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Appendix B - Summary of Comments

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HHS posted a request for comment in the Federal Register on April 23, 2011, asking for comment on how it should structure its retrospective review plan and prioritize regulations for retrospective review.  By the close of the comment period on May 12, 2011, HHS had received 21 comments on specific elements and priorities, on HHS’s preliminary plan.  All responses have been forwarded for agency review, but HHS provides the following summary and its response where appropriate in green:

  • Schedule for Ongoing Review

    Commenters offered a number of suggestions for the timeframe for periodic review ranging from every four to 10 years.  One commenter cautioned that HHS should be careful not to schedule the review of existing rules so early as to reduce the ability or incentive for the industry to adapt.  
    RESPONSE:  At this time, HHS is not defining a specific period for periodic review since appropriate periods may differ depending on the regulation.  Instead, HHS will revisit this issue following the reports of the Analytics Team and the Public Participation Task Force and make a determination at that time.

  • Process for Setting Priorities

    Commenters suggested requiring each agency to develop a ten year strategic plan to identify the regulations, policies, and related guidance and procedures that will be reviewed, using the advice and counsel of a panel of topic experts and representatives of principal stakeholders. Commenters also recommended that the retrospective review be undertaken by a team independent of the staff responsible for the rule during the proposal stage. One commenter suggested that agencies should not limit the scope of their retrospective review plans to promulgated rules, recommending that the review also include decisions to deregulate, denials of public petitions for regulation, and significant areas of inaction. Commenters recommended prioritizing rules for which retrospective review would be most valuable and that agencies establish clearly articulated criteria that will assist interested parties anticipate which rules an agency is likely to review. Several commenters suggested specific criteria for setting priorities, including significant regulations that:

    • were related to a significant change in circumstance so that another opportunity is not provided “for interested groups to rehash arguments and facts presented during the initial notice and comment rulemaking process.”
    • imposed significant implementation burdens;
    • implicated the protection of confidential information;
    • were targeted toward the elimination of regulatory duplication or the need to clarify unclear or confusing rules;
    • Were the subject of advances or changes in technology
    • may serve either explicitly, or in practice as pilot programs for more expansive regulation or novel regulatory strategies; or
    • do not add value or enhance accountability.

Commenters recommended that as agencies gain experience with retrospective review and develop best practices over time they should update and improve their retrospective analysis guidelines and share any best practices with other agencies in the federal and state bureaucracies.

Although the request for comment did not specifically solicit comment on the scope of the preliminary plan, several commenters urged the Department to include guidance documents, particularly those that have been issued to provide interpretation of regulations, and an assessment of paperwork burdens as part of the retrospective review.

RESPONSE: All of these comments have been passed on to the Analytics Team for its consideration as it develops its recommendations for setting priorities and increasing the robustness of the Department’s analytic capacity.

  • Public Participation

    Several commenters supported HHS’s goal of using new technologies to increase public participation in its rulemaking, but cautioned that these efforts should not replace the formal public comment requirements of the Administrative Procedures Act.

    Commenters recommended that the agency notify the public when it is considering selecting specific rules for retrospective review and when it initiates the retrospective review process, as well as what action it intends to take as a result of the review. Commenters urged the Department to consult with outside experts when setting review priorities. Other commenters urged greater consultation with stakeholders or established working groups, prior to sending a regulation or guidance document for review to the Office of Management and Budget, and the creation and use of more specialty-tailored listservs.

    Several commenters suggested greater use of town hall meetings and other public forums during the informal rulemaking process; however other commenters cautioned against the use of town hall meetings, noting that town hall meetings that are not purposeful or do not provide adequate advance information are not meaningful. Suggestions also include surveying stakeholders to determine whether the goals of a regulation and/or policy are being met and whether modifications could reduce the administrative and financial burdens of a regulation while still achieving its original objectives. Another commenter suggested establishing an online tool or an email address for the public, to flag existing rules that have become outdated or need to be modified.

    With respect to the time afforded for public comment, one commenter suggested extending the comment period for all rules to 120 days. Other commenters supported a phased comment period, in which the agency could made an initial request for comments on a proposed rule, organize and summarize those comments by topic, and then publish that summary asking for additional comments on the proposal.

    RESPONSE: Some of these comments are already incorporated into the HHS Plan. For example, HHS intends to increase public access for comment and input in its regulatory activities through the single portal web access button currently under development. With respect to comments on the length of comment period, some agencies already provide for a period of 120 days in many cases. Other regulations that respond to statutory requirements cannot provide for that length of comment period without missing the statutory deadline. In particular, Medicare payment rules that must be promulgated every year have limited public comment periods by necessity, since providers must have sufficient time to plan their potential revenue base for the upcoming year. All other comments have been passed on to the Public Participation Task Force for review as it develops its recommendations for increasing public public participation in the review and development of HHS regulations.

  • Analysis of Costs and Benefits

    Several commenters emphasized that HHS already has the tools in place to appropriately analyze costs and benefits, including the issuance of a Request for Information as an initial step to seek input on how a particular statutory requirement can best be implemented; and urged the use of surveys and studies to evaluate the potential impact of regulatory initiatives. One commenter also recommended that accounting mechanisms be built into new regulations as a means of reducing costs and improving the quality of subsequent retrospective reviews. One suggestion for recommendations on how to do so included the guidelines outlined in the European Commission’s Impact Assessment Guidelines.

