Sheila Arquette, RPh

A session during the National Association of Specialty Pharmacy (NASP) 2020 Annual Meeting & Expo Virtual Experience, held September 14 to 18, 2020, highlighted some of the nonprofit’s activities. Presenters reviewed NASP’s history and growth, top-tier federal policy priorities, and coronavirus disease 2019 (COVID-19) and its impact on specialty pharmacy advocacy efforts, as well as how members are currently engaging in advocacy and ways others can join.

During the session, “NASP in Action,” presenters provided their updates with a video recording using NASP’s virtual reality technology and concluded with a Zoom chat welcoming audience questions and comments. The session was presented by Keith Cook, RPh, president of the Specialty and Ambulatory Services Division at Comprehensive Pharmacy Services, and Julie Scott Allen, principal at Powers Pyles Sutter & Verville PC. Erik D. Halstrom, MBA, managing director at Turning Point and NASP secretary, moderated the session.

The objectives were to understand how NASP conducts government affairs advocacy, review policy priorities supported by NASP, outline congressional and regulatory actions, and illustrate the role NASP members can have in political and policy advocacy efforts.

Allen shared NASP’s top-tier federal policy priorities, which included reforming pharmacy direct and indirect remuneration clawback, establishing a new process for pharmacy performance evaluation, and defining specialty pharmacy. NASP also prioritizes pharmacy payment transparency and oversight and the recognition of specialty pharmacies as essential businesses.

Allen explained how COVID-19 has affected specialty pharmacy advocacy efforts, including timely access to specialty medication within the supply chain distribution and drug shortages, liability protections for pharmacies, small business loans, and COVID-19 vaccine education and access.

In his presentation, Cook encouraged NASP members to stay informed about specialty pharmacy issues and to get involved with these initiatives. He mentioned the many ways members can engage in advocacy, including joining the NASP Government Affairs Committee Forum, the NASP Policy Advisory Group, and the NASP Political Action Committee. Members can also participate in congressional site visits and town hall meetings and take advantage of the NASP Grass Roots Alerts.

Cook, Allen, and Halstrom emphasized the importance for all stakeholders in specialty pharmacy of paying attention to the issues affecting their industry and of engaging with the many NASP resources to advocate for specialty pharmacy as a collective unit.

NASP’s 130 corporate members and more than 1800 individual members include independent specialty pharmacies, pharmaceutical and biotechnology manufacturers, group purchasing organizations, patient advocacy groups, integrated delivery systems and health plans, technology and data management vendors, wholesalers and distributors, and practicing pharmacists.

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A session during the National Association of Specialty Pharmacy (NASP) 2020 Annual Meeting & Expo Virtual Experience, held September 14 to 18, 2020, highlighted some of the nonprofit’s activities.

“NASP in Action” Highlights Organization’s Efforts to Elevate Specialty Pharmacy

On behalf of NASP, I am writing to correct some misperceptions noted in the

article citing the views of PCMA President and CEO Mark Merritt on Direct and Indirect Remuneration Fees

. It is inaccurate to state that DIR Fees “don’t harm the health industry in any way; They only help it.” Unfortunately DIR Fees do harm the health industry, particularly as it relates to the negative impact on specialty pharmacy providers.

In applying DIR fee programs, PBMs have assessed DIR fees to all claims dispensed by specialty pharmacies, including high cost specialty medications and biologics. There are a substantial number of specialty products that after being subject to DIR fees, result in reimbursement to the specialty pharmacy at below the cost to acquire the products being dispensed, even before specialty pharmacies begin to provide the high touch services for which specialty pharmacies are contracted. There is no cap on the dollar figure of the percentage fee applied in some DIR Fee programs, resulting in upwards to $1,000 per prescription being pulled back from the specialty pharmacy.

Specialty pharmacies coordinate benefits investigation and administrative work on behalf of patients and prescribers to assure compliance with Payer Clinical Policy Bulletins and program benefits design. Specialty pharmacies provide patient education, training and support for therapy compliance across the therapy progression (which can be weeks, months, or years depending upon the disease), coordinate therapy dosing, manage multiple therapies to individual patients, manage side effects and therapy changes and report outcomes and performance data.

None of these services can be supported by negative margin on specialty biologics, before even starting the services mentioned above. This results in less than Fair Market Value reimbursement to specialty pharmacies, despite Medicare legislation providing for reasonable, Fair Market Value reimbursement to providers.

The substantial negative financial impact of these fees as constructed and applied by PBMs to specialty pharmacy forces pharmacies with the highest level of expertise and efficacy in supporting complex disease with high cost therapies to question their participation in Medicare networks, thereby risking a lack of willing providers for Medicare beneficiaries. Narrow access to critical on high cost therapies when patients and providers do not maintain persistency and compliance on therapy.

Health plans and referring prescribers consciously chose specialty pharmacies to manage these complex patients and rely on specialty pharmacies’ unique capabilities to maintain patient adherence with these therapies. The most expensive prescription to the healthcare system is the one that is not filled and failure to successfully start and complete medication therapy is one of healthcare’s biggest problems.

Moreover, the DIR programs administered by some PBMs are based upon performance criteria that simply do not apply to specialty pharmacies or the diseases they treat. This results in some PBM DIR programs assessing fees against specialty pharmacies for results these specialty pharmacies have no ability to influence, control or drive. And, the DIR fees are assessed against drugs unrelated to the performance criteria. It is charging fees for measuring “apples” while specialty

Many DIR performance metrics are pointed at STAR ratings, including measurements for treatment for conditions such as Diabetes and Statin adherence in Cardiovascular Disease — two conditions for which specialty therapies are not dispensed. This puts specialty pharmacies in the position of either (a) not being able to influence or impact disease therapy management but being negatively scored for not doing so or (b) not measuring specialty pharmacies for services that the PBMs, providers, patients and plan sponsors seek them to provide. Finally, the

retroactive methodology of applying the DIR fees essentially put pharmacies in the position where they do not know they are providing medicine below cost to a patient until well after the point of dispensing of the therapies.

As it relates to the impact on out of pocket costs, we are concerned that there has not been enough analysis done of the impact of DIR fees, applied after the point of sale without a direct refund to the paying patient as it relates to the high cost drugs in the specialty pharmacy channel. Given the high cost of biologic therapies (average monthly prescription in the range of $2,500 to $3,500) and increasing patient copayments, further study should be given to PCMA’s claim that DIR fees “actually help patients save money on premiums and out-of-pocket costs.”

We believe that any quality measurements applied to accredited specialty pharmacies must be applied prospectively, transparently, and ultimately result in reimbursement to the provider at a Fair Market Value for the drug and the unique services provided by specialty pharmacies. The savings effectuated by specialty pharmacies by providing strict dosing, counseling as to side effects, compliance and coordination management has been well-documented through numerous studies. NASP opposes percentage of drug cost penalties on specialty pharmaceuticals, given their high cost and the low margins with which specialty pharmacies support patients and prescribers.

National Association of Specialty Pharmacy states that direct and indirect remuneration fees do harm the health industry and specialty pharmacy providers.