Agencies | Governor
Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
Action Brown bagging and white bagging
Stage Final
Comment Period Ends 6/9/2021
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11 comments

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5/21/21  2:12 pm
Commenter: Craig Connors on behalf of the Virginia Hospital & Healthcare Association

VHHA Comments on Regulations Governing the Practice of Pharmacy (18VAC110-20)
 

SUBMITTED ELECTRONICALLY

(https://townhall.virginia.gov/L/ViewStage.cfm?stageid=8947)

 

May 21, 2021

 

Caroline D. Juran, RPh

Executive Director

Virginia Board of Pharmacy

9960 Mayland Drive, Suite 300

Richmond, Virginia 23233

 

Re:  Regulations Governing the Practice of Pharmacy [18 VAC 110 ? 20]

 

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 comment to the Board of Pharmacy regarding 18VAC110-20 and the practices commonly referred to as “white bagging” and “brown bagging.”

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.  Three and a half years have passed since that NOIRA, and the practice of “white bagging” has proliferated to a level not foreseen in 2017.

 

The newly added Subsection F of 18VAC110-20-275 contains important safeguards for patient safety in situations when white bagging of drugs from a pharmacy to an alternate delivery site is needed in an urgent, and non-routine circumstance.  Communicating basic logistical details such as arrival date, shipping information, and delivery address are common-sensical steps that should be taken by any responsible pharmacy, even without regulations.

 

White bagging in any circumstance is inherently risky for safe, timely patient care because it breaks down the normal distribution process by removing the direct relationships between manufacturer and clinics/hospitals for provider-administered medications.  Potential implications of white bagging include, but are not limited to: delays in patient care; reduced patient access to the right medication; limited site of care flexibility for patients; compromised drug integrity and efficacy; drug wastage; inappropriate shifting of liability to providers; and administrative inefficiencies.

 

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.

 

Short of white bagging being banned – or at least significantly curtailed – in Virginia, we advocate for the strongest patient protections possible in regulations.  The existing regulations in Subsections B through E of 18VAC110-20-275 provide reasonable safeguards because they require pharmacies that engage in white bagging as a matter of “routine” practice to 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.  Such guiding documents establish processes and associated non-compliance provisions that put patient safety on the forefront – and they are mutually agreed to between two collaborating entities.  Accordingly, subsections B through E of 18VAC110-20-275 should firmly apply when white bagging policies and programs are standardized across patients.

 

“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.

 

Considering our comments above, we recommend the Board of Pharmacy:

  1. Issue guidance that clarifies the applicability of the new Subsection F of 18VAC110-20-275 – specifically what the provision on “routinely receiving deliveries” means in light of high-volume white bagging policies being implemented by insurers and pharmacy benefit managers.  If the Board cannot issue such guidance quickly, then we recommend the Board suspend this regulatory action, reaffirm the requirements in the existing regulations, and develop new regulations that account for the proliferation of insurer-mandated white bagging policies.
  2. Implement the new Subsection G of 18VAC110-20-275 as proposed.
  3. Hold additional stakeholder workgroup meetings on the practice of white bagging to learn more about new programs that have been implemented since previous discussions were held and assess whether even more stringent regulations governing these practices are needed.

 

On behalf of VHHA and its members, thank you for your consideration of these comments and recommendations.

 

Sincerely,

 

 

 

Craig Connors

Senior Director, Payor Relations

CommentID: 98630
 

5/24/21  3:56 pm
Commenter: Douglas E. Lischke on behalf of UVA Health

Comment on Regulations Governing the Practice of Pharmacy [18 VAC 110 ? 20]
 

May 24, 2021

 

Caroline D. Juran, RPh

Executive Director

Virginia Board of Pharmacy

9960 Mayland Drive, Suite 300

Henrico, VA 23233

 

Re:   Public Comment on Regulations Governing the Practice of Pharmacy [18 VAC 110 ? 20]

 

Dear Ms. Juran:

 

On behalf of the University of Virginia Health System (UVA Health), I thank you for the opportunity to provide comment to the Board of Pharmacy concerning the above-referenced Final Regulation dealing with “white bagging” and “brown bagging” practices. UVA Health fully supports and endorses the public comments submitted on May 21, 2021 by the Virginia Hospital and Healthcare Association (VHHA) concerning new Subsections F and G contained in the Final Regulation.  Further, UVA Health urges the Board of Pharmacy to implement the recommendations proposed by VHHA with respect to the Final Regulation. 

