UPDATE I-STOP and E-Prescribing

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1 UPDATE I-STOP and E-Prescribing Tracy Russell PSSNY Executive Director

2 Learning Objectives State the statistics regarding the success of the I-Stop regulations Define electronic prescribing in NYS regulations Identify the timeline for electronic prescribing Describe the requirements for the practitioner Describe the pharmacy application requirements List the requirements for the DEA Take Back Program

3 Prescription Drug Reform Act I-STOP Internet System to Track Over-Prescribing 3

4 Prescription Drug Reform Act (more commonly known as I-STOP) Part A: I-STOP August 27, 2013 Part B: Electronic Prescribing March 27, 2015 Part C: Part D: Part E: Controlled Substance Schedule Changes 3309 Work Group Safe Disposal Program 4

5 Bureau of Narcotic Enforcement Narcotic Investigations Conducts investigations, inspections, outreach; Partners with law enforcement and regulatory agencies. Regulatory Compliance Issues licenses, certifications, and permits. Public Health Initiatives & Administration Administers Official Prescription Program, Prescription Monitoring Program, and grants; Conducts education and outreach; Helps formulate policy and regulations. 5

6 Prescription Drug Reform Act (more commonly known as I-STOP) Part A: I-STOP August 27, 2013 Part B: Electronic Prescribing March 27, 2015 Part C: Part D: Controlled Substance Schedule Changes 3309 Work Group Part E: Safe Disposal Program 6

7 Safe Disposal Program DEA Take Back

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9 Safe Disposal Consumers need a means to safely dispose of prescription medications including controlled substances Safe disposal sites established with local police departments New law in NY Article 33, Section 3343-b Important to note disposal must be in accordance with federal law. Federal rules yet to be finalized 9

10 Medication Drop Box Map Drop Box Available Drop Box Not Available 10

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13 Access to PMP Data Prescribers (excluding Veterinarians) Pharmacists Attorney General s Office County Health Departments engaged in public health research or education Medical Examiner/Coroners Patients 13

14 Designees for Pharmacists Limited to other pharmacists and pharmacy interns Each designee must establish their own HCS Account After the designee obtains an HCS account user ID, the pharmacist will need to log into the HCS, open the PMP application, and click on the Designation tab. On the designation screen, the pharmacist will enter the HCS user ID of the individual that will be performing the look up on their behalf as a designee.

15 PMP Searches by Profession 8/27/13 4/13/14 8% 8% 3% 12% 69% Medicine Nurse Practitioners Pharmacist 15

16 PMP Data Submission After receiving these records, BNE Screens all records for critical errors; Rejects any record containing a critical error and notifies the submitter so it can be corrected; De-duplicates any identical records; Matches new record to existing patient records; Presents new record in PMP Registry This process takes about 2 hours from when BNE receives the original record. 16

17 PMP Data Submission Effective August 27, 2013, pharmacies were required to submit controlled substance prescription data to BNE within 24 hours via the PMP. October 1, 2014, pharmacies are required to submit controlled substance prescription data to BNE using ASAP 4.2 According to BNE 68% records are currently being submitted in % of the submitters are using % of the dispensers are using

18 Prescription Drug Reform Act I-STOP Internet System to Track Over-Prescribing Software Application Update 18

19 Changes related to the ASAP 4.2 submission requirements effective October 1, 2014 Field Name Data Element Edit Effective October 1, 2014 Date Sold DSP17 This field will be required. This field is used to capture the date the controlled substance left the pharmacy (delivery to the patient, not the date it was filled, if the dates differ). Date Filled (DSP05) will continue to be a required data element. If the prescription is filled and delivered to the patient on the same day, the Date Sold and Date Filled fields will contain the same date. An error will result if the field is empty, null or submitted with all zeroes. The date must be a valid date between date written and current date in the following format; CCYYMMDD. Species Code PAT20 This field will be required. This field is used to differentiate a prescription for a human being from one prescribed for an animal. An error will result if the field is empty or null. This field must be submitted with a value of 01 (Human) or 02 (Veterinary) Name of Animal PAT23 This field will be required if PAT20 = 02 (Veterinary Patient). Alphanumeric characters and may contain, and. DEA Number Suffix PRE03 A warning will be generated if this field is left blank or null and the DEA Number field (PRE02) contains an institutional DEA number. This is not a required field for data submission.

