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	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.