Part I Overview Information

Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov/)
Centers for Medicare and Medicaid Services (CMS), (http://www.cms.gov)

Components of Participating Organizations
Office of e-Health Standards and Services, CMS

Title: Pilot Testing of Electronic Prescribing Standards – Cooperative Agreements

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Request For Applications (RFA) Number: RFA-HS-06-001

Catalog of Federal Domestic Assistance Number(s)
93.779

Key Dates
Release Date: September 15, 2005
Technical Assistance Conference Call: September 29, 2005
Letters of Intent Receipt Date(s): October 7, 2005
Application Receipt Dates(s): October 25, 2005
Peer Review Date(s): December 2005
Earliest Anticipated Start Date: December 2005
Expiration Date: October 26, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ), on behalf of the Centers for Medicare & Medicaid Services (CMS), is soliciting applications from interested parties to conduct a pilot of electronic prescribing standards under cooperative agreements that will inform the implementation of the Medicare Prescription Drug Benefit. Under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Medicare will require drug plans participating in the new prescription drug benefit to support and comply with electronic prescribing (e-prescribing) standards. E-prescribing will be voluntary for prescribers and dispensers, but for prescribers and dispensers that choose to send or receive prescription-related information electronically for covered Part D drugs for Part D eligible individuals, compliance with the standards will be required. Part D sponsors, including Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) Organizations offering Medicare Advantage-Prescription Drug (MA-PD) plans, must support and comply with electronic prescribing standards relating to covered Part D drugs for Part D eligible individuals once final standards are in effect. The purpose of cooperative agreements awarded through this RFA is to test the Department of Health and Human Services (HHS) initial standards for electronic prescribing (set forth below) and how the initial standards interact with e-prescribing workflow. CMS intends to commit up to $6 million in FY 2006 to fund cooperative agreements awarded in response to this RFA. CMS is providing funds pursuant to an Interagency Agreement under which AHRQ, on behalf of CMS, will carry out the electronic prescribing pilot testing authorities per section 1860D-4(e)(4)(C) of the Social Security Act enacted by the MMA. The test results will be used to develop final e-prescribing standards. Subject to the adequacy of submissions and the availability of funds appropriated to CMS for fiscal year 2006, AHRQ will organize and administer the overall electronic prescribing pilot testing project pursuant to the above-referenced agreement with CMS. No more than 9 grants will be funded. No single award will be for more than $2 million. The pilot testing will be conducted for up to 12 months in calendar year 2006.

Application requirements and the criteria that will be used to evaluate the applications are set forth in the Request for Applications (RFA) below in the order indicated in the Table of Contents.

Authorities and regulations under which these grants will be funded are described in Section VIII.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2. Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5 . Funding Restrictions
   6. Other Submission Requirements

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
       1. Awardee Rights and Responsibilities
       2. AHRQ Staff Responsibilities
       3. Collaborative Responsibilities
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Purpose of the Pilot

An e-prescribing program under Medicare Part D will enable a prescriber to transmit a prescription electronically to the Medicare patient's choice of pharmacy, and will also enable prescribers and pharmacies to obtain from drug plans information about the patient's eligibility and benefits, including formulary information and information about medication history. Having access to this information at the point of care will make it possible for prescribers and pharmacies to make more informed decisions about appropriate and cost-effective medications. The Medicare Prescription Drug Improvement Modernization Act of 2003 (MMA) requires that prescriptions and certain other information for covered Part D drugs that are transmitted electronically must comply with final uniform standards promulgated no later than 2008 by the Secretary of the Department of Health and Human Services (HHS). These standards must meet MMA's requirements, as well as be compatible with other standards, including standards adopted under HIPAA.

