We’ve heard about government investigations into unnecessary cardiac stent placement and cardiac ablation procedures in the past. On September 15th, 2021, the Department of Justice (DOJ) announced a settlement was reached in a case involving unnecessary cardiac procedures once again. This case is titled, “Orlando Cardiologist Pays $6.75 Million to Resolve Allegations of Performing Unnecessary Medical Procedures”, involved dates of service from January 2013 to December 2019. The Office of Inspector General (OIG) assisting in the investigation. To read over the Department of Justice announcement go to the following website: https://www.justice.gov/opa/pr/orlando-cardiologist-pays-675-million-resolve-allegations-performing-unnecessary-medical
According to the DOJ settlement agreement for the Orlando physician, the details include: (1) performed ablations and stent procedures on veins that did not qualify for treatment under accepted Standards of medical practice; (2) overstated the degree of reflux and the diameter of veins in medical records to make the ablations appear to meet generally recognized medical standards, when, in fact, they did not; (3) falsely documented patient symptoms and conservative therapy measures in medical records to justify the ablation and stent procedures; (4) performed ablations on asymptomatic patients for cosmetic purposes; and (5) placed vein stents in patients in excess of the contemporaneous standards of medical practice. In addition, the United States contends that, in many instances, ablations were performed either exclusively or primarily by one or more ultrasound technicians outside their scope of practice.
In addition, the settlement in the above case requires a multi-year integrity agreement with HHS-OIG, which includes training and reporting requirements as well as a quarterly claims review conducted by an Independent Review Organization, with the requirement that the review team includes at least one interventional cardiologist who is board certified. The settlement document is available online at: https://www.justice.gov/opa/press-release/file/1432846/download
Interventional cardiology covers several procedures to diagnosis and treat cardiac disease, often plaque. An angioplasty, which is also known as percutaneous coronary angioplasty, PTCA is a catheter based procedure used to treat blockages in the coronary or peripheral arteries. Inserted via catheter the point of the blockage a simple balloon or a drug coated balloon is then dilated to open the area to resume blood flow.
Coronary stent placement is another procedures which falls under the specialty of interventional cardiology. With stenting, the cardiac procedure for a stent is a form of angioplasty where a catheter is inserted into the artery to the point of the blockage and a stent, a wire mesh device, is deployed inside the artery to keep it open and restore blood flow. A drug eluting stent emits a medication to help prevent the blockage from reoccurring.
According to the Mayo Clinic, cardiac ablation procedure Cardiac ablation uses heat or cold energy to create tiny scars in your heart to block abnormal electrical signals and restore a normal heartbeat. Cardiac ablation is most often done using thin, flexible tubes called catheters inserted through the veins or arteries. This procedure is used to correct heart rhythm problems (arrhythmias).
Over the years there has been several government investigations regarding cardiac procedures. In January 2015 the DOJ sued a cardiologist for “unnecessary procedures”. In December 2013, the DOJ and a Cardiologist settled for 1.1 million dollars regarding unnecessary cardiac procedures. Also, in November 2011 a cardiologist was sentenced to Federal prison for eight years for performing medically unnecessary cardiac stent procedures. We cannot forget the Redding Medical Center (Tenet) which was raided in October 2002 by the Federal Bureau of Investigation (FBI) due to claims of unnecessary cardiac surgeries being performed.
In all of these cases, not only the clinical coding (ICD and/or CPT codes), but the clinical documentation was carefully reviewed. We know that clinical documentation is vital to support the rationale or justification and the medical necessity for the procedure and also needed to support the code assignment. The patient history, presentation (including clinical indicators), anatomy, as well as the initial and final diagnostic impression should be included in the encounter. Then detailed clinical documentation equally must support the actual procedure(s) that was/were performed. With some of these interventional cardiac procedures there is computer software available to aide in capturing all the key clinical elements in the electric health record. One specific area that these investigations focused upon is the medical record documentation of the percentage of vein occlusion that the patient has. The percentage of occlusion or blockage stated by the physician (Radiologist) who performs the angiogram, can sometimes be different than that of the cardiac interventionist. When this occurs, the encounter should be flagged somehow in order that a “final” determination on the percentage of occlusion can be made and documented. There have been legal cases where this has been a focus due to the large gap in percentages between the two clinicians and the determination of medical necessity is in limbo. In addition, when a stent is placed the documentation must include the make of STENT, the implant location (s), and the length and diameter of each STENT.
CMS has published in there Medicare Learning Network (MLN) great information regarding documentation, the following is some of their guidance: Clear and concise medical record documentation is critical to providing patients with quality care and is required for you to receive accurate and timely payment for furnished services. Medical records chronologically report the care a patient received and record pertinent facts, findings, and observations about the patient’s health history. Medical record documentation helps physicians and other health care professionals evaluate and plan the patient’s immediate treatment and monitor the patient’s health care over time.
Health care payers may require reasonable documentation to ensure that a service is consistent with the
- The site of service
- The medical necessity and appropriateness of the diagnostic and/or therapeutic services provided
- That services furnished were accurately reported
Another good resource is the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines that was formed to gather information and make recommendations about appropriate use of technology for the diagnosis and treatment of patients with cardiovascular disease. Information can be found at: https://www.ahajournals.org/doi/full/10.1161/01.CIR.103.24.3019
Most but not all, of the above interventional cardiology procedures that the government investigated were performed on an outpatient basis, thus CPT codes were assigned and reported. However, as HIM Coding and CDI professionals, while reading over the clinical documentation we can also refer questionable documentation issues (i.e., lack of the percentage of vein occlusion) to the appropriate Medical Staff committee or leadership which may provide to help meet compliance with medical necessity. It might be a best practice for hospitals that perform interventional cardiology services to conduct a random audit on stent placement and ablation procedures to validate both the clinical documentation (medical necessity) and the clinical coding accuracy. Another area to add to your coding compliance list of targets that needs attention and action.