Kentucky Nurse Practitioners: Treating Acute or Chronic Pain
The Spring Issue of the KBN Connection draws attention to the appropriate prescribing of controlled substances for acute and chronic pain. In particular, the Board Practice Consultant focuses on 201 KAR 20:057 recent amendments. Below is the reference to Section 9 (14) limiting the prescribing of hyrdocodone combination products to a three (3) day supply for treatment of acute medical conditions. There are exceptions to be aware of but, most importantly, documentation is essential to support the initial prescribing and when deviating from the three (3) day limit for one of the listed exceptions.
(a) The APRN, in his or her professional judgment, believes that more than a three (3) day supply of hydrocodone combination products is medically necessary to treat the patient’s pain as an acute medical condition and the APRN adequately documents the acute medical condition and lack of alternative treatment options which justifies deviation from the three (3) day supply limit on the patient’s medical records;
(b) … is prescribed to treat chronic pain;
(c) … is prescribed to treat pain associated with a valid cancer diagnosis;
(d) … is prescribed to treat pain while the patient is receiving hospice or end-of-life treatment;
(e) … is prescribed as part of a narcotic treatment program licensed by the Cabinet for Health and
(f) … is prescribed to treat pain following a major surgery, which is any operative or invasive procedure
or a delivery, or the treatment of significant trauma;
(g) … administered directly to an ultimate user in an inpatient setting.
(15) Prescriptions written for hydrocodone combination products pursuant to subsection (14)(a) through (g) of this section shall not exceed thirty (30) days without any refill.
Kentucky Board of Nursing provides Social Media Advisory Opinion
The Kentucky Board of Nursing issued an advisory opinion for Kentucky Nurses to be aware of potential pitfalls in disclosing confidential patient information. We have represented nurses for before the Board on allegations of HIPAA violations. Here are some higlights from the advisory opinion and the link to the opinion. https://kbn.ky.gov/practice/Documents/aos40.pdf
Nurses need to be aware of the potential consequences of disclosing patient-related information via social media. This includes being mindful of employer policies, relevant state and federal laws, and professional standards regarding patient privacy and confidentiality.
As breaches of patient confidentiality or privacy may be unintentional or inadvertent, the Board advises nurses and employers that a nurse:
1. Is obligated to protect confidential patient information unless required by law to disclose the information;
2. Seeks and releases confidential patient information only when there is a clear and substantial “need to know” basis for the information. A “need to know” basis is one that requires individuals to have information in order to render care or service to a patient; and
3. Discloses confidential patient information to the patient’s family members and others only as permitted by the patient.
Principles for Social Media
– Nurses must not transmit or place online individually identifiable patientinformation.
– Nurses must observe ethically prescribed professional patient — nurse boundaries.
– Nurses should understand that patients, colleagues, institutions, and employers may view postings.
– Nurses should take advantage of privacy settings and seek to separate personal and professional information online.
– Nurses should bring content that could harm a patient’s privacy, rights, or welfare to the attention of appropriate authorities.
– Nurses should participate in developing institutional policies governing online conduct.
– Remember that standards of professionalism are the same online as in any other circumstance.
Tips to Avoid Problems
– Do not share or post information or photos gained through the nurse-patientrelationship.
– Maintain professional boundaries in the use of electronic media. Online contact with patients blurs this boundary.
– Do not make disparaging remarks about patients, employers or co-workers, even if they are not identified.
– Do not take photos or videos of patients on personal devices, including cell phones.
– Promptly report a breach of confidentiality or privacy.
Inappropriate use of social media is a violation of Kentucky nursing law. Kentucky Revised Statutes (KRS) 314.091(1)(d),(j), and (n) state that the board shall have power to reprimand, deny, limit, revoke, probate, or suspend any license or credential to practice nursing issued by the board upon proof that the person has:
– negligently or willfully acted in a manner inconsistent with the practice of nursing;
– violated any of the provisions of this chapter; or
– violated the confidentiality of information or knowledge concerning any patient, except as authorized or required by law.
