Gannon Vanscoy, MPBA Candidate

Specialty pharmacy hubs have become increasingly popular in recent years, offering a wide variety of services to pharmaceutical manufacturers. Although many hubs offer similar services, no 2 specialty pharmacy hubs and no 2 hub programs are entirely alike.

Each program has unique needs based on a manufacturer’s desired network, relevant disease state, services required, and many other factors. Hub services may include case management, benefits investigation/verification (BI/BV), prior authorization assistance, co-pay, financial assistance program management, distribution support, nursing support, health care professional education, patient adherence and education, and noncommercial pharmacy dispensing.

In many cases, these services are offered as a “menu” for pharmaceutical manufacturers that may only need a subset of services from the list. Primary aspects of a program that define which services will be used include hub type (hub lite vs full service), hub necessity (mandatory vs non-mandatory), hub size (large/transactional vs small/dedicated), network composition, and therapeutic area/methods of administration.

A recent trend in hub services is the evolution of a “hub-lite” model vs the traditional/full-service hub. In a typical hub-lite model, the hub will perform data intake of all referral forms. In some cases, this will include a light patient benefit investigation.

For products categorized under the pharmacy benefit, this is achievable through a simple electronic BV/E1 eligibility check. Once a light benefit investigation is completed, the referral and all associated details are electronically submitted to a downstream network pharmacy based on the manufacturer’s business rules.

In most hub-lite models, the hub also manages a call center for health care provider and patient questions. Patient assistance program (PAP) qualification is also typically managed at the hub to ensure it is routed to the non-commercial pharmacy quickly and efficiently. 

If the hub offers non-commercial pharmacy dispensing, the hub may also dispense PAP product and provide clinical support. In this hub-lite model, enhanced BI/BV, prior authorizations, nursing support, clinical support, and various other enhanced services are frequently managed at the specialty pharmacy or site of care.  

Traditional or full-service models include many of the aforementioned enhanced services at the hub. When employing a limited network of pharmacies, this allows the manufacturer to provide a consistent experience for all patients, rather than allowing for varied experiences across their network of pharmacies.

In some networks, a specialty pharmacy within the network may not have a capability the manufacturer would like to implement, so the hub is able to take this responsibility for the entire network. In many cases, the hub manages reimbursement support and will provide a welcome call.

Nursing support services are also commonly managed at the hub. This requires close coordination with specialty pharmacies to ensure continuity of care; however, if executed properly, can provide a consistent patient experience. Nursing services can include psychosocial support, behavioral coaching, and adherence support programs.

Another major program decision a manufacturer must make when designing their program is whether they would like a mandatory or non-mandatory hub. If the manufacturer allows prescriptions to be sent directly to a pharmacy (without going through a hub), this is considered a non-mandatory network. Some health care providers find this convenient if they have a preferred specialty pharmacy.

Non-mandatory models are also common in the oncology market, as some hospitals prefer a buy-and-bill model which can be considered a revenue source. These hospitals still in many cases rely on the HUB to assist them through the complex reimbursement landscape associated with specialty products.

Other hospitals choose to let the specialty pharmacy or hub process the enhanced reimbursement given their experience and expertise. Non-mandatory hubs require certain processes and data feeds to be put in place. If a hub does not have experience and a well-defined strategy, this will likely result in duplicate and lost records, miscommunication, and delayed overall time to fill.

Based on experience and approach, some hubs are able to monitor these data/activities, eliminate duplicate records in a timely manner, and ensure no referrals are lost. It is critical for a manufacturer and hub to think through every possible scenario throughout the patient journey so that these instances do not occur.

Mandatory hubs are also frequently used. If executed properly, this model can ensure appropriately distributed referrals among a specialty pharmacy network.

This can also ensure that a referral gets to a pharmacy that can fill the prescription fastest, rather than being sent to out of network pharmacies. Having each referral flow through the hub in a full-service reimbursement model allows the hub to capture extensive data on payer policies.

Specialty pharmacies may be able to capture this information, but they do not capture this in a uniform or centralized manner across the network. With mandatory hubs, these data can be captured at an aggregate level, allowing future reimbursement support to flow more efficiently and improving manufacturer visibility of aggregated payer data.

Another major factor to consider when designing a HUB program is the size. Larger non-rare programs frequently require hundreds to thousands of individuals employed at the hub. These services are commonly managed through shared (non-dedicated) employees in order to more efficiently manage the volume of work.

In non-dedicated support models, manufacturers will be charged by the hub on a transactional basis. This means that the manufacturer pays the hub for transactional occurrences such as BI/BV completion, prior authorizations acceptances, the number of patient calls completed, and the number of referrals triaged to specialty pharmacies. These types of hubs may also maintain relationships with temporary employment agencies to manage major fluctuations in staffing volumes.

Examples of larger providers that service these high-volume programs include Lash, Sonexus, and RxCrossroads manage. Programs with smaller patient populations commonly require a hub to build a highly customized program with dedicated support to meet the complex needs of rare disease populations.

Providers such as RareMed Solutions build teams dedicated to each specific product with specialized training for each disease state. All dedicated employees are able to become familiar with the full patient journey, the disease state, medication use needs, health care provider offices, and the patients themselves. 

