On October 24, 2018, the SUPPORT for Patients and Communities Act (Pub. L. 115-271, the “Act”) was signed into law. Section 3222 of this sweeping federal opioid legislation amends the Controlled Substances Act to permit certain hospice staff to handle lawfully dispensed controlled substances to assist with disposal of the drugs. The Act expressly confers this authority, along with specific training and documentation requirements, and essentially reverses the position of prior federal law. Previously, hospice providers were prohibited by federal law from disposing of controlled substances except in narrow circumstances if expressly permitted under state law. Now, hospice providers are permitted by federal law to dispose of controlled substances pursuant to the Act unless state law prohibits or further restricts that authority. Thus, hospice providers must both familiarize themselves with the new federal law and carefully re-examine state laws to identify conflicting or additional requirements and ensure compliance. Read below for a summary of the Act and recommended action items.
Summary of the New Law
The Act now permits (but does not require) a qualified hospice program’s licensed physicians, physician assistants, and nurses who meet certain requirements (collectively, “Authorized Employees”) to dispose of controlled substances which were lawfully dispensed to the person receiving hospice care in the following situations:
- the disposal occurs after the death of a person receiving hospice care;
- the controlled substance is expired; or
- (I) the employee is—
- the physician of the person receiving hospice care; and
- registered under section 303(f) [of the Controlled Substances Act];
- (II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.
There are certain requirements and restrictions under the Act applicable to such disposal, including:
- Dispose Onsite. Disposal must occur “onsite” in accordance with all applicable federal, state, tribal, and local law.
- Scope of Employment. Authorized Employees must be acting within the scope of employment in accordance with applicable state law.
- Training. Authorized Employees must be trained through the hospice on the disposal of controlled substances.
- Policies. The hospice must have written policies and procedures for addressing the disposal of the controlled substances. Note that the Act specifically requires such policies only in the case of (i) above (i.e., policies for assisting in the disposal of controlled substances after a patient’s death), but hospice providers should consider implementing policies that address the other disposal situations and requirements of the Act as well.
- Patient/Family Education. At the time controlled substances are first ordered, the hospice must provide copies of the policies related to disposal of controlled substances after a patient’s death to patients and their families. Further, hospice providers must discuss the policies with patients and their families in a language and manner that they understand and document in the patient’s clinical record that the written policies and procedures were provided and discussed.
- Documentation. After disposal, the hospice must document in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed, and the time, date, and manner in which that disposal occurred.
Federal v. State Laws
The Act includes the following language:
Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs.
Thus, it is particularly important for hospice providers to understand all applicable state law requirements. Previously, federal law prohibited hospice personnel from taking possession of controlled substances unless: 1) the patient was deceased, and 2) state law authorized the personnel to dispose of the decedent’s property. Now, federal law permits disposal by hospice personnel (as described above) unless state law prohibits it, and state law may impose additional requirements that must be followed. There is significant variation in how states’ hospice licensure regulations address drug disposal, and the provisions are not always clear in what they require of hospice providers from an operational perspective. Excerpts from several states’ regulations illustrate this variation:
- Alabama R. & Regs. 420-5-17-.20(8): “Each hospice program develops written policies and procedures for the destruction of drugs and biologicals when those drugs are no longer needed by the patient. Controlled substances and legend drugs dispensed to patients, that are unused because the medication is discontinued, or because the patient dies, shall be destroyed within 30 days . . . (f) When destruction of medications is conducted within the patient’s home by the hospice nurse, this procedure shall be witnessed by one or more persons.”
- Georgia R. & Regs. 111-8-37-.21(1): “The hospice must provide for the . . . destruction of drugs and biologicals utilized for hospice care in accordance with accepted professional principles and in compliance with all applicable state and federal laws.”
- 175 Neb. R & Regs 16-006.17G: “Controlled drugs no longer needed by the patient are disposed of in compliance with State requirements. In the absence of State requirements, the pharmacist and registered nurse dispose of the drugs and prepare a record of the disposal.”
Previously, state disposal or other requirements which were in conflict with prior federal law on this topic (for example, requirements to dispose of controlled substances no longer needed by a living patient), or which did not confer the requisite disposal authority for a decedent’s property, were preempted by the federal law. Now, the Act has changed the analysis and there is the potential to need policy and operational updates to comply with existing state law disposal requirements.
- Determine Organizational Policy Position. Hospice providers should carefully consider their organizational policy – i.e., whether to permit disposal of controlled substances by Authorized Employees as authorized under the Act. Once their position has been determined, the hospice should take steps to ensure its policies and operations accurately reflect its position.
- Identify State Requirements. Hospice providers—and especially those with operations in multiple states—should focus on identifying the applicable state requirements and update their policies and operations if necessary.
- Monitor for Further Developments. The Act provides that the Attorney General may issue guidance to assist hospice providers in complying with these new requirements, and Section 3223 requires the Government Accountability Office to conduct a study and produce a report within eighteen months on “the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual.” Further, federal agencies such as the Drug Enforcement Administration and the Centers for Medicare and Medicaid Services may issue additional regulations applicable to hospice providers in response to the Act. Finally, state law is evolving in this area in response to the opioid crisis as well, and hospice providers should continue to track any state-level drug disposal changes.