NEW YORK CHAPTER OF THE AMERICAN SOCIETY OF CONSULTANT PHARMACISTS

1. NEW YORK CHAPTER OF THE AMERICAN SOCIETY OF CONSULTANT PHARMACISTS Vince Galletta MS, RPh & Mike Zandri RPh Co-Directors, Professional and Government Affairs Kelly Flynn RPh, BCGP – Chapter President Legislative Issues in NYS Affecting Pharmacy UPDATE April 2018

2. GOALS & OBJECTIVES At the completion of this program, the participant will be able to: • Describe the Bill for Comprehensive Medication Management (A8664) and how it may affect pharmacists. • Describe the status of pharmacist immunizers and the proposed changes to expand the program to add all CDC recommended vaccines for adults and allow pharmacy interns to immunize. • Discuss the current regulations in NY for automated dispensing systems.   • Discuss the proposed legislation to register and or certify technicians in NYS and how it may impact pharmacy workflow. • Describe the Bill A8661 which would authorize pharmacists to administer injectable drugs that treat mental health and substance abuse disorders.

3. Legislative issues in NYS affecting pharmacy COMPREHENSIVE MEDICATION MANAGEMENT (CMM) EXPAND IMMUNIZATION AUTHORITY FOR PHARMACISTS AUTOMATED DISPENSING SYSTEMS IN NY AUTHORIZE PHARMACISTS TO INJECT MEDICATIONS FOR TREATMENT OF MENTAL HEALTH AND SUBSTANCE ABUSE RECOGNIZE REGISTERED AND CERTIFIED PHARMACY TECHNICIANS MEDICATION SYNCHRONIZATION NYS DRUG DISPOSAL & OPIOID TAX FAIR PHARMACY AUDITS PROTECTION FROM CLAWBACKS & GAG CLAUSES NEW PBM TRANSPARENCY BILL

4. PRE-TEST QUESTION #1 A pharmacist in NY that is certified to immunize patients may administer all of the following vaccines EXCEPT: A. Measles B. Pneumococcal C. Tdap D. All of the above may be administered by a pharmacist in NY

5. PRE-TEST QUESTION #2 THE NYS BUREAU OF NARCOTIC ENFORCEMENT HAS APPROVED AUTOMATED DISPENSING SYSTEMS (ADS) IN NY FOR CONTINUOUS DOSING? A. TRUE B. FALSE

6. COMPREHENSIVE MEDICATION MANAGEMENT (CMM) BACKGROUND: • Originally introduced as part of Gov. Cuomo’s 2017 Budget. • NYASCP Prepares a Letter of Support for CMM – Spring 2017 • Letter of Support sent to Assembly & Senate Chairs of Health & Higher Ed Committees on 3-10-2017 • The language for this proposal was dropped in both the Senate and Assembly budgets. • In July 2017, DOH Commissioner Zucker asks Pharmacists from PSSNY, NY Chain Assoc to join in roundtable discussion on Community Pharmacy Programs and Interventions to Better Assist Seniors and those with Disabilities in Managing Pharmacy & Other Medical Needs and Navigating Health Care System

7. COMPREHENSIVE MEDICATION MANAGEMENT (CMM)A8664-A McDonald/S7682 LaValle • Amends Public Health Law and Pharmacy Practice section of Education Law • Would allow written protocol agreements between pharmacists and physicians • Authorizes the pharmacist to be an agent of the MD for prescriptions specifically authorized in the written protocol

8. EXPAND IMMUNIZATION AUTHORITY FOR PHARMACISTS • Since 2008, when the State Education Department first authorized the certification of pharmacists to immunize adults against flu and pneumococcal disease, the response from pharmacists, the medical community, public health officials, insurers and the public has been overwhelmingly positive. • Over this time, the state’s adult immunization rates have improved through expanded access, and more than 12,000 pharmacists have completed the additional requirements to become certified. • A certified pharmacist who meets the requirements of this section shall be authorized to administer to patients 18 years of age or older, immunizing agents to prevent influenza, pneumococcal, acute herpes zoster, meningococcal, tetanus, diphtheria or pertussis disease, pursuant to a patient specific order or a non-patient specific order.

