"A broader set of payers has realized that the traditional models will only ever reach a small percentage of people in need," says one digital therapeutic executive.
With the $1-trillion-plus bipartisan infrastructure bill now signed into law, the healthcare industry has its own infrastructure challenges to tackle: how to deliver, bill, and reimburse entirely new kinds of benefits. Digital therapeutics (DTx) are one of those benefits and one of the answers is by using healthcare's "existing pipes" in novel ways. While only some DTx products require a prescription (PDT, or prescription digital therapeutics), stakeholders are using PBM channels to advance DTx commercialization in a way that reduces friction while answering unmet need—particularly in mental health.
Using PBM infrastructure for non-prescription DTx
The Digital Therapeutics Alliance defines DTx products as those that "deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders" alongside medication. And while only some DTx products require PDT, stakeholders are using PBM channels to advance DTx commercialization.
This approach begins with a simple question, captured by Peter Hames, co-founder of Big Health: "Can we bill for software in the same way as a drug, even though it's not a PDT?" Hames continues: "The approach involves taking a machine designed for one thing and retrofitting it to make it work in a different way. There isn't an obvious answer, so you have to try it."
Big Health—which offers two non-prescription DTx products (Sleepio for insomnia and Daylight for anxiety)—worked with CVS Health to uncover these answers. "In our partnership with CVS, we worked with their senior leaders on the overall concepts of a digital formulary for a couple of years prior to going live," says Hames. "We brought a good hypothesis of value and went in with humility. CVS brought expertise in how to execute."
Jill Borrelli, LICSW, vice president of behavioral health at Point32Health, agrees that "collaborating to make … innovative digital therapeutics more accessible to people" is key to care access and support for multiple behavioral health conditions. Point32Health is doing its own work in the space, with member Tufts Health Planpiloting a PDT for substance and opioid treatment in Massachusetts.
From pioneering to expansion
Using PBM as a channel for non-prescription, non-drug claims goes one step further than, for example, a payer using its pharmacy benefit to provide DTx coverage. As Hames notes: "PBMs have enormous reach and administer for every type of payer. They offer standardized methods and formats to submit and adjudicate claims that we’ve been able to harness."
The Big Health-CVS partnership paved the way for other DTx products to join the PBM's Point Solutions Management, which grew from six in 2020 to 10. Two additional services target fertility and specialty drug cost management for Point Solutions Management which, per CVS, is designed to help its PBM clients "simplify contracting, secure lowest price and monitor ongoing performance of third-party health care point solutions, which can help maximize their benefits program while minimizing associated spend."
CVS Health is not alone in the DTx partnership space. The leading PBMsincluding CVS Health—Caremark, Express Scripts, OptumRx—represent 77% of prescription claims managed, are all linked to payers (Aetna, Cigna, and UnitedHealth, respectively), and are all working with manufacturers to help commercialize DTx and PDT.
The impact of unmet need on patients and payers
This expansion is needed. Mental Health America reports that 57.2%. U.S. adults diagnosed with mental illness receive no treatment. Many face access challenges when they do.
"I often say that we are looking the wrong way when it comes to mental health. With … adult Americans experiencing a clinical level mental health issue, we simply don’t have enough therapists to address the body of need," says Hames. "Due to the limited number of therapists, in-person and teletherapy are only addressing the tip of the iceberg. We are focused on helping those under the waterline."
Provider shortages impact patients and payers alike. Despite federal and emerging state laws that mandate and penalize for inadequate networks and long wait times, Kaiser Health News highlights that there are parts of the U.S. that "don't have enough therapists at any price."
This doesn’t mean that DTx is intended to replace providers. "DTx solutions that are proven clinically effective can function as a standalone while also integrating with existing care models," notes Hames.
He does say, however, that established approaches to mental healthcare are topping out: "A broader set of payers has realized that the traditional models will only ever reach a small percentage of people in need."
Solving payer problems
These scenarios create opportunities for DTx to help payers meet need. In a separate interview with Digital Health Today, Hames shared the related insight that the customer is "whoever economically benefits from … [an] individual being healthy as quickly as possible. That customer is, therefore, whoever pays their healthcare costs." In continued conversation with HealthLeaders, Hames added: "Our goal is to align incentives with the people we’re trying to help to deliver value."
The other goal is working out the mechanics of making PBM DTx delivery a "low-lift engagement" through:
Pre-approved DTx products that make it easier to add them to plan coverage via PBM addendum.
Integration of distribution and care pathways.
DTx itemized alongside drugs on pharmaceutical invoices.
"Leveraging standard coding models, creating new ones, looking at benefit categories and copays, who sends what when and how items appear on the invoice. We looked at every single piece of the process and how to apply it to digital therapeutics instead of drug reimbursement in a way that removes friction from the process."
