Assessment and Support Services

Pharmacy Consulting International has been providing pharmacy focused assessment and recommendation services for over a decade. At PCI we understand that every client is different, so we provide individualized plans that reflect the infrastructure, staffing and culture of your organization. When implemented, our tailored plans ensure rapid and sustainable success.

Drug Cost and Utilization Assessments

Escalating drug costs are a high priority for healthcare organizations throughout the U.S. and around the world. Effective financial management of pharmaceuticals for healthcare providers addresses three primary strategies:

  • Managing price and purchasing processes
  • Drug utilization management
  • Optimizing reimbursement

Assessment Approach

Our unique, comprehensive approach to drug cost and utilization focuses on optimizing each of the three strategies. We incorporates benchmark data using PCI’s proprietary tool BenchmaRx™, literature evidence, proven implementation experience in organizations with varying levels of infrastructure and staffing levels.

Each assessment includes:

  • A request and review purchase, hospital and pharmacy profile data
  • A review of current wholesaler agreements
  • Analysis of purchase data using BenchmaRx™
  • Review preliminary data analysis with pharmacy leadership and clinical team
  • An evaluation of infrastructure for implementation (operations, clinical model, Pharmacy and Therapeutics committee structure, medical staff support)
  • Establishing targets, infrastructure requirements and challenges with pharmacy leadership

Implementation
We offer implementation support for all of our recommendations. Clients can choose as much or as little support based on their existing infrastructure. Using our focused support, most clients start to begin to realize savings within one to two months.

Implementation support includes:

  • Developing client specific implementation and monitoring work plans with priorities and timelines
  • Obtain buy-in from stakeholders – We work directly with stakeholders within pharmacy, medical staff, nursing and other departments and hospital leadership throughout the implementation process
  • Ensure operational feasibility – Understand that operation feasibility is critical to realizing the full potential of any engagement
  • Decades of experience with implementation – we recognize that every organization is unique and we use our experience with various approaches to support implementation
  • Focus on results – results must provide sustainable financial benefits with equal or better patient outcomes
    • Typical clients realize a annual savings of 8-12% of inpatient purchases

Compliance Analysis and Support

Controlled Substance Management

Controlled substance process management, reconciliation and monitoring controls to detect fraud, abuse and diversion are critically important in health care. Trends within the last 5-10 years clearly demonstrate increased attention and scrutiny by state, federal and professional regulatory agencies. Violations found by these groups have resulted in significant fines, criminal prosecutions and sanctions being levied against health care organizations.

PCI has extensive experience in conducting audits, gap analyses, mock inspections and reviewing current practices to identify vulnerabilities In addition, should a potential issue arise regarding controlled substance management, distribution and utilization, PCI can professionally identify and investigate the situation rapidly and provide guidance for immediately addressing and rectifying issues.

Below is a list of controlled substance related services, routinely provided by PCI for our clients:

  • Review of policies and processes
  • Evaluate controlled substance inventory management systems
  • Support diversion investigations
  • Recommend tools and processes to detect and prevent future diversion
  • Develop corrective action plans in response to regulatory or litigation findings

340B Drug Pricing ProgramCompliance and Optimization

PCI partners with clients to evaluate 340B purchasing process, implementation and optimizes for maximal allowable purchases within HRSA (Health Resources Service Administration) guidelines. The rapidly changing landscape surrounding 340B has created challenges for organizations as they develop and implement new policies and procedures and monitoring programs. PCI has significant experience reviewing policies ensuring policies and procedures reflect current practice and recommending modifications as required. We work in partnership with clients on preparing for 340B compliance audits- providing an evaluation of infrastructure, operations, and technology, and program goals.

PCI 340B consultations involve face-to-face meetings and observations with so we can achieve a working and accurate understanding of your organization, operational and functional structure and your community’s unique profile. Our goal is to optimize your 340B program through a combination of personalized attention, understanding of your situation, technology optimization and shared perspective and understanding of the challenges your organization faces.

Review of 340B drug pricing program processes, including:

  • Oversight and management of the program
  • Policy and procedure that is consistent with the current site specific processes
  • 340B savings estimates and savings distributions
  • Self-audit process
  • External audit process
  • Site registrations on the HRSA/OPA web site are consistent with the most recent Medicare Cost Report
  • 340B and GPO drugs being used for eligible patients only
  • Processes used to determine 340B eligibility
  • Maximizing 340B and GPO purchasing and minimizing WAC
  • Process in place to assure no Medicaid duplicate discounts
  • Contract pharmacy contracts, compliance and maximization
  • Split billing software maximization

USP <797> Compliance/Compounded Sterile Products Regulatory Compliance

PCI is experienced in performing outside 3rd party readiness and quality audits and mock inspection services to healthcare institutions and health systems to support USP<797> compliance and readiness for the impending implementation of USP<800> requirements. Within the last 5 years increased attention and scrutiny of USP<797> compliance by state, national and professional regulatory and criminal investigative agencies. Violations found by these organizations have resulted in significant fines, criminal prosecutions and sanctions being levied against health care organizations and pharmacies.

