Drug Utilization Management – are you doing enough?
We are reminded only recently of fatalities resulting from a physician’s over-prescribing of narcotics and the unethical practice by a specialty/mail order pharmacy of altering prescriptions to steer utilization toward a preferred manufacturer for financial gains. To curb such abuses, the Centers for Medicare & Medicaid Services (CMS) is serious about drug plan sponsors’ vigilance of drug utilization provided under Medicare Part D. The goals of drug utilization management (DUM) are twofold. First, to protect beneficiary safety by screening for: a) potential drug therapy problems due to therapeutic duplication; b) age/gender-related contraindications; c) over-utilization and under-utilization; d) drug-drug interactions; e) incorrect drug dosage or duration of drug therapy; f) drug-allergy contraindications; and g) clinical abuse/misuse. And second, to promote cost-effective drug therapy.
The CMS requirements are found in the Medicare Modernization Act 2003 (42 CFR 423.153(c)(2)), Chapter 7 of the Prescription Drug Benefit Manual (PDBM) and multiple HPMS memos since 2009. To meet the CMS requirements, pharmacy benefit managers (PBMs) have implemented drug utilization management (DUM) edits at point of sale (POS) to detect maximum daily dose (notably acetaminophen 4,000mg a day), age-related precautions (for high risk medications) and duplicate therapies (by applying the ‘refill too soon’ edit). Beginning in 2015, PBMs have added drugs with high likelihood of use for non-medically accepted indications (“TIRF” like drugs) to the list of POS edits even when the beneficiary is in his/her transition period. Correctly applied, these edits achieve the goals of DUM stated above.
Drug plan sponsors are ultimately responsible for ensuring beneficiaries’ access to Part D covered drugs; any rationale for POS edits that deny a Part D drug should be reviewed timely to ascertain that any maximum daily dose (MDD) conforms to FDA label information or is supported in a CMS-approved compendium. Repeat rejections of a TIRF-like drug should trigger outreach to members and providers to ensure that the medical indication is appropriate and the drug claim paid or formulary alternatives substituted. Prevalent usage of concurrent DUM edits could present potential pitfalls for unapproved restrictions to access that are not approved by CMS and would not be condoned in a CMS program audit. This becomes a balancing act for a drug plan sponsor in formulary administration and necessitates specialized resources.
Most of the aforementioned edits can be overridden by the dispensing pharmacist (“soft edits”), which will not be available for daily review by the drug plan sponsors. Regular retrospective review complements the concurrent DUM process and should be established as part of the PBM oversight monitoring using the paid claims data sent by the PBM with the payment invoices. POS DUM edits cannot replace clinical evaluation through data analytics and by trained eyes. Paid claims can be filtered and pivoted to identify outliers in dosing (quantities/days supply), costs, therapeutic duplication/over-utilization (or polypharmacy especially when multiple providers are involved) and even drug-drug interactions, especially those identified by CMS for Acumen monitoring. Drug plan sponsors are expected to bring various resources to facilitate their DUM efforts: programming capabilities, the Medication Therapy Management program (internally or externally performed), clinical pharmacist expertise, and case managers. And they are expected to integrate such efforts into their Quality Improvement/Chronic Care Improvement Programs.
To date, CMS expects drug plan sponsors to have implemented a process to address opioid over-utilization, at a minimum. The process should not begin with notification by CMS (via Acumen Patient Safety alert) and end with a lock down at the beneficiary level. Proactive monitoring of potential overuse of opiods and clinical interventions upon discovery that opioids over-utilization is ongoing are expected.
Requirements for administration of Part D continue to evolve and expand. CMS is also providing data sets to assist drug plans such as High Risk Providers, Patient Safety and PDE monitoring reports and soon a database to authenticate providers who have registered with CMS. Drug plan sponsors are well advised to have DUM processes in place or seek outside consultancy, for ultimately what is good for members is also good for quality of care and compliance with CMS.