 

Thank you for your consideration of our comments.

 

Sincerely,

 

Douglas E. Lischke, CPA, MBA

Chief Financial Officer

UVA Health

CommentID: 98672
 

6/3/21  3:51 pm
Commenter: Josh Humphries, Virginia Association of Health Plans

VAHP Comments on White Bagging
 

June 3, 2021

Caroline D. Juran

Executive Director

Virginia Board of Pharmacy

9960 Maryland Drive, Suite 300

Henrico, VA 23233

 

VIA EMAIL

 

Dear Ms. Juran: 

In response to the letters dated April 5, May 11, and comments posted on Virginia Townhall from the Virginia Hospital and Healthcare Association (VHHA) in the matter of 18 VAC 110-20 to the Board of Pharmacy regarding “white bagging,” the Virginia Association of Health Plans (VAHP) would like to share the following information.

White bagging focuses on reducing the cost of certain specialty medications covered under a member’s medical benefit and is part of health plan’s long-term objective to reduce health care costs for the Virginian’s we serve. Health plans cover the vast majority of these costs and play a vital role in helping ensure members can access affordable specialty medications. Some health plans have implemented white bagging programs through designated specialty pharmacy networks. Whatever the approach, the programs ultimately afford the member with significant cost savings while ensuring the safety and efficacy of the medications provided to patients through white bagging.

 

The high costs of certain complex specialty medications administered in the office setting and hospital outpatient setting are the largest driver of rising costs for health plans and can cause members to quickly reach their deductible and out-of-pocket maximums. White bagging seeks to address the out-of-pocket costs members pay for specialty medications and allows the out-of-pocket costs to be more spread out than they otherwise would be before members reach their deductible or out-of-pocket maximum. Currently, the cost of certain specialty medications administered in the hospital outpatient setting can be approximately 200 to 300% more than when the same drug is administered in an office-based setting, with some providers charging over 500% more. Specialty drugs account for only 2% of drugs dispensed but represent nearly 45% of all prescription drug spending, a figure expected to rise to 52% by 2024. The health plan seeks to lower the overall cost of certain speciality medications and reduce out-of-pocket costs for its members.

 

As you know, the issue of “white bagging” has been discussed by the Board of Pharmacy for several years. VAHP appreciates the Board’s commitment to ensuring Virginia’s white bagging programs are safely providing patients with access to specialty medications beginning with  your  initial development of regulations in 2017 through the conclusion of the final adoption period on June 9, 2021. VAHP also appreciates and recognizes the Board’s responsiveness to questions and concerns raised throughout the regulatory process. We agree with the Board’s response to comments suggesting that regulations already include language to establish “any willing provider” requirements that the, “the Board (of Pharmacy) does not have the authority to regulate insurance companies or pharmacy benefit managers and the Board’s statement that “white bagging may assist patients access to medication when delivered in a restricted manner.” Finally, we agree with the Board’s statement in its Agency Background Document developed on March 22, 2019 and posted on Virginia Town Hall on April 1, 2019  during the Proposed Stage of the regulatory process that the, “Board cannot prevent insurance companies or pharmacy benefit managers from requiring a patient to obtain the drug from a specialty pharmacy, but it can place requirements on the pharmacy for how those drugs must be delivered to the patient,” in response to comments submitted to the Board by Premier Health Care Association.

To our knowledge, the Board has not found health plans with existing specialty pharmacy programs in violation of existing requirements.

