Info about state or federal regulatory proceedings

Jonathon Kimes 5-13

Prescription Monitoring Requirements

With the recent flurry of activity regarding our Sunset Bill, as well as the passage of the Pharmacy Board Sunset Bill, there has been some confusion as to the requirements for dentists and the Prescription Monitoring Program (PMP). The PMP actually has been in place for some time. From the Pharmacy Board website:

The Texas Prescription Monitoring Program (PMP) collects prescription data on ALL Schedule II, III, IV and V controlled substances dispensed by a pharmacy in Texas or to a Texas resident from a pharmacy located in another state. The Texas Prescription Program (TPP) was created by the 67th Texas Legislature in 1981 becoming effective January 1, 1982, to monitor Schedule II controlled substance prescriptions. Effective September 1, 2008, the Texas Legislature expanded the TPP to include the monitoring of Schedule III through V controlled substance prescriptions. Beginning September 1, 2016, the PMP transferred from the Texas Department of Public Safety to the Texas State Board of Pharmacy. Although controlled substances have valid medical uses, they also have potential for abuse and addiction. Diversion of prescription drugs is a significant abuse problem, and this program was created to be an efficient, cost effective tool for investing and preventing drug diversion. Federal controls monitor the substances from manufacture through distribution to retail facilities. The program seeks to educate and control misuse by following controlled substances to the ultimate user. The PMP may be used by practitioners and pharmacists to verify their own records and inquire about patients. In addition, the program may be used to generate and disseminate information regarding prescription trends. Pharmacies that dispense Schedule II, III, IV, and V are required to report the information directly to the Texas State Board of Pharmacy’s contracted vendor, APPRISS. Prescription data is reported by the prescriber’s Federal (DEA) number. Prescribers and pharmacies are required by statute to have a current Federal (DEA) registration in order to possess, administer, prescribe or dispense controlled substances. Pharmacies are required to submit data to the PMP no later than the 7th day after the prescription is completely filled. However, pharmacies may submit more frequently. Pharmacies, who fail to report, are subject to an administrative, civil, or criminal penalty. Access to the prescription data is statutorily restricted. The information is available to practitioners and pharmacies who are inquiring about their own prescribing or dispensing history on their patients. State regulatory boards have access as well. A person who knowingly gives, permits or obtains unauthorized access to this information, is subject to criminal penalty.

The initial recommendation from the Sunset Committee was to require dentists to use PMP to query each patient, each time, a controlled substance is prescribed to help curb opioid abuse tendencies. This language was never introduced into the Dental Board Sunset Bill, but it WAS PASSED with the Pharmacy Board Sunset Bill. According to HB 2561 (Pharmacy Board Sunset Bill) Sec.481.0764 of the Texas Health and Safety Code shall be amended to read:

 

DUTIES OF PRESCRIBERS, PHARMACISTS, AND RELATED HEALTH CARE PRACTITIONERS.

(a) A person authorized to receive information under Section 481.076(a)(5), other than a veterinarian, shall access that information with respect to the patient before prescribing or dispensing opioids, benzodiazepines, barbiturates, or carisoprodol.

(b)A person authorized to receive information under Section 481.076(a)(5) may access that information with respect to the patient before prescribing or dispensing any controlled substance.

This “person” the new law refers to is you. The language is slightly vague, as it doesn’t specifically mention the PMP, but the intent is clear. If you write a prescription for the above-mentioned drugs, you will be required to use the PMP to query the patient for each RX. The good news is the implementation of this new law has been pushed back to September 1, 2019. One thing that merits mention; the information contained in the PMP database is sensitive and not public record, therefore you must use the information only as intended or you could face criminal penalty. DO NOT get nosy and search for the prescription patterns of your ex, your neighbor, your children’s teacher, etc. Although we have access to this information, this would be considered misuse…the fall out could be severe.
There are some recent TSBDE rule changes that are currently in effect as of December 2016

Texas Administrative Code, Title 22, Part 5, Chapter 111

Each dentist who is permitted by the Drug Enforcement Agency to prescribe controlled substances shall complete every three years a minimum of two hours of continuing education in the abuse and misuse of controlled substances, opioid prescription practices, and/or pharmacology. This continuing education may be utilized to fill the continuing education requirements of annual renewal.

Each dentist who is permitted by the Drug Enforcement Agency to prescribe controlled substances shall annually conduct a minimum of one self-query regarding the issuance of controlled substance through the Prescription Monitoring Program of the Texas State Board of Pharmacy.

Access to the PMP is available through the Pharmacy Board website (https://www.pharmacy.texas.gov/PMP/)

By Jonathon R. Kimes, DDS
Editor, CADS

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The Root April 2017

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January 23-27 2017 The Root

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Click here to see the January 23-27 2017 issue of The Root, your source for dental legislation, regulation, and advocacy. This periodical published by the Texas Dental Association (TDA) will keep you up-to-date on regulatory and legislative issues facing dentistry.

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The Root January 2017

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Editor’s Corner November 2016

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October 2016 – The Root

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Jonathon Kimes 5-13

Editor’s Report October 2016

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Sunset Review – Part III

The latest info to come out of the Sunset Advisory Commission regarding our state Dental Board is the “Sunset Staff Report with Commission Decisions.”  This report contains the final decisions of the Commission which will form the basis of the agency’s Sunset Bill during Legislative Session, which begins January 10, 2017.

Issue 1 – The Unusually Large Dental Board Inappropriately Focuses on Issues Unrelated to Its Public Safety Mission.

