Contact Us
Categories
- Department of Health and Human Services' Office of Civil Rights
- Medical Residents
- EMTALA
- FDA
- Reproductive Rights
- Roe v. Wade
- SCOTUS
- Medical Spas
- medical billing
- No Surprises Act
- Mandatory vaccination policies
- Workplace health
- Coronavirus Aid, Relief and Economic Security Act
- Code Enforcement
- Department of Labor ("DOL")
- Employment Law
- FFCRA
- CARES Act
- Nursing Home Reform Act
- COVID-19
- SB 150
- Acute Care Beds
- Clinical Support
- Coronavirus
- Emergency Medical Services
- Emergency Preparedness
- Families First Coronavirus Response Act
- Family and Medical Leave Act (“FMLA”)
- KBML
- medication assisted therapy
- Department of Health and Human Services
- Legislative Developments
- Corporate
- United States Department of Justice ("DOJ")
- Employee Contracts
- Non-Compete Agreement
- Opioid Epidemic
- Sexual Harassment
- Health Resource and Services Administration
- Litigation
- Medical Malpractice
- House Bill 333
- Senate Bill 79
- locum tenens
- Senate Bill 4
- Physician Prescribing Authority
- Chronic Pain Management
- HIPAA
- Prescription Drugs
- "Two Midnights Rule"
- 340B Program
- Hospice
- Kentucky minimum wage
- Minimum wage
- Skilled Nursing Facilities (“SNFs”)
- Uncategorized
- Drug Screening
- EHR Systems
- Electronic Health Records (“EHR")
- ICD-10
- Mental Health Care
- Primary Care Physicians ("PCPs")
- Urinalysis
- Accountable Care Organizations (“ACO”)
- Affordable Insurance Exchanges
- Anti-Kickback Statute
- Certificate of Need ("CON")
- Compliance
- Department of Health and Human Services (HHS)
- Federally Qualified Health Centers (“FQHCs”)
- Fee for Service
- Fraud
- Health Care Fraud
- HIPAA Risk Assessment
- HPSA
- KASPER
- Kentucky Board of Medical Licensure
- Kentucky’s Department for Medicaid Services
- Office for Civil Rights ("OCR")
- Office of Inspector General of the United States Department of Health and Human Services (OIG)
- Part D
- Pharmacists
- Physician Assistants
- Qui Tam
- Rural Health Centers (“RHCs”)
- Stark Laws
- Telehealth
- Affordable Care Act
- Alternative Payment Models
- American Telemedicine Association (“ATA”)
- Centers for Medicare & Medicaid Services (“CMS”)
- Charitable Hospitals
- Data Breach
- Electronic Protected Health Information (ePHI)
- False Claims Act
- Health Information Technology for Economic and Clinical Health Act (HITECH Act)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Professional Shortage Area ("HPSA")
- Hospitals
- HRSA
- Kentucky Board of Nursing
- Limited Services Clinics
- Medicaid
- Medical Staff By-Laws
- Medically Underserved Area ("MUA")
- Medicare
- Mid-Level Practitioners
- Patient Protection and Affordable Care Act (“ACA”)
- Rural Health Clinic
- Telemedicine
- APRNs
- Criminal Division of the Department of Justice (“DOJ”)
- Health Care Fraud Prevention and Enforcement Action Team (“HEAT”)
- Hydrocodone
- Kentucky Pharmacists Association
- Qualified Health Care Centers (“FQHC”)
- United States ex. Rel. Kane v. Continuum Health Partners
- Webinar
- Agreed Order
- Chain and Organization System (“PECOS”)
- Chiropractic services
- Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
- Douglas v. Independent Living Center of Southern California
- Drug Enforcement Agency ("DEA")
- Emergency Rooms
- Enrollment
- Hinchy v. Walgreen Co.
