OIG Raps CMS Oversight of Compounded Drugs

The Office of Inspector General recommends 55 practices to ensure quality and safety.


More than 2 years after drugs contaminated with a virulent fungus killed 64 patients and caused related illnesses in another 687, Medicare-approved hospital accreditors still don’t properly oversee contracts hospitals have with compounding pharmacies to assure these drugs are safe, according to an Office of Inspector General report.

It recommends the Centers for Medicare and Medicaid Services (CMS) consider requiring 55 practices for accreditors to use to oversee compounded sterile preparations (CSPs).

“Contracting with standalone pharmacies for CSPs gets limited attention from the oversight entities,” the OIG report says. “Only one in five oversight entities always reviews hospitals’ contracts with standalone pharmacies,” a review that could address “recall procedures, proper storage while in transit, and quality assurance related to CSP sterility and potency.”

Additionally, “none of the entities plan to change how they assess these contracts in light of [the] FDA’s new initiative to register and inspect standalone compounding pharmacies.”

In addition to CMS itself, the agency authorizes four outside organizations to assess and certify hospitals wishing to receive Medicare reimbursement under CMS’ requirements for conditions of participation related to the performance of a hospital’s governing body and its infection control policies.

They are:

  • The Joint Commission, which accredits most of the hospitals in the Medicare program
  • Det Norske Veritas Healthcare (DNV)
  • The Center for Improvement in Healthcare Quality
  • The American Osteopathic Association/Healthcare Facilities Accreditation Program


A 2013 OIG report said that 92% of hospitals use CSPs, and 80% contract with at least one standalone pharmacy for their supplies.

The OIG made two overarching recommendations; CMS agreed with both:

  • Ensure that hospital surveyors receive training on standards from nationally recognized organizations related to safe compounding practices
  • Amend the interpretive guidelines to address hospitals’ contracts with standalone compounding pharmacies.


The report did not say which of the five agencies failed to engage in recommended accreditation practices related to compounding pharmacy product safety, but detailed how many said they engaged in which of 55 practices “always,” “some of the time,” or “never.”

The report said most of the five CMS-approved accreditors “may lack human capital required to thoroughly review hospitals’ preparation and use of CSPs,” and said that “none of them are considering changes to how they oversee hospitals’ contracts with standalone compounding pharmacies.”

Read more here: http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/49723

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