NEW YORK CHAPTER OF THE AMERICAN SOCIETY OF CONSULTANT PHARMACISTS Legislative Issues in NYS Affecting Pharmacy UPDATE October 2017 Vince Galletta MS, RPh & Mike Zandri RPh Co-Directors, Professional and Government Affairs Kelly Flynn RPh, BCGP Chapter President
GOALS & OBJECTIVES At the completion of this program, the participant will be able to: DESCRIBE THE 2017 NYS BUDGET PROPOSAL TO ALLOW PHARMACISTS TO PERFORM COMPREHENSIVE MEDICATION MANAGEMENT AND THE NEW BILL A8664. 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 FOR AUTOMATED DISPENSING SYSTEMS IN NY AND THE DOCUMENTS FROM BNE IN 2017. DISCUSS THE PROPOSED LEGISLATION TO REGISTER AND OR CERTIFY TECHNICIANS IN NYS AND HOW IT MAY IMPACT PHARMACY WORKFLOW
Legislative issues in NYS affecting pharmacy COMPREHENSIVE MEDICATION MANAGEMENT (CMM) EXPAND IMMUNIZATION AUTHORITY FOR PHARMACISTS RECOGNIZE REGISTERED AND CERTIFIED PHARMACY TECHNICIANS MEDICATION SYNCHRONIZATION AUTOMATED DISPENSING SYSTEMS IN NY REVISED DRAFT GUIDANCE ON EXPIRATION DATING OF UNIT-DOSE REPACKAGED SOLID ORAL DOSAGE FORM DRUG PRODUCTS DEC S PILOT PHARMACEUTICAL TAKE-BACK PROGRAM NEW BILL (A8661) AUTHORIZES PHARMACISTS TO INJECT MEDICATIONS FOR TREATMENT OF MENTAL HEALTH AND SUBSTANCE ABUSE
GOVERNOR S BUDGET PROPOSAL 2017 COMPREHENSIVE MEDICATION MANAGEMENT (CMM) Amends Public Health Law Authorizes a qualified pharmacist to modify a patient's drug regimen following a specific written protocol from the patient's physician. To qualify a pharmacist must have completed an ACPE-approved course. This proposal was included as an official policy recommendation of the Value-Based WorkGroup. It allows community pharmacists to collaborate with MDs to manage selected patients. CMM was included in the Governor s budget as the request of the DOH to advance the Medicaid reform agenda (Delivery System Reform Incentive Payment known as DSRIP)
COMPREHENSIVE MEDICATION MANAGEMENT (CMM) NYASCP Prepares a Letter of Support for CMM Spring 2017 Letter of Support sent to Assembly & Senate Chairs of Health & Higher Ed Committees on March 10th The language for this proposal was dropped in both the Senate and Assembly budgets. UPDATE: In July, 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 A8664 (McDonald) CMM Bill recently introduced.
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.
PHARMACIST IMMUNIZERS Remove Sunsets and Add All Centers for Disease Control (CDC) Recommended Vaccines for Adults A455 Paulin/S321 Robach Authorize pharmacists to administer ALL (CDC) recommended adult immunizations Removes the requirement that the authorized practitioner issuing the patientspecific or standing order be in the same or adjoining county where the immunization is to be administered Makes the statute permanent As of June, Bill was dead since Legislature did not sense as urgent.
Authorize Pharmacy Interns to Immunize Adults A2857 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 Expands access to immunization services in communities underserved areas Provides an additional resource for immunizations during a declared emergency. 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.
MEDICATION SYNCHRONIZATION A4306 Quart/S5196 Lanza Voluntary program initiated by Pharmacists Refills are coordinated to be due the same day each month Legislation would: Require insurers to reimburse pharmacies for an initial partially filled prescription and to pro-rate the co-payment based on the days supply Require insurers to pay the full professional dispensing fee because the required record-keeping, consultation and associated services are the same regardless of the quantity of medication dispensed UPDATE: Did not pass either House
PHARMACY TECHNICIANS 2017 BILL S5584-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
PHARMACY TECHNICIANS 2017 BILL 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.
