Pain Law Survey: A Look at Critical Legal-Regulatory Changes (Overview) Jennifer E. Bolen, JD
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Disclosures • Ms. Bolen serves as special legal counsel to lawyers and physicians nationwide on pain policy and laws. She actively litigates cases and periodically serves as an expert witness. • Ms. Bolen serves on the Policy & Advocacy Committee for the American Academy of Pain Management. 2
Disclosures • Ms. Bolen serves as a consultant on a variety of issues, including billing and coding for clinical laboratory services, for the following clinical laboratories:
– Alere Toxicology, AFTS Laboratories, Andor Laboratories, Peace Health Laboratories, Physicians Pharmaceutical Corp. , ReCept Pharmacy – Numerous individual physician-owned and CLIA-waived, CLIA-certified laboratories.
• Grant/Research Support
– Alere Toxicology, AFTS Laboratories
• Honoraria
– ReCept
• Speaker’s Bureau
– Alere Toxicology, AFTS Laboratories, Andor Laboratories, Physicians Pharmaceutical Corp. , ReCept Pharmacy
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Disclaimers • While this course is taught by an attorney who is licensed in good standing and who is educating within the course and scope of her professional practice, there is no intent to create an attorney-client relationship with any participant, nor is there any intent to impart specific legal advice to any participant. • If you need legal counsel, it is imperative that you seek it from an expert-level professional and not a third party who lacks a legal license and legal training and experience on the issues raised herein. 4
Learning Objectives • Describe the basic difference between federal and state government involvement in pain policy and laws • Identify basic distinctions between laws, rules, and guidelines as they pertain to the regulation of pain management; and • Cite the legal standard for a valid controlled substance prescription 5
Lecture Format • This is a survey overview course designed to familiarize attendees with basic definitions and overall changes in pain policy and laws nationwide. • Following the survey overview course, regional sessions will be held to discuss region-specific changes.
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Distinguishing between federal and state government responsibilities and roles
REGULATION OF CONTROLLED SUBSTANCES & PAIN MANAGEMENT 7
The Role of the Federal Government in Regulating the Use of Controlled Substances • • • • •
Drug Enforcement Administration (DEA) Food & Drug Administration (FDA) Centers for Disease Control (CDC) Office of National Drug Control Policy (ONDCP) Substance Abuse Mental Health Services Administration (SAMHSA)
• Impact these agencies have on regulatory material related to the use of controlled substances for the treatment of pain. 8
The Role of State Governments in Regulating Pain Management & the Use of Controlled Substances
• State Controlled Substance Authorities (Varies by state as to actual agency name) • State Professional Licensing Boards • State Prescription Drug Monitoring Authority (May or may not be the same as the appointed controlled substance authority and may be a professional licensing board) 9
Understanding the Regulatory Framework tied to Controlled Substance Prescribing and the Registration and Operation of Pain Management Clinics* (in some states)
LAWS, REGULATIONS, POLICIES
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Basic Legal Platform Guidelines, Policies, Position Statements Regulations & Rules
Laws
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Definition: Laws • Set forth what conduct is allowed and what conduct is prohibited. • Violations bring penalties, including fines, imprisonment, and penalties. • Usually accompanied by regulations/rules to further explain the intent of the specific law. • Usually in form of Act and published in that form and embodied in statutes. .
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Definition: Regulations & Rules • Regulations and rules usually explain legal boundaries and behavioral expectations. • Characterized by specific directive language: Shall, Must – Caveat: Sometimes blended and include guidelines in a regulation or rule, as characterized by directive language: Should, May
• Regulations and rules have the force of law, meaning a violation of a regulation or rule can result in legal sanctions, including fines, penalties, and loss of license, registration, etc. • Key Example in the Past Ten Years: The “Do Not Fill” Rule tied to Issuance of Multiple Prescriptions for Schedule II Controlled Substances. – Caveat: This is a federal rule and it is NOT valid in all states, because states can be more restrictive than the federal rule. .
