Standards of Care

Below are the standards for Long Term Care (LTC) pharmacy as defined by the Centers for Medicare and Medicaid Services (CMS) and further explain for adaptation in the at-home care setting. These standards were originally developed by CMS in 2005 to establish performance and service criteria for LTC pharmacies. Any pharmacy operating within the LTC arena, including LTC Pharmacy at Home, must adhere to these standards to qualify as an LTC pharmacy and engage in any LTC contracts. These criteria represent the essential framework ensuring that pharmacies provide compliant, high-quality care to patients in their homes.

In addition to the CMS standards, there are specific Minimum Care Service Requirements that your pharmacy must meet to be considered an LTC pharmacy at home and to qualify for accreditation. These requirements focus on key aspects of patient care that are critical in the home setting:

• Patient Qualification Review
• Patient Care Coordination
• Medication Dispensing Review

For more details on these essential services and how they contribute to the accreditation process, visit the Minimum Care Services page.

• Standard 1: Comprehensive Inventory and Inventory Capacity

  Pharmacies must maintain a comprehensive inventory of formulary drugs commonly used in the long-term care setting. Additionally, they must provide a secure area for the physical storage of medications, ensuring compliance with federal and state regulations for controlled substances. However, this requirement does not extend beyond the standard inventory or security measures typically maintained in a pharmacy’s normal business operations.

  How to Meet Comprehensive Inventory and Inventory Capacity Standards

  • Along with maintenance and acute medications, maintain availability of medications not typically stocked in retail pharmacies to meet individual patient needs, such as liquid formulations of medications usually provided as tablets or capsules, IV medications (e.g., antibiotics), and other specialized drugs.
  • Ensure sufficient stock to fulfill prescriptions daily, with urgent orders delivered within your contract’s time limit (typically 4-6 hours) and new prescriptions filled within a clinically appropriate time limit (typically 24 hours).
  • Over-the-counter (OTC) medications must also be available and appropriately documented in the patient’s medical record.

  Why Comprehensive Inventory and Inventory Capacity is Important

  • Meeting Unique Patient Needs

    Long-term care patients often require specialized medications not typically available in retail pharmacies. Ensuring the availability of such medications allows pharmacies to provide timely, effective care tailored to the complex health needs of this population.

  • Timely Medication Access

    Prompt access to medications is critical in the long-term care setting to prevent treatment delays that could lead to adverse health outcomes.

  • Comprehensive Care Coordination

    Stocking a full range of prescription and over-the-counter (OTC) medications supports holistic patient care. Including OTC medications in the patient’s medical record ensures all aspects of their treatment are documented, reducing the risk of drug interactions and improving overall care coordination.

  • Regulatory Compliance and Patient Safety

    Secure storage of medications, especially controlled substances, is mandated by federal and state laws to protect patient safety and prevent diversion. Adhering to these standards reflects a commitment to compliance and upholds trust in the pharmacy’s operations.

  • Supporting the Long-Term Care Model

    Long-term care patients often face unique challenges, such as limited mobility or complex care regimens. By maintaining a comprehensive inventory and capacity to fulfill these needs, pharmacies play a vital role in supporting the goals of long-term care: enhancing patient quality of life, reducing hospital readmissions, and ensuring safe medication management in the home or facility setting.

• Standard 2: Pharmacy Operations and Prescription Orders

  Pharmacies are required to provide the services of a dispensing pharmacist to ensure compliance with pharmacy practice standards for dispensing prescription medications to long-term care (LTC) residents. Pharmacies must have the necessary pharmacy software and systems to efficiently manage prescription drug ordering and processing.

  How to Meet Pharmacy Operations and Prescription Orders Standards

  • Ensure Pharmacy Software Readiness
    • Invest in pharmacy software capable of processing both electronic and written prescriptions seamlessly.
    • Regularly update software to stay compliant with evolving industry standards and regulations.
    • Train staff to use the software effectively to reduce processing errors and delays.
  • Develop and Maintain Comprehensive Policies and Procedures

    • Ensure Pharmacy Software Readiness

      • Invest in pharmacy software capable of processing both electronic and written prescriptions seamlessly.
      • Regularly update software to stay compliant with evolving industry standards and regulations.
      • Train staff to use the software effectively to reduce processing errors and delays.