This allows for more consistent, high-touch care and increased likelihood of better patient outcomes. These types of hubs may not have the capability to fluctuate by hundreds of employees on-demand, as they spend significantly more time on the hiring process.

Rather than using a transactional model, this type of hub typically charges the manufacturer a monthly full-time employee (FTE) fee for each dedicated associate employed at hub. These smaller programs in many cases do not work well with larger providers, as they have low volumes relative to the hub’s larger clients.

Therefore, these smaller manufacturers cannot expect the same level of service that would be provided when using a dedicated model at a hub focused on small patient populations. Many larger programs also focus primarily on efficiency and do not offer as much customization that might be required for a smaller complex program.

Network composition can also greatly impact the hub’s role. In networks with a large number of specialty pharmacies, full-service hubs are frequently implemented so that patients have a consistent experience. With a highly limited network of highly capable specialty pharmacies, however, hub-lite models may be preferred because these pharmacies may have similar capabilities and the ability to provide a consistent experience.

In some cases, primarily in the oncology market, specialty pharmacies may not even be used. This situation generally occurs when there is a highly limited number of centers of excellence (COE) offering a complex treatment.

These commonly require significant patient support from a hub. These models generally require patients to travel to the COE for their procedure and hubs, in many cases, provide a single point of contact for logistical, reimbursement, and psychosocial support.

Hospitals may rely heavily on the hub to guide them through the reimbursement process. These hubs are also used in this case for specialty distributor and third-party logistics coordination.

Therapeutic area and methods of administration also play a major role when designing a hub model. The recent emergence of cell and gene therapy (CGT) provides new opportunities and challenges for manufacturers and hub providers.

With these high-touch patient populations, in many cases, fully dedicated support is paramount. However, patient volume can be extremely limited, which can create a challenge for hubs and manufacturers because a number of dedicated FTEs are generally needed in order to provide 8 am-8 pm support.

In many cases for CGT treatments, this support is required on weekends/holidays due to the time-sensitive nature and unpredictable timing of certain gene therapy cultivations. Unique to CGT, these programs usually do not offer a non-commercial pharmacy given the 1-time treatment, limited patient population, and high expense associated with the treatment. Without a patient assistance or bridge program, foundation assistance and effective commercial reimbursement support are absolutely critical.

Due to the high price and complex coordination, some gene therapy manufacturers are opting to utilize a hybrid hub model in which the manufacturer hires individuals in addition to contracting with the hub. Reimbursement and other backend support may be performed at the hub while all patient interaction may be managed through the manufacturer. Some manufacturers even opt to insource their hub services entirely. 

Although this approach may give the manufacturer more control over their program, many of these manufacturers are launching their first product and do not have experience building and managing these types of teams, which can lead to difficulties if not planned appropriately. Insourcing hub services can lead to HIPAA violations if the information is not appropriately de-identified.

Although there is a large number of hub providers in the market, choosing the right hub and service model may not be as simple as selecting a well-known or respected partner. Each manufacturer must consider which type of hub model they want to implement, hub necessity, the size of the program, network composition, and the therapeutic area.

Some hubs have more experience or may be better suited for a specific patient population based on these factors. Most manufacturers work with an experienced consultant to make this decision.

Specialized consultants that frequently guide manufacturers through this process include the Blue Fin Group, Protean, and TwoLabs. Hub selection is a critical process with many variables to consider. For emerging biopharma manufacturers, the success of their product and company’s future can be reliant on a successful launch with an effective hub model and distribution network.

Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB. Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services. Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles.

Gannon earned his Bachelor of Business Administration degree from the University of Miami and is currently pursuing a Master of Pharmacy Business Administration (MPBA) from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.

Articles

Although many hubs offer similar services, no two specialty pharmacy hubs and no two hub programs are entirely alike.

Variations in The Specialty Pharmacy Hub Model

Technology is becoming increasingly important in the hub and patient services space supporting specialty pharmacy, as the effective use of innovative platforms continue to accelerate patient access to care. These platforms and innovations are critical in efficiently driving process flows, managing customized telephonic solutions, capturing and reporting on comprehensive program data, keeping a manufacturers’ field teams updated on patient cases, and driving improved program consent. 

New innovative products are also regularly being introduced to help more efficiently manage existing programs. Artificial intelligence (AI) will inevitably play a major role in hub services, improving efficiency and speed to therapy.

Other comprehensive solutions are also being created to address the challenges of new therapeutic areas, such as those in the fast-growing and rapidly evolving cell and gene therapy space.

Varying Solutions for Patient and Process Flow Management 

Many specialty pharmacy hubs, such as Sonexus, RxCrossroads, and Lash partner with well-respected third-party CRM providers, such as Salesforce, to create their technology platforms.

 These platforms in many cases offer sophisticated reporting dashboards for manufacturers, providers, and patients.  

Others are building their own in-house technology platforms. RareMed Solutions and ConnectiveRx both utilize home grown, internally managed solutions. These platforms can allow for increased customization and faster program changes, all at lower costs given their inhouse development teams.

