How Does the Fight against Opioids Affect Your Practice?

October 27, 2016

Different states are enacting various prescription measures to fight against opioid abuse. Here's what you need to know about these regulations.

Due to the recent focus on prescription opioid abuse, the healthcare industry should anticipate substantial amendments to state and federal laws dealing with controlled substance abuse.  While many commentators blame the pharmaceutical industry for creating this nationwide epidemic, it is likely that governmental agencies will look to physicians and other prescribing practitioners to help enforce a solution.  With no uniform solution or protocol in dealing with the opioid abuse epidemic, practitioners will likely see differing approaches and requirements, as promulgated by the various state governments.

U.S. Health and Human Services (HHS) Secretary Sylvia M. Burwell said in a release: "[t]he opioid epidemic is one of the most pressing public health issues in the United States. More Americans now die from drug overdoses than car crashes, and these overdoses have hit families from every walk of life and across our entire nation." The topic has gained widespread media attention, as over 18,893 Americans died from prescription pain-killer overdose in 2014, according to the American Society of Addiction Medicine.  Most recently, John Oliver's latest episode of Last Week Tonight examined the role of pharmaceutical companies in creating this nationwide epidemic. According to Oliver, the prescription opioid epidemic is largely attributable to the pharmaceutical industry's deceptive and manipulative marketing campaigns to convince practitioners that prescription opioids are safe and not addictive. 

Notwithstanding the alleged transgressions of the pharmaceutical industry, governments will seek to impose new regulations and protocols upon the entire healthcare industry, especially physicians, to help combat this problem.  The federal government has taken certain initial actions to help treat America's opioid epidemic, such as expanding access to buprenorphine - a medication used to treat opioid use disorder.  However, many are dissatisfied with the speed and scope of the federal government's response to date and, as a result, several states have stepped up to adopt their own measures.  In general, intervention on the state government level will likely be quicker and more effective in the short term.  However, the differing approaches amongst the various states have led to a disparity of focus and responsibility in addressing the opioid epidemic.          

New York's has most recently focused on the insurance industry to help patients obtain substance abuse treatment.  New York's Department of Financial Services recently issued guidance directing insurance companies to change the way they authorize coverage for substance abuse treatment. Insurers are now required to adopt the utilization review standards set forth by the state's Office of Alcoholism and Substance Abuse Services, which are less arbitrary than the standards previously used by private insurers.  The guidance also requires insurers to provide coverage for medication used for detoxification or maintenance treatment of a substance use disorder.    

South Carolina also recently addressed access to substance abuse treatment by relying on pharmacists to intervene.  Pursuant to a recently enacted law, South Carolina will permit pharmacists to dispense opioid antagonists without a prescription from a physician.  The newly enacted law will establish a protocol to be followed by pharmacists when acting without a verbal or written order from a prescriber.  It is unclear, however, whether pharmacists will utilize this newly enacted power to intervene and address a patient's condition without a practitioner's order    

Gov. Peter Shumlin of Vermont took a different approach proposing to impose limits on the number of painkillers that could be prescribed at a given time in a press conference on Oct. 19.  The proposed regulations in Vermont seek to limit prescription quantities based on the severity and duration of a patient's pain.  If the proposed regulations are promulgated, physicians will then have to consult regulatory algorithms to determine the appropriate dosage and quantity of painkillers. 

With the growing disparity of substance abuse laws on the state level, practitioners must be mindful of updates and distinctions in all states where they perform professional services.  This poses a heavy burden on the medical community, which must balance its ethical treatment obligations, with the risks of malpractice liability and regulatory or criminal enforcement.  These concerns are largely responsible for the cautious response of the physician community to the substance abuse problem. Some commentators have criticized this response, stating that practitioners are only downsizing the use of painkillers in their treatment regimens, while failing or hesitating to facilitate substance abuse treatment. As noted by the various examples above, it is likely that more states, and possibly the federal government, will impose legal and regulatory obligations that may prohibit physicians from sitting on the sidelines.      

Yulian Shtern, Esq., is a health law attorney with Abrams, Fensterman, Fensterman, Eisman, Formato, Ferrara & Wolf, LLP.