of HHS-wide initiatives designed to eliminate inefficiencies in its regulations, such as updating rules to reflect technological changes in the health industry, analysis reporting, and recordkeeping requirements. For example, the Centers for Medicare and Medicaid Services (CMS) intends to allow a hospital to accept the credentials of a practitioner providing telemedicine services from another participating hospital instead of having to certify the practitioner itself. The Plan also describes a suggestion by CMS included in its proposed Inpatient Hospital Prospective Payment System rule to eliminate the need for hospitals to use actuarial determinations in reporting pension costs to CMS.
The Plan also includes descriptions of "cross-cutting" initiatives within HHS that involve coordination between different agencies to reduce regulatory burdens. For example, CMS and the Food and Drug Administration (FDA) plan to offer a voluntary "parallel review process" of medical devices in which FDA marketing review and CMS national coverage determinations of the device occur at the same time.2 The Plan also includes a description of efforts by the Office for Civil Rights to align the research authorization requirements of the Health Insurance Portability and Accountability Act (HIPAA) with the informed consent requirements of the Common Rule for Protection of Human Subjects, which establishes conventions for human subject research performed or funded by the federal government.
The Plan further explains a number of agency-specific initiatives, including many proposed by CMS, designed to eliminate inefficient regulations. Most significantly, CMS intends to review all of the requirements and conditions it places on hospitals to participate in the Medicare and Medicaid programs. Additionally, CMS will address contradictory requirements of these programs as part of its "Alignment Initiative." In particular, CMS intends to improve access to both programs for dually-eligible beneficiaries, coordinate beneficiary notice requirements, reduce conflicting regulations, and eliminate cost-shifting between the programs. In order to reduce paperwork for healthcare providers, CMS has also issued a proposed rule that eliminates the requirement that the doctor who certifies a patient's continuing need for hospice services be the same doctor who authorized hospice services initially. Additionally, CMS no longer requires practitioner signatures on lab-test requisition forms.
The appendix to the Plan lists a number of other current regulations identified as potential candidates for retrospective review. For example, CMS will change the Home and Community Based Services Waiver regulations to permit states to more easily consolidate waiver programs, and with the Treasury Department, has issued a proposed rule allowing state waivers from certain Affordable Care Act requirements. CMS also intends to reduce documentation and supervisory requirements through the following rules: the Inpatient Rehabilitation Facility Prospective Payment System (PPS) Proposed Rule, the Ambulatory Surgical Centers Conditions for Coverage: Same-Day Services Final Rule, Outpatient PPS Proposed Rule, and the Physician Fee Proposed Rule. Finally, CMS also clarified and reduced the requirements of the Inpatient Rehabilitation Facility PPS in a proposed rule.
In the more general provisions of the Plan, HHS has established a process for performing retrospective reviews of existing regulations and has announced a number of goals it hopes to achieve through the implementation of the Plan. HHS agencies will first have to "take inventory" of their existing significant regulations and then use feedback from the public to help determine which regulations are in most need of review and to establish their own priorities and criteria for deciding which regulations to review. The agencies are then tasked with performing a comprehensive regulatory analysis in order to determine the effectiveness of the regulations and identify less burdensome alternatives to those regulations. Throughout the retrospective regulatory review process, HHS's goals are to increase transparency by making proposed regulations more searchable and accessible online, to improve the analysis of regulations, and to increase public participation through the formation of a Public Participation Task Force and by soliciting comments on the plan.
Footnotes
1 HHS, Preliminary Plan for Retrospective Review of Existing Rules (May 2011) (available at www.hhs.gov/open/recordsandreports/execorders/13563/draft/prelim_ret_revplan05232011.pdf); Exec. Order No. 13563, 76 Fed. Reg. 3821 (Jan. 21, 2011).
2 It is worth noting that FDA and CMS jointly issued a notice about the parallel review process in September of 2010, 75 Fed. Reg. 57045 (Sept. 17, 2010), months before the release of Executive Order 13563.
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