U.S. Department of Health and Human Services’ Innovation Center Revamps Value-Based Payment Models

Innovation Center is Shifting Focus from Medicare to Medicaid

The U.S. Department of Health and Human Services is revamping value-based payment models, which it pursues at its so-called “Innovation Center” or Center for Medicare and Medicaid Innovation (CMMI). The CMMI implements alternative payment models in the government programs Medicare and Medicaid for the purpose of cost containment and improvement in quality of care.

Since its founding in 2010, CMMI has launched more than 50 alternative payment models. An oft-cited success story is the Medicare Part D (outpatient drugs) Senior Savings Model, which the Innovation Center set in motion to test the impact of offering Medicare beneficiaries prescription drug plan options that include comprehensive coverage of all insulin products – including medical devices - with considerably lower out-of-pocket costs. Thanks to a robust public-private partnership between the Centers for Medicare and Medicaid Services (CMS) and entities with whom it contracts - Medicare Advantage and Medicare Part D plans, as well as pharmaceutical companies - this model has achieved the goals laid out by the Innovation Center, which include cost savings, improved quality of care, and more equitable outcomes.

The CMMI payment models – sometimes called demonstration projects - are viewed as ways to bypass statutory or legislative obstacles, for the purpose of experimenting with new approaches to reimbursement. Though often piecemeal in nature, demonstration projects can be a fallback option if legislative efforts fail, as they appear to have done with the Build Back Better Act which is currently on ice.

For example, CMMI payment models are incorporating bundled payments for treatment episodes, to reduce Medicare Part B (physician-administered) drug spending through more prescribing of biosimilars and generics and a streamlining of healthcare services.

The CMMI is now shifting some of its focus of alternative payment models from Medicare to Medicaid. Continued Medicaid expansion appears to the impetus behind efforts by policymakers to prioritize equity and reduce inequality in health outcomes. Total Medicaid enrollment has grown to 86 million, an increase of 20% since February 2020.

In October of last year, the policy and programs group director at CMMI, Ellen Lukens, said that “models have been predominantly Medicare-oriented, and have disproportionately served white beneficiaries.” By contrast, relatively few models have centered around Medicaid beneficiaries, many of whom are minorities. That is about to change.

The CMS administrator, Chiquita Brooks-LaSure, has laid out a vision for the next decade, one in which CMMI will drive “meaningful change” towards an “equitable” and “value-based system of healthcare.”

To carry out the mission of improving equity, policymakers will explicitly address barriers to participation in CMMI payment models by healthcare providers that serve a high proportion of minority populations. Policymakers also want to entice more underserved patients to register to participate in pilot programs.

The CMMI has undertaken a major review of the Center’s existing payment models to determine what works and what doesn’t. The review calls on the Innovation Center to explore new forms of value-based models in Medicare and especially Medicaid. Here, payment would be tied not only to improved patient outcomes and decreased overall healthcare spending, but also reductions in health disparities and increased patient affordability (lower out-of-pocket costs). Partnering with Lyfegen may be the solution for manufacturers and payers alike, as Lyfegen's value-based payment solution is already widely being used by payers and pharma manufacturers in Europe.

As the Innovation Center embarks on a quest to improve the Medicaid program, using alternative payment models, it may need to consider adjusting its criteria of what counts as a successful model. The equity parts may be easier to measure than certain other objectives. For example, lowering federal expenditures appears to be the overriding goal of the CMMI models, and therefore cost savings to the government their standard measure of success. But, depending on the disease area in question, sometimes cost savings might not be easily achievable, even if the model is very much worth it and may save beneficiaries out-of-pocket expenses. In certain disease areas, improved health outcomes might be a better objective, along with a cost-effective use of additional resources.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.

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We are excited to see Denisa grow and thrive in her role at Lyfegen. Welcome to the team, Denisa!

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Finding the right insulin products for payers to cover

Insulin is going through monumental shifts in pricing and reimbursement in the U.S. It started with the announcement of reductions in list prices by drug companies last year. First, Novo Nordisk announced plans to reduce the list prices of several of its insulin products beginning January 1, 2024. This included lowering the price of NovoLog and Levemir by at least 65%. This move was followed by a similar commitment by competitor Eli Lilly to reduce Humalog’s price, among others, and came just days before Sanofi’s announcement to decrease Lantus’s price.

Moreover, biosimilar competition is ramping up, particularly in the long-acting insulin glargine space. Rezvoglar and Basaglar are leading the way, as they gain traction on payer formularies, especially in the public Medicaid market.

And this year, owing to implementation of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services began negotiating the net prices of both NovoLog and Fiasp, with public disclosure of said prices due to be revealed by September. Payers will soon be able to use these net prices as benchmarks to leverage better deals in markets besides Medicare. Also, CMS capped monthly out-of-pocket costs of insulin products for Medicare beneficiaries at $35.

For their large populations of insulin-dependent diabetics, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.

Because both list and net prices have come down, payers will likely lose out on some portion of the rebates—which reflect the difference between gross and net price—that they had grown accustomed to getting in the past. At the same time, the increasing number of payers that are adopting a rebate-free, net cost approach to formulary design will benefit from lower net prices.

And cheaper treatment options for patients may translate into better adherence to drug regimens which in turn could lead to improved health outcomes. For payers with a long-term perspective and comparatively little churn or enrollee turnover the potential downstream cost savings could be beneficial.

Lyfegen can assist in the calculations of value for all insulin products, both short- and long-acting, in addition to the design of appropriate formularies.

If you wish to improve your negotiating leverage for insulin products you can do so with real-world simulations for effective prescription drug contracts. Discover the Lyfegen Drug Contracting Simulator, our intuitive solution for streamlining iterative, collaborative drug contracting design.