    • Develop and Maintain Comprehensive Policies and Procedures

      • Create a tailored policy and procedure manual specific to your pharmacy’s operations. Include:
        • Prescription receipt and processing workflows.
        • Delivery protocols, including timelines for routine and urgent deliveries.
        • Detailed instructions for ordering and handling controlled substances.
      • Use available resources, such as sample policies, as a starting point, but customize them to reflect your pharmacy’s unique needs.
      • Review and update policies regularly to ensure they meet current compliance standards.

  Why Pharmacy Operations and Prescription Orders Are Necessary

  • Ensuring Compliance with LTC Standards

    Long-term care settings require specialized pharmacy operations to meet the unique needs of residents. By adhering to pharmacy practice standards, pharmacies ensure that prescriptions are dispensed safely and appropriately, aligning with the regulatory and clinical requirements of the LTC population.

  • Facilitating Efficient Prescription Processing

    LTC pharmacies often handle high volumes of complex prescriptions. Pharmacy software capable of accepting and processing both electronic and written prescriptions streamlines operations, reduces errors, and ensures timely delivery of medications, which is critical for patient safety and adherence.

  • Establishing Standardized Workflows

    Clear policies and procedures are essential for ensuring consistency and reliability in pharmacy operations.

• Standard 3: Special, Compliance Packaging

  Pharmacies must have the capability to provide medications in specialized compliance packaging formats commonly required in long-term care settings. This includes options such as Unit of Use Packaging, Bingo Cards, Pouch Packs, or other compliance packaging formats. Pharmacies must have access to the necessary supplies, equipment, and arrangements with vendors to provide these packaging options, including labels, auxiliary labels, and options of packaging types.

  How to Meet Specialized, Compliance Packaging Standards

  • Compliance Packaging Standards

    • All maintenance medications must be provided in compliance packaging, typically for a 30-day supply or less.
    • Oral solids, except for medications required to remain in their original containers, must be dispensed in compliance packaging.

  • Available Packaging Options

    • Punch or Bingo Cards (in unit dose or multi-dose packaging).
    • Multi-dose cards (containing multiple medications in each bubble).
    • Pouch or Pillow Packs, with options for single or multiple medications per package.

  • Special Considerations for Non-Oral Medications

    • Products that are not oral solids, such as insulin, creams, ointments, and ophthalmic solutions, may need to be dispensed in supplies exceeding 30 days, depending on patient needs and medication stability.

  Why Special Packaging is Necessary

  • Enhanced Medication Adherence: Special packaging simplifies medication administration, reducing errors for caregivers and patients.
  • Improved Safety: Compliance packaging minimizes the risk of dosing errors, particularly in LTC at home settings where patients often experience polypharmacy.
  • Customized Solutions: Tailored packaging options address the unique needs of LTC patients.
  • Regulatory Compliance: Meeting packaging standards is critical for LTC pharmacies to align with state and federal guidelines, as well as contractual obligations with LTC’s level of service.
  • Operational Efficiency: Utilizing standardized packaging formats streamlines pharmacy operations and supports effective medication delivery systems.

• Standard 4: IV Medications

  Pharmacies must have the capability to provide IV medications to long-term care patients as prescribed by qualified medical professionals. This may require access to specialized facilities, such as a clean room, for the preparation of IV prescriptions. Pharmacies may also have access to or arrangements with vendors to supply the necessary equipment and supplies, as well as personnel trained in IV medication preparation and administration.

