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The goal of producing meaningful data is driving industry progress
The business of providing outsourced patient support and hub services is growing in lockstep with the growth of specialty pharmaceuticals, which are now approaching nearly half of pharma spending in the US. Specialty pharmaceuticals are not only growing in number, but also in cost, with the latest cellular and genetic therapies reaching a half-million dollars or more for a dose.
Even so, the hub business is extraordinarily dynamic, with businesses merging at the same time as others are opening their doors, with competing loci of patient attention from specialty pharmacies and from service providers to healthcare systems, and—crucially—a riskier element of regulatory compliance, as government regulators look more closely at industry practices. Yet another factor is the ebb and flow of pharma’s own interest in owning the patient experience, through in-sourcing some or all patient support activities.
Through it all, the outsourced hub providers are expanding staff, facilities and technology assets, and expanding the range of their offerings to manufacturer clients. Even though only a handful of the buzz-generating cellular and genetic therapies (CGTs), such as Gilead’s Yescarta and Novartis’ Kymriah, have reached commercialization, some hub providers are already building service bundles in anticipation of this next wave of therapies.
“Ten or 15 years ago, the specialty pharmaceutical space was a handful of drugs costing $5,000 per year so, and the rest were mass-market products. Now, you can’t just say “specialty,” because the market is segmenting and realigning—there’s a real transformation occurring in the industry,” says Shawn Seamans, president of the newly reorganized McKesson Life Sciences unit, which includes their traditional hub and patient-support offerings. According to Seamans, different specialty pharma products call for distinct patient-support offerings, ranging from automated patient contacts to healthcare services delivered in the patient’s home.
Most hub providers have claimed highly individualized support programs; as Scott Dulitz, VP of strategy for TrialCard puts it, “if you’ve seen one hub, you’ve seen one hub.” But now, according to Seamans and others, the industry will see different categories of patient support providers, with competitive offerings more attuned to sectors of the specialty pharmaceutical arena.
Growing their businesses
Here are some of the business actions that have occurred in the past 12 months or so:
Consolidation: There have been at least five rollups in recent months: Eversana now incorporates the assets of Dohmen Life Sciences Services and Triplefin (a former unit of HD Smith), among other acquisitions; CareMetx has acquired Biosolutia (another hub provider) along with Virmedica, a provider of electronic benefit verification (eBV) services; ConnectiveRx, formed in 2016 from a variety of patient service assets, added a consulting firm, Macaluso Group in 2018; and McKesson has completed its integration of RxCrossroads, acquired in 2017 from CVS Health.
Expansion: Cardinal Health Specialty Solutions, which acquired the hub provider Sonexus Health several years ago, has opened an additional facility in Louisville, TX. Trialcard added a facility in Oakland, CA. Asembia has added a fourth location, Trevose, PA, to its other sites of patient support centers. In addition, ConnectivRx is about to open its own noncommercial pharmacy, as is CareMetx.
Introduction: The new year has seen the launch of a new hub provider, Diligent Health Solutions; and it’s roughly the one-year anniversary of another entrant, PharmaCord.
It’s worth noting that all these organizations, as well as the hundreds of pharmacies now accredited as specialty pharmacies (SPs), operate in the spaces around the major pharmacy benefit managers (Express Scripts, CVS Health, Optum and Prime Therapeutics [partnered with Walgreens]), each of which has its own large mail-order pharmacy, and offer some level of patient support. The PBM channel dominates in market share; however, many pharma companies will include other pharmacies in their distribution network, and, for some rare diseases, use an independent specialty pharmacy exclusively. The general rap against the PBM patient-support services is that they occur in the context of the PBMs hardball negotiating over drug prices and rebates; and a fraught dynamic is set up between the manufacturer, the PBM, and the insurer over who gets medications, and how they’re reimbursed.
“There’s never been a better time to provide the industry with the right people and the latest technology to best serve their needs and those of the people they serve—patients, caretakers, and health care professionals,” says Mary Anne Greenberg, president of Diligent Health, upon launching her company in January. Greenberg, was former president, North America, of Ashfield, a global pharma services firm.