“Our proprietary technology platform allows us to build an entirely customized patient experience tailored to the unique needs of each biopharma partner and disease state,” said Doug Gebhard, general manager of RareMed Solutions. “Our nimble technology platform, SWFT

, allows us to incorporate manufacturer requests and make process changes to our programs in a matter of hours or days versus other hubs, which may take weeks or months. SWFT

 is able to capture and report on essentially any data element desired by our partners to help identify program insights.”

Although many advanced systems are being used to automate hub process flows, telephonic support is still a critical element for most programs. In order for larger hubs to manage the challenges associated with high patient volumes, some have implemented advanced telephonic technology to record and tag specific phone calls to cases within their process flow systems.

Another challenge some hubs face is manufacturers now frequently asking to listen to recorded patient and health care provider calls. In order for hubs to provide call recordings, patients must have either provided the appropriate program consent or calls must be scrubbed for any element of PHI.

Entities such as CallMiner are able to provide automated PHI scrubbing, however these services can be prohibitively expensive unless the hub has very high call volumes. Language lines are also used by most hubs to provide multilingual support. Some of these providers, such as LanguageLine Solutions, offer support in more than 240 languages.

Benefits investigation (BI), benefit verification (BV), and prior authorizations (PAs) are frequently managed by specialty pharmacy hubs. While launching products that fall under the pharmacy benefit, this process can be streamlined through electronic solutions such as ERx Network for BI/BV. In some cases, this electronic BV can be integrated into process flow platforms.

PAs can also be managed through electronic solutions. For example, CoverMyMeds and Prior Auth Now are frequently used by health care providers. In some cases, manufacturers may need to contract with these entities from a marketing/branded perspective in order for hubs to be able to use these platforms.

Medically billed products, however, have less automated and electronic solutions, and still rely heavily on outbound phone calls to confirm benefits and manage prior authorizations.

Increasing Demand for Extensive Data, Reporting, and Analytics

Extensive data and reporting services have become essential for hubs and specialty pharmacies to compete. Most manufacturers now expect hubs to collect data, proactively analyze it, and suggest actions that improve their program efficiency and patient outcomes. Pharmaceutical manufacturers also use data to monitor and refine their marketing efforts.

Patient outcome data are important for hubs to collect and provide to manufacturers. This helps manufacturers respond to payers’ value-based contracting pressures and the data can possibly extend or improve labeling with the FDA. 

The data is captured via patient and HCP interaction or documents received at the hub. The data are entered into hub process flow platforms and reported through direct feeds, such as SFTP transmissions.

It is important for hubs to offer a nimble technology solution, as if a manufacturer finds new important data elements important during the first few months of their launch, this type of platform can make these changes quickly and efficiently. For example, a manufacturer may learn that a new genetic test is being required in order for patients to be approved on a specific commercial plan.

Rather than investing resources to update their referral form to capture this information, it can potentially be captured by a hub during the first HCP interaction or welcome call to a patient. A nimble system would be able to add this to a call scripting prompt and add a data capture field quickly and at minimal cost.

Some hubs are offering portals to manufacturers in an effort to illustrate program trends. However, in many cases, information is limited on these portals, as they do not incorporate data provided from other network partners, such as specialty pharmacies.  

Many hubs are also offering HCP portals to provide physicians and their staff close to real-time statuses of their patients. However, these are less effective in rare disease programs, as HCPs may have only 1 or 2 patients.

HCPs have thousands of patients using various treatments and it can be difficult to remember the login for each of these. Patient-facing portals are also being utilized in the hub space to provide up-to-date status and resources such as educational information; however, their value to patients is still considered questionable. 

Additionally, depending on the disease state, patients may suffer from comorbidities and be on multiple specialty products, therefore they may not want to manage multiple portals for each product.

Many manufacturers partner with a specialized data aggregation company to receive full visibility of their network data across all of their network partners. Data aggregators in this space include Prometrics, LiquidHUB, ValueCentric, and Shyft Analytics.

Data aggregators, such as Prometrics, offer portals for pharmaceutical manufacturers. This can incorporate data feeds from all network partners to provide critical updates to the manufacturers’ field reimbursement, patient access, and, in some cases, sales teams.

Information provided to sales teams must be highly restricted in order to not violate HIPAA laws and regulations. Many manufacturers now use patient access teams who are not incentivized by sales numbers to help expedite the referral process.

These individuals would be allowed to view certain data elements from a data aggregator that the sales team would not be able to view.

Leveraging New Technologies to Drive Patient Consent, Adherence, and Efficiency

Patient enrollment consent has become increasingly important to manufacturers. Not only does this consent give patients access to enhanced services that may increase adherence, but consent also in many cases allows the manufacturer access important patient data.

Historically, consent has been captured by hubs through the referral form. If consent was missed on the referral form, hubs could attempt to collect this from patients through faxes or mail.

This process was inefficient and relatively ineffective. Recently new businesses are offering consent capture websites, which enable patients to submit their consent electronically.

Text or e-mail links can be sent to patients, and they are able to simply enter their information, and electronically sign these forms almost instantaneously after a welcome call. These platforms can be managed by third-party providers of eConsent platforms, such as eHIPAA. Some hubs have launched their own integrated platforms to capture consent electronically.

Patient referrals and associated data intake tends to still be quite manual in the hub space. Some feel that this is because the original referral image must be maintained to ensure no manipulation to the form by the hub or downstream partners.