Clinical effectiveness and challenging precedent
Demonstrating clinical effectiveness for improved outcomes is part of this process.
About Point Solutions Management, for example, CVS Caremark CMO Sreekanth Chaguturu, MD, states: "We have analyzed pharmacy and medical claims to identify where these benefits can make a difference and employ a rigorous and transparent evaluation process to [ensure] that any vendor included in Point Solutions Management meets high standards for safety, quality and user experience at the vendor's lowest price in the marketplace."
Collectively, Big Health's Sleepio and Daylight products have been the subject of 13 randomized controlled trials as part of the company's clinical evidence focus.
Results like these are important to payers, with their concerns over outcomes being part of the reason why the Centers for Medicare & Medicaid Services is going back to the drawing board on its federal DTx guidelines.
A combination of proven results and the novel delivery and reimbursement will be needed.
"DTx is technology on the front of human-delivered care," says Hames. "This is a hard area of development and healthcare is largely precedent based. But so much is done just because that's the way it's always been done."
"Implementing robust network adequacy requirements is an underutilized tool. Failing to address network adequacy undermines other policy initiatives to expand access to affordable care," says the Legal Action Center.
In October, California became the latest of seven states to mandate that payers reduce wait times for member access to mental health services. But the new law highlights challenges linked to existing federal requirements that remain unmet and often unenforced: provider shortages, network adequacy, and reimbursement parity. As payers seek to make strides, they do so against the backdrop of recommendations from the Legal Action Center (LAC)'s most recent report on network adequacy for mental health and substance abuse disorder (MH/SUD) services.
The LAC recommends the following:
Standardized network adequacy measurement: Specific metrics for network adequacy that include accessibility and availability to "create greater accountability and uniformity across health plan."
Specific MH/SUD metrics: To "address historical discriminatory insurance coverage for these services, the LAC recommends metrics that "cover the full range of MH and SUD practitioners and facilities and that quantitative measures for geographic distance, wait time and provider/enrollee ratios align with those for primary care physicians and comparable medical facilities."
Payer cost-share: To address adequacy and out-of-network care's higher costs, the LAC recommends that states require coverage parity with in-network services.
More transparency: Including the filing and/or public availability of payer access plans, compliance results, and contracting criteria along with required, continuous monitoring programs.
More education: LAC advises that consumers "need to be better informed when selecting a health plan about the carrier’s provider network and the trade-offs associated with plans that offer lower premiums for limited plan networks."
Ongoing oversight: To include enforcement and corrective action.
The LAC's report includes specific state callouts as well. In addition to the states with wait time laws—Colorado, Maine, Maryland, Missouri, New Hampshire, Texas, and now California—a dozen have travel time/distance requirements specific to MH/SUD.
LAC's diverse recommendations are tied to its identification of "other factors that contribute to inadequate networks." These include: the lack of available providers, lower rates of pay, balance billing, and provider directory quality.
"[T]he absence of an established, repeatable, and scalable path to commercialization and prescription of DTx has bottlenecked broader uptake," says one physician leader.
On November 14, 2021, the Centers for Medicare & Medicaid Services (CMS) repealed its final rule on Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary. The repeal marks the fifth MCIT action in 2021 as Medicare, Medicaid, and commercial payers await guidance on digital therapeutics (DTx), including those that require a prescription. Until the regulatory dust settles, DTx commercialization will continue to develop—like so many healthcare innovations—in a "both/and" world, one in which stakeholders work within and around existing frameworks while attempting to forge new ones.
The CMS MCIT 2021 timeline began in January with a final rule that would have "automatically provide[d] Medicare coverage for devices receiving FDA breakthrough designation for four years," writes Health Affairs contributor and physician-investor Nisarg Patel. MCIT sought to close "the current nine- to twelve-month gap between FDA approval and Medicare National Coverage Determinations, as well as the inconsistent coverage by local Medicare administrative contractors."
Additional legislative and industry changes needed
Two delayed effective dates and two proposed rules later, including the intent to repeal, stakeholders await guidance. While the delays have not kept payers from covering DTx products and manufacturers from forging pathways through PBMs, Health Affairsnotes that additional federal legislation would have been required to make the DTx framework whole.
Federal legislation proposed in 2019 would have closed Medicare benefit category loopholes for DTx, while other legislation from 2020 would allow both Medicare and Medicaid "to cover all FDA-cleared or approved prescription digital therapeutics intended to prevent, manage, or treat mental health and substance use disorders."
