Transcript Slide 1

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 (ISTOP) Act -- S-7637/A-10623
• 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 27th duty to consult has
no effect on mandatory e-prescribing (starts
March 27, 2015)
Exceptions to Duty to Consult
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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
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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 1-866-529-1890, Option 1
• It takes approximately 2 weeks to obtain an HCS
Account
How to Apply for an HCS Account
• https://hcsteamwork1.health.state.ny.us/pub/top.html.
• 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
email 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: 1-866-529-1890, Option 2.
How to Access PMP Registry
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https://commerce.health.state.ny.us/public/hcs_login.ht
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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
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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
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Permissible in NYS as of March 27, 2013
Must use DEA-certified software
ID verification procedures
Pre-register with BNE
http://www.deadiversion.usdoj.gov/
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
516-542-0077
[email protected]
www.nyspsych.org
FOR MORE INFORMATION
http://www.health.ny.gov/
professionals/narcotic