As hubs continue to advance, automated data entry through electronic forms that use required fields and automated electronic submission may be implemented.  This would reduce the possibility of manual error and streamline the process overall.

However, this may not occur for a long time given health care providers’ slow adoption of electronic solutions. AI may provide an alternative automated solution. Many AI firms have launched programs that could enable a hub to entirely automate data entry with a simple review after the referral is received.

Future Challenges and Emerging Solutions 

With the explosion of cell and gene therapy, new logistical coordination challenges have arisen for both manufacturers and hubs. These extremely expensive and time-sensitive treatments with limited viable treatment windows require intense coordination between the hub, manufacturer field team, specialty pharmacy, specialty distributor, third-party logistics firm, hospital staff, and patient.

New technologies have been introduced to help manage this intense and critical coordination. TrakCel, for example, is a cloud-based software that delivers personalized processes and workflows for all of these participants in the supply chain, allowing cell and gene therapy owners to safely manage and scale with confidence.

This platform can help coordinate collection, logistics, manufacturing, and treatment administration within a single platform, providing the manufacturer with full supply chain visibility. It will be interesting to see whether hubs are asked to use this type of technology with their own systems to provide an integrated solution.

As competition in the specialty hub market continues to intensify, technology remains a key element for hubs to differentiate themselves from others and accelerate access to patient care. New advances in technology have allowed hubs to efficiently manage complex process flows, manage custom telephonic solutions, capture and report on comprehensive program data, keep manufacturers’ field teams updated on patient cases, and drive improved program consent.

As hubs begin to adopt AI and automation, this will inevitably allow providers to become more efficient and accurate, accelerating patients’ access to therapy. Hub platforms will continue to evolve, and new players will enter the market to meet the needs of quickly evolving specialty pharmacy niches and the cell and gene therapy markets.

Basta, Nicholas. “Patient Support / Hub Services Continue to Evolve.” 

https://pharmaceuticalcommerce.com/brand-marketing-communications/patient-support-hub-services-continue-to-evolve/

Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB.  Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services.  Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles. 

Artificial intelligence will inevitably play a major role in hub services, improving efficiency and speed to therapy.

Continually Evolving Technology in Pharmacy Hub Services

Accreditation has become an increasingly critical component for successful specialty pharmacy businesses. Many pharmaceutical manufacturers consider accreditation a prerequisite when either building their network or adding pharmacies to their network.

Payers are also frequently requiring some form of accreditation for specialty pharmacies to gain network access. According to the 

, 911 specialty pharmacies had at least Accreditation Commission for Health Care (ACHC), Center for Pharmacy Practice Accreditation (CPPA), or URAC accreditation in 2018 compared with 729 at the end of 2017. Many pharmacies also continue to pursue multiple accreditations.

The number of specialty pharmacies with multiple accreditations increased 70% from 179 to 305 over the same period, according to 

. Although accrediting bodies all aim to provide an enhanced standard of patient care and advance the industry overall, each organization has a unique approach to accreditation, with widely different standards and requirements.

URAC, ACHC, CPPA, Digital Pharmacy Accreditation (formerly Verified Internet Pharmacy Practice Sites [VIPPS]), and The Joint Commission are examples of well-recognized accrediting organizations.

However, new accrediting bodies and new specialized distinctions continue to be added each year, advancing the industry’s overall quality of care and allowing the most advanced specialty pharmacies to be recognized for their elevated standards and continued innovation.

URAC is considered by some as the gold standard in specialty pharmacy accreditation. The organization has been operating for more than 25 years and offers approximately 50 unique types of accreditations, including multiple categories within pharmacy, health plan, health care management, health care operations, and telehealth.

For URAC’s specialty pharmacy accreditation, primary measurements of performance include drug interactions, call center performance, dispensing accuracy, distribution accuracy, and turnaround times for prescriptions. URAC uniquely monitors exploratory measures that are not required for accreditation but can help offset deficiencies in other areas. Examples of exploratory measures include proportion of days covered (PDC) and primary medication non-adherence.

ACHC is also among the most popular accreditations in specialty pharmacy and is particularly respected because of its status as a “deeming authority.”

ACHC started accreditation with health care organizations outside of specialty pharmacies. Examples of other health care organizations ACHC accredits include ambulatory care, renal dialysis facilities, and hospitals.

As a deeming authority, organizations such as hospitals are required to have ACHC accreditation in order to bill for Centers for Medicare and Medicaid Services (CMS). Although CMS does not have a specific specialty pharmacy designation, certain standards as a deeming authority do carry over for specialty pharmacies.

For example, ACHC is able to conduct inspections for any of their accreditations on any day without notice. This ensures that organizations such as hospitals and specialty pharmacies are actually adhering to their standards of care and are not just abiding by these standards during a scheduled audit.

Standards of specialty accreditation for ACHC are organized and measured across the categories of organizational and administration, program and service operation, fiscal management, human resources management, provision of care and record management, quality outcomes/performance improvement, and risk management and safety control. ACHC also uniquely accredits locations rather than accreditation at an organizational level. At the end of 2018, there were 761 specialty pharmacy locations with ACHC accreditation.

Although ACHC and URAC are perhaps the most widely known accrediting organizations in specialty pharmacy, new accrediting entities are growing in popularity.  

