CMS to R.Ph.s: Beware of new nursing home guidance

Acompliance guidance for nursing homes proposed by the Office of the Inspector General for the Department of Health & Human Services emphasizes the need for appropriate pharmaceutical care. The proposals, which appeared in the Federal Register earlier this year, are the first comprehensive revision of OIG's compliance guidance since 2000.

"These proposals track existing regulatory requirements and practice standards," said Claudia Schlosberg, director of policy and advocacy for the American Society of Consultant Pharmacists. "The OIG has reiterated best practices and reminded nursing homes to follow the rules. We think that is a good course to follow."

Much of the draft guidance deals with the appropriate use of psychotropic drugs, medication management, and federal kickback statutes. The OIG has found that psychotropic drugs represent two risk areas for nursing homes. One is the use of psychotropics as chemical restraints, the other is the use of unnecessary drugs.

In the guidance, OIG noted that facilities are specifically prohibited from using medications as a means of restraint for "purposes of discipline or convenience, and not required to treat the resident's medical symptoms."

For residents whose condition requires the use of psychotropic agents, regulations from the Centers for Medicare & Medicaid Services require that dosages be gradually reduced unless contraindicated. Residents must also receive behavioral interventions aimed at reducing medication use. "That's something that has been going on in one form or another for at least 20 years," Memoli said. "OIG is reminding nursing homes that they have to make sure it actually happens." In practice, he said, patient records must show an appropriate indication for every medication. In addition, nursing homes must monitor each use of psychotropic agents and document both the need and the monitoring.

Facilities must also document steps taken to ensure compliance. Those steps include education of staff and prescribers and ensuring that individual patient care plans are consistent with patient needs rather than the convenience of the facility or staff. "Those steps are what leads to the proper medication use for each resident," Memoli said. "It sounds easy, but there is a lot involved, especially for the consultant pharmacist."

The draft compliance also notes that federal law requires nursing homes to provide pharmaceutical services to meet the needs of each patient. CMS regulations go even farther, requiring facilities to employ or obtain the services of a consultant pharmacist to provide those services and to review all drug regimens. In many cases, OIG noted, consultant pharmacists are provided by the long term care pharmacy that serves the facility.

The danger is a potential conflict between patient needs for specific agents and long term care pharmacy formularies or other preferred drug selection procedures. Consultant pharmacists working for long term care pharmacies could face a conflict of interest. "Facilities should establish policies that make clear that all prescribing must be based principally on clinical efficacy and appropriateness," OIG wrote in the draft guidance. "Drug switches should not be made by a pharmacist without authorization from the attending physician, medical director, or other licensed prescriber (except for generic substitutions where permitted by State law.)"

One key area the draft guidance did not explore in detail is Medicare Part D. OIG noted in broad terms that nursing homes should work with long term care pharmacies to ensure that all residents can use the Part D plan each resident chooses.

The guidance does discuss anti-kickback statutes and prohibits offering or receiving anything of value to induce or to reward the referral or generation of business. Still, Memoli and Schlosberg both noted that the guidance makes no mention of questionable behavior in the Medicare Part D program. "Part D formularies drive medication use decisions in the real world and formularies are driven by financial relationships between plans and manufacturers," Schlosberg said. "We need the same scrutiny applied to those relationships in the nursing home environment."