For additional hospice survey resources, review NHPCO’s Survey Readiness and Response Toolkit NHPCO.ORG | 1
Sec. § 418.106 Condition of Participation: Drugs and Biologicals, Medical Supplies,
and Durable Medical Equipment
The hospice must provide medical supplies and appliances, durable medical equipment, and drugs and biologicals related to
the palliation and management of the terminal illness and related conditions, as identiied in the hospice plan of care.
Managing drugs and biologicals
• The hospice must ensure that the interdisciplinary team confers with an individual with education and training in drug
management as deined in hospice policies and procedures and State law, who is an employee of or under contract with the
hospice, to ensure that drugs and biologicals meet each patient’s needs.
− It is the decision of the hospice to determine which individual meets this requirement and this individual may include:
▸ Licensed pharmacists;
▸ Physicians who are board certiied in hospice and palliative medicine;
▸ RNs who are certiied in hospice and palliative care;
▸ Physicians, RNs and nurse practitioners who complete a speciic hospice or palliative care drug management course,
and other individuals as allowed by State law.
− The hospice must be able to demonstrate that the individual has speciic education and training in drug management.
• A hospice that provides inpatient care directly in its own facility must:
− Provide pharmacy services under the direction of a qualiied licensed pharmacist who is an employee of or under contract
with the hospice.
− The provided pharmacist services must include evaluation of a patient’s response to medication therapy, identiication of
potential adverse drug reactions, and recommended appropriate corrective action.
Ordering of drugs
• Drugs may be ordered in accordance with the plan of care or State law either
by:
− A physician
− A nurse practitioner
− Physician assistant
• If the drug order is verbal or given through electronic submission:
− It must be given only to a licensed nurse, nurse practitioner (where appropriate), pharmacist, or physician; and
− The individual receiving the order must record and sign it immediately and have the prescribing person sign it in
accordance with State and Federal regulations.
Dispensing of drugs and biologicals
• A hospice must obtain drugs and biologicals from community or institutional pharmacists or stock drugs and biologicals
itself.
• In addition, the hospice that provides inpatient care directly in its own facility must:
− Have a written policy in place that promotes dispensing accuracy; and
− Maintain current and accurate records of the receipt and disposition of all controlled drugs.
For additional hospice survey resources, review NHPCO’s Survey Readiness and Response Toolkit NHPCO.ORG | 2
Administration of drugs and biologicals
• IDT Responsibility: The IDT, as part of the review of the plan of care, must determine the ability of the patient and/or family
to safely self-administer drugs and biologicals to the patient in his or her home.
• Patients in hospice inpatient facilities: Patients in hospices that provide inpatient care directly may only be administered
medications by:
− A licensed nurse, physician, or other health care professional in accordance with their scope of practice and State law;
− An employee who has completed a State-approved training program in medication administration; and
− The patient, upon approval by the interdisciplinary team.
Labeling, disposing, and storing of drugs and biologicals
Labeling
• Drugs and biologicals must:
− Be labeled in accordance with currently accepted professional practice.
− Include appropriate usage and cautionary instructions.
− Include an expiration date, if applicable.
Disposing
• The federal SUPPORT Act, a major piece of legislation aimed at addressing the opioid epidemic, became law in late 2018. It
included a provision to amend the Controlled Substances Act (CSA) to allow certain hospice employees to handle controlled
substances in order to assist patients and families with onsite disposal of them under speciic circumstances.
• NHPCO submitted questions to the Drug Enforcement Administration (DEA) about this legislation. In 2019, the DEA
provided these responses:
− Are hospices now required to dispose of patients’ controlled substances?
The SUPPORT Act permits, but doesn’t require, hospices to develop policies and procedures to allow certain hospice
employees to assist with controlled substance disposal on site under certain circumstances without being DEA
registrants. Hospice employees are not subject to the rules applicable to DEA registrants.
Hospices can decide whether they want to allow qualiied employees to assist families with disposal, or they can
continue to instruct patients and families on options and methods of disposal.
− Who can assist with disposal?
The law speciically allows physicians, physician assistants, and nurses who are employed by (or in the case of physicians,
under contract with) the hospice to assist with disposal if they are acting within the scope of their employment and have
completed hospice program training regarding disposal of controlled substances in a secure and responsible manner.
The law also allows disposal by “other persons” employed by the hospice who are “licensed to perform medical or nursing
services by the jurisdiction”; however, in the absence of guidance from DEA it’s unclear what other categories of licensed
hospice employees might meet this criteria.
− When can these hospice employees assist with controlled substance disposal?
The hospice employees may handle controlled substances for the purpose of onsite disposal after the death of a hospice
patient, or if the drug has expired.
If the hospice employee is the patient’s physician and they are a DEA registrant, they may also dispose of the drugs onsite
when a controlled substance is no longer needed because the patient’s plan of care has been modiied.
− What is the hospice required to do?
