Request for Information: Administrative Streamlining and Burden Reduction

Summary:

The Health Resources and Services Administration (HRSA), under guidance from the Department of Health and Human Services (HHS), is actively working to reduce public and stakeholder burden in complying with administrative and reporting requirements. This effort requires identification of regulations and other policy guidance or procedures that are outdated, unnecessary, or ineffective; impose costs that exceed benefits; or are otherwise inconsistent with established regulatory policy and guidance. HRSA seeks public input on changes that it could make, consistent with current law, that would result in a more streamlined, flexible, and less burdensome compliance and reporting structure, while maintaining appropriate program oversight. This Request for Information (RFI) seeks input from entities significantly affected by HRSA regulations and policy, including State, local, and Tribal governments, health care providers, small businesses, consumers, non-governmental organizations, and trade associations.

View Public Comments Received.

Background:

On January 30, 2017, President Trump announced the Administration's vision for regulatory reform by issuing Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs.” On February 24, 2017, President Trump issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” to lower regulatory burdens on the American public by implementing and enforcing regulatory reform. To meet these objectives, the President directed the head of each agency to designate an agency official as its Regulatory Reform Officer (RRO) and establish a Regulatory Reform Task Force to carry out these reforms, consistent with applicable law. The HHS Task Force also reviews documents that qualify as deregulatory actions under the Office of Management and Budget’s “Final Bulletin for Agency Good Guidance Practices.” As directed by the Task Force, HRSA is working to identify deregulatory actions that include Paperwork Reduction Act information collections, sub-regulatory guidance, and guidance documents. This RFI focuses on these types of deregulatory actions. HRSA is not currently seeking comment on any particular rulemaking actions.

Solicitation of Comments:

HRSA, an agency of HHS, is the primary Federal agency for improving access to health care for people who are geographically isolated or economically or medically vulnerable. Tens of millions of Americans receive quality, affordable health care and other services through HRSA’s 90-plus programs and more than 3,000 grant recipients. HRSA’s responsibilities include improving access to quality care and services; strengthening the health workforce; building healthy communities; and improving health equity.

HRSA's programs help those in need of high-quality primary health care, people living with HIV/AIDS, rural communities, pregnant women, and mothers. HRSA also supports the training of health professionals, the distribution of providers to areas of highest need, and improvements in health care delivery. HRSA oversees organ, bone marrow, and cord blood donation. It compensates individuals harmed by vaccination, and maintains databases that protect against health care malpractice, waste, fraud, and abuse.

In response to the Executive Orders 13771 and 13777, HRSA seeks to reduce burdens and identify improvements in areas where HRSA has jurisdiction. In this RFI, HRSA seeks input from the public on changes to its sub-regulatory guidance and information collection activities within its authority, consistent with applicable laws, in order to achieve these aims.

Provisions of this RFI:

This section describes HRSA programs participating in this RFI and identifies areas where the agency seeks input on changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients and other stakeholders.

A.  HRSA's Bureau of Primary Health Care (BPHC)

BPHC is responsible for the administration and oversight of the Health Center Program. BPHC provides grant funding and technical assistance to a nationwide network of community-based and patient-directed health centers to improve the health of underserved communities and vulnerable populations. BPHC also administers other smaller grant and non-grant programs that support the delivery of primary care, including the Federal Tort Claims Act Program for health centers and the Free Clinics Medical Malpractice Program. Nearly 1,400 health centers operate more than 10,400 service delivery sites that provide care in every State, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. In 2016, HRSA-supported health centers served nearly 26 million people, with 1 in 12 people nationwide relying on a health center for their preventive and primary health care needs.

As part of BPHC's oversight responsibility, health centers must compile and report data and other information as required by HRSA, relating to costs of health center operations; patterns of health center service utilization; availability, accessibility, and acceptability of health center services; and other matters relating to operations of the Health Center Program.