In that both hub providers and SPs interact directly with patients, there is a natural competition between the two, at least when it comes to fees for services that the pharma industry might pay. Hub providers have a more or less clear pathway in this regard, since they are simply acting as agents of the manufacturer; the relationship with SPs is less easy to navigate, in part due to compliance issues regarding bona fide service fees (more about this later). The leading independent SP, Diplomat, set up a “firewalled” hub service, Envoy Health, in 2014 specifically to provide bona fide services separately from its SP. (Diplomat also set up its own PBM, CastiaRx, a year ago, thus positioning itself more strongly against the big PBMs; now that those PBMs are for the most part divisions of insurers, this aspect of healthcare delivery is going to be different, in uncertain ways, going forward.)
“We’ve seen the patient-support services growing at other SPs, but if I were a manufacturer, I’d look under the covers to ensure there are firewalls because there have been so many legal actions it would be reckless not to do so,” says Derek Cothran, SVP at Envoy Health. Relative to a free-standing hub provider, Envoy benefits from the technology platforms operating across the company, and from the financial backing that the parent provides, he says; these translate into higher levels of service for patients and, ultimately, the manufacturer clients.
There’s no regulatory requirement to set up a separate business unit at an SP for patient services, as long as what the service provider does passes regulatory muster, and this is, in part, how Senderra Rx, a Dallas-based SP that now operates nationally, with other locations in North Carolina and Michigan. “We compete against hubs for patient-support services,” says Win Purifoy, CEO. “We believe that because we have a more robust service offering than hubs, and because we get the prescription first, we will win on this front.”
Bob Wilburn, Senderra Rx’ SVP, phama business development, elaborates on Senderra’s approach: “Senderra is physician-centric. While we can provide a range of prescription products, we specialize in high-value drugs for rheumatology and some related conditions. A provider who works with us sends the prescription, and we take care of everything else—prior authorization, reimbursement and patient followup. We take care of all of this, so that the physician can focus on taking care of patients.” He adds that the company “will stay within its lane” of the specialty products and specialty physicians that represent its core value.
Overall, hubs and SPs are accustomed to working cooperatively with each other; “There’s room for both,” is how numerous industry sources characterize the relationship. Many hub providers have a so-called a noncommercial (“closed door”) pharmacy to handle free product dispensed to the indigent, or for fast-fill programs that provide a drug even as benefit verification or prior authorization are being worked out; but for the most part, they stay away from dispensing. On the SP side, the business model is mostly to make revenue as a percentage of the dispensed medication, but to provide patient followup to the extent that refills are part of the therapy. Being able to keep patients on therapy is a concern of the hubs and the SPs, and, ultimately, the manufacturer.
A bigger challenge than SPs to hub providers is, potentially, the desire by manufacturers to keep some or all of the service in-house. Hubs have grown as manufacturers recognized the risk of HIPAA violations, and to keep arm’s length from financial assistance like copays or free goods; but with ultrarare diseases, each patient becomes almost its own project. Manufacturers can also take technology-driven measures to de-identify patient records, even when dealing with patient populations as a whole.
Helio Health, a compliance and auditing consulting firm that specializes in patient support activities, did a survey last year across 28 pharma companies on the mix of insourced, outsourced and SP-sourced services (Fig. 1). Results show that hub providers are most frequently used to manage patient onboarding, benefit verification and prior authorization, but also across the growing range of all types of services. Insourcing was highest for patient education, patient assistance programs and copay assistance. SPs’ involvement was highest for benefit verification and prior authorization.
“The trend is for activities involving financial support, such as copay programs, to be managed by the outsourced provider, while patient education might be handled internally,” says Minna Bak, senior manager at Helio. “The overriding question is, what is a bona fide service as defined by HHS regulations? There are safe harbor arrangements where a service can be offered by an independent third party, but the appropriateness of this is determined almost on a case-by-case basis.”
Regulatory actions involving patient support were headline news in 2018, most notably in California, where the state insurance commissioner, Dave Jones, drafting on a whistleblower lawsuit, filed an insurance fraud compliant against AbbVie, alleging $1.2-billion in fraudulent payments for its Humira biologic by private insurance in the state. Besides “classic kickbacks” (as the commissioner’s news release put it) for dinners and gifts to prescribers, the suit claims that AbbVie “nurse ambassadors” (as AbbVie calls them) influenced patients’ use of Humira while downplaying side effect risks. Further, says Jones, “At no cost and considerable gain to the physician’s office, AbbVie nurses provide pharmacy and insurance authorization assistance, open enrollment resources, paperwork help, advice on insurance products, and other services, all of which provide a substantial value and save physicians’ time, money, and resources.”
