National Association of Specialty Pharamcy
July 13, 2026
Maryland Insurance Administration
Attn: Mary Kwei 200 St Paul St #2700
Baltimore, MD 21202
Re: Specialty Drug Definition Comments
Dear Pharmacy Benefits Managers Workgroup,
I am writing on behalf of the National Association of Specialty Pharmacy (NASP) in response to the Pharmacy Benefits Managers Workgroup Meeting #2, during which the definition of a specialty drug was discussed. As the national association representing the full spectrum of specialty pharmacy stakeholders, we appreciate the opportunity to share our perspective and offer feedback informed by our broad experience across the specialty pharmacy landscape.
NASP is a non-profit trade association representing all specialty pharmacy industry stakeholders, including the nation’s leading specialty pharmacies and practicing pharmacists; nurses; technicians; pharmacy students; non-clinical healthcare professionals and executives; some pharmacy benefit managers (PBMs); pharmaceutical manufacturers; group purchasing organizations; wholesalers and distributors; integrated delivery systems and health plans; patient advocacy organizations; independent accreditation organizations; and technology, logistics and data management companies.
Specialty pharmacies care for some of the nation's most clinically complex and medically vulnerable patients, including individuals living with cancer, multiple sclerosis, rare diseases, autoimmune disorders, those who have received organ transplants, among others. These patients often require intensive clinical management, ongoing monitoring, comprehensive care coordination, and specialized support to achieve optimal clinical outcomes while ensuring the safe, appropriate, and cost-effective use of high-cost therapies.
As the national voice for specialty pharmacy, NASP believes it is essential that the Workgroup benefit from the perspective of a specialty pharmacy. We noted that the current Workgroup does not include a representative from the specialty pharmacy community, which is an interested party as outlined in the legislation. Given the Workgroup's charge, we believe this perspective is critical to ensuring a comprehensive understanding of what constitutes a specialty drug, the unique role of specialty pharmacies, and the qualifications and capabilities required to safely and effectively dispense these complex therapies. We respectfully request the Workgroup to include NASP as a member to ensure the specialty pharmacy perspective is represented in its deliberations. In the absence of a specialty pharmacy representative on the Workgroup, we respectfully offer our perspective on the definition of a specialty drug, and the unique role specialty pharmacies play in dispensing specialty drugs and biologics.
Defining Specialty Drug
The Maryland definition of specialty drug adequately addresses the unique needs for a pharmacy to stock and support a patient receiving a specialty drug by discussing who it is prescribed for – “an individual with a complex or chronic medical condition or a rare medical condition” – as well as highlights the need for handling and storage of a specialty drug or biologic and the need for enhanced patient support. NASP supports highlighting those aspects of a specialty drug or biologic.
Where NASP diverges from the existing Maryland language is using a dollar amount to determine if a drug is specialty. While historically, that has been an easy marker for determining if a drug is a specialty drug it fails to recognize that there are an increasing number of generic specialty drug or biosimilars that fall below that cost threshold. Additionally, there are nonspecialty drugs whose costs exceed this threshold.
NASP also wants to highlight the challenges of using only a specialty drug to define where a drug should be dispensed. Instead, we encourage Maryland to follow North Carolina’s lead in defining specialty drug/biologics and, most critically, move to define a specialty pharmacy. Allowing there to be a definition of specialty pharmacy creates a clearer expectation for what types of services are required and what qualifications are needed for dispensing a specialty drug and supporting the required patient management needs. It also reduces manipulation by some PBMs who may use drug prices or other nebulous definitions of patient support to narrow the network to specific pharmacies that they determine are eligible to dispense specialty drugs.
