Setting the Gold Standard in Long-Term Care at Home

  • Early Foundations of Pharmacy in America

    • 1600s: Colonial Apothecaries – In colonial America, apothecaries served as the earliest pharmacies, preparing and dispensing medications.
    • 1821: Establishment of the Philadelphia College of Pharmacy – The first pharmacy school in the United States was founded to formalize pharmaceutical education.
    • 1852: Formation of the American Pharmaceutical Association – Now known as the American Pharmacists Association (APhA), it was established to standardize pharmacy practices nationwide.

  • Development of Long-Term Care and Pharmacy’s Role

    • 1935: Social Security Act
      Established a federal system for ‘old-age’ benefits, laying the groundwork for Medicare and Medicaid programs to support healthcare costs for the elderly.
    • 1965: Medicare and Medicaid Established
      Signed by President Johnson, Medicare (Title XVIII) and Medicaid (Title XIX) programs were implemented, creating funding streams that expanded skilled nursing facilities (SNFs) and nursing homes for long-term care, supporting patients needing ongoing care outside hospitals.
    • 1974: ASHP’s Institutional Pharmacy Standards
      The American Society of Health-System Pharmacists (ASHP) set standards to improve medication safety and adherence in institutional settings, such as nursing homes and SNFs, laying the groundwork for today’s LTC pharmacy services.
    • 1987: Omnibus Budget Reconciliation Act (OBRA-87)
      This federal law established the Nursing Home Reform Act, mandating comprehensive drug regimen reviews by consultant pharmacists in nursing homes and creating new quality standards to improve care.
    • 1990: Omnibus Budget Reconciliation Act (OBRA-90)
      OBRA-90 expanded upon OBRA-87 by requiring drug utilization review (DUR) and patient counseling for Medicare and Medicaid patients, enhancing pharmacist involvement in nursing homes, and expanding LTC consulting roles.
    • 1997: Balanced Budget Act
      Enacted a prospective payment system for Medicare, impacting reimbursement for SNFs and influencing LTC pharmacy operations. This led to changes in how LTC facilities managed and paid for pharmacy services.
    • 2001: Institute of Medicine Report on Nursing Home Care
      A critical IOM report emphasized the need for improved medication management in nursing homes, spurring further pharmacy involvement in LTC settings to manage medication therapy and prevent adverse drug events.

  • Expansion into Long Term Care Pharmacy at Home

    • 2003: Medicare Modernization Act
      This Act established Medicare Part D, enabling coverage for outpatient prescriptions and expanding LTC pharmacy services. LTC pharmacies became critical for delivering Medicare-covered medications to nursing home residents, fostering new models for medication management in LTC.
    • 2004: Lewin Group Report for CMS on LTC Pharmacy Services
      This CMS-commissioned report by The Lewin Group reviewed federal and state regulations for LTC pharmacies in nursing facilities, emphasizing specialized services such as unit-dose packaging, emergency drug supplies, 24/7 pharmacy access, and medication carts. The report underscored that nursing facilities commonly partner with a single preferred pharmacy to streamline services and comply with federal requirements for drug handling, documentation, and emergency readiness. CMS Guidance on LTC Pharmacy Services 2004
    • March 2005: CMS Long Term Care Guidance for Medicare Part D Plans
      Released on March 16, 2005, this CMS guidance document outlined essential criteria for LTC pharmacies under Medicare Part D, specifying performance and service standards. Some key requirements included:
      • Comprehensive Inventory: LTC pharmacies (NLTCPs) must maintain formulary drugs common to LTC settings and provide secured storage.
      • Specialized Packaging and IV Medications: Pharmacies must offer unit doses, blister packs, and IV medication options.
      • 24/7 On-Call Services: LTC pharmacies must provide round-the-clock access to pharmacists for emergency dispensing.
      • Delivery Services: Pharmacies must arrange regular and emergency deliveries to LTC facilities.
      • Convenient Access Requirements: Part D plans must contract with LTC pharmacies to ensure convenient access for institutionalized beneficiaries.
      CMS LTC Standards Guidance 2005
    • November 2005: CMS Long-Term Care Convenient Access Standard Statement
      CMS clarified that Medicare Part D plans must maintain a network of LTC pharmacies that ensures convenient access to Part D benefits for institutionalized enrollees. This guidance emphasized that plans should not rely on out-of-network pharmacies to meet this access standard. It also underscored that contracting should be ongoing, encouraging LTC pharmacies to meet CMS-defined performance criteria to be part of Part D networks. CMS Convenient Access Standard 2005
    • 2010: Affordable Care Act (ACA)
      The ACA included provisions to expand home and community-based services (HCBS) and reduce avoidable hospitalizations, emphasizing care in settings outside of traditional institutions. The Act prompted pharmacies to offer expanded services in LTC, especially for aging patients at home.
    • 2014: CMS “Mega Rule”
      The Centers for Medicare & Medicaid Services (CMS) issued a rule that required LTC facilities to employ pharmacists for medication regimen reviews and implement quality assurance and performance improvement (QAPI) programs, further embedding pharmacist roles in LTC settings.
    • 2016: Expansion of PACE (Programs of All-Inclusive Care for the Elderly)
      The PACE model integrated Medicare and Medicaid services for elderly individuals in community settings, focusing on providing home-based, long-term care at home services to individuals who are nursing-home eligible.
    • 2018: Pharmacy Quality Alliance (PQA) Medication Adherence Measures in LTC
      The PQA introduced measures focused on medication adherence specifically for LTC settings, emphasizing metrics for quality medication management and creating guidelines for pharmacy involvement in LTC patient care.
    • 2020: COVID-19 Pandemic
      The pandemic led to a surge in home-based care as nursing homes became high-risk environments. This shift accelerated pharmacy services offered directly to patients’ homes, with LTC pharmacies providing medication management, adherence support, and remote consultations to patients isolated at home.
    • 2021: CMS Guidance on Long-Term Care Pharmacy Services at Home – In December 2021, CMS issued guidance clarifying that Medicare Part D dispensing fees can include additional costs for specialized services typically provided in institutional care settings, such as delivery and special packaging, for enrollees with institutionalized level of care needs who are residing at home. CMS December 2021 Guidance
    • 2022: CMS Guidance on HCBS Funding Expansion
      CMS directed states to expand home and community-based services (HCBS) under Medicaid, creating opportunities for long-term care at-home pharmacy services. This expansion aimed to support seniors and individuals with disabilities in receiving care at home.
    • 2024: Long Term Care at Home Pharmacy Quality Commission Standards
      The Long Term Care at Home Pharmacy Quality Commission introduced standards for quality, compliance, and patient safety in long-term care at home. These standards ensure proper medication management, adherence, and safety measures in long-term care pharmacies at home, aiming to improve outcomes for those aging and living with chronic conditions in their preferred community setting.