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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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