Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana

Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications

Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations.

PCORI Proposal COVID-19- Related Enhancement for Existing Research:

The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic:

1. Disparities in continuity of care and
2. Health systems' responsiveness in terms of telehealth delivery for high risk populations.

The enhancement builds upon our current project by further examining effects of CMS payment innovations to expand remotely delivered care. Our proposed study is a rapid assessment of telehealth services, using an existing "learning health system" infrastructure to provide timely, actionable evidence to inform telehealth service provision during the pandemic and recovery.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Chronic Disease

Detailed Description

The first aim is to evaluate the barriers and facilitators for the RE-AIM dimensions as related to the new CMS chronic care management code overall and within each of the health systems. The qualitative study will be used. Focus group interview will be conducted among patients, healthcare professionals and stakeholders. A variety of qualitative techniques will be used to collect data using key informant interviews among organization leaders of LaCDRN partners to assess the organizational cultures, their social architecture, resources, capacity, and communication networks. Face-to-face semi-structured interviews will be used to explore these domains, assess barriers, and refine the data collection for the assessing the RE-AIM framework. Further, semi-structured interviews will provide data to inform the refinement of study outcomes and ensure organizational, cultural, and health-literacy appropriateness. Focus groups will be audiotaped with the written consent of each participant, and each tape will be transcribed verbatim and transcripts will be reviewed and edited by the facilitators for accuracy. Inter-coder reliability will be examined. Interview transcripts will be imported into NVivo 10 software (QSR International, Burlington, MA). Codes and concepts identified in preliminary review will be refined, extended, and cross-referenced. Coded texts will be structured into taxonomies and transformed into a matrix format so that responses and concepts can be compared across respondent groups. Finally, taxonomies and matrices will be summarized by similarities and contrasts to form overarching themes and dimensions. We will use an iterative technique until theoretical saturation, the point at which no additional major themes emerge, is reached. Diabetes care coordination readiness assessment will be conducted with LaCDRN partner health system's medical directors (organizational).

The second one is the health and economic impacts of the NFFCCM to improve health outcomes: glycemic control, CVD risk reduction, medication adherence, patient-reported outcomes (PRO), and health care utilization. Data extraction from the REACHnet. De-identified data from EMR includes birth year, gender, race, state of residency, zip-codes, medical history, lab results and prescriptions. All data comply with the Health Insurance Portability and Accountability Act (HIPAA).

This proposed research is significant because it is the first natural experiment to test an ongoing CMS reimbursement policy on diabetes care in Louisiana. The study questions and study outcomes will be patient-centered, and will generate urgently needed data on effective, practical, and sustainable population-targeted strategies aimed at reducing diabetes-related disease burden in Medicare-eligible populations. Further dissemination and scale-up efforts will create large return on multiple health systems and non-CMS populations.

PCORI Proposal COVID-19- Related Enhancement for Existing Research Aims:

Aim1: Examine facilitators and barriers to uptake, adoption, and implementation of telehealth services among Medicare patients with diabetes from health systems', providers' and patients' perspectives. With the substantial increase in telehealth encounters starting in early March 2020, we hypothesize disparities in adoption and implementation of telehealth at health system, provider and patient levels. For example, our current project has identified significant variations in NFFCCM implementation across three health systems in Louisiana. For the enhancement, we intend to examine variations in health systems' implementation of Medicare-reimbursable telehealth services, which may not mirror the variations we observed for NFFCCM given the dramatically different context of the current pandemic.

Aim 2: Compare diabetes control and continuity of care between patients with and without utilization of telehealth. We hypothesize better diabetes management among Medicare patients with telehealth versus without.

• Study Type: Observational
• Enrollment (Actual): 22242

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane School of Public Health and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population includes Healthcare professionals who treat diabetes patients, medical directors at Louisiana Clinical Data Research Network (LaCDRN) affiliated clinics, patients with diabetes, patients who are registered with REACHnet, and medical records from LaCDRN affiliated clinics.

Description

Healthcare professionals (physician, nurse) will be randomly selected from LaCDRN partner health system.

• Inclusion criteria: physicians and nurses who treat diabetes patients and work at clinic settings within LaCDRN network and consent to participate the study.
• Exclusion criteria: physicians and nurses who do not treat diabetes patients or not work at clinic settings within LaCDRN network; refuse to participate the study.