BPHC is considering changes to the process for submitting annual reports for the Health Center Program, aimed at reducing health center reporting burden while increasing data quality and usability. HRSA is requesting feedback regarding the Uniform Data System (UDS) reporting process.

1. Currently, health centers are required to submit their UDS data to a reporting system annually, between January 1 and February 15. Historically, BPHC's receiving system for UDS data does not open for data entry until January 1. One change to this reporting process being explored is to offer health centers the option to access the UDS data-reporting environment earlier than January 1. This new option, referred to as the Performance Data Collection Environment (PDCE), will give health centers more time (from September 1 to December 31—one quarter prior to the start of the official reporting period) to populate their UDS reports and perform validation on data entered to ensure accuracy and integrity. This extension gives health centers the option to export their UDS data entered in PDCE into the “live” data reporting system when it opens on January 1. In addition, the new option will allow health centers new to UDS reporting to familiarize themselves with the UDS reporting system and the most current data reporting requirements. BPHC is hopeful that PDCE will decrease the burden on both health center and BPHC staff time and resources during the official reporting season, when UDS data are vetted, which often involves back and forth between health centers and UDS data reviewers for questionable data entries. (Respondents, please reference RFI section A.1.)

2. Additionally, BPHC is considering the feasibility and impacts of providing health centers an option for transporting UDS data more directly from their electronic health records (EHRs) and other systems to BPHC for the purposes of annual administrative data reporting. HRSA is seeking comments on: the technical opportunities and challenges for implementing such an option; the potential impact on time spent to extract, transform, integrate, and submit data; and whether such a change would have beneficial impacts on report standardization. (Respondents, please reference RFI section A.2.)

3. BPHC is considering changes to the content of the UDS to reduce reporting burden while increasing analytic value for health centers and the Agency. Changes BPHC is exploring include utilizing data algorithms to more efficiently extract patient data based on countable clinical visits from an anonymous database to populate multiple tables in the UDS, including clinical socio-demographic information. This process would replace the current process of independently pulling data each time a health center populates a single UDS table. Additionally, BPHC is considering the value, given the time and effort involved, of reporting UDS Table 6A elements (selected diagnoses and services rendered). Perhaps some of the clinical information in Table 6A can be retired, since it duplicates content in Table 6B: for example, reporting Pap tests administered in Table 6A and the cervical cancer screening clinical quality measure reported in Table 6B. (Respondents, please reference RFI section A.3.)

B.  HRSA's Healthcare Systems Bureau (HSB)

HSB protects the public health and improves the health of individuals through an array of programs that provide national leadership and direction in targeted areas. The programs include solid organ, bone marrow, and cord blood transplantation; Poison Control Center services; countermeasure and vaccine injury compensation; and Hansen’s Disease program direct patient care, provider education, and research.

1. HSB also administers and provides oversight for the Hill-Burton Program. Created in 1947 under the Hospital Survey and Construction Act, the Hill-Burton Program provided grant funds to health care facilities to build, renovate, or buy equipment. In exchange, these health care facilities signed either a 20-year obligation or an obligation in perpetuity (or until the facility closes or is sold) to provide low or no-cost health care to income-eligible patients. Although the Hill-Burton Program stopped awarding funds in the 1990s, there are minimum requirements that recipient facilities must meet annually and report to HSB every-other year. HSB is considering changes in information collection that might reduce burden while maintaining compliance to the Hill-Burton requirements. These changes may involve decreasing the frequency of reports to HSB from every-other year to once every three years. HSB seeks public comments concerning the impact of this change and invites suggestions on other potential changes to Hill-Burton reporting requirements. (Respondents, please reference RFI section B.1.)

