Medical Liability Reform and Patient Safety

Questions and Answers

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The following set of questions and answers features responses from the Agency for Healthcare Research and Quality (AHRQ) to questions from the public submitted on or before November 6, 2009, about two funding opportunity announcements:

• Medical Liability Reform and Patient Safety Demonstration Projects (R18) (RFA-HS-10-021).
• Medical Liability Reform and Patient Safety Planning Grants (R21) (RFA-HS-10-022).

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Background

AHRQ has received the following types of substantive questions about these Requests for Application (RFAs). AHRQ plans to add to this list as it receives additional questions.

Questions and Answers

Question #1: Does the prohibition against submitting an application "that is essentially the same as one currently pending initial review" mean that an applicant can only apply to either the R18 or the R21 (IV.3.C)
Answer #1: No. An applicant who meets the RFAs' requirements may apply to either or both. However, each application must be clearly distinct. An applicant should not submit an identical application to both RFAs.

Question #2: Can an application propose only a patient safety intervention without a medical liability component, or a medical liability intervention without a patient safety component (I.1)?
Answer #2: No. The RFAs require that an application address both patient safety and medical liability. AHRQ will publish an addendum to the NIH Guide that clarifies the requirement that an application address both patient safety and medical liability.

Question #3: Who may apply for these grants?
Answer #3: The RFA describes two Eligible Institutions: States and Established Health Care Systems.

Question #4: How does the Eligible Institutions section describe "Established Health Care Systems" (III.1.A)?
Answer #4: Please refer to Section III's Eligibility Information for a complete description of who may apply for these grants.

Question #5: Would a single hospital, university, professional practice, professional association, consulting firm, law firm, etc., constitute an Established Health Care System?
Answer #5: Under Roemer's description, a health system must have multiple capacities of multiple types, interconnections between them, and common purpose. A single capacity (e.g., a hospital) would not appear to conform to this description. An organization that does not meet the description could serve as a subcontractor to an Eligible Institution.

Question #6:Would Kaiser Permanente, Intermountain Healthcare, Group Health Cooperative, Geisinger, etc., constitute an Established Health Care System?
Answer #6: This type of health care organization would appear to conform to Roemer's description.

Question #7: Would a small chain of hospitals constitute a health system?
Answer #7: Depending on its organizational relationships, non-hospital capacities (e.g., practitioners, financing), level of integration, and history, such a chain might conform to Roemer's description.

Question #8: Would AHRQ further define "Established Health Care Systems" (III.1.A)?
Answer #8: AHRQ will not further define an Established Health Care System. Applicants should be guided by the definition provided in the RFA.

Question #9: Would AHRQ further define "coalitions of State governments" (III.1.A)?
Answer #9: AHRQ will not further define "coalitions of State governments."

Question #10: Would AHRQ consider expanding the description of Eligible Institutions that may apply for these grants?
Answer #10: AHRQ has no plans to modify or change the Eligible Institutions. An organization not eligible to apply may participate as a subcontractor to an Eligible Institution. The applicant organization must perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party that may not be eligible to receive funding directly.

Question #11: How can a patient advocacy groups participate in these grants?
Answer #11: A patient advocacy group could act as a subcontractor to an Eligible Institution. An application might include a patient advocacy group among its key stakeholders.

Question #12:Would AHRQ provide additional guidance about the qualifications of a Principal Investigator (III.1.B)?
Answer #12: AHRQ will not provide additional information about expectations for the Principal Investigator.

Question #13: Can an application have more than one Principal Investigator?
Answer #13: An application can have only one Principal Investigator. AHRQ has not adopted NOT-OD-07-017 (a notice issued by NIH allowing multiple Principal Investigators).

Question #14: Who are the "key stakeholders" considered in the review and selection criteria (V.2)?
Answer #14: The identity of "key stakeholders" would vary depending upon objectives of the application.

Question #15: Can an existing demonstration apply under these RFAs?
Answer #15: Yes, if it meets the requirements of one or more of the RFAs.

Question #16: What is the specific distinction between a grant and a planning grant?
Answer #16: The NIH Guide defines a grant as a "financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities." AHRQ (and NIH) use a variety of Activity Codes (Rxx) to differentiate the different research-related programs they support. The R21 mechanism for planning grants "encourages new, exploratory and developmental research projects by providing support for the early stages of project development. [It is] sometimes used for pilot and feasibility studies. No preliminary data is generally required." The R18 mechanism for demonstration projects "provide[s] support designed to develop, test, and evaluate health services activities[;] and to foster the application of existing knowledge .

Update as of 11/10/09

Question #17: Is a State university a unit of State government?
Answer #17: It depends. Grant peer review might find that a State university with characteristics of a State executive agency constitutes a unit of State government (e.g., largely State funded, workers employed by the State, management that serves at the pleasure of the elected State government). A State university with characteristics of a private university would not constitute a unit of State government (e.g., substantial private, charitable, and/or grant funding; workers employed by the university; management responsible to an independent board of trustees). An applicant sponsored by a State university should clearly justify how its Eligible Institution meets the RFA's stated criteria.

Update as of 11/12/09

Question #18: If a Grantee receives one of the R21 planning grants and produces a plan for addressing patient safety and medical liability, will AHRQ fund implementation of the plan with a new RFA in 2011?
Answer #18: AHRQ has no plans for future funding of patient safety and medical liability beyond the current RFAs.

Question #19: If a successful Grantee collects sensitive data during the course of its R18 study, can a third party obtain access to the data by pretrial discovery during a court case?
Answer #19: 42 USC 299c-3(c) limits the disclosure of research data that identifies individuals or establishments. No judicial cases test the interaction of this limitation with the discovery provisions of the Federal Rules of Civil Procedure.

Question #20: How does AHRQ define significant State involvement, and what role should the State play in an application?
Answer #20: AHRQ will not provide additional information about expectations for State involvement or role beyond that provided in both RFAs.

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Current as of November 2009