The MMA calls for the HHS Secretary to adopt standards to enable electronic prescribing (e-prescribing) for the Medicare Part D program. Section 1860D-4(e)(4)(C) of the Social Security Act, as added by the MMA, generally requires pilot testing of standards prior to promulgation of the final uniform standards in order to provide for the efficient implementation of the standards. However, the statute provides an exception from pilot testing where there already is adequate industry experience with particular standards as determined by the Secretary of HHS after consultation with affected standard setting organizations and industry users. The Secretary of HHS carried out such consultations, and as a result proposed “foundation standards” that could be adopted for use when the Medicare Part D program begins in January 2006. The proposed foundation standards were published in an HHS Notice of Proposed Rulemaking (NPRM) on Electronic Prescribing, to be codified at 42 CFR 423. See 70 FR 6256 (February 4, 2005). Comments on the NPRM have been reviewed and a final rule is being prepared.

New and emerging standards, identified below as initial standards, will be pilot tested, for up to 12 months during calendar year 2006, under cooperative agreements entered into in accordance with this Request for Applications (RFA). The pilot project will examine the interoperability of these initial standards with the proposed foundation standards. The pilot project will be evaluated by the Secretary of HHS, and a report of the evaluation will be sent to Congress by April 1, 2007 as required under the MMA. Based on the results of the pilot project, the Secretary will adopt final uniform standards in 2008 in accordance with the timing prescribed by the statute.

To view the E-Prescribing and the Prescription Drug Program proposed rule, please use the following web link: http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-1773.pdf

Additionally, a set of questions and answers on the proposed rule can be found on the CMS web site at:
http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php?p_cat_lvl2=167

Information on the MMA can be found at:
http://www.cms.hhs.gov/MMAUpdate/

The MMA specifically directs the Secretary of HHS to “conduct a pilot project to test the initial standards…in order to provide for efficient implementation of the information requirements…” for an electronic prescription drug program, set out in section 1860D-4(e)(2); e.g. information on the drug being prescribed, possible interactions and warnings with respect to other drugs in patient medication history, as well as information on eligibility and benefits, such as drugs included in a formulary or tiered formulary structure.

There are several aspects to standards testing. The first is assuring that a format or code set actually works, i.e., it can effectively and unequivocally communicate the necessary information from sender to receiver. The second is assessing how the information being communicated flows into business processes and how use of initial standards affects those business processes.

Applicants funded under this RFA will conduct pilot testing of initial electronic prescribing standards listed below to allow AHRQ, on behalf of CMS, to determine whether vocabularies and code sets are unequivocal and can communicate needed information, and also how the initial standards to be tested interoperate with the foundation standards. Additionally, proposed projects will consider how information is transported, as well as the suitability and the impact of particular e-prescribing standards with respect to the work flow of the participants. In other words, are the right data being sent the right way and are they usable and useful to recipients. HHS is committed to supporting public-private partnerships that will result in interoperable, standards-based data sharing across multiple care sites and lead to measurable, generalizable and sustainable improvements in patient safety and quality of care. In order to promote national interoperability, investigators are encouraged to use whenever possible Federal health information interoperability standards that have been proposed by the Federal Government's Consolidated Health Informatics (CHI) Initiative and the National Committee on Vital and Health Statistics (NCVHS), and adopted by the HHS Secretary. Additionally, investigators are encouraged to be aware of the activities related to standards harmonization and certification processes underway through the Office of the National Coordinator for Health Information Technology and to engage with that process to the extent possible.

In this RFA, we have conditionally included the proposed foundation standards among the initial standards to be tested. (70 FR 6255) Because HHS has not published a final rule identifying the foundation standards, we cannot specify definitively which of the proposed foundation standards will be adopted as foundation standards. Any proposed foundation standard that is not subsequently adopted as a foundation standard will be included in this pilot as an initial standard. The pilot project seeks to test the interoperability of all initial standards with the foundation standards that are adopted. A summary of the initial and proposed foundation standards follows:

Framework for Proposals

Through the cooperative agreements awarded under this RFA, AHRQ, on behalf of CMS, will obtain information and develop greater understanding that will inform implementation of the e-prescribing components of the Medicare Prescription Drug Benefit program. Specifically, information obtained by addressing the following items will generate data regarding the reliability and usability of the initial standards described above in different care settings.

Core Evaluation Questions

The following questions must be addressed:

Project Characteristics

Application research designs should discuss the following proposed or planned project characteristics. Applications that do not address the items below will be returned without review.