Payer objections
While CMS stated that the FDA breakthrough designation would have automatically satisfied part of its "reasonable and necessary definition" for medical devices, the agency’s proposal to expand this definition to consider commercial insurer coverage policies received significant objection during public comment. CMS noted that the inclusion "presents implementation and appeals process challenges that would likely persist."
In its repeal, CMS also cited concerns with "Medicare patient protections and evidence criteria" and potential disadvantages for DTx technology that does not have FDA breakthrough designation.
Payer objections and existing pathways
America’s Health Insurance Plans (AHIP) summarized collective payer concern by noting "a number of unaddressed operational issues, including how and when CMS would communicate to health insurance providers information on benefit category and appropriate billing codes."
The payer community shared these and other objections to CMS' framework, including the fact that "[m]any of the eligible Breakthrough Devices are coverable and payable through existing mechanisms" and that "a review of claims data showed that Breakthrough Devices have received and are receiving Medicare coverage when medically necessary."
UnitedHealth Group identified inconsistent scope in CMS' proposal and requested "confirmation of all item categories (e.g., devices, drugs, biologics, diagnostics) that CMS deems eligible for the MCIT pathway" beyond FDA breakthrough status.
Cigna and the Blue Cross Blue Shield Association (BCBSA) both proposed utilizing existing codes for some prescription DTx (PDT) billing. This includes National Drug Codes (NDC), which Cigna noted "already provides a sufficient framework for accessing emerging technology that has proven clinical benefit to the Medicare population." BCBSA added that an existing, unfinalized, and applicable rule on durable medical equipment benefit categories and payment provides an opportunity for integrated comment.
Additional coding scenarios
Benefits and coding represent both strategy and tactic for payers—the linkage of operations and strategy necessary for better healthcare access, quality, and affordability. Depending on whether DTx require a prescription and thus whether payers pursue reimbursement under the medical or pharmacy benefit, Health Affairs highlights the following coding strategies:
CPT and HCPCS codes: Using existing codes for remote monitoring, patient self-monitoring, and care management spanning initial provider set-up and education to data collection, monitoring, and interpretation.
CPT updates: Expect CPT codes also to change as DTx framework needs grow. Recent changes from the American Medical Association’s CPT Editorial Panel "will allow providers to adequately describe time spent delivering" cognitive behavioral therapy remote monitoring.
NDC: While NDCs could have provided a path for PDTs, they will be replaced with unique codes for software-as-a-medical-device products.
Value-based from the start?
Even with so much to be determined, some DTx reimbursement contracts are launching as value-based purchasing (VBP) arrangements. In September, DTx provider Pear Therapeutics and PBM Prime Therapeuticsannounced the first VBP for digitally based substance and opioid use treatment. VBP may be the ideal model given the need for the long-term outcomes data that will demonstrate value and that is currently missing from the field, another concern associated with CMS' now-repealed MCIT rule.
The value-based options proposed mirror those that are emerging for PDT's pharmaceutical cousins: novel drug therapies whose results may or may not justify their price tags. These options include outcomes-based payments, rebates for poor performance, and even step therapy approaches.
Both/and, not either/or
Health Affairs author Patel concludes that "the absence of an established, repeatable, and scalable path to commercialization and prescription of DTx has bottlenecked broader uptake. Consequently, current DTx evaluation decisions among commercial payers are largely ad-hoc and based on individual priorities." Regarding the evolution of NDC for DTx, Patel adds that it "may be difficult to wedge [unique device identifiers] into existing information exchange infrastructure."
Welcome to healthcare. EHR and VBP implementation challenges have persisted for more than a decade for this very reason. In its most basic form, VBP continues to not only wedge itself into healthcare’s fee-for-service infrastructure but is still fundamentally dependent on it. As calls emerge for entirely new DTx benefit categories and codes, pioneering stakeholders will continue to operate in a both/and world—until and perhaps even after CMS lands on a final rule.
"[T]here is no guidebook, there is no blueprint, none of us has ever done this before," says one plan executive.
MassHealth, partnering with Pear Therapeutics, will become the first Medicaid program to reimburse for prescription digital therapeutics (PDT). This first for Medicaid is not a first for Pear and other PDT manufacturers that have pioneered partnerships with multiple PBMs to commercialize digital therapeutics as regulations lag. As vendors, PBMs, and commercial payers move forward, PDT highlights one of healthcare's growing challenges: technological innovations that move faster than the delivery and reimbursement systems needed to fully implement them.
Commercial payers advance DTx
While full implementation of Massachusetts Medicaid PDT coverage awaits final state and federal approval, as well as funding, MassHealth MCO Tufts Health Plan is already planning a pilotof reSET and reSET-Owith Spectrum Health Systems, a mental health and addiction treatment provider. Details are still emerging for this commercial population pilot.