Ohio Physicians and Pharmacists: Rule change to require ICD-10 diagnosis code on controlled substance prescriptions.
On March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain. Following that announcement, the State of Ohio Board of Pharmacy proposed rules that, if adopted, will increase the scope of the previously proposed standards by requiring prescribers to include an ICD-10 diagnosis code on all prescriptions for controlled substances, not just opiate pain medications. The new proposed rules aim to include controlled substances that treat conditions such as attention deficit disorder, low testosterone, narcolepsy, and seizure disorders.
On July 28, 2017, associations advocating on behalf of doctors and hospitals reached a compromise with Gov. Kasich’s office and the State Medical Board of Ohio, under which prescribers must begin reporting ICD-10 codes for opiate prescriptions for acute pain as soon as the proposed rules are finalized, but will have an additional nine months to begin reporting ICD-10 codes for other controlled substances. It is expected the boards of medicine, dentistry, and nursing will propose additional rules related to these prescribing standards.
Medical Board Executive Director A.J. Groeber has indicated that the board’s ability to know what conditions Ohio doctors are treating using potentially addictive opiates is “the linchpin” both to effective regulation and education. Executive Director Groeber went on to state, “It’s not just about going after the bad actors. We want to be able to do that, but we also want to educate the vast majority of our well-intentioned licensees to make sure that they know that they can treat patients effectively with fewer pills and fewer days’ supply.”
While the proposed rules will permit an Ohio pharmacist acting in good faith to dispense a controlled substance even if the prescription lacks a diagnosis code, pharmacies that dispense and prescribers who personally furnish controlled substances will be required to transmit the diagnosis code to Ohio’s prescription drug monitoring program (OARRS). The pharmacy board, which oversees the OARRS program, will contact prescribers who issue controlled substance prescriptions without a diagnosis code.
Gabapentin Becomes a Schedule 5 Controlled Substance in Kentucky
Effective July 1, 2017, Gabapentin will be classified as a Schedule V Controlled Substance. Here is a link to a helpful summary published by the Drug Enforcement and Professional Practices Branch for the Kentucky Cabinet for Health and Family Services. This summary addresses the impact for physicians, nurse practitioners, physician assistants and pharmacists. http://www.chfs.ky.gov/NR/rdonlyres/92D10F1A-8842-4E6D-B9D2-935741E2926E/0/KentuckyGabapentinFactSheet.pdf
Kentucky Board of Medical Licensure Issues Suboxone Regulation
201 KAR 9:270 – Professional Standards for Prescribing or Dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-With Naloxone. These regulations were update on June 2, 2017
The KBML recently completed work on promulgating a new regulation and it is now in effect. All physicians prescribing this medication should review the regulation by clicking here.
OIG Special Fraud Alert:
Laboratory Payments to Referring Physicians
The Office of the Inspector General (“OIG”) has issued another Special Fraud Alert, this time specifically targeting a recent trend in arrangements between laboratories and physicians. The alert describes two types of arrangements that may violate the Anti-Kickback Statute.
The latest alert first focuses on “Specimen Processing Arrangements,” when laboratories arrange to pay physicians to collect, process, or package blood specimens. It also notes that similar arrangements for the collection and processing of specimens other than blood, i.e. buccal swabs or urine samples, may also violate the anti-kickback prohibition.
The OIG stresses that it is not just the laboratories who engage in Specimen Processing and Registry Arrangements that face consequences. Physicians who enter into such arrangements are also at risk, and should analyze them carefully to ensure they do not violate the Anti-Kickback Statute.
