Track 1: Recommendations for Medical Directors, Pharmacy Directors, and Quality
               Directors
Track 2: Recommendations for Care Managers

• Release date: April 2011
• Expiration date: October 31, 2012
• Estimated time to complete activity: 1.0 hour for Track 1; 1.0 hour for Track 2
• Compatible with (IE 6 and up, Firefox, Safari)

Target Audience

• Medical Directors and Pharmacy Directors from health plans, HMOs, integrated health systems, employers, quality organizations, and other managed care organizations
• Managed care-affiliated care team members involved with patient evaluation, education, and follow-up for growth/growth disorders including: physicians, pharmacists, nurses, and case managers

Purpose Statement

The purpose of this knowledge-based activity is to improve managed care stakeholders' knowledge of emerging or recent data surrounding the results of evidence-based investigations with recombinant somatropin (somatropin [rDNA origin], rhGH) therapies for growth hormone deficiency and related disorders. Health plan administrators will be provided with the necessary information for designing educational interventions and decision support tools to aid providers in diagnosing and coding for small-for-gestational age (SGA) and idiopathic short stature (ISS), thereby avoiding unnecessary appeals in the rhGH category. The activity will enhance managed care stakeholder knowledge of the American Association of Clinical Endocrinologists' (AACE) medical guidelines for the appropriate use of growth hormone in the treatment of adults with growth hormone deficiency and promote guideline-based diagnosis of GHD and prescribing in the rhGH category. The activity will improve plan administrator and care manager knowledge of currently available rhGH administration devices and their ability to improve therapeutic adherence in the category.

Educational Objectives (Track 1)
After completing this activity, the participant should be better able to:

• Characterize the value-both clinical and financial-of rhGH therapy for GHD and growth-related disorders by explaining the various efficacy, safety, and cost measures met in the clinical literature
• Identify the distinguishing characteristics of SGA and ISS that outline the criteria necessary for the diagnosis and subsequent appropriate coding of both conditions
• Describe the AACE's revised recommendations for growth hormone replacement in deficient adults as they pertain to the appropriate use of rhGH products

Educational Objectives (Track 2)
After completing this activity, the participant should be better able to:

• Characterize the value-both clinical and financial-of rhGH therapy for GHD and growth-related disorders by explaining the various efficacy, safety, and cost measures met in the clinical literature
• Assess the benefits of convenient dosing devices for rhGH derived from the availability of multiple administration options for making patient-specific choices within the category

Distinguished Faculty (Track 1)

Pinchas Cohen, MD Professor and Chief of Endocrinology Mattel Children's Hospital at UCLA David Geffen School of Medicine at UCLA Click here for biography

Neil Minkoff, MD Principal FountainHead HealthCare (Former Medical Director, Harvard Pilgrim Health Care) Click here for biography

Distinguished Faculty (Track 2)

Pinchas Cohen, MD Professor and Chief of Endocrinology Mattel Children's Hospital at UCLA David Geffen School of Medicine at UCLA Click here for biography

Robert Lipsy, PharmD, FASHP, BCPS Clinical Assistant Professor Department of Pharmacy Practice and Sciences University of Arizona – School of Pharmacy (Former Manager, Clinical Pharmacy Services, HealthNet Pharmaceutical Services) Click here for biography

Activity Agenda (Track 1)

• Growth Hormone Replacement Therapy: Clinical and Economic Implications for Managed Care
  Pinchas Cohen, MD
• Guideline-Recommended Diagnosis and Coding of Growth-Related Disorders in Children and Adults in the Managed Care Setting
  Neil Minkoff, MD

Activity Agenda (Track 2)

• Growth Hormone Replacement Therapy: Optimizing Patient Outcomes in Managed Care
  Pinchas Cohen, MD
• Patient Satisfaction and Therapeutic Adherence Considerations of rhGH Dosing Devices
  Robert Lipsy, PharmD, FASHP, BCPS

Continuing Education (Track 1)

Statement of Credit-Participants who successfully complete this activity (including scoring at least 70% on the learning assessment and completing and submitting the evaluation form) will be issued a statement of credit. This statement of credit will be made available immediately.