C.  HRSA's HIV/AIDS Bureau (HAB)

HAB administers the Ryan White HIV/AIDS Program (RWHAP), which provides a comprehensive system of care for people living with HIV. RWHAP uses a public health approach to provide primary medical care, medications, and support services to over 500,000 clients, which was approximately 50 percent of all people living with diagnosed HIV infection in the United States in 2016. The RWHAP funds a comprehensive system of care through grants to cities, States, and clinics/local community-based organizations to support care, treatment, and support services to low-income, uninsured, and underinsured people living with HIV. The RWHAP statute indicates that the program is the “payor of last resort” which means that RWHAP funds can only be used for services not covered by other Federal or State programs, or private insurance.

1. Under RWHAP Parts A, B, and C, grant recipients can submit a request to waive the requirement that they spend at least 75% of their funds on core medical services. The requirements for requesting a waiver are outlined in the HIV/AIDS Bureau’s Policy Clarification Notice (PCN) 13-07, “Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C.” As part of a grant recipient’s request to waive this requirement, the grant recipient must prove that there is no AIDS Drug Assistance Program waiting list for medications and all core medical services are available and accessible in the jurisdiction or service area.

   HAB is considering how to minimize the burden of the overall waiver request for grant recipients and is interested in suggestions that could further this goal. HAB is interested in feedback on the reasonableness of the content and amount of documentation required in PCN 13-07 (PDF - 48 kb) to demonstrate that all RWHAP core medical services are available and accessible. HAB is not seeking feedback on whether the statutorily required waiver is reasonable or whether the statutory 75% requirement is appropriate. (Respondents, please reference RFI section C.1.)

2. Grant recipients and sub-grant recipients submit annual Ryan White Services Report (RSR) client-level data for eligible clients who receive a RWHAP-funded service. However, grant recipients and sub-grant recipients do not submit reports for clients who receive services that are fully funded using RWHAP-related funding, such as rebate dollars or RWHAP-related program income. As more grant recipients fully fund services using other RWHAP-related funding streams, less information is available on RWHAP eligible clients and service utilization. This limits HAB’s and grant recipients’ ability to measure the investment and impact of all RWHAP-related expenditures at State and local levels. HRSA proposes to change client-level reporting to include eligible clients who receive RWHAP allowable services that were funded using RWHAP and RWHAP-related funding (e.g., direct RWHAP funding, sub-grant recipient funding, program income, and RWHAP ADAP rebates) starting with the 2019 RSR. HAB is seeking public comment to better understand the benefits and challenges that grant recipient and sub-grant recipients would experience with this reporting change. (Respondents, please reference RFI section C.2.)

3. HAB has provided consistent policy guidance on the annual eligibility screening and six-month recertification of eligibility for RWHAP clients (HIV/AIDS Bureau’s PCN 13-02, “Clarifications on Ryan White Program Client Eligibility Determinations and Recertifications Requirements (PDF - 40 kb)"); however, RWHAP grant recipients remain challenged to implement the policy in the field. Formal reviews and grant recipient reporting describe several inconsistencies in the application of the recertification requirement by RWHAP grant recipient. In addition, some grant recipients report that the recertification requirement is burdensome as many of their clients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. HAB is seeking input to understand the impact and burden of the six-month recertification policy to assess RWHAP client eligibility for services. HAB is considering how to minimize the impact on patients' access to medical services, retention in care, access to HIV antiretroviral medications, and ultimately reaching viral suppression. (Respondents, please reference RFI section C.3.)

D.  HRSA's Bureau of Health Workforce (BHW)

BHW improves the health of underserved and vulnerable populations by strengthening the health workforce and connecting skilled professionals to communities in need. BHW programs advance the education of a 21st century health workforce and work to meet existing and projected demand for skilled health professionals in high-need areas nationwide. BHW programs also place an emphasis on academic and community partnerships, interprofessional education and practice, and evaluation and data-driven enhancements. BHW manages more than 45 health workforce programs that include a range of grants, as well as direct award loan repayment and scholarship programs, guided by its health workforce research activities. In particular, BHW is interested in public comments regarding improvements to the effectiveness of BHW program data collection and supporting the priorities regarding telehealth and substance use disorder.

