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By William H. Shrank, Nancy-Ann DeParle, Scott Gottlieb, Sachin H. Jain, Peter Orszag, Brian W. Powers, and Gail R. Wilensky

Commentary

Health Costs And Financing: Challenges And Strategies For A New Administration

ABSTRACT It is likely that 2021 will be a dynamic year for US health care policy. There is pressing need and opportunity for health reform that helps achieve better access, affordability, and equity. In this commentary, which is part of the National Academy of Medicine’s Vital Directions for Health and Health Care: Priorities for 2021 initiative, we draw on our collective backgrounds in health financing, delivery, and innovation to offer consensus-based policy recommendations focused on health costs and financing. We organize our recommendations around five policy priorities: expanding insurance coverage, accelerating the transition to value-based care, advancing home-based care, improving the affordability of drugs and other therapeutics, and developing a high-value workforce. Within each priority we provide recommendations for key elected officials and political appointees that could be used as starting points for evidence-based policy making that supports a more effective, efficient, and equitable health system in the US.

I tis likelythat 2021willbe adynamic year for US health care policy. More than a decade after the Affordable Care Act (ACA) was passed, health reform re- mains a top concern for the American

public.1 The number of uninsured Americans is rising. Affordability—at both the system and in- dividual levels—is eroding. And the numerous ways in which racism and prejudice drive unac- ceptable disparities in health and well-being are increasingly evident. The coronavirus dis- ease 2019 (COVID-19) pandemic, which placed historic stress on an already strained system, has only exacerbated many of these shortcomings. Against this backdrop, the National Academy

of Medicine convened the Vital Directions for Health and Health Care: Priorities for 2021 ini- tiative, which, following a 2016 initiative of the same name,2 aims to provide expert guidance on several focus areas for US health policy. In this article we draw on our collective backgrounds in

healthfinancing,delivery,andinnovationtooffer a setofconsensus-based policyrecommendations focused on health care costs and financing.

System Goals Our recommendations are grounded in three overarching goals for the US health system: ac- cess, affordability, and equity. Access Every American should have access to

health care. However, the US has a large and growing uninsured population. After reaching a nadir of 28.7 million (8.9 percent of the popu- lation) in 2016, the number of uninsured people is expected to rise to 37.2 million (10.6 percent of the population) by 2028.3 This comes at a time when a growing body of research links insurance coverage to improvements in financial security, health, and longevity.4–6

Affordability Every American should have access to affordable health care. However, health

doi: 10.1377/hlthaff.2020.01560 HEALTH AFFAIRS 40, NO. 2 (2021): 235–242 This open access article is distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) license.

William H. Shrank ([email protected]) is chief medical and corporate affairs officer of Humana in Louisville, Kentucky.

Nancy-Ann DeParle is a managing partner and cofounder of Consonance Capital Partners, in New York, New York.

Scott Gottlieb is a resident fellow at the American Enterprise Institute, in Washington, D.C.

Sachin H. Jain is president and CEO of the SCAN Group and Health Plan and an adjunct professor of medicine, Stanford University School of Medicine, in Stanford, California.

Peter Orszag is the CEO of Financial Advisory at Lazard Freres and Co., LLC, in New York, New York.

Brian W. Powers is deputy chief medical officer at Humana in Boston, Massachusetts.

Gail R. Wilensky is a senior fellow at Project HOPE, in Bethesda, Maryland.

February 2021 40:2 Health Affairs 235

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care spending continues to grow at an unsustain- able rate. Whereas spending growth initially slowed after implementation of the ACA, it has accelerated once again.3,7 The consequences of this acceleration are well established and include a growing national debt; strained federal, state, and local budgets; stagnant wages; and in- creased financial insecurity for Americans.2,8,9

Even for those with insurance coverage, health care is increasingly unaffordable: Roughly half of US adults have delayed or avoided care because of cost.10

Equity Every American should have equal ac- cess to affordable health care. However, there remain unacceptable inequities in health care access and outcomes by race, ethnicity, socioeco- nomic status, and other dimensions.11,12 This has been made painfully obvious during the COVID- 19 pandemic, which has taken an unacceptably high and disparate toll on underserved commu- nities and people of color.13–15

Interrelated Goals These three goals of ac- cess, affordability, and equity are deeply interre- lated. In some cases, improvements are comple- mentary. Increased access can improve equity.16

In others, conflicts arise. Expanding access pre- sents a substantial affordability challenge at the system level. Although difficult trade-offs are in- evitable, we believe there are opportunities to simultaneously improve access, affordability, and equity. When identifying policy recommen- dations, we aimed to identify those most likely to yield balanced improvements across all three areas.

