Summer 2011
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Guidelines for a Systematic Approach to Pharmacy Involvement in Chronic Disease Management
Rita Shane, PharmD, FASHP, FCSHP
Director, Pharmacy Services
Cedars-Sinai Medical Center
Los Angeles, CA

Editor's Note: This checklist will help you analyze the strengths and weaknesses of your approach to chronic disease management.

Management of chronic diseases is characterized by a new set of complexities, as described in the accompanying articles. As a result, those of us responsible for outpatient pharmacies must develop new competencies and an understanding of the many challenges ensuing from breakthrough therapies, changing reimbursement and the current healthcare environment. These complexities include the following:

  • Injectable medications rather than oral solid dosage forms.
  • Biologics rather than traditional manmade compounds.
    • When will generic biologics become available?
  • Importation and counterfeit drugs and concerns about patients who are admitted as inpatients or come to outpatient infusion centers with their own injectable medication.
  • Medicare Part D and its implications.
  • Challenges in reimbursement.
    • How can we ensure we get paid?
    • How can we manage with reduced reimbursement?
  • Will outpatient infusions and injectable therapies result in profit or loss for health systems?
  • How will specialty pharmacies affect health systems?
    • What are the implications for product integrity and reimbursement?
  • How will employers, patients and health systems deal with the expenses associated with lifelong infusion therapy?
  • What is the future of physician office-based infusion suites? What are the implications for health systems if physicians discontinue infusion therapies in their offices?
  • How will the ethical dilemmas surrounding issues of cost vs value be addressed?

The following is a list of proposed responsibilities and competencies for pharmacy managers and staff involved in managing high-cost outpatient therapies:

  • Develop criteria for use of new agents, in collaboration with medical staff with expertise in the therapeutic areas in which the drugs are used.
  • Develop preprinted order forms or order sets that reflect usage criteria.
  • Evaluate usage on a routine basis and provide feedback to medical staff.
  • Involve clinical pharmacists in review of orders to ensure appropriateness of drug regimens and absence of contraindications.
  • Develop policies and procedures to ensure the quality of procurement, preparation, administration and monitoring.
  • Assign responsibility for developing expertise in outpatient reimbursement for injectables to a designated person, who will serve as the departmental reimbursement specialist.
  • Develop a relationship with the contracting department and maintain ongoing communication re:
    • release of new agents and implications for contracting of outpatient services.
    • specialty pharmacies.
  • Determine whether outpatients receiving injectable drugs are required to obtain these from specialty pharmacies based in their health plan.
  • Develop a policy for patients bringing their own medications for ambulatory infusion/injection. Evaluate risks and financial implications.
  • Assign responsibility for monitoring Centers for Medicare & Medicaid Services (CMS) updates and ongoing updating for charge master codes to reflect CMS coding changes.
  • Work with staff from Admissions, Patient Accounting and Medical Records to ensure that revenue-cycle management processes are in place.
  • Who is responsible for coding?
  • Will there be an individual dedicated to preauthorization for these agents?
  • Who will be responsible for denials management?
  • Develop a process for managing ethical issues associated with patient need vs. reimbursement.
  • Evaluate admissions for expensive injectables that can safely be administered on an outpatient basis.
  • Read updates on the websites of the Association of Community Cancer Centers ( and ASHP reimbursement ( on an ongoing basis.
  • Evaluate the top 20 high-cost drugs administered in the outpatient setting.
    • Evaluate appropriateness of use based on indications, dosing regimen, and frequency; share results with physicians.
    • Evaluate effectiveness of revenue cycle management processes.
  • Examine reimbursement at the patient level to ensure that reimbursement was obtained.
  • Develop a system for following up on partial payments and denials.
    • Determine if changes in contracting are warranted.
    • Determine the impact of average sales price plus 6% on reimbursement for Medicare patients.
  • Evaluate the implications of Medicare B vs Medicare Part D on outpatient pharmacy operations.
  • Develop a network of pharmacy reimbursement specialists to share experiences and lessons learned.
  • Attend educational sessions offered at professional meetings, such as ASHP, to keep up to date on management of outpatient injectables.

We recognize that this list of responsibilities will continue to evolve as we gain a better understanding of the impact of the Medicare Modernization Act, employers and health plans make decisions about managing the growth of expensive outpatient therapies and we witness the continued growth of specialty pharmacies. We hope this article can serve as a starting point for ongoing dialogue regarding the many complexities involved in managing chronic diseases in the 21st century.

Volume 20
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