Whether federal law and policies are preventing nursing home residents from getting the pain medications they need has become a major concern. In May 2009, the Milwaukee Office of the Drug Enforcement Administration (DEA) received a tip that PharMerica, a provider of pharmacy services to nursing facilities, was delivering controlled substances, including Fentanyl and OxyContin, to nursing homes without appropriate prescriptions, in violation of the Controlled Substances Act (CSA). In late July 2009, the DEA searched a PharMerica office and six nursing homes in Wisconsin.
Controversy about DEA raids in Wisconsin, Ohio, Michigan, and Virginia has now moved to Washington, D.C., where two nursing home trade associations, the American Medical Directors Association, and the "Quality Care Coalition for Patients in Pain (QCCPP)," a new coalition formed by the American Society of Consultant Pharmacists, are asking Congress to amend the CSA to conform to current practice in nursing homes. The trade associations and coalition argue that obtaining certain controlled drugs based on facility-initiated "chart orders" (described below) is a routine nursing home practice for providing medications to residents. Without a change in the law condoning the long-time industry practice, they argue, residents in nursing homes will be denied timely access to pain medication.
The United States Department of Justice has rejected industry efforts. Unfortunately, the debate has ignored the issue that is most crucial to beneficiaries – a requirement of the federal Nursing Home Reform Law that physicians be available 24 hours a day for residents. From beneficiaries' perspective the issue is not whether residents receive the pain medication they need – the answer to that must, of course, be yes – but whether residents' care will be properly overseen by physicians, as required by the Nursing Home Reform Law.
The CSA requires that an authorized or DEA-registered prescriber write and sign prescriptions for all controlled substances, including many pain medications commonly received by nursing home residents. The DEA, which enforces the CSA, allows a prescriber to fax an order for a nursing home resident, but it prohibits oral orders except in narrowly defined circumstances.
Since its October 1990 effective date, the Nursing Home Reform Law has required that the care of each resident be under the supervision of a physician and that each nursing facility "provide for having a physician available to furnish necessary medical care in case of an emergency." Regulations addressing Physician Services reiterate the statutory requirement for emergency physician availability and require that "(1) The medical care of each resident is supervised by a physician; and (2) Another physician supervises the medical care of residents when their attending physician is unavailable."
Current Practice in Nursing Homes
Many nursing homes use "chart orders" for prescriptions, including controlled substances. As described by the American Association of Homes and Services for the Aging (AAHSA), the national trade association of not-for-profit facilities, a nursing home nurse who assesses a resident's changed condition may contact the physician by phone to describe the resident's symptoms and vital signs. If the physician gives the nurse a "verbal" (i.e., oral) order for a new drug or a changed drug, the nurse records the order in the resident's chart – a "chart" order – and then faxes the chart order to the pharmacy for dispensing.
The DEA, however, does not consider the nursing home nurse an agent of the physician and requires the physician to initiate prescriptions for all controlled substances.
Nursing Home Industry Arguments
The nursing home industry argues in three different analyses that current nursing home practice should be recognized by the DEA and not sanctioned, or that Congress should amend the CSA to allow the practice of chart orders for controlled substances. None of the industry analyses refers to requirements of the Nursing Home Reform Law.
AAHSA argues that chart orders should be recognized for several reasons. First, the association contends that facilities receive residents "at all hours of the night and day, and on weekends. These patients are often coming directly from hospitals and are in dire need of pain medication." Second, it contends that more than 40% of physicians who see residents "work out of their vehicles and do not have an established office or staff." Finally, delaying prescriptions for residents can cause residents distress and subject the facility to "regulatory enforcement rules."
A joint brief by the American Health Care Association (AHCA) and the American Medical Directors Association (AMDA) describes "verbal orders," which the associations define as orders "that are not written directly by practitioners," as necessary "because – among other reasons – physicians generally are only present in the facility intermittently and may not be readily available to receive and discuss information or give orders directly in a timely fashion." The Issue Brief recommends that each nursing facility should:
- "Educate its staff and practitioners about the implications of writing orders on the [Physician's order sheet], and related documentation guidelines;"
- "Have a policy and/or protocol governing written orders on the POS, including circumstances for writing verbal orders;"
- "Be aware of how its physician order sheet (POS) is used;"
- "Institute measures that seek to reduce errors related to verbal orders;"
- "Have a clear and thoughtful approach to developing and using preauthorized orders;" and
- "Medical directors should review issues related to verbal orders with their attending physicians."
The QCCPP Issue Brief calls on Congress to amend the CSA to (1) clarify that a nursing home nurse "is an agent of the prescriber," (2) define chart orders as valid prescription orders, and (3) "ensure that pharmacists cannot be penalized for preparing prescription drug orders for the review and signature of a practitioner for long-term care residents."
On October 19, 2009, Senators Herb Kohl (D, WI) and Sheldon Whitehouse (D, RI) wrote to U.S. Attorney General Eric H. Holder, Jr. about the DEA issue, including draft legislation (the "Long-Term Care Patients' Access to Medically Necessary Controlled Substances Act of 2009") that would deem the nursing home's licensed nurse to be the medical practitioner's agent and would make chart orders legal.
Department of Justice Response
In December 2, 2009 letters to the Senators, Assistant Attorney General Ronald Weich reported that pharmacists' complaints to the DEA had prompted the recent investigations. Mr. Weich shared the Senators' concern in assuring the health and welfare of residents and argued that business practices like chart orders "trivialize the doctor-patient relationship and weaken the quality of care for the frail and infirm," while increasing the risk of diversion of controlled drugs. Mr. Weich defended the DEA's practices in enforcing the CSA and rejected the Senators' position that the CSA does not recognize current practices in long-term care facilities:
The assumption underlying this statement appears to be that because some Long-Term Care Facilities have established improper patterns of behavior relating to the prescribing of controlled substances (and which lack appropriate involvement by a properly licensed practitioner), this conduct should be declared permissible going forward.
He described two existing accommodations in federal regulations implementing the CSA that recognize the "unique characteristics" of nursing homes. The regulations permit nursing homes to use automatic dispensing machines to dispense controlled drugs to residents and they allow pharmacists to dispense prescriptions for nursing home residents when they receive faxed prescriptions.
Advocates for residents recognize that residents' pain must always be promptly and thoroughly addressed. They point out that the under-treatment of residents' pain is, in fact, a serious and long-standing problem. But the industry's approach seems misguided. If a resident becomes so suddenly and seriously ill that he or she urgently requires pain medication at the level of a controlled substance, he or she is also likely to need immediate medical attention. Getting a resident pain medication, but no medical care, may not solve the resident's underlying medical problem.
Moreover, the Nursing Home Reform Law requires that physicians be available in emergencies and to oversee residents' medical care 24 hours a day. Enforcing the Reform Law would reduce, if not eliminate, the problem of residents failing to get the physician-prescribed pain medication they need.