Policy Priorities We propose five policy priorities to advance these system goals: expand insurance coverage, accel- erate the transition to value-based care, advance home-based care, improve the affordability of drugs and other therapeutics, and develop a high-value workforce. Within the broad domain of health costs and financing, there surely are many other policy priorities worth considering. These five represent our view of the most prom- ising near-term opportunities to leverage health care financing and payment to improve access, affordability, and equity. Expand Insurance Coverage From 2010 to

2016, policies in the ACA led to a steady decline in the number of uninsured Americans.17 These coverage gains have led to improved health, eq- uity, and financial well-being.4–6,16 When the orig- inal Vital Directions initiative was convened in 2016,2 the uninsurance rate was at an all-time low. Since then, the number of uninsured Amer- icans has risen steadily.3,17 The COVID-19 pan- demic will only accelerate this trend and has

highlighted the limitations of employer-spon- sored insurance. During the height of the pan- demic, millions of Americans lost their jobs and their access to employer-based insurance cover- age over the span of several months.18,19

Multifaceted and fiscally prudent approaches to closing the growing coverage gap are neces- sary but face significant barriers. There remains political resistance to expanding coverage through mechanisms set forth in the ACA. Twelve states have not expanded Medicaid, sev- eral coverage-related provisions in the ACA have been repealed, and support of the Market- places for individual coverage has been uneven. Bipartisan approaches and public-private part- nerships are needed. Sustainable financing presents another chal-

lenge. Mechanisms for publicly financing cover- age expansion—through deficit spending, new revenue sources, or revenue transfers—come with inherent trade-offs and will require biparti- san compromise.We believe that reallocating the substantial resources spent on care that does not improve health20 represents an opportunity to expand coverage without sacrificing affordabili- ty or quality, but the impact of associated reve- nue reductions on providers needs to be closely considered. Accelerate Transition To Value-Based

Care A central action priority identified in the original Vital Directions initiative was to “pay for value”—specifically, to “drive health care pay- ment innovation providing incentives for out- comes and value.”2 Since that time, value-based payment has grown notably. According to the Health Care Payment Learning and Action Net- work, the share of health care payments admin- istered via alternative payment models increased from 23percent in2015 to 36 percentin 2018.21,22

Although selected models have generated signif- icant savings,23–25 the overall impact of new payment models on cost and quality has been mixed.26–28

We believe that significant potential remains for payment models to accelerate value-based care delivery, but several barriers must be ad- dressed. First, most alternative payment models remain anchored in a fee-for-service architec- ture. Only 5 percent of health care payments in 2018 were population based (for example, global budgets).22 Broader adoption of advanced population-based payment is needed. Second, the penetration of value-based payment lags among commercial and Medicaid payers. In 2018, 40.9 percent of payments in traditional Medicare and 53.6 percent of payments in Medi- care Advantage occurred through advanced value-based models, compared with 23.3 percent in Medicaid and 30.1 percent among commercial

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payers.22 Medicare can serve as a catalyst for payment reform, but fundamental changes in the delivery system will not occur without multi- payer alignment. Finally, there are growing con- cerns that certain value-based payment models may exacerbate inequities or penalize organiza- tions that care for vulnerable populations.29 It is essential that value-based payment help amelio- rate, not exacerbate, disparities. Accelerating the transition to value-based care

necessitates more than new payment models. Redesigning care delivery to provide more value to patients requires new tools, competencies, and infrastructure.2,30 To that end, it is necessary that payment models be accompanied by techni- cal assistance and infrastructure support. This will be especially important to encourage partic- ipation and ensure success for independent pro- viders, who appear to be most successful when engaging in value-based models.24

Infrastructure improvements at the system level are also needed. Robust, interoperable data exchange is a prerequisite for value-based care.31

There has been important progress on interop- erability since the original Vital Directions ini- tiative.2 In early 2020 the Department of Health and Human Services (HHS) issued a final rule implementing interoperability and the patient access provisions of the 21st Century Cures Act of 2016, although enforcement has been delayed because of the COVID-19 pandemic.