Calling it the “largest health care fraud case in department history,” the state wants to claw back the $1.2 billion (there might also be a multi-billion-dollar multiplier penalty). AbbVie has not responded publicly to the filing, even though its stock took a hit the day the action was announced. What is notable about the fraud claims is that, on the surface, all these actions are conventional and widely-practiced components of hub programs.
In December, related whistleblower cases were the subject of an unusual Dept. of Justice motion that federal courts should throw out 11 whistleblower suits that were brought by individuals supported by an organization, the National Healthcare Analysis Group, in district counts around the country. According to a Forbes article, that group is “limited liability [company] set up by investors and former Wall Street investment bankers” expressly to win False Claims Act settlements. After examining the cases, DoJ found that “the allegations to lack sufficient merit to justify the cost of investigation and prosecution” and should be dismissed.
The outcome of both the DoJ motion and the California suit remain to be seen; if nothing else, the actions highlight how carefully manufacturers need to operate in their interactions with providers and patients. There are multiple safeguards that manufacturers, and their outsourced hub providers, can do to minimize the risks of regulatory issues, according to Helio Health and others in the field. The primary concern is to restrict protected health information (PHI—an official category of information as defined by HIPAA rules) to where they belong, and use a variety of de-identification technologies in cases where patient data is aggregated, such as for monthly reports. Manufacturers can ensure more-favorable consideration from regulators simply by the outsourcing process itself (on the assumption that PHI doesn’t pass from the hub to the client).
The other major regulatory concern is almost anything touching financial or reimbursement matters involving patients, under federal and state anti-kickback statutes. According to Helio’s 2018 survey, 55% of manufacturers use a third party to manage free goods dispensing; however, a sizable fraction of them do not monitor the programs’ actions, and an even larger proportion do not audit results (monitoring and auditing being two defensive measures manufacturers can take). Worrisomely, a significant number of Big Pharma names—including Alexion, J&J, Pfizer, Lundbeck’s US subsidiary and United Therapeutics—have made multimillion-dollar settlements with DoJ over patient assistance allegations, some of which involved financial support, funneled through charitable organizations, for patients on Medicare.
Lash Group, the AmerisourceBergen unit that was one of the pioneering firms in the patient support field (see interview on p. 16), puts a significant effort into regulatory compliance as part of its overall quality control, according to Tommy Bramley, Lash president. Fully 100 of its more-than 3,000-person staff operates within a Quality Center of Excellence, and that group is segregated physically from the rest of the staff. Quality checks include periodic monitoring of patient interactions, and extensive training on care coordination and regulatory compliance, says Bramley.
A near-universal objective of organizations involved in patient support is to collect more data, and to perform more advanced analytics on that data, to achieve accurate, actionable results for patients and health outcomes. Some of this is coming from the current trend toward value- or outcomes-based contracting—someone needs to keep score if a manufacturer’s products are to be reimbursed based on improved health. But the data/analytics drive was accelerating even before value-based contracts appeared. Hub providers are scored on how well they are managing patients; hub providers are looking to sophisticated behavioral analyses to both minimize the need for, and cost of, human intervention in patient care, and to ensure that, when that intervention is called for, it is being directed in a meaningful way.
“There’s a need for automating enrollment and reimbursement tasks, and our focus is to move away from the need for significant human capital and balancing that with automation,” says Shabbir Ahmed, chief commercial officer at CareMetX. “We’re taking a very deliberate approach to automation, with more granular programs in adherence and compliance, and using analytics to provide intelligence back to those who are touching the patient.”
Quite a few hub providers contacted for this report have built or installed a relationship-management system based on Salesforce.com’s platform, which is then customized with workflows and dashboards to meet the hub’s requirements. Cardinal Health worked with Converge Health, a unit of Deloitte, to build its platform, ConnectSource, all of which is standing on the SalesForce platform. “ConnectSource has been a big lift for us,” says Tara Herington, VP, Cardinal Health Sonexus Access and Patient Support. Besides providing significant internal advantages—being able to access data, generate reports, initiate analytics and the like—the system provides a fast way to onboard clients. “We had a client who had to start up a program in less than 30 days, and we were able to turn that around,” she says. That timeline would have been impossible in the recent past.
