Title of Regulation: 18VAC105-20. Regulations Governing the Practice of Optometry (amending 18VAC105-20-5, 18VAC105-20-70; adding 18VAC105-20-48, 18VAC105-20-49).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

February 8, 2019 - 9:05 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 200, Conference Center, Henrico, VA

Public Comment Deadline: April 5, 2019.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Optometry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4508, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Optometry the authority to promulgate regulations to administer the regulatory system.

Purpose: The opioid addiction crisis was declared to be a public health emergency in Virginia on November 21, 2016. In the declaration announcement, it was noted that by the end of 2016, the numbers of fatal opioid overdose deaths were expected to increase by 77%, compared to five years ago. In 2014, for the first time in Virginia, more people died from opioid overdoses than fatal car accidents. Emergency department visits for heroin overdose for January through September 2016 increased 89%, compared to the same nine-month period in 2015. In the first half of 2016, the total number of fatal drug overdoses in Virginia increased 35%, when compared to the same time period in 2015, and in 2013, fatal drug overdoses became the number one cause of unnatural death. In addition to overdoses from opioids, overdoses from heroin and other illicit drugs continue to soar. Many of those who become addicted to heroin started with an addiction to prescription drugs. In order to stem the tide of addiction, practitioners need enforceable rules for proper prescribing of drugs containing an opioid in the treatment of pain to protect the public health and safety.

The purpose of the regulatory action is the establishment of requirements for prescribing controlled substances containing opioids to address the overdose and addiction crisis in the Commonwealth. The goal is to provide optometrists with definitive rules to follow so that they may feel more assured of their ability to treat pain in an appropriate manner to avoid under-prescribing or over-prescribing.

Substance: The proposed provisions for the management of acute pain includes requirements for the evaluation of the patient, limitations on quantity and dosage, and recordkeeping. The proposed provisions for the management of chronic pain require either referral to a pain management specialist or adherence to regulations of the Board of Medicine.

Issues: The primary advantage to the public is a reduction in the amount of opioid medication that is available in Virginia communities. A limitation on the quantity of opioids that may be prescribed should result in fewer people becoming addicted to pain medication, which sometimes leads them to turn to heroin and other illicit drugs. There are no disadvantages to the public; the only covered substance optometrists prescribe is hydrocodone with acetaminophen, so the proposed regulations will not have a negative impact on such prescribing.

The primary advantage to the Commonwealth is the potential reduction in the number of persons addicted to opioids and deaths from overdoses, and there are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Optometry (Board) proposes to promulgate provisions for optometrists prescribing controlled substances containing opioids.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs.

Estimated Economic Impact.

General Opioid Background: The Department of Health Professions reports that in 2014, for the first time in Virginia, more people died from opioid overdoses than from fatal car accidents. Emergency department visits for heroin overdoses for January to September 2016 increased 89 percent, compared to the same nine-month period in 2015. In the first half of 2016, the total number of fatal drug overdoses in Virginia increased 35 percent, when compared to the same period in 2015, and in 2013, fatal drug overdoses became the number one cause of unnatural death. Many of those who become addicted to heroin started with an addiction to prescription drugs. In order to stem the tide of addiction, the Board believes practitioners need enforceable rules for proper prescribing of drugs containing opioid in treatment of pain to protect the public health and safety.

Optometry Background: The Regulations of the Virginia Board of Optometry include certification for qualified optometrists to treat diseases and abnormal conditions of the human eye and its adnexa and to prescribe and administer certain therapeutic pharmaceutical agents (TPA). The certification is referred to as TPA certification. The TPA that a TPA-certified optometrist may prescribe include a limited number of controlled substances containing opioids. The current regulation does not include any requirements that specifically pertain to opioids.

Proposal: The proposed regulation includes the following provisions:

• A TPA-certified optometrist must consider nonpharmacologic and non-opioid treatment prior to prescribing opioid treatment for patients with acute pain.¹

• Prior to prescribing an opioid for acute pain, the TPA-certified optometrist must perform a health history and physical examination appropriate to the complaint, query the Prescription Monitoring Program (PMP) as set forth in § 54.1-2522.1 of the Code of Virginia, and conduct an assessment of the patient's history and risk of substance abuse.

• When prescribing an opioid, the practitioner must prescribe the lowest effective dose for the fewest number of days, not to exceed a seven-day supply as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the patient record.

• The optometrist must carefully consider and document in the patient record the reasons to exceed the equivalent of 50 morphine milligrams per day.

• Naloxone shall be considered for patients when risk factors of prior overdose, substance abuse, or concomitant benzodiazepine are present.

• If another prescription for an opioid is to be written beyond seven days, the patient must be reevaluated, the need for continued prescribing must be documented in the patient record, and the optometrist must check the patient's prescription history in the PMP.

• The patient record must include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan, and the medication prescribed (including date, type, dosage, strength, and quantity prescribed).