9. PHARMACIST IMMUNIZERSA455 Paulin/S321 Robach • Remove Sunsets and Add All Centers for Disease Control (CDC) Recommended Vaccines for Adults. • Authorize pharmacists to administer ALL (CDC) recommended adult immunizations • Removes the requirement that the authorized practitioner issuing the patient-specific or standing order be in the same or adjoining county where the immunization is to be administered • Makes the statute permanent • NYS Budget 2018: Assembly & Senate accept Governor’s proposal to authorize RPh’s to immunize children for flu and to extend current adult immunization laws to 12/2019.

10. Authorize Pharmacy Interns to Immunize AdultsA2857 McDonald/S1043 Funke Allows a pharmacy intern who has successfully completed the immunization certification training to administer an authorized vaccine to adults when the intern is under the direct supervision of a licensed, certified pharmacist In 2017 PASSED Senate unanimously. Never made it to Assembly for vote. Committee members with colleges of Pharmacy in their district are asking Glick to move it. Bill A9073/S7189 Hoylman Amends Education Law to authorize MDs and NPs to issue standing orders to nurses and pharmacists to administer Hep A vaccine

11. Automated Dispensing Systems • On January 13, 2017, BNE issues letter to Class 11 Pharmacy Licensees • ADS units at Residential Health Care Facilities are approved for emergency medication kits use only. • Feb 2017, BNE updates their ADS Checklist (Appendix D) • Nov 2017, NYASCP meets with BNE & BOP to discuss 24 hour lockout and continuous dosing requirements noted in Jan 2017 letter from BNE. • Jan 2018, NY-ASCP sends “ask” letter to BNE and BOP.

12. New Bill for 2017-2018A8661 • Assemblyman John McDonald has also introduced a new bill (A8661) that authorizes pharmacists to inject medications for the treatment of mental health and substance use disorder, as prescribed or ordered by a licensed prescriber in accordance with regulations promulgated by the commissioner in consultation with the board of pharmacy.

13. PHARMACY TECHNICIANS BILLS5584-A (Griffo)/A4611-A (Engelbright) • Pharmacy technicians are individuals who directly assist licensed pharmacists. Current law refers to pharmacy technicians as “unlicensed persons.” • This bill replaces the term with the titles of “registered pharmacy technician” and “certified pharmacy technician,” strengthening the Education Department’s jurisdiction over these individuals. • One year after this legislation is enacted into law, every pharmacy technician in New York will be SED-registered or certified. • The legislation defines pharmacy technicians as individuals who have access to prescription drugs and are either directly assisting a licensed pharmacist or have authority to add or to modify prescription records

14. PHARMACY TECHNICIANS Requirements for a registered pharmacy technician are: • Be at least seventeen years of age; • Meet good moral character standards established by the Department including a disclosure, under penalty of perjury, of convictions under penal law; • At a minimum, have completed high school or earned a general equivalency diploma (GED), or be currently enrolled in a course of study leading graduation • the legislation authorizes the Education Department to issue registrations to experienced individuals who may not have met the education requirement but who are in good standing with their employer and have been employed as a pharmacy technician for at least five years, including at least eighteen consecutive months with the same employer.

15. PHARMACY TECHNICIAN BILL Requirements for a certified pharmacy technician are: • Meet requirements for registered pharmacy technicians; • Be at least eighteen years of age; and • Have completed certified pharmacy technician requirements from a national certifying body acceptable to the department. • any technician directly assisting a pharmacist to compound medications in any practice setting must be certified based on the pharmacy mathematics and compounding skills associated with certification. NYASCP joins PSSNY, NYSCHP, Chain Pharmacy Assoc NY, NY-ACCP Memo of Support for the Technician Bill. UPDATE: Passed Senate. Push back from SED related to implementation.

16. MEDICATION SYNCHRONIZATION A7492 Gottfried/ S5622 Hannon • Voluntary program initiated by Pharmacists • Refills are coordinated to be due the same day each month • Quart/Lanza Bill passed the Assembly in 2017. Legislation would: • Amend Social Services Law authorizing Med Sync in FFS and Managed Care UPDATE: Senate Health Committee reported bill to Calendar. Could pass anytime

17. NYS DEC PILOT PHARMACEUTICAL TAKE BACK PROGRAM In July 2017, DEC opens enrollment to Class 3A Facilities. Email sent to Class 3A Facilities in July: “DEC wants to help you safely collect and dispose of your unused pharmaceuticals. Toward this end, DEC encourages you to reach out to your local pharmacies for assistance. They can apply for and participate in DEC’s Pilot Pharmaceutical Take-Back Program and can then partner with you to put a collection box in your facility to help properly dispose of your pharmaceuticals. DEC covers the costs of consumer drug collection boxes and disposal for two years.    Please ask your pharmacy how they can maintain a collection box in your long-term care facility (also known as class 3A facility).    More information about pharmacies maintaining collection boxes in your long-term care facility (LTCF) can be found at http://www.dec.ny.gov/chemical/108213.html.” • Applicants must agree to continue collection efforts, AT THEIR OWN EXPENSE, for minimum of 6 months after the 2 year pilot program ends.