Other commercial payers are also laying a DTx framework. A recent Access & Reimbursement surveyfrom Clarivate found that 9 in 10 pharmacy and medical directors said their MCO "either already had a policy in place for covering DTx or expected to have one by June 2021." While the study focused on insomnia, results may be applicable to other conditions given that many digital therapeutics focus on mental, behavioral, and neurological conditions.
"The future of pharmacy is to lean in and step forward and understand that this is new, this is different …" says Snezana Mahon, PharmD, vice president and general manager of Care Solutions Evernorth, the Cigna health services division that also manages the company’s PBM, Express Scripts. Also in conversation with Clarivate, Mahon further states that "there is no guidebook, there is no blueprint, none of us has ever done this before."
PBMs pioneer DTx pathways
Direct contracting with PBMs is another path DTx manufacturers are taking to get their products to market. The leading PBMs—Caremark, Express Scripts, OptumRx—represent 77% of prescription claims managed and are all linked to payers (Aetna, Cigna, and UnitedHealth, respectively).
Clarivate reports that "[p]harmacy benefit coverage tends to be a better fit for a prescription-based DTx … [which] facilitates easier application of member cost-sharing and provides multiple touchpoints for member engagement." Other payers use the medical benefit "for products categorized as DME and those sourced directly from the manufacturer, as well as products used during an office visit and those that require specialist or case manager intervention." Clarivate adds that "plans whose PBMs limit their contracting on the pharmacy side may choose to cover DTx under medical."
Innovating innovation
Risk-based contracts are also finding their way into DTx reimbursement. Pear and Prime Therapeutics have a value-based PDT contract for substance and opioid use treatment. This is a particularly interesting development: that a new therapy would begin its life under advanced payment models as the industry struggles to move to full-risk-based contracting.
In the meantime, be prepared for a flow of "firsts" on DTx reimbursement as each manufacturer with a condition-specific technology contracts with a PBM, payer, or self-insured employer for product reimbursement. Watch also for the tail to continue to wag the dog as federal DTx guidance continues to be delayed.
The Digital Therapeutics Alliance is developing a payer-specific "framework for healthcare decision makers … to better understand, evaluate, and implement digital therapeutics."
For payers who want to learn more about emerging, technology-based treatments, the Digital Therapeutics Alliance (DTA) is an aggregated source for news and guidance. The nonprofit trade association’s primary role is to provide health plans, as well as "patients, clinicians, … and policymakers with the necessary tools to evaluate and utilize" products in the digital therapeutics (DTx) space. The following summarizes DTA's current and forthcoming resources, plus recent innovations from association members.
1. Foundation documents. As a starting point, the DTA site library includes five "Foundational Documents" with DTx product oversight essentials for "safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact":
2. Coding changes. DTA CEO Andy Molnarstates that "reimbursement remains [a] big issue" in the DTx field. This makes reimbursement design critical, including industry coding changes. Beginning in 2023, select CPT code updates will make it easier for physicians to be “reimbursed for their time spent prescribing, monitoring, and supplying online CBT [cognitive behavioral therapy] technologies."
3. A government-payer first. While DTA reports that "Medicare and Medicaid … are still working to determine how to formally recognize and provide patients with access to DTx products," one company is leading the way. Pear Therapeutics has become the first DTx vendor to partner with a state Medicaid agency for product reimbursement. Pending government and funding approvals, MassHealth will cover Pear’s reSET and reSET-O, two prescription DTx (PDT) products for substance and opioid use disorders.
4. Reimbursement innovation. Pear is one of several companies pioneering DTx and PDT reimbursement through PBMs. It has partnered with at least three PBMs—OptumRx, RemedyOne, and Prime Therapeutics—with the Prime partnership including a value-based contracting component. Big Health, which offers its Sleepio and Daylight DTx products for insomnia and anxiety, has created a unique PBM strategy with CVS Caremark.
5. Forthcoming payer guidance. DTA reports that it is developing a payer-specific "framework for healthcare decision makers … to better understand, evaluate, and implement digital therapeutics."
"Insurers need to become a strategic orchestrator of services. They will need to shift away from just paying claims … [and] start assuming the role of a 'strategic payer'"—The Geneva Association
A recent brief from The Geneva Association defines the role of what it calls New Care Models (NCM), an expansion of value-based purchasing (VBP) that includes five distinct models and incorporates life insurance as a factor in whole health planning. Based on a literature review and stakeholder interviews, the brief matches these models to multiple impact criteria and defines NCM drivers. Their key recommendation is for payers to shift from simple claims processing to strategic players through better risk stratification and partnerships that lead to full risk-sharing over time.