  How to Meet IV Medications Standards

  • Flexibility Through Subcontracting or In-House Capabilities

    • Pharmacies can meet this requirement by:
      • Subcontracting or outsourcing to an external provider, such as another pharmacy, a hospital, a home infusion provider, or a specialized IV services pharmacy.
        • Clarification on Subcontracting
          • The term subcontracting here is not meant in a strict legal sense (i.e., as defined in legal or regulatory contracts). Instead, it refers broadly to any arrangement where a pharmacy utilizes an external party to fulfill the IV medication service requirements.
          • When a pharmacy chooses to outsource these services, a formal contractual agreement — such as a referral agreement, memorandum of understanding (MOU), or service agreement — must be executed. This agreement should:
            • Clearly define the responsibilities of both parties.
            • Outline service expectations, compliance obligations, and quality standards.
            • Be kept on file at the pharmacy as part of its compliance records.
            • Be reviewed and updated in accordance with the terms specified in the contract (e.g., annually, upon renewal, or when service changes occur).
            • Maintaining proper documentation of these agreements helps ensure compliance with state and federal regulations, PBM and health plan requirements, and supports audit readiness.
      • In-House IV Medication Preparation.
        • If a pharmacy chooses to prepare IV medications on-site, it may fulfill the requirement through the following approaches:
        • Maintaining all necessary state licenses and permits required for sterile IV compounding activities. Some states may require separate licensure and/or accreditation for sterile compounding operations in addition to a standard pharmacy license.
        • Using prepackaged or premixed IV products that do not require compounding or preparation within a clean room. These commercially prepared solutions can often be stored and dispensed without additional sterile compounding steps, reducing the infrastructure burden on the pharmacy.
          • Note: Full inventory capacity must be maintained to ensure the pharmacy can meet patient needs at all times. If the pharmacy does not have the capability to stock and maintain a full inventory of necessary prepackaged or premixed IV products, it cannot meet this standard through this route. Pharmacies must be able to provide timely and consistent access to IV medications without delay to qualify as meeting this requirement.
        • Installing and maintaining sterile compounding infrastructure such as:
          • A clean hood (laminar airflow workbench or compounding aseptic isolator) that meets USP <797> standards for low- and medium-risk sterile preparations.
          • A clean room or segregated compounding area, if preparing compounded sterile products (CSPs) that require a higher level of environmental control.
          • The pharmacy must follow all applicable USP <797> and <800> guidelines, where relevant, including environmental monitoring, cleaning protocols, staff competency and training requirements, and documentation standards.
          • Ensuring appropriate staff training and credentialing in sterile compounding practices to meet regulatory and accreditation requirements.
        • Note: Pharmacies opting for in-house IV preparation must evaluate their capacity to maintain ongoing compliance with USP, state board of pharmacy, FDA, and contractual standards — as well as readiness for inspection or audit at any time.
        • Note: The pharmacy must have documented SOPs, quality control workflows, and accurate records of all compounded medications.

  Why IV Medication Capability is Necessary

  • Critical for Complex Care Needs

    Many LTC patients require IV medications for acute treatments, such as antibiotics, hydration, or pain management, which are vital for maintaining their health and avoiding hospitalizations.

  • Ensuring Patient Safety and Compliance

    Access to specialized facilities or vendors ensures IV medications are prepared and delivered in compliance with stringent safety and regulatory standards.

• Standard 5: Compounding / Alternative Forms of Drug Composition

  Pharmacies must have the capability to provide specialized drug delivery formulations tailored to the unique needs of long-term care patients. For patients unable to swallow or ingest medications through conventional routes, pharmacies must be able to modify drug forms, such as splitting or crushing tablets, or preparing suspensions, gels, or other alternative formulations to ensure effective medication administration.

