Avalere Health Advisory

advisory.avalerehealth.com · American English

Avalere is a healthcare consulting and advisory firm specializing in strategy, policy, and data analysis for life sciences, health plans, providers, and private equity companies.

rss2 wordpress content slash wfw atom dc sy

Open the feed

https://advisory.avalerehealth.com/feed

Last post: Sep 21, 2026
Posts in 24 h · 7 days · 30 days: 0 · 0 · 4
Our last check: Answering
Served from: Romania
Site title: Avalere: Leading Healthcare Consulting & Advisory Firm
Text score at discovery: 9,581
Format: rss2
Features in the feed: content, slash, wfw, atom, dc, sy
Community: wordpress

Posts

What our queue read from this feed. Open one to read it here, or go to the site that published it.

The Role of Comparator Selection in Ex-US HTA and International Drug Pricing
Sep 21, 2026 · original
Avalere Health sought to better understand the comparator choices that underpin ex-US health technology assessments (HTAs), as these choices can significantly impact the assessment of relative benefits and costs, and subsequently inform price negotiations and reimbursement decisions. We evaluated the extent to which comparators for the same product differed across countries, contrasting comparator selections by six international HTA agencies for five products. We also compared product prices across reference markets to better understand how differences in HTA approaches and local healthcare contexts may contribute to variation in pricing and reimbursement outcomes. Key Findings Avalere Health found significant variability in the comparator products chosen by ex-US HTA bodies when assessing the same drug. Of the five products evaluated, one of them (oncology product) was assessed by all s
HHS Appoints Eight New USPSTF Members, Reshaping the Panel’s Expertise and Raising Implementation Questions
Sep 18, 2026 · original
On September 17, the Department of Health and Human Services (HHS) announced eight new appointments to the U.S. Preventive Services Task Force (USPSTF). The new members will join the eight members currently serving on the Task Force, returning the panel to its customary 16-member size. HHS named Dr. Seth J. Corey, a pediatric hematologist-oncologist and academic physician at Cleveland Clinic and Case Western Reserve University, as chair. No vice chairs were appointed. The appointments follow a prolonged period of uncertainty for the USPSTF. The Task Force has not convened since March 2025, with multiple scheduled meetings canceled since then. The Task Force’s composition is expected to continue to evolve, with three current members’ terms set to expire at the end of 2026. For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to
Surprise Proposed Updates to the Provider Taxes Have Implications across Medicaid
Sep 15, 2026 · original
In July 2025, Avalere Health analyzed how the provider tax provisions in the One Big Beautiful Bill Act (OBBBA) could affect state Medicaid financing, health plans, providers, and beneficiaries. The analysis focused on the law’s reduction of the indirect hold harmless threshold, often called the provider tax “safe harbor.” Under the OBBBA, the law will lower the safe harbor percentage, from the current 6% to 5.5% beginning in fiscal year (FY) 2028 and 3.5% in FY 2032. In July 2026, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Proposed Rulemaking (NPRM) titled “Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes” ( CMS-2452-P ). The proposed rule implements Section 71115 of the OBBBA, which it refers to as the Working Families Tax Cut legislation. Not only does the NPRM confirm the phasedown described in Avalere Health’s
Health Plans’ Quarterly Performance: A Path to Recovery But Continued Margin Pressures
Sep 2, 2026 · original
Publicly traded health plans recently reported their second quarter financial performance. To assess reported trends, Avalere Health analyzed 10Q forms and filings and earnings call transcripts from six publicly traded health plans: Centene, Cigna, CVS Health, Elevance Health, Humana, and UnitedHealth. Overall, we found that while margins have increased year-over-year, elevated medical costs continue to pressure plans, forcing plans to reexamine membership profitability and reevaluate growth strategies. The table below summarizes Q2 year-over-year trends in key metrics across all the plans we analyzed. Table 1. Health Plans Trends and Outlook in Q2 We identified trends across three lines of business: In MA margins are the biggest growth factor, not membership . After years of aggressive MA expansion, the industry is now focused on strategic market decisions where per-member- profitabilit
Hearing What the Data Can’t Say: Why Qualitative and Survey Research Matter in Rare Disease Evidence Strategy
Aug 26, 2026 · original
The Rare Disease Evidence Problem More than 10,000 rare diseases affect over 30 million Americans and 400 million people worldwide, yet fewer than 10% have an approved treatment. That gap is both a clinical and evidence challenge, shaping decisions from clinical development through market access. For rare disease therapeutics manufacturers, the standard evidence toolkit presents a fundamental mismatch. Claims databases depend on large populations for statistically meaningful results, but rare disease populations are small. A condition affecting 1 in 50,000 people may yield only a few hundred identifiable patients even in a comprehensive claims dataset—too few for robust subgroup analyses or a complete view of the patient journey. Claims data also only captures what the healthcare system bills for, not what patients experience between appointments, the burden on caregivers, or why patient
Legislative Proposals Aim to Modify the 340B Program
Aug 18, 2026 · original
Proposed Changes to 340B Over the years, the 340B Drug Pricing Program has grown across multiple metrics, including the number of drug purchases, participating covered entities (CEs), child sites, and contract pharmacy arrangements. Recently, the Health Resources and Services Administration (HRSA) reported that 340B drug purchases reached $100 billion in 2025 , a 23% increase from 2024. The substantial growth in the 340B program has intensified debate over program oversight and transparency. Recently, policymakers released the following proposals and discussion draft legislation: 340B Drug Pricing Integrity and Affordability for Patients Act : Authored by Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) on June 29, 2026 as a discussion draft, not introduced legislation, for stakeholder comment. SECURE 340B Act (Strengthening the Exercise of Controls
