New approaches for enhancing stakeholder input and feedback
Stakeholder input is critical to the ongoing development and improvement of HHS programs. Many HHS agencies are developing new approaches to soliciting stakeholder input and feedback. These include new initiatives to solicit stakeholder feedback at the earliest stages of an initiative, before any action is taken; new strategies for providing ongoing feedback and status updates; and the use of standing forums (as opposed to ad hoc) for interacting with stakeholders. The issue of public participation is so important that HHS established a department-wide task force on public participation in regulatory review and associated activities to explore these issues and develop recommendations.
- Public Participation Task Force and Related Initiatives
To increase its efforts to promote and develop meaningful public participation, HHS established a Public Participation Task Force which is comprised of members from a number of offices in the Department. The Task Force explores ways to increase interactivity in the public comment process with respect to regulatory review and ongoing regulatory activity, including the use of technology and new media. Some HHS agencies already use these tools to foster public participation in regulatory activities, and other agencies can enhance the regulatory review and development process with increased use of these technologies. The Task Force initiated a Department-wide survey in February 2012 to gain a comprehensive understanding of the regulatory activities and the level of public participation, as well as the tools and methods used to increase public participation.
Several themes emerged from the survey results and the Task Force’s research, including needs to:
- better educate the public on the regulatory comment process;
- simplify the comment process;
- increase access for individuals with disabilities or Limited English Proficiency; and
- increase public participation in retrospective review.
The Public Participation Task Force submitted a report to the Deputy Secretary in March 2012, which included specific suggestions to promote and develop meaningful public participation in the Department’s regulatory processes.
Additionally, the Task Force is developing a comprehensive website devoted to HHS regulations and retrospective review activities. This website will be an interactive, easy-to-navigate, single entry portal allowing users to:
- link to specific regulations;
- find regulations published as proposed and provide comment;
- provide input on the review of any existing regulation;
- read supporting data and other background material; and
- otherwise participate in the regulatory process.
HHS will also post links to its Unified Agenda, as well as information relating to regulatory compliance and enforcement actions.
- Promoting Electronic Health Records Adoption through Open Government Approaches
The Office of the National Coordinator for Health Information Technology (ONC) has enabled dramatic progress in electronic health records (EHR) adoption nationwide using Open Government, collaboration with innovators, and outcomes-oriented regulation. In just three years, ONC has worked with federal partners and private sector stakeholders to establish:
- a clear policy framework for the certification and “meaningful use” of EHRs;
- a competitive market-based program for EHR testing and certification;
- consensus-based standards for medical vocabularies and system interfaces, and technical protocols for securely sending health information over the internet;
- a network of 62 local non-profit “extension centers” that give hands-on assistance to 40% of primary care providers in the United States;
- cooperative agreements for coordination of health information exchange activities in every state;
- a widely used health IT curriculum, competency exams, and a network of 85 university and community college training programs that have enrollment over 20,000 students.
For years technical disagreements and proprietary industry approaches prevented the emergence of widely-implemented standards for health information exchange. The time and effort needed to negotiate each data interchange leads to high costs and low information flow. But top-down promulgation of standards carries significant risk. The ONC’s approach is to establish the conditions for accelerated consensus:
- clear objectives (e.g., consensus protocols for sending health information securely over the internet, within 90 days);
- criteria for success (simple enough for “the little guy”);
- policy guideposts (no patient identifiers revealed in transit);
- the process (rough consensus and running code) and;
- an open online “wiki.”
Over 1,000 private sector experts have volunteered their labor to these collaborative efforts. In February 2012, ONC recognized the first ever consensus standards for laboratory results interfaces, patient summary records for transitions in care, and protocols for sending health data securely over the Internet.
- Project Evolve
The Substance Abuse and Mental Health Services Administration (SAMHSA) recently launched Project Evolve, a new web consolidation and modernization project. To promote participation and collaboration while still in its developmental stages, Project Evolve actively solicited and incorporated input from the public on key decisions on website organization and how information on the site will be presented. One question that was asked of the public related to what was missing in the agency’s initial design of its website (see http://feedback.samhsa.gov/forums/144246-closed-evolve-what-is-missing). In the spirit of transparency, project planning and status updates have been regularly documented on the agency blog (http://blog.samhsa.gov/category/evolve). Using Open Government principals as a foundation for the project helped ensure the final project will align as closely as possible with the needs of the website’s visitors. Moreover, integrating these new approaches to engagement and participation into business processes helps SAMHSA increase flexibility and responsiveness to changes in priorities or stakeholders’ needs. The website redesign is slated for completion in Spring 2013.