Outcomes to be Reported

Applicants must describe the outcomes that will be reported. Examples include but are not limited to:

Additional Characteristics to be Considered

To improve the outcomes of the cooperative agreements, the following application characteristics will also be considered.

Applicants must offer a proposed evaluation methodology. Applicants should provide an estimate of what the proposed evaluation would cost. The actual evaluation for the entire pilot testing project will be done by an independent contractor.

All proposed cooperative agreements must comply with the privacy, security and transaction and code set requirements set forth under HIPAA.

Definitions

For the purposes of this RFA, the following definitions are applicable:

E-prescribing - also called electronic prescribing, is the transmission, using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan, either directly or through an intermediary including an e-prescribing network. E-prescribing includes two-way transmissions between the point of care and the dispenser. (Please note that these functions can be performed using single purpose software or electronic prescribing functionality imbedded in a multifunctional system such as electronic health record.)

Medication Error - is defined as preventable, inappropriate use of medication including prescribing, dispensing, and administering.

Adverse Drug Event - is defined as an untoward and unintended (usually), and negative outcome that occurs in association with therapeutic drug usage. Preventable adverse events are a subset of adverse events that are judged to have been avoidable if appropriate and reasonable steps had been taken. For example, an anaphylactic reaction to penicillin is an adverse event. It is a preventable adverse event if the patient's allergy to penicillin is noted in his or her chart or if the patient knows of his or her history of penicillin reactions and is capable of communicating it to the clinician.

Prescriber - a physician, dentist, or other person licensed, registered, or otherwise permitted by the U.S. or the jurisdiction in which he or she practices, to issue prescriptions for drugs for human use.

RxNorm - is a clinical drug nomenclature produced by NLM, in consultation with the FDA, VA, and HL7. It provides standard names for clinical drugs and for dose forms as administered.

Section II. Award Information

1. Mechanism(s) of Support

This RFA will use a cooperative agreement (U18) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the project proposal. Under cooperative agreements administered by AHRQ, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with agency staff being substantially involved, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

CMS intends to commit up to $6 million to fund cooperative agreements in accordance with the terms of this RFA. The anticipated range of each cooperative agreement award will be between $500,000 and $2 million in total costs (direct and indirect). An applicant may request a project period of up to 12 months. The Government does not plan to continue the projects beyond the awarded project period. Applications proposing project periods of more than 12 months will be returned without review. Expanded authorities that are applicable to AHRQ grant awards (which pertain to the extension of a grant project period and the carryover of funds) are not available to CMS awards under this RFA and or to one year projects. The size of the award may vary based on the specific funding needs of each application.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization has any of the following characteristics:

If an application proposes a plan for pilot testing initial standards that will be conducted through a collaborative arrangement, such as a public/private partnership or consortium, the application must specify the details of the arrangement. This includes, but is not limited to, the names of the participating entities, a description of roles and responsibilities for each, breakdowns of funding for each, and description of nonmonetary contributions (such as training) for each. If this information is not included, the application will be returned without review.

As specified by MMA, CMS intends to enter into cooperative “agreements with physicians, physician groups, pharmacies, hospitals, PDP sponsors, MA organizations, and other appropriate entities under which health care professionals electronically transmit prescriptions to dispensing pharmacies and pharmacies” to be administered by AHRQ on behalf of CMS. Other appropriate entities include long term care facilities and rural health clinics.

Because this RFA is intended to increase the safety, efficiency, and reliability of prescribing in the U.S., foreign institutions are not eligible to apply. Foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by foreign institutions will be returned without review. Organizations described in sections 501(c)(4) of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with eligible institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to submit an application on behalf of their institutions..

The Principal Investigator should be an experienced senior level person familiar with managing organizational change and IT program implementation. This person must devote at least 25% of his/her time to this project. The required 25% may not be split between more than one individual PI at any given time. Applications that do not meet this requirement will be returned without review.

2. Cost Sharing or Matching

There is no cost sharing, cost matching, or cost participation requirement associated with this project. However, applicants are encouraged to contribute resources to the project that will improve the quality or effectiveness of the outcome. Institutional contributions should be detailed as appropriate.