  How to Meet Compounding / Alternative Forms of Drug Composition Standard

  • Flexibility Through In-House or Subcontracted Capabilities
    • Pharmacies can meet compounding and alternative drug composition standards through either:
      • Subcontracting or outsourcing to an external provider, such as a compounding pharmacy or specialized facility, supported by a formal agreement such as a referral agreement, service agreement, or memorandum of understanding (MOU).
        • Clarification on Subcontracting
          • The term subcontracting here is not meant in a strict legal sense (i.e., as defined in legal or regulatory contracts). Instead, it refers broadly to any arrangement where a pharmacy utilizes an external party to fulfill the IV medication service requirements.
          • When a pharmacy chooses to outsource these services, a formal contractual agreement — such as a referral agreement, memorandum of understanding (MOU), or service agreement — must be executed. This agreement should:
          • Clearly define the responsibilities of both parties.
          • Outline service expectations, compliance obligations, and quality standards.
          • Be kept on file at the pharmacy as part of its compliance records.
          • Be reviewed and updated in accordance with the terms specified in the contract (e.g., annually, upon renewal, or when service changes occur).
          • Maintaining proper documentation of these agreements helps ensure compliance with state and federal regulations, PBM and health plan requirements, and supports audit readiness.
          • Providing compounding services in-house, with appropriate equipment, infrastructure, training, and compliance protocols.
          • Maintaining all necessary state licenses and permits required for sterile IV compounding activities. Some states may require separate licensure and/or accreditation for sterile compounding operations in addition to a standard pharmacy license.
          • Using pre-made or commercially available products (e.g., pre-split, pre-crushed, or pre-mixed formulations) that do not require preparation within a clean room or sterile compounding environment. This can reduce infrastructure needs while still meeting certain alternative formulation requirements.
          • Note: Full inventory capacity must be maintained to ensure the pharmacy can meet patient needs at all times. If the pharmacy does not have the capability to stock and maintain a full inventory of necessary pre-made or prepackaged products, it cannot meet this standard through this route.
      • Installing and maintaining compounding infrastructure, including:
        • Tablet splitters, crushers, suspension devices, and mixing equipment for non-sterile compounding.
        • A clean hood or clean room for sterile or complex non-sterile compounding as required by the types of preparations being made.
        • Compliance with applicable USP standards (e.g., <795>, <797>, <800>) and all relevant state and federal regulations.
      • Training and documentation:
        • Staff must be properly trained and competency-tested in compounding techniques, with records of training and ongoing assessments maintained.
      • The pharmacy must have documented SOPs, quality control workflows, and accurate records of all compounded medications.

  Why Compounding / Alternative Form of Drug Composition Are Necessary

  • Enhances Patient-Centered Care

    Many long-term care patients have unique needs that prevent them from taking medications in standard forms. Compounding ensures these patients can safely and effectively receive their prescribed treatments.

  • Supports Medication Adherence

    Providing medications in a form that is easier for patients to take reduces barriers to adherence, improving therapeutic outcomes.

• Standard 6: Pharmacist On-Call Service

  Pharmacies must provide 24/7/365 on-call service with a qualified pharmacist available to handle after-hours calls and ensure medication dispensing during emergencies, holidays, and outside normal operating hours. This is a critical requirement to meet the urgent needs of LTC patients and caregivers.

  How to Meet Pharmacist On-Call Service Standards

  • Availability of Pharmacy Services

    A pharmacist must be accessible to patients, caregivers, and providers 24 hours a day, 365 days a year, to address medication-related inquiries or urgent needs.

  • After-Hours Communication

    The pharmacy must have a dedicated phone service to manage after-hours calls, ensuring they are answered promptly and appropriately.