20 All pharmacies accepting E-Prescriptions for Controlled substances must report the following data elements using the ASAP 4.2 standard Field Name Electronic Prescription Reference Number Data Element DSP20 Description of Edit This field is required if AIR01 = NY and AIR02 = eeeeeeee (electronic prescription). The value must be alphanumeric. Electronic Prescription Order Number DSP21 This field is required if AIR01 = NY and AIR02 = eeeeeeee (electronic prescription). The value must be alphanumeric.

21 PMP Resources Bureau of Narcotic Enforcement Contact information Riverview Center Regional Offices: 150 Broadway, Albany, NY NYC: (212) (866) Buffalo: (716) Syracuse: (315) Rochester: (585)

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24 Electronic Prescribing of Controlled Substance (ECPS)

25 Electronic Prescribing Effective June 1, 2010 Federal ruling, DEA allows for electronic prescribing of controlled substances Effective March 27, NYS Regulations allows for electronic prescribing of controlled substances (EPCS). Effective March 27, Electronic prescribing of controlled and non-controlled substances becomes mandatory for all prescribers. 25

26 Regulations Federal Rule Electronic Prescriptions for Controlled Substances 10 NYCRR Part 80 Rules Click on the link to New York State Regulations related to Electronic Prescribing of Controlled Substances 26

27 Why Electronic Prescribing? Next step in medical technology Curtail forged and counterfeit prescriptions Reduce medication errors associated with bad handwriting Will eventually allow for interstate communication to potentially reduce prescription theft and forgery 27

28 What is Electronic Prescribing? Authorizes a practitioner to issue an electronic prescription in Schedules II-V Requires a pharmacist to annotate, dispense, endorse and electronically archive electronic prescriptions for controlled substances Electronic Prescription defined as A prescription issued with an electronic signature and transmitted by electronic means in accordance with regulations of the commissioner and the commissioner of education and consistent with federal requirements. "Electronic" is defined as - means of or relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic or similar capabilities. 28

29 NYS Regulations for Computer Applications Requires all prescribers and pharmacists engaging in electronic prescribing and dispensing of controlled substances to utilize computer applications that meet federal security requirements All computer applications must be registered with the NYS DOH/BNE All computer applications must be certified by the DEA 29

30 Must be capable of retrieving controlled substance prescriptions by practitioner name, patient name, drug name, date filled and date dispensed Must allow downloading of prescription data into a database or spreadsheet that is readable and sortable Must maintain an audit trail of a number of actions (e.g., receipt annotation, alteration, changes in logical access) Must conduct internal audits and protect records Retain archived records electronically 30

31 Registering Certified Application with BNE Current Process contact BNE, forms to be completed will be sent Upcoming Forms will be available online Ultimately online registration process BNE Website - Once Registration Form is Received About one week to process Registrant will receive an advising that application has been registered with NYS 31

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33 How do I know my software vendor has met the requirements? Do NOT call BNE Ask your software vendor representative Check the Surescripts website Products and Services/Pharmacy/EPCS/Certified Software Vendors and Pharmacies 33

34 BNE doesn t have all the information on software/logical access that would verify if an application is in compliance with the federal rule. We are aware of different vendors that have different types of software or applications and not only are we not allowed to comment on this we cannot verify whether a particular software or version is compliant or not. The best recommendation is to advise pharmacists/pharmacies to contact the vendors directly and ask. Pharmacies may have different needs for software. First inquiry be to your existing pharmacy software vendor and then just as a business would choose other types of software, evaluate what is out there that meets their needs and meets the federal requirements.

35 How do I know my software vendor has met the requirements? Do NOT call BNE Ask your software vendor representative Check the Surescripts website Products and Software Vendors and Pharmacies Services/Pharmacy/EPCS/Certified 35

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40 Electronic Prescribing of Controlled Substance (ECPS) Prescriber Responsibilities

41 EPCS Transmission EPCS application must transmit the electronic prescription as soon as possible after signature by the practitioner Electronic prescription may be printed only if practitioner has been notified of transmission failure Printed version must contain information relating to original electronic transmission failure 41

42 EPCS Transmission Copies of EPCS transmitted prescription must state Copy only not valid for dispensing. EPCS application must not allow for electronic transmission if original was printed prior to electronic transmission At no time may an intermediary convert the electronic prescription to another form (e.g., facsimile) for transmission 42

43 EPCS Prescriber Requirements Obtain and use a two factor authentication credential Something you have (token) Something you know (password, PIN) Something you are (biometric) Ensures prescription integrity and non-repudiation Use a certified application (software) that records, stores and transmits information required under Sections 1311 and 1306 of 21 CFR Safeguard credentials 43

