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1/Okay. This is going to be a long thread about the variability in DEFINITIONS in play across federal agencies that are leading to SYSTEMATIC ERROR.
Buckle up!
HEDIS Measure: Use of Opioids at High Dose (OUD) [sic]
For members 18 yrs+, the rate per 1,000 receiving RX opioids at a high dosage for ≥15 days during the measurement year (average morphine equivalent dose [MED] >120 mg).
3/CFR42.1 § 8.2 Definition Opioid use disorder
(A) A cluster of cognitive, behavioral, and physiological symptoms in which the individual continues use of opioids despite significant opioid-induced problems.
3/(B) Opioid use disorder TX means the dispensing of an opioid agonist treatment med, along with a comprehensive range of medical and rehab services, when clinically necessary, to an person to alleviate the adverse medical, psychological, or physical Fx incident to OUD.
3/(C) This term includes a range of services including detoxification treatment, short-term detoxification treatment, long-term detoxification treatment, maintenance treatment, comprehensive maintenance treatment, and interim maintenance treatment.
4/DSM-5: Opioid Use Disorder (OUD)
DSM-5: A problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least 2 out of 11 criteria within a 12-month period. Excludes those under Dr care for pain.
5/FDA’s Draft Guidance for Industry:
Citation source: CDER. (2018, August). Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry.
5(A) In general, clinical trials evaluating fx of medications for the treatment of OUD for regulatory purposes have used reduction in drug-taking behavior (drug use patterns) as an endpoint.
5(B) FDA accepts DRUG USE patterns as surrogates for the benefits of abstinence from drug taking or presumed benefits of reduction of drug taking.
5(C) A.Reductions in adverse outcomes related to OUD. Examples of these adverse outcomes include: Mortality (overall mortality or overdose mortality), Need for emergency medical interventions, Hepatitis C seroconversion.
5(D)B.Changes in disease status: Diagnostic criteria for OUD encompass both drug use and its effect on patient well-being.
5(E) C. Pt reported outcomes: Using input from patients and family members to determine the most concerning symptoms/experiences associated with OUD,eg how pts feel or function (e.g., improvement in sleep/ mood); urge to use or craving, neg consequences of drug use; Abstinence;
5(f) D.Other outcome measures: demonstrated clin benefit of medications for the treatment of OUD...clinically meaningful endpoints eg reduction in hospitalizations, ED visits, OD, and death as well as improvements in ability to resume work, school, or other productive activity.
6/HEDIS Measure:Use of Opioids from Multiple Providers
For members 18+ yrs, the rate/1,000 receiving Rx opioids for ≥15 days during the measurement year who receive opioids from multiple providers. Three rates are reported.
6.1.Multiple Prescribers: The rate per 1,000 of members receiving prescriptions for opioids from four or more prescribers during the measurement year.
6.2.Multiple Pharmacies: The rate per 1,000 of members receiving prescriptions for opioids from four or more pharmacies during the measurement year.
6.3.Multiple Prescribers and Multiple Pharmacies: The rate/1,000 of members receiving prescriptions for opioids from 4 or more prescribers and 4 or more pharmacies during the measurement year (i.e., the rate/1,000 of members who are numerator compliant for both rates).
7. CFR 42 Part D Prescription plans
An at risk beneficiary at risk for abuse/diversion is a person who is enrolled in a plan, who receives a 2 or more prescriptions for controlled substances (any) in a period of 12 mos.
7. Exempted beneficiary means (drug mgmt program), an enrollee who (1) Receives palliative, hospice or end-of-life care; (2) Is resident in a LT care facility, or another facility which dispenses thru one pharmacy; or (3) Is being treated for active cancer-related pain.
8.1 Federal Register, Vol. 83, No. 73 / Monday, April 16, 2018 / Rules and Regulations govinfo.gov/content/pkg/FR…
...adding these exemptions would align the drug mgmt programs with the CDC Guideline.
8.2..specifically provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of life care.
8.3 Therefore, for consistency with the CDC Guideline, beneficiaries who are receiving non-hospice palliative and end-of-life care but who have not elected hospice will be EXEMPTED from Part D drug management programs as well.
9. HOUSTON we have a systematic error running throughout the implementation of the CMS2019 FINAL RULE.
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