# Surveillance for outcomes of genomic medicine policies

> **NIH NIH R35** · HARVARD PILGRIM HEALTH CARE, INC. · 2020 · $570,612

## Abstract

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.

## Key facts

- **NIH application ID:** 10046759
- **Project number:** 1R35HG011285-01
- **Recipient organization:** HARVARD PILGRIM HEALTH CARE, INC.
- **Principal Investigator:** Christine Lu
- **Activity code:** R35 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $570,612
- **Award type:** 1
- **Project period:** 2020-09-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10046759

## Citation

> US National Institutes of Health, RePORTER application 10046759, Surveillance for outcomes of genomic medicine policies (1R35HG011285-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10046759. Licensed CC0.

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