The original recommendations were for a reduction in the total size of the board from 15 to nine, with a reduction in the number of dentist board members from eight to four.  The final recommendation was somewhat of a compromise, recommending a reduction to a total size of 11 members, including six dentists, three hygienists, and two public members.

The Board will also be directed to create a more detailed system for stakeholder input as well as informal settlement hearings, both of which aim at increasing the Boards concentration on public safety

Issue 2 – State Regulation of Dental Assistants Is Unnecessary to Ensure Public Protection and Is an Inefficient Use of Resources.

Again a compromise between current regulation and the original recommendation.  The final decision, in lieu of the original recommendation to discontinue the licensure of dental assistants, is to combine the board’s four dental assistant certificate programs into one registration for dental assistants.  This one registration will cover radiology, nitrous monitoring, sealants, and coronal polishing.  Whether or not current dental assisting licensees with be grandfathered in or will be required to show proof of CE or take a new examination remains unclear.  Dental assistant registrations will be renewed biennially.

Issue 3 – The Board Lacks Key Enforcement Tools to Ensure Dentists Are Prepared to Respond to Increasing Anesthesia Concerns.

The Board will be authorized to conduct inspections of dentists administering parenteral sedation in office settings.  The Board will also establish four levels of sedation permits, with appropriate education and standards for each, with an additional limitation to be placed on pediatric and high-risk patients.

Dentists with one or more anesthesia permits will also be required to maintain adequate written emergency plans, and will have requirements for necessary equipment and drugs prior to administering sedation/anesthesia.

A nine-member board-appointed standing Advisory Committee on Dental Anesthesia will be created to advise the Board on the development and revision of rules related to dental sedation and anesthesia.  The board will track and report anesthesia-related data and to make publicly available on its website aggregate enforcement data by fiscal year and type of license.

The Board is directed to define portability, methods to obtain a portability permit, and establish advanced didactic and clinical training requirements for the permit.

Issue 4 – Key Elements of the State Board of Dental Examiners’ Licensing and Regulatory Functions Do Not Conform to Common Licensing Standards.

The Board will be required to monitor licensees for adverse licensure actions, and be allowed (i.e. encouraged) to deny applications to renew a license if an applicant is not compliant with a board order, be allowed to require evaluations of licensees suspected of being impaired, and be allowed to remove unnecessary qualifications required of applicants for licensure or registration.

There is also a recommendation to stagger registration renewals, but the details have not been given yet.  Maybe every two years?

Previous recommendation didn’t address any prescription drug issues, but the final decisions do contain a Prescription Monitoring Program.

As of September 1, 2018, dentists will be required to search the Prescription Monitoring Program and review a patient’s prescription history before prescribing opioids, benzodiazepines, barbiturates, or carisoprodol.  A dentist who does not check the program before prescribing these drugs will be subject to disciplinary action by the Dental Board.

The Board will be required to query the Prescription Monitoring Program on a periodic basis for potentially harmful prescribing patterns among its licensees.  The Board will work with the Pharmacy Board to establish potentially harmful prescribing patterns that the Board should monitor by querying the database for dentists who meet those prescribing patterns.  Based on the information obtained from the Prescription Monitoring Program, the Board will be authorized to open a complaint for possible non-therapeutic prescribing.

By Jonathon R. Kimes, DDS
Editor, CADS

 

 

 

 

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Editor’s Corner September 2016

Jonathon Kimes 5-13

Sales and Use Tax

As a young(er) dentist, I learn something almost every day about practice ownership.  More often than not, it is some obscure regulation and I often have no idea if I’ve been doing the thing correctly or not, and for how long!  The issue of sales tax and use tax was recently brought to my attention, and I quickly realized that not only was I unsure of my own practice’s compliance, but I was unsure of even the true meaning of any of it.

For those unaware, sales tax is basically a tax on the sale of goods or certain services and is paid by the customer to the vendor and then remitted to the state by the vendor.  Use tax, in the case of a dental practice, is tax remitted to the state by the dentist when he or she purchased a taxable item and didn’t pay sales tax on it.  Fortunately for the average dental practice, almost everything we “sell” is not taxable.  According to the Texas Administrative Code (TAC),

“Sales or use tax is not due on the sale, lease, or rental of medical equipment meeting the definition of a dental device. Sales tax is not due on replacement parts designed specifically for such devices and appliances. A dental device is defined as an artificial replacement of one or more teeth or a dental appliance worn on the teeth to correct irregularities of growth or position. The term dental device does not include toothbrushes, toothpaste, dental floss, mouth mirrors, or other devices used to prevent cavities or plaque build-up or removal.”

Drugs and medicines are also exempt from sales and use taxes, as long as they contain a FDA required “Drug Fact” label.  In the case of a dental office, this is where things can get tricky.  Non-fluoride toothpaste, for example, is taxable as defined as a dental device, whereas fluoride toothpaste is tax exempt as defined by a Drug or Medicine.  Whitening gel is taxable, unless it contains a FDA label stating that it “mitigates, treats, or prevents disease.”

The TDA has a nice article outlining some of the basic items that dentists routinely buy and sell and the taxable status of those items.  The article can be found on the TDA website, TDA Today archives, April 2014.  You can also use the following:

https://issuu.com/texas_dental_association/docs/140431_tda_today_nl_apr14

If you’re selling toothbrushes, you should be collecting sales tax.  Also, check that your vendors are charging you sales tax on taxable dental equipment, or you’re also on the hook for the use tax!  The final say is found with the Texas Comptroller and your accountant.  Visit comptroller.texas.gov for the latest information.

By Jonathon R. Kimes, DDS
Editor, CADS

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The Root, June 2016

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