The purpose of this Program Assistance Letter (PAL) is to describe the Health Resources and Services Administration’s (HRSA) process for Health Center Program grantees to submit Federal Tort Claims Act (FTCA) deeming applications for calendar year (CY) 2014. Eligible grantees and subrecipients may be deemed by HRSA as employees of the Public Health Service (PHS) for purposes of FTCA medical malpractice coverage under the Federally Supported Health Centers Assistance Acts (FSHCAA) of 1992 (Pub. L. 102-501) and 1995 (Pub. L. 104-73). This PAL supersedes PAL 2012-02, “Calendar Year 2013 Requirements for Federal Tort Claims Act (FTCA) Medical Malpractice Coverage.”
This PAL is intended to clarify, and disseminate the requirements for the CY 2014 FTCA deeming and renewal application submissions. Technical Assistance (TA) Webcasts on these requirements are available at http://bphc.hrsa.gov/ftca/healthcenters/hcappprocess.html.
Health Center Program grantees and qualifying entities receiving section 330 funds (hereafter “entities” or “health centers”), in order to receive deemed status under FSHCAA, must demonstrate compliance with all applicable FTCA Program requirements (including implementation of applicable policies and procedures).
Section 224(h)(1) of the PHS Act requires the Secretary, as a condition of deeming, to determine that the entity has implemented “appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity.” Similarly, under section 224(h)(2), the Secretary must determine that the entity has reviewed and verified “the professional credentials, references, claims history, fitness, professional review organization findings, and license status of its physicians and other licensed or certified health care practitioners ….” In addition, section 224(h)(3) requires that the Secretary determine that an entity that has a history of any FTCA claims “either has taken, or will take, any necessary corrective steps to assure against such claims in the future.”
Please note that deeming applications by eligible entities must be submitted in the form and manner prescribed by HRSA and must demonstrate that the entity seeking FTCA coverage has successfully implemented all deeming requirements set forth in law and further described in this PAL. Applications that do not meet the applicable requirements in the evaluation of the program will not be approved, and affirmative deeming determinations will not be issued.
Each entity seeking FTCA coverage (including both health center grantees and subrecipients) must submit an initial FTCA deeming application or an FTCA redeeming application in the form and manner prescribed by HRSA. Program requirements include not only the submission of written documentation of appropriate policies, procedures, and practices, but also evidence of their implementation. Because of the critical importance of this process to an effective deeming determination, all deeming applicants must:
1. Submit FTCA application materials in a timely manner (including responding within specified time frames to all clarification and additional information requests from HRSA);
2. Demonstrate implementation of the required policies, procedures, and requirements, as further outlined in this PAL; and
3. Present and verify all material facts during the application process (including FTCA site visits), where applicable.
Applications that do not meet the Program requirements will not be approved, and affirmative deeming determinations on such applications will not be issued.
This PAL applies to eligible grantees that are public and private nonprofit entities receiving grant funding under section 330 of the PHS Act, including sections 330 (e), (g), (h), and/or (i), collectively referred to as “grantees.”
Eligible subrecipients for purposes of FTCA coverage are those entities receiving funds from a covered section 330 grantee under a grant or contract to provide a full range of services on behalf of the covered entity. Subrecipient entities are eligible for coverage only if they provide a full range of health care services on behalf of an eligible grantee and only for those services carried out under the grant-funded project. All subrecipient entities seeking FTCA deeming must be identified on the grantee of record’s current Scope of Services (i.e., their approved Form 5B).
Please note that only the grantee of record (the organization named on the Notice of Award) can transmit a request to HRSA for FTCA deeming coverage. Requests for coverage of a subrecipient must be submitted on behalf of the subrecipient by the grantee of record. Health centers requesting FTCA coverage on behalf of a subrecipient are required to submit a separate and complete deeming application in accordance with the deeming guidelines specified within this PAL and other FTCA Program requirements. The subrecipient application must be submitted along with the grantee of record’s deeming application package, and is subject to the same requirements as the grantee of record’s application.
This PAL contains the instructions for grantees submitting either:
1. An FTCA application requesting initial deeming; or
2. An annual redeeming application for deeming coverage for CY 2014 (January 1, 2014 - December 31, 2014).
IV. MECHANISM FOR SUBMITTING FTCA APPLICATIONS
All FTCA deeming applications must be submitted electronically through the FTCA deeming module within the HRSA Electronic Handbook (EHB). This module supports electronic web-based functionality for the deeming process including grantee completion and submission of applications, HRSA review and processing of applications, and electronic notice of deeming status to grantees. The EHB system will be available to begin receiving CY 2014 deeming applications on March 28, 2013.