Dr. James Patrick Murphy Discusses Pain Management
Dr. James Patrick Murphy, Pain Management Specialist practicing in Kentucky and Indiana, joined Dr. Wayne Tuckson on KET’s Kentucky Health on October 14, 2013 to discuss acute and chronic pain management. Please view attached link for the discussion. http://www.ket.org/cgi-bin/cheetah/watch_video.pl?nola=KKHEA%20000902&altdir=&template=
House Bill 1 Emergency Administrative Regulations
The Kentucky Board of Medical Licensure has issued new emergency regulations in compliance with HB1. These regulations should be reviewed immediately by physicians as they potentially impact all physicians. Some of the highlights are:
- Mandatory registration with KASPER for any physician with an active DEA 201 KAR 9:230E
- How the Board will determine if a physician’s practice constitutes a “pain clinic”; thereby, subjecting the physician to additional registration, monitoring and certification requirements 201 KAR 9:250E
- Professional standards for prescribing and dispensing controlled substances 201 KAR 9:260E
- NEW Continuing medical education requirements specific to controlled substances 201 KAR 9:310E
- NEW Emergency Order and hearing processes 201 KAR 9:240E
- NEW Disciplinary requirements for failure to report action/sanction by another state licensing board or criminal convictions within set time frame 201 KAR 9:081E
Additionally, the Kentucky Board of Medical Licensure has issued the following message on its website with the new emergency administrative regulations:
Transition Period for Emergency Regulations
On July 20, 2012, the provisions of HB 1 and various emergency regulations issued pursuant to that statute become effective. Licensees should be re-assured that the standards for prescribing controlled substances are the same standards employed by the Board for the past 20 years.
While licensees must comply with the provisions of HB 1 from July 20 forward, the Board recognizes that the emergency regulations include some new requirements. We want to assure licensees that the Board does not intend to impose disciplinary sanctions for an isolated and simple failure to comply with one of the new requirements during the immediate period following filing of the emergency regulations.
It is important that each licensee become familiar with and come into compliance with the various requirements of the emergency regulations, which have been posted on this website, as quickly as possible. The Board expects all licensees to be in full compliance with each of the new requirements by October 1, 2012.
Kentucky Pain Management Legislation
Kentucky has enacted new legislation addressing geared toward the practice of pain management. You can connect to the full text of HB 1 from the Kentucky Board of Medical Licensure’s website. www.kbml.ky.gov The KBML also has a summary of the legislation of the following areas for practitioners on its website:
- What is a pain management facility?
- Who can own a pain management facility?
- Qualifications and certifications to own or work at a pain management facility.
- How will variousKentuckyagencies coordinate efforts?
- Kentucky Boards that are impacted and must promulgate additional regulations.
- New Kentucky Board requirements?
- What are the statutorily mandated professional standards for prescribing or dispensing Schedule II or III with hydrocodone?
- What are the changes or requirements regarding KASPER?
Portions of this legislation became effective when the Act was signed by the Governor in April 2012. The majority of the Act will become effective on July 20, 2012. It is absolutely critical for any practitioner – Physician, Dentist, Nurse Practitioner, Podiatrist or Optometrist to review this new legislation and their licensing agency’s own regulations to ensure compliance. The attorneys at Elder & Good are available to consult with any professional on this important and developing matter.
Pilot Project Allows Users to Access Data from Kentucky and Ohio
Recently, the Kentucky Cabinet for Health and Family Services completed a pilot project that allowed Kentucky and Ohio to automatically exchange prescription medication data. This program is called Prescription Monitoring Information Exchange (PMIX) and it is a partnership between the Kentucky’s KASPER system and the Ohio Automated Rx Reporting System (OARRS).
Under the pilot program, authorized users in Kentucky and Ohio securely
accessed live Prescription Drug Monitoring Program (PDMP) data from both states’ prescription monitoring systems utilizing the PMIX Hub server. For example, a Kentucky physician would be able to request a KASPER patient report and stipulate that they need Ohio data on the report. The resulting KASPER report would include any prescription records that the Ohio PDMP provides for the patient as well as the KASPER prescription records, and will identify in which state each prescription was dispensed.