Advance Home-Based Care Improvements in internet, video, and remote monitoring capabil- ities increasingly allow for the delivery of health care services in more cost-effective, patient- centered settings. Patients now can receive home-based acute care,32 primary care,33 and be- havioral health services34 of equal or better qual-

ity compared with facility-based delivery, and at a lower cost. Despite promising evidence, few programs have reached meaningful scale. In 2018 only 2 percent of commercially insured people had a telehealth visit with a provider, with rates even lower in Medicare and Medicaid.35

Home-based acute, postacute, and long-term care occur at even lower rates. As the logistics and infrastructure to support

home-based care mature, reimbursement and financing models present a substantial barrier to widespread adoption. Although telehealth ser- vices were reimbursed by many payers before 2020, payment rates did not support the process and workflow changes needed for adoption at scale. For other home-based services such as acute, postacute, and long-term care, there are scant reimbursement models outside of small pilots. The COVID-19 pandemic has made clear the drastic impact that reimbursement policy can have on the adoption of telehealth and home-based care. Facilitated by the introduction of reimbursement parity, there has been a rapid transition to virtual visits in the ambulatory set- ting during the pandemic.36 Shifting care to the most appropriate and cost-effective settings will require permanent reimbursement changes for telehealth and tailored financing models for home-based care across the continuum of dis- ease severity. Improve The Affordability Of Drugs And

Other Therapeutics Access to novel therapeu- tics is a distinguishing feature of the US health system, but also a key driver of high spending.37–39

The crisis of affordability for drugs and other therapeutics has only intensified since the origi- nal Vital Directions initiative was convened in 2016.2,37 Highly effective therapeutics may lower aggregate spending by reducing the need for costly interventions or hospitalizations, but many of these novel medicines command high prices.40 More challenging is the fact that high prices are not always aligned with value. Prices on existing, branded drugs have increased sub- stantially during the past decade, limiting afford- ability and access.37,41,42 And even in circumstanc- es where the benefits are unclear or modest, many new therapeutics are still reimbursed at high rates.37,43

With continued innovation on the horizon— including gene therapy—these challenges will become more acute. Broadening the pool of Americans who can obtain and afford high-value therapeutics will require reimbursement struc- tures that align payment with value and balance affordability with the continued need for inno- vation. Such efforts face a number of challenges: regulatory barriers that limit generic and bio- similar development; a lack of robust informa-

Although difficult trade-offs are inevitable, we believe there are opportunities to simultaneously improve access, affordability, and equity.

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tion from which to base comparative effective- ness, coverage, and reimbursement decisions; and societal discomfort around limiting access to any therapies, including those that are of low value. Develop A High-Value Workforce The US

benefits from a highly skilled health care work- force and is home to premier training institu- tions. But there are significant and growing workforce shortages in the areas of primary care, behavioral health, and dental care.44 A coordinat- edstrategytotrain, deploy,and supporta diverse health care workforce is an essential enabler of access, quality, and value, particularly in under- resourced communities. Regulatory restrictions remain a key barrier

to progress. Current licensure and credentialing requirements and state-by-state variation in scope-of-practice laws limit the opportunity to leverage technology and advanced practice pro- viders to address workforce shortages, improve access, and provide the most cost-effective care.45,46 The response to COVID-19 has shown the benefit of relaxing such structures. During the pandemic, regulatory bodies and payers moved quickly to augment in-person workforce capacity in regions experiencing surges in COVID-19 cases and to allow for telehealth to serve as a substitute for in-person care. Many state medical boards waived licensing require- ments for telehealth and provided expedited, temporary licenses for out-of-state providers.47

Formalizing these changes outside of the pan- demic will be important. Alongside reducing regulatory barriers, devel-

oping a high-value workforce will also require a better use of community members and less spe- cialized individuals (for example, community health workers and navigators) to support care delivery in uniquely effective, efficient, and cul- turally appropriate ways.48

Recommendations For Key Elected Officials And Political Appointees The priorities we have outlined represent near- term opportunities to improve access, afford- ability, and equity. To help catalyze action along these dimensions, we developed a short list of recommendations for key stakeholders.We focus on three key federal leaders—the secretary of HHS, the administrator of the Centers for Medi- care and Medicaid Services (CMS), and the com- missioner of the Food and Drug Administration (FDA)—and state governors, because of their ability to quickly and effectively affect change. Comprehensive reform will require close collab- oration with other elected officials and political appointees and commensurate attention, activi-

ty, and innovation from the private sector. Expand Insurance Coverage The HHS sec-

retary should develop alternative pathways to insurance coverage, including strengthening and better supporting the individual insurance Marketplaces and working with Congress to de- crease the age of Medicare eligibility to fifty-five. Doing so will help ensure coverage, improve affordability, and offer greater choice for older Americans unable to obtain employer-based coverage. Governors should also create opportunities

for expanded coverage in their states. Optimal use of the Medicaid program offers the greatest opportunity to expand coverage and promote health equity. Governors in states that have not yet expanded Medicaid should work closely with their legislative bodies to do so. Outside of Medicaid expansion, governors—working with their insurance commissioners—should support the individual Marketplace by offering risk- management mechanisms to private payers providing individual coverage via state-based exchanges and by extending open enrollment periods. Accelerate Transition To Value-Based

