Meet
Milena Sullivan
Practice Director
Milena Sullivan advises life sciences clients on the impact of the evolving healthcare policy landscape on their commercial, access, and advocacy priorities.
She focuses on federal health policy in government-regulated markets such as Medicare policy and payment as well as on state policy advocacy and strategy.
Prior to re-joining Avalere, Milena was associate director for Oncology Policy, Market Access, at Bristol-Myers Squibb, where she identified, analyzed, and communicated policy risks and opportunities impacting the oncology business unit, its patients, and customers. She identified competitive opportunities for the company under new CMS payment models and educated internal teams on the evolving public payer landscape. Prior to that, she was a senior manager at Avalere Health, where she supported life science clients on various policy and strategy issues and managed engagements with vaccine companies. She was a project manager, Government Affairs and Public Policy, at Novartis, where she analyzed the impact of the ACA on the vaccine division’s products and customers and led trainings for field-based staff.
Milena has an MA in international policy and practice from The George Washington University and a BA from Miami University of Ohio.
Authored Content
CMS released the rationale for the maximum fair prices under the Medicare Drug Price Negotiation Program for Year 1 drugs.
Avalere finds that between 0.03% and 0.1% of Medicare FFS beneficiaries would experience lower OOP costs for the first 10 Part B drugs likely to be negotiated.
HRSA 2023 340B purchase data demonstrates continued program growth and that sales for the top 10 340B drugs exceeded sales for those drugs in Medicare.
Avalere finds that between 0.1% and 0.2% of Medicare FFS beneficiaries would experience lower OOP costs for the Part B drugs subject to Q3 2024 inflation rebates.
Physicians could lose at least $25 billion in add-on payments for 10 Part B drugs expected to be negotiated by CMS, with oncology products accounting for at least $12 billion.
Avalere experts share initial impressions of the publicly released negotiated MFPs for the first round of selected drugs, highlighting implications to industry.
Updates in the Initial IPAY 2027 ICR highlight the increasing needs for specific evidence planning and generation for industry to prepare for negotiation.
Sixty-nine percent of 340B contract pharmacies were associated with a PBM through vertical integration (53%) or contractual arrangement (16%).
Avalere surveyed providers on the administrative and economic costs of white-bagging requirements on infusion centers.
As federal and state policymakers debate the role of contract pharmacies (CPs) in 340B, Avalere analyzed how CP relationships inform the policy landscape.
Stakeholders are debating potential reforms to the 340B program, with specific policies directly or indirectly impacting federal spending.
In 2023, 54% of Medicare Advantage enrollees were in plans that required step therapy for 10 commonly used rheumatoid arthritis drugs covered under Part B.
Manufacturers anticipating potential selection or therapeutic impact for 2027 Medicare negotiations should begin preparations and align internal decision-making, applying learnings from Year 1.
Avalere experts dive into Trend #9: Policy’s Pressure on HEOR and explore implications of recent policy developments on evidence strategies.
Medicare negotiation has ripple effects across therapeutic markets, requiring manufacturers to reassess strategies to stay ahead of the changing drug landscape.
A new Avalere white paper raises important considerations on potential added lifecycle pressures for sponsors of cardiovascular disease products.
The IRA requires covered entities to pay the lesser of a drug’s 340B ceiling price and MFP, presenting operational complications for manufacturers and providers.
As the US value assessment landscape evolves, a new third-party framework may standardize requirements and open reimbursement pathways for digital health.
Manufacturers should reevaluate CMS engagement strategies as soon as possible to maximize the opportunity to influence the IPAY 2026 Medicare negotiations.
Physician reimbursement for some services under Medicare FFS has declined, while payment increased for the same services in the hospital outpatient setting.
CMS selected 10 Part D drugs for the first year of negotiation. Stakeholders should consider engagement opportunities and evaluate broader therapeutic dynamics.
ICER announced proposed changes to its Value Assessment Framework. Stakeholders have limited time to review and comment by June 30.