CPPA has become increasingly recognized with approximately 100 locations. This organization focuses specifically on pharmacy and does not offer accreditation for other types of health care organizations. CPPA currently offers accreditation programs for community pharmacy practice, specialty pharmacy practice, and telehealth pharmacy practice.

The American Pharmacists Association, American Society of Health-System Pharmacists, and National Association of Boards of Pharmacy (NABP) partnered to form CPPA in 2012. In its earlier days, CPPA grew quickly through its partnership with a retail-based pharmacy organization, Kloud Script.   

In 1999, NABP also created a VIPPS program/accreditation. This program was launched to help safe and legitimate pharmacies with an internet presence stand out against rogue websites. This is not a specialty-focused program, however, as many specialty pharmacies are pursuing this additional distinction.

This program verifies the internet legitimacy of pharmacies; however, it also has numerous pharmacy specific operational requirements that are unique from other accreditations. Some specialty pharmacies are also pursuing the NABP’s Verified-Accredited Wholesale Distributors (VAWD) accreditation. This accreditation is recognized by 24 US states. VAWD primarily focuses on wholesaler and drug storage standards.

The Joint Commission accreditation has also become increasingly popular within pharmacy, partially due to its status as a deeming authority. The Joint Commission is widely-recognized because of its popularity and necessity for hospitals.

This entity accredits many different types of health care entities including hospitals, physician offices, nursing homes, office-based surgery centers, behavioral health treatment facilities, and providers of home care services. Similar to VIPPS, this accreditation is not “specialty” pharmacy specific, but The Joint Commission is working on launching a specialty specific accreditation.

Some accrediting organizations are now pursuing new distinctions within specialty pharmacy. For example, ACHC currently has distinctions in nutrition support, hazardous drug handling, palliative care, infectious disease related to HIV, oncology, and behavioral health. 

Earlier this year ACHC additionally launched a distinction in rare diseases and orphan drugs.  This distinction monitors standards across areas such as specialized training of patients and pharmacy staff, manufacturer collaboration, supply-chain logistics, disaster preparation, risk evaluation and mitigation strategies, adverse event reporting, and analysis of patient outcomes.

Similarly, URAC is in the process of launching a rare disease distinction in 2020. URAC has organized an industry panel to develop these new standards, which includes entities such as PANTHERx Rare Pharmacy, Amber Pharmacy, National Organization for Rare Disorders, and other industry experts.

According to URAC’s press release, “Because of the sporadic nature of rare disease cases, it is challenging for professionals to diagnose, treat, and support people living with these diseases…The FDA drug development pipeline is dominated by orphan and ultra-orphan therapies to treat rare diseases, but a rare disease recognition program will assist in properly delivering these therapies to patients by developing standards for helping patients suffering with these devastating conditions.”

Although there has been great progress in developing new and specific standards for specialty pharmacy accreditation, specialty pharmacy hubs have made less progress with standardizing best practices through accreditation. Specialty pharmacy hubs have become more regularly used and are playing an increasingly important role in the continuum of care.

Hubs are generally used on behalf of a manufacturer to collect all referrals for a specific product and triage these referrals to the appropriate specialty pharmacy. Hubs are now taking on additional responsibilities to ensure a consistent patient experience and, in many cases, performing services that were historically performed at the specialty pharmacy.

Each program is built based on the specific needs of a manufacturer, product, and disease state. However, programs commonly include case management, reimbursement support, co-pay, financial assistance program management, nursing support, health care professional education, patient adherence and education, and noncommercial pharmacy dispensing.

Although there are numerous accreditations and special distinctions for specialty pharmacies, there seem to be no programs developed specifically for specialty pharmacy hubs. When going through a hub provider selection process, manufacturers frequently ask about hub accreditation. Unfortunately, there are few accreditations standards in the market which can accurately measure HUB specific performance.

URAC currently offers a health call center accreditation. This program is intended for a wide audience of health care organizations, including hospitals, triage and crisis lines, state agencies, pharmaceutical drug hotlines, health plans, health call centers, medical management companies, behavioral health care organizations, and disease management companies.

The accreditation requires policies for effective responses to health concerns of patients, measures adherence to defined thresholds for telephone performance, and requires around-the-clock access to clinical support in addition to many other requirements. Many specialty pharmacy hubs have pursued this or similar call center accreditations.

However, these programs may not be directly applicable to hub activities, as they do not focus on hub-specific metrics. Some may consider important hub metrics to include time to complete benefits investigations/verifications, time to complete prior authorizations, time to complete patient assistance program determinations, and non-commercial pharmacy time to dispense.  

These metrics can vary widely based on the therapeutic area, product type, and payer environment. A benefit investigation and prior authorization for a life-saving rare oncology treatment, for example, may be easier to process quickly than a non-devastating condition with less clinical efficacy.

It may also be difficult to define hub standards and measurements, as each program managed at a hub can provide services entirely different from other programs. For example, one hub could manage programs that use a “hub-lite” model, in which referrals are almost immediately triaged to specialty pharmacies, whereas others can have enhanced clinical, dispensing, and/or reimbursement activities.