44 Electronic Prescribing Exceptions Technological or electrical failure; Use of EPCS would impact the patient s medical condition (up to 5 day supply); Issued by a practitioner to be dispensed outside of New York State; Federal Departments that do not fall under NY jurisdiction Veterinarians; Practitioners who have received a waiver from the Department of Health. 44

45 Electronic Prescribing Waivers Practitioners may apply for a waiver from the requirement to electronically prescribe controlled substances. Waivers will be granted upon a proper showing of economic hardship, technological limitations outside of the practitioner s control or other exceptional circumstances. By statute, waivers are good for one year, after which a practitioner may apply for a renewal. 45

46 Electronic Prescribing of Controlled Substance (ECPS) Pharmacy Responsibilities

47 Official Prescription Program NY issues forge-proof official prescription forms to all registered practitioners within the State Over 147,620,300 forms issued in 2012 Over 141,289,600 issued in 2013 At a cost of $78.7 M

48 EPCS Pharmacy Application Requirements Must meet DEA s requirements May only process controlled substance prescriptions using a certified pharmacy application Application must be able to set access controls Application must be able to import, store and display prescription requirements and verify the practitioner s digital signature Application must allow for pharmacist annotations and be maintained electronically

49 EPCS Take Aways Permissive now--mandated for ALL prescriptions March 27, 2015 Practitioners and pharmacists are required to use a certified application Certified application must be registered with BNE If the prescription starts electronically, it remains electronic Fax does not equate to electronic

50 What s Next Ensure that your software meets federal security requirements and that you are submitting controlled substance data to BNE in ASAP 4.2 standard Ensure that your certified software is registered with BNE Check BNE s website often for more information Prepare for a new work flow with the increase in Electronic prescriptions 50

51 New York State Laws and Pharmacy Where are we? What does it mean to Pharmacy? What do we do now? Elizabeth Lasky Capital Affairs, PSSNY Lobbyist

52 2014 Legislative Session Recap Part One: New Laws Bills that passed and what the new laws mean to practicing pharmacists Part Two PSSNY Priority Bills Recap and Update Part Three Additional Bills of Interest

53 2014 Legislative Session Recap Part One: New Laws Bills that passed and what the new laws mean to practicing pharmacists

54 2014 Legislative Session Recap New Law Consent for Delivery - A8612 A McDonald/S6449-A Hannon Requires registered pharmacies to contact the patient/caregiver before delivering prescriptions off-premises. Consent means 1. Signature upon delivery OR 2. Documented contact in the pharmacy s records OR 3. Opt-in program patient consent program updated every six months Pharmacies that deliver prescriptions without patient consent must 1. Accept medications that are returned 2. Credit patients for the co-pay Consent for delivery does not conflict with adherence programs, refill reminder programs and it does not apply to long term care.

55 2014 Legislative Session Recap New Law Vaccine Registry A9561-A Paulin/S7253 Hannon Gives pharmacists access to NYS and NYC children and adult registries Requires pharmacists and nurses to report immunizations to NYC or NYS registry with patient consent PSSNY s concerns 1. Excessive reporting requirements 2. Registries are not accurate unless reporting is mandatory for all

56 2014 Legislative Session Recap New Law CDTM extender - A9715 Glick/S7435 Hannon Moves the sunset from September 14, 2014 to September 14, 2015 Collaboration between a physician and a pharmacist

57 2014 Legislative Session Recap New Law Heroin response: Naloxone A8637-B Dinowitz/S6477-B Hannon Amends NYS Controlled Substances law allowing pharmacists to dispense naloxone/opioid antagonists with a prescription or non-patient specific order Requires Health Department to collect data and issue annual reports If non-patient specific order, pharmacist must document name of prescriber, name of opioid antagonist, date and name of person who received the medication For BNE updates check PSSNY E-scripts (available on line)

58 2014 Legislative Session Recap New Law Heroin Response: Criminalizes Not-In-Good-Faith Sale of Controlled Substances by Pharmacists and Practitioners S7902 Hannon/A10154 Rules (Governor s Program Bill) Class C felony Heroin Response: Adds Misrepresentation as a Pharmacist to Fraud and Deceit used to unlawfully obtain a controlled substance S7907 Marcellino/A10155 Rules (Governor s Program Bill) Class A Misdemeanor

59 2014 Legislative Session Recap New Law Mandatory insurance coverage for ostomy supplies A8137-A Magnarelli/S5937-A Valesky Mandates insurance coverage for ostomy supplies

