If a patient has been newly prescribed a biologic and/or immune response modifier that includes a warning for potential reactivation of a latent infection, then the medical record should indicate TB testing in the preceding 12-month period.
This measure is to be submitted a minimum of once per performance period for patients who are being considered or prescribed a first course of a biologic and/or immune response modifier therapy seen during the performance period. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.
NOTE: Patient encounters for this measure conducted via telehealth (e.g., encounters coded with GQ, GT, 95, or POS 02 modifiers) are allowable.
Measure Submission Type:
Measure data may be submitted by individual MIPS eligible clinicians, groups, or third party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.
All patients aged 18 years and older who are receiving a first course of therapy using a biologic and/or immune response modifier (such as kinase inhibitors) that includes a warning for potential reactivation of a latent infection
Patients are considered to be receiving a first course of therapy using a biologic and/or immune response modifier that includes a warning for potential reactivation of a latent infection only if they have been prescribed such a biologic and/or immune response modifier during the performance period and also have not been prescribed any such biologic and/or immune response modifier in the 15 months preceding the encounter at which the biologic and/or immune response modifier was newly started. A biologic and/or immune response modifier that includes a warning for potential reactivation of a latent infection includes:
- Abatacept (Orencia)
- Adalimumab (HUMIRA)
- Adalimumab-adbm (Cyltezo)
- Adalimumab-atto (Amjevita)
- Anakinra (Kineret)
- Baricitinib (Olumiant)
- Brodalumab (Siliq)
- Canakinumab (ILARIS)
- Certolizumab pegol and lyophilized certolizumab pegol (CIMZIA)
- Etanercept (Enbrel)
- Golimumab (Simponi)
- Guselkumab (Tremfya)
- Infliximab (REMICADE)
- Infliximab-abda (Renflexis)
- Infliximab-axxq (Avsola)
- Infliximab-dyyb (Inflectra)
- Ixekizumab (Taltz)
- Risankizumab-rzaa (Skyrizi)
- Sarilumab (KEVZARA)
- Secukinumab (Cosentyx)
- Tildrakizumab (Ilumya)
- Tocilizumab (ACTEMRA)
- Tofacitinib (XELJANZ)
- Upadacitinib (RINVOQ)
- Ustekinumab (STELARA)
The list of therapies is subject to change as new therapies are approved by the FDA.
To be included in the denominator, patient must have an encounter and a prescription for a biologic and/or immune response modifier in the performance period (1/1/2023-12/31/2023) WITHOUT a prior prescription for a biologic and/or immune response modifier within the 15 months prior to the biologic and/or immune response modifier prescribed during the performance period.
DENOMINATOR NOTE: *Signifies that this HCPCS code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for the MIPS CQMs.
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years on date of encounter
Patient encounter during the performance period (CPT or HCPCS): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350, 99424, 99426, G0402, G0468*
Patient receiving first-time biologic and/or immune response modifier therapy: G2182
Patients for whom any record of TB testing is documented or performed (PPD, IFN-gamma release assays, or other appropriate method) in the medical record in the 12 months preceding the biologic and/or immune response modifier prescription.
Performance Met: TB screening performed and results interpreted within twelve months prior to initiation of first-time biologic and/or immune response modifier therapy (M1003)
Denominator Exception: Documentation of medical reason for not screening for TB or interpreting results (i.e., patient positive for TB and documentation of past treatment; patient who has recently completed a course of anti-TB therapy) (M1004)
Performance Not Met: TB screening not performed or results not interpreted, reason not given (M1005)
Regardless of a patient's diagnosis, it is essential to screen the patient for tuberculosis before initiating therapy with a biologic and/or immune response modifier, as research has documented a higher incidence of TB after anti-TNFα therapy. All patients being considered for a biologic and/or immune response modifier should receive a tuberculin skin test, even if the patient has previously received the BCG vaccination. Test results, in addition to patient risk for TB and other tests, should be used to assess the patient’s risk for latent TB infection; for documented latent TB infection, treatment with isoniazid or similar medication should be started prior to or concurrent with biologic initiation as clinically appropriate (https://www.cdc.gov/tb/publications/ltbi/default.htm).
Clinical Recommendation Statements
The American College of Rheumatology recommends screening to identify latent TB infection (LTBI) in all RA patients being considered for therapy with biologic agents, regardless of the presence of risk factors for LTBI. (Level of Evidence: C) (ACR, 2012) The Centers for Disease Control and Prevention (CDC) also recommends screening for tuberculosis prior to starting therapy with any TNF-α blocker (Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2004;5:683–686). Multiple studies have found similarly increased risks of latent TB reactivation with biologics in other auto-inflammatory syndromes other than RA, such as inflammatory bowel disease, ankylosing spondylitis and psoriasis. This has led to many consensus statements supporting screening of latent TB prior to initiation of a range of biologic and/or immune response modifiers in a range of autoimmune/auto-inflammatory diseases (Hasan et al. BMJ Open 2018;8:e022445. doi:10.1136/bmjopen-2018-022445; Doherty et al. J Am Acad Derm 2008 59(2): 209–217), supporting that this measure applies to a broad population of patients being considered for biologic and/or immune response modifier therapy.