Nursing Home Regulatory Obligations Related To Medications

NURSING HOME REGULATION

KEY POINTS FROM CMS INTERPRETIVE GUIDANCE
(Medicare State Operations Manual, Appendix PP; CMS Survey & Certification Letter 12-48-NH)

42 C.F.R. § 483.25 Quality of Care

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

F309 (483.25) – End of Life Care

• For residents nearing end of life, nursing homes have specific guidelines under the "Medications/Drugs" section that require them to "review the continued need for any routine administration of medication and adjust or discontinue, as appropriate."
• This section also emphasizes that the "use of medications be consistent with the goals for comfort, control of symptoms, and for the individual's desired level of alertness."
• These standards apply regardless of whether the patient is on hospice, and requires the nursing home to "review and revise the care plan as necessary to address the resident's situation, including expectations and management of specific symptoms and concerns."
• For residents receiving hospice care, the "nursing facility coordinates care planning with the hospice."

42 C.F.R. § 483.25(l) Unnecessary Drugs

Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: (i) in excessive dose (including duplicate drug therapy); or (ii) for excessive duration; or (iii) without adequate monitoring; or (iv) without adequate indications for its use; or (v) in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) any combinations of the reasons above.

F329 (483.25(l)) – Unnecessary Drugs

• The guidelines note that the "indications for initiating, withdrawing, or withholding medication(s), as well as the use of non-pharmacological approaches, are determined by assessing the resident's underlying condition, current signs and symptoms, and preferences and goals for treatment. This includes, where possible, the identification of the underlying cause(s), since a diagnosis alone may not warrant treatment with medication."
• When evaluating residents' drug/medication regimen, the reviewer will consider and recognize the need for end of life or palliative care, if applicable.
• Nursing homes must collaborate with the prescriber and "utilize[] only those medications in appropriate doses for the appropriate duration, which are clinically necessary to treat the resident's assessed conditions."

42 C.F.R. § 483.60(c) Drug Regimen Review

The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. The pharmacist must report any irregularities to the attending physician and the director of nursing, and these reports must be acted upon.

F428 (483.60(c)) – Drug Regimen Review

• Monitoring residents' drug/medication regimens includes the "ongoing collection and analysis of information and comparison to baseline data in order to . . . support decisions about modifying, discontinuing, or continuing interventions."