Care The CMS administrator should increase the adoption of advanced value-based payment models. Value-based payment in Medicare has grown, but most value-based payments remain anchored in a fee-for-service architecture. Popu- lation-based payment has the greatest potential to improve outcomes and lower costs. The CMS administrator should set a goal of having 25 per- cent of Medicare payments administered via population-based payments by 2025. The CMS administrator also must align pay-

ment models with equity. Value-based payment has the potential to advance health equity but may inadvertently exacerbate health disparities. The administrator should conduct a thorough review of existing payment models to evaluate their impact on equity while developing new payment models that create financing flexibility to address structural racism and social determi- nants of health and explicitly reward reductions in health disparities. It will also be important for CMS to help stabi-

lize independent primary care providers. COVID-19 has placed significant financial strain on independent primary care providers. This is especially troubling, as these clinicians provide critical access to health care for much of the US population and have been uniquely successful at delivering value-based care.24 The administrator should take action to stabilize finances for inde- pendent primary care providers by providing prepayment to offset lost fee-for-service revenue as a path to population-based payment.

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The CMS administrator can also play an im- portant role in broadening value-based insur- ance design. Expanding on existing pilot programs in Medicare Advantage, the adminis- trator should use the authority of the Center for Medicare and Medicaid Innovation (CMMI) to reduce cost sharing for cost-effective, high-value services in traditional Medicare and Medicare Advantage. In addition, Medicare Advantage should be

strengthened. More than a third of Medicare beneficiaries are now enrolled in Medicare Ad- vantage plans.49 The program benefits from strong bipartisan support50 and has catalyzed the adoption of advanced value-based payment models.21 Strengthening the program could po- sition it to serve as a chassis for coverage expan- sion. To achieve this goal, the administrator should continue to increase flexibility for Medi- care Advantage plans to design new benefit pack- ages, incentivize healthy choices, and redistrib- ute funding to reduce disparities and improve equity. As voluntary enrollment in Medicare Ad- vantage begins to outpace that in traditional Medicare in some regions, the administrator will need to reconsider financial models that deter- mine benchmark payments as well. Finally, the administrator should continue to explore new approaches to sustainable risk adjustment for Medicare Advantage plans. The CMS administrator can help accelerate the

transition to value-based care by enforcing reg- ulations that promote interoperability. Interop- erable data exchange supports care coordination and the delivery of high-quality, cost-effective care.30 Although it was appropriate to delay en- forcement of key interoperability provisions of the 21st Century Cures Act in the context of the COVID-19 pandemic, the administrator should avoid any further delays. State governors can also play an important

role in accelerating the transition to value-based care models by expanding their use in Medicaid. The penetration of value-based care in Medicaid lags behind Medicare and commercial markets, limiting the ability to achieve cost-effective, high-quality care for vulnerable populations.

Governors, working with their Medicaid direc- tors, should expand the use of value-based pay- ment through Medicaid managed care contract- ing and Section 1115 waivers. Governors should aim to achieve the goal set by the Health Care Payment Learning and Action Network of having 50 percent of Medicaid payments in advanced value-based payment models with downside risk by 2025.51

Advance Home-Based Care To advance home- based care, the CMS administrator should for- malize changes to telehealth reimbursement. Working with Congress where needed, the ad- ministrator should make permanent some of the changes to telehealth reimbursement that were instituted under the COVID-19 public health emergency. Approaches could include continued reimbursement at parity for audiovisual tele- health visits, with more modest payments for telephonic and asynchronous interactions. It will be important to ensure that reimbursement policies position telehealth as a substitute for more expensive and less accessible sites of care and do not induce unnecessary spending and utilization. The CMS administrator should also develop

reimbursement models for home-based care. Under the authority of CMMI, the administrator should create and test new payment models for home-based acute, postacute, and long-term care. Improve Affordability Of Drugs And Oth-

er Therapeutics The FDA commissioner should expand on recent efforts to reduce bar- riers to generic and biosimilar development and market entry with the goal of increasing compe- tition, improving access, and reducing prices. Potential strategies include enabling more effi- cient pathways for the approval of safe and effec- tive generic and biosimilar versions of complex drugs that often face no or limited competition, even after patents and exclusivities have lapsed; closing regulatory loopholes that can be ex- ploited to maintain a monopoly through the granting of patents and other exclusivities; har- monizing regulatory filing requirements for ge- neric medicines with other global regulators; and fostering the development of advanced manufacturing platforms that lower costs and improve quality and reliability. This is especially important for biologics, for which manufactur- ing challenges are a barrier to the entry of bio- similars. The FDA commissioner also should accelerate

efforts to build a robust real-world evidence pro- gram and develop rigorous, science-based crite- ria for how real-world evidence can be used to inform decisions about the safety and effective- ness of new therapeutics. Such a framework not

Any effort at reform will occur in the shadow of the COVID- 19 pandemic.

