Brief Description of Measure:
​CMS249: Appropriate Use of DXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for Osteoporotic Fracture:
Percentage of female patients 50 to 64 years of age without select risk factors for osteoporotic fracture who received an order for a dual-energy x-ray absorptiometry (DXA) scan during the measurement period

Description of Issue:
The current specification is based on the 2011 USPSTF recommendation, which relied on the Fracture Risk Assessment Tool (FRAX). The 2018 USPSTF guideline recommends use of five clinical risk-assessment tools to assess osteoporosis or fracture risk.
 
To bring the measure into alignment with the 2018 USPSTF recommendation, the measure developer, in support of the measure steward, proposed adding 3 additional risk assessment tools to the measure exclusion logic—the Osteoporosis Index of Risk (OSIRIS), the Osteoporosis Risk Assessment Instrument (ORAI) and the Osteoporosis Self Assessment tool (OST). With this change, individuals with a positive result on one of these tools will be excluded from the measure. This change expands the list of tools that are available for clinicians to use to assess osteoporosis risk, and to maximize the likelihood that patients who have an increased risk for osteoporosis, as determined by one of these tools, are excluded from the measure. The three tools added to the measure are named in the “Clinical Considerations” section of the USPSTF osteoporosis recommendation alongside the FRAX; there is another tool mentioned, the Simple Calculated Osteoporosis Rise Estimation tool (SCORE). The SCORE does not have an existing LOINC code yet and therefore has not been added to the measure; it is expected to be published in LOINC in the near future and may be added to the measure at that time.
In the current specification, patients with a positive risk assessment result are excluded as Denominator Exclusions. The intent is to exclude individuals who have a positive risk assessment result prior to a DXA scan; therefore, applying the criteria as a numerator exclusion enables tying the timing of the exclusion to the numerator event. The measure developer would like to make this change to align with the measure intent.

Proposed Solution:
Below are changes to the header.

//DEFINITION
//Before
The measure allows for clinicians to use the Fracture Risk Assessment Tool (FRAX[R]) to calculate 10-year absolute fracture risk. The FRAX was developed by the World Health Organization in 2008 to evaluate a patient's 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip, or shoulder fracture). It is applicable to people aged 40-90 years.

//After
The measure allows for clinicians to use 4 tools to assess osteoporosis or osteoporotic fracture risk.
1.    The Fracture Risk Assessment Tool (FRAX[R]) is used to calculate 10-year absolute fracture risk. The FRAX evaluates a patient's 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip, or shoulder fracture). It is applicable to people aged 40-90 years.
2.    The Osteoporosis Risk Assessment Instrument (ORAI) is used to calculate osteoporosis risk. It is applicable to women >=45 years.
3.    The Osteoporosis Index of Risk (OSIRIS) is used to calculate osteoporosis risk. It is applicable to patients of any age.
4.    The Osteoporosis Self Assessment Tool (OST) is used to calculate osteoporosis risk. It is applicable to patients of any age.

//GUIDANCE
//Before
There are two ways that a patient can be excluded from the measure:
... The patient has one or more of the "independent" risk factors, including a 10-year probability of major osteoporotic fracture of 8.4 percent or higher as determined by the FRAX.

//After
Patients are excluded from the measure if they have one or more risk factors for osteoporosis, including a result indicating that the patient should be considered for bone density testing on one of the following risk assessment instruments:
•    10-year probability of major osteoporotic fracture of 8.4 percent or higher as determined by the FRAX.
•    ORAI score of >=9
•    OSIRIS score of <1
•    OST score of <2

//DENOMINATOR EXCLUSIONS
//Remove the following:
The following risk factors may occur at any time in the patient's history prior to the start of the measurement period, but do not need to be active during the measurement period:
... FRAX[R] ten-year probability of all major osteoporosis related fracture >= 8.4 percent...

//NUMERATOR EXCLUSIONS
//Add the following:
Exclude patients with a result on one of the following tools, which indicates the patient should be considered for bone density testing, anytime in the patient’s history prior to the time of the first DXA scan during the measurement period:  
FRAX[R] ten-year probability of all major osteoporosis related fracture >= 8.4 percent
ORAI score of >=9
OSIRIS score of <1
OST score of <2

Below are changes to the logic and terminology.

//Before
code "Major osteoporotic fracture 10-year probability [Likelihood] Fracture Risk Assessment" ("LOINC Code (90265-0)")

//After
code "Major osteoporotic fracture 10-year probability [Likelihood] Fracture Risk Assessment" ("LOINC Code (90265-0)")
code “Osteoporosis Risk Assessment Instrument” (“LOINC Code (98139-9)”)
code “Osteoporosis Index of Risk panel” (“LOINC Code (98133-2)”)
code “Osteoporosis Self-Assessment Tool” (“LOINC Code (98146-4)”)

//Before
define "Denominator Exclusions":
 ... or "Has Independent Risk Factors Before Measurement Period"

define "Has Independent Risk Factors Before Measurement Period"
exists ( ... union "Osteoporosis Fracture Probability Assessment")

define "Osteoporosis Fracture Probability Assessment":
["Assessment, Performed": "Major osteoporotic fracture 10-year probability [Likelihood] Fracture Risk Assessment"] ProbabilityAssessment
  where ProbabilityAssessment.result >= 8.4 '%'
    and start of Global."NormalizeInterval" ( ProbabilityAssessment.relevantDatetime, ProbabilityAssessment.relevantPeriod ) before start of "Measurement Period"

define "Numerator":
  exists ["Diagnostic Study, Order": "DXA (Dual energy Xray Absorptiometry) Scan"] DXA
    where DXA.authorDatetime during "Measurement Period"

//After
define "Denominator Exclusions":
 ... 

define "Numerator Exclusion"
  exists "Osteoporosis Fracture Risk Assessment Prior to First DXA Scan"

define "Osteoporosis Fracture Risk Assessment Prior to First DXA Scan":
  ( ( ["Assessment, Performed": "Major osteoporotic fracture 10-year probability [Likelihood] Fracture Risk Assessment"] FRAX
      where FRAX.result >= 8.4 '%'
  )
    union ( ["Assessment, Performed": "Osteoporosis Risk Assessment Instrument"] ORAI
        where ORAI.result >= 9
    )
    union ( ["Assessment, Performed": "Osteoporosis Index of Risk panel"] OSIRIS
        where OSIRIS.result < 1
    )
    union ( ["Assessment, Performed": "Osteoporosis Self-Assessment Tool"] OST
        where OST.result < 2
    ) ) RiskAssessment
    where start of Global."NormalizeInterval" ( RiskAssessment.relevantDatetime, RiskAssessment.relevantPeriod ) before First("DXA Scan Order During Measurement Period").authorDatetime

define "Numerator":
  exists "DXA Scan Order During Measurement Period"

define "DXA Scan Order During Measurement Period":
  ["Diagnostic Study, Order": "DXA (Dual energy Xray Absorptiometry) Scan"] DXA
    where DXA.authorDatetime during "Measurement Period"
    sort by authorDatetime asc

Rationale for Change
​The goal of this change is to implement most recent USPSTF guideline and to align the exclusion criteria with the measure intent.