When a grantee submits a FTCA application, the EHB will assign a tracking number. Grantees may create and submit a FTCA application in one session, or create and save part of the application and return as many times as necessary to complete the request before submitting it for HRSA review. Grantees are responsible for ensuring that their deeming application(s) have been successfully submitted to HRSA through the EHB.
For additional information or technical assistance on how to submit a FTCA application, please visit http://www.bphc.hrsa.gov/ftca/healthcenters/hcappprocess.html. Additional technical assistance for EHB and this PAL will be made available prior to the application submission deadline and will also be available online with other technical assistance information.
V. OVERVIEW OF APPLICATION SUBMISSION DATES AND KEY PROGRAM UPDATES
In this PAL, HRSA has provided additional guidance regarding application deadlines and various information requests. Similar to last year’s deeming process, after receiving a change request for additional or updated information, grantees will be required to update and resubmit their applications in a timely manner. Applicants will have 10 business days to update and resubmit their applications after receiving such notice of an incomplete application . If the grantee fails to respond, the application may be deemed incomplete and disapproved or returned to the grantee without further action for additional information. Please see Section VI: Initial FTCA Applications and Section VII: FTCA Renewal Applications of this PAL for additional details.
FTCA redeeming applications must be submitted within EHB on or before May 3, 2013.
Please also pay special attention to the following requirements within this year’s application:
More information on each of these updates and all application components is further described below in the section titled, “Complete FTCA Application Package: Initial and Renewal Applicants.”
VI. INITIAL FTCA APPLICATIONS
All grantees considering FTCA coverage are encouraged to carefully review the FTCA policies and regulations found on the HRSA website at http://www.bphc.hrsa.gov/FTCA/, as well as the Health Centers Program policy page found at http://www.bphc.hrsa.gov/policiesregulations/policies/index.html. They should also consult with the FTCA Program and their Project Officer prior to submitting an initial deeming application.
Health centers may submit an initial application via the electronic, web-based EHB system at any time during the year when the system is open to accept applications. However, due to the program review requirement, grantees should request FTCA coverage well in advance of their desired coverage start date.
Once a complete initial FTCA application is submitted (see Section VIII: Complete FTCA Application Package: Initial and Renewal Applicants), HRSA will conduct its review within 30 days. Please note that an FTCA deeming application is not considered complete until all required documentation has been completed and submitted through EHB. Grantees are responsible for ensuring that the information needed to complete their applications has been successfully submitted to HRSA through the EHB. Grantees that do not submit complete applications in a timely manner may not receive deemed status (i.e., FTCA coverage) on the date desired. If additional information or clarification is needed, HRSA will notify the grantee through the EHB, and the grantee will be given 10 business days from the date of the EHB notification to provide the requested information to complete its application. Should requested information not be submitted within 10 business days of notification, the FTCA application may be deemed incomplete and marked “VOID” in the EHB system, and disapproved.
Within 30 days after a complete initial FTCA application has been received by HRSA, HRSA will notify through EHB the contact person(s) identified by the health center of a final determination. Eligible entities will be covered under applicable FTCA regulations only on and after the effective date identified by HRSA. Initial grantees are advised to maintain private malpractice insurance until they receive written documentation confirming the deeming determination from HRSA.
VII. FTCA RENEWAL APPLICATION
All currently deemed grantees must submit a FTCA renewal application and for any subrecipients (as applicable) by May 3, 2013 in order to be eligible to be deemed for the entirety of CY 2014 without a gap in coverage. Grantees who fail to submit a redeeming application by the deadline date may be required to reapply for coverage. Eligible entities (grantees and grantees on behalf of subrecipients) that do not submit a renewal application by the May 3, 2013 deadline may experience a gap in anticipated FTCA coverage and should strongly consider purchasing private medical malpractice insurance for calendar year 2014.
Grantees are responsible for ensuring that the information needed to complete their deeming application has been successfully submitted to HRSA through the EHB. If additional information or clarification is needed to support an application, HRSA will notify the grantee through the EHB. The grantee will be given 10 business days from the date of such EHB notification to resubmit the application with the requested information. It is important that grantees provide a timely response to all requests for information in order to assure a timely review and notification. Grantees that do not provide a responsive submission within 10 business days after receiving notice may have their application deemed incomplete and marked “VOID” in the EHB system, and disapproved. Should that occur, the grantee seeking coverage may be required to submit a resubmission application. Eligible entities (grantees and grantees on behalf of subrecipients) that do not timely respond to change requests may experience a gap in anticipated FTCA coverage and should strongly consider purchasing private medical malpractice insurance for calendar year 2014.