  • Flexible On-Call Arrangements Pharmacist availability can be achieved through:
    • In-House On-Call Pharmacist Coverage
      • Employ or designate on-call pharmacists who are available after hours, overnight, weekends, and holidays.
      • This can be accomplished through:
        • A rotating schedule among existing pharmacy staff.
        • Hiring dedicated on-call pharmacists whose primary responsibility is after-hours coverage.
      • On-call pharmacists must have access to:
        • Patient records, medication profiles, and clinical notes (via secure systems as needed).
        • The ability to authorize or facilitate emergency medication dispensing.
      • Documentation: Maintain schedules, SOPs, and logs of all on-call interventions or consultations.
    • Subcontracting or Partnering for On-Call Support
      • Pharmacies may purchase or contract on-call support through:
        • Specified on-call providers, also known as backup pharmacy providers, who specialize in delivering after-hours pharmacist availability and emergency medication dispensing.
        • Partner pharmacy networks, hospitals, or specialized service vendors that offer formalized after-hours coverage.
      • These partnerships must be formalized through a contract, service agreement, or memorandum of understanding (MOU) that clearly defines:
        • The services provided, including pharmacist availability and emergency dispensing protocols.
        • The provider’s licensure, compliance obligations, and quality expectations.
        • Communication and documentation requirements between the primary pharmacy and the backup provider.
      • Documentation: Agreements must be kept on file and reviewed per contract requirements. Pharmacies must also maintain records demonstrating that on-call services were accessible and responsive when utilized.

  Why 24/7 Pharmacist On-Call Service is Necessary

  • Immediate Access to Expertise

    Long-term care patients often face urgent or complex medication needs that require immediate consultation with a qualified pharmacist.

  • Supports Emergency Medication Needs

    Providing after-hours dispensing ensures that patients receive critical medications without delay, preventing health complications.

  • Fulfills Regulatory and Contractual Requirements

    Many LTC contracts and regulations mandate 24/7/365 pharmacist availability, making compliance essential for maintaining contracts.

• Standard 7: Delivery Service

  Pharmacies must provide reliable delivery services to ensure medications reach long-term care patients safely, securely, and in a timely manner. Delivery services must accommodate both routine and emergency needs, with flexible arrangements tailored to patients, caregivers, and/or facility requirements. Secure exchange systems and proper delivery documentation are critical for compliance and patient safety.

  How to Meet Delivery Service Requirements Standards

  • Routine and Emergency Deliveries

    • Routine deliveries should occur at least once per month, with additional deliveries as needed for medication changes or urgent needs.
    • Patients recently discharged from a hospital or facility may require more frequent deliveries (e.g., every 7 or 14 days).

  • Delivery Documentation

    • All deliveries must include proof of delivery, such as:
      • A photo of the package delivered to the home.
      • A signed receipt or manifest from the caregiver, family member, or patient.
      • Documentation can be captured electronically or on paper.
    • Patients or caregivers must be educated during onboarding about delivery processes and what actions to take if no one is available to receive the delivery.

  • Delivery Execution

    • Pharmacies must ensure timely, secure, and compliant delivery of medications.
    • Deliveries can be handled by:
      • The pharmacy directly.
      • A courier service — defined as a service contracted or employed to provide hand delivery of medications directly to the patient, caregiver, or authorized recipient. Courier service involves the medication being physically transported and handed off by a delivery agent who can obtain a receipt or proof of delivery at the point of handoff.
      • NOTE: This differs from common courier services (e.g., ‘mailing,’ USPS, FedEx, UPS) that primarily handle general mail and package shipments through standard shipping processes, without direct hand delivery or guaranteed handoff to a specific individual at the point of delivery.

  Use of Common Courier

  • Common courier services (e.g., ‘mailing,’ USPS, FedEx, UPS) may only be used in emergency or urgent situations where standard pharmacy delivery or hand-held courier service is unavailable.
    • The reason for using a common courier must be documented in the patient record.
    • The pharmacy must notify the patient or caregiver in advance when common courier is being used and provide tracking information to support timely receipt.
    • The pharmacy remains responsible for ensuring delivery confirmation and addressing any delivery issues that arise.
    • The use of common courier should not be a routine service provided or documented for the patient.
    • All use of common courier services must comply with Board of Pharmacy state laws and regulations. For example, some states do not permit pharmacies to mail medications into the state without holding a valid pharmacy license for that state.
    • Use of common courier services may place the pharmacy at risk for additional audits under contracts with PSAOs, PBMs, or health plans. Pharmacies must abide by all applicable state laws, licensing requirements, and contractual obligations.
    • Pharmacies must review and follow their PSAO, PBM, and health plan contracts carefully to ensure that use of a common courier does not violate contractual terms.
  • Refer to the Commission’s position on the use of common courier services online at the Commission’s website under News & Statements.
    • www.ltcathomequalitycommission.com/long-term-care-pharmacy-about/news-and-statements

  Why Delivery Services Are Necessary

  • Ensures Timely Access to Medications

    Routine and emergency delivery services help ensure that patients receive their medications at the right time and dose, reducing the risk of treatment interruptions.

