Deborah Abrams Kaplan

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n healthcare, one action often begets another. A patient is treated for cancer, resulting in nausea, and then is treated for nausea. Changes in payer policies also can trigger a cascade of events affecting patients, providers and payers in unanticipated ways. An example is “white bagging,” in which a prescription is filled by a third-party specialty pharmacy and then administered by the provider without the provider taking ownership. The seemingly minor change of using a third-party pharmacy can raise patient copays and plan sponsor bills, interrupt scheduling and treatment, affect the provider’s bottom line, disrupt pharmacy receiving and storage systems, and introduce safety concerns. It can also save the payer a lot of money.

The white bagging model is a change from traditional buy-and-bill in how the prescription is filled and payment is processed. With buy-and-bill, the provider’s in-house pharmacy often fills the prescription from stored supply or through normal ordering. The treatment is typically billed under the patient’s insurance medical benefit. Commercial payers reimburse a negotiated amount for the drug and administration. Medicare usually covers these therapeutics under Part B, with the reimbursement rate set at the average sales price plus 6%.

With white bagging, the prescription is filled by a contracted specialty pharmacy that collects needed copayments or coinsurance and settles the claim with the payer. It’s typically billed under the pharmacy benefit. The medication is sent directly to the provider to prepare and dispense.

White bagging is not new, but many people working in the pharmacy sector see evidence of it increasing. “It has increased significantly in the past year and a half. I think the big insurance companies are trying to use it as leverage during the contract period to drive down their contract pricing,” says Thomas Lausten, MBA, director of pharmacy services at Children’s Wisconsin, a children’s hospital in Milwaukee. White bagging is primarily driven by an area’s biggest payer, he says, but “I’ve heard from people across the country having the same issue we’re having.”

The practice has been around in some form for the past decade or two, though less so in oncology, says Jonas Congelli, RPh, chief of pharmacy for Hematology-
Oncology Associates of Central New York (HOACNY). He’s seen slight momentum recently, given pharmacy benefit manager (PBM) and payer integrations, he says: “They’re seeing the potential opportunity to insert themselves into the whole distribution process.” The practice is concerning enough to HOACNY that it instituted a policy in 2017 not to administer drugs unless they were directly purchased from a manufacturer or an accredited wholesale distributor.

White bagging usage varies widely based on site and treatment type. A 2019 survey about infused therapies included 48 commercial plans, representing 126.6 million covered lives. It showed that at physician-affiliated clinics, 11% of oncology and 43% of nononcology treatments were obtained via white bagging. For hospital outpatient departments, 28% of oncology and 31% of nononcology infusions were from white bagging. That’s only infused drugs. A 2018 report estimated that 9% of drugs administered in hospital outpatient settings were white bagged and 26% of those in office settings.

Physicians and clinicians don’t have many good things to say about white bagging. Here are some of the downsides, from their point of view:

Therapeutics obtained through white bagging are purchased and sent specifically for that designated patient. If the treatment regimen changes last minute or the entire vial is not used, the medication must be discarded, even if unopened. “The specialty pharmacy won’t take it back. The drug company won’t take it back,” Lausten says. “It was bought and paid for by the patient. We can’t reuse it. Think of the healthcare dollars literally thrown away because of that system.” Although not an everyday occurrence, “it happens enough,” Lausten says. His hospital recently threw out two doses of Spinraza (nusinersen), the spinal muscular atrophy treatment drug, priced at $125,000 per dose.

The disposal may require special handling, which can be costly because of government compliance requirements. Still, white bagging still may be worth it for the payers. “We heard from payers, even with drug waste, it’s still a lower-cost practice,” says Sara Sadownik, deputy director of research and cost trends at the Massachusetts Health Policy Commission (HPC). Sadownik co-authored a 2019 HPC report on white bagging.

White bagging focuses on expensive specialty drugs, says Lausten, with some payers mandating that specific therapeutics be acquired this way. But that is not always the case. A major health plan in Lausten’s area requires white bagging for commonly used drugs, such as Remicade (infliximab) and Botox (onabotulinumtoxinA). That presents pharmacy management issues. Traditionally, the pharmacy checks regular shipments against the bar codes in its system. “When [white bagging medications] come in, there’s nothing to bar code against,” says Lausten. The items are already labeled for the patient, requiring a manual bar code and entering them into the pharmacy management system as the patient’s own medication, he explains.