The health plans are in compliance with applicable laws and regulations. Section F of the Virginia regulation, 18VAC110-20-275, specifically applies to most health plan’s white bagging programs in which the specialty pharmacy will deliver member’s specialty drugs to the hospital pharmacy as the alternate delivery site.  These will not be “routine” deliveries, and instead will only deliver to the hospital pharmacy as required by the member’s need for a specialty drug.  The coordination, delivery and chain of custody of the specialty medication will be managed by the specialty pharmacy well in advance of the member’s administration of the drug as described above.  As the Board of Pharmacy noted in response to the revisions to 18VAC110-20-275, the intent of the regulation was to make access to important specialty medications more accessible to Virginians.  Accordingly, the health plans are critical partners to ensure quality and safe administration of the specialty drugs under their respective Programs while trying to improve the affordability for members.

Regarding concerns about the handling of white bagging drugs presenting unnecessary safety risks, a speciality pharmacy used by a number of health plans in Virginia does not mix or compound any of the drugs that are shipped to hospitals.  All drugs that are shipped from the speciality pharmacy are in their original manufacturer’s packaging similar to how they are currently receiving their drugs from distributors and manufacturers.  Responsibility for preparing/compounding these drugs remains with the hospitals giving them flexibility to make any last minute dose adjustments.  The specialty pharmacy’s dedicated team of professionals will work closely with hospitals to determine the drug/dosage that is needed, shipping information and member’s appointment date so arrangements can be made to have the drug delivered to the hospital in advance of the member’s appointment.  Drugs that require special handling (i.e. refrigeration) are shipped in thermal containers with sufficient frozen gel packs to maintain the drug’s integrity during transit.

 

In the event of a last minute dose increase and the quantity of drug shipped is insufficient to prepare the dosage needed (and the speciality pharmacy is unable to ship additional quantities in time for the member’s appointment), an exception process exists that will allow the hospital to be reimbursed for using their own supply of the drug.  This same exception process may be utilized in instances where a drug arrives damaged or unusable, last-minute change in drug regimen or if the drug does not arrive on-time despite the best efforts of the hospital to obtain the drug.  This exception process will help eliminate any potential impact to a member’s course of treatment and ensure the member receives timely administration of the drug.

 

Since the drugs that are shipped to the hospitals are in their original manufacturer’s packaging, any concerns regarding errors or patient harm should not be any greater than if the drug was purchased directly from a distributor or manufacturer. 

 

We appreciate your attention to this matter. Please let me know if you have any questions.

 

Sincerely,

Doug Gray

Executive Director

Virginia Association of Health Plans

CommentID: 98935
 

6/4/21  7:42 am
Commenter: Cynthia Williams on behalf of Riverside Health System

Regulations on White Bagging/Brown Bagging
 

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….

  1. 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.
  2. Implement the new Subsection G of 18VAC-110-20-275 as proposed. 
  3. 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

CommentID: 98943
 

6/4/21  11:33 am
Commenter: Community Oncology Alliance (COA)

COA's Comments on Payor-Mandated Specialty Drug Programs
 

On behalf of the undersigned Virginia community-based oncology clinics and the Community Oncology Alliance (COA), we are writing to provide information regarding new specialty pharmacy programs being introduced and expanded by several commercial health plans in Virginia.  We have significant collective and mutual concerns about the programs as they relate to the ability to provide safe, timely, and efficient patient care. At least two health plans have already implemented initial versions of their programs in Virginia.

COA is an organization that is dedicated to advocating for the complex care and access needs of patients with cancer and the community oncology practices that serve them. COA is the only non-profit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. COA’s mission is to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work. For almost 20 years, COA has built a national grassroots network of community oncology practices and physicians to advocate for public policies to support patients with cancer and their provision of care in the most effective and cost-efficient ways. At the core of our mission is the transformation of the health care system focusing on a patient-centered model of care.

The programs of concern, collectively known as “white bagging,” prohibit in-network providers from procuring and managing certain vital medications for their patients like they typically do today, where clinics procure the appropriate medications on behalf of patients for the timely and safe administration of these drugs.  Instead, in white bagging, a payor-designated (and often payor-owned) third-party pharmacy dispenses a drug and ships it to a clinic or a second pharmacy for eventual preparation and administration to a patient.

