P03 - JA - 36C24E-23-AP-0001 - Assessing Quality in MISSION Era.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-23-AP-0001

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) East 1010 Delafield Road Pittsburgh PA 15215-1802

Requiring Activity:

Department of Veterans Affairs, VISN 506 Ann Arbor VA Medical Center 2215 Fuller Road Ann Arbor, MI 48105-2303

Purchase Request 2237 Number: 506-23-1-1383-0012

2. Nature and/or Description of the Action Being Processed:

This request is for Other Than Full and Open Competition for the procurement of a new, Firm Fixed Price contract with the the President and Fellows of Harvard College dba Harvard Medical School (“Havard”) for the acquisition of Research and Development Subject Matter Expert Services to adapt/translate a set of claims-based measures developed by Harvard for use in Medicare data to VA data. The anticipated value of this requirement inclusive of a base period of one year and three one-year options periods for an estimated period of performance of May 26, 2023-May 25, 2027 is approximately $693,667.00:

Estimated Total Value Base Year: $191,284.00 Option Year 1: $193,528.00 Option Year 2: $183,833.00 Option Year 3: $125,013.00

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This is a new requirement for the Ann Arbor VA Medical Center. The Ann Arbor VAMC requires the subject matter expertise of the Harvard researchers to adapt/translate a set of claims-based measures developed by Harvard for use in Medicare data to VA data for the HSR&D funded study titled ‘Assessing Quality of VA and Community Care in the MISSION Era.” The researchers at Harvard are the sole known developers and providers of the claims-based measure algorithms required for this study, which are not available to the public commercially or from any other known vendor at this time. The vendor will use data from CMS for fee-for-service Medicare enrollees in the U.S.

attributed to oncology practices in the U.S. to conduct an analysis to estimate differences in measure performance for patients cared for at U.S. practices contracted to provide VA community care for cancer to those cared for at neighboring U.S. practices that do not provide VA community cancer care.

4. Statutory Authority Permitting Other than Full and Open Competition:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The research project requires the use of claims-based quality measures that assess cancer care quality in four specific domains: timeliness of care, underuse of evidence-based services, overuse of treatment or service, and complications.

Harvard University has already begun conducting research in this area using such claims, which involves significant investment in validating existing administrative data and defining outcomes as well as clinical expertise in understanding what defines appropriate care. Researchers, such as Dr.

Keating at Harvard University, have already published multiple peer reviewed articles on their findings using these algorithms:

(1) Keating NL, Cleveland JLF, Wright AA, et al. Evaluation of Reliability and Correlations of Quality

Measures in Cancer Care. JAMA Netw Open. 2021;4(3):e212474

(2) Keating NL, Jhatakia S, Brooks GA, et al. Association of Participation in the Oncology Care Model with Medicare Payments, Utilization, Care Delivery, and Quality Outcomes. JAMA.

2021;326(18):1829-1839

(3) Keating NL, Landrum MB, Samuel-Ryals C, et al. Measuring Racial Inequities in The Quality Of Care Across Oncology Practices In The US. Health Aff (Millwood). 2022;41(4):598-606.

The team has also developed code to attribute patients to medical oncologists and medical oncology practices, demonstrating their grasp of clinical practice in the field of oncology.

Reference:

(4) Gondi S, Wright AA, Landrum MB, Meneades L, Zubizarreta J, Chernew ME, Keating NL.

Assessment of Patient Attribution to Care From Medical Oncologists, Surgeons, or Radiation Oncologists After Newly Diagnosed Cancer. JAMA Netw Open. 2021 May 3;4(5):e218055.

Several unique features require the services of the Harvard team. First the measurement team at Harvard developed and maintains the exact claims-based measure algorithms required for the study. These measures they have created are not yet in the public domain, not available commercially, and not available anywhere else. It would require another entirely separate grant to develop the measures independently, and independent development would risk losing the congruence of measures across payers that is one of the key features of national core measure set initiatives.

Second, the measurement team has substantial experience examining quality of care using administrative data and brings extensive prior experience examining care deliver and outcomes for individuals with cancer across care settings, including the VA. In fact, members of the Harvard measurement team previously co-led a congressionally-mandated evaluation of the quality of oncology care delivered in VA vs. the private sector (2001-2004) and have examined variation in cancer care across VA facilities. Further, they have expertise in several of the innovative methods proposed in the current study.

