Preventing Drug Diversion: Disposal of Controlled Substances in Home Hospice Settings
Released: 2020-04-14T00:00:00

Letter

Background

Hospice Services

Hospice care helps patients who are terminally ill—as well as the families of those patients—maintain their quality of life. Hospice care focuses on the comfort of patients (palliative care), not curing the illness. Patients are eligible for hospice care under Medicare if they have a life expectancy of six months or less. Most patients get hospice care at home, which typically includes use of controlled substances, including opioids such as oxycodone, to provide pain relief. According to CMS, hospice teams are required to include a physician, nurse, social worker, and pastoral or other counselor; and may also include hospice aides, trained volunteers, and speech, physical, and occupational therapists. The patient selects a primary caregiver when first admitted into home hospice, and this person becomes a member of the home hospice team. The primary caregiver, often a family member, provides most of the care for the patient in home hospice, including most of the physical care for the patient, keeping records of symptoms and other problems, and communicating with the hospice team.

Disposal of Controlled Substances in Home Hospice

The Controlled Substances Act regulates the manufacture, distribution, use, and disposal of controlled substances. In general, the Controlled Substances Act was enacted to facilitate the use of controlled substances for legitimate medical, scientific, research, and industrial purposes while preventing them from being diverted for illegal uses. DEA is the primary agency with responsibility for administering and enforcing the law, and DEA provides oversight of all persons or entities required to register with DEA. The Controlled Substances Act has been amended twice to clarify federal requirements for patient disposal of controlled substances.

2010. The Secure and Responsible Drug Disposal Act of 2010 amended the Controlled Substances Act to allow a patient who has lawfully obtained a controlled substance to deliver the controlled substance to another person for the purpose of disposal, without being registered with DEA. Any person lawfully entitled to dispose of a deceased patient’s property may also deliver the patient’s controlled substances to another person for the purpose of disposal. The person receiving the controlled substances must be legally authorized to do so and the disposal has to take place in accordance with DEA regulations, which DEA issued in 2014. Among other things, the DEA rulemaking clarified that home hospice personnel could not dispose of a deceased patient’s controlled substances unless authorized to dispose of the patient’s property by a state or local law. Instead, the rulemaking encouraged home hospice personnel to assist patients and their families in disposing of controlled substances in accordance with the Controlled Substances Act, and partner with authorized collectors to promote or jointly conduct mail-back programs.

2018. The SUPPORT Act amended the Controlled Substances Act to allow employees of qualified hospices, whether or not registered with DEA, to dispose of a patient’s unused controlled substances onsite and in accordance with all applicable laws after the patient’s death or the controlled substance expires. The employee must be a physician, physician assistant, nurse, or other person who is: employed by a qualified hospice; licensed to perform medical or nursing services by the jurisdiction in which the patient is receiving hospice care; acting within the scope of their employment in accordance with applicable state law; and trained on the disposal of controlled substances by the qualified hospice.

If the hospice patient no longer requires the controlled substances because of a change in his or her care plan, only the patient’s DEA- registered physician may dispose of the patient’s unused controlled substances. The authority to dispose of unused controlled substances under the SUPPORT Act applies only to qualified hospices. Such hospices must have written policies and procedures for assisting in the disposal of controlled substances after the patient’s death, and must document that they provided and discussed these policies and procedures in an understandable manner with the patient and family. In addition, the hospice must document the type of controlled substance, dosage, route of administration, and quantity disposed, as well as the time, date, and manner in which the disposal occurred. The SUPPORT Act also allows the Attorney General to issue guidance to hospices regarding the disposal of controlled substances in patients’ homes.

Federal Oversight

According to DEA officials, DEA’s oversight of the disposal of controlled substances in home hospices is limited to instances of suspected or actual diversion. This is because the SUPPORT Act allows employees of qualified home hospices to dispose of unused controlled substances in patients’ homes without registering with DEA.

CMS regulates Medicare-certified home hospices through the Hospice Conditions of Participation, which are intended to protect the health and safety of individuals under hospice care. Hospices must be in compliance with the Hospice Conditions of Participation to participate in the Medicare program. CMS oversees compliance with the Hospice Conditions of Participation primarily through inspections, which are conducted by state survey agencies contracted by CMS or CMS-approved national private accrediting organizations. Among other things, the Hospice Conditions of Participation require hospices to have written policies and procedures for the management and disposal of controlled substances in the patient’s home, discuss the hospice policies and procedures for managing the safe use and disposal of controlled substances with the patient and family in a manner that they understand, and document that the written policies and procedures for managing controlled substances were provided and discussed. CMS does not oversee the disposal process.