18. DRUG TAKEBACK BILL 2018A9576 Gunther/ S7354 Hannon • Comprehensive Takeback bill, funded by manufacturers • DEC Roundtable Discussion in February. • DEC promoting bins/boxes. • This Bill allows for alternatives.

19. NYS Budget 2018OPIOID TAX • The Assembly accepts the tax but raises the tax to two and a half cents per Morphine Milligram Equivalent (MME) to raise an additional $31.75 million. The Assembly creates a separate account to be used for addiction treatment. Exceptions: (1) Pharmacies and hospice providers; (2) FDA-approved drugs that treat addiction including but not limited to methadone, buprenorphine and naltrexone. • The Senate fully rejects the tax and has proposes the largest commitment ever to prevent opioid and heroin abuse including $265 million for drug abuse prevention and treatment. The funding is not generated by a tax.

20. FAIR PHARMACY AUDITSA6733 Lavine/ S 2763A Golden • Pharmacists valuable time is best spent taking care of their patients • Pharmacy audits can take a considerable amount of time preparing for the audit, during the audit, and collecting information after the audit • While pharmacy audits are not necessarily abusive, establishing a law that sets ground rules for all pharmacy audits would deter abuse UPDATE: Passed the Assembly on March 5th 2018.

21. Patient Protection from Gag Clauses & ClawbacksA8781 Rosenthal/S6940 Hannon What is a clawback? • PBM’s take back a portion of the patient copayment from the pharmacy after the PBM determines what it will actually pay for the drug. • That money does not necessarily go to the patient, but is generally kept by the PBM. • This model has the patient directly improving the bottom line of the PBM with no additional benefit to the patient’s healthcare. Proposed Legislation would: • Protects the patient from paying more for the drug than the dispensing pharmacy’s everyday retail cash price • Promotes transparency in drug pricing • Deters excessive co-payment charges to the patient UPDATE: Passed the Senate March 6, 2018 and the Assembly on Feb 5, 2018.

22. New PBM TRANSPERANCY BILLA10026  Ortiz  • AN ACT to amend the insurance law, in relation to implementing the pharmacy benefit manager transparency act • Does not require PBMs to register of be licensed but does authorize DFS to regulate PBMs. • Requires PBMs to exercise "good faith"  and "fair dealing" and "perform duties with care, skill, prudence, diligence and professionalism." • Requires PBMs to disclose conflicts of interest. • Requires PBMs to disclose to health plans or other covered entities and DFS:  WAC of every covered drug; rebates/discounts associated with every covered drug;  amount paid to pharmacies for every covered drug; amount paid by health plans/covered entities for every covered drug. • Requires DFS Supt to file an annual report by 2/1 every year aggregating information from PBMs to assess their impact on cost, availability of prescription drugs and to make policy recommendations to the legislature. • Authorizes DFS to regulate PBMs.

23. POST-TEST QUESTION #1 A pharmacist in NY that is certified to immunize patients may administer all of the following vaccines EXCEPT:  A. Measles B. Pneumococcal C. Tdap D. All of the above may be administered by a pharmacist in NY

24. POST-TEST QUESTION #2 THE NYS BUREAU OF NARCOTIC ENFORCEMENT HAS APPROVED AUTOMATED DISPENSING SYSTEMS (ADS) IN NY FOR CONTINUOUS DOSING? A. TRUE B. FALSE

25. Legislative Issues in NYS Affecting Pharmacy Update April 2018 Acknowledgments: PSSNY – 2018 Legislative Agenda – “The Pharmacy Patient’s Right to Care” Capital Public Affairs – Elizabeth Lasky – PSSNY Lobbyist MIRram Group LLC – PSSNY Lobbyists BNE Website NYSED.GOV Website NYS DEC website www.dec.ny.gov.chemical/108213.html Illustrations By Andrew Flynn RPh – ACPHS Pharmacy Practice Department

26. Dates to Remember