Our Tests
Clinical Science
Resources
- Resources
- Order A Test
About Us
For Patients
Contact Us

Journal of Clinical Oncology, April 9, 2024 Presenter: Rios-Hoyo et al.

Read More

Karen Guzdzial2024-04-16T10:43:09-07:00April 16th, 2024|Evidence, I-SPY2, Immunotherapy, Neoadjuvant, Other, SWOG S2206|

Quick Links

Our Tests
Resources
Landmark Trials
Order A Test
For Patients

Legal

Contact

For the US, Puerto Rico, Canada
and South America
Agendia Inc. USA, 22 Morgan, Irvine, CA 92618
(888) 321-2732
customercare@agendia.com

For outside the Americas
Agendia NV, Radarweg 60, 1043 NT Amsterdam, The Netherlands
+31 (0)20 462 1510
customerservice@agendia.com

Page load link

Agendia CMS Compliance

Agendia, Inc. is committed to providing quality testing for patients and their treating physicians by offering timely results, reliable customer service, and adhering to responsible billing practices. As a part of Agendia’s regulatory policy, we follow all Federal & State requirements, based on applicable rules and regulations as it relates to Clinical Laboratory services.

What is the 14-Day Rule?

The “14 Day Rule” is a regulation set forth by the Centers for Medicare & Medicaid Services (CMS) that generally requires laboratories, including Agendia, to bill a hospital or hospital-owned facility for certain clinical and pathology laboratory services and the technical component of pathology services provided to Medicare patients when services are ordered less than 14 days after an inpatient discharge.

How do we determine the date of service?

In general, the date of service (DOS) for clinical diagnostic laboratory tests is the date of specimen collection unless the physician orders the test at least 14 days following the patient’s discharge from the hospital. In the latter situation, the DOS is the date the test is performed, instead of the date of specimen collection.

Who is impacted by the 14-Day Rule?

Hospitals and hospital-owned facilities where the patient’s specimen was collected for a hospital inpatient encounter.

Is there an exception to the Date of service (DOS) policy?

The test is performed following a hospital outpatient’s discharge from the hospital outpatient department:
The specimen was collected from a hospital outpatient during an encounter (as both are defined 42 CFR 410.2);
It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;
The results of the test do not guide treatment provided during the hospital outpatient encounter; and
The test was reasonable and medically necessary for the treatment of an illness

Below is an outline of the scenarios under which the Medicare date of service rules will apply to Agendia’s tests. The decision to submit an order for testing should be guided by the clinical judgment of the ordering physician and should not be based on the application of any billing rules.

Status at Specimen Collection

Outpatient
Nonpatient
Inpatient; ordered >14 days after date of discharge
Inpatient; ordered >14 days after date of discharge

Medicare Billing
Agendia, Inc. bills Medicare

Agendia, Inc. bills Hospital

Our Cookie Policy

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.

Manages Preferences ACCEPT

Privacy & Cookies Policy

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.

Save & Accept

Go to Top

Neoadjuvant CT & Immunotherapy in HR+/HER2-negative breast cancer