60 2014 Legislative Session Recap New Law Safe Disposal: Requires Office of Alcoholism & Substance Abuse Services and Department of Environmental Conservation to publicize collection events and issue guidance A1609 Cymbrowitz/S6691 Boyle Guidelines issued August 14, 2014 with requirements for conducting household pharmaceutical collection events. (PSSNY E-Scripts August 28, 2014)

61 2014 Legislative Session Recap New Law Safe Disposal: Department of Environmental Conservation Demonstration Program A5465-A Sweeney/S3985-A Grisanti At least three disposal sites in State Police facilities Urban, Suburban, Rural DEC must promote safe disposal practices

62 2014 Legislative Session Recap New Law Medical Marijuana A6357-E Gottfried/S7923 Savino Authorizes NYS Health Department to register no more than five for-profit and not-for-profit geographically distributed organizations that are created for the purpose of acquiring, possessing, manufacturing, selling, delivering, transporting, distributing or dispensing marijuana for certified medical use to DOH-certified patients. DOH will set prices and establish excise tax Medical marijuana cannot be lawfully dispensed by a licensed pharmacist Sunsets in 7 years. Governor can stop the program at any time.

63 PSSNY PRIORITY LEGISLATION FOR 2015 Part Two PSSNY Priority Bills Recap and Update AMMO Reform MAC Appeal Scope of Practice 1. Expand and Reform Immunizer Law 2. Expand CDTM 3. Authorize pharmacists to perform CLIA-waived test

64 PSSNY PRIORITY LEGISLATION FOR 2015 Anti-Mandatory Mail Order A 5723-B Heastie/S 3995-B Maziarz Defines mail order pharmacy in Insurance Law Levels the playing field between community and mail order pharmacies Removes terms and conditions barrier imposed by PBMs Defines same reimbursement (same benchmark index, same NDC)

65 PSSNY PRIORITY LEGISLATION FOR 2015 Generic Fair Pricing MAC Appeals A9264-A Rosenthal/S7025-A Hannon Defines pharmacy benefit manager Amends Public Health Law (not Insurance Law) Requires PBM contracts to include a reasonable process to appeal, investigate and resolve disputes regarding multi-source generic drug pricing Right to appeal is limited to 60 days from filing original claim Requires PBMs to respond within 7 business days Successful appeals will apply retroactively to all similarly situated pharmacies Denials must document product is available at or below MAC

66 PSSNY PRIORITY LEGISLATION FOR 2015 Immunizer Expansion and Reform A9211-A Paulin/ S5688-A Hannon Removes sunsets (March 31, 2016 for flu, pneumo, meningococcal and July 1, 2015 for Zoster) NYS Health Department Program Bill Removes county restriction for non-patient specific orders Adds Tdap Retains adults-only For all vaccines, both patient-specific and non-patient-specific orders Allows NYS Commissioner of Health to issue statewide orders

67 PSSNY PRIORITY LEGISLATION FOR 2015 CDTM A7521 McDonald Allows CDTM by certified pharmacists in any setting Written collaborative agreement with a physician, nurse practitioner, physician assistant, facility or practice Certification requirements must meet two of the following 1. board certified by a national accrediting body acceptable to SED 2. accredited post-graduate residency with at least 50% direct patient care 3. documented experience providing clinical services to patients for 1,000 hours

68 PSSNY PRIORITY LEGISLATION FOR 2015 CLIA-Waived Tests Legislation is being researched and drafted Conducted with patient consent Screenings, upon request, including sub-emergent conditions Adjunct to ongoing medication therapy, results sent to primary care provider designated by the patient

69 Additional Bills of Interest Part Three Additional Bills of Interest

70 Additional Bills of Interest Medication Synchronization Facilitates synchronization of prescription refills (same day each month) Amends insurance law to require insurers to cover short fills Full dispensing fee for short fills Requires co-pay to be pro-rated National initiative

71 Additional Bills of Interest Require SP in out of state pharmacies to have NYS license LaValle/Glick Fills loophole in existing law (Out-of-state pharmacies must follow NYS controlled substances laws without knowing what they are) PBM Transparency Gottfried Defines PBMs as fiduciaries

72 Additional Bills of Interest Limited Services Clinics in pharmacies To be regulated by NYS Public Health Council For treatment of minor traumas not reasonably likely to be life-threatening For acute episodic illness or condition For episodic preventive treatment and services, i.e. immunization

73 What do we do now? Know your legislators. Relationships are VERY important. Stay informed with PSSNY s Weekly E-Script Support Pharmacy s Political Action Committee Educate others

74 Tracy Russell, CAE Executive Director Elizabeth Lasky Capital Affairs/Lobbyist