Storage is an issue, too. Children’s Wisconsin may buy 50 to 100 vials of Remicade at a time, handling them once and storing them together. When the hospital pharmacy receives a patient order, the pharmacist pulls out the needed vials to dispense and prepare, according to Lausten: “We control purchasing, dispensing and billing for the drug.” The hospital pharmacy’s technology doesn’t easily track drugs coming from a specialty pharmacy, all of which must be handled individually. A separate refrigerator is needed, as well. These medications can’t be stored with the buy-and-bill drugs, because they are designated for specific patients. The hospital pharmacy is struggling to manage a few white bagging drugs, Lausten says, but the health plan is asking it to do so for up to 60 drugs. “It creates a tremendous storage problem. It’s a difficult situation to manage,” he says.

Because specialty pharmacy medications are entered as the patient’s own medications, they don’t go through the same order-entry system checks and balances. There is no automated drug interaction checking, because that’s built into the system only for hospital pharmacy’s medications. “From a quality and safety perspective, it’s not good for the patient,” says Lausten.

He has seen some occasional problems like the specialty pharmacy sending the wrong dosage or strength, or sending a drug for the wrong patient.

With white bagging, the drugs are not always delivered to the right place or in time for the patient’s appointment. With the buy-and-bill model, the pharmacy typically has the drugs or ensures the distributor delivers them in time. If the white-bagged medications aren’t available when needed, the patient must reschedule, which can result in less adherence and scrambled treatment plans. “The biggest unintended consequence is the impact on patients that is not captured in dollars to the healthcare system,” says Sadownik. “It’s wasted travel time, time off work, childcare and frustrations of navigating a more complex system.”

Sometimes the white-bagging medication arrives in time but the doctor changes the treatment. The drug is now wasted, and the needed therapeutic isn’t available. With buy-and-bill, it’s easier for the onsite pharmacy to make that change. “People don’t understand how disruptive it is,” Congelli says.

White bagging can also affect provider reimbursement, and some critics say much of the criticism from providers is, to some degree, animated by the fact that white bagging means they lose out on the markup that comes with buy-and-bill. Lausten says that with white bagging, “we’re managing the order and dose, making sure it’s drawn up correctly in USP (United States Pharmacopoeial Convention) sterile product rooms, which are expensive to operate and maintain. We get no reimbursement for drawing them up.”

The white bagging also affects the 340B program, Lausten says. The federal 340B program means providers can get drugs at discounted prices if a substantial fraction of their patients have low incomes, are uninsured, or both. “Those (drug) savings pay for unfunded programs we provide at our hospital,” he says. “When the drug comes through the specialty pharmacy, those 340B savings go away.” But 340B program has plenty of critics, who say it has been distorted by health systems for financial gain.

The reimbursement system is different for each drug acquisition model. Buy-and-bill typically is reimbursed under medical benefits. White bagging is typically reimbursed under pharmacy benefits. The pharmacy benefits reimbursement is often much higher, Congelli says. “We see the difference in what it would be to the payer and to the employer by running it through pharmacy benefits. It always costs them more,” he says.

There is another side to the white bagging story, one that shows that it has benefits, particularly with respect to cost. Of course, lower costs benefit payers and, depending on the particulars, perhaps some patients. Specialty pharmacies use lower cost as one of their chief selling points.

Specialty pharmacies may be able to negotiate better discounts on the high-priced medications with volume pricing. Sadownik’s research showed that with white bagging, one payer was able to lower per-unit drug prices by between 15% and 38% for several of the drugs, compared with buy-and-bill (excluding rebates). When the payer implemented a site-neutral payment policy, there was still a price discrepancy between the two methods, but it decreased slightly. The report noted one example where a drug cost $4,000 a month through traditional billing methods versus $1,000 a month from white bagging, saving the payer $36,000 per patient on a yearly basis.

Some providers, especially small ones, may not have the infrastructure to take the financial risk of stocking expensive drugs, particularly if they are rarely prescribed. An organization without that cash flow can rely on the specialty pharmacy for distribution, knowing the financials won’t affect them.

Children’s Wisconsin has a policy against white bagging, although Lausten says “in certain situations, we are forced to” accept white bagging because the patient may not have another treatment option. Congelli says HOACNY’s policy has worked well but on occasion must be enforced with a payer outside the area. The payers usually don’t get very far into the process before they agree to buy-and-bill. If the payer mandates white bagging, the HOACNY physician notifies the patient and with the patient’s permission, the physician reaches out to their employer’s human resources. Usually that’s the end of the matter.