- Feedback Project
SAMHSA recently launched Feedback Project, using it in concert with its blog to interact with the public and solicit feedback on some of SAMHSA’s highest priority projects.
These include the drafting of SAMHSA’s Strategic Initiative Paper, creating a standard definition of recovery and the ten principles of recovery, SAMHSA’s web project – Evolve, and the National Health Communications Conference. In the coming years, SAMHSA will continue to use feedback.samhsa.gov to share new initiatives, gather new ideas, and cultivate a conversation and relationship with SAMHSA’s constituency. More information on SAMHSA’s Feedback project can be found at: http://feedback.samhsa.gov/forums/148531-help-samhsa-highlight-advances-of-the-behavioral-h
- Centers for Medicare & Medicaid Alignment Initiative
The CMS Alignment Initiative is an ongoing effort of the Medicare-Medicaid Coordination Office to identify and address conflicting requirements between the Medicare and Medicaid programs that may create barriers to providing high-quality and cost-effective care for Medicare-Medicaid enrollees. The initial phase of the Alignment Initiative compiled a wide-ranging list of opportunities for statutory, regulatory, and policy alignment in areas identified through numerous discussions with internal and external partners. There were 29 specific areas identified for improved coordination across both programs, which fell into the following categories: care coordination, fee-for-service benefits, prescription drugs, cost sharing, enrollment, and appeals. CMS published this list in the Federal Register on May 16, 2011, and requested public comment to help inform policy and program development. These comments are publicly available on regulations.gov. The Medicare-Medicaid Coordination Office has publicly posted the link to these comments on its webpage which will permit users to link directly to the public comments from the Alignment Initiative and permit a more open and transparent process. Moving forward, CMS will release a public summary providing stakeholders and partners with a broad breadth and scope of the comments received on the Alignment Initiative. Likewise, CMS will continue to host public listening sessions to facilitate a dialogue on better coordination of the Medicare and Medicaid programs on specific alignment opportunities. More information on the CMS Alignment Initiative can be found at: https://www.cms.gov/medicare-medicaid-coordination/07_AlignmentInitiative.asp
- International Cooperation on Cosmetics Regulation – Stakeholder Session
The International Cooperation on Cosmetics Regulation (ICCR) was founded in 2007 as an international forum for exchanging ideas for how to best maintain global consumer protection in the area of cosmetic products without creating unnecessary obstacles to international trade. FDA’s Center for Food Science and Applied Nutrition (CFSAN) is working with counterpart regulatory agencies in Canada, the European Commission, and Japan to host a Stakeholder Session at the upcoming annual ICCR meeting for organizations that are active in the field of cosmetics. The session will provide an opportunity for the exchange of viewpoints among a broad range of participants and to identify potential areas for future work and engagement. FDA will hold a Public Meeting in advance of this event to request information and possible agenda items from interested parties. The annual meeting and ICCR Stakeholder Session are scheduled for July 2012. More information about the ICCR can be found at:
- Additional Outreach Stakeholder Efforts led by the Food and Drug Administration – Webinars and Liaison and Roundtable Meetings
FDA has a number of efforts underway to increase communications with its stakeholders. For example, in an effort to increase collaboration and transparency, the Center for Biologics Evaluation and Research (CBER) established a liaison meeting program whereby the Center meets with external industry organizations on a routine, rather than ad hoc, basis. These meetings are intended to:
- discuss issues of mutual interest to the Center and the requesting organization;
- provide for an exchange of information to allow outside organizations to inform CBER of specific concerns;
- discuss events which have occurred for products of interest; and
- provide information to the external organizations on how the Center operates.
As another example of the agency’s outreach efforts, the Center for Food Safety and Applied Nutrition (CFSAN) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are co-sponsoring a webinar in Spring 2012 to acquaint food and nutrition professionals with FDA’s regulatory policies related to applied nutrition. This web-based training program will assist nutrition practitioners and educators in understanding regulatory policy issues that are relevant to professional practice.