In response to the growing nationwide and statewide opioid epidemic, the Virginia Board of Medicine recently adopted new rules to respond to the health danger of opioids and buprenorphine, two medications given for acute and chronic pain. These new regulations are largely based on the CDC Guidelines which came out in 2016. On March 15, 2017, the new regulations were signed by Governor McAuliffe and became active as the law in the Commonwealth of Virginia on July 1, 2017. Additional regulations have been proposed.
The Crisis in Virginia
At least 1400 people died in Virginia in 2016 from Drug Overdoses, with the biggest increases from 2015—175 percent—coming from powerful opioids such as Fentanyl or Carfentanil being laced into street heroin, according to The Virginia Department of Health and law enforcement. While Fentanyl is 10 times more potent than heroin, Carfentanil can be 10,000 times stronger. The drug is generally only prescribed for large animals, such as elephants.
In 2015, opioid overdose deaths accounted for 79% of all overdose deaths in Virginia.
Our Concern as a Workers Comp Law Firm
While this is certainly a horrific crisis that must be dealt with, as a law firm trying to help severely injured workers, we are concerned that the new regulations merely make our clients unwitting victims of regulations designed to combat illegal behavior mostly by young drug addicts and drug dealers. We agree something must be done, but at what cost? When we start hearing our clients— who have just had hardware literally screwed into their bones— complain of excruciating pain, what are we to do when the doctor says, after only 2 weeks, that he can no longer prescribe our client any more pain medication due to these new regulations?
The current approved regulations apply to medical doctors, osteopathic practitioners, podiatrists, and physician assistants. Nurses have adopted similar regulations for nurse practitioners who have the authority to prescribe medications. There are some exceptions. The regulations don’t apply if a person is being treated for pain (chronic or acute) related to cancer and patients who are getting palliative or hospice care for their pain. The regulations also don’t apply if the patient is being treated for pain as a hospital patient, while in a nursing home or in assisted living facility – if that facility uses just one pharmacy source. Medical providers may also be exempt if the patient is part of a federal or state clinical trial.
Summary of the Regulations
Acute pain is defined as pain that happens during the normal course of a disease or condition (such as a workplace injury) or because of surgery where controlled medicines are prescribed for three months or less.
Chronic pain is defined as pain that happens outside of any disease or any condition where controlled medicines can be ordered for more than three months.
Opioids and treatment of acute pain under the new regulations
The regulations provide that prescribers of opioids must:
· First duly consider non-pharmacologic and treatments that don’t involve opioids before prescribing opioids.
· Prescribers must conduct a history and a physical exam, assess the risk of the patient for abuse and conduct a Prescription Monitoring Program query pursuant to the Virginia Code
Various bills and proposals had different conditions for pain medicine prescriptions. The regulations that were passed will became law on July 1, 2017 and will sunset on January 1, 2022 unless further legal moves are made.
Prescribing opioids for acute pain treatment under the regulations
When doctors and others with authority to prescribe opioids do fill out the prescription for opioids, they must start the patient with short-acting opioids and not long-acting drugs because of the concern by the Virginia Board of Medicine that the likelihood of addiction increases with long-acting opioids. The amount given should not be more than a 7-day supply unless there are “extenuating circumstances.” If opioids are given pursuant to surgery, they shouldn’t be prescribed for more than 14 days in a row unless there are “extenuating circumstances.”
The regulations suggest that prescribers review the Centers for Disease Control information on morphine milligram equivalent (“MME”). The regulations provide additional requirements on prescribers on how to handle pain management medicines for acute pain.
If other medications such as benzodiazepines are prescribed along with the opioids, the prescribers must document a “tapering plan” so that the lowest effective does is prescribed. Doctors need to document all the prescriptions for acute pain that they make. The documentation requirements are very strict. Doctors, nurses, and others who are allowed to prescribe opioids can be subject to disciplinary action for noncompliance.
Prescribing Opioids for Chronic Pain
The second part of the new Virginia regulations covers opioid prescription for chronic pain. Prescribers must conduct a physical exam of the patient and take an oral history. The doctor or other prescriber must also evaluate the patient’s mental health. Mental health can be a key factor in determining the probability the patient who uses opioid will become addicted.