NASP recommends that Maryland define specialty pharmacy with a clear understanding of the clinical capabilities and operational infrastructure a pharmacy must possess to dispense specialty drugs. We have found that the easiest way to do that is to require that a pharmacy be accredited as a specialty pharmacy by a single, nationally recognized, independent third-party specialty pharmacy accreditation organization. This allows for:
- Ensuring a pharmacy meets the requirements set forth in Maryland's existing specialty drug definition, including prior authorization support, insurance and financial assistance coordination, shipping and handling standards, and patient management services, as these elements are already required by nationally recognized independent specialty pharmacy accrediting organizations;
- Eliminating duplicative accreditation requirements imposed by PBMs by recognizing accreditation from a single nationally recognized, independent third-party specialty pharmacy accrediting organization. PBMs frequently create unnecessary administrative barriers by requiring multiple accreditations, including accreditation programs they own or operate;
- Allow for any pharmacy that meets the single accreditation requirement to dispense specialty drugs. Furthermore, this would align Maryland with existing legislation passed in other states, including by North Carolina as recently as 2025 with H.B 163.
Requirements to Dispense a Specialty Drug
During Workgroup Meeting #2, questions were raised regarding the requirements pharmacies must satisfy to participate in a specialty pharmacy network, the rationale for those requirements, and the types of services that constitute "enhanced patient education, management, or support." NASP welcomes the opportunity to provide insight into each of these areas based on our extensive experience representing the full spectrum of specialty pharmacy stakeholders.
Regarding the first question on accreditation requirements, pharmacies seeking specialty pharmacy accreditation must demonstrate that they meet rigorous standards established by a nationally recognized, independent third-party accrediting organization. These standards include utilizing appropriate packaging, shipping, and temperature controls to preserve medication integrity; implementing standardized patient management processes, including initial assessments, routine reassessments, and documented clinical interventions; providing ongoing patient education at the start of therapy and whenever adherence or clinical concerns arise; regularly engaging with the patient's care team to support appropriate medication management; and maintaining the specialized equipment and refrigeration necessary to safely store and dispense specialty medications.
Specialty pharmacy accrediting organizations evaluate a pharmacy's ability to meet these requirements through a rigorous initial accreditation survey followed by comprehensive reaccreditation reviews every three years. This process assesses whether the pharmacy consistently meets the operational, clinical, and quality standards necessary to deliver safe, effective, and high-quality specialty pharmacy services. Importantly, accreditation is not a pointin-time achievement. Accredited specialty pharmacies are expected to maintain continuous compliance with these standards between survey cycles and remain subject to ongoing oversight and quality improvement requirements.
With respect to the comprehensive and specialized patient services patient services provided by a specialty pharmacy, NASP considers the following components to be essential:
Due to their inherent capabilities and infrastructure, accredited specialty pharmacies are uniquely situated to manage these complex patients and medications.
In conclusion, NASP respectfully requests inclusion on the Workgroup as the nation's leading organization representing all specialty pharmacy industry stakeholders, or at the very least participation in Workgroup discussions on defining specialty drug. Given NASP's broad membership and deep expertise in specialty pharmacy practice, patient care, accreditation standards, and operations, we believe our participation would provide valuable perspective as the Workgroup continues its deliberations and develops its recommendations.
In addition, we encourage the Workgroup to consider defining specialty pharmacy, rather than focusing solely on the definition of a specialty drug. Establishing clear criteria for both would help ensure that specialty medications are dispensed by pharmacies with the specialized infrastructure, clinical capabilities, and accredited processes necessary to optimize patient outcomes and promote the safe, appropriate, and cost-effective use of these therapies. A clear definition of specialty pharmacy would also reduce the potential for inconsistent network participation requirements and arbitrary or duplicative accreditation standards that can unnecessarily limit patient access to care.
We look forward to continuing conversation. For additional information or questions please contact Taryn Couture at [email protected].
Sincerely, Sheila Arquette, RPh
President & CEO
Arthritis & Rheumatism Associates, P.C.