PHARMACY TECHNICIAN BILL 2017 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.
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) Both documents have been posted on our Chapter Webpage
Mandatory Electronic Prescribing March 2, 2017 Commissioner of Health Howard Zucker issues letter stating blanket waiver for LTC exemption from E-prescribing. Effective until 10/31/2017 The Department further acknowledges that, while many nursing home/residential health care facilities have adopted electronic prescribing, there remain some facilities in which electronic prescribing may not be currently possible due to technological or economic issues or other exceptional circumstances, including a heavy reliance upon oral communications with the prescriber and pharmacy.
Controlled Substance Fact Sheet & CMS Opioid Limits Pharmacies are required to provided a Controlled Substance Fact Sheets issued by DOH at the time of dispensing Does this apply to pharmacies servicing LTC/RHCF? From OASAS (Sara Osborne) on January 23, 2017, We have opined that this requirement does not apply where the pharmacy does not directly dispense the medication to the patient
EXPIRATION DATING OF UNIT-DOSE REPACKAGED SOLID ORAL DOSAGE FORM DRUG PRODUCTS In Chapter <795>, for non-aqueous formulations, the BUD is assigned no later than the expiration date of the product or six months, whichever is earliest. BUT, that is also the same guidance document that exempts packaging for patients in LTC facilities. In a footnote in that document, it reads: FDA is considering the applicability of this condition to certain non-sterile drug products repackaged by State-licensed pharmacies for distribution to long-term care facilities, and intends to revise this guidance or issue separate guidance to address this issue. During this interim period, FDA does not intend to apply this condition to non-sterile drug products repackaged by State-licensed pharmacies for use in long-term care facilities. In the absence of these FDA guidance documents, the regulations for 503A facilities would revert to state pharmacy regulations as it is written in each state. Most commonly that time period is one year, but may vary by state. This is our best opinion, based on the above documents. Reference: Email from ASCP on 8-21-17
NYS DEC PILOT PHARMACEUTICAL TAKE BACK PROGRAM In July, 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.
New Bill for 2017-2018 A8661 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.
IMPROVE THE APPEALS PROCESS FOR BELOW-COST REIMBURSMENT FOR GENERICS (MAC APPEALS) A4714 Rosenthal/ S5623 Hannon Pharmacy Benefit Managers (PBM s) are largely unregulated middlemen that manage pharmacy networks. In March 2016, a new state law gave local pharmacies a mechanism for recovering amounts due when reimbursement from PBM s When state law allows pharmacies to have a mechanism to resolve below cost payments from PBM s, it: Allows local pharmacies to maintain sufficient inventory to meet patient demand Ensures patient access to prescribed medications and a health care provider from local community pharmacy Promotes pharmacy services of consistent quality and reliability
ESTABLISH RULES FOR FAIR PHARMACY AUDITS A6733 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: Still before Health committee. Ways and Means (Assembly) does not want any more PBM bills. PSSNY still working to move this Bill forward.
AMMO Anti-Mandatory Mail Order A4786 Joyner/ S3484 Golden Despite the passage of a No Mandatory Mail Order Insurance law in 2012, patients are still being forced into mandatory mail programs when they express a clear preference to obtain their prescriptions from a local pharmacy. State laws should: Strengthen patient protections against mandatory mail order protect patient s choice UPDATE: Passed the Assembly. In Senate Insurance Committee
Legislative Issues in NYS Affecting Pharmacy Update October 2017 Acknowledgments: PSSNY 2017 Legislative Agenda The Pharmacy Patient s Right to Care Capital Public Affairs Elizabeth Lasky PSSNY Lobbyist MIRram Group LLC PSSNY Lobbyists DOH Letter issued March 2, 2017 BNE Website NYS DEC website www.dec.ny.gov.chemical/108213.html Illustrations By Andrew Flynn RPh ACPHS Pharmacy Practice Department
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