We have very serious concerns about ‘white bagging”, beginning with the potential for serious adverse impacts on patient safety and care. The drugs subject to this practice are usually specialty pharmaceuticals administered by injection. Not having control over the sourcing, storage, preparation, and handling of specialty oncology medications exposes patients to potentially serious harm while increasing the administrative burdens and liability for practices and their oncology providers. White bagging policies compromise and are detrimental to patient care on so many levels, ranging from optimization of therapy, patient access and missed doses, interruptions to critical treatment, worsening disease states, increasing risks of medication errors, adverse events, interference with the patient-physician relationship, and failure to ensure and monitor FDA-mandated Risk Evaluation and Mitigation Strategies (REMS). 

Injectable oncology medications often require special handling and preparation to preserve their efficacy and ensure their safety.  This can include refrigeration, preventing exposure to light, or avoiding temperatures above room temperature.  There was a similar situation with the COVID-19 vaccine, which is why they were sent in bulk directly to hospitals and physicians’ offices that were equipped to handle the delicate nature of the vaccine and prepare them for patient administration.

Additionally, many patients need immediate treatment to prevent hospitalization or severe complications.  Treatment delays are common with white bagging. The white bagging requirements prohibit the option for patients to begin treatment immediately.  Prior authorization delays of sometimes weeks to months have occurred. Medications will not be shipped unless the patient pays the co-pay or co-insurance, which can be thousands of dollars for these medications. And even once approved, providers must wait for the drug to be delivered with patient-specific use only, instead of acquiring the drug beforehand and using on-hand stock.  Sometimes the drugs are delivered but to the wrong person or address.  When delivered to larger community practices, oftentimes, they go to a general mailroom or receiving area and can take hours to get routed to the right place within the facility.  These delays and hardships are exacerbated by the fact that the physician often orders a regimen – essentially, a “cocktail” – of different drugs that must be taken in concert.  To the extent one or more of the drugs in a regimen needs to be supplied by the insurer’s affiliated specialty pharmacy through white bagging, there is a greater risk that the process, timing, and coordination of these therapies could be jeopardized. 

The problems do not end even when the white-bagged drug has been received by the practice – if the dose of the drug needs to be altered on the day of treatment, the provider is left with no option other than to reschedule and deprive the patient of the needed medicine. Oncology regimens are complex and often require dosing adjustments at the time of administration or treatment changes depending on the patient’s laboratory results, scans, and other clinical considerations, such as shifts in the patient’s weight. In these cases, the white-bagged drug must then be wasted because the insurer’s specialty pharmacy will not accept returns under any circumstances.  This is in sharp contrast to oncology medications inventoried on-site at practices where there is no waste because dosing and therapy changes are made on-site before the drugs are prepared for administration. White bagging may well be more profitable to the insurers, but the waste factor will end up costing employers and their employees far more. White bagging represents a significant waste of resources and financial burden to the healthcare system.

White Bagging also poses a significant liability to clinics, surgery centers, and physicians with regard to product integrity, product labeling, and accuracy. The prescriber remains legally responsible for any drug injected into the patient, even when he/she has lost control of the process. It is not clear or established the degree to which medical malpractice policies or other insurance policies would safeguard practices and providers against these types of claims. 

These are just a few examples of what can happen when providers are stripped of their ability to manage the sourcing, storage, preparation, and safe handling of the specialized medications covered by these programs.  Injectable medication preparation and administration is complicated.  When the delicate chain of custody is compromised for the sole purpose of purported cost savings, patients can be exposed to unnecessary and harmful outcomes

The impacts of these programs are far-reaching and include compromised drug safety, untimely treatment, dosing inflexibility, operational issues, resource waste, and legal liability.

We, along with others, have reviewed policies of the Virginia Bureau of Insurance, Board of Pharmacy, and Department of Health Office of Licensure and Certification.  Even though these “white bagging” policies are being dictated by the health plans with no opportunity for providers to negotiate the process or terms, thus far, it seems there are no enforceable laws or regulations that will stop the health plans from implementing their white bagging requirements in Virginia. Other states, such as California, Minnesota, and Texas,[1]  have implemented or are considering legislation to keep this dangerous process from occurring in their states.