During the review process, if HRSA determines that the applicant has not successfully demonstrated compliance with the FTCA deeming requirements and is in danger of being disapproved for CY 2014 coverage, the grantee will be notified of such non-compliance and be provided a final opportunity to demonstrate compliance and evidence of implementation. The notice will outline the following:
1. The areas of non-compliance;
2. Additional documentation that must be submitted to demonstrate evidence of compliance and implementation;
3. The time-frame within which the documentation must be submitted; and
4. The form and manner in which the submissions must be presented.
Once the additional information is submitted, HRSA will review the documentation and make a final determination.
After a final determination is made for each application, HRSA will notify the contact person(s) identified by the health center of the program’s deeming status through the EHB.
VIII. COMPLETE FTCA APPLICATION PACKAGE: INITIAL AND RENEWAL APPLICANTS
To be considered complete, an initial or renewal application must contain all of the following documentation within EHB. Please note that, in order to address privacy concerns for all pertinent parties, QI/QA committee minutes and board minutes submitted to HRSA must be redacted of all patient and staff identifiers as well as sensitive unrelated material. HRSA also encourages applicants to consult with their private legal counsel to address any associated privacy concerns, including specific questions about redactions.
1. Quality Improvement/Quality Assurance (QI/QA) Plan, with clear documentation that the Board reviewed and approved the plan within 3 years of the date of submission to HRSA (i.e., on or after April 5, 2010 for a renewal application).
a. Specifically, the QI/QA plan must be approved, dated, and contain the appropriate signature(s) of the Board of Directors (such as the Secretary and/or other appropriate Board members). If the QI/QA plan has not been signed by the Board, then the health center must submit an unsigned plan and provide Board meeting minutes that are dated, with appropriate signature(s), that demonstrate clear evidence that the plan was approved by the Board.
b. If the Plan has not been approved by the Board within the last 3 years, the application will be returned to the grantee without further review until the plan is resubmitted with a Board signature/date indicating review/approval, or signed, and dated board minutes that clearly indicate that the plan was approved by the Board.
2. Minutes from any six QI/QA committee meetings that took place between April 5, 2012 and the submission date of the application. The application must provide an explanation if fewer than six sets of minutes are provided. Please note that HRSA utilizes meeting minutes as one of its primary sources of evidence of successful implementation of a QI/QA program. Lack of documentation or incomplete documentation of activities may be considered evidence of a failure to implement a successful QI/QA program and may therefore adversely affect the deeming determination.
3. Any health center committee reports that further evidence QI/QA activities.
4. Minutes from any six Board meetings evidencing oversight of QI/QA activities that took place between April 5, 2012 and the submission date of the application. The application must provide an explanation if fewer than six sets of minutes are provided. Please note that HRSA utilizes meeting minutes as one of its primary sources of evidence of successful oversight of a QI/QA program. Lack of documentation or poor documentation of activities may be considered evidence of a failure to provide proper oversight of the QI/QA program and may therefore adversely affect the deeming determination.
5. Credentialing and privileging policies and procedures. The health center’s credentialing and privileging policies and procedures must include those elements outlined in Policy Information Notice (PIN) 2002-22 (http://bphc.hrsa.gov/policiesregulations/policies/pin1102.pdf). Also, please note available related credentialing resources at http://bphc.hrsa.gov/ftca/riskmanagement (including related ECRI resources and credentialing toolkit). Similar to the QI/QA plan, there must be clear documentation that the Board has reviewed and approved these policies and procedures. Specifically, the credentialing and privileging policies and procedures must be approved, signed, and dated by the Board. If the plan does not have a physical signature, then submission of an unsigned set of credentialing and privileging policies and procedures as well as Board minutes that are dated and have a signature from the Board, are acceptable evidence of approval. Please note that policies that fail to incorporate the requirements outlined in PIN 2002-22 may be considered evidence of a failure to successfully implement the program’s credentialing and privileging requirements.
6. A list of all licensed and certified staff members providing services at all health center sites and their current credentialing/privileging status. The list must include employed or contracted practitioners, volunteers, and locum tenems with evidence of credentialing and privileging within the last two years (i.e., all credentialing must have been documented to have taken place on or after April 5, 2011). For the purposes of this application, documentation of a credentialing date within the last 2 years is required in accordance with Policy Information Notice 2002-22. If any listed individual’s most recent credentialing did not occur within the last two years, the application will be returned to the grantee as described in Section VI: Initial FTCA Applications and Section VII: FTCA Renewal Applications.
