As a former manager of clinical documentation integrity (CDI) and utilization review (UR) at an academic medical center, my focus was on understanding all possible sources of revenue leakage. At that time, the UR staff focused on activities that demonstrated a patient’s medical necessity, as defined by a variety of payers, but often required application of InterQual criteria, while the CDI team focused on capturing patient acuity to support accurate reimbursement under the Inpatient Prospective Payment System (IPPS) and other DRG payers.
However, we had a blind spot – before medical necessity can be supported and diagnoses reported on a claim, the services provided must first be covered by the payer. The approval process is somewhat straightforward, when it comes to commercial payers, as it involves prior authorizations (or precertification) – and most healthcare organizations have staff dedicated to obtaining these authorizations. But this is less well-known when it comes to Medicare beneficiaries.
Medicare coverage polices specify which items and services are covered under the Medicare program, and under which circumstances – such as when required specific clinical criteria are met. We see some outpatient CDI efforts supporting medical necessity (e.g., ensuring that the right diagnosis codes are included with imaging or injections), but it is far less common in the inpatient setting, where healthcare is much more expensive. When specific clinical criteria must be met to support Medicare coverage, it is often outlined in National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). The Centers for Medicare & Medicaid Services (CMS) states that “services must meet specific medical necessity requirements in the statute, regulations, manuals, and specific medical necessity criteria defined by National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), if any apply to the reported service. For every service you bill, you must indicate the specific sign, symptom, or patient complaint that makes the service reasonable and necessary.”
Now, not all services have NCDs or LCDs, but if there is one associated with a service, the medical necessity must be demonstrated with specific clinical criteria. Some services are specialized (e.g., transcatheter aortic valve replacement, or TAVR), and there may be a dedicated team within your organization to serve these types of patients – and they may be responsible for demonstrating the service as covered, while other, less specialized procedures (e.g., implantable cardioverter defibrillators (ICDs) or cardiac pacemakers) may also have associated NCDs. The NCD for ICDs has only been effective since 2018, but the NCD for single-chamber cardiac pacemakers has been effective since 1983.
An example of criteria that must be included for a single-chamber cardiac pacemaker to be covered are the following diagnoses, which must be “chronic or recurrent and not due to transient causes such as acute myocardial infarction, drug toxicity, or electrolyte imbalance:”
- Acquired complete (also referred to as third-degree) AV heart block;
- Congenital complete heart block with severe bradycardia (in relation to age), or significant physiological deficits or significant symptoms due to the bradycardia;
- Second-degree AV heart block of Type II (i.e., no progressive prolongation of P-R interval prior to each blocked beat. P-R interval indicates the time taken for an impulse to travel from the atria to the ventricles on an electrocardiogram);
- Second-degree AV heart block of Type I (i.e., progressive prolongation of P-R interval prior to each blocked beat) with significant symptoms due to hemodynamic instability associated with the heart block; and
- Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, congestive heart failure), or substantial sinus bradycardia (heart rate less than 50) associated with dizziness or confusion. The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia, rather than to some other cause.
NCDs are established criteria for when a service is not covered by Medicare, for example regarding the single-chamber pacemaker: “conditions which, although used by some physicians as a basis for permanent cardiac pacing, are considered unsupported by adequate evidence of benefit and therefore should not generally be considered appropriate uses for single-chamber pacemakers in the absence of the above indications.” These include:
- Syncope of undetermined cause;
- Sinus bradycardia without significant symptoms;
- Sino-atrial block or sinus arrest without significant symptoms;
- Prolonged P-R intervals with atrial fibrillation (without third-degree AV block) or with other causes of transient ventricular pause;
- Bradycardia during sleep;
- Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent AV block);
- Asymptomatic second-degree AV block of Type I, unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His bundle (a component of the electrical conduction system of the heart); and
- Asymptomatic bradycardia in post-MI patients about to initiate long-term beta-blocker drug therapy (effective Oct. 1, 2001).
LCDs are similar to NCDs, but defined by the Social Security Act as a “a determination by a fiscal intermediary or a carrier under Part A or Part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis.” General information about LCDs can be found in Chapter 13 of the Medicare Program Integrity Manual. However, specific LCDs would be available from the applicable Medicare Administrative Contractor (MAC), or there is a searchable database for both NCDs and LCDs at https://www.cms.gov/medicare-coverage-database/new-search/search.aspx. An example of an LCD is cardiac catheterization and coronary angiography, which is currently effective for two contractors. This LCD outlines indications supporting a right, left, or both a right and left heart catheterization, as well as limitations (such as when a right heart catherization or left heart catheterization is not considered medically necessary).
As you can see from the NCD example above, these criteria don’t really fall into typical CDI or UM work, but could result in significant lost revenue if not provided when necessary. There is a component of both departments, as there is often a requirement for specific diagnoses to be present, often with an associated ICD-10-CM code (of note, CMS is still in the process of converting ICD-9-CM codes to ICD-10-CM/PCS codes for some NCDs and LCDs), as well as supporting clinical criteria so the diagnosis can be clinically validated. To see an example of what updated codes are included in the NCD for ICDs, effective July 6, 2021, go online to https://www.cms.gov/files/document/r10635CP.pdf. This document provides instructions to the MACs when processing claims for ICDs to ensure that NCD criteria are met by listing what ICD-10-CM and ICD-10-PCS codes should be present on the claim.
As CDI departments continue to grow, some are venturing out into to new areas like covered services, as defined by NCDs and LCDs, to avoid service denials. Unlike DRG changes, these types of denials often result in no payment, rather than reduced payment, which can be costly if it involves a procedure and the cost cannot be shifted to the Medicare beneficiary if due diligence was not completed by the organization. This is not an area that can be easily integrated in the CDI workflow, so it would likely require dedicated CDI staff with knowledge and understanding of where to find NCDs/LCDs and how to apply the criteria correctly.