CMS’ draft call letter for 2012 raises some interesting questions regarding “Scope of Practice”.  Specifically, CMS will require Part D sponsors to validate DEA numbers for prescribed Schedule II controlled substances, and further ensure that the drug is within the prescribers “Scope of Practice”.  A portion of CMS’ document says:

In 2012, we will also impose additional requirements on plan sponsors with regard to Part D claims for Schedule II drugs. We believe that resources are currently available to enable sponsors to buy or build appropriate internal controls to enforce the submission of valid prescriber identifiers from their network pharmacies for these drugs. We also believe that sponsors should ensure that their network pharmacies enforce state and federal laws concerning prescriber scope of practice with respect to authority to prescribe controlled substances. As a result, effective January 1, 2012 Part D sponsors will be required to confirm the validity of DEA numbers on Schedule II drug claims or map NPIs on these claims to the prescriber‘s DEA. In addition, sponsors will be required to confirm that the controlled substance is within the prescriber‘s scope of practice to prescribe. Plan sponsors may elect to comply with these requirements by engaging a commercial vendor that provides validation/mapping services or by executing a Memorandum of Understanding with the DEA to access the DEA‘s Controlled Substance Registration File.

What is “Scope of Practice”?

“Scope of Practice” is the label given to state level regulations limiting prescriptions for controlled substances based on the prescriber’s credential type (Medical Doctor versus Nurse Practitioner versus Dentist, etc).  Each state regulates the ability of licensed practitioners to prescribe controlled substances, and each state does it differently.  Try searching the web for the plight of Florida Nurse Practitioners and Physician Assistants, and you will get a sense for the myriad regulations that exist.  The DEA attempts to help by publishing the mid-level practitioner’s authority by state, which is a great resource for NPs and PAs, but still leaves open questions for other practitioner types, and there is no guarantee that a state will not change their rules tomorrow. 

Health Market Science’s (HMS) Prescriber Eligibility  is a configurable data service that helps answer this question.  In addition to solving the challenges of deceased prescribers, or exclusions from participation in Medicare/Medicaid due to appearing on the Office of Inspector General (OIG) excluded entities list (among 40+ other prescriber compliance checks), HMS also checks the schedule for a prescribed drug against the DEA schedule for the prescriber.  While this solves part of the problem, the answer gets more complicated.

Each Plan D sponsor will likely interpret the regulations differently, and HMS is aggressively pursuing the information our customers need to implement data solutions for compliance, but the overriding requirement is flexibility and configuration as our customers react to changing regulations.  This is why Prescriber Eligibility is the answer, allowing customers to calibrate by state, practitioner type/credential, and controlled substance schedule producing a deliverable that allows part D sponsors to prepare for the 2012 “Scope of Practice” enforcement.

Now, you may not understand the “Scope of Practice” problem, but you know how to solve it!