ExCPT · Laws · 7 min read
OBRA 90, Medicare, PPPA and Other Federal Acts
- Identify the core requirements of OBRA ’90, including prospective Drug Utilization Review, patient profile maintenance, and counseling mandates.
- Distinguish between Medicare Parts A, B, C, and D, and describe the pharmacy technician's supportive role in Medication Therapy Management (MTM) programs.
- Apply Poison Prevention Packaging Act standards, container reuse rules, package exemptions, and Schedule III anabolic steroid dispensing limits within pharmacy practice.
The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)
The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) fundamentally reshaped pharmacy practice by establishing standards for patient care and medication safety. Congress originally enacted OBRA ’90 to mandate prospective Drug Utilization Review (DUR) for Medicaid outpatients. Recognizing the clear clinical benefits of these safety checks, many states have since extended OBRA ’90-style prospective DUR and patient counseling requirements to all pharmacy patients, reaching well beyond Medicaid beneficiaries.
A prospective DUR is a vital safety screen conducted prior to dispensing a prescription to identify potential drug-related problems before the medication reaches the patient. During this process, screening systems and pharmacy staff evaluate prescriptions for therapeutic duplication, drug-disease contraindications, and drug-drug interactions. Prospective DUR screenings also evaluate prescriptions for incorrect drug dosage, inappropriate duration of treatment, and drug-allergy interactions. As a pharmacy technician entering prescription data, you may flag DUR alerts that appear on your computer terminal and gather background information. However, clinical assessment, clinical judgment, and the resolution of these clinical alerts belong solely to the supervising pharmacist.
Under OBRA ’90, pharmacies must offer Medicaid outpatients or their caregivers an opportunity to receive counseling from a pharmacist about their prescriptions. Pharmacy technicians play a vital communication role by asking a patient if they would like to speak with the pharmacist, but technicians cannot conduct patient counseling. Medication counseling must be performed by a licensed pharmacist or, where state law permits, a pharmacy intern practicing under pharmacist supervision. Patients possess the legal right to refuse medication counseling offered by the pharmacy. When a patient declines this service, the technician or pharmacist must document the patient's refusal of medication counseling as required by state law and pharmacy policy.
To support safe medication use, OBRA ’90 requires pharmacies to make a reasonable effort to maintain medication profiles for Medicaid outpatients. Technicians assist in keeping these records complete by collecting and inputting demographic and clinical details. Patient profiles should record available demographic information, including the patient’s name, address, telephone number, age or date of birth, and sex. Profiles must also record available clinical information, such as known allergies, drug reactions, relevant medical conditions, and comprehensive medication history. While prospective DUR occurs before dispensing at the pharmacy counter, retrospective DUR involves an ongoing post-dispensing review of claims data conducted by state agencies or health plans to identify broader patterns of fraud, abuse, or inappropriate prescribing across healthcare systems.
Common mistakes
- Assuming that prescribers can request a blanket waiver for non-child-resistant packaging, whereas only the patient can request a blanket waiver; prescribers may only request non-child-resistant caps per individual prescription.
- Believing that pharmacy technicians are allowed to counsel patients if the pharmacist is busy; technicians may only ask if the patient wants to speak with the pharmacist, while actual counseling is strictly limited to pharmacists and supervised interns.
- Assuming that plastic prescription vials can be reused on refills if they look undamaged; federal PPPA guidelines strictly prohibit reusing plastic vials and caps due to wear and container fatigue.
- Thinking that CMS mandates universal annual fraud, waste, and abuse (FWA) training for all pharmacies, when training requirements are actually governed by plan contracts and pharmacy policies rather than a universal CMS annual mandate.
Key points
- OBRA ’90 mandates prospective Drug Utilization Review (DUR) and the offer to counsel for Medicaid outpatients, and many states extend these rules to all patients.
- Prospective DUR screens for therapeutic duplication, contraindications, interactions, incorrect dosage, inappropriate duration, and drug-allergy conflicts prior to dispensing.
- Medication counseling must be provided by a pharmacist or supervised intern; technicians may only offer counseling, and patient refusals must be documented.
- Medicare Part D covers outpatient prescription drugs using tiered formularies and mandates MTM programs, where technicians provide administrative and scheduling support.
- The PPPA requires child-resistant packaging enforced by the CPSC; patients can request blanket non-safety waivers, whereas prescribers can only request waivers per prescription.
- Select medications, including sublingual nitroglycerin and certain unit-dose potassium supplements, are legally exempt from child-resistant packaging requirements.
- Anabolic steroids are Schedule III controlled substances expiring after six months with up to five refills, requiring the same recordkeeping and storage as other Schedule III drugs under pharmacist supervision.
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