Last updated: December 31st, 2024
This Program Description is incorporated by reference in the Codex Health Order Form entered into between you (“Customer”) and Codex and governed by the Codex Health Enterprise Terms of Service and Business Associate Agreement. It describes the Codex Virtual Cardiometabolic Program. Capitalized terms that are used but not defined herein have the meaning set forth in the Terms.
1. Program Rationale: The primary goal of the Virtual Cardiometabolic Program (the “Program”) is to help educate Customer's patients with a diagnosis of hypertension, diabetes, or obesity/being overweight to self-manage their condition and to maintain glucose/blood pressure within ranges recommended by the American Diabetes Association, the American Heart Association (AHA) and the American College of Cardiology (ACC), or to manage sustainable weight loss.
2. Program Details:
a. Eligible patient identification: Patients will be identified by Customer based on Electronic Health Record (“EHR”) data, subject to the following criteria:
i. Inclusion criteria: patients must meet all of the following criteria in order to qualify:
1. Pre-existing Doctor-Patient relationship
2. Monitored by a physician within Customer's healthcare practice (a minimum of one visit in the prior 24 months)
3. Over the age of 18
4. A diagnosis of hypertension, diabetes, or being overweight/obese
ii. Exclusion criteria: patients with any of these characteristics or conditions may not be eligible for the the Program:
1. Lack of an Android or Apple smartphone
2. Poor digital literacy and/or likely inability to use mobile apps on smartphones
3. Potential exclusions for which provider review is recommended:
a. Current pregnancy or postpartum (within 4 weeks)
b. Has an eating disorder such as anorexia or bulimia (not including binge-eating disorder) for which he/she has received treatment in the past 12 months
c. Transient ischemic attack or stroke
d. Heart attack (myocardial infarction)
e. Hospitalization for congestive heart failure
f. Cardiac surgery (such as coronary artery bypass grafting, coronary artery stenting)
g. Organ transplant (kidney, liver, etc.) within the past 6 months
h. Recent cancer treatment such as major cancer surgery or chemotherapy (not including hormone therapy or immunotherapy)
i. Bariatric/gastric bypass surgery, including gastric sleeve, gastric balloon within the past 6 months.
j. On dialysis treatment
b. Patient outreach: Customer will be responsible for sending Program benefits material and opt-in enrollment instructions to eligible patients.
i. Codex will collaborate with Customer to create the appropriate materials and FAQs to (i) educate eligible patients about the Program; and (ii) provide information on how to enroll in the Program.
ii. With prior approval from, or upon request from Customer, Codex may communicate with Eligible Patients to inform them about the opportunity to enroll in the Program.
iii. Codex agrees that it will provide only such communications to eligible and enrolled patients as are reasonably necessary to the management and support of their conditions consistent with the scope of the Program.
c. Enrollment and Registration: Codex will provide Customer with the following resources to support eligible patient enrollment:
i. Links to the Allie app in the Apple App Store and the Google Play Store (URL and QR codes for simplified access)
ii. Instructions on account set-up and self-enrollment through the Codex support site (https://help.codexhealth.com/) or support@codexhealth.com
d. Enrolled Patient Product Support: Codex will provide the following services to enrolled patients:
i. Logistics and fulfillment: Deliver devices in an expedited manner, and support return/exchange in the case of defective devices. See “Service Level Agreement”
ii. Technical support: through Allie, the mobile app, through the Codex support site (https://help.codexhealth.com/), and through support @codexhealth.com. See “Service Level Agreement”
e. Healthcare Provider Product Support: Codex will provide support through Foresight, through the Codex support site (https://help.codexhealth.com), and through support@codexhealth.com.
f. Supervision of Codex Services: Customer acknowledges that Customer and its professional providers have ultimate responsibility for the care of Customer patients. All Codex services are provided on behalf of the Customer, and under the supervision of Customer professionals.
g. Business Support Services:
i. Billing reports: Codex will make supporting materials available in Foresight that will enable Customer to bill payers for reimbursement using the CPT codes that have been designated for this purpose by CMS and used by commercial insurers as well.
ii. Reporting, Outcomes, and Operational Analytics: Codex will provide Customer with regular reporting designed to measure overall program effectiveness. These reports will include eligible member enrollment, levels of engagement, utilization and adherence, analytics on patient vitals and measurements, and patient satisfaction data. All reports will be in compliance with HIPAA regulations. The parties agree that all such reports and presentations shall be treated as Confidential Information and shall otherwise be maintained in accordance with applicable law.
h. Outcomes and Metrics: the parties will compile the outcomes and metrics enumerated below:
i. Metrics compiled by Codex (at patient and cohort levels):
1. Primary Clinical Metrics:
a. Blood Pressure (BP), glucose or weight changes measured at appropriate intervals in the program.
1. Secondary Metrics:
a. Adherence to pharmacotherapy - self-reported
b. Measurement adherence
ii. Metrics compiled by Customer
1. ED visits
2. Hospital admissions
3. Patient onboarding
a. Patients will be sent devices that are relevant for the management of their condition(s).
b. During the onboarding process, if necessary, patients will be coached on proper use of the device.
c. An enrollment survey will be used to collect information about the patient’s medication list, weight, typical diet, physical activity patterns, as well as the patient’s own goals in terms of managing their condition.
4. Patient journey
Patients enroll in the program in Active mode, and will transition into Maintenance mode based on clinical criteria that are specified for the patient’s medical condition. Typically, this transition occurs in a 3-6 month window. Patients can continue indefinitely in Maintenance mode where their data continues to be monitored, and may be transitioned back to Active mode as needed. Patients may opt out of the program at any point for any reason.
5. Care protocol:
a. The Codex care team will monitor measurements and provide feedback or solicit context for values that are outside of the normal ranges.
b. Patients will be provided support and encouragement for consistent adherence to the care plan and measurement cadence. This will be done through automated interactions in the Allie app, as well as personalized messages from The Codex care team, operating under the supervision of the Customer.
c. The Codex care team will educate patients on nutritional intake, exercise, and medication adherence.
d. General and personalized educational content will be delivered through the Allie app, based on an understanding of the patient’s awareness and interests.
e. The Codex care team will only provide education, health coaching, and support. They will not make any recommendations regarding medications (beyond adherence) and will not provide medical care.
f. Patients who are not achieving control will proactively be escalated to the attention of Customer’s clinical staff, along with any relevant contextual information (eg. medication non-adherence, etc.). The data collected can be used to determine whether the patient is prescribed the correct therapeutic regimen.
g. The Codex care team will guide patients to seek care from a provider (PCP, Urgent Care of Emergency Department as appropriate) based on the acuity of their measurements readings.
6. Escalation protocol:
a. Customer will designate a clinical person who will serve as the operational liaison.
b. Codex will establish a secure and HIPAA-compliant communication mode with Customer for communication regarding specific patients, including escalation.
c. The Codex team will escalate under the following scenarios:
i. Hypertension hypertensive crisis events, hypotensive events, persistent Stage 2 hypertension
ii. Diabetes: hypoglycemic events, persistent hyperglycemia
iii. Weight Management: abnormal changes in weight
