USP MEDICARE MODEL GUIDELINES V6.0
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FINAL REPORT, SUMMARY OF METHODOLOGY AND APPROACH USP MEDICARE MODEL GUIDELINES v6.0 COOPERATIVE AGREEMENT USP Medicare Model Guidelines Version 6.0 Award Authority: Congressional Earmark, Section 1860-D-4(b)(C)(ii) of the Medicare Prescription Drug Improvement and Modernization Act of 2003 Grant Number: 1C0CMS331232-01-00 Project/Program Title: USP 2013 Federal Project Officer: LT. Marie Manteuffel CMS Grants Management Specialist: Linda Gmeiner USP Principal Investigator: Angela G. Long, M.S. Project Director: Jami S. Earnest, Pharm.D. Submitted by the United States Pharmacopeial Convention February 3, 2014 (Revised April 15, 2014) The statements contained in this report are solely those of the authors and do not necessarily reflect the views or policies of the Centers for Medicare & Medicaid Services (CMS). The grantee assumes responsibility for the accuracy and completeness of the information in this report. CMS only funds the development of Categories and Classes and not additional material. TABLE OF CONTENTS INTRODUCTION ............................................................................................................. 4 METHODOLOGY AND APPROACH .............................................................................. 5 Update Categories and Classes ................................................................................................................ 5 Summary. .................................................................................................................................................. 5 Interactions Between USP and CMS ........................................................................................................ 6 Start-up Meeting .................................................................................................................................... 6 CMS Attendance at Expert Committee Meetings. ................................................................................ 6 USP-CMS Staff Meetings. ..................................................................................................................... 7 Submission of Written Materials............................................................................................................ 7 Therapeutic Information and Formulary Support Expert Committee (TIFS EC) ....................................... 7 Reporting of Conflict of Interest............................................................................................................. 8 Deliberation of the Expert Committee ................................................................................................... 8 Balloting of the TIFS Expert Committee ................................................................................................ 8 Guiding Principles of Model Guidelines Expert Committee ...................................................................... 9 Identification of New Part D Drugs and New Therapeutic Uses ............................................................... 9 Review of FDA actions. ......................................................................................................................... 9 Comparison of CMS Formulary Reference File and USP Medicare Model Guidelines v5.0 .............. 10 Review of New Medicare Legislation. ................................................................................................. 10 Development of Drug Information Resources to Support Expert Committee Deliberation ..................... 10 Drug Summary Files. .......................................................................................................................... 10 USP Management and Personnel .......................................................................................................... 11 USP Staff ............................................................................................................................................. 11 Drug Information Support. ................................................................................................................... 11 Address Issues .......................................................................................................................................... 11 Public Comment Mechanisms................................................................................................................. 11 Stakeholder 1:1 Consultations ............................................................................................................ 12 Open Microphone Web Meetings........................................................................................................ 12 Public Comments ................................................................................................................................ 12 CMS Comments ...................................................................................................................................... 12 TIFS Expert Committee Deliberation on Public Comments .................................................................... 12 Comments Directed to CMS from External Parties ................................................................................ 13 Comments Directed to CMS from USP ................................................................................................... 13 Comments from USP: Interagency Communication and Stakeholder Input ........................................... 14 SUMMARY OF REVISIONS, USP MEDICARE MODEL GUIDELINES V6.0 ............... 14 USP Categories and Classes ................................................................................................................... 14 Stability of USP Categories and Classes ................................................................................................ 14 Revision Summary .................................................................................................................................. 15 Revised USP Categories ........................................................................................................................ 16 Removed USP Category/ USP Class: Hormonal Agents, Suppressant (Sex Hormones/ Modifiers), Antiandrogens ..................................................................................................................................... 16 Renamed USP Category: Respiratory Tract/ Pulmonary Agents ....................................................... 17 Revised USP Classes ............................................................................................................................. 17 Removed USP Class: Glucocorticoids/ Mineralocorticoids ................................................................ 17 New USP Class: Opioid Dependence Treatments and Renamed USP Class: Opioid Reversal Agents ............................................................................................................................................................ 17 New USP Class: Antineoplastics, Antiandrogens ............................................................................... 17 2 New USP Class: Anti-hepatitis C (HCV) Agents, and Renamed USP Class: Anti-hepatitis B (HBV) Agents ................................................................................................................................................. 18 New USP Class: Anti-HIV Agents, Integrase Inhibitors (INSTI) ......................................................... 18 New USP Class: Benzodiazepines ..................................................................................................... 18 New USP Class: Angioedema (HAE) Agents ..................................................................................... 18 New USP Class: Cystic Fibrosis Agents ............................................................................................. 19 Renamed USP Class: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) .................................................................................................. 19 Renamed USP Class Phosphodiesterase Inhibitors, Airways Disease .............................................. 19 Single-Drug USP Categories or Classes ................................................................................................ 19 Alignment of USP Medicare Model Guidelines with CMS Formulary Reference File ........................ 21 Erratum: Classification of Combination Product, Atripla (Efavirenz/ Emtricitabine/ Tenofovir disoproxil fumarate) .................................................................................................................................. 21 Appendix II: Excerpts from Rules and Procedures of the 2010-2015 USP Council of Experts ........ 23 Appendix III: Members of the USP Therapeutic Information and Formulary Support Expert Committee .................................................................................................................................................. 26 Appendix IV: Guiding Principles ............................................................................................................. 28 Appendix V: Drugs Reviewed by the TIFS EC........................................................................................ 30 Appendix VI: Stakeholder 1:1 Consultations ......................................................................................... 48 Appendix VII: Open Microphone Web Meetings 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