A mid-January directive to state survey agencies provides new details about Medicare’s expectations for pharmacy activities and compounding practices at critical access hospitals.
The Centers for Medicare and Medicaid Services (CMS) communication provides an update to imperative guidelines for state surveyors, and has wider ramifications. The CMS is mandating well-established pharmacy practices that the Institute for Safe Medication Practices, the United States Pharmacopeial Convention, the ASHP, and a number of other professional groups have endorsed for years. Ultimately, CMS is likely to require the same practices for all hospitals.
The updated pharmacy practice expectations are incorporating minimum standards for everyone, those which are known to be safe ways of practicing medicine. A large portion of the 93-page CMS communication addresses pharmacy practice, including both sterile and nonsterile compounding, medication safety, administration, handling, and storage.
For many pharmacies, it’s not necessarily any different from what is already being done. Some pharmacists, like Todd Lemke of CentraCare Health, say they believe it is just regulation catching up with practice. Lemke maintains catching up to the new Medicare required standards is not difficult for many hospitals, but finding the time to document compliance may be an issue.
According to CMS, 83% of hospitals overall were met at care certified through a deeming agency in the fiscal year 2013. However, only 33% of critical access hospitals that same year were also Medicare certified. This suggests that state survey agencies play a big part in making sure the critical access hospitals meet Medicare’s conditions of participation.
The CMS document officially establishes USP Chapter 795 as the minimum standard for non sterile compounding, and USP Chapter 797 for compounded sterile products. USP Chapter 795 has been enforceable since 2000, meaning that state boards of pharmacy and other organizations can use it as a basis for fines and other adverse actions against any noncompliant regulated entities. Chapter 797 has been enforceable since 2004.
The CMS requirement that compounding can only be performed by a pharmacist or other personnel authorized in accordance with state and federal law may cause compliance issues for any use sparsely staffed critical access hospitals.
If the hospital contracts for compounding activities, there must be a written contract in place and there must be access to the vendor’s quality assurance data to verify compliance with chapters 795 and 797. Every hospital is required to document that it obtained and reviewed the data. CMS also expects vendors to follow state laws and meet requirements of section 503A of the food, drug, and cosmetic act in relation to compounding of human drug product.