	Physicians. The Meniscus Educational Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Meniscus Educational Institute designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

	Nurses. This activity for 1.0 contact hours is provided by the Meniscus Educational Institute.

The Meniscus Educational Institute is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

Accreditation refers to recognition of educational activities only and does not imply approval or endorsement by the Meniscus Educational Institute or the American Nurses Credentialing Center's Commission on Accreditation of any product mentioned.

Provider approved by the California Board of Registered Nursing, Provider No. 13164, for 1.0 contact hours.

	Pharmacists. This educational activity is sponsored by the Meniscus Educational Institute.

The Meniscus Educational Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. The ACPE Universal Activity Number assigned to this program, for 1.0 contact hours (0.10 CEUs), is 0429-9999-11-004-H04-P.

Continuing Education (Track 2)

Statement of Credit-Participants who successfully complete this activity (including scoring at least 70% on the learning assessment and completing and submitting the evaluation form) will be issued a statement of credit. This statement of credit will be made available immediately.

	Physicians. The Meniscus Educational Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Meniscus Educational Institute designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

	Nurses. This activity for 1.0 contact hours is provided by the Meniscus Educational Institute.

The Meniscus Educational Institute is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

Accreditation refers to recognition of educational activities only and does not imply approval or endorsement by the Meniscus Educational Institute or the American Nurses Credentialing Center's Commission on Accreditation of any product mentioned.

Provider approved by the California Board of Registered Nursing, Provider No. 13164, for 1.0 contact hours.

	Pharmacists. This educational activity is sponsored by the Meniscus Educational Institute.

The Meniscus Educational Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. The ACPE Universal Activity Number assigned to this program, for 1.0 contact hours (0.10 CEUs), is 0429-9999-11-003-H04-P.

Financial Disclosures

All individuals in positions to control the content of this program (eg, planners, faculty, content reviewers) are expected to disclose all financial relationships with commercial interests that may have a direct bearing on the subject matter of this continuing education activity. Participants have the responsibility to assess the impact (if any) of the disclosed information on the educational value of the activity. All faculty have been offered a modest honorarium from the accredited provider for their participation in this activity.

Pinchas Cohen MD, Faculty, serves as a consultant or advisor for Novo Nordisk, Teva Pharmaceuticals, and Ipsen, and receives grant or research funding from Genentech, Inc.
Robert Lipsy, PharmD, FASHP, BCPS, receives honoraria from Teva Pharmaceuticals.
Neil Minkoff MD, Faculty, serves as a consultant or advisor for Genentech, Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc, and UCB.
Karen Abbas RN, MS, AOCN, Project Director, has nothing to disclose.
Carol Balmer, PharmD, BCOP, Education Committee Reviewer, has nothing to disclose.
Catherine Flynn RN, MSN, CPNP, Nurse Planner, serves as a consultant or advisor for Animas Corporation and Medtronic MiniMed, Inc.
Paul B. Gilman, MD, Education Committee Reviewer, has nothing to disclose.
Beth Taubes, RN, BSN, OCN, CBCN, Education Committee Reviewer, receives honoraria from Eli Lilly and Company.
Steve Casebeer, MBA, Planner, has nothing to disclose.

Disclaimer

This activity has been designed to provide continuing education that is focused on specific objectives. In selecting educational activities clinicians should pay special attention to the relevance of those objectives and the application to their particular needs. The intent of all Meniscus Educational Institute educational opportunities is to provide learning that will improve patient care. Clinicians are encouraged to reflect on this activity and its applicability to their own patient population.

The opinions expressed in this activity are those of the faculty and reviewers and do not represent an endorsement by MEI or the companies providing educational grant support of any specific therapeutics or approaches to diagnosis or patient management.

Product Disclosure

This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the US Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product.

There are no fees for participating in these activities.