Understanding Clinical Practice Guidelines and Medical Review
Jay S. Grider, DO, PhD, MBA
Member, ASRA Practice Management Committee
Pain Medicine Specialist, Professor
University of Kentucky College of Medicine
Since the advent of evidence-based medicine in the mid 1990s, the use of medical literature to guide treatment decisions has grown dramatically. Concomitantly, insurance companies and payers began using in-house or con-tracted services to review medical records for alignment with accepted evidence-based practice. While this practice is well-intentioned, there are many practical flaws with this approach. Many practitioners feel that medically reasonable procedures are denied because electronic medical records inadequately convey clinical concerns and reviewers lack understanding of medical issues. Denials are sometimes based on technicalities such as absence of a key phrase or use of a diagnosis code that is accurate but not what the published insurer guidance specifically requires. While the review process is dynamic and constantly changing, there are principles that the practicing physician can employ to better understand it. This article introduces the concept, and subsequent articles will address specific topics.
The creation of clinical guidelines has had an unexpected negative consequence for the practice of medicine. In recent years, many guidelines and consensus papers have been written with the goal of distilling the vast and growing body of medical literature for the clinician. They were meant to inform clinical judgement. In many cases, however, these guidelines have become clinical standards with the unintended consequence of replacing medical judgement.
It is important to understand the language used in systematic reviews and clinical guidelines to convey the strength of a recommendation. There is variability among systematic review methodologies and scoring systems. Generally, level one evidence consists of high-quality randomized controlled trial(s). Some review methodologies and/or criteria require more than one randomized controlled trial to be considered level one evidence. Level two evidence usually consists of moderate-quality randomized trials or many large observational trials. Lower levels of evidence are based on smaller observational trials, case series, and case reports. The lowest level of evidence (usually level 5) is consensus opinion. Many excellent consensus documents related to pain management have been created that certainly guide and improve clinical care. Unfortunately, consensus papers are considered low-value to managers of guideline clearinghouses. There is a growing movement in the medical literature to regard large “real world” observational trials more highly, as many randomized controlled trials deliver results that are not applicable to clinical reality. The guideline repositories listed in Table 1 are used in payer/insurer clinical review and employ various methodologies.
With increasing frequency, insurers are using in-house clinical review for musculoskeletal issues or outsourcing review to entities such as Ortho-Net©. These review entities use similar (albeit slightly ever-changing) criteria for procedural approval.
For example, a request for diagnostic lumbar facet intervention using current AIM criteria requires:
- Pain of at least 3 months’ duration
- Axial pain without radiculopathy, myelopathy, or neurogenic claudication
- Physical exam consistent with facet arthropathy and absence of other sources of pain
- Absence of prior fusion at requested levels
- Lack of improvement after at least 6 weeks of conservative therapy
For diagnostic blocks, the AIM criteria require a confirmatory block if the initial block is positive for facet arthropathy (maximum of 2 levels in a single session).
Therapeutic facet injections may be performed a maximum of three times per year if ≥50% pain relief is achieved.
AIM criteria allow radiofrequency neurotomy if dual diagnostic blocks achieve ≥80% relief of pain. They may be repeated twice annually as long as ≥50% pain relief is achieved and may be done at two levels bilaterally or four levels unilaterally in one session.
As the majority of payers continue to move toward evidence-based guidelines for approval of treatment, it is imperative for the practicing physician to be aware of the sources of these guidelines and to constantly tailor documentation to prevent unnecessary delays in treatment. Failure to follow the process results in increased internal overhead costs and delayed throughput to the practice because of subsequent appeals and peer-to-peer requirements. The provider should be aware that CPT coding requirements continuously change, and coverage determinant bulletins from payers can change the accessibility of a procedure without warning. One payer may make changes in coverage determination that are not universal across the rest of the payers in the provider’s local area. Additionally, non-covered services may be termed “experimental.” This can be distressing to patients who may perceive they are being included in medical research without their consent. It is important to prevent this misconception by providing a clear explanation of what experimental means in this context in the patient’s pre-procedure information sheet. It would be a recommended best practice to review the insurance criteria for commonly performed procedures at least twice yearly to keep abreast of the ever-changing landscape.
- Manchikanti L, Falco FJ, Benyamin RM, Kaye AD, Boswell MV, Hirsch JA. A modified approach to grading of evidence. Pain Physician. 2014;17(3):E319-325.
- Clinical Appropriateness Review. AIM Specialty Health. Available at: http://www.aimspecialtyhealth.com/Why-AIM-Evidence-based-care.html. Accessed April 20, 2018.
- Musculoskeletal Program: Interventional Pain Management. AIM Specialty Health. Available at: http://www.aimspecialtyhealth.com/PDF/Guidelines/2017/Nov01/AIM_Guidelines_Interventional-Pain-Management.pdf. Accessed April 20, 2018.