If white bagging is still mandated, the patient would need to receive treatment at the hospital or an alternate facility. “We’ve never had to admit the patient or find an alternative care center to do that,” Congelli says.

Deborah Abrams Kaplan covers medical and practice management topics.

Articles

Having specialty pharmacies fill prescriptions may lower costs, but critics of the practice see safety issues and other drawbacks.

How ‘White Bagging’ Affects Patients, Physicians and 340B Funding

 in the U.S. live with multiple sclerosis (MS), according to a study funded by the National Multiple Sclerosis Society and, by some estimates, the average lifetime medical cost is $4.1 million. This disease has the second highest all-cause medical cost for those with chronic conditions. Getting patients into treatment quickly, and keeping them on treatment, is important to decrease the chances of the disease worsening but also to keep costs and healthcare utilization down.

“Patients should stay on their therapy indefinitely, as long as their condition hasn’t changed,” said William Trombatt, Pharm.D., CSP, manager of clinical programs manager of clinical programs for specialty and home delivery pharmacy for 

 at the 4th Annual Pharmacy Benefit Management Institute Specialty Rx Forum, which was held virtually on October 16. Those adhering to MS treatments are 42% less likely to relapse, require 52% fewer hospitalizations, and have fewer outpatient visits as well. Not surprisingly, this has a correlating impact on utilization costs.

The need for a “higher touch” program is important for patients with MS, said Trombatt’s colleague and co-presenter at the meeting, James Adams, chief information officer for AllianceRx Walgreens Prime. Patients can’t just walk into a regular pharmacy to quickly fill a prescription as many people with other condition can do, he noted. “There’s a tremendous amount of coordination between the pharmacy, doctor and insurance company before the patient is even approved for the medication,” said Adams. For the patient, that includes co-pay discussions, insurance coverage and scheduling shipments to their house.

A good pharmacy benefit management program for MS includes clinical management to educate the patient on the initial and subsequent fills, along with discussions about the medication and their disease, how to administer medication, managing adverse effects and symptoms, and conducting a fatigue and depression screening, said Adams. “This is where the specialty pharmacist has an opportunity to stretch their legs as experts,” he added. Following up with the patient after therapy begins can address any adherence issues like side effect management, building patient trust in the process, Adams told the forum attendees.

The monthly refills are an opportunity to deepen the relationship with the patient while not overwhelming them with the same information, Adams said. The pharmacy should understand, he said, that “the refill process doesn’t necessarily get easier for the patients, as they often need to call the specialty pharmacy to again coordinate payment and delivery, and to complete clinical assessments.” Adams said. Online clinical assessments have been successful at AllianceRx Walgreens Prime, according to Adams, who said 75% of their patients are eligible to complete their refill information online and almost all of those who use this method don’t require pharmacist intervention.

The difference shows for patients who are considered well managed versus those who are less managed, according to a study done by Walgreens. That study showed that better managed patients had adherence levels of just over 75% compared with just 45% for those who were less managed

. “These programs make a difference,” Adams said.

William Trombatt and James Adams of AllianceRx Walgreens Prime discussed specialty pharmacy for people with MS at PBMI Specialty Rx Forum last week. The need for "higher touch" programs is important for people with MS, said Adams.

Best Practices for Specialty Pharmacy Management of Multiple Sclerosis 

Real-world evidence (RWE) is a buzzword, and there’s nothing that American healthcare likes more than the zzzzz of a good buzzword.

But the buzz of RWE has some substance to it. RWE research is changing how medications and medical devices are approved and paid for. It’s nipping at the heels of the randomized clinical trial that remains the standard by which all medical research is judged. And RWE proponents are covetously eyeing the mountains of data that patient Fitbits, Apple watches and other devices could produce.

Last year Pfizer used RWE to win expanded approval for its breast cancer drug Ibrance (palbociclib), adding male breast cancer treatment as an indication. The FDA accepted the analysis of data from electronic health records (EHRs) and medical databases as proof of Ibrance’s efficacy. The growing acceptance of RWE is due, in part, to former FDA commissioner Scott Gottlieb, M.D., who welcomed using data from outside of clinical trials.

Over the past four years, Jeff Morgan, a managing director at Deloitte Consulting LLP, has seen a significant increase in RWE in life sciences. Morgan, who leads Deloitte’s RWE unit, called ConvergeHealth, sees it as part of a trend of people becoming more engaged in their healthcare and the data associated with it. “There [are] a lot more patient data available than ever [before].”