Respectfully, we believe there are no benefits to patients brought on by these white bagging programs.  Rather, the potential for negative impacts – including patient harm – is real and alarming.  We welcome the opportunity to discuss our concerns and options for addressing potential model legislation to forbid this insurer practice in Virginia with you in the weeks ahead.  Thank you for your attention to this very important matter.

Sincerely,

Ricky Newton, CPA

Chief Financial & Operating Officer


[1] See, e.g., CA Health & Safety Code §1637.02 (2019).

CommentID: 98950
 

6/7/21  1:10 pm
Commenter: Mark Hickman, Virginia Society of Health-System Pharmacists (VSHP)

VSHP Comment on White/Brown Bagging
 

The Virginia Society of Health-System Pharmacists (VSHP) submits the following public comment:

 

VSHP supports the goal of the proposed regulations which were developed, including VSHP comment provided at the time, as a positive first step in setting up guard rails 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.

The implementation of actual payor policies has revealed serious patient safety and hospital pharmacy operational concerns, many of which our colleagues at the Virginia Hospital and Healthcare Association (VHHA) outline in their letter dated May 21, 2021 submitted as public comment, with which we associate ourselves.

 

While we are aware at this time of certain temporary delays in implementation of payor specialty pharmacy policy, we note that the delay is from only one payor and can be ended at any time, and that other existing policies and practices of concern have been and are still in place. 

 

We also note that current white bagging practices do not allow for the kind of flexibility, adjustments, supply chain processes, and safety procedures used by hospital systems to help avoid waste and ensure drug integrity for the patient.

  

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 do continue to support the “brown bagging” component of the proposed regulations, and we also reserve the opportunity to evaluate brown bagging policies and practices as they continue to emerge.

 

VSHP supports the Board of Pharmacy’s decision taken at its June 4, 2021 meeting to issue a Guidance Document clarifying the meaning of routine delivery and compliance with existing regulations. We look forward to engaging in the guidance development process.

We encourage the Board of Pharmacy to continue to monitor the proliferation of payor white bagging policies and their impact on patient safety to determine whether a reevaluation of relevant regulations may be necessary in the future. 

 

Thank you for your consideration.

CommentID: 98962
 

6/7/21  2:44 pm
Commenter: Melanie Massiah-White, Inova Health System

Inova Comments on Regulations Governing the Practice of Pharmacy (18 VAC 110-20)
 

June 7, 2021

Caroline D. Juran, RPh
Executive Director
Virginia Board of Pharmacy
9960 Mayland Drive, Suite 300
Richmond, Virginia 23233

Re: Regulations Governing the Practice of Pharmacy (18 VAC 110-20)

Dear Ms. Juran,

On behalf of Inova Health System, I write to share our perspective on 18VAC110-20, a proposed regulation related to the practices commonly referred to as “white bagging” and “brown bagging.”  These policies under consideration are impactful to many of the most vulnerable patients in the communities we serve.

At Inova, safety is a core principle in guiding our “patient always” organizational value. “White bagging” policies raise serious patient safety and experience concerns, especially for oncology patients with complex needs.  Chemo and immunotherapies are highly complex treatments that require skilled compounding and monitoring – fragmenting the care team as a result of a mandatory white bagging policy places patient safety at risk.  

Additionally, in many cases infusion drugs are administered with a highly specific dosage that can fluctuate based on a patient's clinical status on a given day. On-site pharmacists and the patient care team will collaborate in real time to adjust drug dosage based on the infusion day’s bloodwork and the specific needs of the patient regarding their care plan. Mandatory use of white bagged drugs can delay treatment while waiting for a new drug order or shipment and delivery from an external pharmacy, leading to suboptimal patient outcomes and experience. Moreover, there is an additional risk of cost increases given the greater number of missed doses, interruptions to critical treatment, wasted drugs, and higher out of pocket patient cost due to multiple unnecessary drug copays.