The law applies to employees of a “qualiied hospice program”, allowing them to assist hospice patients and families with
controlled substance disposal onsite.
For additional hospice survey resources, review NHPCO’s Survey Readiness and Response Toolkit NHPCO.ORG | 3
This means:
▸ The hospice must have written policies and procedures for assisting in the disposal of controlled substances and must
provide patients and families with a copy of them at the time the controlled substances are irst ordered.
▸ The hospice is required to discuss these policies and procedures with the patient and family in a language and manner
they understand, to ensure they’re educated regarding safe disposal of controlled substances, and must document in
the patient’s record that these policies and procedures were provided and discussed.
▸ Following the disposal of the controlled substances, the hospice must document in the patient’s clinical record:
• the type of controlled substance, dosage, dosage form i.e. tablet, patch, vial, etc.)
• route of administration
• quantity disposed of
• time, date and manner of disposal
− Best practices for hospices:
▸ For safe disposal of controlled drugs in the patient’s home, the hospice must:
• Provide the actual copy of the hospice written policies and procedures on the management and disposal of
controlled drugs to the patient or patient representative and family.
• Discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the
patient or representative and the family during the admission process in a language and manner that they
understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs.
• Document in the patient’s clinical record that the written policies and procedures for managing controlled drugs
was provided and discussed.
• NOTE: The above steps must be completed by the hospice by the time that the controlled drugs are irst ordered.
▸ Providers must follow state and federal regulations related to disposal of controlled and uncontrolled drugs. See a full
description of the SUPPORT Act, hospice drug disposal provisions in the April 9, 2019 Regulatory Alert – SUPPORT Act
– Controlled Substance Disposal
− Hospices that provide inpatient care directly must:
▸ Dispose of controlled drugs in compliance with the hospice policy and in accordance with State and Federal requirements.
▸ Maintain current and accurate records of the receipt and disposition of all controlled drugs.
Storing
• The following additional requirements are to be met by hospices that provide inpatient care directly.
• Hospices must store all drugs and biological in secure areas.
− All controlled drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of
1976 must be stored in locked compartments within such secure storage areas.
− Only personnel authorized to administer controlled drugs as noted in this section may have access to the locked
compartments. These authorized personnel are:
▸ A licensed nurse, physician, or other health care professional in accordance with their scope of practice and State law;
▸ An employee who has completed a State-approved training program in medication administration; and
▸ The patient, upon approval by the interdisciplinary team.
• Discrepancies in the acquisition, storage, dispensing, administration, disposal, or return of controlled drugs must be
investigated immediately by the pharmacist and hospice administrator.
− Where required, these discrepancies must be reported to the appropriate State authority.
− A written account of the investigation must be made available to State and Federal oficials if required by law or
regulation.
For additional hospice survey resources, review NHPCO’s Survey Readiness and Response Toolkit NHPCO.ORG | 4
Use and maintenance of equipment and supplies
• A hospice provider must contract with a DMEPOS accredited supplier that meets the Medicare DMEPOS Supplier Quality
and Accreditation Standards at 42 CFR § 424.57.
− If the hospice owns its own DME, then no accreditation is needed.
• Hospice provider responsibilities:
− Ensure that manufacturer recommendations for performing routine and preventive maintenance on durable medical
equipment are followed.
− Ensure that the equipment is safe and works as intended for use in the patient’s environment.
− Ensure that repair and routine maintenance policies are developed for equipment that does not come with a
manufacturer recommendation.
− Ensure that the patient, where appropriate, as well as the family and/or other caregiver(s), receive instruction in the safe
use of DME and supplies.
• Hospice providers may:
− Use persons under contract to ensure patient and family instruction.
− Use persons under contract to ensure the maintenance and repair of durable medical equipment.
• Patient/caregiver/family expectation:
− The patient, family, and/or caregiver must be able to demonstrate the appropriate use of durable medical equipment to
the satisfaction of the hospice staff.
Compliance Suggestions for Hospice Providers
• Ensure documented evidence of all designated individual’s education and training in drug management.
• Ensure that documentation of the ability of the patient and/or family to safely self-administer drugs and biologicals to the
patient in his or her home is included in regular IDT meetings.
• Ensure compliance with state and federal laws regarding ordering, labeling, disposing and storing of drugs and biologicals,
as well as the administration of drugs and biologicals.
• Utilize state pharmacy boards for information related to drug distribution and disposal.
• Incorporate education about hospice aide requirements into your orientation program and continuing education for
physicians, pharmacists, nurse practitioners, and nurses.
Please note that hospice providers need to comply with the most stringent regulatory requirements (Federal or State).
Resources
• NHPCO Regulatory & Compliance Center, Opioids
References
• Part II - Department of Health and Human Services, Centers for Medicare & Medicaid Services
42 CFR Part 418 Medicare Hospice Care Regulations eCFR :: 42 CFR Part 418 -- Hospice Care