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should re-examine their commercialization strategies in response to market dynamics.
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should examine their value and evidence strategy in response to new dynamics.
The Supreme Court is expected to hear oral arguments in Loper Bright Enterprises v. Raimondo, which challenges Chevron deference.
The introduction of the maximum fair price through the Medicare drug price negotiation process is expected to lower provider reimbursement.
Guidance adds clarity on drug selection, maximum fair price application (MFP), evidence submission, and manufacturer engagement, but leaves questions on determining MFP.
CMMI releases long-awaited response to President Biden’s executive order on drug pricing with a directive for the Centers for Medicare & Medicaid Services (CMS) to develop three models.
Avalere found that from 2016 to 2022, hospitals undergoing mergers and acquisitions were more likely to have 500+ beds and to be a 340B covered entity.
Avalere analysis shows that a CMS policy to increase payment for 340B drugs, compared to alternative approaches, will result in lower payment to most hospitals.
IRA would lead to a minimum 47% add-on payment reduction on average for Medicare providers who furnish the Part B drugs initially targeted for negotiation.
President Biden’s executive order directs HHS to identify CMMI model options that could lower drug costs and promote access for Medicare and Medicaid enrollees.
Government price-setting provisions in the IRA have highlighted the diverse nature and interpretation of value across the US healthcare system.
With EOM’s immediate downside risk, the model may appeal more to practices ready to implement care transformation activities and value-driven decision making.
To assess how changes in OPPS payment for reimbursement of drugs under the 340B program would affect hospital reimbursement and Medicare Part B beneficiary cost sharing, Avalere estimated the impact of increasing reimbursement for 340B drugs in Medicare Part B to ASP + 6%. The analysis finds that most hospitals would see overall payment decreases, while payments would be subject to higher cost sharing.
Avalere estimates that the CMMI will produce net costs of approximately $9.4 billion through 2026, in contrast to the CBO’s projected net savings of $34 billion.
Stakeholders should consider how the Enhancing Oncology Model’s design and incentives will impact cancer care management and treatment selection.
CMS announces long-awaited successor to the Oncology Care Model (OCM), which is scheduled to conclude on June 30, 2022.
The SCOTUS decision is the most prominent action related to the 340B program, but ongoing litigation among stakeholders and growing activity at the state level are catalyzing developments that could shape the 340B landscape
International methods of expedited approval offer approaches that policymakers may adopt to reform the US system, as signaled in recent legislative proposals.
Avalere analysis finds that 340B child sites and contract pharmacies are often located in less diverse and higher income ZIP codes than their disproportionate share hospital parent entities.
The final CMS NCD for amyloid beta-targeting monoclonal antibodies for Alzheimer’s Disease establishes a dual pathway to Medicare coverage based on FDA approval and likely creates access and operational challenges for stakeholders.
Avalere analysis seeks to understand potential access to clinical trial sites by race, given the draft requirement to ensure diverse participation.
Join Avalere for a live discussion on key trends in drug pricing, value, and regulatory shifts, and how these trends will impact manufacturers.
Avalere analysis conducted in collaboration with the Community Oncology Alliance (COA) was published in the American Journal of Managed Care, showing disparities in breast cancer screening rates during the COVID-19 pandemic among racial and ethnic minority groups and based on insurance type.
As manufacturers prepare for discarded drug rebates to begin in 2023, an Avalere analysis identified 39 drugs at risk for rebates totaling $151 million.
On February 2, 2022, President Biden announced a revitalization of the Obama-era Cancer Moonshot Initiative, including updated goals to reduce cancer deaths by at least 50% over the next 25 years and improve the experience of cancer survivorship for patients and their families.
Thirty-one percent of rural Medicare fee-for-service beneficiaries with early-onset Alzheimer’s disease or a mild cognitive impairment diagnosis do not have access to a hospital outpatient department in their county, and fewer than 1% live near an Alzheimer’s disease research center.