Disease states, roles, and call types differ dramatically based on the program requirements. To make up for a general lack of relevant accreditation in the hub space, manufacturers may lean more heavily on experience in specific therapeutic areas and inquire on their own performance indicators during the hub selection process. Although no hub-specific accreditations exist currently, we may see accrediting organizations attempt to overcome these challenges and begin to enter this market.

Accreditation has become even more essential within specialty pharmacy. Payers are requiring multiple accreditations in order for specialty pharmacies to maintain contracts. Pharmaceutical manufacturers are requiring accreditation in order for specialty pharmacies to be considered in their networks.  

The bar continues to be raised within specialty pharmacy as new standards and quality measurements are added. Some accrediting organizations are creating even more stringent requirements for specialty pharmacies to earn specific distinctions. It will be interesting to see how accreditations continue to evolve and adapt to unique areas within specialty pharmacy and other increasingly relevant areas, such as hub services.

Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB.  Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services.  Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles.

Many pharmaceutical manufacturers consider accreditation a prerequisite when either building their network or adding pharmacies to their network.

The Continuously Evolving Accreditation Landscape in Specialty Pharmacy

As specialty pharmacy continues to evolve, new technology is becoming more vital to ensure the successful management of increasingly sophisticated products, patients with growing needs, and a more difficult payer landscape. Particularly, patient management and comprehensive data capture needs are intensifying while many pharmacy management platforms try to keep up with the new requirements.

Many specialty pharmacies have implemented new external systems, while others have developed their own in-house solutions to meet these evolving needs.

Evolving Specialty Pharmacy Management Technology

Although electronic prescriptions are frequently utilized in the traditional pharmacy environment to seamlessly process and dispense medication, most electronic prescription platforms are not capable of capturing the data needed for approving and processing specialty pharmacy prescriptions. Additional information required in specialty pharmacy varies based on each disease state but may include, for example, patient weight, genetic test results, and other supporting information for these drugs to be approved and administered.

Due to the limitations within electronic prescribing platforms, most physicians resort to faxing prescriptions along with supporting clinical information to specialty pharmacies. This method is also preferred by many manufacturers, as the faxed image ensures that there is no risk of alteration by their specialty pharmacy. Once the prescription information is received, specialty pharmacies electronically transcribe the relevant information into their pharmacy adjudication and patient management systems.

Pharmacy adjudication systems vary among specialty pharmacies and many limitations still exist across most providers in the market. Although all of these systems are able to adjudicate claims, many are not able to meet all of advanced needs of specialty pharmacy products and patients.

Examples of more advanced specialty pharmacy adjudication platforms that incorporate more advanced patient management include WellSky’s CPR+ and their newly launched platform CareTend. CPR+ was originally based off of WellSky’s home infusion platform; however, it lacked some capabilities required for specialty pharmacies.

Specialty pharmacies using CPR+ in many cases used an advanced protocol interface (API) to integrate with other technology platforms, such as FedEx for shipment and TherigySTM for patient management to make up for these limitations. CareTend has recently been introduced by WellSky as a pure play specialty pharmacy system that fills many of the gaps presented by CPR+ and offers new capabilities such as medical billing.

ScriptMed, an entity headquartered in Pittsburgh, Pennsylvania, also offers a specialty pharmacy platform, ScriptMed Enterprise. This platform is highly customizable to meet the evolving needs of specialty pharmacy and maintains a large market with major clients such as Walgreens Specialty.

Although this a widely used platform, it may be considered by some to be prohibitively expensive that only the largest specialty pharmacies can afford. However, ScriptMed has introduced less expensive options to attract the smaller independent pharmacies that may have previously not been able to afford this platform.

Many specialty pharmacies that cannot afford more advanced systems are also using other platforms that have historically been focused on traditional pharmacy. The pharmacies using these systems may rely on other platforms to manage the sophisticated needs of specialty pharmacy patients and products such as process flow management, comprehensive data capture, status dashboards and reports, and Risk Evaluation and Mitigation Strategy (REMS) management.

Ancillary systems may include TherigySTM, Asembia-1, and CTM (MHA). In some cases, these platforms are able to integrate with a specialty pharmacy’s adjudication system, however many manage these platforms independently.

To manage the sophisticated data needs of more complex therapies, some large and sophisticated providers, such as CVS, PANTHERx Rare, Accredo, and Diplomat have built their own inhouse workflow management and data capture platforms. In some cases, these proprietary platforms integrate with existing dispensing platforms; however, they are able to communicate bi-directionally.

PANTHERx Rare, for example, has developed a proprietary platform called Specialty Workflow Technology

), which is bidirectionally integrated with an adjudication platform.

This process/patient management system allows PANTHERx to build their processes and workflow entirely around the unique needs of each product and patient population with minimal development time. SWFT

 is able to capture essentially any data element at any point in the patient journey.

It is also able to offer status reports on this data, manage REMS programs, prioritize patient calls, initiate automated texts and e-mails, and offers many other customizable features that PANTHERx has developed in-house.

Increasing Importance of Capturing Comprehensive Program Data

As the specialty pharmacy industry matures, it is becoming more critical to not only manage the advanced needs of specialty pharmacy products and patients, but also capture and report on comprehensive data. Many existing specialty pharmacy systems managed by a third-party vendor have limitations in the data that they capture and updating the platform to capture new data elements can be time consuming and costly.

