State Board of Medical Examiners

DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

For immediate release

On Friday the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data.  The Federal Register has made the Final Rule available for preview on its website today at http://go.usa.gov/mc8d.  


This Final Rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle or propose to handle HCPs.  It goes into effect in 45 days (October 14, 2014).


The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V.  (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.)  HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. “Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart, “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

 

When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II.  The current analysis of HCPs by HHS and the DEA shows they have a high potential for abuse, and abuse may lead to severe psychological or physical dependence.  Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential.  The many findings by the DEA and HHS and the data that support these findings are presented in detail in the Final Rule on the website.  Data and surveys from multiple federal and non-federal agencies show the extent of abuse of HCPs.  For example, Monitoring the Future surveys of 8th, 10th, and 12th graders from 2002 to 2011 found that twice as many high school seniors used Vicodin®, an HCP, nonmedically as used OxyContin®, a Schedule II substance, which is more tightly controlled.
In general, substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations.  Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party.  (Detailed information on the scheduling and rescheduling process can be found beginning on page 8 of Drugs of Abuse on the DEA’s website at http://www.justice.gov/dea/pr/multimedia-library/publications/drug_of_abuse.pdf.)

 

Supervising Physician’s New Requirement for Approval of Permit

Effective October 1st, all physicians submitting applications for the one-time supervising physician (SP) credential must successfully complete a short online course on the subject of Physician Assistant Supervision to demonstrate their knowledge of the rules and regulations.  The course is entitled “Supervising Physician Assistants” and can be accessed via the Online Education section on the Board’s homepage. 

 

Clarification to Comments re PA's

Louisiana State Board of Medical Examiners provides clarification to comments concerning regulations for physician assistans. See here.

 

Recent Law/Rule Changes Related to Prescriptions and PMP

The Board would like to make all practitioners authorized to prescribe controlled substances aware of recent  changes to the classifications of certain controlled substances and changes in the rules regarding access to the PMP.

 

1. Effective August 1, 2014, La. Rev. Stat. §40:964 D.(b) was amended to classify Soma as a Schedule II CDS in LA.

2. Effective Aug 18, 2014, the DEA has classified Tramadol as a SCH IV, CDS.

3. In August 2013, prescribers were authorized by La. Rev. Stat §40:1007.E.(1) to select delegates to access the PMP, as defined by rule, (emphasis added.)  The rules are now effective as of June 20, 2014. 

 

Perfusionists Rules

The Board has submitted a final report to the Louisiana Legislature in connection with the proposed adoption of administrative Rules governing General, Licensure and Certification, and practice of Perfusionists, LAC 46:XLV .251-255, .2701-2751, .5801-5811, which appeared in February 20, 2014 edition of the Louisiana Register.

The use of Telemedicine Technologies with Established Patient

The use of Telemedicine Technologies with Established Patients. In recent months, the Board has received inquiries from Louisiana licensed physicians engaged in the practice of medicine within this state who would like to use telemedicine technologies to communicate with patients who have been seen in their office between regularly schedule office visits but are unable to do so in strict compliance with the Board’s Telemedicine Rules.[1]  Because these communications typically take place when the patient is at home, a licensed health care provider is not present in the room with the patient to assist with the interaction.[2]

 

The Board recognizes that telemedicine technologies are rapidly advancing and continue to provide opportunities for improving the delivery and accessibility of quality healthcare to patients in this state.  In an office practice particularly, telemedicine technologies can enhance medical care by facilitating communication between physicians and their patients as they monitor chronic conditions, assess responses to new medications or therapies, review and discuss the results of diagnostic studies or consultations, or provide health care information to clarify medical advice.  In the Board’s view, physician use of telemedicine technologies in this manner is wholly consistent with the manner that physicians have typically utilized telephone or email to follow-up with their established patients. 

 

In consideration of the above, and in line with our on-going desire to facilitate the use of telemedicine technologies in the delivery of medical care, the Board wishes to advise physicians that the use of telemedicine technologies[3] to communicate with established patients between regularly schedule office visits will not, for purposes of enforcement, be considered telemedicine provided the following conditions are observed: (i) such interactions may only be used with an established patient (e.g., those with whom there has been a face-to-face office visit); (ii) the patient’s medical record is available to the physician; (iii) such interactions would not be used to address any condition that would require a physical examination; (iv) the patient maintains the option of being seen by the physician if the patient or physician believes that the complaints warrant a face-to-face interaction and/or physical examination; and (v) such interactions shall not be used to prescribe controlled substances.

 

In due course, the Board plans to undertake a rule-making effort to amend its Telemedicine Rules consistent with this advice.

 

Louisiana State Board of Medical Examiners




[1]LAC 46:XLV.7501-7521.

[2]As with the law, the Board’s rules require that ‘A licensed health care professional who can adequately and accurately assist with the requirements of §§7509 and 7511 of this Chapter shall be in the examination room with the patient at all times that the patient is receiving telemedicine services.’ La. Rev. Stat. §37:1271B(2); LAC 46:XLV.7407B.

[3]The Board reminds physicians of their obligation to insure that all patient-physician interactions are conducted in a manner that is consistent with state and federal requirements governing patient privacy and security.

 

PT Dry Needling

PT Dry Needling.  The Board has recently received inquiries and complaints from physicians in this state concerning the appropriateness of physical therapists (PTs) performing dry needling on their patients.  Some have advised that this procedure was performed without the referring physician’s knowledge or direction and in one instance the physician reported that due to the patient’s condition dry needling was contraindicated.  The question has also been raised as to whether the referring physician could bear some liability in the event of a complication.

 

Given that dry needling is a form of “treatment” it must be preceded by a prescription or referral of a physician or other authorized provider.[1]  In our on-going discussions with the Louisiana Physical Therapy Board, and our consideration of this issue generally, it has become apparent that PTs believe that they are authorize to perform this procedure under a general order of a physician to “evaluate and treat.” 

 

In the Board’s view, dry needling constitutes the practice of medicine and should only be performed by a physician or an acupuncturist’s assistant.  While the Board is considering how this issue might best be addressed, we take this opportunity to alert physicians that unless specifically excluded from a physical therapy referral, it is possible that dry needling may be performed on your patient.  Therefore, if you do not intend to authorize dry needling on a patient for whom you prescribe physical therapy services you will need to specifically exclude it from your referral.

 

Louisiana State Board of Medical Examiners

 


[1]La. Rev. Stat.§37:2418B.

 

 

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