PCI works cooperatively with clients to evaluate sterile product compounding and safety. We will provide a thorough report to the client with actions necessary to promptly address and remedy any deficiencies identified during the evaluation in order to comply with USP<797>  guidelines and prepare the client for the pending implementation of USP<800> in August 2016.

Some typical parameters assessed for clients include:

  • Evaluation of current USP<797>  compliance
  • Readiness for planned USP<800> enforcement
  • Deficiency identification and actionable recommendations for immediate remedy
  • Gap analysis and recommendations for improvement

Pharmacy Technology Assessment & Implementation

Ever-evolving, technologic advancements in the practice of pharmacy result in enhanced performance capabilities that allow for greater institutional efficiency, patient safety, improved workflow and desired outcome improvements. PCI’s highly experienced pharmacy consultants support and assist clients with many aspects of the technological intricacies of the practice of pharmacy. .

Some typical parameters assessed by PCI for clients include:

  • Assessment of current and new technologies under consideration
  • Preparation, management, analysis and scoring of Request for Proposal (RFP) submissions for new technology purchases
  • Selection of new technology best suited for clients individual situations
  • Planning of the transition and implementation phase
  • Implementation of the newly selected technology
  • Optimization of new technology implementation and deployment
  • Support and assist with renegotiations of new contract pricing and terms

Integrated Delivery Network Integration

PCI team has over 20 years of experience working with leading Integrated Delivery Network’s (IDN) to optimize Pharmacy & Therapeutics (P&T) Committee operations, functions and processes. A highly functioning institutional P&T Committee is a keystone component of optimal cost-effective and safe drug use within an organization. As hospitals continue to integrate, the coordination of drug formulary and policy decisions product standardization and clinical use guidelines becomes more imperative. PCI partners with individual hospitals and multi-hospital delivery networks to establish policies and procedures that support standardization while allowing for the unique and diverse nature of the needs of each client’s organization we are engaged to support.

PCI routinely assists the pharmacy department with issues related to integration

  • P&T support (Individual Committee & System-Wide Committees)
    • Direct support
    • Indirect support
  • Health system integration
  • Distribution model development and implementation
  • Hub-Spoke model assessments and process improvement
  • Cost allocation modeling and process improvements
  • Revenue enhancement and maximization
  • Value based purchasing and management of vendor relationships

Pharmacy Operational Assessments

PCI has skilled and highly experienced pharmacy professionals with vast experience in the area of pharmacy operations to support, guide and aid clients in this critical functional area of pharmacy practice.

  • Pharmacy facility design
  • Workflow enhancement and optimization
  • Standardization & integration of policies
  • Business plan development
  • Cost justification evaluation & support
  • Proposal writing and budgets

Ambulatory Pharmacy Programs

The shift of healthcare to the ambulatory setting has resulted in organizations needing to develop new strategies to prepare for the ongoing and planned changes. Specialty Pharmacy is the fastest growing segment within the pharmaceutical market. Many organizations are developing strategies to deal with Specialty Pharmacy products as potential providers of serves and as purchasers of these products for their employees. PCI has been at the forefront of developing and implementing Ambulatory Pharmacy Programs including Specialty Pharmacies for over 20 years.

Ambulatory Pharmacy services provided to PCI clients include:

  • Conducting ambulatory pharmacy feasibility assessments
  • Ambulatory pharmacy business plan development
  • Facility design and technology selection
  • Merger and acquisition viability assessments
  • New store opening support
  • Employee prescription benefit strategy development
  • Specialty pharmacy opportunity assessments
  • Ambulatory Clinical Program Development to support risk and value-based reimbursement models
  • Readmission risk reduction strategy development

Legal and Litigation Support

Pharmacy Consulting International (PCI) has extensive experience providing invaluable expert knowledge and comprehensive litigation support and services for clients and their legal counsel. Some of the valuable services we provide to attorneys and their clients include but are not limited to the following:

  • Generation of expert reports on specific therapeutic issues, best practice guidelines, drug selection, utilization, dosing, preparation, billing issues as well as pertinent industry topics
  • Assisting counsel in understanding the therapeutic effects of drugs and practice standards,  and preparing the legal team for cross-examination questioning, argument development, scenario possibilities and rebuttal commentary and questions
  • Evaluation of scientific and medical literature, scientific, clinical and billing data, medical and pharmacy records, opposing expert witness positions/reports and expert witness testimony, depositions and testimony at trial
  • Evaluation and feasibility assessments of M&A transaction and financing vehicles and logistics
  • PCI supports attorneys and their clients in response to ongoing or pending action; inquiries and citations from regulatory authorities and false claims cases. Industry topics addressed include but are not limited to:
    1. Controlled substance reconciliation and best practices
    2. Appropriate drug therapy and best practices guidelines
    3. Product pricing, purchasing and reimbursement issues
    4. Pharmacy dispensing and operational standards of practice
    5. Pharmacy billing and claims adjudication processes
    6. Industry best practices guidelines and trends
    7. Drug adverse effects and drug toxicity issues
    8. Drug-drug, drug-food and drug-device issues
    9. Expert witness identification and expert and fact witness support