Medicare Provides Guidance on Billing for Implantable Automatic Defibrillators

Medicare has found that approximately 85% of improper payments relating to the billing of implantable automatic defibrillators were due to insufficient documentation.

This is according to a recent issue of Medicare Quarterly Provider Compliance Newsletter (pdf), a newsletter from CMS developed to help providers to avoid common billing errors and other erroneous activities when dealing with the Medicare Program.

The figure was determined through a Comprehensive Error Rate Testing (CERT) program's special study of Healthcare Common Procedure Coding System (HCPCS) code 33249 (Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber).

The Centers for Medicare & Medicaid Services (CMS) calculates the Medicare Fee-for-Service (FFS) improper payment rate through the CERT program. Each year, CERT evaluates a statistically valid random sample of claims to determine if they were paid properly under Medicare coverage, coding, and billing rules.

Implantable automatic defibrillators are electronic devices designed to detect and treat life-threatening rapid heart rates. The device consists of a pulse generator and electrodes for sensing and defibrillating, and they are commonly referred to as Automatic Implantable Cardioverter Defibrillators (AICDs).

Insufficient Documentation and Medical Necessity Errors

Insufficient documentation means that required information is missing from the medical records or is inadequate to support payment. The CERT study found that approximately 85 percent of the improper payments were due to insufficient documentation, and this included lack of:

  • Physician's signature on the procedure note;
  • Signature log or attestation for cases in which the physician's signature was illegible;
  • Electronic record protocol/policy that documents the process for electronic signatures, if applicable;
  • Hospital records;
  • Records for the specified date of service;
  • Records that support the clinical indication for the procedure; or
  • Records to support that the beneficiary was enrolled in a clinical study/trial.

In the CERT study, medical necessity errors caused approximately 12 percent of the improper payments. A medical necessity error occurs when the CERT reviewer receives adequate documentation from the medical records submitted to make an informed decision that the services billed were not medically necessary, based upon Medicare coverage policies.

For example,

1. For all AICDs, the beneficiary must not have irreversible brain damage from preexisting cerebral disease; also

2. For primary prevention of sudden cardiac death, criteria include that the beneficiary must not have:

  1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
  2. Had a Cardiopulmonary Artery Bypass Graft (CABG) surgery or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 3 months;
  3. Had an acute Myocardial Infarction (MI) within the past 40 days;
  4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
  5. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

Examples of Improper Payments for AICDs

Example 1: Improper Payments due to Insufficient Documentation for AICDs

A physician billed for insertion of an AICD using HCPCS 33249 and modifier Q0 (Investigational clinical service provided in a clinical research study).

Review of the documentation found that the following was missing:

1. Clinical documentation supporting a previous Myocardial Infarction (MI) (documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction);

2. Clinical documentation supporting the defibrillator implantation for primary prevention is enrolled in either:

  1. A Food and Drug Administration (FDA) approved category B investigational Device Exemption (IDE) clinical trial;
  2. A trial under the CMS Clinical Trial Policy; or
  3. A qualifying data collection system including approved clinical trials and registries.

The CERT reviewer also received a device implant report for the correct date of service showing implantation of two leads, removal of a previous pacemaker, and threshold testing of the device with induced ventricular fibrillation and shock. The physician signed the report and authenticated the electrophysiology report. Additional information was requested and several unauthenticated clinical records were received that supported the beneficiary's history of heart disease.

However, the beneficiary's condition did not meet the criteria for Medicare coverage of an AICD. Although AICDs that are not covered based on Medicare coverage criteria are covered under Category B IDE trials and the CMS routine clinical trials policy, there was no documentation of enrollment in a clinical trial in this case.

There was no support for the use of the Q0 modifier in the documentation received, so this claim was scored as an insufficient documentation error and the Medicare Administrative Contractor (MAC) recouped the payment from the provider.

Example 2: Improper Payments due to Insufficient Documentation for AICDs

A physician billed for HCPCS 33249 at time of initial AICD implantation. The submitted documentation showed that the 73 year-old beneficiary had a past medical history of pulmonary hypertension, severe left ventricular dysfunction, non-ischemic dilated cardiomyopathy, dyslipidemia, and congestive heart failure (New York Heart Association Class III). The patient's symptoms included shortness of breath, fatigue, intermittent swelling in his feet, and he was unable to sleep lying flat. He was on maximal medical therapy that included Beta blockers, Angiotensin-Converting Enzyme (ACE) inhibitors, and diuretics. His cardiac catheterization showed an ejection fraction of 30 percent.

An operative report showed that he had an AICD implanted; however, the date on the report did not match the billed date of service. Medicare payment rules do not allow reviewers to accept documents with dates that are significantly different from the billed date of service.

This claim was scored as an insufficient documentation error , and the MAC recouped the payment from the provider.

Example 3: Improper Payments due to Medical Necessity Errors for AICDs

A cardiac surgeon billed for HCPCS 33249. He/she submitted medical records showing that the beneficiary had dilated ischemic cardiomyopathy with paroxysmal atrial fibrillation and that he had a Coronary Artery Bypass Graft (CABG) procedure 16 days prior to the AICD implantation.

There was no documentation of a prior MI or of an investigational research study. Documentation included an unsigned post-operative history and physical examination note. The CERT reviewer requested additional documentation to support this claim and received a copy of the previously unsigned post-operative history and physical examination note to which a signature had been added without a signature date.

Note: Providers should not add late signatures to the medical record (beyond the short delay that occurs during the transcription process), but instead should make use of the signature authentication process.

The related NCD requires that the beneficiary must not have had a CABG within 3 months prior to the AICD implantation.

The submitted documentation did not support the NCD requirements for reasonable and necessary services. This claim was scored as a medical necessity error and the MAC recouped the payment from the provider.

Amendments, Corrections and Delayed Entries in Medical Documentation

Providers are encouraged to enter all relevant documents and entries into the medical record at the time they are rendering the service.

A provider may discover that certain entries related to actions that were actually performed at the time of service but not properly documented, need to be amended, corrected, or entered after rendering the service. When making review determinations, the Medicare review contractors consider all submitted entries that comply with the widely accepted Recordkeeping Principles described in the "Medicare Program Integrity Manual," (Section 3.3.2.5 (Amendments, Corrections and Delayed Entries in Medical Documentation), Section B (Recordkeeping Principles); see the Resources section below). MACs, CERT, Recovery Auditors, and Zone Program Integrity Contractors (ZPICs) DO NOT consider any entries that do not comply with the principles listed in Section B, even if such exclusion would lead to a claim denial. For example, Medicare review contractors exclude from consideration undated or unsigned entries handwritten in the margin of a document.

Source: CMS

Cardiology billing is complex, requiring a high level of experience and knowledge for appropriate coding and general medical billing procedures. Billing specifics such as checking medical necessity verification and component coding require ever increasing levels of billing expertise and efficiency.

PGM has over thirty years of experience in cardiologist billing. Contact PGM to learn how we can manage all aspects of your practice's billing to help ensure you receive proper reimbursement for services provided.


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