Selected Home Hospices’ Experiences, Best Practices, and Challenges in Disposing of Controlled Substances

Selected Home Hospices’ Experiences Disposing of Controlled Substances

According to a national hospice association official, each hospice had a different approach to disposal prior to the DEA rulemaking in 2014. Some hospices asked their employees to dispose of controlled substances to prevent diversion and others did not. After the DEA rulemaking, some states enacted laws granting authority to hospice employees to dispose of patients’ unused controlled substances when the medications were no longer needed, upon death of the patient, or both. Requirements under states’ laws vary (see appendix I).

Hospices in some states without laws on the disposal of controlled substances in home hospice began, or resumed, disposing controlled substances in patients’ homes following the enactment of the SUPPORT Act in 2018. Officials from six selected home hospices expressed support for the authority to dispose of controlled substances granted by the SUPPORT Act, and officials we interviewed from two hospices operating in states without disposal laws told us their hospices had resumed disposing of controlled substances in patients’ homes under the authority granted by the SUPPORT Act. In contrast, an official from one hospice told us that their hospice had not begun disposing of these medications with the enactment of the SUPPORT Act because the state department of health directed it not to do so until a state law granting disposal authority to hospices had been enacted. For now, the hospice has continued with its practice of educating patients’ family members on how to dispose of controlled substances themselves.

Selected Home Hospices’ Policies and Best Practices for Disposing of Controlled Substances and Reducing the Risk of Diversion

Medicare-certified hospices, including the seven we selected for our review, are required by CMS’s Hospice Conditions of Participation to have written policies and procedures for the safe disposal of controlled substances in a patient’s home. The policies and procedures may include best practices, such as measures for assessing and mitigating the risk of diversion in a patient’s home, and if and how the hospice will conduct controlled substance disposal. According to officials we interviewed from the selected hospices and state hospice associations, hospices utilize various strategies or best practices to attempt to mitigate diversion risks, including, but not limited to, the following:

Education on controlled substance use and disposal. Hospice policies may include disposal education for patients and their caregivers. Specifically, officials from five hospices and five state hospice associations said that patient and family member education on controlled substances and their disposal begins or should begin upon the patient’s admission into hospice care or as soon as possible thereafter. According to officials from three hospices, their staff may use written agreements or acknowledgements that must be signed by the patient or their caregiver. An official from one hospice association told us the association made an agreement template available to their hospice members that can be used to ensure patients understand how to properly use prescribed controlled substances, agree to use them properly, and will not give them to anyone else.

Prescription drug counts. Officials from four hospices and two state hospice associations told us that, in general, nurses conduct prescription drug counts at every visit to check if the proper amounts of medications remain. Officials from two of these hospices said that drug counts should require the family’s acknowledgement or be witnessed. Officials from three other state hospice associations mentioned that their members use drug counts as well but did not specify if this occurred at every visit. These counts can be used to recognize possible drug misuse or diversion. If there is an indication that diversion may be the cause of an incorrect count, hospices can put additional drug diversion risk reduction practices in place.

Lockboxes. If diversion is suspected to be a risk or if there are children present in the patient’s home, a hospice may choose to use a lockbox to store the patient’s medications and limit access to only an alert patient or their caregivers. Officials from five hospices and five state hospice associations mentioned that their employees and members use lockboxes for such purposes. One hospice official explained that lockboxes may also be used as an accountability tool so that those with access cannot accuse others of stealing if drugs are unaccounted for.

Pharmacy cooperation. A hospice may choose to have the pharmacy mail a prescribed controlled substance in smaller quantities and with greater frequency. For example, an official from one of the selected hospices explained that the pharmacy they use will deliver medications as often as daily if needed to reduce the risk of controlled substances being diverted. Similarly, an official from a state hospice association explained that some pharmacy managers and benefits managers note when a refill for a prescription is requested sooner than it should have been and alert the hospice.

Witnessed disposal or assisted disposal. Pursuant to some state disposal laws and according to officials from five hospices and four state hospice associations, controlled substance disposal and assisted disposal must or should be performed with a witness present. The state disposal laws may specify who the witness must be. For example, according to two state laws, a family member or a second hospice employee may witness disposal.

In-home disposal products. Hospices may have varying preferences for how they dispose of controlled substances; officials from four of the selected hospices mentioned using in-home disposal products, and two specifically explained they believed these to be the safest disposal method, even though, according to the officials, it can be costly. Officials from another hospice told us they receive their in- home disposal products through a grant program.

Documentation. Officials from four selected hospices told us their employees document the completion of certain tasks, such as diversion risk assessments, drug counts, drug disposal, and the refusal of drug disposal. An official from one of these hospices told us their staff perform and document a diversion risk assessment of the patient’s home. While officials from four hospices told us their employees perform drug counts, only one official specified that employees from their hospice document the drug counts. Another hospice official explained that disposal documentation includes the name, dosage, form, and administration method of the medication. One hospice official told us that if a patient’s family members refuse disposal, they must sign a form stating they declined to allow the nurse to dispose of the patient’s remaining drugs.