Congress would operationalize Medicare negotiation for Part B drugs as outlined in the Build Back Better Act (BBBA) by cutting drug reimbursement to providers, which raises 4 potential downstream implications
New Avalere analysis finds that the latest version of Medicare negotiation in the Build Back Better Act (BBBA) would lead to a 40% cut on average for Medicare providers that furnish the Part B drugs that are likely to be initially targeted for negotiation.
On July 19, the Centers for Medicare & Medicaid Services (CMS) released the CY 2022 OPPS/ASC Proposed Rule, which includes a number of proposals to modify the timing and design of the Center for Medicare & Medicaid Innovation’s forthcoming Radiation Oncology (RO) Model. The design proposals include changes to the set of included modalities and cancer types, reduction of the CMS discount factors applied to the prospective payments, and adoption of an extreme and uncontrollable circumstances policy. Looking ahead, stakeholders should continue to assess the model payment methodology and design in the context of evolving care delivery and practice patterns.
The Patient Centered Outcomes Research Institute (PCORI) recently announced an open comment period for a new set of proposed national priorities to inform its research agenda. Avalere analysis finds that from March 2019 to September 2020, PCORI directed roughly $259 million to comparative effectiveness research (CER) awards with an increasing share of new projects focused on drugs.
Beginning July 1, 2021, average sales price (ASP) calculations for Part B drugs with an additional non-covered self-administered formulation could alter Medicare reimbursement.
As the Oncology Care Model (OCM) approaches its conclusion, stakeholders are anxiously awaiting the details of the Center for Medicare & Medicaid Innovation's (CMMI’s) next oncology episodic payment model, Oncology Care First (OCF).
Join Avalere’s panel of data analytics, market access, and policy experts for a discussion on the potential for federal drug pricing reform in Congress or via administrative action.
A second reconciliation package could include significant drug pricing reforms as a means to pay for permanent coverage expansion and other top priorities.
New Avalere analysis finds that the the Most Favored Nation (MFN) Model would have a significant negative impact on Medicare providers that furnish Part B drugs—especially in oncology and rheumatology—and those in rural areas.
Avalere analysis found that in 2017 and 2018, more than half (56%) of Medicare patients with breast cancer taking a medicine covered by Medicare Part B received a therapy that was not routinely covered by England’s National Health Service (NHS) or its Cancer Drug Fund (CDF).
New Avalere analysis finds that most Medicare fee-for-service (FFS) beneficiaries would not see a substantial reduction in their out-of-pocket (OOP) costs as a result of the Most Favored Nation (MFN) model.
Earlier today, the Trump Administration released long-anticipated drug pricing reforms, including rules related to a Most Favored Nation (MFN) approach for drugs administered by providers in Medicare and rebate reform for the Medicare Part D program. Both rules represent fundamental shifts in our current system and have significant implications for manufacturers, health plans, pharmacies, providers, and patients.
Avalere research was published online in the Journal of Clinical Oncology Clinical Cancer Informatics, showing a considerable drop in cancer screening, diagnosis, and treatment for Medicare beneficiaries as a result of the ongoing COVID-19 pandemic.
Avalere analysis finds that patients with Crohn’s disease who experience a negative outcome when required to step through a plan’s preferred product may face higher upfront out-of-pocket (OOP) costs and could increase costs to payers.
Avalere experts took a closer look at emerging oncology trends, innovative approaches to payment and delivery, and what these changes will mean for patient access.
Tune into our third episode of the Avalere Health Essential Voice: 2020 Election series. In this segment, our experts discuss candidates’ respective approaches to drug pricing policies, and where there is unexpected overlap.
Tune into our third episode of the Avalere Health Essential Voice: 2020 Election series. In this segment, our experts discuss candidates’ respective approaches to drug pricing policies and where there is unexpected overlap.
On September 13, the Trump Administration released the much-anticipated “Most Favored Nation” (MFN) Executive Order (EO), calling for models that would cap the price Medicare pays for select Part B and D drugs. The President’s EO underscores the administration’s continued focus on reducing prescription drug price disparities between the US and other developed countries.
