Patient Protection and Affordable Care Act

The Patient Protection and Affordable Care Act (ACA) contains several provisions that address the opioid epidemic and drug diversion. The ACA created stronger penalties for submitting false claims or knowingly false information related to the ordering of prescription drugs. It requires state Medicaid agencies to suspend payments to physicians and other providers when there is credible evidence of fraud. In addition, if providers are terminated for cause by Medicare or any state Medicaid agency, they must also be terminated by Medicaid and the Children’s Health Insurance Program (CHIP) in all states.17

In addition, the ACA improved mental health care and made drug addiction treatment more accessible by requiring addiction treatment to be covered by health insurance policies. It also mandated that addiction coverage be on par with treatments for other chronic diseases. The ACA expanded prescription drug coverage for eligible Medicare and Medicaid patients. According to the U.S. Department of Health and Human Services, the number of uninsured patients seeking care for addiction has declined since the enactment of the ACA. In states that expanded Medicaid under the ACA, the number of uninsured hospitalizations for substance abuse and mental health disorders dropped from
20 percent in 2013 to about 5 percent in 2015.18

State Regulations

Possession or distribution of illegal drugs is a crime under state laws and most municipalities. In most states, it is a felony to attempt to divert drugs by misrepresentation, fraud, forgery or deception. Drug convictions can result in heavy fines and/or prison sentences. Providers may also have their licenses suspended. The severity of the penalties typically depends on the drug’s schedule, the quantity of drugs involved, and whether the offender has previous convictions for similar crimes.

Hospital Drug Diversion Programs

Drug diversion is an ongoing problem for hospitals that can threaten patient safety and create significant liability. An effective program to prevent drug diversion includes safeguards to reduce the ability of employees to divert prescription drugs, as well as appropriate systems for detecting such activity and dealing with workers who are addicted to prescription drugs. A comprehensive plan incorporates all of the disciplines where employees can come into contact with prescription drugs, not just the pharmacy. This would include the medical staff, nursing, human resources, legal and regulatory compliance, and security.19

Hospital leadership should review its drug diversion program regularly. A comprehensive risk assessment can help hospitals identify areas where there may be a breakdown in policies and procedures, or areas where monitoring, controls and security may need to be strengthened. A thorough review of controlled substances and the drug inventory process can help identify gaps in the dispensing and administering of controlled substances to patients and can develop solutions. Security managers have an important role to play in preventing and reducing drug diversion, and should work with hospital management to identify gaps in security and controls, and ensure the effectiveness of the diversion program.

Policies and Procedures

Hospitals must have policies and procedures in place to control access to prescription drugs and minimize the opportunities for diversion. Written policies should regulate all aspects of the purchase, storage and dispensing of controlled substances. It is important for there to be a clear division of duties in procurement, stocking and dispensing. Invoices must be carefully reviewed to ensure consistency between what is ordered, signed for and received into stock. Staff should be required to verify dispensing and receipt of controlled substances, and there should be a clear chain of custody throughout the dispensing process. Review and restocking of returns should be done by two staff members.

Hospitals also need procedures regarding the handling, storage, and disposal of controlled substance pharmaceutical waste, and disposal must comply with federal, state and local laws. Some of these procedures might include:

  • Hospital staff should be monitored when disposing of controlled substances.
  • Pharmaceutical waste containers should be attached to a wall with small openings so devices and waste cannot be easily retrieved.
  • Access to waste containers should be limited to only a few staff members.
  • Security patrols should include regular monitoring of areas where pharmaceutical waste containers are located.