- Jimmo v. Sebelius
- Kentucky Senate Bill 7
- Maintenance Standard
- Medicare Part D
- Minors
- Ophthalmological services
- Overpayments
- Physician Compare website
- Re-validation
- Texting
- Vitas Innovative Hospice Care
- 2014 Medicare Physician Fee Schedule (“PFS”)
- 501(c)(3)
- Affinity Health Plan
- All-Payer Claims Database ("APCD")
- Appeal
- Cadillac tax
- Centers for Disease Control and Prevention
- Chronic Care Management
- Community health needs assessment (“CHNA”)
- Compliance Officer
- Compounding
- CPR
- Denied Claims
- Dispenser
- Drug Quality and Security Act (“DQSA”)
- Essential Health Benefits
- Federation of State Medical Boards (“FSMB”)
- Food and Drug Administratio
- Form 4720
- Grace Period
- HealthCare.gov
- House Bill 3204
- ICD-9
- Individual mandate
- Kentucky Medical Practice Act
- Kindred v. Cherolis
- Kynect
- Long-term care communities
- Mobile medical applications ("apps")
- Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”)
- National Drug Code ("NDC")
- National Institutes of Health
- New England Compounding Center ("NECC")
- Nonprofit hospitals
- Outsourcing facility
- Physician Payments
- Ping v. Beverly Enterprises
- Power of Attorney ("POA")
- Prescriber
- Qualified Health Plan ("QHP")
- Social Media
- Spousal coverage
- State Health Plan
- Sustainable Growth Rate (“SGR”)
- UPS
- "Plan of Correction"
- Advanced Practice Registered Nurses
- Arbitration
- Audit
- Business Associate Agreements
- Business Associates
- Call Coverage
- Condition of Participation ("CoP")
- Daycare centers
- Decertification
- Department of Medicaid Services’ (“DMS”)
- Division of Regulated Child Care
- Doe v. Guthrie Clinic
- EHR vendor
- Employer Group Health Plans
- Employer Mandate
- ERISA
- Fair Labor Standards Act (FLSA)
- False Billings
- Group Purchasing Organizations ("GPO")
- Health Professional Shortage Areas (“HPSA”)
- Health Reform
- Home Health Prospective Payment System
- Home Medical Equipment Providers
- Hospitalists
- House Bill 104
- Inpatient Care
- Intermediate Sanctions Agreement
- Kentucky Health Benefit Exchange
- Kentucky House Bill 217
- Licensed practical nurses (LPN)
- Licensure Requirements
- List of Excluded Individuals and Entities
- LLC v. Sutter
- Long-Term Care Providers ("LTC")
- Low-utilization payment adjustment ("LUPA")
- Meaningful use incentives
- Medicare Administrative Coordinators
- Medicare Benefit Policy Manual
- Medicare Shared Saving Program (MSSP)
- Network provider agreement
- Nonroutine medical supplies conversion factor (“NRS”)
- Nurse practitioners (NP)
- Office of the National Coordinator for Health Information Technology (“ONC”)
- Part A
- Part B
- Patient Autonomy
- Patient Privacy
- Payors
- Personal Health Information
- Personal Service Entities
- Physician Recruitment
- Physician shortages
- Provider Self Disclosure Protocol
- Quality reporting
- Registered nurses (RN)
- Residency Programs
- Self-Disclosure Protocol
- Senate Bill 39
- State Medicaid Expansion
- Statement of Deficiency ("SOD")
- Trade Association Group Coverage
- Upcoding
- “Superuser”
- Autism/ASD
- Center for Disease Control
- Compliance Programs
- Critical Access Hospitals (“CAHs”)
- Essential Health Benefits (“EHBs”)
- Genetic Information Nondiscrimination Act ("GINA")
- Healthcare Information and Management Systems Society (HIMSS)
- Kentucky House Bill 159
- Kentucky Primary Care Centers (“PCCs”)
- Managed Care Organizations (“MCOs”)
- Medicare Audit Improvement Act of 2012
- Occupational Safety and Health Administration (“OSHA”)
- Recovery Audit Contractors (“RAC”)
- Senate Finance Committee Report
- Small Business Health Options Program (“SHOP”)
- Sunshine Act
- Abuse and Waste
- Consumer Operated and Oriented Plan programs (“CO-OPS”)
- Employee Agreement
- Free Conference Committee Report
- Health Care Fraud and Abuse Control Program
- House Bill 1
- House Bill 4
- Kentucky Cabinet for Health and Family Services
- Kentucky Health Care Co-Op
- Kentucky Health Cooperative (“KYHC”)
- Kentucky “Pill Mill Bill”
- Pain Management Facilities
- Health Care Law
- Health Insurance
- Healthcare Regulation
McBrayer Blogs
Reclassification of Hydrocodone Takes Effect This Week
The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products (such as Vicodin, Norco, and Tussionex) were previously listed on the less-restrictive Schedule III. In determining whether rescheduling was necessary, the DEA considered multiple factors including the potential for abuse, likelihood of dependence, and the threat to public health posed by the drug.