Some in-house systems may be preferred by a manufacturer due to their customizable, nimble, and comprehensive data capture capabilities. These data can be critical for pharmaceutical manufacturers, as they have been able to understand and act upon data faster than ever, improving the success of product launches and the lives of the patients they serve.

Understanding reimbursement data can help manufacturers improve processes at specialty pharmacies by adapting patient and health care provider outreach plans. Manufacturers can also educate physicians’ offices so that the appropriate information is being collected upfront and claims can be approved faster.

Relations teams can analyze payer data provided by a specialty pharmacy, identify payers that are denying claims, and negotiate with these payers to improve access to their product. Reimbursement data can also be useful for a manufacturer to understand the amount patients are paying out-of-pocket and update their co-pay assistance program accordingly to ensure easier patient access.

Specialty pharmacies may be able to analyze patterns and insights around the regional distribution of patients, prescriber habits, and payer patterns. If the specialty pharmacy can communicate these findings to a manufacturer, the manufacturer may reallocate and retrain their patient access and sales teams based on this information, allowing for a more successful launch.

Although these data can be useful, most emerging manufacturers are not equipped to consolidate, clean, and display a comprehensive view of their program across the hub and specialty pharmacies in their network. Most pharmacies in a network, for example, may use a specific set of status and sub-status codes in their system, which cannot be changed.

There would be no way, therefore, to view their entire patient population at an aggregate level in a consistent manner. Data aggregators, such as LiquidHUB and Prometrics, are able to provide an aggregated and consistent view of these data in a near real-time view.

The manufacturer can then analyze trends and view cases across their network. This can be particularly valuable in a portal format, allowing manufacturers’ field-based patient access teams to work with physicians’ offices and accelerate access to therapy.

If a pharmaceutical manufacturer is able to find the right specialty pharmacy partner and enter into an exclusive distribution network, this model eliminates the need and costs associated with data aggregators. This exclusive model also limits the monthly fees manufacturers must pay their specialty pharmacies to receive data. If a manufacturer has a wider network of pharmacies, the fees they pay to receive these valuable data can reach hundreds of thousands of dollars each year.

Payers are also requiring more outcome and care management data to justify the high costs of specialty products. This supplemental, post-launch information can be crucial for a manufacturer when negotiating reimbursement and potential rebates.

Outcomes-based data are particularly important for products that treat rare and orphan disease patients. Due to the smaller number of eligible patients in orphan populations, rare products have significantly smaller clinical trials.

If a product is awarded an accelerated rare disease voucher, the clinical trials may be shorter than standard trials. With limited trial data, the FDA may conditionally approve a rare disease product for certain indications.

It is possible to utilize post-approval data, captured by a specialty pharmacy, to reconvene with the FDA. With positive data, some manufacturers may be able to update and improve their product’s label and potentially eliminate additional requirements, such as REMs programs, giving the manufacturer a significant competitive advantage. Data measured after a launch can also give the manufacturer and network partners additional insights into how the drug performs and implement methods to improve efficacy, patient adherence, and retention.  

As new specialty products continue to be approved at record rates, the sophistication associated with managing these products continues to increase. In order to manage these needy patient populations, collect critical data, and report these data to network partners, pharmacies are becoming more reliant on specialized process flow technology and advanced patient management platforms.

Some specialty pharmacies not satisfied with existing third-party solutions have built their own proprietary systems. If a program is launched with the right technology that captures critical patient data, manufacturers can increase the likelihood of a successful product launch and continually improve their program. These data capture and sophisticated patient management programs highlight the importance of selecting the appropriate specialty pharmacies when launching new products and managing complex disease states.

“Transforming Specialty Pharmacy Operations to Deliver Better Patient Care.” 

www.managedhealthcareconnect.com/content/transforming-specialty-pharmacy-operations-deliver-better-patient-care

 is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB.  Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services.  Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles.

Pharmacy adjudication systems vary among specialty pharmacies and many limitations still exist across most providers in the market.

Evolving Technology, Data Capture Needs in Specialty Pharmacy

As cases of coronavirus disease 2019 (COVID-19) continue to increase around the world, all industries are acting quickly to help prevent the spread of the disease and ensure continuity of business. Many companies in the United States, especially in areas near significant identified outbreaks, have moved to entirely remote workforce solutions.

In countries where the virus has spread at a near uncontrollable rate, such as Italy, one of the critical businesses continuing to operate with staff onsite are pharmacies that treat patients in need. Specialty pharmacies are an essential subset of this group, which must also adapt to increasing contagion concerns.

These entities frequently provide patients living with chronic and potentially devastating conditions with life-saving treatments. Prescription delays can be a matter of life and death, therefore, operations must continue without disruption.  

For specialty pharmacies, contingency plans aren’t as simple as moving a workforce to their remote access solutions. Most specialty pharmacies are implementing their existing plans to prevent disruption of their complex supply chains.

However, many potentially unexpected challenges from drug manufacturing, ancillary supply needs, workforce disruptions, and technological solutions are requiring fast and creative solutions. US officials are currently monitoring 20 drugs that are facing increased shortage risk as a result of the coronavirus and its impact on drug manufacturing.

Only 1 drug shortage related to the virus has been reported to date, although details of the specific drug have not been announced by the FDA.

