Prescription Drug Monitoring Programs: Analysis of State Level Usage Requirements Matthew Penn, JD, Carla Chen, JD Director, Public Health Law Program Legal Fellow, Public Health Law Program Office for State, Tribal, Local and Territorial Support Centers for Disease Control and Prevention State Health Department Training and Technical Assistance Meeting: From Epidemiology to Policy: Prescription Drug Overdose April 22 and 23, 2013 Centers for Disease Control and Prevention Office for State, Tribal, Local and Territorial Support
Transcript
Prescription Drug Monitoring Programs:
Analysis of State Level Usage Requirements
Matthew Penn, JD, Carla Chen, JD
Director, Public Health Law Program Legal Fellow, Public Health Law Program
Office for State, Tribal, Local and Territorial SupportCenters for Disease Control and Prevention
State Health Department Training and Technical Assistance Meeting:
From Epidemiology to Policy: Prescription Drug OverdoseApril 22 and 23, 2013
Centers for Disease Control and Prevention
Office for State, Tribal, Local and Territorial Support
Disclaimer
The contents of this presentation do not represent official CDC determinations or policies.
The contents are for educational purposes only and are not intended as a substitute for
professional legal advice.
Always seek the advice of an attorney or other qualified professional with any questions
you may have regarding a legal matter.
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Introduction
CDC Collaboration: Public Health Law Program (PHLP) & National Center for Injury Prevention and Control
National Alliance for Model State Drug Laws (NAMSDL): Prescription Drug Monitoring Project
Status of State Prescription Monitoring Programs (PMPs)
Variety of legal issues
“States that Require Prescribers and/or Dispensers to Access PMP Information in Certain Circumstances”
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States with PMP Usage Laws
PMP Usage Laws: PHLP
10 states have laws requiring PMP usage Prescriber and dispenser
trends• Certain drugs• Certain circumstances
Exceptions Enforcement Unique Provisions
6 states have laws related to usage but do not require checks for prescribing and dispensing
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PMP Usage Laws: Detecting Fraud, Abuse, or Diversion
States with prescribing or dispensing laws
Provision applies to prescribing
Provision applies to dispensing
Colorado
Delaware
Kentucky
Louisiana
Nevada
New York
Ohio
Oklahoma
Tennessee
West Virginia
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PMP Usage Laws: Detecting Fraud, Abuse, or Diversion
States that require prescribers or dispensers to check PMPs when they suspect fraud, abuse, or diversion
Delaware, Ohio, and Nevada: • Reasonable belief of nonmedical use
Kentucky and Ohio: • Long-term prescribing
Tennessee: • Aware or reasonably certain of fraud
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PMP Usage Laws: Certain Schedules or Drug Types
States with prescribing or dispensing Laws
Provision applies to prescribing
Provision applies to dispensing
Colorado
Delaware
Kentucky
Louisiana
Nevada
New York
Ohio
Oklahoma
Tennessee
West Virginia
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PMP Usage Laws: Certain Schedules or Drug Types
States that require prescribers or dispensers to check PMPs when dealing with certain schedules or types of drugs
New York: • By schedule
Colorado, Oklahoma, and West Virginia:• By drug type
Kentucky and Tennessee:• By schedule and drug type
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PMP Usage Laws: Explicit Frequency or Duration
States with Prescribing or Dispensing Laws
Provision Applies to Prescribing
Provision Applies to Dispensing
Colorado
Delaware
Kentucky
Louisiana
Nevada
New York
Ohio
Oklahoma
Tennessee
West Virginia
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PMP Usage Laws: Explicit Frequency or Duration
States that require prescribers or dispensers to check PMPs with an expressed frequency or duration
Kentucky: • at least once every three months
Ohio: • at least once annually for long-term prescribing
Tennessee and West Virginia: • annually
Delaware , Nevada, and Ohio: • data must span at least previous twelve months
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PMP Usage Laws: Exceptions
States with Usage Laws
Exception for temporary access problems
Waiver for longer term lack of access
Direct administration of drugs
Environment-focused exceptions
Patient-focused exceptions
Colorado
Delaware
Kentucky
Louisiana
Nevada
New York
Ohio
Oklahoma
Tennessee
West Virginia
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PMP Usage Laws: Exceptions
Temporary access problems Kentucky:
• Unable to obtain PMP report in a timely manner
Ohio, Tennessee, and New York:• PMP report or internet is not available
Waiver for longer term lack of access Delaware and New York:
• Technological limitations
Tennessee: • Undue hardship
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PMP Usage Laws: Exceptions
Direct administration of drugs Delaware, Tennessee, and New York:
• Generally or for emergency patient care
Environment-focused exceptions Delaware, Kentucky, New York, Ohio, and
Patient-focused exceptions New York: potential adverse impact to patient Kentucky: younger than 18 years of age with
ADD/ADHD14
PMP Usage Laws: Enforcement
Explicit reference to enforcement Kentucky: enforceable through licensing penalties Colorado: enforceable through workers’ compensation
statute
Delegation of enforcement Delaware, New York, Tennessee, and West
Virginia:• Administrative bodies to promulgate rules and
regulations regarding procedures, implementation, and penalties
No enforcement language within usage provision Louisiana, Nevada, Ohio, and Oklahoma
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PMP Usage Laws: Unique Provisions
Law does not apply if PMP is not operational Delaware: dependent upon funding Ohio: dependent upon state pharmacy board maintaining
the PMP
Provisions dealing with liability Delaware, New York, Tennessee, and West Virginia:
• Provisions range from providing immunity from civil liability to providing an absolute defense in civil or criminal actions
What to do when fraud is suspected Kentucky: cease prescribing/dispensing; shall notify law
enforcement West Virginia: practitioner may notify law enforcement
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Laws Related to Using PMPs
States with laws related to using PMPs
Usage required at other times
Practice sites required to provide access
Rulemaking authority delegated
Colorado
Kentucky
Massachusetts
Ohio
Tennessee
West Virginia
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Laws Related to Using PMPs
States that require usage at times other than prescribing or dispensing
Colorado: for medical history and drug screens
Kentucky: for admission to a hospital, long term care facility,or surgical center
States that require practice site access to PMP
Tennessee: each person operating a practice site shall provide for electronic access
West Virginia: opioid treatment program shall allow access to PMP 18
Laws Related to Using PMPs
States with provisions delegating authority to make rules about PMP usage
Massachusetts: the department of public health
Ohio: state dental board, board of nursing, board of optometry, board of pharmacy, and medical board to develop regulations
Tennessee: medical directors at pain management clinics
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PMP Registration Laws
“States that Require All Licensed Prescribers and/or Dispensers to Register with PMP Database” (http://www.namsdl.org/documents/StatesthatRequirePractitionerstoRegisterorHaveAccesstoPMP09112012.pdf )
8 states: Arizona, Kentucky, Maine, Massachusetts, New Hampshire, New Mexico, Tennessee, Utah
The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
