Legislative Changes Affect Opioid Prescribing

During the 2018 regular session of the West Virginia Legislature, Senate Bill 273, commonly referred to as the Opioid Reduction Act, was enacted with the goal of curbing the opioid crisis. Legislators revisited the law during the 2019 session and passed House Bill 2768, which makes several revisions to clarify the original language.

The following is a quick reference guide to the 2019 revisions/amendments to the Opioid Reduction Act contained in HB 2768. The new law:

• Clarifies that the Opioid Reduction Act applies only to Schedule II opioid drugs;
• Clarifies that the Opioid Reduction Act does not apply to a patient being prescribed, or ordered, any medication in an inpatient setting at a hospital;
• Clarifies that a prescription for a four-day supply of a Schedule II opioid drug issued to a patient in the emergency room for outpatient use is not an initial prescription;
• Clarifies the nature/scope of required physical examinations for patients prescribed Schedule II opioid drugs, providing that, “[t]he physical exam should be relevant to the specific diagnosis and course of treatment, and should assess whether the course of treatment would be safe and effective for the patient;”
• Clarifies that a narcotics contract is not required until the issuance of a third prescription for a Schedule II opioid drug and adds a new provision that a narcotics contract must include whether another physician is approved to prescribe to the patient;
• Clarifies that a pharmacist is not responsible for enforcing the requirements of the Opioid Reduction Act;
• Removes the prohibition against issuance of a subsequent Schedule II opioid drug prescription less than six days after the initial prescription; and,
• Amends the Opioid Reduction Act in circumstances when a practitioner acquires a patient after Jan. 1, 2018 who is currently being prescribed a Schedule II opioid drug from another practitioner, at a different practice or practice group. As amended, the first Schedule II opioid drug prescription issued by the new practitioner to the acquired patient is considered an initial prescription, such that the prescription must be limited to a seven-day supply, unless the acquiring physician and the previous prescriber are members of the same practice group.

The following is a summary of the notable statutory provisions in the Opioid Reduction Act (ORA), updated to include the 2019 amendments, that impose conditions, limitations and requirements on physicians and podiatrists (collectively referred to hereinafter as “providers”) when prescribing Schedule II opioid drugs. Italicized language below indicates 2019 amendments/revisions to the ORA pursuant to HB 2768.

1. When do the 2019 amendments to the ORA pursuant to HB 2768 become effective?

HB 2768’s amendments to the ORA became effective on June 7, 2019. The original ORA, pursuant to SB 273 in 2018, became effective on June 7, 2018.

2. Are any patients fully exempted from the ORA’s prescribing requirements?

Yes. The ORA does NOT apply to:

1. Prescriptions for patients currently in active treatment for cancer, receiving hospice care from a licensed hospice provider or palliative care provider, or residents of a long-term care facility, or to any medications that are being prescribed for use in the treatment of substance abuse or opioid dependence.

2. An existing provider-patient relationship established before January 1, 2018, where there is an established and current opioid treatment plan reflected in the patient’s medical record.
3. Patients being prescribed, or ordered, any medication in an inpatient setting at a hospital.
4. The prescribing of non-opioid Schedule II controlled substances and opioid medications not classified as Schedule II controlled substances.

3. Excluding Schedule II opioid drugs, how does the ORA impact the prescribing of other controlled substances?

Pursuant to amendments to the ORA by HB 2768, the ORA applies only to the prescribing of Schedule II opioid drugs. The ORA does not apply to the prescribing of non-opioid Schedule II controlled substances or opioid medications not classified as Schedule II controlled substances, such as tramadol.

4. For patients not exempted from the ORA, what are the requirements for prescribing

Schedule II opioid drugs?

1. Prior to prescribing a Schedule II opioid drug
   1. Prior to prescribing a Schedule II opioid drug for the treatment of pain, a provider shall refer or prescribe any of the following treatment alternatives, as is appropriate based on the provider’s clinical judgment and availability of the treatment: physical therapy, occupational therapy, acupuncture, massage therapy, osteopathic manipulation, chronic pain management program and/or chiropractic services. Provided, a provider is not required to prescribe all of the alternative treatment options prior to prescribing a Schedule II opioid drug.
   2. Prior to issuing a prescription for a Schedule II opioid drug, a provider shall: (1) advise the patient regarding the quantity of the Schedule II opioid drug and a patient’s option to fill the prescription in a lesser quantity; and (2) inform the patient of the risks associated with the Schedule II opioid drug prescribed.
   3. Additionally, prior to issuing an initial prescription for a Schedule II opioid drug, a provider shall:
      1. Take and document a thorough medical history, including the patient’s experience with nonopioid medication, nonpharmacological pain management approaches, and substance abuse history;
      2. Conduct and document the results of a physical examination. The physical exam should be relevant to the specific diagnosis and course of treatment, and should assess whether the course of treatment would be safe and effective for the patient;
      3. Develop a treatment plan with particular attention focused on determining the cause of the patient’s pain; and,
      4. Access relevant prescription monitoring information under the Controlled Substance Monitoring Program Database (“CSMP”).
2. Schedule II opioid drug prescription limitations/conditions/requirements
   1. Initial Schedule II opioid drug prescription

A provider may not issue an initial prescription for a Schedule II opioid drug for more than a seven (7) day supply. The prescription shall be for the lowest effective dose which in the medical judgment of the provider is the best course of treatment for this patient and his/her condition.

