RE:  Regulations Governing the Practice of Pharmacy [18 VAC 110-20]

Dear Ms. Juran:

Riverside Health System, a non-profit health care organization, represents four acute care hospitals, one behavioral health hospital, and two specialty hospitals. We have more than 600 clinical providers and over 9,500 team members. We provide care that covers 8,000 square miles in Coastal Virginia.

Given our commitment to provide the highest level of care to every patient, every day, we feel compelled to share our concerns over the practice of “white bagging”, a payer mandate which requires hospitals and health systems to order certain infusion drugs through a specialty drug network of a patient’s insurer versus managing the full drug supply chain internally.  When the Notice of Intended Regulatory Action (NOIRA) was issued on December 11, 2017, the intent of the updated regulations was to protect the public by codifying rules to ensure infrequently “white bagged” drugs are handled appropriately.  Since that time, the practice of mandated “white bagging” has grown, with significant expansion seen over the last 12 months, and now includes oncology care.

“White bagging” in any situation is inconsistent with regulatory guidance and best practice.  As an example, Centers for Medicare and Medicaid Services Conditions of Participation for Acute Care Hospitals requires that hospital pharmacy services, encompassing the function of procurement, is directed by a competent registered pharmacist employed by the hospital.  Drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice and consistent with Federal and State law.  The practice of “white bagging” removes the hospital pharmacy from the procurement process.  Additionally, the practice is inconsistent with the federal Drug Supply Chain and Security Act, which does not recognize “white bagging” as an exemption to the requirement for transaction information. 

“White bagging” is also risky for safe, timely provision of patient care since it breaks down the traditional distribution process by removing the direct relationship between manufacturer/distributor and hospitals/clinics for provider-administered medications.  Potential implications of “white bagging” include but are not limited to delays in patient care, reduced patient access to medication, compromised drug integrity, drug wasting, increased administrative burden and inappropriate shifting of liability to providers.

The practice of “white bagging” should be limited only to those truly rare cases in which a patient has no other way to obtain a needed medication.  The newly added Subsection F of 18VAC110-20-275 contains important safeguards for patient safety in these cases when “white bagging” of drugs from a pharmacy to an alternate delivery site is needed in urgent, non-routine situations.  But payer mandates for “white bagging” of defined medications are routine, and as such, Subsection F does not apply.

Short of “white bagging” being banned in Virginia, we are asking for the strongest patient protections possible in regulation and guidance documents.  The existing regulations in Subsections B through E of 18VAC 110-20-275 provide safeguards to improve patient safety and care and should be enforced until such time that stronger legislation or regulation is introduced.

“Brown bagging”: the practice of delivering dispensed drugs that require administration in a healthcare setting directly to a patient’s residence, is also risky and potentially dangerous.  “Brown bagging” should be banned except in cases where patients have inherited bleeding disorders and the drugs are needed for emergency, lifesaving treatment.  We therefore support the new Subsection G of 18VAC110-20-275 and recommend it be implemented as planned.

With the growth of payer mandated “white bagging” policies, we recommend the Board of Pharmacy:

1. Consider modification of the new Subsection F as below:

F. The pharmacy and alternate delivery site shall be exempt from compliance with subsections B through E of this section if (i) the alternate delivery site is a pharmacy, a practitioner of healing arts licensed by the board to practice pharmacy or sell controlled substance, or other entity holding a controlled substances registration for the purpose of delivering controlled substances; (ii) the delivery of the Schedule VI controlled substance by the pharmacy is  due to an emergency and not otherwise available at the alternate delivery site and (iii) compliance with subsections B though E of this section would create a delay delivery that will result in  patient harm.  However, the pharmacy and alternate delivery site shall comply with the following requirements….

2. Issue guidance that clarifies the applicability of the new Subsection F of 18VAC110-20-275, and that this new Subsection does not apply to published payer mandates requiring “white bagging” of medications.  If the Board cannot issue such guidance, then we recommend the Board suspend this regulatory action (Subsection F), reaffirm the requirements in the existing regulations and develop new regulations that account for the proliferation of insurer-mandated “white bagging” policies.
3. Implement the new Subsection G of 18VAC-110-20-275 as proposed. 
4. Hold additional stakeholder workgroup meetings on the practice of “white bagging” to learn more about the new programs that have been implemented since previous discussions were held and assess whether more stringent regulations governing these practices are needed.

On behalf of Riverside Health System, thank you for your consideration of these comments and recommendations.

Cynthia Williams, BS Pharm, FASHP

Vice President/Chief Pharmacy Officer

Riverside Health System