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Example: Final Rule on Issuance of Multiple Prescriptions for Schedule II Controlled Substances
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Final Multiple SII Rule – DEA Caution
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Definition: Guidelines, Policies & Position Statements • These DO NOT HAVE THE FORCE OF LAW. • Generally used to explain an agency’s regulation or rule. • Key Example in the past ten years: The DEA’s FAQ on Prescribing Controlled Substances to Treat Pain. – What happened to this document? The DEA retracted it in late 2004 and ultimately replaced it with a formal policy statement published in the Federal Register. You should read the replacement document. .
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Key Federal Laws Key Federal Laws
Drug Abuse Treatment Act of 2000 (DATA2000) and the Narcotic Addiction Treatment Act of 1974 (NATA1974) Food & Drug Administration Administrative Acts of 2007 (FDAAA)
Guidelines, Policies, Position Statements
Controlled Substances Act of 1970 (the CSA) and the Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Regulations & Rules Laws
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Key Federal Rules Key Federal Rules
Code of Federal Regulations DEA & FDA under Title 21 Code of Federal Regulations Example: 21 CFR 1306.04 - Purpose of issue of prescription
Guidelines, Policies, Position Statements
http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr1306_main_02.tpl
Regulations & Rules Laws
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Key Federal Guidelines, Policies, Position Statements Key Federal Guidelines, Policy Statements
FDA Blueprint for Provider Education (a Guideline) in October 2011
DEA Final Policy Statement on Dispensing Controlled Substances to Treat Pain (Sept. 2006) Guidelines, Policies, Position Statements Regulations & Rules Laws
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DEA FAQ
(published in 8/2004, retracted in 12/2004)
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DEA Final Policy Statement of 2006
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Sample State Laws Sample State Laws
Controlled Substances Act Pain Clinic Registration Act* (some states) Prescription Drug Monitoring Programs* (name varies by state) Medical Practice Act, Pharmacy Practice Act, Nursing Practice Act
Guidelines, Policies, Position Statements Regulations & Rules Laws
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Sample State Rules Sample State Rules
Pain Clinic Operation Rules & Standards* (some states) Training Rules & Standards for Physicians Practicing in Pain Clinics* (some states) Medical, Pharmacy, Nursing Practice Rules & Standards
Guidelines, Policies, Position Statements Regulations & Rules Laws
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Sample State Guidelines, Position Statements Sample State Guidelines, Position Statements
Guidelines for the Office-Based Treatment of Opioid Addiction (Patterned from the FSMB Model Policy)
Guidelines for the Use of Controlled Substances for the Treatment of Pain (Patterned from the FSMB Model Policy)
Guidelines, Policies, Position Statements Regulations & Rules Laws
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The Legal Perspective
WHAT CONSTITUTES A VALID PRESCRIPTION FOR A CONTROLLED SUBSTANCE? .
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Legitimate Medical Purpose • What is it? • Where is it defined? • What does this mean in terms of my state laws on prescribing controlled substances to treat pain? • Discussion
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Usual Course of Professional Medical Practice • What is it? • Where is it defined? • What does this mean in terms of my state laws on prescribing controlled substances to treat pain? • Discussion
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Breakout Regions • Group 1 - IL, IN, OH, PA, NJ, NY, NH, VT, RI, CT, ME, MS, VA, WV, DC, DE, MD – Thursday, 9/6/12 at 9:20 am to 10:20 am • Group 2 – AL, AR, GA, FL, KS, KY, LA, MO, MS, NC, SC, TN – Friday, 9/7/12 at 9:20 am to 10:20 am. • Group 3 – AK, AZ, CA, CO, HI, NM, NV, OK, TX, UT – Friday, 9/7/12 at 11:10 am to 12:10 pm. • Group 4 – IA, ID, OR, MI, MN, MT, ND, NE, SD, WA, WY – Saturday, 9/8/12 at 9:20 am to 10:20 am.
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