Since 1972, National Health Service Corps (NHSC) clinicians have served patients across the nation in communities with limited access to health care that are designated as Health Professional Shortage Areas (HPSAs). In particular, the NHSC has collaborated with HRSA-supported Health Centers to help meet their staffing needs. Over 60 percent of NHSC clinicians serve in Health Centers around the nation, and 15 percent of clinical staff at Health Centers are NHSC clinicians. The NHSC also places clinicians in other community-based systems of care that serve underserved populations, targeting HPSAs of greatest need. The NHSC consists of four different subprograms: NHSC Scholarship Program, NHSC Loan Repayment Program, NHSC Students to Service Loan Repayment Program, and the State Loan Repayment Program. These programs collectively serve the immediate needs of underserved communities and support the development of a pipeline of clinicians who will be ready to practice in underserved communities.

The NURSE Corps Program helps to improve the distribution of nurses by supporting nurses and nursing students committed to working in communities with inadequate access to care. In exchange for scholarships or educational loan repayment, NURSE Corps members fulfill their service obligation by working in Critical Shortage Facilities located in HPSAs and medically underserved communities around the nation, which include rural communities and other identified geographic areas with populations that lack access to primary care services.

1. Currently, BHW collects data on applicants and participants through the NHSC and NURSE Corps application process in an online Customer Service Portal. BHW is interested in feedback from current and former participants on how to collect data more effectively – in particular, if there are data points and/or documents that BHW requests as part of the application process that are particularly burdensome to applicants.

   BHW is also interested in feedback on how the Application and Program Guidances for the various NHSC and NURSE Corps programs can be streamlined and improved to assist applicants in deciding if they are a viable candidate for the program. For example, if it would it be helpful to applicants who are interested in applying to have educational sessions to ensure that they understand the requirements of the NHSC programs, similar to the “Welcome to Service Webinars” hosted once individuals are awarded. BHW has recently updated the functionality to assist people looking for NHSC-approved service sites with the implementation of the Health Workforce Connector. It would be helpful to know if there are additional technical assistance/search functions and/or resources for participants who are looking for employment while an NHSC or NURSE Corps participant in service. (Respondents, please reference RFI section D.1.)

2. BHW is interested in how NHSC can support the priorities on telehealth and substance use disorder. In particular, BHW is interested in which data and indicators for telehealth and the provision of substance use prevention and treatment it should collect from its sites and participants to:

   i.   Assess the level of service provided by NHSC clinicians to determine the impact of the NHSC policies related to telehealth and substance use prevention and treatment;
   ii.  Verify compliance with NHSC requirements to endure program integrity; and
   iii. Ensure that the policies meet the NHSC's goal of meeting provider and community workforce needs.

   (Respondents, please reference RFI section D.2.)

3. BHW's health professions training programs span the fields of behavioral health, oral health, medicine, nursing, and public health. These programs advance the education and training of a 21st century health workforce to address existing and projected demand for skilled health professionals in high-need areas nationwide. The National Center for Health Workforce Analysis (NCHWA), part of the BHW, is a national resource for health workforce research, information, and data. In addition to analyzing the supply, demand, distribution, and education of the nation’s health workforce, NCHWA coordinates and manages the data collection, analysis, and evaluation efforts for BHW programs. By using performance metrics and evaluation, NCHWA develops and publishes performance measures and benchmarks for BHW’s health workforce training and education programs, conducts performance management/measurement of grant program outcomes, and conducts multi-year retrospective and prospective program evaluations.

   BHW is interested in feedback from stakeholders on what additional performance measure data could be collected to enhance evaluations of BHW training programs. BHW is also interested in informational feedback on existing databases that could provide benchmark data to evaluate program performance. For example, the National Provider Identifier may be used for longitudinal tracking of practice outcomes for BHW trainees. HRSA is also interested in collecting data as effectively and efficiently as possible and is interested in feedback about which existing BHW performance measures and reporting requirements could be streamlined or reduced (see performance measures), as well as potential outcomes upon which HRSA could evaluate training programs. (Respondents, please reference RFI section D.3.)