2. Subsequent Schedule II opioid drug prescription
   1. After issuing the initial prescription for a Schedule II opioid drug, the provider may issue a subsequent prescription if:

1. The subsequent prescription would not be deemed an initial prescription;
2. The provider determines the prescription is necessary and appropriate for patient’s treatment needs and documents the rationale for the subsequent prescription; and
3. The provider determines the subsequent prescription does not present an undue risk of abuse, addiction, or diversion and documents that determination.

**HB 2768 removed the prohibition in SB 273 against issuing a subsequent prescription less than six days after issuing the initial prescription.

     2.  Prior to issuing the subsequent prescription for a Schedule II opioid drug, the provider shall discuss with the patient, or the patient’s parent or guardian, the risks associated with the prescribed drug. The discussion, which must be documented in the patient’s medical record, shall include

1. The risks of addiction and overdose associated with Schedule II opioid drugs and the dangers of taking Schedule II opioid drugs with alcohol, benzodiazepines, and other central nervous system depressants;
2. The reasons why the prescription is necessary;
3. Alternative treatments available; and
4. Risks associated with the use of the Schedule II opioid drug being prescribed, specifically that opioids are highly addictive, even when taken as prescribed, that there is a risk of developing a physical or psychological dependence, and that the risks of taking more opioids than prescribed, or mixing sedatives, benzodiazepines, or alcohol with opioids, can result in fatal respiratory depression

3. Third Prescription for Schedule II Opioid Drug/Ongoing Treatment; Referral to Pain Clinic or Specialist; Narcotics Contract
   1. At the time of the issuance of the third prescription for a Schedule II opioid drug, the provider shall consider referring the patient to a pain clinic or pain specialist. The provider shall discuss the benefits of seeking treatment through a pain clinic/specialist and provide the patient with an understanding of any risk associated by choosing not to pursue that option.
   2. If the patient declines to seek treatment from a pain clinic/specialist and opts to remain a patient of the provider, and the provider continues to prescribe the patient a Schedule II opioid drug, the provider shall:
      1. Document in the medical record that the patient knowingly declined treatment from a pain clinic/specialist;
      2. Review, at a minimum of every three (3) months, the course of treatment, any new information regarding the etiology of the pain and the patient’s progress toward treatment objectives and documents the results of the review;
      3. Assess the patient prior to every renewal to determine whether the patient is experiencing problems associated with physical and psychological dependence and documents the results the assessment; and
      4. Periodically make reasonable efforts, unless clinically contradicted, to either stop the use of the controlled substance, decrease dosage,try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence, and document with specificity the efforts undertaken.

3. Narcotics Contract. In conjunction with the issuance of a third prescription for a Schedule II opioid drug, the patient shall execute a narcotics contract with the prescribing provider. The narcotics contract shall be made a part of the patient’s medical records, and at minimum, shall provide that:
   1. The patient agrees only to obtain scheduled medications from this particular prescribing provider;
   2. The patient agrees to fill the prescriptions at a single pharmacy which includes a pharmacy with more than one location;
   3. The patient agrees to notify the prescribing provider within 72 hours of any emergency where he or she is prescribed scheduled medication;
   4. If the patient fails to honor the narcotics contract, the provider may terminate the physician-patient relationship or continue to treat the patient without prescribing a Schedule II opioid drug for the patient; and
   5. If another physician is approved to prescribe to the patient.

** HB 2768 amended SB 273 to provide that the narcotics contract is not required until the third prescription for the Schedule II opioid drug. SB 273 previously required a narcotics contract when the patient was prescribed a Schedule II opioid drug for greater than a 7-day period.

     4.  HB 2768 clarifies that a pharmacist is not responsible for enforcing the provisions of the ORA, and that the Board of 
          Pharmacy may not discipline a licensee pharmacist if he or she fills a prescription that violates the ORA.

4. Ongoing Physical Exams

A provider is required to conduct and document the results of a physical examination every 90 days for any patient the provider continues to treat with a Schedule II opioid drug. The physical examination should be relevant to the specific diagnosis and course of treatment and should assess whether continuing the course of treatment would be safe and effective for the patient.

**HB 2768 amended SB 273 to clarify that a physical exam every 90 days is required only for patients being prescribed a Schedule II opioid drug. SB 273 previously required a physical exam every 90 days for patients being prescribed any Schedule II controlled substance.

5. CSMP

Providers are still required to assess the CSMP prior to initially prescribing any Schedule II controlled substance, any opioid or any benzodiazepine to a patient who is not suffering from a terminal illness, and at least annually thereafter should the provider continue to treat the patient with a controlled substance.

6. Emergency Room Opioid Prescriptions

When issuing a prescription for a Schedule II opioid drug to an adult patient seeking treatment in an emergency room for outpatient use, a provider may not issue a prescription for more than a four (4) day supply. Provided, that a prescription for a Schedule II opioid drug issued to an adult patient in an emergency room for outpatient use is not considered to be an initial prescription.