RWE may have some financial advantages for drug developers. Traditional research, anchored in clinical trials, is becoming increasingly expensive. A study published in the March 3, 2020, issue of 

 investigated the costs of developing 63 of 355 new therapeutic drugs and biologic agents that the FDA approved between 2009 and 2018. The researchers calculated that the research cost per product was $985 million, a figure that includes expenditures on failed trials. Experts debate estimates such as those, and there are always questions about which costs should be included. But no one would question that drug development is an expensive proposition.

Proponents of RWE say it will yield information that is both more targeted and more thorough than the evidence that clinical trials can provide. But that doesn’t mean RWE research is easy to do — or inexpensive, notwithstanding the relative cost of the randomized trial. What’s more, EHRs and insurance claims may contain a wealth of information, but neither are designed for medical research. And if wearable devices were to live up to merely half of their hype, even more data would come pouring into the mix. Collecting, organizing and understanding data requires skill, time and money, and many current computer systems just aren’t up to dealing with that data firehose.

Today RWE is predominantly used by the pharmaceutical industry to help demonstrate a product’s effectiveness to both prescribers and payers when it is used outside a controlled clinical trial. Patients who are enrolled in clinical trials of a drug may differ from those who are prescribed a medication after it has been on the market, notes Morgan. Those patients are often older than the study participants, and they tend to have more comorbidities.

RWE has been used for trial design, trial recruitment and marketing insights, says Dan Riskin, M.D., CEO of Verantos, an RWE technology company in Menlo Park, California. “None of these uses makes clinical assertions, saying one drug is better than another,” or that treatment with drug A will result in 20% better outcomes, he says. He considers the use of RWE to make clinical assertions as an “advanced use” case, when investigators pull data from multiple sources including EHR unstructured data, wearables, and the like. Advanced RWE might be used to expand indications and provide evidence-based results for use in value-based care, says Riskin, whose company provides these types of services.

A 2018 McKinsey & Co. report on RWE said that pharmaceutical companies have entered a second phase of RWE research that involves using it in a more integrated fashion. Companies have created centralized RWE teams that are often situated in their medical affairs departments. But McKinsey said there is still a problem in the industry of RWE expertise being scattered throughout the companies.

In addition to companies wanting other methods to prove safety and efficacy, payers are eyeing RWE because of drug costs. “The pressure to demonstrate the value of the product is of the highest importance,” says Morgan. “We will see a transformation in the reimbursement model from the traditional price-per-pill model. We’re seeing a lot of adoption and experimentation of value-based pricing.” And RWE research is critical to value-based pricing because it reveals the outcomes a drug produces once it is “in the wild” and on the market, in contrast to the tightly controlled environment of a clinical trial.Many value-based contracts hinge on whether there is a significant difference between the results a drug produced in clinical trials and those it produces in a particular payer’s population.

The amount of data that can be collected on patients is exploding. In some cases, the quality of the analysis is not keeping pace with the quantity of the data. It was simpler with “old school” RWE that relied on claims data, which Riskin says have their virtues. They’re readily available, and the databases include millions of people. But, he says, “[The data are] not very accurate. [They’re] not very rich.”

The FDA made great strides in collaborating with industry to arrive at an understanding of quality RWE. “If you look at their most recent framework in RWE, data validity, it’s trying to get at what is believable,” Riskin says. It’s a difficult task, he continues, one that requires “rich” data sources that include the narrative sections of doctor reports, representing what he says are 80% of the EHRs. According to Riskin, some large oncology companies are including that narrative data. “It’s rich information but it’s an expensive version of RWE.” The data must be moved and extracted, enriched and then tested for accuracy.

Although medical records data aggregators aren’t new, says Morgan, “we’re seeing a lot of experimentation with unstructured data and how you curate that.” Data curation includes machine learning and natural language processing to extract data from the written or typed narrative. Some organizations hire armies of human abstractors to manually abstract the data, he says. “There is no perfect solution.”

Better data access and formatting would be welcome, but each data set does what it’s supposed to do, says Riskin. “Claims data is perfectly situated for decisions on claims reimbursement. It’s not designed to help someone run a study,” he says. Doctor narratives are intended to be a quick reference to the patient’s important problems and what has been done to address them. A researcher would want to know more about the patient’s medical conditions, what was prescribed or tried before, and the doctor’s thought process for choosing one treatment over another.