Yesterday, the Administration released the awaited “Most Favored Nation” Executive Order (EO), which calls for a model that would cap the price Medicare pays for select Part B and D drugs.
The administration’s 4 drug pricing EOs direct agency action across a host of policy areas, including Part D rebates, Part B reimbursement and pricing, 340B drug discounts, and drug importation. Next steps and a timeline for agency action will vary by EO dependent on the specific policies to be advanced or finalized. In the interim, stakeholders should explore outstanding questions and contemplate near- and longer-term policy scenarios.
Avalere continues to find a significant drop in utilization of key physician-administered therapies in 2020 relative to 2019.
In the first episode, Sam Ferguson and Biruk Bekele, consultants in Avalere’s Market Access practice, along with Milena Sullivan, a principal in Avalere’s Policy practice, will discuss how stakeholders are defining value in oncology.
Recent Avalere analysis finds decreases in utilization of oncology and autoimmune treatments across all care settings since the onset of the health crisis.
Oncology practices with a substantial proportion of Oncology Care Model (OCM) episodes in areas with high numbers of COVID-19 cases—such as Connecticut, Louisiana, Massachusetts, New Jersey, New York, and Pennsylvania—may face new challenges in containing total expenditure below target amounts.
Avalere experts discuss how the COVID-19 pandemic has affected oncology care and delivery, and the Oncology Care Model (OCM).
New Avalere analysis finds that practices currently participating in the Oncology Care Model (OCM) would be more likely to receive a Novel Therapy Adjustment (NTA) in the newly proposed Oncology Care First (OCF) Model.
Avalere analysis finds that, despite substantial list price decreases across the PCSK9 inhibitor class, out-of-pocket costs for the majority of 2020 Part D beneficiaries remain significant
Avalere analysis finds that 24 of the top 50 non-vaccine Part B drugs are not on the U.S. Department of Veterans Affairs’ National Formulary.
Avalere analysis of 1,375 Medicare Advantage plans’ 2019 medical benefit drug coverage policies finds that 672—covering approximately 14.3 million lives—apply step therapy to at least 1 of the rheumatoid arthritis biologic drugs covered under Medicare Part B in 2019.
As policymakers explore opportunities to reform Medicare Part B, a tiered average sales price (ASP) add-on payment may be under consideration to align system incentives and curb spending.
Ahead of the American Society of Clinical Oncology's annual meeting, Avalere experts discussed the latest trends in policy, reimbursement, and market access reshaping oncology care.
The costs of ensuring the safety and efficacy of imported drugs and preventing the entry of counterfeit products are among the many factors that must be weighed against any potential savings from a drug importation program.
New Avalere analysis finds that most seniors in Medicare would not see a reduction in their out-of-pocket costs as a result of the International Price Index Model.
Avalere analysis finds that most of the payment reductions from the proposed International Pricing Index Model for Part B drugs would affect oncologists, rheumatologists, and ophthalmologists.
Avalere experts examine the current drug pricing policy landscape and what potential changes stakeholders should prepare for.
New research from Avalere finds that Medicare patients with rheumatoid arthritis (RA) may face higher out-of-pocket costs under a proposal to move Medicare Part B drugs into Part D, absent additional policy change to lower cost sharing in the Part D program.
Under an indication-based formulary design approach, Part D plans will be able to tailor the drugs that are on their formulary by indication.
Beginning in January 2019, Medicare Advantage (MA) plans will have the flexibility to use step-therapy techniques for Part B drugs, according to a CMS memo released on August 7.
A proposed shift of Part B drugs into Part D could affect patient access and increase the burden on providers.
The Department of Health and Human Services is seeking public input on a variety of proposals related to drug costs, providing stakeholders with an unprecedented opportunity to shape the administration's drug pricing policies.
President Trump is expected to announce a drug pricing plan in the coming weeks; signals from the White House indicate potential alignment around several priority policies.
As the discussion intensifies, one of Avalere's experts provides keen observations on what you need to know about this topic.