  • Supports High-Risk Patients

    Frequent deliveries for patients with complex or changing medication regimens, such as those recently discharged, promote adherence and safety.

  • Enhances Patient and Caregiver Confidence

    Reliable delivery services reassure patients and caregivers that their needs will be met promptly and consistently.

• Standard 8: Miscellaneous Reports, Forms, and Prescription Ordering Supplies

  Pharmacies must provide the necessary reports, forms, and prescription ordering supplies to support the delivery of quality pharmacy care. These materials assist patients, caregivers, and providers in managing medications effectively and ensuring compliance with best practices.

  How to Meet Miscellaneous Reports, Forms, and Prescription Ordering Supplies Standards

  • Develop and Standardize Forms and Reports

    • Create templates for commonly required forms, including medication instructions, health monitoring tools, and ordering guides.
    • Regularly update templates to align with regulatory and operational requirements.

  • Educate Patients and Caregivers

    • Train patients, families, and caregivers on how to use provided forms and tools effectively.
    • Offer written or digital instructions and follow up to ensure understanding.

  • Collaborate with Families

    • Work closely with families to understand their needs and customize forms and reports accordingly.

  • Ensure Compliance with Controlled Substance Regulations

    • Provide secure, easy-to-use forms for controlled substance tracking.
    • Educate caregivers and patients on legal and safety requirements for managing these medications.

  Why Miscellaneous Reports, Forms, and Prescription Ordering Supplies Are Necessary

  • Supports Medication Adherence

    Clear and accessible materials help patients and caregivers follow complex medication regimens, reducing errors and improving health outcomes.

  • Improves Patient Safety

    Providing specific instructions for medication administration ensures medications are used correctly and safely.

  • Enhances Monitoring and Management

    Tools for tracking health metrics enable better management of chronic conditions, providing critical data for healthcare providers.

• Standard 9: Emergency Boxes and Logbooks

  Pharmacies providing Long-Term Care Pharmacy at Home services are expected to deliver an institutional level of pharmacy care that aligns with the standards and expectations set forth for traditional long-term care (LTC) facilities. As such, the Long Term Care at Home Pharmacy Quality Commission requires that all pharmacies engaging in LTC-level pharmacy services maintain the capability to provide emergency kits (also referred to as emergency boxes) and maintain emergency medication logbooks when requested by a facility, provider, or care team.

  This requirement reflects the Commission’s position that any pharmacy delivering LTC-level services must be prepared to support the full spectrum of institutional pharmacy care, including readiness for emergency medication access. This standard ensures that pharmacy services align with CMS requirements for LTC services and supports patient safety, timely care delivery, and regulatory compliance.

  While the National Council for Prescription Drug Programs (NCPDP) defines Level of Service Code (418-DI) 07 (Medical at Home) as “Medical at home with special pharmacy services identical to Long Term Care beneficiaries except for emergency kits”, the Commission recognizes that comprehensive LTC-level care demands preparedness for emergency medication needs.

  How to Address Emergency Boxes and Logbooks Standards

  • NCPDP and CMS Requirements differ

    • NCPDP defines the Long-Term Care Pharmacy at Home level of service code (418-DI) value “7” as:
      • “Medical at home with special pharmacy services identical to Long Term Care beneficiaries except for emergency kits.”
    • However, CMS still requires pharmacies to have the capability to provide emergency kits and logbooks to facilities if needed. Pharmacies offering LTC Pharmacy at Home services must understand how to meet these requirements if the situation arises.