Unusual among hub providers, ConnectiveRx not only has a proprietary IT system that it touts, but it also licenses the software out to pharma companies that insource their patient support activities. Through its acquisitions, the company has a long history of managing copay programs and providing medical information directly to physicians (The Prescribers Desk Reference is a longstanding go-to resource for prescribers) and with its latest acquisition of the Macaluso Group, can provide comprehensive reimbursement support for buy-and-bill prescribing, something that many physicians’ offices depend on. “We built our software to be very flexible and modular,” says Josh Cordle, SVP of product and client solutions. “A biopharma client can turn on and off different features, or manage a hybrid program.” Called BrandHub, the platform integrates product procurement, inventory management, trade support, patient access EHR integration, prior authorization, among other features. “Biopharma companies want to own the patient experience, and need an infrastructure to do that,” he says.
Other SalesForce-based systems in the industry include Lash Group’s Fusion platform, Health At Work, Conduent’s system, and the in-house system for Diligent Health Solutions. McKesson’s Seamans says the company is on a pathway to unify the data-generating platforms of its various units (RxCrossroads, Biologics SP, and its existing Specialty Health and Patient Relationship Solutions units); SalesForce.com will be the underlying platform. One plus for these platforms is that they integrate well with SalesForce platforms in use at pharma companies themselves.
However, other hub providers are sticking with home-grown systems, claiming to provide a better client experience by avoiding “commoditized” platforms. Envoy Health uses a home-grown system called eNAV, which Cothran says is geared to rapidly develop content (i.e., the care program designed for a specific drug, and then the patient data gathered by it). TrialCard touts the fact that its proprietary system has just passed ISO 27001 certification, a fairly rigorous process, reviewed by an outside auditor, that can provide the highest levels of privacy protection for patient data. PharmaCord’s platform, called CORsend, was developed with a global IT services company, EXL; the two are partnering in offering healthcare data management services to phama.
Mention of EXL brings up another pathway toward comprehensive data management: use of a third-party data aggregator that collects data from the hub provider and/or SPs, and combines it with other data sources (which the pharma client might possess) to provide a more complete picture of the patient journey. Such companies include ProMetrics (now a unit of Symphony AI), LiquidHub (now a unit of Cap Gemini), Integrichain, ValueCentric and Shyft Analytics (now a unit of Medidata Solutions), among others. (Healthcare data aggregation is a fast-expanding field in healthcare generally; the abovementioned companies have experience in working directly on commercial specialty-pharmaceutical projects.)
“Digital enablement” is the term Siddhartha Sharad, GM for Pharma and Life Sciences at Conduent, uses for his company’s push into data aggregation. The company, which was divested from Xerox in 2017 (not long after Xerox purchased the Patient Solutions hub business of what was then inVentiv Health), provides direct patient support, as well as enterprise-level patient-services aggregation, including linking ordering processes for drugs and medical procedures at pharmacies and health systems. Fifteen of the top 20 pharma companies are current clients, either for commercial activities around patient support, or for clinical services and phamacovigilance. Sharad says that his group now has over 1,000 employees in locations around the world, working primarily for US and European patient-support programs.
In the recent past, these IT systems, whether within a hub itself, or from a data aggregator, were used to manage interactions with patients, and to report cumulative data to the client. The basic set of performance indicators included such data as:
• Time to first fill
• Benefit verification status
• Prior authorization status
• Copay assistance fulfillment
• Time on therapy
• Gap days
• Medication possession ratio
• Patient count
• Patient contact cadence
• Fill rate
• Time to cancellation;
but this list could rise to dozens more items. For some programs, pharma clients want daily updates in a push toward “real time” reporting. For a traditional limited-distribution specialty drug, which might involve a dozen specialty pharmacies, the hub would aggregate these data and report them to the pharma client. All that being said, the data-aggregation field is moving on, says Yash Shah, executive director at ProMetrics.