7. Due to EHB technical requirements, the credentialing list must be in an Excel Spreadsheet compatible with EHB and include the following for all licensed and certified staff members (please see attachment 1 for an example):
The identification of credentialing/privileging status must be based upon evidence of credentialing and privileging under PIN 2002-22 for all listed licensed and certified staff members within the previous 2 years (e.g., credentialing and privileging actions for each provider must have been documented to have taken place on or after April 5, 2011).
The purpose of requiring submission of this credentialing and privileging documentation is to show that the grantee has reviewed and verified required credentialing information. Inclusion of practitioners on this listing does not infer the deeming (or absence of deeming) for any individual or practitioner, as this is based on satisfaction of statutory deeming criteria under 42 U.S.C. 233(h). Please note that HRSA may view errors and missing information as evidence of failure to comply with the requirements of PIN 2002-22, as well as Health Center FTCA Program requirements.
8. Health center policies and procedures for the following:
9. Statement verifying whether or not there were any medical malpractice claims or allegations presented during the past 5 years, that any such claims or allegations were internally analyzed, and that appropriate actions were implemented as needed in response to such claims or allegations. The statement should include the following for each allegation/claim:
10. Electronic signature of the Executive Director certifying the contents of the application. If the FTCA application is not signed by the Executive Director, the application will be returned to the grantee as described in Section VI: Initial FTCA Applications and Section VII: FTCA Renewal Applications.
11. Deeming applications for any subrecipient(s) that appear on the health center’s most recent Form 5B, who are requesting FTCA coverage. The subrecipient(s) deeming application is considered part of the deeming application of the grantee of record. If a subrecipient’s application is incomplete, HRSA will notify the grantee through the EHB, and the grantee will have 10 business days to respond. If the grantee does not respond within 10 days, the entire application package may be deemed incomplete and marked VOID in the EHB system and disapproved. Please see Section VI: Initial FTCA Applications and Section VII: FTCA Renewal Applications for more information.
IX. SITE VISITS
HRSA may conduct a site visit at any point during the application review process and/or as part of its oversight responsibilities relative to the FTCA program to ensure that risk management, QI/QA policies and procedures, and credentialing have been appropriately implemented. HRSA may also conduct a random site visit to any initial applicant or deemed grantee to ensure implementation under 42 U.S.C. 233(h). If a site visit results in a finding of a lack of implementation of the FTCA program requirements, this may be grounds for a negative deeming determination.
Factors that may prompt a site visit include, but are not limited to:
1. Submission of an initial FTCA deeming application;
2. Documentation submitted which indicates non-compliance with requirements during the review of the health center’s FTCA application;
3. The need for follow-up based on prior site visit findings or other identified issues;
4. History of repeated pertinent conditions, or current conditions, placed by HRSA on the health center’s 330 grant, as documented on the health center’s associated Notice of Award; and/or
5. History of medical malpractice claims.
Site visits are conducted to ensure that the requirements under the relevant statutory authority contained within 42 U.S.C. 233(h) have been implemented. Site visit reviewers will assess whether the grantee has:
• Implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity;
• Reviewed and verified the professional credentials, references, claims history, fitness, professional review organization findings, and license status of its physicians and other licensed or certified health care practitioners, and, where necessary, has obtained the permission from these individuals to gain access to this information; and
• Should a history of claims exist, validate that the grantee has fully cooperated with the Attorney General in defending against any such claims and either has taken, or will take, any necessary corrective steps to assure against such claims in the future.
X. ADDITIONAL USEFUL RESOURCES: RISK MANAGEMENT RESOURCES
Ongoing risk management is essential to the provision of quality health care services. HRSA is committed to ensuring that health centers have access to risk management resources. On the HRSA/FTCA website, http://bphc.hrsa.gov/ftca/riskmanagement, you will find useful risk management webinars, tool kits, and risk management related articles.
XI. CONTACT INFORMATION
For programmatic support regarding the FTCA Program, application requirements (including credentialing, QI/QA Plan, etc.), and technical/EHB support, please contact:
FTCA/BPHC Help Line
Phone: 1-877-974-BPHC (877-974-2742)
9:00 AM to 5:30 PM (ET)
Printer-Friendly PAL 2013-05 (includes attachment 1) (PDF - 656 KB)
The Bureau of Primary Health Care held a technical assistance webcast about the Program Assistance Letter (PAL) 13-05. This webcast discussed the FTCA application process for Calendar Year (CY) 2014 coverage.
Presentation: CY 2014 Application Technical Assistance 2/26 - (PPT 1.2 MB)
Presentation: CY 2014 Application Technical Assistance 2/28 - (PPT 1.3 MB)
Please note that applications are DUE by May 3, 2013