Data are often messy, but those with expertise in knowing how to control for certain parameters or conditions can arrive at some accurate inferences, Morgan says. But there are plenty of pitfalls. Riskin points to standardized data fields, such as checked boxes, as an example. Consider when patients with cancer or heart failure are asked whether they smoke. If only 10% of smokers accurately mark the box for positive smoking status, is it fair to treat these boxes as valid data, Riskin asks. “I’ve seen entire models made on that one field where an engineer thought it was (accurate) because they checked the box.” But peer reviewed articles show that for conditions such as cancer and heart failure, the rate of filling out that box correctly is less than 50%.

Each type of medical information provides a piece of the puzzle. Morgan says there’s growing interest among RWE researchers in finding ways to link the data sources at the patient level by, for example, matching up claims data and health records that would weave together clinical and economic information. Those links can also be to national registries and patient-reported outcomes. “This is a situation where advanced RWE has a lot of room to grow,” says Riskin. With so much information available, it has to be done the right way, with a high-quality protocol, institutional review board approval when necessary, and compliance with patient privacy rules.

The FDA is still working on its guidance for RWE. A 2018 framework established some ways to evaluate RWE in support of new drug indications or post-approval study requirements, but the agency expects to issue a more complete guidance for RWE in the next year, says Riskin. The guidance will, no doubt, be influential in setting expectations for RWE. Still, researchers, drugmakers, clinicians and payers will probably be battling it out over RWE and the quality of the evidence it produces. Making those assessments may start from the perspective of evaluating studies of variable quality, and determining what is believable and what isn’t, according to Riskin. “(Verantos) put a stake in the ground to decide what we think is believable,” he says of his company. “We are very happy that regulators are now involved. They make it their business to determine what is believable.” For Verantos, a quality RWE study has a protocol measuring data accuracy and ensuring minimum requirements for that accurate measurement. With that, “you can create a high-quality study. You will have to do a lot to achieve that.”

RWE research may vary with the study’s objective. “The FDA’s term is ‘fit for purpose.’ It means that depending on the purpose, that determines what the validity of the data is to be,” says Riskin, noting that the data required for marketing insights are not the same as those required for regulatory purposes.

In the next few years, Morgan anticipates a massive shift in use. “There is great promise in these data, which can drive efficiencies in research and development. We can design trials that are more patient-centric, to decrease the burden on patients.”

In addition to EHRs, the data for RWE research will come from daily at-home measurements, such as heart and respiration rates. “It’s just going to help start answering questions that a few years ago you couldn’t answer,” Morgan says. Instead of an EHR providing specific patient information a dozen times a year, or less, at visits, the information could be streaming daily. That will strain current information systems; most are not yet set up to receive this data volume. Healthcare organizations will need to move from on-premise legacy systems to cloud systems.

As cloud-based platforms are continually adopted, the data will be analyzed by more than just data scientists, says Morgan. He explains that data analytics are being democratized by increasingly accessible technology, allowing more stakeholders to work with them.

The future involves providing therapies targeted for an individual’s situation. If a 45-year-old woman has hypertension and a history of diabetes, “I want to know what works well for other people like her,” Riskin says. That may be in the future, but that’s where this is heading, he says.

Can data mined from EHRs match that from the gold standard, randomized clinical trials? 

Real-World Evidence: A Reality Check

PillPack, Amazon Care, Haven, Amazon Comprehend Medical, and yes, Alexa.

This is not an exhaustive list, but these are some of Amazon’s forays into healthcare and its one-fifth share of American gross domestic product. The Seattle-based online retailer has also become an infrastructure company with major market positions in logistics and cloud storage. Predictions that Amazon would be transforming American healthcare perhaps shot too high, but healthcare is very much on its agenda.

Although it’s impossible for Amazon to operate in total stealth mode, the company hasn’t shared a sweeping vision of its healthcare strategy publicly, although analysts and reporters do pick up nuggets here and there from earning reports and company press releases. When Bryan Niehaus, vice president of Advis, a healthcare consulting firm in Mokena, Illinois, looks at Amazon’s various entry points into the industry, it shows him that the company is perusing and being selective. “They’re learning about the healthcare industry and picking their spots on where to get involved. Some areas might be disruptive, some are extensions of their current business,” Niehaus says.

The potential disruption may result from attempts by Amazon Care and Haven (although Haven has struggled to find its footing) to provide direct patient care and influence quality and cost. Extensions of their current business includes PillPack, a consumer prescription delivery model, and the various data storage and analytics efforts.