Several states, including Kentucky, currently allow a prescriber, dispenser, or
law enforcement officer from another state to register and obtain access to their PDMP. However, due to the effort required to establish and maintain separate accounts with each state and review multiple reports and formats, only a limited number of practitioners and law enforcement officers have done so. Now that the pilot program has been completed, the Cabinet is integrating the PMIX code into the production KASPER system. The Cabinet is also working on data sharing agreements with Ohio and several other states (including border states) with hopes of implementing KASPER data sharing with these states during 2012
Buprenorphine Diversion and Misuse Training
A special educational opportunity for physicians designed to provide useful and the most up-to-date information about best practices in office-based opioid dependence treatment that minimizes risk of buprenorphine diversion and misuse from patients in your practice.
Registration for this training is free and is encouraged for any physician who is qualified to prescribe buprenorphine in an office-based setting for the treatment of opioid dependence regardless of whether they are currently prescribing buprenorphine products.
This educational opportunity is endorsed by the Kentucky Board of Medical Licensure, the Kentucky Medical Association, and the Kentucky Board of Pharmacy.
For registration information: http://www.cecentral.com/addictionmedicine
KMA Addresses Prescription Drug Abuse in Kentucky
The Kentucky Medical Association and the Kentucky Board of Medical Licensure have become active members of a coalition that joined resources to address prescription drug abuse in Kentucky and offer comprehensive solutions through education. The KMA has devoted the January issue of the Journal of the KMA to the topic of substance abuse, which is available for all physicians to review at the KMA website, http://www.kyma.org.
Physicians, Physician Assistants and Nurse Practitioners practicing in the Commonwealth of Kentucky will find these articles useful in addressing the diversion of controlled substances and in adopting monitoring procedures for controlled substance compliance in their own practices.
DSM-5 Proposed Revisions Include New Category of Addiction and Related Disorders
The American Psychiatric Association’s proposed diagnostic criteria for the fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM) will eliminate the current categories of substance abuse and dependence, replacing them with the new category “addiction and related disorders.” This will include “substance use disorders,” with each drug identified as a category such as “alcohol use disorder.” The DSM Substance-Related Disorders Work Group members also have recommended a new category of behavioral addictions, in which gambling will be the sole disorder.
“The field of substance abuse and addiction has witnessed an explosion in important research in the past two decades,” said David Kupfer, M.D., chair of the DSM-5 Task Force. “These work group recommendations reflect the best science in the field and provide new clarity in how to diagnose these disorders.”
“The term dependence is misleading, because people confuse it with addiction, when in fact the tolerance and withdrawal patients experience are very normal responses to prescribed medications that affect the central nervous system,” said Charles O’Brien, M.D., Ph.D., chair of the Substance-Related Disorders Work Group. “On the other hand, addiction is compulsive drugseeking behavior which is quite different. We hope that this new classification will help end this wide-spread misunderstanding.”
O’Brien also explained the work group’s reasoning behind the new category of behavioral addiction. “There is substantive research that supports the position that pathological gambling and substance use disorders are very similar in the way they affect the brain and neurological reward system,” he said. “Both are related to poor impulse control and the brain’s system of reward and aggression.” Pathological gambling is listed in the current version of DSM, but in a different category. While “internet addiction” was considered for inclusion in this category, the work group decided there was insufficient research data to do so. They are recommending it be included in the manual’s appendix instead, with a goal of encouraging additional study.
All proposed draft changes to DSM are being posted on the Web site www.DSM5.org, for public review and comment until April 20. More information on the process for developing DSM-5 is also available on the Web site. Final publication of DSM-5 is planned for May 2013.
HIPAA – Breach of Patient Information
A new HIPAA regulation that went into effect on February 22, 2010, requires physician practices and other medical providers to notify patients regarding breaches of a patient’s information. “Breach” is defined as the acquisition, access, use, or disclosure of unsecured patient information. There are exceptions to when a patient must be notified of a breach, as well as specific items that must be included in any notice to a patient.