According to the Geneva Association, NCMs are marked by holistic, continuous, and coordinated care with a patient-centered approach that includes aspirations and spans individuals, communities, and policymakers. The result should be comprehensive, a "[s]hared responsibility and accountability for population health, tackling the determinants of ill-health through intersectoral partnerships."
The Geneva Association identifies three key industry drivers for NCMs:
Greater numbers of older, sicker patients with more complex medical and whole-life needs
Increasing healthcare costs and the mounting burden on consumers via higher premiums and deductibles
Public funding strains as the number of private and public-private ventures grow
These drivers—combined with multiple impact criteria and the diverse rationales for NCM adoption—can lead payers to the ideal NCM option. Using a supply-and-procurement lens, the Association recommends options that shift from traditional approaches:
Multiple Accountable Care Organization (ACO) models
Global risk and full payer-provider integration
Direct-to-consumer services, delivered by providers
Consumer-directed purchasing based on needs and resources
The brief's authors identify the strengths and weaknesses of each model based on eight criteria, ranging from outcomes, consumer attractiveness and market potential, and provider/organizational capabilities to care utilization influence, insurer risk, and cost containment potential. Under these criteria, the ACO models rank the highest, surpassed only by global risk, fully integrated approaches.
The authors' final recommendations include a value chain that delivers for consumers, distributors, providers, and organizations alike and that marries health and life insurance planning. What does this mean for payers? The brief notes: "Insurers need to become a strategic orchestrator of services. They will need to shift away from just paying claims, start assuming the role of a ‘strategic payer’ and ensure a favourable supply-side condition that can fulfill the promise of NCMs made to policyholders."
"It's not clear yet what America's health care future will look like, but the continuing impact of the COVID pandemic and debates among policymakers over the future of government programs are shaping consumer experiences and expectations."—eHealth
eHealth, a large health insurance exchange in the U.S., has released its biannual Health Insurance Trends report. Topics range from Medicare, COVID-19, technology, and disparities to insurance coverage selection, costs, billing, and customer experience. The report is based on a survey of more than 6,400 consumers and 15 health plans, and for the first time includes response breakdowns based on racial and ethnic demographics. The results below highlight areas of interest for payers.
Consumer response varies on Medicare benefits, costs, and private sector roles.
Expanding Medicare: 92% want added dental, vision, and hearing benefits for traditional Medicare but only 50% would be willing to pay for them.
Public versus private: A majority believe Medicare should continue to be a public/private program but results vary among Republicans (56%), Independents (56%), and Democrats (51%).
COVID-19 consumer opinions mixed while pandemic impact on health insurers less than expected.
Vaccination status and premiums: 45% of consumers support higher insurance costs for people who are unvaccinated, with 37% opposed.
Modest cost increases: 55% of insurers indicate that COVID has increased member medical costs but most by 10% or less.
Post-pandemic picture: 38% of insurers have reduced, or plan to, their voluntary COVID coverage expansions. Only 12% plan to raise premiums.
Diverse communities see more surprise billing, fewer choices.
Unexpected charges: Compared to 46% of White respondents and 45% of men, many consumers who are Hispanic (60%), Black (56%), or women (54%) have encountered unexpected medical costs.
Coverage doesn't reflect community: Fewer people of color believe that their insurance options meet their specific racial or ethnic medical needs. This includes 41% of Hispanic, 45% of Asian, and 46% of Black respondents compared to white (58%).
Response varies on insurance options and innovation.
Marketplaces: 69% of consumers want additional, private options for marketplace shopping, comparison, and enrollment.
More faith in the private sector: More than half of respondents (52%) believe private enterprise is better at technology and innovation than the government (18%).
"Data gaps and the lack of race data have been a challenge for years. Physicians can't do these kinds of interventions on their own," says BCBS-MA CMO Sandhya Rao.
Lagging, missing, and unstructured data is one kind of healthcare challenge. Some data, however, is hiding in plain sight, waiting to make a difference. One payer, BlueCross Blue Shield of Massachusetts(BCBS-MA), is focusing on existing HEDIS data to reveal multiple racial and ethnic disparities and link solutions to its current value-based purchasing (VBP) model. As reported in September by The Boston Globe, this initiative "will begin paying doctors more money if they close longstanding and pernicious gaps in care for people of color." Although the initiative has just begun, payers can consider what its design is already revealing as they seek to implement similar programs.
Equity begins at home
The initiative is rooted in two ideas and three program elements, according to Sandhya Rao, CMO for BCBS-MA.
"We've been aware of disparities for years and doing a lot to address them. But the events of 2020—including the murder of George Floyd and COVID-19—inspired us to look at our own HEDIS data across groups and to build on being at the forefront of value-based purchasing for more than a decade through our Alternative Quality Contracts (AQC)."