How does the new rule affect prescribers?
According to DEA, HCPs prescriptions issued prior to October 6, 2014 and authorized to be filled or refilled may be dispensed if such dispensing occurs before April 8, 2015. In some cases, pharmacy dispensing software products may not be able to process existing refills starting on October 6, or pharmacies may simply choose not to dispense refills after the effective date.
Pursuant to the Final Rule, HCPs prescriptions written on or after October 6, may not be refilled. No refills are allowed by any practitioner for Schedule II controlled substances and Schedule II prescriptions may only be given for maximum of a 30-day supply. Commentators to the proposed rule worried that rescheduling would result in more trips to the doctor to receive appropriate pain control. In response to these concerns, the DEA noted in the Final Rule that prescribers may issue multiple prescriptions authorizing patients to receive up to a 90-day supply, provided certain regulatory requirements (established in 21 CFR 1306.12) are met.
In addition, in Kentucky, Schedule II controlled substance prescriptions may not be faxed or called in to a pharmacy except as provided for in 902 KAR 55:095. Schedule II controlled substance prescriptions that are electronically prescribed must use a system that has been audited for compliance with the regulations specified in 21 CFR 1311. Further, Schedule II controlled substance prescriptions are valid for 60 days from the date written and controlled substance prescriptions must be signed and dated on the date issued by the prescriber.
Kentucky prescribers should be aware that restrictions on prescribing existing Schedule II pure hydrocodone products remain under current Kentucky statutes and regulations because these products were not rescheduled to Schedule II.
Midlevel providers who operate under collaborative agreements or are limited in their ability to prescribe certain Schedules of medications may be particularly affected by the Final Rule. In Kentucky, KRS 314.011, Section 8 (a) limits APRN prescribing of Schedule II controlled substances to a 72 hour supply with no refills, except certified psychiatric-mental health nurses are permitted to prescribe up to a 30-day supply of a Schedule II psychostimulant with no refills. KRS 314.011, Section 8 (b) limits APRN prescribing of Schedule III controlled substances to a 30-day supply with no refills. Because KRS 314.011, Section 8 (b) was in effect March 19, 2013, all APRNs will continue to be permitted to prescribe a 30-day supply of Schedule II hydrocodone combination products if allowed under their DEA license.
Even if the Final Rule does not specifically affect a prescriber’s abilities, prescribers should be prepared to work with pharmacies in order to minimize dispensing disruptions after the effective date. They should also identify and inform patients who are currently receiving HCPs about the rescheduling and, if necessary, discuss alternative pain management options. And, as prescribers well know, any new regulatory framework also brings with it the expectation of greater scrutiny and oversight in the future from regulatory authorities and law enforcement agencies.
Christopher J. Shaughnessy is a member at McBrayer law. Mr. Shaughnessy concentrates his practice area in healthcare law and is located in the firm’s Lexington office. He can be reached at cshaughnessy@mcbrayerfirm.com or at
(859) 231-8780, ext. 1251.
Services may be performed by others.
This article does not constitute legal advice.