Keeping a Watchful Eye in 2021

Dawn Holcombe, MBA, FACMPE, ACHE
Editor-in-Chief
President, DGH Consulting, South Windsor, CT

Last year was an adventure. We learned a lot, and we changed even more. Many of us woke up on January 1, 2021, wondering what the new year would bring. We are already getting some answers. Activities and initiatives that slowed down during the learning curve of the COVID-19 pandemic are beginning to rev up again. The ushering in of the new administration has opened doors to staffing and policy changes, with new directives being sent out at an unprecedented rate.

We need to keep our eyes and ears open and remain diligent about sharing information with our colleagues so that we can catch trends before they take root. Good communication will be our greatest defense against being blindsided. It is important to stay connected through state societies and professional networks. One such network is the National Oncology State Network (NOSN), a not-for-profit organization established by state oncology leaders who recognized the value of communication and collaboration across diverse groups and states (nosn.info).

The Value of Proactive Communication

NOSN was formalized in 2015 to facilitate responsive and effective advocacy on a national basis, seeking out rising trends and issues of common interest across individual states and regions, and leveraging consistent communication and awareness. NOSN members touch base via monthly volunteer partner calls and team meetings formed around major topics such as collaboration, pharmacy, legislation, and policy. The members discuss new findings and initiatives that appear in their markets. This allows the whole group to identify growing trends and then decide which ones may be worth exploring further.

Some of these issues have smoldered or sparked in individual states but could easily flare up elsewhere. As you concentrate on the urgent matters involved in running your practice, keep a watchful eye on what may arise—you may be on the cutting edge of a significant change that could affect all oncology patients and groups.

Shared Review of Payer Policies

The power of connecting voices across states was illustrated a few years ago when a major national insurer started to roll out its own version of clinical specialty pathways. These were initially introduced to oncology groups on the West Coast, and then made their way to the East Coast with little notice. At some point, the local introductory messaging around these payer pathways became, “Physicians on the West Coast have reviewed these pathways and support them, so you should just accept them.”

When they reached our state, we had significant questions, including what the impact of these pathways would be on physician medical decision-making and patient access to appropriate care. We communicated with our colleagues on the West Coast and learned that there had been no endorsement, but rather a polite noncommittal consideration of what was being presented. As practices across the affected states began talking and expressing their individual concerns, their shared initiatives led to challenges and reform, proving that the power of communication and messaging could keep us from reinventing the wheel or being caught off guard by issues that may have already started elsewhere.

Pharmacy Issues

The US Pharmacopeia (USP) pharmacy compounding and hazardous drug handling standards, commonly known as USP <797> and USP <800>, were of great concern to practices in 2018 and 2019, and versions of each were published as official standards on December 1, 2019. In early 2020, successful appeals resulted in the repeal of the 2019 Revised USP <797> and the announcement that USP <800> would remain “official” but not compendial. The rise of the COVID-19 pandemic—and resultant travel and visitor restrictions—greatly reduced the focus on USP standards, and the drives of state boards of pharmacy regarding the oversight and inspection of compliance with these standards in medical communities seemed to slow down.

However, an alert practice received notice of a new state rule (and updates to older regulations) issued in mid-December 2020, detailing inspection standards based on USP <797> and parts of <800>. The new inspection rule is planned to become effective on March 31, 2021, and comments were due at the end of January 2021. This practice sounded the alarm to its colleagues, including those at NOSN, which quickly led to the preparation of comments for the rule and the development of resources for practices in that state and others when the need arises.

These new requirements, which were written in mid-2020, paved the way for inspectors to enter and review medical practices licensed with the Board of Pharmacy for dangerous drugs. The line between ideal pharmacy compliance and reasonable medical compliance is open for discussion and collaboration. By being proactive in relevant markets, we can move toward that discussion and avoid interruptions in patient care.

Medical practices are not pharmacies. Although the National Association of Boards of Pharmacy has pushed repeatedly for pharmacy inspection of physicians mixing under their medical license, to date there has only been sporadic movement. Pharmacy inspectors have gone into medical practices in a few states, and in New Hampshire, they have even issued citations and fines, and have closed drug mixing. Effective interventions and support from experts in both pharmacy and medical policy led to an improved strategic direction, including removal of the penalties.

It is important to keep in mind that issues concerning drug mixing policies and oversight do not only affect oncology. When alert oncology practices raise the alarm regarding new issues, it leads to review, support (for local practices and other colleagues across the country), and collaboration among groups like NOSN, as well as state and national organizations for other specialties. Working together across silos of care strengthens our collective voices.

PBM Issues

Practices that write prescriptions and those that also dispense prescriptions have experienced rising challenges over the years from specialty pharmacies and pharmacy benefit managers (PBMs). The specialty pharmacies and PBMs may undertake policies to separate oral cancer therapies from the point of care and the control of oncologists. These actions and policies can interfere with the physician–patient relationship and affect medication adherence, adverse effect management, and follow-up monitoring, and can lead to delays in drug delivery, diminished patient financial support and services, and other problems.

The Community Oncology Pharmacy Association (COPA) was created in 2015 as an initiative of the Community Oncology Alliance. The goal of this organization is to help community practices provide and manage oral oncolytics (coapharmacy.com). Similar to NOSN’s model, COPA facilitates information exchange, education, and resources among its members regarding community oncology pharmacy issues supporting patient care.

Despite the challenges of patient care during the pandemic, alert leaders of oncology and urology practices shared information and realized that there was a trending pattern; one of the largest health plans and its affiliated PBM to “slow roll” (or treat with bad faith) community practice applications into the pharmacy networks accepted by that PBM. This policy could result in an application for entry into the pharmacy network pending without decision for months or years. A “bad faith” policy would lead to denied network participation on a purely pretextual (nongood faith) basis. Thirty-five practices joined together late in 2020 and, with the support of COPA and appropriate legal partners, informed this national health plan and PBM of their challenges and concerns. The letter voicing their collective concerns was successful and the negative actions have been corrected to the satisfaction of the affected practices. Community practices realized that they were being adversely affected by these policies. By speaking up and sharing their concerns, they were able to address the adverse trending practice together rather than individually.

What Can Practices Do?

As the transportation and security industries slogan goes, “If you see something, say something.” Recognize that every new alert, letter, or newsletter mentioning a new rule or policy coming to your region may be worth sharing with your state society. I also invite you to share them with me at This email address is being protected from spambots. You need JavaScript enabled to view it.. If you wish, I can also forward the information to the NOSN teams.

NOSN is creating a dashboard of issues and topics that are cropping up across the country so that trends can be spotted more easily. Whether or not your state is currently a member of NOSN, this will become a good place to register your concerns. If it turns out that other practices have reported the same issue, NOSN members may already be developing talking points, strategies, and policies.

The impact of the pandemic is beginning to dissipate. Decisive actions are going to escalate as the months go by. We cannot afford to be caught off guard by something piloted or developed in another state that may pop up locally. Collaboration, teamwork, and collectively watching each other’s backs will benefit the oncology community as a whole and ensure a great start to 2021.

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