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

Applications for this AHRQ-administered research project must be prepared using the forms listed below. These application forms are available in a fillable pdf format on the CMS web site at http://www.cms.hhs.gov/researchers/priorities/GrantAppnInfo2005.pdf.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications for this AHRQ-administered research project must be prepared using the forms listed below. These application forms are available in a fillable pdf format on the CMS web site at www.cms.hhs.gov/researchers/priorities/GrantAppnInfo2005.pdf. Applicants should note that the applicable review and selection processes, including review criteria, are discussed in Section V of this RFA. Evaluation criteria provided in the Standard Form 424 (SF-424) application instructions will not be used for review of applications submitted in response to this RFA. Applicants should also note that, as discussed in Section III.2, this RFA does not contain a requirement for cost sharing. Thus, within the SF-424 Guidelines for Application Content (see page 5, Level of Effort) the discussion regarding an expectation of cost sharing is not applicable.

Applicants should provide a detailed breakdown of the aggregate numbers for the budget recorded on S-F 424 as well as a programmatic justification for the numbers. The breakdown should include personnel (name of each individual, role on project, percent effort, salary requirement) as well as other budget categories. Similar level of detail should be included for all collaborating institutions. At the time of award AHRQ staff may request additional information for those applications selected for funding.

Regarding submission of applications, applicants should follow the procedures indicated in Section IV.3.B of this RFA rather than submission procedures provided in the SF-424.

Application Form

In addition to a “project narrative” that provides a detailed description of the proposed project, the grant application should include the following completed forms.

Form SF-424, Application for Federal Assistance – this is the cover sheet to the application. It must be completed and signed.

Form SF-424, Budget Information – information about the proposed budget should be shown on this form. More detailed budget information can be shown on attached pages.

Form SF-424-B, Assurances, and the Additional Assurances: Certification forms. These forms must be signed and included with the application.

Applicants may not use the Modular Grant Application and forms. Applications submitted in modular format will be returned without review.

Technical Assistance

Potential applicants are encouraged to take advantage of a conference call that will be conducted by AHRQ staff.  This conference call will provide potential applicants with background information and will address questions about the preparation of an application in response to this RFA.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to eprescribingRFA@ahrq.gov by September 28th .  Questions of a similar topic and nature may be grouped at the sole discretion of agency staff. The conference call is open to any individual or organization intending to apply.  Participation is not a prerequisite to applying.  The conference call will take place on September 29th at 1 PM EDT and last approximately 2½ hrs. To register to participate in the call , please send your request to eprescribingRFA@AHRQ.gov by September 28th.

Transcripts of the conference call will be available seven business days after the call on the AHRQ website: http://www.ahrq.gov.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Technical Assistance Conference Call: September 29, 2005
Letter of Intent Receipt Date: October 7, 2005
Application Receipt Date(s): October 25, 2005
Peer Review Date: December 2005
Earliest Anticipated Start Date: December 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allow AHRQ staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document and as noted above.

The letter of intent should be sent to:

Jon White, MD
Agency for Healthcare Research and Quality
540 Gaither Road
Room 6121
Rockville, MD 20850
Telephone: (301) 427-1171
FAX: (301) 427-1597
Email: eprescribingRFA@ahrq.gov

3.B. Sending an Application to the NIH

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Jon White, MD
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1171
FAX: (301) 427-1597
Email: eprescribingRFA@AHRQ.GOV

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the AHRQ . Incomplete and non-responsive applications will not be reviewed.

Any application in response to this funding opportunity that is essentially the same as one currently pending initial review will not be accepted, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Applicants are encouraged to read all SF-424 instructions prior to preparing an application in response to this RFA. A pplications violating these requirements will be returned without review.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of pilot testing. .

The RFA is also available on the AHRQ Web site, http://www.ahrq.gov, (see under Funding Opportunities).

Although there is no immediate acknowledgement of the receipt of an application, applicants generally are notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm (See also Section VI.3. Reporting.) Applications proposing testing as part of this project beyond the end of calendar year 2006 will be returned without review.

