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The procedures and services involved in specialty pharmacy are different from the community model.
Often I hear pharmacists say, “I fill specialty prescriptions all the time through my store(s). What is the big deal?” I then reflect back 15 years when I had the same perception. What about the “reality” of the specialty care model? What are the components? Why is specialty different? What must do as a pharmacy to succeed? What are the expectations from the stakeholders in the process?
Most full focused service specialty pharmacies (SPs) provide much more than the traditional pharmacy test claim. A full review is completed for almost every patient. This includes 1) A pharmacy claim review (a test claim); 2) A phone call to the insurance carrier to verify the pharmacy benefit (Is it retail or mailorder? Is there a preferred pharmacy for the patient? What are the copay/deductible amounts for each option? Is there a Prior Authorization/Statement of Medical Necessity? Requirements?); the medical benefit (Out of Pocket? Deductible? Prior Authorization? Requirements? Buy and Bill by MD?); nursing benefit/injection training/home health care (What is coverage policy? Preferred local and national vendors? Patient responsibility? What is covered? Billing process and coding requirements? Rates?); compounding/per diem rates if applicable; and 3) understanding and reviewing Compassionate Care Program options (Is there a copay assistance program for the product? Who is administering program? What are the requirements? Is there a copay card, credit card, or other? How to process? How to get paid?); is the patient eligible for a Patient Assistance Program? (Who is administering program? What are the requirements? What does the patient need to do to apply? What does the MD office need to do as part of the process?); are there any alternative coverage organizations? (eg, American Cancer Society, local advocacy organization); do you provide payment plan options for your customers?
Most full-service SPs provide intense training programs and educational services by disease category and product. This includes educational training sessions for pharmacists, technicians, and billing staff at least 2 times a year for each focused disease category; customized enrollment forms (a 1-pager that captures patient information; insurance information; service needs, eg, nursing, injection training; clinical information, eg, ICD-9; traditional Rx prescribing requirements; and customized or manufacturer educational materials (storage of materials, inventory tracking of materials).
Most full-service SPs are contracted with the payers/insurance companies to provide administration supplies as part of the contracted rate. These materials include syringes, needles, sharps containers, and alcohol swabs.
High–Touch MD Office/ Clinical Services
Offices/MDs prescribing and processing specialty Rxs typically do not handwrite an Rx for the patient. Approximately 90% of specialty Rxs/referral forms are sent via fax. E-prescribing, although becoming more prevalent, has not been widely accepted by “specialty prescribers” due to the complexity of the products and the required adjuvant regimens. These services include 1) fax or call back to the MD/office letting them know the fax was received. This can be done within 15 minutes or batched to a certain time of day or MD/office preference; 2) MD office notification of referral status: Did the patient’s insurance approve the prescription? Is there additional paperwork that the MD office must provide?; 3) patient stratification by disease and severity: MD/offices expect SPs to provide different levels of service and support depending on if the patient is naïve (patient has never taken Rx) or experienced (patient has been on therapy before); 4) compliance/persistency services: is the patient getting their refills? On time? Any side effects? Has the patient stopped therapy? Any interventions? (MD/office expects fax or phone notification if the patient is experiencing any issues. Some SPs have secure Web portals that allow MD to see all patients under their care and clinical information); and 5) proactive refill requests.
Pharmaceutical manufacturers may have requirements for participation in a limited distribution network product, open distribution product service agreements, and the FDA may have Risk Evaluation Mitigation Strategies requirements. These requirements may include inventory tracking and reporting (852 standardized EDI inventory reports); sales tracking and reporting (867 standardized sales reports); packing, shipping, tracking via a national courier in validated containers; performance tracking and reporting (turnaround times, call metrics); continuous quality improvement tracking, documentation, resolution; clinical data capture and reporting: disease- or product-specific capture, talk tracks, by patient severity stratification; and coordination with manufacturer 800 Call Center/Service Center/ HUB.
In summary, specialty pharmacy is taking what you likely do every day and enhancing the process with very tangible controls (it must be real and segregated to meet the needs of the stakeholders). Often pharmacies will set up a separate facility or separate area for specialty Rx processing. On top of all of this is the need for a very flexible scalable IT platform that includes an Rx Dispensing system, a workflow manager, and a data warehouse with robust internal and external reporting ability. To participate, these are just some of the basic requirements to compete, and hopefully if done right, to succeed.
David Suchanek, RPh, is senior vice president of biotech and specialty services at D2 Pharma Consulting, LLC. He is a member of the Specialty Pharmacy Times editorial board. For more information visit www.SpecialtyPharmacy.com.