Pain Medication: Regulatory Conflicts Must Be Resolved

Legislation | August 28, 2017 | by

Nursing homes and hospice providers are caught between two federal agencies, the Drug Enforcement Administration (DEA) and the Centers for Medicare and Medicaid Services (CMS), with conflicting regulations on the administration of medically-necessary pain medications to nursing home residents and hospice patients.

Nursing home and hospice providers in several states are experiencing significant delays in obtaining controlled substances prescriptions for their residents because of recent enforcement actions by the Drug Enforcement Agency (DEA) against long-term care pharmacies pursuant to the Controlled Substances Act (CSA) and its implementing regulations.  These enforcement actions are resulting in sick and dying residents being left for hours—and even days—without adequate symptom relief to treat pain, seizures, psychiatric and end of life symptoms.  Residents’ unnecessary suffering is bad enough, but nursing homes’ inability to get pain relieving medication on a timely basis also puts them at risk for citations of care deficiencies related to pain management.

The regulations implementing the CSA require that all prescriptions for controlled substances on Schedules II-V be written, signed by the prescriber, and presented to a pharmacy for fulfillment. Specifically, regulations require that “prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner.”  The practitioner or the practitioner’s agent may transmit the prescription to the pharmacy by facsimile; however, the prescription must be signed by the prescriber. Verbal orders are prohibited except in “emergency situations”; which the DEA has very narrowly construed so as to apply only when immediate administration of the medication is required (i.e., within minutes, not hours or the next day to account for delivery of the medication from a pharmacy).

By long-standing practice throughout the health care field, nurses routinely create “chart orders” based on verbal instructions from patients’ physicians. Nurses then are responsible for seeing that physician orders are carried out according to the chart order. Chart orders are especially important in the nursing home and hospice fields for several reasons. First, nursing homes and hospices receive residents at all hours of the night and day, and on weekends. These residents are often coming directly from hospitals and are in need of pain medication—hospital physicians do not provide prescriptions to individuals being discharged to another institution. Second, approximately 40% of physicians working in the long term care environment do not have an office-based practice.  Many work from their vehicles and do not have an established office or staff. As a result, requiring an original or faxed prescription necessarily will result in delays getting the medications to the nursing home resident.

The DEA has taken the position that under no circumstance does a legal agency relationship exist between nurses in the nursing home and the resident’s physician. DEA’s refusal to recognize the nurse/agent relationship in nursing facilities or for hospice patients even extends to situations in which the nurse and physician are employed by the same entity.

DEA audits and enforcement actions have resulted in huge fines against long-term care pharmacies that serve nursing homes: in one case amounting to over $32 million.  As a result, pharmacies have changed their policies to accord with DEA regulations, resulting in significant delays in the delivery of pain medication to nursing facility residents.

Meanwhile, the Centers for Medicare and Medicaid Services (CMS), which administers the federal survey and  enforcement system governing nursing homes, has issued  guidelines that specifically require timely and effective pain management for nursing home residents. Any delay in providing a resident with needed pain medication places the resident at risk for re-hospitalization and violates quality of care standards.  While CMS has been made aware of the DEA’s enforcement activities and the resulting delays in the ability of nursing facilities to obtain controlled substance prescriptions for their residents, the agency has said that it must nevertheless enforce its own regulatory requirements. 

Related Statute/Regulation:  

21 CFR Sections 1306.05, 1306.11(d), 1306.11(f)

Proposed Solution:

Amend the Controlled Substances Act and its implementing regulations to (a) permit nurses in long-term care facilities participating in the Medicare and Medicaid programs to act as the agent of  their residents' physicians and (b) to recognize chart  orders created by nurses under instruction from a residents’ physicians’ for scheduled medications.