THE NEW I-STOP DUTY TO CONSULT Presented by Rachel A. Fernbach, Esq. Staff Attorney New York State Psychiatric Association July 15, 2013

Prescription Drug Reform Internet System for Tracking Over-Prescribing (I- STOP) Act -- S-7637/A Signed into law August 27, 2012 Duty to Consult Mandatory e-prescribing (March 27, 2015) Changes to controlled substance schedules Continuing education on pain management and prescription medications New safe disposal program for controlled substances

Prescription Monitoring Program I-STOP establishes a new Prescription Monitoring Program (PMP) registry for the collection, monitoring and reporting of information concerning the prescribing and dispensing of controlled substances Accessible on the internet through the DOH Health Commerce System website Prescribing information to be available on a real time basis

Duty to Consult Effective August 27, 2013, all practitioners must consult the PMP prior to prescribing or dispensing any Schedule II, III or IV controlled substance Purpose: to review patients’ controlled substance history to determine whether a Rx for a CS is appropriate Reminder – the August 27 th duty to consult has no effect on mandatory e-prescribing (starts March 27, 2015)

Exceptions to Duty to Consult Veterinarians Methadone programs If practitioner is administering a CS For use within an institutional dispenser In a hospital emergency department, limited to a 5 day supply Hospice Practitioner is reasonably unable to access PMP in a timely manner and no other practitioner or designee is reasonably available, limited to a 5 day supply Consultation would result in patient’s inability to obtain Rx in a timely manner, thereby adversely impacting patient’s medical condition, limited to a 5 day supply Technological failure of PMP or inability to access PMP due to temporary technological or electrical failure Waiver based on technological limitations not within control of practitioner or other exceptional circumstances

Institutional Dispensers Two prong test: (i) institution has its own BNE institutional dispenser license AND (ii) the drugs will be entirely consumed on premises. If any portion of the Rx will be used off the premises, this exception will no longer apply and PMP must be consulted

When to Consult the Registry Practitioners must consult the PMP no more than 24 hours prior to prescribing or dispensing a controlled substance for a patient Applies to prescriptions for children Applies to all refills Practitioner must still consult PMP even if Rx is to be filled outside of New York State.

Failure to Consult Willful misconduct $2,000 fine One year jail time OPMC professional misconduct charges

Health Commerce System Account In order to access the registry, all practitioners must obtain a Health Commerce System (HCS) Account (previously known as an HPN Account) If you currently order your Rx forms online, you already have an HCS account (Reminder: once you obtain an HCS account, you must order your Rx forms online using this system – old paper forms will no longer be available) If you think you already have an HCS account but are not certain, you may contact the Commerce Account Management Unit at , Option 1 It takes approximately 2 weeks to obtain an HCS Account

How to Apply for an HCS Account Click on "Apply for an HCS Medical Professions Account." Complete online form, including name, address, medical license number, DEA number, driver’s license number, etc. Within 3 days of submission of the online form, you will receive an from the state with an attached document. The document is a Medical Practice Agreement and Account Request. It must be printed out, signed and your signature must be notarized. The account request form must then be sent to DOH via regular mail. Make sure you retain a copy of the account request form because it contains your temporary access word. Within two weeks, you will receive a letter from DOH with your PIN number and instructions on how to activate your account. For assistance, contact the Commerce Accounts Management Unit at: , Option 2.

How to Access PMP Registry ml Click "Applications" at the top of the page. Click on the letter "P." Scroll down to "Prescription Monitoring Program Registry." The first time you login, you will be required to complete an attestation indicating your understanding of PMP guidelines Patient Search: Enter first name, last name, gender and DOB, confirm attestation Confidential Drug Utilization Report Will include a section entitled My Prescriptions and Other’s Prescriptions

Using the Registry PMP information = patient home address, dates, prescriptions, prescriber names, payment method and name of dispenser It is a criminal offense (misdemeanor) to enter in another prescriber’s DEA number and search their Rx history

Using the Registry Phase II and III of the PMP– may not be available today, but will be completed before August 27 Searches by pharmacies and pharmacy designees, bulk patient searches, ability to generate practitioner Rx histories

Search Sensitivity/Confidentiality Issues BNE has indicated that a search will return all similar results and will allow practitioners to make a determination about whether it is the same individual. Information on PMP is only as good as what is submitted by the pharmacy BNE working with pharmacies to standardize reporting and maintain consistency with hyphenated names

Immunity No practitioner or designee acting with reasonable care and in good faith will be subject to any civil liability arising from any false, incomplete or inaccurate information submitted to or reported by the registry or for any resulting failure of the system to accurately or timely report such information

Designees Practitioners may authorize a designee to consult the PMP on their behalf Designee must be employed by or under contract with same professional practice. Ultimate decision whether or not to prescribe must remain with the practitioner Designees may be designated immediately, but will not be able to access the system until August 27, 2013 According to the proposed regulations, designees must be located in NYS when accessing PMP

Designees, cont’d No limit on number of designees one practitioner may have Also no limit on number of practitioners a particular designee may work with Practitioners will have the capability to audit searches done by their designees – up to 6 months in the past Designee must be trained in use of the PMP and in relevant federal and state privacy statutes Must immediately revoke a designee’s authorization to access PMP upon termination of employment, for any reason

Documentation Proposed DOH regulations require practitioners to document that they consulted the registry Under proposed regulations, must document any legitimate reason for failing to consult, including a description of the circumstances presented that made consultation of PMP unreasonable or created adverse consequences DOH will also be logging all searches done, even if no results were returned

Reporting to DOH Under pre-existing DOH regulations, practitioners have a duty to make a report to DOH regarding an individual under treatment who appears to be an addict or habitual user of a narcotic drug. It is unclear whether the I-STOP program also imposes a duty to report evidence of doctor shopping or drug seeking behavior NYSPA plans to seek further guidance on this issue If a situation arises, members may feel free to contact NYSPA Central Office for advice

Electronic Prescribing of Controlled Substances Permissible in NYS as of March 27, 2013 Must use DEA-certified software ID verification procedures Pre-register with BNE Certified systems so far: Allscripts, Cerner Corporation, DrFirst, Epic, Glenwood Systems, MD Toolbox, NewCrop, NextGen, and RxNT Stratus EMR.

Mandatory E-Prescribing Effective March 27, 2015 – e-prescribing will become mandatory across the state, for all practitioners in the state, for all medications, including controlled substances Limited exceptions: –temporary technological or electronic failure –adverse medical consequences to patient (limited to 5 day supply) –if Rx is to be filled out-of-state, –pursuant to one-year waiver

New York State Psychiatric Association FOR MORE INFORMATION professionals/narcotic professionals/narcotic