Measure Description
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.
Instructions
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 (including but not limited to encounters coded with GQ, GT, POS 02, POS 10) are allowable. Please note that effective January 1, 2025, while a measure may be denoted as telehealth eligible, specific denominator codes within the encounter may no longer be eligible due to changes outlined in the CY 2024 PFS Final Rule List of Medicare Telehealth Services.
Measure Submission Type:
The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this collection type for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. The coding provided to identify the measure criteria: Denominator or Numerator, may be an example of coding that could be used to identify patients that meet the intent of this clinical topic. When implementing this measure, please refer to the ‘Reference Coding’ section to determine if other codes or code languages that meet the intent of the criteria may also be used within the medical record to identify and/or assess patients. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.
Denominator
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
Denominator Instruction:
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. The list of biologic and/or immune response modifier therapies are subject to change as new therapies are approved by the FDA. Newly approved biologic and/or immune response modifier therapies requiring TB testing prior to the first course of therapy would be eligible for inclusion within the Denominator even if not listed within the Table 1.
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
AND
Patient encounter during the performance period (CPT or HCPCS): 98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014, 98015, 98016, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350, 99424, 99426, G0402, G0468*
AND
Patient receiving first-time biologic and/or immune response modifier therapy: G2182
Reference Coding/Medication: Table 1: Denominator Criteria for first-time biologic and/or immune response modifier therapy [G2182] is defined by the following medications; however, the list may change as new therapies are approved by the FDA:
| Abatacept (Orencia) | Anakinra (Kineret) | Rituximab (Rituxan) |
| Adalimumab (HUMIRA) | Baricitinib (Olumiant) | Sarilumab (KEVZARA) |
| Adalimumab-aacf (Idacio) | Brodalumab (Siliq) | Secukinumab (Cosentyx) |
| Adalimumab-aaty (Yuflyma) | Canakinumab (ILARIS) | Tocilizumab (ACTEMRA) |
| Adalimumab-adaz (Hyrimoz) | Certolizumab pegol and lyophilized certolizumab pegol (CIMZIA) | Tocilizumab-aazg (Tyenne) |
| Adalimumab-adbm (Cyltezo) | Etanercept (Enbrel) | Tocilizumab-bavi (Tofidence) |
| Adalimumab-afzb (Abrilada) | Golimumab (Simponi) | Tofacitinib (XELJANZ) |
| Adalimumab-aqvh (Yusimry) | Guselkumab (Tremfya) | Upadacitinib (RINVOQ) |
| Adalimumab-atto (Amjevita) | Infliximab (REMICADE) | Ustekinumab (STELARA) |
| Adalimumab-bwwd (Hadlima) | Infliximab-abda (Renflexis) | Ustekinumab (Pyzchiva) |
| Adalimumab-ryvk (Simlandi) | Infliximab-axxq (Avsola) | Ustekinumab (Selarsdi) |
| Adalimumab-fkjp (Hulio) | Infliximab-dyyb (Inflectra) | Ustekinumab (Wezlana) |
| Adalimumab-afzb (Abrilada) | Ixekizumab (Taltz) | Upadacitinib (RINVOQ) |
| Adalimumab-aqvh (Yusimry) | Risankizumab-rzaa (Skyrizi) | Ustekinumab (STELARA) |
| Adalimumab-atto (Amjevita) |
Numerator
Patients for whom any record of TB testing is documented or performed (PPD or TST, 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.
Numerator Options:
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)
OR
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)
OR
Performance Not Met: TB screening not performed or results not interpreted, reason not given (M1005)
Rationale
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 TB test (tuberculin skin test or blood 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 (also called inactive TB); 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) 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, 2018Doherty, 2008), supporting that this measure applies to a broad population of patients being considered for biologic and/or immune response modifier therapy.