Coding Tip: Code Z00.6 and Clinical Trials
RHIA, CDIP, CCS, CCS‑P, CIRCC
Executive Director Of Education
AHIMA‑Approved ICD‑10‑CM/PCS Trainer and Ambassador
Some of our clients have received denials on certain cardiovascular procedure cases (and others) whereby code Z00.6, Encounter for examination for normal comparison and control in clinical research program was not coded, and also WAS NOT in the SECOND code position on the UB-04 claim. This includes examination of participant or control in clinical research program.
What are Clinical Trials and Studies?
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
See this site to search for clinical trials. https://www.clinicaltrials.gov/
Why Z00.6, Encounter for examination for normal comparison and control in clinical research program?
Some clients have enrolled in clinical trials for certain procedures and devices or other medical treatments and are a part of the clinical trial registry. It is important for the coder to find out if their facility is participating in clinical trials and which ones they are. Not all facilities participate. Usually coders are given this information and specific instructions on the clinical trial and coding of the procedures. Coders should have this information handy when coding as it is easy to overlook the Z00.6 code and place it as the first secondary diagnosis on the claim (such as Palmetto, the Georgia MAC). Not all payors require it as the first secondary diagnosis, however some do. It is important to contact your MAC to see their requirements.
Procedures and conditions that may require code Z00.6: (some can be added down the line)
Please note that there may be other procedures not on this current list that affect your facility. Not all of the possible codes are displayed below. Coders can contact their facility on which procedures they are participating in clinical trials on.
NOTE THIS APPLIES TO BOTH INPATIENT AND OUTPATIENT PROCEDURES!
- Leadless Pacemakers – for IP & OP procedures – seen with PCS codes 02HK3NZ & 02H63NZ and CPT codes 0387T & 0388T. Micra™ is the newest and smallest in our line of pacemakers, approved for use in the United States by the FDA in April 2016.
- IC-HOT clinical trial (Intracoronary Hyperoxemic Oxygen Therapy) in Anterior Acute Myocardial Infarction Patients
- TMVR – Transcatheter Mitral Valve Repair (MitraClip) coded 02UG3JZ – Supplement Mitral Valve with Synthetic Substitute, percutaneous approach https://clinicaltrials.gov/ct2/show/NCT01626079
- LAA/LAAC – Percutaneous Left Atrial Appendage Closure – This is the Watchman coded 02L73DK – Occlusion of LAA with Intraluminal Device, percutaneous approach
- TAVR – Transcatheter Aortic Valve Replacement (Endovascular) & Transapical Aortic Valve Replacement (Thoracotomy Incision) coded: 02RF37Z, 02RF38Z, 02RF3JZ, 02RF3KZ, 02RF37H, 02RF38H, 02RF3JH, 02RF3KH
- TTVR – Transcatheter edge to edge tricuspid valve repair. The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve. Device: Intrepid™ TTVR System. https://clinicaltrials.gov/ct2/show/NCT04433065
- Absorb IV Trial/Absorb BVS device a clinical trial with a new device called the Absorb IV/Absorb BVS Device where a stent is placed in coronary lesions and it absorbs away. In the news recently, this is a new breakthrough procedure where the newly approved drug-eluting stent is designed to dissolve when it is no longer needed.
- To make sure we give appropriate advice on how to code these, the 6th character should be “4” for drug eluting intraluminal device. So, dilation of coronary artery, xx site(s) with drug eluting intraluminal device, percutaneous approach, 027-34-.
- ARRIVE Study – clinical trial (pregnancy)
- Purpose: Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal morbidity & perinatal mortality.
- Official Title: Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
- CHAP – Chronic Hypertension and Pregnancy (CHAP) Project – The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe. This is seen on pregnancy charts when an antihypertensive therapy is given such as Nifedipine & Labetalol.
- TOP – Transfusion of Prematures Trial (TOP) – purpose is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
- VEST – VEST Venous Graft External Support Pivotal Study (VEST Pivotal) Brief Summary: Prospective, multi-center, randomized, within-subject-controlled, trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set. https://clinicaltrials.gov/ct2/show/NCT03209609
Hybrid Coronary Revascularization Trial (added to list 6/1/18)
Study: “Hybrid Coronary Revascularization Trial”, federally-funded by the NHLBI. This trial is evaluating two treatment strategies: 1) hybrid revascularization (a combination of CABG + PCI) vs. 2) PCI. Trial Info: https://clinicaltrials.gov/ct2/show/NCT03089398?term=hybrid+coronary+revascularization&rank=2
Keep in mind there may be more clinical trials going on at your facility. This is not an exhaustive list.