6. Other Submission Requirements

Priority Populations

The Healthcare Research and Quality Act of 1999 (42 USC 299, et. seq.) directs AHRQ, in carrying out its work, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). AHRQ will follow this policy in making award recommendations to CMS. Applicants under this RFA should be guided by this notice to develop research designs that include, if possible, populations specified in the Notice. 

Publication Transmittal: General AHRQ Requirements

In keeping with the AHRQ's efforts to translate the results of AHRQ-assisted health care research into practice and policy, grantees and/or contractors are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles derived from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will require thoughtful coordination between the press offices of the grantee's or their sub-contractor's institutions and OCKT. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and their sub-contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of its research coordination and assistance efforts. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ-administered grant awards, and other information helpful in evaluating the impact of such research.

AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their research conducted pursuant to awards made under this RFA. Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants' potential for responsible stewardship of awarded funds.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. This regulation does not apply directly, but CMS has requested that AHRQ use these procedures in evaluating and administering the cooperative agreements under this RFA.

As part of the initial merit review, all applications:

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals outlined in the RFA. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have a major impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Applications will be assessed in two specific areas: 1) technical merit of the proposed pilot; and 2) potential of the new and existing organizations to implement the pilot. Peer reviewers will be asked to specifically comment in these two areas.

The Director of AHRQ will make recommendations to CMS,for the final selection of applications from among the most highly qualified applicants, taking into consideration a number of factors including operational feasibility, geographic location, and program priorities (for example, informing Part D implementation). AHRQ reserves the right to conduct one or more site visits before making recommendations for awards. It is anticipated that grant award decisions will be made in late 2005 and that grant activities will begin immediately thereafter.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Also, the adequacy of attention to priority populations (see discussion on Priority Populations in the section on Other Submission Requirements, above, and in the section on Required Federal Citations, below.)

2.B. Additional Review Considerations

Peer reviewers will be asked to comment on the following features of applications:

Geographic diversity (regional and urban vs. rural) will be sought as will a mix of provider types and large and small entities. Applications from public/private partnerships whose patient base includes Medicare beneficiaries are encouraged. Programs will be noted if their organization and patient population will yield results that are relevant to the Part D program. Proposals with a plan for both intervention and control sites are encouraged.

Cooperative agreements conducted at multiple sites and proposals which employ partnerships beyond a single provider network are also encouraged. The primary focus of the e-prescribing in the MMA is ambulatory settings; however partnerships that include prescription flow between ambulatory and long term care or inpatient settings are encouraged. Partnerships may be formed across various components of the health care delivery system, potentially including traditional and non-traditional partners, State and local governments, educational institutions, payers, providers, community organizations, not-for-profit and for-profit entities. Strengths of such partnerships, with particular emphasis on the operations of the partnership, evidence of progress toward concrete accomplishments, active participation, and resource allocation from partners toward the project, and ability to demonstrate broad community commitment will all be assessed favorably.

Proposed projects which offer and evaluate the impact of financial incentives for electronic prescribing are also encouraged. Finally, use of the FDA/NLM structured product labeling for electronic drug information is encouraged.

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ–supported study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. Because CMS is requesting that AHRQ provide administrative support for this pilot project, applicants should be aware of the above statute and describe procedures that they will use to ensure the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. In addition, all proposed projects must address how the pilot will comply with any applicable privacy requirements set forth in 42 CFR Parts 160 and 164. Individually identifiable health information collected by covered entity awardees will be managed in accordance with Federal regulations pertaining to the privacy of protected health information. These privacy regulations, developed by HHS pursuant to HIPAA are mandatory for all covered entities. These regulations serve to limit the use and disclosure of individually identifiable health information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, for example, health plans, generally must obtain either patient authorization of disclosures of individually identifiable health information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) in accordance with the standards set by 45 CFR § 164.512(i)(1)(ii). The HHS Office of Civil Rights is the enforcement body for these privacy regulations. All proposed project descriptions must also address how the pilot activities will comply with any applicable provisions of the HIPAA security and transaction and code set requirements in 42 CFR Parts 160, 162, and 164.

Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa.

The awardee should ensure that computer systems containing “electronic protected health information,” as defined in 45 CFR § 160.102, have a level and scope of security that equals or exceeds those established under the HIPAA Security Rule as well as those set by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

2.D. Sharing Research Resources

Rights in Data

Awardees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes, in accordance with 45 CFR Parts 74 and 92. Government purposes may include making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to budget constraints, final products may be made available to the health care community and the public, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish its statutorily mandated distribution of research products that it helps to develop, AHRQ publicizes research findings that have been produced with its support, but relies on awardees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities.

3. Anticipated Announcement and Award Dates

Cooperative agreement awards will be made to successful applicants late in 2005. The project period for the e-prescribing pilots will be from the date of the award through December 31, 2006. The pilot testing will be conducted in calendar year 2006, as required by the MMA. Depending on the scope of the project, testing can be conducted during part of the year, or span the entire year. Ideally the pilots will be conducted concurrently. The Agency will not look favorably upon requests to extend the projects beyond December 31, 2006.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a summary statement.

If the application is under consideration for funding, AHRQ will request “just-in-time” information from the applicant. Just-in-time information generally consists of other support information for key personnel and any necessary IRB review and approval of protection of human subjects involved in the project under 45 CFR Part 46.

Selection of an application for award is not an authorization to begin performance. The notice of award signed by the grants management officer is the authorizing document that indicates that performance may begin. Notification will be made electronically to the designated administrative/institutional official. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from AHRQ, on behalf of CMS, to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative Requirements

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award.

Awardees should be aware that compliance with the Paperwork Reduction Act (44 U.S.C. Ch. 35) might require Department and OMB review of data collection instruments in which case some grantee time may be required to explain, defend or amend data collection instrument items. (See also 5 CFR 1320)

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines: HHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable when State and local Governments), and other HHS, PHS, and PHS grant administration policy statements. CMS has requested that AHRQ use these procedures in evaluating and administering the cooperative agreements under this RFA.

The administrative and funding instrument used for this program will be the cooperative agreement (U18), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ and CMS programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the AHRQ and CMS as described in this subsection of the RFA.

2.A.1. Awardee Rights and Responsibilities

Awardees will have primary and lead responsibilities for the respective project, including project design and protocol development, participant recruitment, development of measures, data collection, quality control, preparing reports, participating in required phone calls and meetings, and preparation of presentations and publications related to their projects. During the course of the project period, awardees are expected to meet the requirement of compliance with the CHI-adopted Federal Health information interoperability standards, or if this is not met, provide a detailed explanation as to why it was not. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access and use consistent with current Department of Health and Human Services regulations and other policies referenced in this notice.

2.A.2. AHRQ Staff Responsibilities

CMS and AHRQ Program Officials will have substantial scientific and programmatic involvement in guiding grant activities to address priority issues of CMS, the Department of Health and Human Services, or the Federal Government regarding the use of e-prescribing to improve patient safety and quality of care. Specific cooperative tasks and activities in carrying out individual projects may be shared among the awardees, AHRQ and CMS Program Officials. AHRQ staff, on CMS's behalf, may also provide expertise/technical assistance to the awardees, e.g. helping to ensure that high quality statistical and analytical standards mandated in 42 USC 299c-2(b) are met, and assisting them with their project activities or in coordinating the activities of different grantees. However, as indicated above, the dominant role and prime responsibility for project activities will reside with the awardees. Site visits by AHRQ staff or their agents may be conducted.

2.A.3. Collaborative Responsibilities

When appropriate and feasible, awardees will be expected to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects. These collaborative relationships may be facilitated by AHRQ and CMS, instigated by the awardees through self-identified opportunities, or developed via other mechanisms during the life of the project. The pilots will be expected to collect data as specified in the RFA and by the project officer. It is expected that the cooperative agreements will be conducted in a dynamic environment with AHRQ and CMS reviewing the results on an ongoing basis.

There will be an independent evaluation contractor for these grants. Evaluation contract activity is not intended to evaluate the specific performance of individual projects but rather to provide an objective, comprehensive, and longitudinal view of the electronic prescribing pilot project overall.  All awardees under this RFA are required to cooperate fully with the evaluation contractor.