Selected Home Hospices’ Challenges with Disposing of Controlled Substances

Officials from selected hospices and state hospice associations in our review described various challenges associated with disposing of controlled substances in patients’ homes. The challenges described by the selected hospices and state hospice associations include but are not limited to the following:

Certain disposal methods may be too costly. An official from one state hospice association said that most of its members do not use a drug disposal process, which may include a mail-back program or in- home disposal product, because it is an extra expense, and an official from one hospice said that after pricing an in-home disposal product, their hospice decided it was cost prohibitive. One state hospice association official explained that although most of its in-home hospice members use an in-home disposal product, in instances when the hospice employee is disposing of 40 to 50 vials, the expense of this disposal method can be burdensome. The official told us the product costs approximately $6 each and fits four to five vials of pills in each.

Disposal can be time consuming. One hospice official said that disposal can sometimes be a time-consuming and resource-intensive activity. According to two state hospice association officials, sometimes a patient’s family will ask the disposing hospice employee to dispose of all of the patient’s unused prescription drugs that remain in the home, not only controlled substances or drugs prescribed under hospice care. Officials from two of our selected hospices and two state hospice associations told us that it is not atypical for a hospice patient to have bags or boxes full of unused medications, though the officials did not describe this as a disposal challenge for hospices.

Lack of a witness. One hospice official told us that it is a challenge when a witness is not available or is unwilling to participate in a drug count or disposal. Another hospice official indicated that the patient’s primary caregiver is not always the family member present at the time of a drug count or disposal. This can create a challenge, as the hospice employee must either wait for the patient’s primary caregiver to arrive, or for that person to agree to witness a count, disposal, or both.

Family members and caregivers sometimes refuse to dispose of controlled substances. Officials from two hospices and three state hospice associations indicated that a family’s refusal to dispose of a patient’s remaining medications can be a challenge, though one hospice official said it occurs infrequently. An official from another hospice said that if a family initially refuses disposal, hospice staff return after two weeks to complete the disposal process.

Inconsistencies between state laws and federal law. Hospices must comply with applicable federal and state laws governing controlled substances, and to the extent state law is inconsistent with the Controlled Substances Act, hospices must follow federal law. Hospice officials told us that inconsistencies between state laws and federal law can cause challenges. For example, the SUPPORT Act limits disposal to only physicians, physician assistants, nurses, or other hospice employees who are licensed to provide medical or nursing services. An official from one hospice stated that the hospice used the help of social workers and volunteers to dispose of controlled substances. Regulations in this state do not specify which types of hospice employees are permitted to assist with disposal. According to the official, social workers and volunteers helped dispose of patients’ controlled substances when disposal occurred at a later time, rather than immediately following a patient’s death. Since the SUPPORT Act limits disposal to home hospice personnel with specific qualifications, it is unclear whether hospices are able to allow social workers and volunteers to help in that capacity.

As another example, under the SUPPORT Act, only a hospice patient’s DEA-registered physician can dispose of the patient’s controlled substances if the plan of care has been modified. However, some state laws allow other types of hospice employees to perform disposal in this circumstance. Officials from two hospices in these states indicated it will be a challenge for disposal to be limited to physicians when a patient’s plan of care is modified. Similarly, officials from two other selected hospices in states without disposal laws also stated that this would be a challenge. For example, one hospice official explained that their hospice does not have many physicians, and it would be unlikely for a physician to be able to visit a patient’s home solely to handle disposal.

Agency Comments

We provided a draft of this report to the Departments of Justice and Health and Human Services for review. The Departments of Justice and Health and Human Services provided technical comments, which we incorporated as appropriate.

We are sending copies of this report to the appropriate congressional committees, the Attorney General of Justice, the Secretary of Health and Human Services, and other interested parties. In addition, the report will be available at no charge on GAO’s website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact me at (202) 512-7114 or at CosgroveJ@gao.gov. Contact points for our Office of Congressional Relations and Office of Public Affairs can be found on the last page of this report. Other major contributors to this report are listed in appendix II.

Appendix I: Summary of Five States’ Controlled Substances Disposal Laws for Hospices

To describe what is known about selected hospices’ experiences disposing of and preventing the diversion of controlled substances in home settings, we selected five states with laws on the disposal of controlled substances in home hospices and six states without such laws. The five states with disposal laws were chosen for this review because they had state hospice associations that were involved in disposal discussions with a national hospice association or they had higher opioid-related death rates than most states. The summaries in Table 1 below reflect our reviews of the five states’ laws.

Appendix II: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact name above, Martin T. Gahart (Assistant Director), Deborah J. Miller (Analyst in Charge), Samuel G. Amrhein, Kaitlin M. Farquharson, and Christina C. Murphy made key contributions to this report.