Doctors, oncology nurses, oncology infusion trained pharmacists, hospitals and health systems are best equipped to manage the complex needs of our patients in a cost-effective manner that is safe, highly reliable, and most importantly, centered around the patient.  The recommendations submitted by the Virginia Hospital and Healthcare Association in their comment letter dated May 21, 2021 are consistent with those priorities, and Inova concurs with the recommendations and comments shared in that letter.

Thank you for your consideration of our perspective on this issue of importance to Virginians and their healthcare needs.

Sincerely,

Melanie Massiah-White, BS Pharm, MHA
Vice President & Chief Pharmacy Officer
Inova Health System

CommentID: 98963
 

6/8/21  12:10 pm
Commenter: Christina Barrille, Virginia Pharmacists Association

Request BOP revisit white bagging regulations
 

SUBMITTED ELECTRONICALLY
(https://townhall.virginia.gov/L/ViewStage.cfm?stageid=8947)

June 8, 2021
Caroline D. Juran, RPh
Executive Director
Virginia Board of Pharmacy
9960 Mayland Drive, Suite 300
Richmond, Virginia 23233

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

Dear Ms. Juran:

On behalf of the Virginia Pharmacists Association’s members, thank you for the opportunity to provide comment to the Board of Pharmacy regarding 18VAC110-20 and the practices commonly referred to as “white bagging” and “brown bagging.”

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. Three and a half years have passed since that NOIRA, and the practice of “white bagging” has proliferated to a level not foreseen in 2017.

The newly added Subsection F of 18VAC110-20-275 contains important safeguards for patient safety in situations when white bagging of drugs from a pharmacy to an alternate delivery site is needed in an urgent, and non-routine circumstance.

White bagging in any circumstance is inherently risky for safe, timely patient care; it also limits consultation with a pharmacist. Further, patients risk unexpected drug interactions due to the timing and handling of various medications. If the Board of Pharmacy is seeking cost saving solutions for patients, this is not it. Additionally, costs could be controlled, and patient access expanded by simply increasing pharmacy access to specialty contracts.

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. It should be a practice of last resort.

VPhA advocates for the strongest patient protections possible in regulations. The existing regulations in Subsections B through E of 18VAC110-20-275 provide some measure of reasonable safeguards because they require pharmacies that engage in white bagging as a matter of “routine” practice to establish mutually agreed-upon contracts and policies and procedures. In the least, the regulations should be clear regarding “routine” practices. A guidance document is not adequate to offer clarity, as it will not have the enforcement strength that the teeth of regulations have.

We strongly urge the Board to revisit the regulations to limit the practice as to only those cases where there is no other means available to dispense and administer. On behalf of VPhA and our members, thank you for your consideration of these comments and recommendations. We stand ready to assist with any follow up questions.

Regards,

Christina Barrille
Executive Director

CommentID: 98971
 

6/8/21  1:54 pm
Commenter: Bryant Thomas on Behalf of Children's Hospital of The King's Daughters

CHKD Comments on Regulations Governing the Practice of Pharmacy (18VAC110-20)
 

Commenter: Bryant Thomas on behalf of Children's Hospital of The King's Daughters

 

June 8, 2021

 

Caroline Juran, RPh, Executive Director

Board of Pharmacy

9960 Mayland Drive, Suite 300

Henrico, VA 23233

Delivered via email to: Caroline.Juran@dhp.virginia.gov

 

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

 

Dear Ms. Juran:

 

I am writing on behalf of Children’s Hospital of The King’s Daughters (CHKD) and appreciate the opportunity to comment on the proposed changes regarding 18VAC110-20 governing the practice of “white bagging” and “brown bagging” by the Board of Pharmacy. The practice of “white bagging” has recently been drawing more attention nationally over the proliferation of the practice by payers. These new practices and changes in regulation have the potential to have an immense impact on the way that healthcare is delivered in the Commonwealth. Our pharmacy at CHKD provides pharmaceutical care to our pediatric patient population and is a critical part of the comprehensive continuum of services that we offer to our patients and their families. These proposed regulatory changes as well as growing concerns over the propagation of “white bagging” practices by payers have made this conversation both timely and necessary.