“Collecting the SP data is a given now,” says Shah. “Now the challenge is how to integrate these operational data with other data sources, such as claims data and EHR systems, or the ability to apply behavioral science algorithms on patient profiles, in order to predict adherence.” He says that some pharma clients have sought to perform such analysis even pre-launch (which would preclude obtaining operational data from hubs) as a way of predicting drug takeup patterns once the product is launched. ProMetrics has worked with pharma clients that bring clinical data they possess into the mix of data ProMetrics is gathering, in order to better understand patient journeys.
Mention of electronic health-record (EHR) data brings up what seems to be the front line in patient support analytics: integrating the entire patient journey, after initial diagnosis and prescribing, and through to multi-year outcomes. The fact that most health systems now have fairly complete EHR systems that generate (among other things) claims data and care episodes, will ultimately give manufacturers (and insurers and healthcare providers) a more complete picture of the effectiveness of a therapy.
There is, however, a mixed message currently about how possible, or how meaningful, the hub-EHR data integration can be. According to some sources in the patient-support field, EHR integration remains a bridge too far, due to interoperability problems among EHR systems, and the quality of data therein. Conduent’s Sharad, however, says that his company, through its role as a data services provider to pharma and to health systems, is able to fulfill this goal.
There are links between the services that patient-support providers deliver, and EHR systems, but most of them are oriented toward providing coupons or medical information at the point of prescribing, in a doctor’s office (more about his later). The topic comes up, also, in the context of value-based contracts, something that more pharma companies are engaging in with insurers and health systems (see article on p. 18).
ePA and eBV
Another aspect of hub services that is rapidly evolving is also something that was routine mainstay in past years: managing benefit verifications (BVs), and handling the prior authorization (PA) paperwork that insurers impose when most specialty pharmaceuticals are prescribed.
All hub providers are positioned to handle BVs and PAs—it is a critical service to overworked, time-constrained physicians’ offices. Some have developed their own database of necessary forms and contacts with insurers; others rely on one of several companies that have grown in recent years to do the process electronically. One of the more prominent is CoverMyMeds, now owned by McKesson (but separate from McKesson Life Sciences).
CoverMyMeds has spent a decade, and the efforts of hundreds of staff, to create links to some 700,000 physicians and to 94% of the payer segment, according to Erica Conroy, VP of specialty at the firm. Physicians and pharmacies use the service for free; payers and manufacturers pay CoverMyMeds for the service.
For manufacturers, the main concern is to ensure that a drug, once prescribed, will actually be dispensed to the patient. PAs can vary from quite routine to quite complex, with rejections necessitating intervention. CoverMyMeds’ ePA processes cut out as much of the phone calling and faxing that goes on between physicians’ offices and payers, thereby reducing the effort to get the PA approved, and speeding up the time to a patient receiving the therapy. Notwithstanding CoverMyMeds’ (and others’) efforts, the company’s just published ePA National Adoption Scorecard reports that half of all PAs are still handled by faxes from doctors’ offices.
CoverMyMeds has since branched out to eBV services (much of which it says can be completed in real time), including a version called RxBenefit Clarity, which combines the patient’s benefit check with prescription-cost information from another McKesson service, RelayHealth. The combination enables prescribers to provide ready access to the cost of a prescription at the point where it is prescribed. (CoverMyMeds has extensive linkages into EHR systems, enabling convenient information access to the prescriber.)
An ePA competitor to CoverMyMeds tries to do that organization one step better by ensuring that the PA is completed and (to the extent that this is controllable) approved: PARx Solutions. Dan Rubin, CEO, says that his company’s advantage is to take the PA process out of the doctor’s hands to the extent possible. “PAs can be very confusing to doctors; we inject ourselves between the prescriber and the payer, reviewing the submission, ensuring its accuracy and submitting it.” The result, he says, is a higher percentage of successfully approved PAs, and ultimately, a higher proportion of patients on therapy.
PARx is also notable for partnering with ZappRx, a company that is providing automated tools for handling PAs and other tasks, but is doing so one therapy class at a time. PARx provides the ePA resource for ZappRx customers.
A competitor to CoverMyMeds in the eBV arena is Virmedica, now a unit of CareMetX. Virmedica’s eAccess Provider solution, geared toward serving specialty pharmacies, speeds up the benefit investigations process within the pharmacy’s workflow. With CareMetX opening up a noncommercial pharmacy, the company will be able to provide starter prescriptions even as the eBV and ePA processes are being carried out.