Check with your facility
The information contained in this post is valid at the time of posting. Viewers are encouraged to research subsequent official guidance in the areas associated with the topic as they can change rapidly.
Wow, have you seen the proposed rule for FY2023 IPPS yet? There are 1,495 proposed coding changes to ICD-10-CM diagnoses codes alone! There are also some IPPS changes to note. As for ICD-10-PCS, there are not as many new codes, most significantly occlusion of prostate artery and knee joint replacement codes.
Coding denials are sent after the auditor has reviewed the record in question and the auditor does not agree with the DRG that was paid. This can be for either a diagnosis or a procedure code that they think does not meet reporting requirements.
Introducing HIA’s Cloud-Based Audit Software, Atom Audit, Streamlining Your Coding Auditor’s Workday and Transforming Data into Action
Our new coding audit platform is an easy-to-use and intuitive coding review application, with a customizable reporting dashboard, that enables auditors to efficiently and effectively manage the entire audit lifecycle.
As of April 1, 2022 discharges, the following changes in ICD-10 and IPPS will be implemented. For years the coding community did not see changes occurring in April of the fiscal year. HIM professionals were used to not even worrying about April changes. This year, we do have some significant code additions and a change in the IPPS CC/MCC edit. The ICD10MCE and Grouper Version will be 39.1.
DRG 640 (Miscellaneous disorders of nutrition, metabolism, fluids, and electrolytes with MCC) was the number 9 most common DRG with recommendations from HIA in 2021.
DRG 981 (Extensive O.R Procedures unrelated to principal diagnosis with MCC) was the number 8 most common DRG with recommendations from HIA in 2021.
DRG 291 (Heart failure with shock with MCC). This should be no surprise to coders that DRG 291 is in the top DRG’s with recommendation. It seems to always be in the top 5 and a focus for denials.
DRG 177 (Respiratory infections and inflammations with MCC) and 178 (Respiratory infections and inflammations with CC). This should be no surprise to coders that DRG 177 is in the top DRG’s with recommendation.
Sepsis is and will most likely always be a troubled area for coders. There are multiple reasons for this and we will look at a few of these. There are many different criteria being used to validate the diagnosis of sepsis.
During a recent review of spinal fusion cases at a client, we found coding issues on the cases in which both an anterior interbody fusion, anterior open approach was done on one day and two days later, the patient was brought back for a posterior fusion, posterior open approach. Below are some of the recommendations we made along with education explanations.
This is Part 5 of a five part series on the new 2022 CPT codes. For the remaining areas we will just briefly summarize the section. Due to the intricate nature of these sections in CPT, it is recommended that the coder read the entire section notes associated with the new codes.
This is Part 4 of a 5 part series on the new 2022 CPT codes. In this one we will explore the nervous, ocular and auditory systems CPT changes.
This is Part 3 of a 5 part series on the new 2022 CPT codes. In this one we will explore the digestive, urinary and reproductive system CPT changes.
This is Part 1 of a five part series on the new 2022 CPT codes. In this series we include examples to help the coder understand the new codes.
10 ICD-10 Codes from the Christmas movie Home Alone. T20. 10XA for Harry, Burn of first degree of head, face, and neck, unspecified site, initial encounter. T20.56XA for Kevin and his aftershave incident, Corrosion of first degree of forehead and cheek, initial encounter.
In Part 4 of the series, we will review the NTAP procedure codes and reimbursement add-on payments. Prepare yourself as this is rather lengthy due to continuation of NTAP that would normally expire.
Coders are instructed, at this time, to follow the AHA Frequently Asked Questions Regarding ICD-10-CM/PCS Coding for COVID-19. Lately, we have seen missing PCS codes for the new technology drugs that were introduced on August 1, 2020 and thereafter.
With the creation and implementation of ICD-10-CM, multiple codes are available to describe the type of pulmonary emboli that occur.