Amazon bought PillPack in 2018, when it was already a full-fledged mail-order pharmacy able to dispense in 50 states, with local brick-and-mortar pharmacy relationships. Amazon has a Midas-touch image, but that talent isn’t always so homegrown. “Not everyone thinks of Amazon being innovative in mergers and acquisitions,” says Nathan Ray, director of healthcare mergers and acquisitions at West Monroe, a business and technology consultancy headquartered in Chicago.

PillPack had not only a growing business model, but also the regulatory expertise Amazon needed to get into the pharmacy business. They had the licensing and the infrastructure to supply retail pharmacies and mail-order services. “Clearly they saw the opportunity to break into this large market and connect to their existing consumer base,” says Niehaus. PillPack has the potential to be a digital front door for customers to add to the goods and services Amazon offers. “Maybe they can partner with a large electronic health record (EHR) system and have a sign-on space,” he says. This could allow them to consolidate across prescriptions, medical devices or other medical supplies.

Blue Cross Blue Shield of Massachusetts announced a deal with PillPack in December to offer the pharmacy services to plan members, including free delivery of multiple medications. In its press release, the Massachusetts Blue plan said it was the first health plan to offer “direct integration” with the PillPack’s services.

Another possible fit with PillPack, say Niehaus and Ray, is telehealth services. “The possibilities are wide in how they can approach and streamline disparate parts of the health system,” Niehaus says.

Aside from Amazon Care, which currently serves some Amazon employees and their dependents in Seattle, the company doesn’t offer its own telehealth services. But that doesn’t mean Amazon is a total bystander. A large fraction of the telehealth services launched amid the COVID-19 pandemic use Amazon Web Services (AWS) data centers, notes Ray.The connection between telehealth and AWS is a reminder that almost anything having to do with the internet is a business opportunity for Amazon. Combine telehealth with the data collection and analysis from wearables and remote monitoring, and this could be the biggest healthcare change of our lifetime, says Ray. Amazon has made advances in technology-enabled care, but “I would have expected them to move faster,” in terms of telehealth, he adds.

In September 2019, months before the COVID-19 pandemic whetted appetites for virtual healthcare, Amazon took the prescient step of launching Amazon Care, a virtual health program offering telehealth visits and in-person follow-up care to a subset of Seattle headquarter employees. Among the eligible employees are those living in 105-designated ZIP codes with Amazon-sponsored health plans (as opposed to those with Kaiser Permanente plans). Vin Gupta, M.D., a pulmonologist and high-profile public health expert, was hired in January as principal scientist. In February, the endeavor was expanded to include dependents of those employees. Amazon Care is very interesting, says Ray, because Amazon, in a sense, is experimenting on itself and its staff with a new care model.

As a large employer with some of the deepest pockets around, Amazon has the scale to save money and innovate simultaneously. Large companies are often centers of healthcare innovation, Ray says, sometimes helping payers with utilization management for specific populations. Amazon Care has the opportunity to remove access barriers with convenient hours and proximity of care. “All that sounds small, but it’s enormously instrumental in conceiving ... different ways to receive and manage care,” he says.

Ray says he wonders what success will look like for Amazon Care if it were expanded to include employees at its warehouses and subsidiaries across the country. Large, self-insured employers actively participating in employee health management can get better valueand offer more services than companies with commercially insured plans. The Amazon Care model could be extended to other sites across the country or even to other companies.

Amazon Care’s primary care clinics could become a great proving ground for healthcare innovation.

The prospects for Haven are perhaps cloudier, especially considering the once sky-high expectations that surrounded the enterprise. Launched in January 2018, Haven is a joint effort of Amazon, Warren Buffett’s Berkshire Hathaway and JPMorgan Chase. Healthcare’s chattering class was talking about the “Amazonification” during its perinatal period. The naming of Atul Gawande, M.D., as CEO of Haven added cachet.

But Gawande announced in May that he was stepping down as CEO. The Haven website says its goal is to pursue “a number of commonsense fixes, as well as innovative approaches, to address issues like making primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable. We are looking at new ways to use data and technology to make the overall healthcare system better.” Those are admirable but middle-of-the-road objectives. “They’re encountering some existential questions about how they go about effecting change,” says Niehaus. “What is Haven’s true goal? Cutting costs in healthcare is a wide one. How they’ll go about doing so hasn’t become clear at this point.”