There are nine evaluation items that must be recorded:
1. Current treatment for pain and past treatments
2. How intense the pain is and the scope of the pain
3. The diseases and conditions (such as injury) that are causing the patient’s pain
4. How the pain is affecting the patient’s physical and emotional health – including his/her quality of life and daily activities such as sleeping, eating, and walking
5. The patient’s history of addition, substance abuse, and psychiatric problems – and those of any family members
6. The results of a urine test to determine what drugs are in the patient’s system or a serum medication test
7. A Prescription Monitoring Program query – as defined in the Virginia Code
8. The risk of substance abuse based on the patient’s prior history
9. A request to see and examine prior medical reports and records
Prescribers of opioids are also required to review the safe and best way to store controlled medications that contain opioids and the proper way to dispose of them. Prescribers must also discuss with patients, where the opioid prescriptions are not effective, a methodology for terminating the use of the opioids.
As with acute pain prescriptions, prescribers of opioids for chronic pain management should consider other less risky alternative and properly document use of MME medications.
The new Virginia regulations require that prescribers document the reasons for opioid prescriptions that last more than three months and if benzodiazepine and other medications are used with opioid medications, the prescriber must document how the lowest doses can be achieved.
Prescribers must routinely monitor the patient for signs of an opioid use disorder. If such a disorder is present, the physician or other prescriber should begin a treatment plan, refer the patient for evaluation and treatment, and review the case with a qualified healthcare professional.
Patient treatment plan, according to the Virginia Board of Medicine, must include detailed requirements including detailed documentation of the patient’s progress, including diagnostic evaluations and risks of abuse, misuse, or diversion – and other steps that can be taken.
Informed consent
Patients who are being prescribed opioids for chronic pain should be told of the risks, alternative remedies, and benefits of opioid medications before any treatment plan begins. The informed consent must be in writing before the prescriptions can be started. The informed consent should be properly documented. The informed consent must have the patient’s signature and must also disclose the treatment conditions, when treatment will cease, and any behaviors that require a referral.
There should also be a signed treatment agreement. The Medical Society of Virginia has a template of an informed consent form. The treatment plan should include the patient’s consent to obtain serum medication levels or urine drug screening, the Prescription Monitoring Program query and identify any other prescribers or pharmacies that are dispensing the opioids.
Prescribers must periodically review how the treatments are working – at least once every three months. Precise documentation is a must. If the patient is not responding well to the opioid medications, the prescriber has to document the reason for continuing the opioid prescription and what other treatment options are being considered.
The Prescription Monitoring Program query must also be conducted every three months. Urine tests or serum tests must be given every three months to see how well the patient is doing and what other medications he/she may be using. After the first year of opioid treatments, the tests can be done once every six months. As with acute pain, doctors and other health care providers who write opioid prescriptions should evaluate any opioid use disorders.
Prescribers, according to the Virginia Medical Board’s regulations, must also refer patients for new evaluations and treatments when needed or if the chronic patient has an opioid use disorder.
Documentation should be detailed and ready for review. Prescribers must include in their documentation of chronic pain:
1. An oral history and physical exam
2. The patient’s past medical history
3. The records of prior treatment doctors and healthcare providers
4. Laboratory test results, diagnostic statements, and therapeutic results
5. Any evaluations and consultations with other doctors
6. The goals of treatment
7. A review of the risks and benefits that were disclosed
8. An informed consent and a treatment agreement plan
9. Descriptions of any treatments
10. All medications the patient is taking including type, dosage, quantity, any refills, and the dates of the prescriptions
11. The patient instructions
12. What reviews have been given, when, and the summaries of the reviews
The third part of the Regulations – Buprenorphine Prescriptions-Used to Battle Addiction
Buprenorphine is one of the most common types of medications used in attempting to battle heroin or other opioid addiction. It actually reverses the effects of opioids and is fast-acting. Commonly prescribed names are Naloxone, and Narcan (nasal spray). Some of the regulations promulgated by the Virginia Medical Board are:
1. Acute pain – buprenorphine is not indicated for acute pain if the setting is an outpatient setting unless there is a primary diagnosis of addiction.
2. There are specific regulations indicating how doctors, physician assistants, and nurse practitioners are able to obtain waivers to allow them to prescribe Buprenorphine/Naloxone in an outpatient setting. There are certain waivers that must be obtained through the DEA.
3. Important especially for folks suffering from anxiety in addition to the pain: Anti-anxiety Medications containing Benzodiazepine, such as Lorazapam (Valium) or Xanax, can cause an adverse reaction when used with opioids. So the regulations require that if the physician is prescribing both the anxiety medication and the opioid, Naloxone MUST also be prescribed.
