2 comments
SUBMITTED ELECTRONICALLY
(https://townhall.virginia.gov/l/Comments.cfm?GdocForumID=639)
September 14, 2021
Caroline D. Juran, RPh
Executive Director
Virginia Board of Pharmacy
9960 Mayland Drive, Suite 300
Richmond, Virginia 23233
Re: Guidance on alternative delivery of prescriptions in Virginia, pharmacy to physician or pharmacy to controlled substance registrant (Document ID 110-3)
Dear Ms. Juran:
On behalf of the Virginia Hospital & Healthcare Association’s 26 member health systems – with 110 community, psychiatric, rehabilitation, and specialty hospitals and more than 125,000 employees – thank you for the opportunity to provide comments to the Board of Pharmacy on the newly-updated Guidance Document 110-3.
We are pleased the Board voted to update this document at its June 4, 2021, meeting to clarify the regulatory interpretation of the requirements in 18VAC110-20-275 related to the practices commonly referred to as “white bagging” and “brown bagging.” Payor-mandated white bagging programs have proliferated since the Notice of Intended Regulatory Action (NOIRA) was issued for these regulations on December 11, 2017. Establishing clear guidelines to ensure drug safety and patient wellbeing and choice are exceptionally important, especially since some payors have previously asserted Subsections B through E of 18VAC110-20-275 do not apply to their programs.
We support these provisions of the Guidance Document concerning standardized and routine white bagging programs:
A pharmacy making regular deliveries of a standardized list of drugs to the same alternate delivery site over time would NOT be exempt from compliance with subsections B through E as this constitutes routine delivery from the pharmacy.
A pharmacy delivering a drug to an alternate delivery site when compliance with subsections B through E of this section would not create a delay that may result in patient harm is NOT exempt from subsections B through E of this section.
These additions to the document help to create clearer expectations that the payor-designated third-party pharmacies engaged in white bagging must establish mutually agreed-upon contracts and policies and procedures with the partner pharmacies and providers that treat patients and are ultimately responsible for administering the drugs.
Consistent with the intent of the regulations, we would interpret these additional examples to mean that “regular” deliveries would include any “repeat” delivery and that the word “regular” does not require that there is a pre-determined frequency of deliveries. Under circumstances where it is expected that there will be any repeat delivery to an alternate delivery site, then the requirements at Subsections B through E of 18VAC110-20-275 should apply, no matter what frequency those deliveries may occur.
Similarly, it would interpret circumstances that “would not create a delay that may result in patient harm” to include circumstances where the need for delivery to an alternative delivery site is known in advance (e.g., at least 24 hours), such that subsections B through E of 18VAC110-20-275 could reasonably be complied with without creating a delay in delivery that may result in patient harm.
Looking ahead, while the 18VAC110-20-275 regulations combined with this updated guidance provide important protections to patients and their treating providers, we are advocating for even stronger restrictions on the practice of white bagging. White bagging should be limited only to rare cases in which a patient has no other way to obtain a needed medication in a timely manner. And when that occurs, the decision to obtain a drug via a white bagging delivery should be the decision of the treating provider.
Considering this, we recommend the Board of Pharmacy:
Thank you for your attention to these comments and recommendations.
Sincerely,
Craig Connors
Senior Director, Payor Relations
The Virginia Society of Health-System Pharmacists (VSHP) supports the draft Guidance Document 110-3 Guidance on alternative delivery of prescriptions, pharmacy to physician or pharmacy to controlled substance registrant.
We particularly support the following examples stated in the Guidance Document:
Examples: A pharmacy is exempt from subsections B through E of this section when it needs to deliver a drug to a licensed alternate delivery site that does not routinely receive deliveries from the pharmacy and compliance with subsections B through E of this section would create a delay in delivery that may result in potential patient harm.
A pharmacy making regular deliveries of a standardized list of drugs to the same alternate delivery site over time would NOT be exempt from compliance with subsections B through E as this constitutes routine delivery from the pharmacy.
A pharmacy delivering a drug to an alternate delivery site when compliance with subsections B through E of this section would not create a delay that may result in patient harm is NOT exempt from subsections B through E of this section.
The guidance examples above help clarify the intent of current regulations that were developed as a positive first step in setting up guardrails in anticipation of this emerging practice. Payors recently implemented additional, specific white bagging policies that have added to the challenges and burden posed by current white bagging practices that prevent providers from timely and optimized care.
VSHP aligns itself with the American Society of Health System Pharmacists (ASHP) white bagging statement:
ASHP stands opposed to payer-mandated white bagging models that jeopardize optimal, safe, and effective medication use. It is ASHP’s position that payer-mandated distribution models that require clinician-administered drugs to be dispensed exclusively via third-party specialty pharmacies are placing patients at risk and threaten to compromise organizations’ well-established practices intended to ensure patient safety. Additionally, white bagging negatively impacts pharmacists’ ability to validate medication integrity and maintain oversight of storage and handling. Further, by sidestepping well-established supply chain procedures, white bagging disrupts efforts to maintain adherence with protocols designed to ensure patient safety, quality, and continuity of care.
We also associate ourselves with the letter from the Virginia Hospital and Healthcare Association (VHHA) submitted as public comment on this matter, including VHHA's interpretation of "regular" deliveries and recommendations for future steps on new stakeholder meetings or a workgroup, data collection and analysis, and potential regulatory or legislative action to address the patient safety risks of white bagging.
Thank you for your time and consideration.
Virginia Society of Health-System Pharmacists