July 14, 2026
Mary Kwei, Associate Commissioner, Market Regulation and Professional Licensing
Maryland Insurance Administration
Athos Alexandrou, Director, Office of Pharmacy Services
Maryland Department of Health
VIA EMAIL: [email protected]
RE: MIA PBM Workgroup – Written Comments on Specialty Drug Access (§15-847 / COMAR 10.67.06.04)
Arthritis and Rheumatism Associates, P.C. (ARA PC) is the largest rheumatology practice group in the Mid-Atlantic region. We are dedicated to the diagnosis and treatment of people with disorders of the joints, muscles, tendons, and other connective tissue. Our practice integrates excellent medical care with comprehensive services, including specialty drug pharmacy dispensing, a full-service laboratory, x-ray facilities, a physical therapy division, seven centers for the diagnosis and treatment of osteoporosis, and seven infusion centers. We care for more than 30,000 patients each year at five of our centers located in Maryland.
Maryland’s current specialty drug framework—particularly the pharmacy steering permitted under §15-847 and COMAR 10.67.06.04—creates significant barriers to timely, safe, and patient-centered care for individuals with autoimmune and inflammatory diseases. While Maryland protects patient choice for nearly all other medications, specialty drugs remain the sole category where PBMs and insurers can force patients into specific pharmacies. This carve-out has direct consequences for cost, access, and quality.
We appreciate the opportunity to comment on the “Questions for Group Discussion on Specialty Drug Access” that were the subject of the most recent meeting of the PBM workgroup on June 30th. Our answers and feedback are detailed below.
Impact on Patients: Delays, Missed Doses, and Avoidable Harm
Patients routinely experience:
- Extensive time lost navigating specialty pharmacy call centers and “telephone tag.”
- Cold-chain medications left on insecure doorsteps, sometimes at unsafe temperatures.
- Long wait times at designated chain pharmacies when trying to avoid mail-order.
- Missed doses leading to painful disease flares and preventable disability.
Reliance on toxic steroid stop-gap therapy, increasing risks of diabetes, fractures, and serious infections requiring hospitalization.
Even after receiving mail-order shipments, patients often wait additional days to schedule in-person injection teaching, delaying safe initiation of therapy.
Cost and Quality Implications
These access barriers drive higher downstream medical spending through flare-related visits, steroid complications, and avoidable hospitalizations. Quality of care declines when clinicians cannot adjust doses or dispense urgently needed medication during a flare. Out-of-pocket costs rise when shipments are delayed, mishandled, or wasted.
Specialty Drug Definition: Needed Reforms
While the definition appropriately recognizes drugs requiring enhanced handling and education, it also enables PBM-controlled steering that harms patients. Physician offices already provide:
These services meet or exceed the “enhanced patient education, management, or support” cited in COMAR. Allowing point-of-care dispensing would improve access, reduce delays, and lower costs.
Exemptions for Oncology, Diabetes, HIV, and AIDS
Maryland has already acknowledged that pharmacy steering can harm patients with serious conditions. Autoimmune patients experience similar risks, yet remain excluded from these protections - resulting in higher costs and poorer outcomes.
Why Change is Needed
It is time for Maryland to rebalance the longstanding principle of patient choice for life-changing and life-sustaining medications. Eliminating the specialty drug steering carve out will:
- Streamline care by allowing clinicians to dispense medication and provide injection teaching at the point of care.
- Make biosimilar transitions more efficient and cost-effective.
- Enable clinicians to authorize and dispense new doses immediately when flares occur.
- Reduce delays, prevent flares, and avoid steroid-related complications.
The impact of pharmacy steering is uniquely harmful for patients whose medications determine whether they can work, parent, or simply function without pain. Modernizing Maryland’s specialty drug framework and aligns it with patient-centered, clinically sound care.
Insurers continue to argue that specialty drug steering will save costs and physician dispensing only adds cost. Financial cost is an ever-present factor in modern health care delivery, but as physicians, we must also weigh the physical and emotional costs our patients endure every day.
Several states - including Arkansas, Louisiana, and Texas—have enacted policies limiting insurer mandates that interfere with physician-directed access to specialty medications. Experience in these states demonstrates that such protections do not increase health insurance costs.
We appreciate the opportunity to provide this input to the MIA. If we can be of further assistance, please contact me at 301-942-7600 or [email protected].
Angus Worthing, MD
Arthritis & Rheumatism Associates, P.C.
