Pharmacy Group Releases LTC Pharmacy at Home Guidelines

Contributed by: Steve Postal, Senior Director, Policy and Regulatory Affairs at National Community Pharmacists Association (NCPA), and Editorial Director of American Society for Pharmacy Law (ASPL)

Several pharmacy groups have joined efforts to alert Medicare and Part D plans about long-term care (LTC) pharmacy at home services, and to reimburse pharmacies for those services. To enhance efforts and to provide the industry a roadmap for consistency, the Alliance for Long-Term Care Pharmacy at Home (the Alliance) published guidelines for pharmacies providing LTC pharmacy at home services. The guidelines serve to incorporate the Centers for Medicare and Medicaid Services (CMS) pharmacy guidance for LTC facility-based patients to patients living at home. 

The Alliance is made up of LTC pharmacies, professional associations, and care management groups that seek to improve the lives of those living in the community with complex medical needs, including those with chronic conditions and disabilities. 

The Alliance published its long-term care pharmacy at home guidelines in both paragraph and table versions. These guidelines address several aspects of LTC pharmacy, including: inventory, pharmacy operations, special packaging, IV medication availability, and others. Some examples are the following:

Comprehensive Inventory  & Inventory Capacity

According to the CMS guidance, network institutional long-term care pharmacies must provide a comprehensive inventory of plan formulary drugs commonly used in the long-term care setting. In addition, these pharmacies must provide a secured area for physical storage of drugs, with necessary added security as required by federal and state law for controlled substances. CMS further stipulated in the guidance that this is not to be interpreted that the pharmacy will have inventory or security measures outside of the normal business setting. 

The new Alliance guidelines for LTC pharmacies at home state that inventory should include the following: 1) medications not normally stocked in a retail pharmacy to meet individual patient needs such as liquid formulations of drugs usually dispensed as tablets or capsules; 2) adequate stock to fulfill orders and prescriptions daily and to fulfill urgent orders in a timely manner; 3) over-the-counter medications that should be available as well and recorded in the patient’s medical record. Additionally, the Alliance’s guidelines on inventory for LTC pharmacies at home included that the pharmacy will confirm delivery of all new prescription orders to determine urgency, and any existing supply the patient has on hand, and the pharmacy will coordinate any fills with a local or back up pharmacy if needed to ensure the patient receives the medication in a timely manner.

Pharmacy Operations & Prescription Orders

According to the CMS guidance, network institutional long-term care pharmacies must provide services of a dispensing pharmacist to meet the requirements of pharmacy practice for dispensing prescription drugs to LTC residents, including but not limited to the performance of drug utilization review (DUR). In addition, the pharmacist must conduct DUR to routinely screen for allergies and drug interactions, to identify potential adverse drug reactions, to identify inappropriate drug usage in the LTC population, and to promote cost-effective therapy in the LTC setting. Lastly, the CMS guidance stipulated that the pharmacy must also be equipped with pharmacy software and systems sufficient to meet the needs of prescription drug ordering. 

The new Alliance guidelines clarifies standards for pharmacy operations and prescription orders for LTC pharmacies at home, including that those pharmacies: 1) must meet the requirements of pharmacy practice for dispensing prescription drugs to LTC residents, including but not limited to the performance of DUR; 2) must have pharmacy software to accept and process both electronic and written prescriptions; 3) must have policy and procedures for both the pharmacy and each patient’s home available for review with PBMs; and 4) must have policy and procedures that include workflow and procedures in the pharmacy to receive prescriptions, process prescriptions, delivery of prescriptions, and how controlled medications are ordered and delivered.

Special Packaging

According to the CMS guidance, network institutional long-term care pharmacies must have the capacity to provide specific drugs in unit of use packaging, bingo cards, cassettes, unit-dose or other special packaging commonly required by LTC facilities. The pharmacies must also have access to, or arrangements with, a vendor to furnish supplies and equipment including but not limited to labels, auxiliary labels, and packing machines for furnishing drugs in such special packaging required by the LTC setting. 

The new Alliance guidelines adds that for long-term care pharmacy at home, special packaging provisions include that: 1) compliance packaging for all medications, including maintenance medications, must be provided in 30 days or less; 2) oral solids except for products that must be dispensed in original containers, must be dispensed in compliance packaging; 3) options for packaging include punch or bingo cards, multiple dosage cards (multiple medications in each bubble), pouch or pillow packages with one or multiple medication in each package; 4) patients with unstable chronic conditions may need to have medication dispensed for less than 30 days to avoid delivery of separate packaging for new orders and repackaging of other medications; and 5) products such as insulin, creams and ointments, and ophthalmic products may need to be dispensed in more than a 30-day supply.

IV Medications

According to the CMS guidance, network institutional long-term care pharmacies must have the capacity to provide IV medications to the LTC resident as ordered by a qualified medical professional. These pharmacies must also have access to specialized facilities for the preparation of IV prescriptions (clean room). Additionally, these pharmacies must have access to or arrangements with a vendor to furnish special equipment and supplies as well as IV trained pharmacists and technicians as required to safely provide IV medications.

The new Alliance guidelines state that for IV medications for LTC pharmacies at home, the pharmacy 1) must have the capacity to provide IV medications regardless of setting; and 2) may subcontract or make arrangements with a hospital, home infusion, or company that provides IV services to meet this requirement. Additionally, the new guidelines stipulate that the pharmacy may provide IV medications, equipment, and supplies as needed, and can install a clean room or IV hood or may provide prepackaged products that do not require a sterile hood to be installed in the pharmacy.