Third, the measurement team has expertise in mapping the Medicare data elements required by our measures to VA databases and can work closely with the Ann Arbor team to ensure measures are mapped appropriately to allow operationalization in VA data. Further, the study involves the development of several new measures relevant to VA and not available in the Harvard measure set (e.g., prostate cancer related measures) and the measurement team has the experience and data required to operationalize those in CMS data.

Fourth, this collaboration is synergistic with a grant held by the Harvard team which is using these claims-based measures to look at how the organization of U.S. oncology practices affects quality of care. The collaboration thus offers a unique opportunity to identify and compare quality for non-VA practices with whom the VA contracts for cancer care with those in the same area who do not contract with VA, a key policy question about the adequacy of community care networks for the VA and a Specific Aim of the current study. Harvard has the expertise, code and data required to complete this Aim of the study.

Market research indicates that there are not at least two VIP verified eligible SDVOSB/VOSBs or other SB concerns that can fulfill this requirement. An intent to sole source under notice ID 36C24E23Q0104 was issued from 3/23/2023 to 3/28/2023 to inform industry that a requirement for research and development subject matter expert services would be solicited. That notice yielded no responses. No SB concerns in any socioeconomic category responded to the notice, nor appears capable of fulfilling this requirement. Market research supports that this requirement can only be fulfilled by Harvard.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Notice ID 36C24E23Q0104 was posted to the GPE from 3/23/2023 to 3/28/2023. The Contracting Specialist/Contracting Officer did not receive any expressed interest from any other source than the Harvard. No SB concerns in any socioeconomic category responded to the posted notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Price is expected to be fair and reasonable and will be evaluated against prices in the current market for similar services, comparison of proposed prices found reasonable on previous purchases, current price lists Harvard charges the public and other Government entities for the substantially same item, and comparison to the Independent Government Estimate. Market research prices indicate that comparable research and development services prices from Contract 75A50120C0018 awarded in May 2020 for $592,791.00 for R&D for system and algorithm optimization for patient population;

from 75N91020C00033 awarded June 2021 for $361,254.00 for developing an MHealth application for use in Patient Navitor Breast Cancer Care Workflows; and from Contract 75N91021C00038 awarded in January 2023 for $397,359.00 for reconstruction algorithm for personalized radiopharmaceutical therapy have been determined fair and reasonable by BARDA and NIH NCI Contracting Officers. Furthermore, since this contract will be issued on a sole source basis, negotiations and discussions with the contractor may be required to establish price reasonableness, as further determined by the scope and requirements of the project. All these steps will be taken by the Contracting Officer to ensure fair and reasonable pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described above, market research, in accordance with FAR Part 10, was conducted by advising industry of the pending acquisition and soliciting inquiries from interested parties. No interested parties submitted capability statements. A review of the Vendor Information Page (VIP) was conducted as required and zero (0) possible vendors were identified such that there is no reasonable expectation that an SD/VOSB could fulfill VA’s requirement. Based on the information above, only Harvard can provide the service described.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition The researchers at Harvard are the sole known developers and providers of the claims-based measure algorithms required for this study, which are not available to the public commercially or from any other known vendor at this time.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

President and Fellows of Harvard College Doing Business As: Harvard Medical School 25 Shattuck St.

Boston, MA 02115-6027

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

There are no actions to be taken to remove or overcome barriers to competition. The inherent nature of the intellectual property of the required algorithms restricts possible sources; and homogeneity across usage in order to have comparable results requires that the research at the Ann Arbor VA incorporate the Harvard team’s previous research. Only Harvard is able to meet the requirement identified.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Name Date Title Facility

Rachel R. Lipson 1148367

Digitally signed by Rachel R.

Lipson 1148367 Date: 2023.05.08 16:12:24 -04'00'

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Michael Haydo Date Contracting Officer RPO East, VHA

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Seth J. Custer Date Division Chief VHA R&D Contracting Division RPO East, VHA https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

VHALEBCUSTES

Typewritten Text 5/16/2023