4. The National Practitioner Data Bank (NPDB) is a workforce tool that provides information about past adverse actions of practitioners, providers, and suppliers to authorized health care entities and agencies. With approximately 1.3 million reports, the NPDB helps reduce health care fraud and abuse by collecting and disclosing information to authorized entities on health care-related civil judgments and criminal convictions, adverse licensure and certification actions, exclusions from health care programs, and other adjudicated actions taken against health care providers, suppliers, and practitioners.

   The NPDB has implemented several system enhancements to improve the querying and reporting workflow. These enhancements include streamlined self-query workflow, implemented paperless registration renewal process, improved login workflow for agents and Credentials Verification Organizations (CVOs), and improved process to handle unknown data elements submitted by entities. HRSA is seeking comment on these initiatives as well as future opportunities for:

   i.   Streamlining operations and improving customer service via the website and call center;
   ii.  Reducing user burden in submitting reports to the NPDB; and
   iii. Performing queries of the NPDB.

   (Respondents, please reference RFI section D.4.)

E.  HRSA's Office of Federal Assistance Management (OFAM)

OFAM provides leadership in the administration and assurance of the financial integrity of HRSA’s grant programs, and provides oversight of HRSA grant activities to ensure they are managed in a fair, efficient and effective manner. OFAM is considering how to minimize the administrative burden on HRSA grantees, especially grantees with multiple HRSA grants. Consistent with 45 CFR Part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, OFAM is seeking input from current HRSA grantees, especially those with multiple HRSA grants in the following areas of grants management.

1. Application Process. OFAM is interested in feedback on data points, documents, or other aspects of the application process for HRSA grants that are particularly burdensome, as well as suggestions as to how the application process can be streamlined and improved. (Respondents, please reference RFI section E.1.)

2. Post-award Process. OFAM is interested in feedback on actions or requirements that are burdensome in the post-award process for organizations managing single or multiple HRSA grants. OFAM is especially interested in any input on the use of expanded authorities. These are operational authorities provided to recipients that automatically waive the requirement for prior approval for specific actions, e.g., carryforward unobligated balances to subsequent periods of performance, no-cost extension, etc. HRSA is looking to determine if an increased use of those authorities would be beneficial in reducing recipient burden. (Respondents, please reference RFI section E.2.)

3. Notices of Funding Opportunity. OFAM is interested in receiving feedback from both current recipients, and past, present, or future applicants regarding the clarity of its Notices of Funding Opportunities (NOFOs) published on Grants.gov. Specifically, OFAM would appreciate suggestions as to how HRSA may streamline and improve the clarity of its NOFOs, so that applicants have a better understanding of what is required of them to submit a high quality application. HRSA would also like feedback on how OFAM may improve communication and technical assistance associated with submitting an application in response to a NOFO posted on Grants.gov. (Respondents, please reference RFI section E.3.)

Submitting Comments:

Please submit comments via email to [email protected] and reference “Administrative Streamlining and Burden Reduction RFI” in the title. Please also include the specific RFI section to which your comment is directed. If you provide comments to more than one section, please identify the specific RFI section to which each comment is directed. Information obtained as a result of this RFI may be used by HRSA for program planning on a non-attribution basis. Responses to this RFI will be made publically available; therefore, respondents should not include any information that might be considered proprietary or confidential. HRSA will not respond to any individual comments. Comments will be received through July 2, 2018.

Special Note to Commenters:

Whenever possible, respondents are asked to draw their responses from objective, empirical, and actionable evidence and to cite this evidence within their responses.

This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal, applications, proposal abstracts, or quotations. This RFI does not commit the Government to contract for any supplies or services or make a grant or cooperative agreement award. Further, HRSA is not seeking proposals through this RFI and will not accept unsolicited proposals. HRSA will not respond to questions about the policy issues raised in this RFI. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future procurement or program, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request.