Navigating Regulatory Compliance in Urodynamics Testing

Posted by Clark Love on Jan 16, 2024 2:26:05 PM

illustration-of-a-Navigating-Regulatory-Compliance-in-Urodynamics-TestingPractice administrators and physicians can't take compliance for granted. The more the medical profession evolves, the more the legal landscape seems to shift in kind. But treatment is far from the only area where this matters. The diagnostic side also demands close regulatory management.

What makes a good governance and regulatory compliance strategy? The ideal looks different for each practice, but it's wise to understand a few highlights.

Urodynamics Regulations Don't Just Apply to Uroflowmetry

Urodynamic testing covers a wide range of bladder, urethra, and pelvic floor diagnostics. The American Urogynecologic Society (AUGS) makes this pretty clear. While uroflowmetry is often viewed as the gold standard for bladder function measurement, it's just one of many diagnostic tools. Cystometrics, electromyography, urethral closure testing, and video urodynamic tests all contribute to accurate diagnoses.

From a regulatory standpoint, this means you need to take a broad approach to governance and compliance. Your obligations may be farther reaching than you thought. Never assume something isn't covered just because it's not explicitly listed in legislation.

Why should you avoid the narrow view? Well, the U.S. Code of Federal Regulations (CFR) uses some fairly loose terminology, such as when it defines urodynamics measurement systems in 21 CFR 876.1620. According to the CFR, urodynamics systems include volume and pressure tools, but if you read closely, they also include systems that measure electrical muscle activity. The law even describes these devices using the term "generic", underscoring legislators intended it to be broad.

It's worth noting that the CFR mainly deals with device manufacturers, FDA approvals, and the like, but it's still a good indicator of scope. Federal laws often serve as effective frameworks for self-guided governance and harmonization efforts even when they don't address usage in the field. Of course, they can also determine how you get reimbursed...

Coding Urodynamics

The diversity of urodynamics procedures makes more work for practitioners. Physicians, nurses, and billing staff need to be extremely precise when using CPT codes.

AUGS is a solid source of information on this front. As it correctly points out, you'll need to use different codes for procedures that may seem similar.

Sometimes things can get confusing, so having a guide helps. For instance, there are codes for multiple types of complex cystometrograms depending on what kind of pressure studies they include. One complex cystometrogram code includes voiding pressure studies, but some codes for voiding pressure studies must be listed separately in addition to the primary procedure code. In this case, the distinction lies in what area the pressure study targets, meaning you need to pay close attention to your billing practices.  The applicable cystometrogram CPT codes and descriptions are:

  • CPT code 51726: Complex cystometrogram (i.e., calibrated electronic equipment)
  • CPT code 51727: Complex cystometrogram; with urethral pressure profile studies (i.e., urethral closure pressure profile), any technique
  • CPT code 51728: Complex cystometrogram; with voiding pressure studies (i.e., bladder voiding pressure), any technique
  • CPT code 51729: Complex cystometrogram; with voiding pressure studies (i.e., bladder voiding pressure) and urethral pressure profile studies (i.e., urethral closure pressure profile), any technique

It's impossible to understate the value of comprehensive medical education here. Practitioners can't just get away with having their staff perform tests and write up vague bills. They also need to train their teams on what each procedure does, means, and targets to bill with complete accuracy.

Thorough training is a pillar of coding compliance. After all, it's far easier to stay on regulators' (and patients') good side when you avoid basic billing errors. Your skills-building program should train your staff on:

  • Which procedures have the highest RVUs, as those should be reported first
  • Which procedures require direct physician supervision to be billable and which don't apply to urodynamics studies, such as measuring bulbocavernosus reflex latency time for erectile dysfunction
  • The fact that some reimbursements include pre- and post-testing, making it vital to bill no more than once per service day
  • How to use modifiers to designate additional procedures, signify that tests occurred within another procedure's global period, and indicate separate E&M services
  • How to create complete documentation in the form of independent reports that reference each procedure, its CPT code, raw diagnostic data generated, and provider interpretations

As a summary, a typical urodynamics test would result in reporting the following four CPT codes:

  • 51741 for complex uroflowmetry
  • 51729 for complex cystometrogram, including measurement of urethral pressure and bladder voiding/flow pressure
  • 51784 or 51785 for the EMG (typically 51784 is used; 51785 requires additional supplies and requires that the practitioner place the EMG needles)
  • 51797 for the abdominal pressure, whether measured rectally or vaginally

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Avoiding “Incident To” Mishaps

Medicare and CMS “Incident To” guidelines requires that the physician be “immediately available” during the procedure for any charge to be billed, and this applies to urodynamics. Under Medicare rules, being "immediately available" means that the physician is in the office suite at the time the service was provided.  If urodynamics is being performed by a nurse or technician, “Incident To” guidelines are applicable.  This does NOT mean that the “ordering physician/practitioner” must be readily available but rather any practitioner affiliated with the respective practice must be readily available.   In other words, the ordering physician can be out of the office, but another physician or APP must be readily available.  Other guidance has broadened readily available to mean “on the campus” if the respective practice occupies multiple buildings or a campus.   

Therefore, if there is not a practitioner readily available, urodynamics should not be performed. The bottom line is that if the physician or other qualified provider, such as a physician assistant or a nurse practitioner, is NOT readily available when urodynamics is performed, the service cannot be charged to Medicare. 

For private insurance payers, the definition of “incident to” can vary materially.   Some private insurance companies define "immediately available" as being within 20 miles of the office and others define it as “available by phone”.   It is advisable for most practices to stick with the CMS requirements to avoid issues since CMS’s definition of “incident to” is the most detailed and slightly more restrictive. 

Finally, “immediately available” does not mean the practitioner must be in the same room during the urodynamics test.  Most practices have a nurse perform urodynamics testing while practitioners are seeing other patients, and this is totally acceptable. 

 

Avoiding Stimulus Evoked Response (CPT Code 51792) Issues

 

Many years ago, Stimulus Evoked Response (CPT Code 51792) was often billed frequently in conjunction with urodynamics testing.  However, in recent years CMS has issued guidance stating that this is a procedure that most typically is performed for erectile dysfunction, and should not be billed at the time of urodynamic studies.  CMS has specifically stated Stimulus Evoked Response has a limited application in practical urology, but can be used to evaluate cases of suspected cauda equina syndrome. 

AUGs states that Stimulus Evoked Response should never be performed in conjunction with urodynamics.  However, CMS states that it could possibly be used in conjunction with urodynamics in the case of suspected cauda equina syndrome.  Therefore, if your practice is billing 51792 in conjunction with other urodynamics CPT codes, you should tread lightly, and you certainly should not be billing it with every urodynamics test. 

Split Billing vs. Global Billing for Urodynamics

Split billing in the context of a medical practice, particularly for procedures like urodynamics testing, refers to the practice of separating the billing of different components of a single medical service. Urodynamics testing, which assesses how well the bladder and urethra are storing and releasing urine, involves multiple components such as:

  1. Professional Component: This includes the interpretation of the test results by the physician.
  2. Technical Component: This covers the actual performance of the test, including the use of equipment and technical staff.

Alternatively, if both the professional component and technical component are performed at the same time are approximately at the same time, then the practice can bill globally.  Most practices opt to bill globally because it is more efficient and makes the billing process more streamlined.  Additionally, from an economic perspective the amount received for billing globally is equivalent for billing the professional component and the technical component, so there is no reason to bill the professional component and technical component separately. 

From a compliance perspective, it is important to bill separately if the facility performing the service is different from the facility where the interpretation is provided.  For example, the test is performed at a regional clinic then interpreted by specialist in a metro area.  Moreover, split billing might be recommended if there's a significant time gap between when the test is conducted and when the results are analyzed.  For example, if the test is performed on the 1st of the month and it is not interpreted until the 15th of the month, then it would be advisable to perform split billing. 

In summary, split billing involves separating the charges for the professional component (physician's interpretation of test results) and the technical component (actual test performance, including equipment and staff). Global billing, on the other hand, combines these components into a single bill, usually preferred by practices for its efficiency and streamlined process. Economically, global billing yields equivalent revenue to split billing. However, compliance issues may necessitate split billing, especially when the testing and interpretation facilities differ, or there is a significant time gap between the test performance and its interpretation.

