State Legislative Compounding Update David A. Kosar Consultant NASPA & IACP Disclosures David A. Kosar declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 1 2 Learning Objectives At the conclusion of this program, the participating pharmacist and technician will be able to: Discuss four legislative topics currently in state legislatures. List three future legislative proposals. Discuss the importance of state legislative issues to practice. States Biennial Sessions 2015-16 50 states & DC convened 33 adjourned as of 6/5 17 remain in session 7 meet year round 22 states carryover bills to 2016 4 states have limited carryover to 2016. 3 4 State Legislative Overview Legislation in: AL, AZ, AR, CA, CT, DE, FL, ID, IL, IA, LA, MD, MA, MI, MS, NE, NH, NJ, OK, PA, SC, TX, VA 39 compounding bills introduced as of 5/8/15 11 bills passed by legislatures 9 bills signed by governors 5 bills died 15 still in committees State Legislative Overview Signed into law Dead/Killed AZ HB 2322 FL HB 981 AZ SB 1039 FL SB 1180 AR HB 1751 MS SB 2487 ID HB 8 NV SB 408 MD SB 69 VA SB 1393 MS HB 910 NE LB 37 OK SB 787 VA HB 1737 5 6 1
What s Trending Compounding Licensure Compounding licensure requirements Outsourcing facilities registrations, requirements Lethal injections CA SB 619 (sterile) CT HB 5103 (hospitals must verify license) MD HB 181, SB 69 (sterile) NJ AB 244, 1946, SB 249 (sterile/nonsterile, PCAB certification) 7 8 State 503B Outsource Licensure as of 12/14 License required by states (number of states): Wholesaler 26 Pharmacy or Nonresident Pharmacy 9 Manufacturer 3 Combination of two licenses 3 503B (outsource) 2 Other 2 No requirements (can ship into the state) 3 Undecided 2 Outsourcing Facilities License CA SB 619 IA SSB 1021 NH SB 202 OK SB 787 (also pharmacy license if dispensing) VA HB 1737 9 10 Lethal Injections Pharmacy Trends States may contract with a compounding pharmacist AR HB 1751(sent to governor) SC HB 3853, SB 553 (in committees) VA SB 1393 (House voted no) Prescription Drug Abuse naloxone PBM Reform audits, MAC pricing Payment for Pharmacists Services Medicaid Scope of Practice Changes Provider Designation for Pharmacists in State Code 11 12 2
Resources for Compounding and Pharmacy-Related Issues IACP staff & website (www.iacprx.org) National Alliance of State Pharmacy Associations (staff)(www.naspa.us) State Pharmacy Associations (staff, newsletters) National Association of Boards of Pharmacy (website, e-newsletters)(www.nabp.net) State Boards of Pharmacy (staff, websites, newsletters) Taking A Closer Look State Legislation Impacting Compounding David G. Miller, R.Ph. Executive Vice President International Academy of Compounding Pharmacists 13 14 What s in 503A? State Reporting to the FDA State Boards will be required * to report Disciplinary actions taken against a pharmacy for compounding violations Disciplinary actions taken against a compounding pharmacy for violations May prompt an FDA inspection/determination of 503A violations This is new!!! * Part of the draft Memorandum of Understanding also is part of a whole new section in the FDCA. Regulatory Implementation State Reporting to the FDA A direct outcome of the NECC/FDA/Mass Board of Pharmacy bungle Will this be before, after or during a state investigation/disciplinary hearing? What happens if there is an appeal of a notice of violation? Assume that any compounding violation will precipitate an FDA action Still unknown Nothing requires a Board of Medicine or nursing, dentistry, podiatry, etc. to report compounding violations of physicians How About the States? Where Do You Get This Stuff? 2012 NECC Tragedy 2013 64 state pieces of legislation (26 passed) 2014 79 pieces of state legislation (18 passed) 2015 52 pieces of state legislation This does not include new rules, regulations, work groups! 3
Updated Weekly State Legislative Focus What IACP Watches For Changes in out-of-state requirements for licensure and/or permits California (sterile) Massachusetts Pennsylvania 19 State Legislative Focus What IACP Watches For Changes in office-use policy Arizona Massachusetts Michigan North Carolina Texas Scrutiny by Boards Complaints filed by Pharmacists Patients Payors Tricare Announcement 12-month retrospective audit of submitted claims Potential fraud to be reported to DOJ and Boards of Pharmacy 22 Part 2 Part 3 https://youtu.be/by9udfryg0i https://youtu.be/0x3hvk1fzpu 23 24 4
Addressing Marketing Non-pharmacy marketers Telemarketing Websites Payment to physicians for prescriptions Payment for studies Model Legislation Louisiana HB 568 Representative Ledricka Thierry Provide BoP investigation and disciplinary authority over: Employee or contract marketers Self-Referral by physicians (apply Stark to state) Prohibit direct/indirect remuneration based upon a directed prescription 25 26 Louisiana - HB 568 Legislative History House Committee Hearing 6 May, passed unanimously House Vote 15 May, passed unanimously Senate Committee Hearing 2 June Senate Vote 6 June, passed unanimously Louisiana HB 568 Why Did IACP Become Involved? Investigations underway Texas Hurting member business Existing patient freedom-of-choice laws Prohibitions on payment for prescriptions (existed in Louisiana) Reputation of compounders proactive 27 28 Need More Information? David A. Kosar Independent Consultant Phone: 703-836-5483 davidakosar@gmail.com David G. Miller Independent Consultant Phone: 703-836-5483 davidakosar@gmail.com 29 5