4. The Virginia Board of Medicine also requires that health care providers refer patients who are being prescribed buprenorphine to treat addiction to a mental health care provider for counseling or give the patient their own counseling – provided everything is documented. Mental health care providers include “a person who provides professional services as a certified substance abuse counselor, clinical psychologist, clinical social worker, licensed substance abuse treatment practitioner, licensed practical nurse, marriage and family therapist, mental health professional, physician, professional counselor, psychologist, registered nurse, school psychologist, or social workers. . .”
There are many additional requirements for health providers who prescribe Buprenorphine such as:
· Urine drug tests
· Pregnancy tests for women who might be pregnant
· Prescription Monitoring Program tests for HIV, Tuberculosis, and Hepatitis B and C) if indicated
· A tapering plan when buprenorphine is combined with other medications
Patients who take buprenorphine should start with 8mg/day or less. The health care prescriber should see the patient once a week and document any occasions for subscribing more than 8mg/day. Dosages over 16 mg/day require detailed medical documentation and dosages over 24 mg/day are specifically forbidden.
If buprenorphine is being prescribed for addiction treatment, then, as with chronic pain prescriptions, health care prescribers need to conduct urine drug tests or serum drug level tests at least once every three months during the first year and, at least, once every six months for the second year and beyond
Patients who are 15 years or younger should not be prescribed buprenorphine as part of a treatment plan for addition until the FDA gives its approval. Patients who are getting buprenorphine for addiction treatment should be monitored to see if their chronic pain is improving. Patients who have unstable psychiatric problems should get psychiatric help and treatment before buprenorphine is considered.
Summary and Our Take on these Regulations
The new laws were enacted in response to the rising dangers of Opioid Addiction and Abuse and the growing crisis in response to the rise in deaths due to overdose from opioids.
Unfortunately, for many of the severely injured workers’ compensation clients who we represent, which clients frequently require ongoing, severe pain management, these regulations simply mean more “hoops” to jump through in order to obtain relief from their unrelenting pain. This is in addition to the already burdensome issues which often accompany obtaining prescriptions in workers compensation cases, such as miscommunications or lack of approval from the comp adjusters or disconnects between the pharmacies and comp adjusters.
Our take on this is that while opioid addiction and overdose deaths from drugs like heroin and fentanyl are horrific problems which much be addressed, severely injured workers should not have to pay the price or be lumped in with criminals, and common drug addicts who abuse themselves and routinely break the law in order to feed their addiction.
We do applaud the efforts to make sure doctors are monitoring patients to make sure that opioids are being used for actual, real pain and are not the first drug of choice, particularly in cases where there is a history of addiction for the patient. We certainly do not want our clients to have the added problem of opioid addiction added to their work injuries.
That being said, we do have many clients who undergo spinal fusion surgeries and other highly invasive surgeries that often entail implantation of hardware and severe pain that may last for many weeks or even months; but now, under these new regulations, the surgeon must provide proof of “extenuating circumstances” to provide opioids beyond two weeks after performing surgery. This will cause needless suffering of our clients—mostly due to the reckless actions of a small minority of criminals and drug dealers.
The truth is most pain practices are already heavily regulated and follow certain protective protocols already in existence. Our office has already has a “warning letter” that goes out to every client we represent who enters a pain management program which basically states: beware of running afoul of the protocols of your pain management physician’s practice. Most of these doctors require you to sign a pain management “contract” which states that you will religiously take all of your medications as prescribed, be subjected to urine screens at each appointment, obtain no outside prescriptions even remotely considered pain medication or anxiety medication, stay off of illicit drugs such as marijuana, and bring all prescribed pills to each and every appointment to undergo a “pill count.” If anything seems out of place, these physicians will routinely eject you from the practice, which could result in damage to your workers compensation claim, and of course, difficultly and interruption in your course of pain management, which can be devastating in the most severe cases.
Now, these restrictions and limitations on physicians will only become more onerous for our clients and their doctors. Many physicians may simply refuse to prescribe pain medications for fear of running afoul of these regulations.
Contact a skilled Virginia work injury to learn more about the medical requirements for prescribing opioids
The new Virginia regulations on opioid prescriptions have just started. Many Virginia workers’ compensation employees do see pain management doctors and other physicians to try to manage their pain. Attorney Joe Miller Esq. can help you understand how these new regulations apply to you, your doctors, and your workers’ compensation case. To learn more and to speak with an experienced legal advocate, please call (888) 694-1671 or fill out our contact form.