Kentucky Medical Board Adopts Opinion Relating to Use of Suboxone and Buprenorphine
The Kentucky Board of Medical Licensure has issued a new opinion relating to the standards of acceptable and prevailing medical/osteopathic practice relating to the use of Suboxone and Buprenorphine. The Board issued this opinion pursuant to the Board’s statute, KRS 311.602, to assist physicians in determining what actions would constitute unacceptable conduct under the provisions of KRS 311.595. The Board states that it “has decided to publish this opinion because it addresses issues of significant public and medical interest.”
The Board notes “that these standards will be utilized by the Board and its consultants in their review of any grievance or investigation involving the use of Suboxone and/or Buprenorphine.” Any Kentucky physician that incorporates the use of Suboxone and/or Buprenorphine into their practice should review this new opinion, which is available on the Board’s website, http://kbml.ky.gov/board/policies.
Responsible Opioid Prescribing:
A Physician’s Guide Available for Online Purchase
The Kentucky Board of Medical Licensure has recommended the following resource for practitioners: Responsible Opioid Prescribing: A Physician’s Guide. According to the Board this guide offers physicians effective strategies for reducing the risk of addiction, abuse and diversion of opioids that they prescribe for their patients in pain. This concise, 150 page book offers pragmatic steps for risk reduction and improved patient care, including:
• Patient evaluation, including risk assessment
• Treatment plans that incorporate functional goals
• Informed consent and prescribing agreements
• Periodic review and monitoring of patients
• Referral and patient management
• Compliance with state and federal law
Written by pain medicine specialist Scott M. Fishman, M.D., Chief of the Division of Pain Medicine at the University of California-Davis, the book translates the Federation of State Medical Boards’ (FSMB) consensus model policy on pain management into practical, office-based pain management guidelines. Responsible Opioid Prescribing: A Physician’s Guide is available at www.fsmb.org.
Attention Kentucky and Ohio Physicians, Nurse Practitioners and Pharmacists: You can now access the prescription monitoring programs of all Kentucky’s bordering states. You can go to the KASPER website, http://chfs.ky.gov/os/oig/KASPER.htm and find the links to each border state’s registration for access to their respective prescription monitoring program. This list includes Indiana, Illinois, Ohio, Tennessee, Virginia and West Virginia.
Tramadol Listed as Schedule IV Controlled Substance in Kentucky
In response to significant concerns raised by healthcare professionals, the Kentucky Cabinet for Health and Family Services, Office of the Inspector General, Division of Audits and Investigations, Drug Enforcement and Professional Practices Branch submitted a request to the Kentucky Legislature to add Tramadol to the list of Schedule IV controlled substance products in Kentucky.
The regulation change was adopted and became effective on December 5, 2008. At that time any prescriber without a valid DEA license cannot write or issue a prescription for Tramadol. In addition, any remaining refills on a Tramadol prescription issued by a prescriber without a valid DEA license may not be dispensed. All provisions of 21Ch.II 1306.22 regarding refilling of controlled substance prescriptions should be followed. If you are a pharmacist and have a prescription from a DEA licensed prescriber with refills remainining and the prescription is not over 6 months from the date written it may be refilled.
Controlled substance dispensers must report all dispensing of Tramadol to the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system.
Controlled substance distributors and wholesalers must adhere to KRS 218A.170:
“A duly licensed manufacturer, distributor, or wholesaler may sell or distribute controlled substances, other than samples”. As a result all Tramadol samples should be destroyed by a hazardous materials handler within 30 days or inventoried on the appropriate DEA form and sent to a reverse distributor licensed by the DEA.“
If you have any questions regarding this regulation change, please contact the Drug Enforcement and Professional Practices Branch at (502) 564-7985.