3. Reporting

Project Monitoring Requirements:

Meetings

Applicants must include in their proposal provision for attendance of up to two organizational representatives at two meetings for the purpose of project discussions. Grantees must attend an initial kickoff meeting in the Washington, DC area to meet AHRQ and CMS staff and review work plans.

Each grantee will have a monthly progress telephone conference with AHRQ, with the option of more frequent calls at the discretion of AHRQ and CMS. Topics to be covered in the monthly calls include but are not limited to:

Additionally, grantees will participate in monthly progress telephone conferences between AHRQ, other grantees, and the evaluation contractor.

Reports

Awardees must agree to cooperate with any Federal evaluation of the program and provide initial, quarterly and final reports as prescribed by AHRQ, on behalf of CMS, (including the SF-269a Financial Status Report form). The reports will be designed to outline how cooperative agreement funds were used and to describe program goals, objectives, progress and barriers. Awardees also agree to provide data on key aspects of their system improvements, scaled to the size of their cooperative agreement award.

In order for AHRQ and CMS to monitor awardees' efforts toward reaching the legislative goals for these pilot projects, awardees must submit the following required reports throughout the period of performance:

Initial Report:

Quarterly Report

The awardee must report, by the 10 th working day after the close of each project quarter, information reflecting the experience of the pilot.

Quarterly written progress reports in a format specified by AHRQ (electronic and hard copy) include:

Data must also be provided to the evaluation contractor on a quarterly basis.

Final

The awardee must submit a final report by the 30 th working day after the close of the project. This deviation from the standard 90 days is due to the statutory reporting requirement to Congress contained in the MMA.

Final report should include:

Formal Evaluation

Independent of this solicitation, AHRQ, on behalf of CMS, will contract with an evaluation contractor who will undertake and provide a formal evaluation of pilot test project results. The independent evaluator will analyze the experience of the pilot sites and how each of the initial standards performed. Grantees will interact with the evaluation contractor as required by the project officer. The evaluation contractor will prepare a project assessment report based on the project data. This report will be used to form the basis for a Report to the Congress.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Direct your questions about scientific/research issues, including information on the inclusion of priority populations in the study to:

Jon White, MD
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1171
FAX: (301) 427-1597
Email: eprescribingRFA@AHRQ.GOV

2. Peer Review Contacts:

Direct your questions about peer review issues to:

Scott Andres, Ph.D.
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1546
FAX: (301) 427-1562
Email: sandres@ahrq.gov

3. Financial or Grants Management Contacts:

Direct your questions about AHRQ financial or grant management matters to:

Al Deal
OPART - Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
FAX: (301) 427-1462
Email: adeal@ahrq.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women, Minorities, and Children in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported or AHRQ–assisted research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES).

AHRQ also encourages investigators to consider including children in study populations, as appropriate.

Access to Research Data through the Freedom of Information Act:

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon a federally-supported research project, the underlying data is not subject to this disclosure requirement. However, if a Federal regulatory action is taken in reliance on an AHRQ-supported data collection, under FOIA, 5 USC 552(b), statutorily protected confidential identifiable data,is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its potential impact on data collected under this pilot. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Standards for Privacy of Individually Identifiable Health Information:
HHS issued the last modification to the "Standards for Privacy of Individually Identifiable Health Information", on August 14, 2002. This regulation was mandated by HIPAA which governs the protection of individually identifiable health information. It is administered and enforced by the HHS Office for Civil Rights (OCR). Compliance with the Privacy Rule is mandatory (for those classified as covered entities under the Rule).

Decisions about applicability and implementation of the Privacy Rule reside with covered entities. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is staff of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Healthy People 2010:
HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. Therefore, applicants are encouraged to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/, Number 93.779. Awards are made under Section 1860D-4(e)(4)(C) of the Social Security Act. Awards will be administered using procedures described in the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. CMS has requested that AHRQ use these procedures in evaluating and administering the cooperative agreements under this RFA.

HHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children.


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