So far, Haven has only one concrete achievement: Working with Cigna and Aetna, employees at JP Morgan were offered plans with more price transparency.

Comprehend Medical, an outgrowth of AWS, is a natural language processing and artificial intelligence (AI) service. It’s complicated to pull data out of medical records because EHR systems were developed more for billing than data capture and clinical analysis. Amazon is offering not only transcription services that put the data into the appropriate fields but also data standardizing to healthcare clients so they can better access and use their data. AI is also used in imaging studies to identify potential abnormalities, but algorithms are developed for specific-use cases, making it a slow process to develop new functionality. “These concepts are valuable but incrementally being brought into how things work,” Ray says.

Anthem Blue Cross and Blue Shield has a program in 12 states that lets members use Alexa, Amazon’s smart speaker, to refill prescriptions, schedule appointments and answer insurance-related questions about claims and deductibles. “The larger trend here is, how do we simplify the experience for our members?” says Rajeev Ronanki, Anthem’s chief digital officer. Anthem offered the service for informational questions starting in 2018, providing the nearest doctor or pharmacy information without Alexa identifying the user. “Once the technology partners like Amazon got HIPAA certified in 2019, we started looking into more specialized services,” he says.

National Health Service in Great Britain partnered with Amazon for Alexa to provide general health guidance in 2019. Niehaus wonders out loud whether the Alexa of the future would prompt users on what purchase to make based on the questions she is asked.

With so many points of entry into Amazon’s data reach, the natural question is how are they using the collected data? In the context of the deal with National Health Service, Amazon told 

 that the company was not building health profiles or using health information to recommend or sell products. The devices record what is said, however, and there have been cases of the smart speakers sending recordings without user consent. Amazon also retains recordings to help train its AI algorithm.

Ronanki says that Alexa is not storing any member information. “We’ve verified that through our contract,” he says. Alexa authenticates the member’s voice to ensure it’s the right person, and Amazon sends a passkey to the user’s phone for each unique conversation. The resulting action is confirmed, like a scheduled appointment or prescription refill, based on the member’s stored preferences.

However, even without retaining health data, Amazon can use the lessons learned from the experience to develop systems for other organizations, Niehaus says. Amazon will have, for example, access to all the information gleaned from the entire British population that can be applied elsewhere. But there are clear restrictions about which data Amazon can access from healthcare organizations using AWS, precluding Amazon from mining that data. “It’s fairly common for cloud services to host data in accordance with HIPAA. There’s no evidence they’re inappropriately accessing the data,” says Niehaus.

The bigger concern for Ray is the potential consumerization of the healthcare data for marketing purposes. “One of the largest areas of healthcare is marketing, especially around Medicare Advantage. Do I worry about what data they’re mining about my parents,” resulting in targeted ads? Yes, he says.

Amazon’s future in healthcare may partly depend on how the entrenched players respond, says Niehaus. With continued industry consolidation, other players are building market share. With COVID-19, there’s been an accelerated focus on catering to patient convenience, and the relaxation of regulations has helped telehealth take off. Amazon may be on the sidelines now, and telehealth company valuations are high so there’s no bargain to be had. But Amazon bought its way into mail-order pharmacy when it bought PillPack. It could do the same with the purchase of a telehealth company.

Amazon’s overall healthcare strategy still hasn’t come into focus. “It’s unclear if there’s one person directing all the efforts,” says Niehaus, adding that he isn’t sure if Amazon will try to serve as a connection point or focus on specific healthcare services.From a mergers and acquisition perspective, says Ray, the challenge for Amazon is integration: how to fit together the various technologies.

Amazon has an opportunity now to acquire other companies that are short on capital because of the pandemic. That could be a company complementing PillPack — a competing supplier, for example. With more healthcare migrating to the home due to the COVID-19 pandemic, wearable devices and remote monitoring are likely to become more important. “The hub around your health,” says Ray, “will probably answer to the name Alexa in the not-so-distant future.”

Deborah Abrams Kaplan is a regular contributor to Managed Healthcare Executive.®

Whether the online giant has larger healthcare ambitions is unclear.

Deborah Abrams Kaplan

Articles

How ‘White Bagging’ Affects Patients, Physicians and 340B Funding

Best Practices for Specialty Pharmacy Management of Multiple Sclerosis

Real-World Evidence: A Reality Check

Amazon’s Quiet, Selective Forays into Healthcare