 

Urodynamics Documentation Requirements for Regulatory Compliance

Ensuring proper documentation for urodynamics procedures is crucial for both billing accuracy and compliance with regulatory standards. Here's a general guide on the type of documentation needed and the regulatory bodies involved:

  1. Patient's Medical History and Physical Examination Records:
    • Detailed patient history relevant to urodynamic concerns.
    • Results of physical examinations, including any relevant urological, neurological, and gynecological findings.
  2. Physician's Order for the Test:
    • A written or electronic order from the attending physician specifying the need for urodynamics testing, including clinical justification.
  3. Informed Consent:
    • Documented consent from the patient after explaining the procedure, potential risks, and benefits.
  4. Procedure Notes:
    • Detailed notes on the procedure, including the date and time of the test, the specific tests performed (e.g., uroflowmetry, cystometry), and any medications administered during the test.
    • Observations and immediate findings during the procedure.
  5. Test Results and Interpretation:
    • Detailed results of the tests performed.
    • Interpretation and analysis by the qualified healthcare professional, usually a physician specialized in this area.
  6. Billing Information:
    • Accurate coding of the procedure (CPT codes) and diagnosis (ICD-10 codes).
    • Clear delineation if split billing is being used, indicating the technical and professional components.

Each of the above is relatively straight forward, except for items 4 and 5.  These two items require a deeper understanding of urodynamics.  If you would like to see an example of a thorough urodynamics report, email info@bhnco.com and insert “Example Report” in the subject line, and we will email you a copy of a report that fully addressed Items 4 and 5. 

Getting Urodynamics Training up to Standard

As with any other medical field, standards play a major role in impactful urodynamic training. Finding a continuing medical education program that satisfies a common framework can go a long way toward effective compliance, but there's no shortage of benchmarks to choose from.

What should your guiding principle be? Once again, taking a broad approach may be best. Here are some good resources to know:

ICS Good Urodynamic Practices

The ICS's Good Urodynamic Practices is a framework geared specifically toward urodynamics in the clinical setting. It covers some of the challenges to implementing standard practices and breaks down critical considerations for different procedures, like:

  • Patient positioning during uroflowmetry
  • How to instruct patients to report what they feel during filling cystometry
  • Recommended terms and language for describing common features, errors, and artifacts during invasive procedures

ICS guidelines undergo periodic updates, so be sure you're working with the latest version.

AUGS Urogynecology Core Competency Training Guides

The AUGS publishes training guides to help practices hire and train advance practice providers (APPs) in the urogynecology context. These guides are extremely helpful because they address knowledge gaps in APPs who lack experience specific to urogynecology. For instance, they cover things like:

  • General procedures, including performing patient assessments, ordering medications and therapies, consulting with physicians and non-physician caregivers, and admitting and discharging patients
  • Special procedures, such as conducting uroflow assessments, screening patients for urinary tract infections, inserting and removing catheters, and performing simple cystometrograms, anorectal manometry, and cystoscopies
  • Which competencies APPs need to achieve to be safely entrusted with tasks like shadowing mentors or seeing women without direct oversight

Although this example was urogynecology-specific, there's enough overlap that it makes a good starting point for urology and ObGyn practices as well.

Medical Literature Reviews

If you're running your own compliance training program, keeping up with literature reviews is a smart idea. In the absence of industry-wide guidelines, bodies like the AUGS, ICS, the American Urological Association, and others periodically publish reviews and papers covering the latest in urodynamics testing. Understanding how the field is evolving is integral to anticipating the regulatory pitfalls.

Make Your Compliance Outlook More Favorable

Effective urodynamics compliance takes an appreciation for regulatory scope and coding awareness. Good governance also demands intensive theoretical and applied training to ensure your entire practice stays on the same page. Compliance may seem like a lot to keep up with, but discussing it with an expert can help break the problem down.

Ready to get your practice on top of training and compliance? Talk to the Brighter Health Network team.

 

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Topics: Urodynamics compliance

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