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Plan for Retrospective Review of Existing Rules

In Executive Order 13563, the President recognized the importance of a streamlined, effective, efficient regulatory framework to achieve economic growth, investment flows, job-creation, and competition. While HHS’s systematic review of regulations will focus on the elimination of rules that are no longer justified or necessary, the review will also consider strengthening, complementing, or modernizing rules where necessary or appropriate—including, if relevant, undertaking new rulemaking.

The following Outline of the HHS Plan for Retrospective Review of Existing Rules provides links to each complete section of the Plan.  These links - underlined in blue - will take you to individual sections of the Plan. 

Download the Plan for Retrospective Review of Existing Rules (PDF)

Download the Preliminary Plan (PDF)

  1. Statement of Commitment to a Culture of Ongoing Retrospective Review
    The Department of Health and Human Services (HHS) is the principal federal agency charged with providing health and other essential human services so Americans can live healthier, more prosperous, and more productive lives. Many of its activities are regulatory in nature.
  2. Scope of Plan
    All HHS Operating and Staff Divisions (Agencies) that establish, administer, and/or enforce regulations are included in this plan.
  3. Undertaking the Initial Retrospective Review    
    HHS will ask each agency to inventory its existing, significant regulations, use existing information on what agencies should review, set priorities, integrate regulatory analysis into the retrospective review process, and evaluate regulatory effectiveness.
  4. Existing Retrospective Review Requirements
    HHS agencies currently conduct routine reviews of existing regulations pursuant to a variety of authorities or circumstances.
  5. Initial list of Significant Rules that Are Candidates for Retrospective Review Pursuant to Executive Order 13563 Over the Next Two Years
    A preliminary list of regulations the agencies within the Department have identified as candidates for review pursuant to Executive Order 13563 over the next two years.
  6. Some Highlights of the Initial List of Significant Rules that Are Candidates for Retrospective Review and Other Activities in Response to E.O. 13563
    The following information provides a summary of some of the major initiatives the Department is undertaking in response to the President’s Executive Order 13563.
    1. HHS Department-wide Initiatives
      1. Updating regulations in recognition of changing technology
        The FDA Bar Code Rule, Increase Use of Electronic Reports and Submissions, Use of Telemedicine to Increase Access
      2. Review reporting and recordkeeping requirements to reduce burdens
        Streamlining and standardizing data collection for federal HIV programs; Revisions to Health Insurance Portability and Accountability Act; Reduce ACF Reporting Requirements; Eliminate Requirement for Actuarial Reporting for Hospital Pension Costs

B.  Cross-cutting efforts within HHS

      1. Improving Pre-Market Review for Medical Devices
        In a non rule-making initiative, FDA and CMS intend to pilot a voluntary process for the parallel review of medical devices for marketing (FDA) and national coverage determinations (CMS) that will reduce the total combined time it takes for a medical device to be authorized for sale in the marketplace and then for reimbursement under Medicare.
      2. ACF-SAMSHA efforts to increase flexibility and reduce burdens on states
        Both ACF and SAMHSA are committed to reducing the administrative burdens on states and their grantees and increasing flexibility in their programs.
      3. Regulations designed to enhance research
        In continuing efforts by the Department to harmonize regulations that apply in the research context, OCR proposed modifications to the HIPAA Privacy Rule to streamline the research authorization requirements to better align with the requirements for informed consent under the Common Rule.

C.  Agency-specific Initiatives

      1. Regulation of Medical Devices
        Supplementing its non-regulatory activities with respect to medical devices, FDA is also taking steps to reduce the burdens imposed by its medical device regulations.
      2. Good Manufacturing Practices and Labeling for Drugs and Food
        In another initiative, FDA is reviewing its current Good Manufacturing Practices (CGMP) regulations, both for foods and drugs.
      3. Review of Health Professional Shortage Designations
        The Affordable Care Act requires the Secretary to establish a comprehensive methodology and criteria for designating Medically Underserved and Health Professional Shortage Areas through a negotiated rulemaking process.
      4. Conditions of Participation for Hospitals
        In a major initiative, CMS intends to conduct a major retrospective review of the conditions of participation it imposes on hospitals to remove or revise obsolete, unnecessary, or burdensome provisions.
      5. Medicare and Medicaid Alignment Initiative
        CMS has also initiated an Alignment Initiative to identify and address conflicting requirements between Medicaid and Medicare that potentially create barriers to high quality, seamless, and cost-effective care for dual eligible beneficiaries.
      6. Streamline Beneficiary Notice Requirements
        Closely related to the Alignment Initiative, CMS intends to review its operations manuals and other documents to coordinate and streamline as many of the Medicare and Medicaid beneficiary notice requirements as possible.
      7. Review of Quality Reporting Requirements
        Moving forward with implementation of retrospective review activities, CMS will also review current and future quality measure reporting requirements to determine whether any measures might be eliminated or revised because they are outdated or redundant and whether standardization of measures might facilitate both the reporting on quality measures and the analysis of those reports.
      8. Review Process for Disallowance of State Federal Funds Participation
        Another review CMS will undertake may result in a new rule to implement a new reconsideration process for states when CMS disallows federal funds participation and could lengthen the time states have to credit the federal government for uncollected overpayments, revise repayment installment standards, and clarify certain interest charges for states.
      9. Promoting Efficiency, Transparency, and Burden Reduction
        CMS will propose reforms in Medicare and Medicaid regulations to increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or divert activities away from providing high quality patient care.
      10. Reducing Obstacles to Access
        As it does every year, CMS will review its payment rules for hospitals, physicians, nursing homes, and other health care providers and determine whether there are any regulatory requirements that may be eliminated without sacrificing patient care or safety.
  1. HHS Goals for Ongoing Retrospective Review
    1. Streamline or eliminate unjustified costs and burdens
      The overarching goal of ongoing retrospective review is to streamline regulations the Department promulgates and to eliminate unnecessary, costly, or burdensome regulations wherever possible.
    2. Increasing Transparency
      Ongoing retrospective regulatory review efforts will be more effective if they are accompanied by efforts to make more information available to all interested parties, introduce clarity into the regulatory system, and provide the foundation for regulatory decisions.
    3. Increasing Public Participation in the Ongoing Review of Regulations:
      HHS intends to increase the breadth and quality of public participation in its rulemaking and retrospective review activities.
    4. Setting Priorities
      The President has repeatedly stated his goal of achieving a regulatory system that is balanced, flexible, and maintains freedom of choice.
    5. Strengthening Regulatory Analysis
      Agencies already use analytic tools such as cost-benefit or cost-effectiveness analysis, as appropriate, in setting priorities.
  1. Person Responsible for Implementing this Plan
    Dawn Smalls, Executive Secretary
  2. Initial List of Candidates for Review (Listed in Section 5)
    1. Initial list of significant rules that are candidates for retrospective review pursuant to Executive Order 13563 over the next two years
    2. Summary of Comments
    3. Public Comments on HHS Preliminary Plan for Retrospective Review of Existing Rules
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