Patients for qualitative study:

• Inclusion criteria: Diabetes patients who consent to participate the study; Age 65+; Diagnosis code for diabetes in the last 2 years; Diagnosis code for at least one additional chronic condition in the last 2 years.
• Exclusion criteria: age<65; patient with diabetes without other chronic conditions.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
EMR data extraction; EMR Data extraction from the Louisiana Clinical Data Research Network (LaCDRN). The Louisiana Clinical Data Research Network (LaCDRN) data will be requested, including patients' records of pharmacy, inpatient, outpatient and lab results from January 01, 2016 to December 31, 2021. It is a retrospective data analysis without interaction with any participants. All data is de-identified and the study participants will not be contacted in any way. Inclusion criteria: Patients with type 2 diabetes, whose age>=18 years old will be extracted from database of LaCDRN. Exclusion criteria: Patients without type 2 diabetes or age<18 years old.
Healthcare Professionals; Healthcare professionals (physician, nurse) will be randomly selected from LaCDRN partner health system. An email will be distributed to the registered clinicians at partner health systems. Inclusion criteria: physicians and nurses who treat diabetes patients and work at clinic settings within LaCDRN network and consent to participate the study. Exclusion criteria: physicians and nurses who do not treat diabetes patients or not work at clinic settings within LaCDRN network; refuse to participate the study.
Patients for Qualitative Study; Patients with diabetes who are a members of Diabetes Advisory Group or partner LaCDRN health system will be contacted via email, letter or phone call. Inclusion criteria: Diabetes patients who consent to participate the study.; Age 65+;; Diagnosis code for diabetes in the last 2 years;; Diagnosis code for at least one additional chronic condition in the last 2 years. Exclusion criteria: age<65; patient with diabetes without other chronic conditions.
LaCDRN partner health system's medical directors; Face-to-face semi-structured interviews will be used to explore organizational cultures, their social architecture, resources, capacity, communication networks, assess barriers, and refine the data collection for the assessing the RE-AIM framework. The one time interview will take 1 hour. A 10 minutes questionnaire of Diabetes care coordination readiness assessment (DCCRA) will be emailed to them annually during entire 5 years of study period.
PROMIS® survey; Patients for PROMIS® survey (National Institutes of Health's Patient-Reported Outcome Measurement Information System Global Health Measures). Patients will be administered the surveys at the point-of-care visit (in exam rooms) using REACHnet's tablet-based application. Inclusion criteria: All patients age 18+ who registered at REACHnet.; Able to provide informed consent Exclusion criteria: patients who do not provide inform consent or age<18 years old.
PACIC+ survey; Patients for PACIC+ survey (Group Health Research Institute's Patient Assessment of Care for Chronic Conditions+). Patients will be administered the surveys at the point-of-care visit (in exam rooms) using REACHnet's tablet-based application. Inclusion criteria: All patients age 18+ with a Diabetes diagnosis and who registered at REACHnet.; Able to provide informed consent Exclusion criteria: patients who do not provide inform consent or without diabetes diagnosis or age<18 years old
Telehealth Services using HCPCS/CPT for COVID-19 Patients; Study population with versus without telehealth services. Telehealth services using the HCPCS/CPT codes will be defined in the following categories: Medicare telehealth visits (CPT codes: 99201-99215; HCPCS codes: G0425-G0427, G0406-G0408), virtual check-in (HCPCS codes: G2010, G2012), and e-visits (CPT codes: 99421-99423, HCPCS codes: G2061-G2063). Propensity score-matching will be used to ensure comparison groups are comparable at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in use of CMS care coordination reimbursement code over 5 years	Over 5 years the utilization of the CMS care coordination reimbursement code will be analyzed to see if there is any change in how often the code is used.	5 years
Change in glycemic control over 5 years	Over 5 years diabetes patients extracted from the EMR will be analyzed to see if patients are able to achieve glycemic control by having a Hemoglobin A1c <7% and maintain staying below 7.0%.	5 years
Change in healthcare utilization over 5 years	Records from the EMR will be assessed by counting the number of outpatient visits, number of inpatient visits, and number of emergency room visits, to determine if there has been a change in the utilization of the healthcare system.	5 years
Change in patient satisfaction over 5 years	Patients registered in REACHnet, diagnosed with Type 2 diabetes, and complete the PACIC+ survey will be analyzed to see if there is a change in patient satisfaction over 5 years.	5 years
Change in status of received diabetes care over 5 years	Patients registered in REACHnet, diagnosed with Type 2 diabetes, and complete the PACIC+ survey will be analyzed to see if there is a change in the patient's status of received diabetes care over 5 years.	5 years
Change in patient reported physical health over 5 years	Patients registered in REACHnet and complete the PROMIS survey will be analyzed to see if there is a change in patient reported physical health score over 5 years.	5 years
Glycemic Control (HbA1c) for Telehealth visits for COVID-19 patients	Measured before and within 12 months after 03/06/2020	Baseline, post-baseline period within 12 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Lizheng Shi, PhD, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Chronic Disease
• Other Study ID Numbers: 16-906810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No