IMPORTANT NOTICE OF EMERGENCY RULE FILING 

On Friday June 8, 2012, the Board filed a new emergency rule 11 CSR 10, PRACTITIONER REQUIREMENTS FOR ACCESSING THE WEST VIRGINIA CONTROLLED SUBSTANCES MONITORING PROGRAM DATABASE.  This emergency rule filing is required by a new law passed in the 2012 Legislative Session, at West Virginia Code § 60A-9-5a.  The Secretary of State will decide if an emergency exists, in which case the rule will then be effective for a maximum of fifteen (15) months.  We will tell you immediately when the Secretary of State makes the ruling.

Please acquaint yourselves with the provisions of 11 CSR 10 NOW, so that you are prepared.  Note that the rule requires at 3.1. that “prior to the initial provision of any pain-relieving controlled substance as part of a course of treatment for chronic nonmalignant pain to any patient not considered by a practitioner to be suffering from a terminal illness, a practitioner shall apply for and receive capability to access the CSMP for purposes of compliance with this rule.”  CSMP is the Controlled Substances Monitoring Program repository and database.

The Board has also filed 11 CSR 10 as a proposed Legislative rule, as required by law.  There is a comment period on the proposed Legislative Rule ending July 20, 2012 at 4:30 p.m.

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The Governor signed into law SB 437 on March 29, 2012.  This was the biggest healthcare related piece of legislation of the Session and is the most comprehensive approach taken in recent history on addressing the epidemics of prescription drug diversion and substance abuse.  The bill was offered by Governor Tomblin following regional meetings held around the state including stakeholders from all sides of the issue.  The bill was structured upon the recommendations issued last fall by the WVSMA in our report “Physician Leadership in Addressing Prescription Drug Diversion”. 

The bill contains five main areas of focus:
• Implements additional regulation of opioid treatment centers (Methadone Clinics);
•  Establishes licensing and regulation of Chronic Pain Clinics;
• Establishes review capabilities of the Controlled Substances Database under the Board of Pharmacy to flag abnormal or unusual usage patterns of controlled substances by patients and unusual prescribing or dispensing patterns by licensed practitioners;
• Implements a requirement for continued education for physicians and other prescribers, dispensers and persons who administer controlled substances; and,
• Regulation of pharmacies sale of pseudoephedrine.

The following is a brief synopsis of the law. For a detailed synopsis please visit www.wvsma.com:

1. Methadone clinics are subject to monitoring by the DHHR; additional education and safety training for employees; and must follow national guidelines that include a recovery model in the individualized treatment of care among other regulations. 

2. Requires licensure of “pain management clinics” which are defined as all privately owned pain management clinics: (1) Where in any month more than fifty percent of patients of the prescribers or dispensers are prescribed or dispensed opioids or other controlled substances specified in rules for chronic pain resulting from non-malignant conditions; (2) The facility meets any other identifying criteria established by DHHR rule.
Chronic pain is defined as: “pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months. Chronic pain does not include pain associated with a terminal condition or with a progressive disease that, in the normal course of progression, may reasonably be expected to result in a terminal condition.”
There is a lengthy list of exemptions from this regulation including all practices associated with medical schools and hospitals, hospice, nursing homes and ambulatory care facilities. There are many specific operational requirements for the clinics set in law.

3. The 2 hours of CME in “end of life care and pain management” is removed from law. A new biennial requirement is established for “drug diversion training” and “best practices for prescribing of controlled substances training” for prescribers, dispensers and those who administer controlled substances.

4. Prescribing a combination of buprenorphine and naloxone to treat opioid addiction is limited to sublingual film unless the film is clinically contraindicated.

5. An Advisory Board of physicians and pharmacists is established under the Board of Pharmacy to review the controlled substances database and “develop, implement, and recommend parameters to be used in identifying abnormal or unusual usage patterns of patients in the state…” A Database Review Committee of physicians, prosecutors and a pharmacist is established to make determinations on specific unusual prescribing or dispensing patterns.

6. Prescribers and dispensers granted immunity for reporting suspected doctor shoppers.

7. All prescribers and dispensers are required to check the controlled substances database upon initially prescribing or dispensing a pain relieving controlled substance to a patient for chronic nonmalignant, non-terminal pain and annually thereafter.

8. Felony for unauthorized use or disclosure of the controlled substances database punishable by imprisonment for 1-5 years or fined $3,000-$10,000, or both.

9. Regulation of the sale pseudoephedrine products at retail pharmacies requiring the use of a Multi-State Real-Time tracking system and limiting the sale to individuals to 3.6g per day, 7.2 grams monthly and 48 grams annually.
 

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