Wednesday, December 24, 2025 12/24/2025

Surveillance for outcomes of genomic medicine policies

Award Number: R35HG011285
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

Group Awards By:

View Award Description

Surveillance for outcomes of genomic medicine policies - PROJECT SUMMARY/ABSTRACT Patients and health care professionals are now able to use genetic information to help prevent, diagnose and select treatments for diseases. Health policies can improve or reduce access to genomic tests. Implementation of policies for genomic tests is growing rapidly but we know little about the effects of such policies. There are currently no surveillance structures in place to examine outcomes associated with policies for genomic tests. Randomized trials are generally not feasible to examine the effects of policies. Monitoring the outcomes of policies is an important public health issue. I propose to advance the field of genomic medicine research and practice by developing and validating analytical methods for efficient, rigorous evaluation of policies that could impact access to genomic tests and associated outcomes. My vision is to pioneer a new approach for efficient, rigorous evaluation of outcomes of genomic medicine policies. I will lead a team to build the foundation by adapting and validating rigorous analytical methods in a distributed data network environment that enables efficient but privacy-preserving multi-site analyses of data from large, diverse populations. We will lay the groundwork through two innovative outputs: (1) Adapt one of the strongest quasi-experimental study designs, the interrupted time series method, for novel applications: evaluation of policies for genomic tests. We will adapt the method within a renowned distributed data network of 17 health systems. No single system has sufficient data for genomic medicine. This approach allows efficient aggregation of data across sites from large, diverse populations without sharing person-level information (patient privacy-preserving); and (2) Showcase and refine our analytical methods by using a test case: we will evaluate the consequences of Medicare’s coverage of next-generation sequencing for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer. Our approach will have broad applicability for other policies for genomic tests and/or related services. The United States, as the world’s leader in precision medicine, has a vital stake in analytical tools for assessing rigorously and efficiently the effects of policies for genomic tests—a much-needed resource for patients, clinicians, policymakers who seek to maximize individual and population health through the integration of genomic medicine into healthcare policy and practice.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$467,045 )
2026	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Human Genome Research	000	5	12/17/2025	NON-COMPETING CONTINUATION	-$467,045
														Subtotal = -$467,045

Issue Date FY: 2024 ( Subtotal = $485,882 )
2024	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Human Genome Research	001	5	9/25/2024	NON-COMPETING CONTINUATION	$485,882
2024	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Human Genome Research	002	5	9/27/2024	NON-COMPETING CONTINUATION	$0
2024	2023	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Human Genome Research	000	4	9/25/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $485,882

Issue Date FY: 2023 ( Subtotal = $484,596 )
2023	2023	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Human Genome Research	000	4	9/19/2023	NON-COMPETING CONTINUATION	$484,596
														Subtotal = $484,596

Issue Date FY: 2022 ( Subtotal = $485,832 )
2022	2022	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Human Genome Research	000	3	7/27/2022	NON-COMPETING CONTINUATION	$485,832
														Subtotal = $485,832

Issue Date FY: 2021 ( Subtotal = $487,556 )
2021	2021	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Human Genome Research	000	2	6/14/2021	NON-COMPETING CONTINUATION	$487,556
														Subtotal = $487,556

Issue Date FY: 2020 ( Subtotal = $570,612 )
2020	2020	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Human Genome Research	000	1	9/1/2020	NEW	$570,612
														Subtotal = $570,612

Grand Total All Awards = $2,047,433

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Surveillance for outcomes of genomic medicine policies

Award Number: R35HG011285

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer