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Long Term Care: Medicare Prescription Drug Coverage in Institutions and Our Communities Larry Kocot Vanessa Duran MMA Requirements regarding Access to Part D Drugs in LTC Facilities • Section 1860D-4(b)(1)(C)(iv) of the Act requires convenient access to Part D drugs for residents of LTC facilities. • Sec. 107 of the MMA requires a report to Congress: – Assessing the current standards of practice, clinical services, and other service requirements generally used for pharmacy services in long-term care settings – Evaluating the impact of those standards with respect to patient safety, reduction of medication errors and quality of care. Regulatory Access Standards for LTC Pharmacies (§423.120(a)(5)) • Plans must demonstrate convenient access to LTC pharmacies – Offer standard contracting terms & conditions to all I/T/U pharmacies in service area – Must contract with “any willing pharmacy” • Standard terms and conditions must conform with certain performance and service criteria for the provision of LTC pharmacy services established by CMS in further guidance • CMS has provided separate guidance regarding how convenient access to LTC pharmacies will be assessed Regulatory Network Access Standards for LTC Pharmacies (§423.120(a)(5)) • Anticipated benefits of our LTC access policy: – Plans may negotiate more competitive market rates with LTC pharmacies – LTC facilities will likely be able to select just one LTC pharmacy to serve their residents – May allow LTC facilities to negotiate more competitive rates for additional services for their residents from LTC pharmacies LTC Guidance: LTC Pharmacy Performance and Service Criteria – – – – – – – – – – Comprehensive inventory and inventory capacity Pharmacy operations and prescription orders Special packaging IV medications Compounding/alternative forms of drug compositions Pharmacist on-call service Delivery service Emergency boxes Emergency logbooks Miscellaneous reports, forms, and prescription ordering supplies LTC Guidance: Convenient Access • Convenient access to LTC pharmacies for 2006: – – – – Work plan Performance and service criteria Contracting with any willing pharmacy Attestation of convenient access and list of network LTC pharmacies by August 1, 2005 • Convenient access in future contract years may look at: – Enrollment/disenrollment rates – Complaints – Linking beneficiaries to LTC pharmacies to verify LTC pharmacy capacity LTC Guidance: Formulary • Plans must have a single formulary for all enrollees • Plans must establish an appropriate transition process for new enrollees: – Procedures for medical review of non-formulary drugs – Procedures for switching enrollees to therapeutically equivalent alternatives failing affirmative medical necessity determination – Temporary one-time supply fills recommended – Documentation of range and circumstances impacting transition timeframes – Other transition methods (e.g., contacting enrollees in advance of initial effective date of enrollment) LTC Guidance: Exceptions & Appeals • We expect plans to consider interrelationship between LTC facility, LTC pharmacy, attending physician, and relevant laws and regulations in establishing grievance, coverage determination, and appeals processes • Part D sponsors must clearly articulate financial responsibility of plans when Part D requirements and Medicare conditions of participation (COPs) conflict • Recommend that plans consider one-time temporary or emergency supply process as a stopgap while an exception or appeal request is in process • Regulations allow an appointed representative to act on an individual’s behalf