Linking current data, practice leadership, and payment approaches form the programmatic core of the plan's new disparities initiative.
How it will work
BCBS-MA will launch the initiative using publicly reported HEDIS data to identify the most critical gaps in care for members who are Asian, Black, and Hispanic. Early findings from the plan's 2021 Health Equity Report compared disparities in care across ethnic groups in the following areas:
Colorectal screenings: Lower rates for Asian (67.0%), Black (63.8%), and Hispanic members (65.4%) versus non-Hispanic White members (70.8%).
Adolescent well-care: Fewer visits by Black (68.9%) and Hispanic (70.3%) members compared to non-Hispanic White members (80.2%).
Severe maternal morbidity: Rates were more than double for Black members versus White non-Hispanic (2.8% vs. 1.2%).
Antidepressant medication management: Black and Hispanic members were 15%–20% less likely to receive the recommended management than White non-Hispanic members.
BCBS-MA will target these areas first, focusing on commercial members already attributed to its primary-care-focused AQCs, which more than 80% of BCBS-MA's physicians and hospitals participate in. Rao notes that the plan published these findings to “start the conversation” on how existing data can help identify disparities and how to address them.
BCBS-MA will use the AQC model to design incentives for its new equity-based initiative. "This is the part we know the least about now. We always start by sharing data and metrics for a few years to ensure those components are right, then build in incentives over time." This will begin in 2023, according to the plan.
To support providers in this new AQC direction, BCBS-MA is partnering with the Institute for Healthcare Improvement (IHI). The IHI will bring together plan practice leaders who are effective at sharing data to impact disparities and engaging other physicians to close gaps.
Measuring success and applicability for other plans
As to how BCBS-MA will know the initiative is working, Rao says that the plan will "start with the known, provide physicians with ongoing member reports, and refresh and refine the data as often as possible."
Rao says that, based on existing data, the initiative may launch with different metrics for different physician groups and grow from there. "Our general quality strategy is to expand the measure set beyond HEDIS, such as behavioral health where we could use more measures of quality."
Common opportunities and challenges
As is true of many aspects of healthcare, opportunity and challenge are often rooted in the same elements.
"Data gaps and the lack of race data have been a challenge for years," says Rao. The health plan is using multiple approaches to overcome this, including working with providers and employers to collect data, and continuing to ask members to self-identify. The plan will also use imputed data (i.e., data that assumes a member's race based on multiple factors).
Supporting providers is another challenge. "Physicians can't do these kinds of interventions on their own," says Rao. Closely linked to this are BCBS-MA's AQCs, designed so that it "doesn't put all of the burden on the physician."
Paramount to this is whether the current AQC model has worked, given that it will be the chassis for the new program. A Harvard Medical School study published in The New England Journal of Medicine found that BCBS-MA's AQC "slowed the rate of medical spending growth by up to 12% while improving patient care" from 2009–2016 compared to averages nationally and across New England. On the quality and efficiency side, researchers noted that the AQC "has helped change the rates that physicians order tests and some imaging modalities, the rates of emergency department admissions, and the management of chronic conditions."
It is also true that an asterisk can be placed at the end of nearly every VBP result. These include other factors that could contribute to results, including "the presence of Medicare ACOs [accountable care organizations], payment reform among other commercial payers, and state policies," to name a few.
Understanding whether VBP can fully deliver is an ongoing question. Even the IHI's involvement in the new BCBS-MA equity initiative reinforces these challenges. Over the past 20 years, key IHI publications on quality and medical errors have revealed other truths hiding in plain sight: that healthcare was (and still is) struggling to meet its Triple Aim: better cost, outcomes, and customer experience.
Here, Rao cites her colleague Dr. Mark Friedberg, SVP for performance measurement & improvement at BCBS-MA: "We can't just say we want to close these gaps without acknowledging the resource and effort involved."
And also without acknowledging existing data. As payers and other stakeholders look increasingly to alternative data sets from multiple external sources, BCBS-MA is using what it already has to bring into focus a story that was already there.
'The challenge is, how do plans maintain and increase Star scores in the clinical measures for higher-risk members while proactively enhancing the customer experience,' poses one executive.
It has been exactly one month since the Centers for Medicare & Medicaid Services (CMS) published its 2022 Star Ratings for Medicare Advantage plans. One year from now, Star Ratings measures for Patient experience will quadruple in value—a shift in priorities that may disrupt plan ratings and benefits parity. And while some external Stars measures data pose challenges, payers' own data and operational focus can help create a robust, integrated Stars strategy that achieves what CMS' program shift is designed to accomplish.