 While the impact to the US supply chain is not significant currently, a heavy reliance on API production outside of the United States may lead to new shortages in the near future. 

The severity and timing of the impact is currently unclear. A director at the FDA’s Center of Drug Evaluation and Research notes in congressional testimony in 2018, that “We cannot determine with any precision the volume of API that China is actually producing, or the volume…entering the US market.”

Given that most drug ingredients (APIs) are produced in China, the region originally most heavily impacted by COVID-19, some downstream impacts on the supply chain may occur. Some pharmacies have investigated the chemical makeup of their most important products to understand if they are produced in countries with high levels of infection and potentially halted API production.

Although these shortages would clearly impact specialty pharmacies’ ability to dispense product, there are minimal precautions the industry can take to prepare for unexpected shortages, given that overstocking on a product may lead to shortages for other pharmacies that actually need it. Fortunately, many factories in China have recently resumed production, although the effect from the earlier halts in production and factories in hard hit areas outside of China are still unclear.

In addition to actual product shortages, medical supplies and ancillary products that are needed at specialty pharmacies may be limited. Medical supply needs at a specialty pharmacy may evolve in variety and volume needed if COVID-19 continues to spread.

For example, some pharmacies may begin to require highly demanded protective wear to limit the spread between colleagues and to avoid potential contamination of products being packaged and shipped. For example, surgical masks and protective gowns are, in many cases, on back order.

In reaction to potential shortages of medical supplies, US trade officials have granted tariff exemptions for dozens of medical items imported from China, including protective gowns, protective masks, and gloves.

 There have even been instances in which philanthropic organizations in quickly recovering countries, such as China, have sourced and donated protective masks to the United States and other heavily affected countries.

Based on the relatively complex and rare nature of most specialty pharmacy products, treatments are typically stored in a highly limited number of pharmacies and mailed to patients. These products are not readily available for pickup at a retail pharmacy near patients’ homes.

Specialty pharmacies are therefore reliant on national shipping services, such as FedEx and UPS. Many specialty pharmacies also contract with networks of local couriers around the country in the case of localized service interruptions.

If an interruption is expected, specialty pharmacies may send patients larger supplies of treatment to last until the interruption ends. Recently, even pharmacy benefit managers are encouraging increased supplies on-hand for their pharmacy members.

Anthem, Cigna, and UnitedHealth Group have all recommended extending their member prescriptions up to a 90-day supply where possible.

 Regulators in some states, such as Kentucky, have even expanded pharmacist prescribing rights, allowing for 30-day prescriptions to be filled in the event that they are unable to reach the patient’s physician.

For cold chain products, sophisticated pharmacies will send coolers with increased insulation to patients to ensure they are able to access viable products during any interruption in the supply chain. Although these practices reduce risk, the US national shipping system is generally expected to remain operable.

If an interruption in our national shipping system were to occur, our nation would likely have even more widely impactful issues; however, this is fortunately considered by many as a highly unlikely scenario.

Most businesses within specialty pharmacy have already limited non-essential business travel. This practice limits the number of individuals traveling, potentially being exposed to COVID-19, and bringing the virus back to the pharmacy where product is being dispensed.

As a result, virtual meetings have increased in popularity. Interviews are also being updated from onsite meetings to online video meetings through platforms such as Skype or Zoom. Many industry conferences have been canceled or delayed, including the industry’s leading conference, the Asembia Summit.

Workforce disruptions are another challenge specialty pharmacies face, which have become increasingly important in recent weeks. Many pharmacies are implementing remote working solutions for non-essential personnel. This practice limits the risk of spreading the disease within the company as a proactive measure.

This solution is also becoming increasingly important for specialty pharmacy employees, as many schools and day cares around the country have announced temporary closures, requiring some employees to stay at home and care for their children.

One proactive practice employed by some specialty pharmacies has been surveying their employee base to understand how much of an impact school closures will have on their onsite staffing. This allows the pharmacy to determine or update reduced onsite staffing models and implement their staffing plans accordingly.

Many specialty pharmacies also are updating their onsite preparation plans if the virus were to spread to the workplace. These instances would of course require intense cleaning and sterilization, over and above the higher level of cleaning likely to have been recently implemented.

Social distancing is also intensified during the outbreak. Common areas will likely be closed, if they haven’t been already, and employees may be asked to work at stations at least 6 feet away from each other.

At this point, only essential personnel that have not been quarantined may be permitted to enter the facility. Some entities may contract with temporary employment agencies or partner organizations if the spread infects too many of the company’s existing employees in a worst-case scenario.

Most leadership teams have updated their lists of essential and non-essential personnel to understand which roles can truly be performed remotely and which individuals must be onsite in order to meet the needs of their patients. Essential personnel would of course include dispensing pharmacists to get products out the door. This may also include a skeleton crew of employees who are able to manage the team and adapt as a situation evolves.

Although some of these roles may be performed at home, some pharmacies may not be fully equipped to operationalize these activities at home. For roles in which employees may be asked to work from home, technology solutions are of course required. Less prepared pharmacies may need to order laptops for their employees.

For specialty pharmacies, contingency plans for COVID-19 are not as simple as moving a workforce to their remote access solutions.