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only would expand opportunities for pre- and postmarket evidence on safety and efficacy but also would be available to payers and other enti- ties to support comparative effectiveness and cost-effectiveness analyses. This infrastructure is a prerequisite for any effort at value-based pricing for therapeutics. The CMS administrator can also play a key role

in improving the affordability of drugs by devel- oping value-based reimbursement models for high-value therapeutics. Under the authority of CMMI, the administrator should expand on re- cent efforts to create and test new payment mod- els for prescription drugs,52 including reference pricing, outcomes-based payment, and Medicare Part B payment reform. As multiple models of reimbursement are tested, it will be important to both guard against and monitor for efforts at gaming different pricing models. Develop A High-Value Workforce Through

a partnership with state governments and pri- vate payers, the HHS secretary should facilitate the development and deployment of a national workforce of community health workers. Evi- dence suggests that such a program could reduce disparities, improve health outcomes, and lower health care spending.53–55 This workforce could also aid in pandemic response (for example, con- tact tracing) and support insurance education and enrollment. Outside of the benefit to pa- tients, it would provide valuable economic op- portunity for the workers themselves, who should be recruited from the historically disad- vantaged communities they serve. Governors could promote the development of

a high-value health care workforce by removing barriers to affordable telehealth access. They should, in collaboration with state licensing bod- ies, formalize changes to state licensure laws made during the COVID-19 pandemic that re- duce or eliminate the barriers facing out-of-state providers who wish to provide telehealth ser- vices and coordinate care across state lines.

Conclusion As 2021 begins, there is pressing need and op- portunity to reform health care financing to bet- ter support access, affordability, and equity. Any effort at reform will occur amidst the COVID-19 pandemic, which has placed unprecedented strain on policy makers and public institutions. There will simply not be the same capacity or appetite for sweeping regulatory changes that would have been present in other circumstances. Limited attention and resources will require dis- ciplined prioritization and a willingness to ac- cept incremental progress and small wins. Fur- thermore, reforms will need to occur under increasingly strained federal and state budgets. Achieving meaningful change in this environ- ment will require significant resolve from policy makers and public support for difficult decisions (forexample, lesscoveragefor low-valueservices and technologies). We hope that the policy pri- orities and recommendations articulated in this commentary provide a focused starting point for evidence-based policy making that supports a more effective, efficient, and equitable health system in the US. ▪

William Shrank reports equity holdings in Humana and serving as a director at GetWellNetwork. Nancy-Ann DeParle (administrator of the Health Care Financing Administration [HCFA], now the Centers for Medicare and Medicaid Services [CMS], from November 1997 to September 2000) reports being a director of CVS Health, HCA Healthcare, Psychiatric Medical Care, and Sellers Dorsey. Scott Gottlieb (commissioner of the Food and Drug Administration from 2017 until April 2019) is affiliated with New Enterprise Associates and CVS Health and sits on the boards of Pfizer, Illumina, Tempus, and Aetion. Sachin Jain reports equity holdings in Anthem,

Merck, Blink Health, DataVant, Thrive, Curisium, Valera, Firefly, and Vital and serving as a director at Abode Hospice. Peter Orszag (head of the Office of Management and Budget from 2008 until July 2010) reports employment by Bloomberg. Brian Powers reports employment by Mass General Brigham, prior employment by Anthem and Fidelity Investments, and equity holdings in Humana. He is the editor of Healthcare: The Journal of Delivery Science and Innovation (Elsevier). Gail Wilensky (administrator of HCFA [now CMS] from 1990 until 1992) is a director for Quest Diagnostics Inc. and UnitedHealth Group and a trustee for

the United Mineworkers of America Combined Benefits Fund. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of their employers. This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) license, which permits others to distribute this work provided the original work is properly cited, not altered, and not used for commercial purposes. See https:// creativecommons.org/licenses/by-nc-nd/ 4.0/. [Published online January 21, 2021.]

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NOTES

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