  • Emergency Boxes

    • Emergency medication kits (e-kits) are generally not required for LTC Pharmacy at Home patient support.
    • CMS expects LTC pharmacies — including pharmacies engaging in only LTC Pharmacy at Home services — to have the capability to provide e-kits to facilities if needed (e.g., if a patient transitions to a facility setting temporarily or if the pharmacy is recognized as an LTC provider under state law).
    • Pharmacies should review and comply with state-specific requirements and ensure protocols are in place to supply and manage e-kits where applicable.

  • Emergency Logbooks

    • Since e-kits are typically not generally required for the LTC Pharmacy at Home patient, emergency logbooks for tracking and charging medications from emergency stock are not generally necessary.
    • To comply with CMS LTC standards of care, the pharmacy must establish and maintain a system for logging medication usage, charges, and comprehensive records of medication orders and administration.

  How to Meet Emergency Box and Logbook Standard

  Pharmacies must have robust, compliant processes in place to ensure patient safety, regulatory adherence, and audit readiness. Key components include:

  • Emergency Stock Management

    • Establish clear procedures for the secure storage of emergency medications, ensuring they are properly labeled, segregated, and easily accessible in compliance with state and federal requirements.
    • Define processes for the routine inspection and inventory of emergency stock to monitor expiration dates, integrity, and availability of medications.
    • Implement a replenishment plan that ensures timely replacement of medications used from emergency supplies, preventing lapses in availability.
    • Emergency boxes (e-kits) can be purchased online through pharmacy supply vendors, specialized providers, or other e-commerce websites. These may be in the form of lockable portable boxes or lockable medication carts. Similarly, emergency medication administration logbooks and booklets can be sourced through these channels.
    • Pharmacies should maintain these supplies as part of their inventory to demonstrate — during audits or inspections — that they have the capability to provide emergency supplies promptly if needed.

  • Logging and Charging System

    • Create a reliable system to track every instance of medication dispensed from emergency supplies, including the date, time, medication details, quantity, and the name of the individual who administered or removed the medication.
    • Ensure charges for medications dispensed from e-kits are accurately applied to the appropriate resident or patient account, with supporting documentation for billing and reimbursement purposes.
    • Maintain records that meet payer, PBM, and contractual audit standards.

  • Medication Orders and Administration Records

    • Require written or electronic medication orders to support the dispensing of all emergency medications, in alignment with state law and facility policies.
    • Document all administration details in the patient’s record, including the indication for use, dosage given, and outcome of administration.
    • Maintain these records in a manner that ensures they are readily accessible for review during audits or inspections by state boards, PBMs, health plans, or other regulatory bodies.

  • Ongoing Compliance Monitoring

    • Periodically review and update emergency supply protocols to ensure continued compliance with changing state laws, federal regulations, and contractual requirements.
    • Provide staff training to ensure all team members understand their responsibilities related to emergency supplies, logging, and documentation.

  Why This Approach is Necessary

  • Ensures Regulatory Compliance

    • Maintaining emergency kits, log books, and related supplies — even if not routinely used — helps the pharmacy demonstrate preparedness and compliance with federal, state, and contractual requirements. This proactive approach reduces the risk of regulatory violations, fines, or failed audits, particularly in states where emergency supply capabilities are mandated.

  • Promotes Patient Safety and Quality of Care

    • Having emergency supplies and documentation systems readily available ensures that patients can receive critical medications without delay in urgent situations. A clear, compliant process supports continuity of care and reinforces the pharmacy’s role in safeguarding patient health during emergencies.

  Page Reference:

  Standards are referenced from Centers for Medicare & Medicaid Services, Medicare Prescription Drug Benefit Manual – Chapter 5 (Sept. 20, 2011), available at https://www.cms.gov/Medicare/Prescription DrugCoverage/PrescriptionDrugCovContra/Downloads/MemoPDBManualChapter5_093011.pdf.