URAC has recently released Specialty Pharmacy Standards (3.0), and many specialty pharmacies may be uncertain of what these changes will require or how these requirements may affect them upon reaccreditation.
“This is not a small update to the standards,” said Pam DeVaul, VP Clinical Services at Therigy. “This is a major revision. There are major edits, minor edits, title changes, standards removed, new standards added, standard weight changes, and major edits to guide language.
“Overall, URAC 3.0 standards are easier to read, the interpretations are clearer, and the points-to-remember sections are very helpful and should be taken into consideration by everyone. The 3.0 standard requirements are good and the updates were needed, however there may be some standards that can pose problems, as they affect operational processes, systems, resources, and patient record documentation.”
DeVaul has more than 20 years experience helping specialty pharmacies in the accreditation process and notes the following changes will have significant impact:
- The requirement to have a Care Management Plan is a new standard and one that may be problematic for specialty pharmacies, which generally do not provide direct care to patients. Documented care plans have long been required for direct-care pharmacies and organizations, including infusion pharmacies, home medical equipment providers, consulting pharmacies, home care agencies, and hospices.
URAC has now made care plans a mandatory requirement for all specialty pharmacies, but most do not have information systems that support this kind of documentation and must come up with a way to meet this requirement. Pharmacies also must consider clinical resources to support the writing and upkeep of these patient-specific care plans.
“Therigy’s therapy management platform, TherigySTM, offers pre-configured care plans to assist pharmacies in this effort to meet URAC’s standards and provide excellent clinical care for patients,” said DeVaul.
The TherigySTM software is in the process of being updated to comply with 3.0 and the Care Management Plan and will be able to accommodate these requirements.
- If a pharmacy is “in process” with URAC and has applied under 2.1, it will be surveyed for 2.1. However, upon renewal in three years, the pharmacy will be expected to be compliant with 3.0. Pharmacies preparing for reaccreditation should verify with URAC which standards they will be surveyed under. Therigy representatives can assist with this transition.
Also of note:
- SDrM5 Drug Utilization Review Reporting. This mandatory standard now requires reporting for drug utilization management to the Quality Committee on a quarterly basis.
- PHARM OP 7 Cold Chain Distribution: Process Controls and Monitoring System. This standard requires a validated distribution process for the cold chain process, including issues such as criteria for packing products, modes of transport, validated distribution processes, and temperature controls and guidelines.