• Due to a higher risk of fatal overdose when opioids are prescribed for a patient also taking benzodiazepines, sedative hypnotics, tramadol, or carisoprodol, a TPA-certified optometrist shall only co-prescribe these substances when there are extenuating circumstances and shall document in the patient record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

• If an optometrist treats a patient for whom an opioid prescription is necessary for chronic pain,² the licensee shall either: (1) refer the patient to a medical doctor who is a pain management specialist, or (2) comply with regulations of the Board of Medicine, 18VAC85-21-60 through 18VAC85-21-120, if choosing to manage the chronic pain with an opioid prescription.

• Definitions for "acute pain," "chronic pain," "controlled substance," and the "Prescription Monitoring Program" have been added to the regulation.

Analysis: The proposed provisions increase time costs for both TPA-certified optometrists and patients, and recordkeeping costs for the optometry practice. By effectively requiring additional office visits for opioid treatment beyond seven days, fees paid by patients and/or their insurance carriers would increase as well. By discouraging the use of opioids, the proposed provisions may result in some patients experiencing more pain or being in pain for more time than without the proposed requirements.

The proposed requirements are designed, of course, to help reduce opioid addiction and opioid-related deaths. It is not known how successful the provisions would be in achieving those goals. To the extent that the proposals would be successful in reducing opioid addiction and opioid-related deaths, the benefits likely would exceed the costs. If the provisions are ineffective in reducing opioid addiction and opioid-related deaths, then the costs would exceed the benefits.

Businesses and Entities Affected. The proposed amendments potentially affect the 1,669 TPA-certified optometrists licensed in Virginia, and their practices.³ All or most of their practices would qualify as small businesses.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments moderately increase time and recordkeeping costs for optometry practices.

Alternative Method that Minimizes Adverse Impact. There is not an apparent alternative method that achieves the same policy goal at a lower cost.

Adverse Impacts:

Businesses. The proposed amendments moderately increase time and recordkeeping costs for optometry practices.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments may result in some patients experiencing more pain or being in pain for more time than without the proposed requirements.

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¹Acute pain is defined as "pain that occurs within the normal course of a disease or condition for which controlled substances may be prescribed for no more than three months."

²Chronic pain is defined as "nonmalignant pain that goes beyond the normal course of a disease or condition for which controlled substances may be prescribed for a period greater than three months."

³Data source: Department of Health Professions

Agency's Response to Economic Impact Analysis: The Board of Optometry does not fully concur with the analysis of the Department of Planning and Budget on proposed regulations for 18VAC105-20, Regulations Governing the Practice of Optometry, relating to the prescribing of opioids.

The analysis states that the proposed provisions "increase time costs for both TPA-certified optometrists and patients and recordkeeping costs for the optometry practice." Optometrists on the board uniformly agreed that seven days following an optometric treatment, a patient should not be experiencing pain significant enough to continue prescribing opioids. If that is the case, the current standard of care would necessitate that the patient be rechecked to assess the problem, and a referral for medical care may be warranted. Therefore, the proposed regulations for opioid prescribing are consistent with current practices and do not represent an increase in costs to the practice or the patient.

Summary:

Proposed regulations for optometrists prescribing controlled substances include (i) provisions for the management of acute pain that require prescribing a dosage not to exceed seven days and include requirements for the evaluation of the patient and limitations on quantity; (ii) requirements for prescribing an opioid beyond seven days to include a reevaluation of the patient, check of the Prescription Monitoring Program, and specific information in the patient record; and (iii) if a TPA-certified optometrist finds an opioid prescription for chronic pain is necessary, a requirement to refer the patient to a physician or comply with Board of Medicine regulations for managing chronic pain. The proposed amendments replace emergency regulations currently in effect.

18VAC105-20-5. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute pain" means pain that occurs within the normal course of a disease or condition for which controlled substances may be prescribed for no more than three months.

"Board" means the Virginia Board of Optometry.

"Chronic pain" means nonmalignant pain that goes beyond the normal course of a disease or condition for which controlled substances may be prescribed for a period greater than three months.

"Controlled substance" means drugs listed in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) in Schedules II through V.

"MME" means morphine milligram equivalent.

"NBEO" means the National Board of Examiners in Optometry.

"Prescription Monitoring Program" means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

"TPA" means therapeutic pharmaceutical agents.

"TPA certification" means authorization by the Virginia Board of Optometry for an optometrist to treat diseases and abnormal conditions of the human eye and its adnexa and to prescribe and administer certain therapeutic pharmaceutical agents.

18VAC105-20-48. Prescribing an opioid for acute pain.

A. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. If an opioid is considered necessary for the treatment of acute pain, a TPA-certified optometrist shall follow the regulations for prescribing and treating with opioids.

B. Prior to initiating treatment with a controlled substance containing an opioid for a complaint of acute pain, a TPA-certified optometrist shall perform a health history and physical examination appropriate to the complaint, query the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia, and conduct an assessment of the patient's history and risk of substance abuse.

C. Initiation of opioid treatment for all patients with acute pain shall include the following:

1. A prescription for an opioid shall be a short-acting opioid in the lowest effective dose for the fewest number of days, not to exceed seven days as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the patient record.

2. A TPA-certified optometrist shall carefully consider and document in the patient record the reasons to exceed 50 MME per day.

3. A prescription for naloxone should be considered for any patient when any risk factor of prior overdose, substance misuse, or concomitant use of benzodiazepine is present.

