Patient-Centered Care

References and links to documentation can be found at the end of the manual.

• 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.
  • 1981: Section 1915(c) Home and Community-Based Services (HCBS) Waivers (Medicaid)
    • Authorized by the Omnibus Budget Reconciliation Act of 1981, these waivers allowed states to provide home and community-based services to Medicaid beneficiaries who would otherwise require care in a nursing facility, intermediate care facility, or hospital.
    • The goal was to give states flexibility to deliver services like personal care, case management, home health aide services, and respite care — enabling more individuals to receive care at home rather than in institutions.
    • This is the foundational waiver program for HCBS across the U.S.
  • 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.
  • 1999: Olmstead v. L.C. Supreme Court Decision
    • The ruling affirmed that unjustified institutionalization of individuals with disabilities is a form of discrimination under the Americans with Disabilities Act (ADA).
    • This decision reinforced states’ obligations to expand HCBS options and provide supports that allow individuals to receive care in the least restrictive setting — often their homes.
  • 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.
    • 1986
    • 2001

• 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.
  • 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.
  • 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 ensure 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.
  • 2006: Deficit Reduction Act (DRA) & Section 1915(i)
    • The DRA added Section 1915(i) to the Social Security Act, allowing states to provide HCBS as part of their Medicaid state plan without needing a full 1915(c) waiver. This created an easier pathway for states to expand HCBS programs and offer long-term care services at home.
    • Deficit Reduction Act of 2005 (enacted 2006)
      • https://www.govinfo.gov/content/pkg/PLAW-109publ171/pdf/PLAW-109publ171.pdf
      • https://www.kff.org/wp-content/uploads/2013/01/7486.pdf
  • 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.
      • Community First Choice (CFC) Option (Section 1915(k)): Offered states increased federal funding to provide personal assistance services at home.
      • Balancing Incentive Program (BIP): Provided incentives for states to shift Medicaid spending toward home and community-based settings.
      • Money Follows the Person (MFP) Expansion: Continued support for transitioning individuals from institutions to home- or community-based care.
    • Affordable Care Act (2010)
      • https://www.congress.gov/bill/111th-congress/house-bill/3590
      • https://www.kff.org/health-policy-101-the-affordable-care-act/
  • 2014: CMS Memo on Patient Residence and Pharmacy Service Type Coding
    
    • CMS issues guidance requiring all pharmacies to include a valid Patient Residence code on Medicare Part D claims.
    • Retail and mail-order pharmacies may default to PRC 01 (Home) if residence is unknown, but LTC, home infusion, and specialty pharmacies are expected to report residence codes accurately due to direct delivery.
    • CMS emphasizes that pharmacies must report the correct pharmacy service type code on all Part D claims.
  • 2014-2016: 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.
    • CMS “Mega Rule” (2014-2016)
      • https://www.williamsmullen.com/insights/news/legal-news/cms-releases-nursing-facility-mega-rule
      • https://www.federalregister.gov/documents/2016/05/06/2016-09581/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-delivered
  • 2015: NCPDP DERF 1306 Approval
    
    • NCPDP passes DERF 1306, approving a new Level of Service code (418-DI value 07) for Medical at Home services.
    • The code defines medical at home as providing special pharmacy services identical to those provided to LTC nursing facility beneficiaries, excluding emergency kits.
  • 2016: Expansion of PACE (Programs of All-Inclusive Care for the Elderly)
    • PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY IN RURAL AMERICA POLICY BRIEF AND RECOMMENDATIONS TO THE SECRETARY (2023)
    • NORC Program of All-Inclusive Care for the Elderly (PACE) Market Assessment (2025)
  • 2017: Medical at Home Residence Code Added to NCPDP ECL
    • NCPDP updates its External Code List (ECL) to include the Medical at Home Level of Service (418-DI value 07).
    • The industry is instructed to use this code when providing LTC-equivalent pharmacy services to patients residing at home.
  • 2018: NCPDP Editorial Update
    • NCPDP issues an editorial update reaffirming the use of Level of Service 07 on claims for patients at home receiving special pharmacy services identical to LTC beneficiaries, including services like special packaging and delivery.
  • 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.
  • 2019: NCPDP WG9 Medicare Part D Q&A
    • CMS responds through NCPDP Q&A, clarifying that identifying an LTC claim is more complex than assigning a place of service code.
    • CMS states it expects accurate identification of LTC residents and that sponsors should know to whom LTC policies apply.
  • 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.
      • COVID-19 Relief and American Rescue Plan Act (ARPA 2021-2022)
  • 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.
  • 2021-2022: COVID-19 Relief and American Rescue Plan Act (ARPA)
    • ARPA included a 10% increase in federal funding for states to expand, enhance, or strengthen HCBS through Medicaid. Many states used these funds to further support long-term care at home programs and services, including pharmacy services that align with HCBS goals.
  • 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.

