January 30, 2020

QUESTION:        I heard that the Department of Health and Human Services released a new rule on partial fills of opioid prescriptions.  Can you give me a brief overview of the change?

ANSWER:          Yes.  The Department of Health and Human Services (“HHS”) has issued a final rule designed to improve tracking of transactions involving Schedule II drugs.  Briefly stated, this change requires certain covered entities to report “quantity prescribed” data for transactions involving Schedule II drugs.  The data will track whether the prescription was partially filled (which is legal under some circumstances) or refilled (which can potentially be a violation of the Controlled Substances Act).

If your organization is covered by HIPAA and has a retail pharmacy that dispenses Schedule II drugs, you should check to see whether this law may have an impact on your workflows and recordkeeping.  The final rule is available here.

March 7, 2019

QUESTION:        The Department of Health and Human Services requires us to take reasonable steps to provide meaningful access to Limited English Proficient (“LEP”) persons.  Can we rely on a patient’s family members or friends to help with this?

ANSWER:            No.  The only exception is if it is an emergency or if the patient specifically requests otherwise.  All entities that receive federal financial assistance from the Department of Health and Human Services (“HHS”) are generally prohibited from requiring patients with limited English proficiency to use family members or friends as interpreters.  HHS acknowledges in its regulatory guidance that there may be times when a patient feels more comfortable having a trusted friend or family member act as interpreter — under these circumstances, you can honor the request.  However, you should consider factors such as competency, confidentiality, privacy, and/or conflicts of interest.

Your legal obligations will vary depending on the size of your organization and the patients you typically encounter.  This area of the law is developing quickly and we expect to see more case law on this topic in the next few years.  In the meantime, we encourage you to review your policies on this matter and have your lawyers assess whether you are in compliance with all federal regulatory obligations.