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8/3/2004

'Locked Storage' Addressed in CMS's New Interpretive Guidelines

Donna Young

The Centers for Medicare and Medicaid Services (CMS) on June 2 published new guidelines to help hospitals interpret the Conditions of Participationfederal requirements to receive Medicare and Medicaid payments.

The guidelines are available online at www.cms.hhs.gov/manuals/107_som/som107ap_a_hospitals.pdf (PDF).

Sections of the guidelines that pertain specifically to pharmacy are found in 482.25, 482.25 (b)(2), and 482.23 (c), according to a CMS official.

CMS's conditions of participation for hospitals state: "Drugs and biologicals must be kept in a locked storage area."

According to the agency official, CMS relies on the strict definition of drugs and biologicals found in Section 1861 of the Social Security Act, which states that drugs and biologicals include only such products that are found or approved for inclusion in "the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital."

The new medication management standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) require that medications should be secured in accordance with "the organization's policy and law and regulation so that unauthorized persons cannot obtain access to them," said Darryl S. Rich, JCAHO's associate director of surveyor management and development.

CMS also expects bedside medications to be locked or secured, he added.

Many of the new survey-process questions for state surveyors included in CMS's new guidelines are "identical to the elements of performance" in JCAHO's medication management standards, Rich said, "and thus will assist in assuring uniformity of interpretation between JCAHO and CMS surveyors."

When JCAHO gets questions about medication security, he said, "we defer the caller to CMS for an interpretation and will not provide a response."

But, he added, JCAHO "will abide by any interpretation of the law an organization receives from CMS as long as the conversation is documented or the response from CMS is in writing. Otherwise, we follow the above definition we received from CMS."

But the CMS official stressed that the new guidelines "supersede" any interpretations that a regional agency office or surveyor has provided to a hospital.

Agency surveyors and regional CMS offices should not attempt to "judge the content" of the law's definition, he added.

Janet A. Silvester, pharmacy director at Martha Jefferson Hospital in Charlottesville, Virginia, said that the law's strict definition creates a barrier to patient care.

"We will always lock things that we deem to be a risk," she said. "No one has a problem locking things that could cause someone to be harmed."

But, she said, because there are numerous products defined by the law as a drug that is used routinely, such as alcohol swabs, it would be "impractical" to keep those items locked.

"My suspicion is that hospitals will choose to take their chances and not lock everything," Silvester said.

The new guidelines are helpful in interpreting the government's law, she added. "I just don't like the interpretation."

CMS's new guidelines state that pharmaceutical services must be administered in accordance with accepted professional principles, which include compliance with federal and state laws and regulations, guidelines governing pharmaceutical services, and standards and recommendations promoted by nationally recognized professional organizations.

CMS specifically names the American Society of Health-System Pharmacists as an example of a professional organization.