D. If another prescription for an opioid is to be written beyond seven days, a TPA-certified optometrist shall:

1. Reevaluate the patient and document in the patient record the continued need for an opioid prescription; and

2. Check the patient's prescription history in the Prescription Monitoring Program.

E. The patient record shall include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan, and the medication prescribed (including date, type, dosage, strength, and quantity prescribed).

F. Due to a higher risk of fatal overdose when opioids are prescribed for a patient also taking benzodiazepines, sedative hypnotics, tramadol, or carisoprodol, a TPA-certified optometrist shall only co-prescribe these substances when there are extenuating circumstances and shall document in the patient record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

18VAC105-20-49. Prescribing an opioid for chronic pain.

If a TPA-certified optometrist treats a patient for whom an opioid prescription is necessary for chronic pain, he shall either:

1. Refer the patient to a doctor of medicine or osteopathic medicine who is a pain management specialist; or

2. Comply with regulations of the Board of Medicine, 18VAC85-21-60 through 18VAC85-21-120, if he chooses to manage the chronic pain with an opioid prescription.

18VAC105-20-70. Requirements for continuing education.

A. Each license renewal shall be conditioned upon submission of evidence to the board of 20 hours of continuing education taken by the applicant during the previous license period. A licensee who completes more than 20 hours of continuing education in a year shall be allowed to carry forward up to 10 hours of continuing education for the next annual renewal cycle.

1. The 20 hours may include up to two hours of recordkeeping for patient care, including coding for diagnostic and treatment devices and procedures or the management of an optometry practice, provided that such courses are not primarily for the purpose of augmenting the licensee's income or promoting the sale of specific instruments or products.

2. For optometrists who are certified in the use of therapeutic pharmaceutical agents, at least 10 of the required continuing education hours shall be in the areas of ocular and general pharmacology,; diagnosis and treatment of the human eye and its adnexa, including treatment with new pharmaceutical agents, or; new or advanced clinical devices, techniques, modalities, or procedures; or pain management.

3. At least 10 hours shall be obtained through real-time, interactive activities, including in-person or electronic presentations, provided that during the course of the presentation, the licensee and the lecturer may communicate with one another.

4. A licensee may also include up to two hours of training in cardiopulmonary resuscitation (CPR).

5. Two hours of the 20 hours required for annual renewal may be satisfied through delivery of professional services, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services. One hour of continuing education may be credited for three hours of providing such volunteer services, as documented by the health department or free clinic.

B. Each licensee shall attest to fulfillment of continuing education hours on the required annual renewal form. All continuing education shall be completed prior to the renewal deadline unless an extension or waiver has been granted by the Continuing Education Committee. A request for an extension or waiver shall be received prior to the renewal deadline of each year.

C. All continuing education courses shall be offered by an approved sponsor or accrediting body listed in subsection G of this section. Courses that are not approved by a board-recognized sponsor in advance shall not be accepted for continuing education credit. For those courses that have a post-test requirement, credit will only be given if the optometrist receives a passing grade as indicated on the certificate.

D. Licensees shall maintain continuing education documentation for a period of not less than three years. A random audit of licensees may be conducted by the board which will require that the licensee provide evidence substantiating participation in required continuing education courses within 14 days of the renewal date.

E. Documentation of hours shall clearly indicate the name of the continuing education provider and its affiliation with an approved sponsor or accrediting body as listed in subsection G of this section. Documents that do not have the required information shall not be accepted by the board for determining compliance. Correspondence courses shall be credited according to the date on which the post-test was graded as indicated on the continuing education certificate.

F. A licensee shall be exempt from the continuing competency requirements for the first renewal following the date of initial licensure by examination in Virginia.

G. An approved continuing education course or program, whether offered by correspondence, electronically, or in person, shall be sponsored, accredited, or approved by one of the following:

1. The American Optometric Association and its constituent organizations.

2. Regional optometric organizations.

3. State optometric associations and their affiliate local societies.

4. Accredited colleges and universities providing optometric or medical courses.

5. The American Academy of Optometry and its affiliate organizations.

6. The American Academy of Ophthalmology and its affiliate organizations.

7. The Virginia Academy of Optometry.

8. Council on Optometric Practitioner Education (COPE).

9. State or federal governmental agencies.

10. College of Optometrists in Vision Development.

11. The Accreditation Council for Continuing Medical Education of the American Medical Association for Category 1 credit.

12. Providers of training in cardiopulmonary resuscitation (CPR).

13. Optometric Extension Program.

H. In order to maintain approval for continuing education courses, providers or sponsors shall:

1. Provide a certificate of attendance that shows the date, location, presenter or lecturer, content hours of the course, and contact information of the provider or sponsor for verification. The certificate of attendance shall be based on verification by the sponsor of the attendee's presence throughout the course, either provided by a post-test or by a designated monitor.

2. Maintain documentation about the course and attendance for at least three years following its completion.

I. Falsifying the attestation of compliance with continuing education on a renewal form or failure to comply with continuing education requirements may subject a licensee to disciplinary action by the board, consistent with § 54.1-3215 of the Code of Virginia.