• The Long Term Care at Home Pharmacy Quality Commission Era

  • 2022: Recognition of Market Gap
    • Increased Scrutiny and Demand for Guidance
      • Pharmacy billing practices for long-term care patients at home begin to come under scrutiny by audit teams, with increased requests for justification and documentation regarding why patients are being processed as long-term care under a long-term care NPI.
      • Audit teams begin questioning pharmacies more frequently about how patients qualify for LTC at home services, revealing the need for standardization.
    • Industry Awareness and Early Advocacy
      • Industry leaders recognize a critical gap in compliance standards, practice guidelines, and formal pathways for pharmacies supporting long-term care patients at home.
      • Early conversations begin about the need for a dedicated body to protect, formalize, and professionalize this emerging sector of pharmacy care.
    • First Patient Identification Tool Developed
      • The first documented form on how to identify a Long Term Care at Home pharmacy patient is developed by a pharmacy that is successfully used during pharmacy audits specifically questioning the long term care pharmacy at home market. This resource becomes a foundation for future standard-setting efforts.
    • Rising Demand for Education
      • Industry stakeholders, including conference organizers, healthcare organizations, and plans, increasingly request education, guidance, and tools for long-term care pharmacy at home services.
  • 2023: Formation and Foundation
    • Formation of the Commission
      • The Long Term Care at Home Pharmacy Quality Commission is formally established to define, support, and promote minimum care standards, compliance expectations, and accreditation readiness for pharmacies serving LTC-at-home patients.
      • The Long Term Care at Home Pharmacy Quality Commission was established to elevate quality standards for pharmacies caring for long-term care patients residing in non-institutional settings. The Commission’s goal has always been to promote consistency, safety, and accountability in delivering LTC-level services—and to serve as a trusted resource for stakeholders across the care continuum.
      • The Commission emerged as a response to increasing demand for structured, comprehensive pharmacy oversight in the long term care at home market.
      • Its founding acknowledged a gap in consistent standards and quality expectations across participating payers, providers, and regulators.
    • Development of Standards & Infrastructure
      • The Commission emerged as a response to increasing demand for structured, comprehensive pharmacy oversight in the long term care at home market.
      • Its founding acknowledged a gap in consistent standards and quality expectations across participating payers, providers, and regulators.
    • Stakeholder Education & Industry Integration
      • Begins collaboration with PBMs, payers, health plans, PSAOs, and accrediting bodies to validate and integrate standards.
      • Releases CE-accredited educational sessions and publicly promotes the need for standardization in LTC at Home pharmacy services.
  • 2024: Accreditation Rollout and Integration
    • Supports PBMs and health plans with custom audit guidance and credentialing language.
    • Publishes comprehensive standards of care, minimum service requirements, patient qualification criteria, and compliance tools.
    • Launches accreditation programming with major accreditation organizations.
    • Begins plan-level integration of standards into PBM and health plan credentialing, contracting, and reimbursement models.
  • 2025: National Scaling, Standardization, and Vision for the Future
    • Central Compliance and Quality Partner
      • The Commission becomes firmly established as the central compliance and quality partner across the pharmacy ecosystems.
      • Plays an integral role in supporting Medicare Advantage, Medicaid, dual-eligible plans, waiver programs, PBMs, PSAOs, and accrediting bodies, ensuring that Long Term Care at Home pharmacy services are delivered in alignment with standards of care, regulatory expectations, and payer requirements.
    • Publication of Manual of Compliance and Care Expectations
      • The Manual of Compliance and Care Expectations for Pharmacies Engaging in Long Term Care Pharmacy at Home Services and Supports is published.
        • The manual provides a comprehensive, field-tested guide for pharmacies, payers, PSAOs, accrediting bodies, and other stakeholders.
        • It is made freely available to promote sector-wide standardization, transparency, and a unified understanding of what compliant, high-quality Long Term Care Pharmacy at Home service looks like.
    • Integration into Network Requirements
      • Commission standards and tools are formally integrated into network credentialing, contracting language, audit frameworks, and plan design requirements across multiple PBMs and health plans.
      • The Commission supports real-time credentialing review, audit assistance, and contract alignment to ensure the LTC Pharmacy at Home sector remains compliant and viable.
  • 2026 and Beyond:
    • Vision for the Future
      • Long Term Care Pharmacy at Home is formally recognized as a distinct and vital sector of pharmacy practice — with clear regulatory pathways, defined reimbursement structures, and full integration into the healthcare system.
      • Patients requiring skilled-level pharmacy services at home have equitable access to high-quality, compliant pharmacy care, regardless of geography, payer, or provider network.
      • Independent and community-based pharmacies are empowered to thrive in delivering LTC at Home services, supported by consistent standards, fair contracting, and recognition of their critical role in home-based care models.
    • The Commission continues to work collaboratively with PBMs, plans, state boards, regulators, and accrediting bodies to protect the integrity of the sector, ensure patient safety, and foster innovation in pharmacy care for the most vulnerable populations.
    • The work of the Commission is ongoing — dedicated to safeguarding compliance, supporting operational excellence, and advancing the role of pharmacy in the future of home-based long-term care.