    One commenter recommended that attention also be paid to the distributional impact of regulations, arguing that in addition to the aggregate costs and aggregate benefits, the distribution of those costs and benefits is relevant to decision-making as well. Commenters also recommended that the full range of distributive impacts should be addressed, rather than focusing exclusively on the impacts to a single community, like small businesses.

    Other commenters urged specific recommendations to reduce burdens; for example, one commenter urged HHS to consider a special category or exemption, like the exemptions afforded small businesses, for research contracts or for institutions of higher education, hospitals and other non-profit organizations that fall under the uniform administrative requirements for grants and agreements.

    RESPONSE: All of these comments have been passed on to the Analytics Team for its consideration as it develops its recommendations for increasing the robustness of the Department’s analytic capacity, particularly with respect to cost-benefit analysis.

  • Coordination with Other Departments

    Commenters strongly supported efforts to consider the combined effects of regulations, and urged greater coordination among federal agencies and the agencies of HHS in their rulemaking. Several commenters offered specific suggestions where greater coordination would be beneficial, including several that are included in the initial list of candidate regulations appended to this plan including: the coordination of reporting metrics, reporting periods, and reporting mechanism across programs.

SPECIFIC SUGGESTIONS FOR CANDIDATE RULES TO REVIEW

In addition to providing responses to the questions posed, a number of commenters also took the opportunity to suggest specific candidate regulations for retrospective review.  These suggestions, in conjunction with the additional public comment the Department received on the Preliminary Plan, have been forwarded to the appropriate agency for consideration in developing revisions to existing regulations or proposed new regulations.  Specific Regulations nominated as candidate regulations for retrospective review, include:

  • Requirements to provide translators for Medicare and Medicaid patients with hearing impairments or limited English proficiency.
  • Integration and coordination of reporting requirements for overlapping incentive programs, such as the Physician Reporting system (PQRS), e-prescribing, and meaningful use of electronic health records.  
    RESPONSE:  CMS will be addressing these suggestions in forthcoming regulations as reflected in the Department’s Regulatory Agenda for the upcoming fiscal year.
  • Streamlining of claims review by multiple contractors including Medicare Parts A and B Recovery Audit Contrators, Medicare Administrative Contractors, Medicaid Integrity Conractors, Comprehensive Error Rate Testing Contractors, and Zone Program Integrity Contractors, which were presented as often redundant.
  • Expedited implementation of ACA’s administrative simplification provisions relating to the standards and operating rules for the electronic exchange of information that are intended to address patient eligibility and financial responsibility; timely acknowledgement, response, and status reporting consistent with a transparent claims and denial management process; and the description of administrative data that inform physicians when a service has been denied and the reason for the denial, efforts that could significantly reduce the administrative complexity of the claims processing cycle.   
    RESPONSE:  CMS is addressing these suggestions in the forthcoming administrative simplification rules.
  • Review of the pre-Authorization requirements for drug and Medicare Advantage plans
  • Review of Emergency Medical Treatment and Labor Act (EMTALA) requirements
  • Review of Medicare documentation requirements
  • Updates to the Medicare Economic Index (MEI)
  • Review of the prohibition on the use of consultation codes in favor of lower valued visit codes
  • Improvements to the Medicare Enrollment Process
  • Improvements on the timeliness of PQRS Feedback Reports to allow physicians to assess their reporting and performance status in time to revise their reporting practices to be a successful participant.
  • Improved education and outreach to physicians about new requirements
  • Suggestions for cross Department collaboration between CMS and DEA to secure a change in DEA policy to allow nurses at long term care facilities to act as agents of physicians in communicating with pharmacists.
  • Coordination of the regulation developed by HHS, Department of Labor, and the IRS relating to Wellness Programs, with overlapping guidance on the same subject by the Equal Opportunity Commission.
  • Coordination of the CDC select agent regulation with the Department of Agriculture select agent program.
  • Coordination of Privacy Act requirements with the “Common Rule.”
  • Harmonization of the human subjects protections between the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
    RESPONSE:  The Department has published an Advance Notice of Proposed Rulemaking on this subject to begin to address this issue.
  • Elimination of the Health Insurance Portability and Accountability Act (HIPAA) requirements from research, or suggestion to harmonize HIPAA regulations with OHRP regulations.
  • Review of Expanded Form 1099 reporting requirements for an assessment of whether additional requirements create additional burden.
  • Modification of requirements on sub-recipient monitoring so that grantees are no longer required to monitor sub-recipients who regularly receive federal awards.
  • Alignment of regulations of the Office of the National Coordinator (ONC) with other HIPAA and ACA requirements.
  • Review of requirements related to Medicare’s Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) Adjustment, including Medicare policies of counting resident time for DGME and IME payment purposes; cost reporting required by GDME and IME-related information hospitals; and the IRIS system.
  • Requirements under the current Conditions of Participation that require all verbal orders to be dated, timed, and authenticated promptly by the ordering practitioner or another practictioner who is responsible for the care of the patient to authenticate the order.
    RESPONSE:  These requirements are under review as part of the revisions to Hospital Conditions of Participation, anticipated to be published as proposed new rules in September 2011.
  • Requirements for participation in Medicare’s Provider Enrollment and Chain Ownership (PECO) system for all services
  • Call for additional flexibility in physician self-referral regulations
  • Call for greater flexibility in OIG regulations so that they incorporate changes occurring in the health care system.
  • Reduction of requirements that are duplicative of the A-133 audit as required under the Single Audit Act.
  • The prohibition of voluntary committed cost sharing across the Federal government and create a mandatory cost sharing exemption for research universities.
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