Star Ratings measures, weights, and methodology change annually to reflect CMS priorities and address parity across measures and plans to ensure continuous performance improvement. For the 2022 MA plan year, Stars Ratings include multiple measures across five categories weighted from one to five: Outcomes, Intermediate outcomes, Patient experience, Access, and Process. Plans that earn 4.0 stars or more qualify for quality bonus payments while plans that achieve 5.0 can market year-round.
The soon-to-be quadrupled weighting of the Patient experience category is no small change. It means that customer experience metrics will represent 57% percent of an individual health contract's overall Star Rating. A prior HealthLeaders article featured this payer call to arms from Amy Amick, president and CEO SPH Analytics, a firm specializing in healthcare analytics and population health: "If you don't want to let be left behind with 2023 Star Ratings, or if you want to continue to use experience as a way to differentiate and outperform, you need to be taking action today." Amick's advice came more than a year ago, a time for plans to begin to act given the challenge of improving customer experience.
Can a focus on customer experience move the needle?
McKinsey notes that while "customer experience measures have been a component of Stars ratings for years, health plans have not been as successful in improving their customer experience compared to other industries." Clearly it is time for a change, and for multiple reasons. For more than a decade, analysts have been citing the Star Ratings "Lake Wobegon" effect, named for a fictional town where "all the children are above average." In 2022, approximately 90% of MA enrollees are in plans rated four stars or higher.
McKinsey further notes that the Stars program has generated $15.1 billion in payer incentives. Despite this, the MA program is not achieving one of its primary objectives: to generate savings for the overall Medicare program while delivering higher quality, coordinated care. This is according to MedPAC, the independent agency that advises Congress on the state of the Medicare program. In its March 2021 report, MedPAC notes that "aggregate MA payments … are about 4 percent higher than expected FFS expenditures." They further add: "The current state of quality reporting in MA is such that the Commission can no longer provide an accurate description of the quality of care in MA."
Similar challenges abide in the Medicare Shared Savings Program (MSSP), which established accountable care organizations (ACO). MedPAC reports have "shown modest success in improving quality" and "modest reductions in spending relative to their benchmarks" compared to FFS." This includes the NextGen ACOs that take on greater risk and which have resulted in no reduction in spending when accounting for shared savings distributed. It's important to note that 43% of MSSP quality measures pertain to patient/caregiver experience.
Implications for payers
While the above data raises questions about Stars and customer experience metrics as a direct path to savings and quality, plans certainly can't go wrong in treating their members well. Amick from SPH Analytics notes that Patient experience can be a payer strategy to "differentiate and outperform"—an especially important one given the current parity in not only Star Ratings but another development leveling the playing field: MA plan supplemental benefits. Randy Strite, director of government programs practice with healthcare consulting firm FluidEdge, notes: "This is not your parents' Medicare. This is a second generation in terms of the rating model and benefits offered.
CMS notes that "[t]he Star Rating system helps Medicare consumers compare the quality of Medicare health and drug plans being offered. As part of this effort, patients are empowered to make health care decisions that are best for them." Improved retention is a possible outcome, given that positive experiences should drive customer loyalty. And while MA members already tend to stick with their plans (85% between 2013-2019), Star Ratings that weight customer experience over clinical outcomes could impact this dynamic.
Embedded challenges
The above-referenced dynamic raises one of the most important questions about the new Stars Ratings weighting, also raised by FluidEdge: "How do plans maintain and increase Star scores in the clinical measures for higher risk members while proactively enhancing the customer experience and ensuring sound operational processes are in place?"
Another challenge is how difficult customer experience is to capture, in general and given the nature of some of the data used to measure it. A portion of Star Ratings Customer Experiences derives from CAHPS. Star Ratings include 21 CAHPS measures across six domains.
Cherié Shortridge, vice president of government programs practice at FluidEdge, highlights the challenges of the data arising from these measures: "CAHPS scores are deidentified so health plans can't nail down the results to specific customers or regions, etc. CAHPS questions are also quite vague and subjective, questioning consumers as to needs versus wants and this is where health plans have trouble. They are tapped into the data but feel they don’t have as much control."
A broader challenge on payers' 2023 Start Ratings is the impact of current baseline scores. Shortridge notes that "[p]lans had artificially inflated scores for this year [2021]; they received the better of the scores from this year and last year due to the impact of COVID-19."
What payers can do
These challenges, and the importance of proprietary intelligence, can inform a payer's readiness for strong 2023 Star Ratings. "This is where health plans need to take a fresh look at their own data," Shortridge notes. "Plans don't have to wait for CAHPS to understand what drives member dissatisfaction. Their own complaints, grievances, and appeals are a window into what needs to be fixed from an experience perspective. This data is also included in the plan operations metrics (e.g., appeals decision timeliness and uphold rates, or how often a plan's original decision stays after appeal and external review), as is the availability of translation services," says Shortridge. "Plans have the operations metrics down because of clear numerators and denominators, and the availability of real-time data."