 

As you may know, CHKD is the only freestanding children’s hospital in Virginia and one of fewer than 50 in the United States. It serves the medical and surgical needs of children throughout greater Hampton Roads, the Eastern Shore of Virginia, and northeastern North Carolina. Our Health System operates primary care pediatric practices, surgical practices, multi-service health centers, urgent care centers, and satellite offices throughout our service region.

 

Pharmaceutical care at CHKD not only involves medication therapy, but also decisions regarding medication selection, dosages, routes, methods of administration, and therapeutic drug monitoring. Patients’ medications, diseases, and doses are reviewed for safe and effective treatment. Pharmacists also provide drug information to other health care professionals and counseling to patients and/or their caregivers. In addition, pharmacists at CHKD are responsible for documenting clinical interventions and reporting adverse drug reactions, and they play an important role in formulary management, medication safety, and error prevention.

 

The CHKD Pharmacy Department manages the pharmaceutical supply chain for all inpatient and ambulatory centers that fall under the hospital umbrella, to include our two ambulatory infusion centers and hematology/oncology infusion center.  White bagging in any circumstance is inherently risky for safe, timely patient care because it breaks down the normal distribution process by removing the direct relationships between manufacturer and clinics/hospitals for provider-administered medications. Potential implications of white bagging include, but are not limited to: delays in patient care; reduced patient access to the right medication; limited site of care flexibility for patients; compromised drug integrity and efficacy; drug wastage; inappropriate shifting of liability to providers; and administrative inefficiencies. 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.

 

We are in support of the proposed changes to 18VAC110-20, specifically the additions of subsections F and G. These additions contain important safeguards for patient safety in situations when “white bagging” of drugs from a pharmacy to an alternate delivery site is needed in an urgent and non-routine circumstance. This additional regulation of “white-bagging” helps ensure that appropriate coordination of patient care is being followed.  

 

We respectfully request that the Board be sensitive to any potential unintended consequences that may affect our health system as we continue to navigate this new landscape of expanded “white-bagging” practices in the Commonwealth. Further, CHKD urges the Board of Pharmacy to implement the recommendations proposed by VHHA with respect to the Final Regulation. 

 

Our hospital appreciates the longstanding partnership that we have enjoyed with the Virginia Department of Health and the Board of Pharmacy. CHKD would welcome the opportunity to participate in future conversations regarding updating and modernization of current practices in the provision of pharmaceutical services the Commonwealth and these future policy considerations.

 

Sincerely,

 

Jim Dahling

President and CEO

Children's Hospital of The King's Daughters

CommentID: 98978
 

6/9/21  6:13 pm
Commenter: Chad Alvarez, Carilion Clinic

Carilion Clinic Comments on Regulations Governing the Practice of Pharmacy 18 VAC 110-120
 

June 8, 2021

Caroline D. Juran RPh
Executive Director
Virginia Board of Pharmacy
9960 Mayland Drive, Suite 300
Richmond, Virginia 23233

Subject: 18 VAC 110-20 Proposed Regulations Governing the Practice of Pharmacy

Dear Ms. Juran,

Carilion Clinic is a not–for–profit, integrated health care organization based in Roanoke providing high quality care for nearly one million Virginians. Our mission, To Improve the Health of the Communities We Serve, is conducted through our comprehensive network of hospitals, primary and specialty physician practices and other complementary services. Our western Virginia service area spans much of the I-81 corridor, and much of it is rural.

Thank you for the opportunity to provide comments relating to the proposed regulations governing the practices often referred to as “white bagging” and “brown bagging” (18VAC110-20). The proposed policies being considered have the potential to adversely impact some of the sickest and most vulnerable of our patients. As you consider these and other stakeholder comments, it is our belief that patient safety must be at the core of these considerations.

I am aware that the Virginia Hospital and Healthcare Association (VHHA), has already provided significant, detailed comments on behalf of member health systems relating to the proposed regulatory changes in their letter of May 21, 2021. VHHA touched on many of the same thoughts we have, and we are aligned with those comments and recommendations, so I will not repeat them.

