Why Specialty Accreditation?


  • Higher level of pharmacy care for those patients receiving specialty medications.
  • Standards that require the comprehensive, rigorous management of patient care
  • Standards support safe and cost-effective patient care outcomes



  • Integration of specialty pharmacy practice services with manufacturer HUB services, including patient registration
  • Compliance with financial assistance, copay rules, targeted counseling pursuant to REMS, REMS changes, manufacturer  labeling changes, and other targeted or contractual safety interventions
  • Documentation of use of data reports supporting targeted formulary interventions; targeted adherence improvement; persistency metrics with formulary; plan cost avoidance
  • Evidence of REMS compliance and patient notification materials of REMS changes
  • Data reporting validation prior to submission to payer and manufacturer partners
  • Policy and procedures for data systems review and validation (minimum annually)


Provision of comprehensive benefits investigation, prior authorization assistance, and benefits coordination is essential to patient medication access

  • Facilitation of patient enrollment in financial assistance sources including patient referral or transfer; pharmacy-based reimbursement resources; benefit investigation outcomes; related patient education
  • Coordinated patient access to preferred specialty pharmacy choice/manufacturer HUB when required by third-party payer or manufacturer requirement
  • Coordination of benefits investigation with prescriber including alternate formulary-preferred therapy and step-therapy requirements for specific  therapeutic medication classes
  • Documentation of interventions to avoid non-formulary utilization of therapy; inappropriate use of manufacturer-sponsored copay cards
  • Integration of benefits coordination information and documentation into the patient profile

Evaluation of quality metrics and outcomes are essential to assess the effectiveness of patient care services.

  • Adherence rates, based on consensus guidelines for therapeutic class
  • Persistence on therapy and persistence metrics
  • Monitoring, assigning cost avoidance, and reporting for pharmacist interventions.
  • Patient and provider satisfaction
  • Patient, provider and employee complaints about  any specialty pharmacy practices services including delegated contract partner services
  • Quality-related events and medication errors
  • Active patient volume being maintained on pharmacy patient case management protocols, by disease state 
  • Quality improvement project results

Relationships and consistent communications with prescribers and patients results in better care coordination and leads to more cost effective care. Patient education and understanding are critical to medication therapy adherence and acceptance

  • Required elements for communication with prescribers and other healthcare providers including pharmacy providers
  • Patient consultation, education and documentation regarding expectations for therapy - expected outcome and clinical goals of therapy; adverse event management; time to benefit; role of adherence and persistence in expected outcome
  • Management of patient language requirements and ability to understand, barriers to communication, if applicable
  • Maintenance of a comprehensive patient profile
  • Therapy initiation and abandonment
  • Patient transition to alternate site of care/alternate provider of care
  • Upcoming surgical procedures, chemotherapy cycling, etc.
  • Necessary prescriber follow-up with patients
  • Medical history and medication profile view (specialty, other Rx ,OTC)
  • Pharmacy interventions made on behalf of the patient or provider,
  • Allergies and adverse drug reactions
  • Lab results
  • Patient evaluation and adherence related to FDA-mandated MedGuide and REMS program requirements
  • Profile review and updated profile information, prior to each dispense, with each patient contact, supplemental demographic or clinical information from other care providers
  • Management and documentation of patient care milestone

CPPA defines Pharmacy Patient Case Management: A collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services for patients including:

  • Coordination and collaboration with other pharmacy providers and other healthcare providers
  • A comprehensive review of the patient’s medication history
  • Use and maintenance of a patient’s personal medication list
  • A care plan or action plan with action items for the patient to achieve the desired medication therapy outcomes
  • Patient-specific assessments and information obtained, incorporated and documented as part of the patient case management process - Assessment of current and prior medication therapy; Vaccination status assessments at initiation and annually; Assessment of all patient parameters needed to determine appropriate medication therapy; Patient reported side effects to any medications; Date of previous refill and adherence assessment; Drug-specific assessment and/or disease state-specific assessment including pertinent lab testing and reporting, symptom assessment; REMS and MedGuide accommodation and documentation
  • Use of medication or disease state specific protocols
  • Pharmacist interventions as needed to address potential problems or issues
  • Modification of standardized care plans based on patient-specific assessment and patient and provider input
  • Ongoing patient monitoring and follow-up
  • Referrals to other health care providers and services
  • Documentation of all pharmacy case management activities
  • Prohibited use of refill protocols without direct patient contact