As a nonprofit focused on enhancing patient care. COPA is in a unique position to serve as a noncommercial organization dedicated to addressing community oncology pharmacy issues, all in the sole interest of patient care.
An increasing number of cancer drugs and ancillary therapies are now delivered in oral formulations, with some estimates reporting that up to 35% of all cancer medications in the research pipeline are administered in this form. In response to these trends—and to meet the needs of patients for oral oncology treatments that are dispensed in a safe, reliable, and affordable environment closely integrated with their overall care—over the last decade, community oncology clinics began to establish facilities to dispense oral drugs.
At the same time, due to the increasing use and expense of these drugs, several commercial interests, such as specialty pharmacies and pharmacy benefit managers (PBMs), began parallel efforts to separate oral cancer therapies from the point of care and the control of oncologists. To care providers, this introduced unnecessary interference into the physician—patient relationship and had a very real impact on medication adherence, adverse effect management, follow-up monitoring, delays in drug delivery, lack of patient financial support and services, and more.
A survey of oncology practices revealed a strong interest in, and desire for, direction on the management and operation of their oncology pharmacies. Concurrently, PBMs were beginning to greatly disrupt patient care by redirecting prescription fulfillment away from practices and toward specialty or mail order pharmacies. To help community oncology pharmacies provide oral oncolytics within community oncology practices and to manage external pressures, the Community Oncology Pharmacy Association (COPA) was officially formed in March 2015 as an initiative of the Community Oncology Alliance (COA).
As a nonprofit focused on enhancing patient care, COPA is in a unique position to serve as a noncommercial organization dedicated to addressing community oncology pharmacy issues, all in the sole interest of patient care. COPA believes patients do better when they receive their oral medications at the site of care, which allows oncologists to follow their patients and better help manage adverse effects, which ultimately leads to more positive outcomes. When patients are forced to have their prescriptions filled outside the clinic, there is a greater likelihood that there will be a delay in treatment, adherence issues, or the prescription not being filled at all.
In its role, COPA facilitates peer-to-peer information exchange; provides general information, education, and resources; has helped with the establishment of oncology pharmacy standards; and advocates for a patient-centered model of integrated, high-quality cancer care. Since its founding, COPA has grown to include 674 diverse members, including physicians, pharmacists, pharmacy technicians, and administrators at 400 community oncology and urology practices. COPA’s advisory board features pharmacists from some of the largest community oncology practices around the country.
PBM Abuses: A Major COPA Focus
PBMs have long represented one of the biggest challenges to community oncology pharmacies and dispensing. Initially established so insurance companies could outsource the management of drug benefits, PBMs have morphed from handling prescription transactions to managing pharmacy benefit plans, including negotiating with drug manufacturers for discounts and determining which drugs a patient may receive and where.
However, community oncology practices and patients frequently feel as though PBMs have become more focused on profits than patients and that their policies all too often end with unnecessary treatment delays or denials.
Since its inception, COPA and its members have worked to address PBM issues and abuses through a number of channels, including legal, legislative, and the media. One notable recent COPA success was getting OptumRx to reverse a policy that required overly burdensome accreditation in order to participate in UnitedHealthcare’s Medicare and reimbursement network. COPA also is currently challenging Prime Therapeutics’ decision to exclude physician-dispensing pharmacies from its network, as well as its decision to terminate physician-dispensing pharmacies that were previously in network.
Legislatively, COPA is working with COA on a bill that would require PBMs to fill cancer drug prescriptions within 72 hours or permit patients to obtain the drug at a pharmacy of their choice at in-network reimbursement rates. Known as the Improving Patient Access to Cancer Treatment (IMPACT) Act, it is expected to be introduced in the next legislative session. Another bill we are pursuing would require PBMs to (1) have quality indicators specific to the specialty of the provider (eg, oncology) if it charges direct and indirect remuneration (DIR) fees and (2) reward pharmacies for high performance and be penalized for poor performance while providing specific details as to why a pharmacy scored lower, which would allow them to improve for future reporting periods.
Currently, PBMs charge DIR fees of up to 12% under the guise of providing quality performance programs, allowing PBMs to “clawback” millions of dollars from pharmacies on dispensed medications, increasing their profits at the expense of Medicare and its beneficiaries. Most of these quality programs assess pharmacy performance against dispensing unrelated medications, such as statins and diabetes drugs. Community oncology pharmacies are not being assessed on their quality performance on oncology specific measures. This proposed legislation would stop that practice.
Over the past 2 years, COPA members have collected hundreds of patients’ PBM horror stories showcasing delays, denials, and suffering. These have been compiled into a series of “Horror Stories” papers that have received great attention from policymakers, the media, and lawmakers.1 The stories form the backbone of COA’s PBM Abuses campaign, which seeks to bring about lasting change to the PBM system and ensure the patient impact of PBMs is not forgotten.2
Setting Oncology Pharmacy Accreditation and Standards
A key part of COPA’s founding mission was to establish national quality standards, best practice benchmarks, operating procedures, and other processes to enhance patient care. Demonstrating that a pharmacy is meeting standards is an increasing requirement from payers who want to ensure high-quality care through enhanced collaboration among the physician, pharmacist, and patient; increased safety measures for staff and patients; and a focus on cost containment.
Leading the way, COPA partnered with the Accreditation Commission for Health Care (ACHC) to develop oncology-specific pharmacy accreditation standards. Known as Distinction in Oncology, the accreditation process includes a 1-day comprehensive, on-site evaluation that must be achieved in combination with ACHC specialty pharmacy accreditation. During the ACHC accreditation process, pharmacies demonstrate their commitment to providing the highest-quality service by complying with stringent national regulations and industry best practices.
COPA Provides Resources to Help Practices Survive and Thrive
COPA also provides several resources and educational tools for community oncology practices to ensure they are able to not only survive, but also to thrive when faced with the variety of issues that affect their pharmacies and dispensing. Perhaps the most valuable resource is the closed, members-only, peer-to-peer COPA network, in which professionals can share challenges they face and get feedback on strategies to overcome these hurdles.
The website (coapharmacy.com) features free access to the latest news affecting oncology pharmacies and resources, such as an interactive listing of state Any Willing Provider laws, PBM laws, DIR fee laws, prompt pay laws, fair audit laws, and maximum allowable cost laws; the status of step therapy legislation state by state; and states’ pharmacy dispensing regula- tions, pharmacy boards, and applications.
The COPA site also hosts numerous resources for practices to quickly overcome or report PBM dispensing challenges, including being excluded from a network, only being allowed to dispense the initial drug to the patient, trolling, and other egregious acts such as delays, changing patient therapies from what was prescribed, and waste. Also provided are surveys for practice pharmacies to get patients' feedback about their experiences receiving their drugs from both inside and outside the practice. These results are then benchmarked against others, on the national and state levels. Finally, a practice benchmarking tool called COAnalyzer can help practice pharmacies evaluate themselves against others to maximize efficiency and provide the best quality patient experience possible.
COPA is also helping members manage the transition from USP <797> to USP <800>. In March 2018, COA sponsored an educational webinar for administrators and pharmacists on USP <797> and <800>, with presentations from the 3 largest group purchasing organizations in oncology.3
COPA also develops and organizes a full pharmacy educational track at the annual COA conference, which provides community oncology pharmacists, pharmacy technicians, and other team members with resources that support pharmacy operations, education on challenges and best practices, and advocacy opportunities. The 2019 annual meeting featured a full pharmacy track with nearly 100 community oncology pharmacists and pharmacy technicians alongside more than 1500 conference attendees in the clinical, business, and advocacy tracks.
Ricky Newton, CPA