Plans may also miss opportunities to improve experience by not considering all of their customer-facing departments, including care management, disease management, and call center operations. "These are all points of light as to the root causes of poor customer experience." The balance, then, is between what Strite calls "managing to the metric" where that yields value and a comprehensive view in other areas.
"It's important to take a systems-wide view of contributing factors—what are you successful at, what can you tweak," says Shortridge. Her firm's approach for working with payers includes assessments, road mapping, strategy, intervention, implementation and two analytics tools: a Stars decision engine and score forecasting based on what/if analysis.
"Stars is not a single event"
Despite MedPAC's assertion that Star Ratings quality reporting is insufficient, it is the best mechanism currently available and one that requires a sophisticated, strategic response. "Stars is not an action," says Shortridge. "It's not a single event. It’s a way of operating, of taking care of members and managing customer experience. It is a culture, embedded in everything you do. If you're meeting customer needs with quality, positive Star Ratings will follow."
"Expanding into virtual-first health plans is the next step in providing a convenient and comprehensive care experience," says one health plan executive.
A growing number of regional and national payers are putting telehealth at the center of their care delivery, benefit, and plan designs. With these developments, the virtual visits mothered from pandemic necessity could transform to permanent innovations built on the telehealth foundations that already existed. Implemented well, virtual health could solve multiple problems while paving the way for future virtual therapies that are smartly reimbursed from the start.
Telehealth as care delivery design
Under the care design category, CareFirst has introduced CloseKnit, a "virtual primary care" [model that] … will offer a wide variety of care services, including preventive and urgent care, behavioral and mental health, care coordination, insurance navigation and more." CareFirst will offer CloseKnit to its Maryland commercial enrollees to test this new model. The plan also offers plans in Maryland and the District of Columbia. Larger payers are also taking a pilot approach, while embedding telehealth even more deeply in benefit and plan design.
Telehealth as benefit and plan design
Aetna, Cigna, and UnitedHealth are three national providers announcing their telehealth developments as part of a broader, virtual care strategy. Aetna has called its Virtual Primary Care the "first nationwide virtual primary care solution," while Cigna and UnitedHealth offerings include "virtual-first" health plans. Aetna's Virtual Primary Care, Cigna's MDLive, and UnitedHealth's NavigateNOW all include virtual primary, behavioral, and urgent care, and in some cases dermatology.
Some rollouts are large-scale, others tiered. In contrast to Aetna's national Virtual Primary Care network, Cigna will offer its expanded MDLive services to all employer-group members, with exchange plan members having access to virtual dermatology. This is in addition to a broader "virtual-first" plan option, also for select employers. The plan does not require referrals for in-person, in-network visits and includes $0 copays for "MDLIVE primary care providers, comprehensive chronic condition management and care navigation." UnitedHealth's NavigateNOW offers similar $0 copays and for select employers in nine markets.
Can virtual first deliver on accessible, primary care promises?
In its announcement, CareFirst President and CEO Brian D. Pieninck notes that "[n]early 40% of our members don't have a primary care doctor" and that "CloseKnit helps fill critical gaps for many patients, particularly those who lack a PCP." This raises the question: Can virtual first help achieve what every other coordination model—from HMOs to medical homes to value-based contracting—are often still struggling to produce: cost-effective services rooted in primary care that create better outcomes?
Making convenience a reimbursable commodity rather than "a nice to have" may be the missing ingredient. Along these lines, Pieninck adds: "We created CloseKnit because people deserve an enhanced, modern care experience that meets their expectations, needs and preferences for choice in how they connect and experience care."
Post-pandemic staying power?
What began as a solution for patients in rural areas with limited access to providers could have much broader applications for decades to come. This is particularly true now that commercial telehealth is growing and with the Centers for Medicare & Medicaid Servicers (CMS) permanently expanding telehealth's definition and scope.
And there could be a wraparound effect. Well before the pandemic, consumers were already turning to apps and wearables to put better health at their fingertips. Well after COVID-19 is no longer a public health emergency, it's likely that more prescription digital therapeutics will be reimbursed, ideally via value-based contacts from the start.
Current-state virtual care emerged from unanticipated, systemic disruption that could create planned and permanent systemic innovation. This is not to say that payer and provider virtual capabilities were in 2019 what they are in 2021. Email and text communication, however automated, is not remote monitoring. The question continues to be: Why does it take a crisis to not only drive change but fully implement and reimburse existing solutions?