As a pharmacist, I am acutely aware of the complex medical conditions that many of our patients experience, especially those under oncology care. Their safety is our highest priority, as it is for all patients. Complex chemo and immunotherapies demand highly skilled and strictly- controlled compounding, handling, storage, monitoring and timing. “White bagging” policies pose significantly higher risks for these patients, adding additional parties and steps to the treatment processes they will experience. As a colleague shared, “fragmenting care adds another risk element to the care equation and threatens patient care”.

Our providers must address changing patient needs on a daily and often, hourly basis. This is particularly true at our infusion centers. Being able to address these changes immediately in our clinical settings with our patients is an imperative. Requiring mandatory use of “white bagging” for a drug from an external supplier can complicate patient care, cause unnecessary and harmful treatment delays, adversely impact patient outcomes, increase waste, and yield higher costs. None of these are beneficial to our patients.

In short, the patient care teams in our health system are in the best position to address the pharmacy and other complex needs of our patients and deliver high quality, cost-effective care when and where it is needed. 

Our industry is a complex, but unique and critically important one. We have the privilege of seeing and treating patients in some of their happiest moments, as well as during some of their most difficult ones. This privilege and responsibility demands the most competent, capable and compassionate skills of our providers and patient care teams. it also demands that we have the resources available to support these patients when needed. 

On behalf of Carilion Clinic, and the patients and communities we have the honor of serving, thank you for the opportunity to comment on the proposed regulations and to write in support of the recommendations offered by VHHA. We appreciate your thoughtful consideration.

Sincerely,

Chad E. Alvarez PharmD, MBA                                                                                          Senior Director of Pharmacy                                                                                              Carilion Clinic

CommentID: 99029
 

6/9/21  6:32 pm
Commenter: John Lubkowski

IMPLICATIONS OF WHITE BAGGING
 

 

    • My hospital provides a full range of oncology and infusion services with medications being acquired, prepared and dispensed through the pharmacy department for both inpatients and outpatients. 

    • A new trend in the healthcare insurance industry is for a PBM (pharmacy benefits manager) to require that their patients receive medications that are filled at the PBM’s contracted specialty pharmacy.  This is in contrast to the hospital acquiring the medications through our regular wholesaler distribution system.   We have an agreement with our contracted wholesaler that provides us assurance of drug storage and shipping conditions.  White bagging goes outside our supply chain and ships via common carrier, which could introduce the risk of compromised packaging or temperature excursions.  

    • The medications sent from specialty pharmacies are not always the same size, strength or presentation that we normally use, resulting in safety risks from using non-standard products.  This may bypass barcode scanning technology that we use in our IV room.   A change in product may require a new order from the patient’s physician which may cause additional delays.  Storage of these medications must be separate from the standard hospital inventory.  The space for storage presents a challenge as well.

    • Patient delays in treatment may result from processing time associated with obtaining medications from a required specialty pharmacy.  Care coordination is more difficult when an additional external entity is brought into the process.  Patient stress can be exacerbated, by being overwhelmed with this process.  It is not unusual for the coordination and management of one shipment to take several hours, potentially distracting the pharmacist from providing safe patient care. Follow up is imperative to ensure the product will be available when needed.  The time required for shipping impacts the ability to make same day treatment decisions based on laboratory findings, or changes in the patient's condition.  Additionally shipping delays may impact patient care.  

    • Insurance mandated White Bagging denies the patient’s freedom of choice in selecting their pharmacy provider.

    • As of July 1, 2015 the FDA requires pedigree information to accompany all drugs that we purchase.  Specialty pharmacies decline to send this information claiming to be shipping product to the patient, when in fact they ship to the hospital.  If indeed this is considered dispensing to the patient then Virginia Board of Pharmacy regulations would consider this “alternate site delivery” and require a contractual agreement with each specialty pharmacy, and there are many involved. 

 

I appreciate the opportunity to provide input into this potential risk to patient safety.

 

The contents of this letter are my own personal and professional opinion, not as a representative of my employer or facility.

 

CommentID: 99032