How Rare Diseases Are Reshaping Evidence Generation Strategies
Aug 17, 2026 · original
Defining “Rarity” in the Modern Evidence Landscape Rare diseases collectively represent a significant public health challenge despite their individual low prevalence. In the United States, a rare disease is defined under the Orphan Drug Act as one affecting fewer than 200,000 individuals; definitions vary internationally. Although each condition affects relatively few patients, more than 10,000 rare diseases have been identified worldwide , together impacting hundreds of millions of individuals. Despite decades of regulatory incentives ––including orphan drug designation, accelerated approval pathways, and other Food and Drug Administration (FDA) programs designed to stimulate drug development––most rare diseases still lack approved therapies. One challenge in bringing such products to market is evidence. Limited understanding of disease biology, delayed diagnosis, geographic dispersion
MFP Effectuation and the SDRA: The Possibility of ASP Spirals in Competitive Drug Classes
Aug 17, 2026 · original
Background On July 16, the Centers for Medicare & Medicaid Services (CMS) released the Draft Guidance on Manufacturer Effectuation of the Maximum Fair Price (MFP) for Initial Price Applicability Year (IPAY) 2028 under the Medicare Drug Negotiation Program (MDNP). The guidance proposes policies governing how manufacturers of selected Part B drugs will effectuate (i.e., refund the difference between acquisition cost and the negotiated price) the MFP beginning in 2028. In a previous Avalere Health Insight , the challenges facing products in classes where substantial provider discounts create a significant gap between wholesale acquisition cost (WAC) and Average Sales Price (ASP), which we referred to as competitive classes. We highlighted that under CMS’s WAC-based Standard Default Refund Amount (SDRA) methodologies, refund obligations could be overestimated because WAC does not reflect dis
340B Payment Proposal Would Increase Payment to Most Hospitals
Aug 11, 2026 · original
In the 2027 Outpatient Prospective Payment System (OPPS) proposed rule , the Centers for Medicare and Medicaid Services(CMS) is considering a change to reimbursement for 340B drugs in Medicare Part B, from average sales price (ASP)+6 % to ASP-33.4%. Avalere Health previously estimated the impact of a similar change to Medicare payments. Based on CMS’s survey findings on average hospital acquisition cost for 340B drugs, we refreshed the analysis to estimate how overall hospital payment would be impacted by using the survey-based rate. Avalere Health found that if the proposed reimbursement change were applied to CY 2025 claims and implemented in a budget-neutral manner (rather than the current ASP+6%), Part B payments would have increased for 78% of all hospitals. The proposed change would benefit small and rural hospitals, with an estimated average payment increase of 7% for hospitals wi
On the Record: Health Plan and Provider Perspectives Video Series
Aug 11, 2026 · original
Federal and state policymakers are actively shaping health coverage and access, and we’re here to explain exactly what these changes mean for plans and providers. In a new video series, our experts bring real-world industry experience to the latest policy questions. Watch our 5-10 minute explainers: What’s Shaping Healthcare Right Now? Series introduction that offers an overview of who we are and top-of-mind issues shaping the US payer environment The Impact of CMS and HHS Rules on Responsible AI Use Learn about how CMS and other HHS regulations are shaping AI use in health plans, driving transparency and accountability, and speeding responsible adoption across an increasingly automated system. Predictably Unpredictable: Medicare Risk Adjustment Medicare risk adjustment is shifting. We explain recent policy changes, RADV expansion, and how evolving models may affect payments and market s
Effectuation and SDRA: The Dilemma of Competitive Drug Classes
Aug 7, 2026 · original
On July 16, the Centers for Medicare & Medicaid Services (CMS) released the Draft Guidance on Manufacturer Effectuation of the Maximum Fair Price (MFP) for Initial Price Applicability Year (IPAY) 2028 under the Medicare Drug Negotiation Program (MDNP). The guidance proposes policies governing how manufacturers of selected Part B and Part D drugs will effectuate the MFP beginning in 2028, including the methodologies available to reconcile payment under a retrospective effectuation model. In a previous Avalere Health Insight , we examined the tradeoffs between prospective and retrospective MFP effectuation models and evaluated the four Standardized Default Refund Amount (SDRA) methodologies proposed by CMS. The SDRA is a CMS-calculated standardized default refund amount that serves as a proxy for the difference between a provider’s acquisition cost and the MFP when the actual acquisition c
340B Purchases Surge Past $100 Billion
Aug 5, 2026 · original
On July 15, the Health Resources & Services Administration (HRSA) released the 2025 update to its annual report on 340B covered entity purchases. Drug purchases at discounted 340B prices reached a record of $100 billion in 2025, representing a 23% increase from 2024. This data allows stakeholders to better understand the size of the 340B program and its use by different covered entity types. The data reported by HRSA is from the Prime Vendor Program, which captures most, but not all, 340B transactions. It shows that disproportionate share hospitals (DSHs) made $79.2 billion in 340B purchases in 2025, accounting for approximately 80% of total 340B drug purchases. The next largest category of purchases was for health center programs, accounting for $5.9 billion (5.9%) of total purchases, followed by children’s hospitals, which made up roughly $2.5 billion (2.5%) of total purchases. Continu
State Pricing Controls at an Inflection Point: MFP and the Shifting PDAB Landscape
Aug 4, 2026 · original
Background The first prescription drug affordability board (PDAB) was enacted in Maryland in 2019, modeled on a National Academy of State Health Policy (NASHP) framework. The process was originally intended to be board-driven: a PDAB would review drugs’ affordability and, where authorized in statue, set an upper payment limit (UPL) through methodology of its choosing. As PDABs have moved from concept to reality, states appear to be aligning around setting UPLs based on the Medicare Drug Price Negotiation Program’s (MDPNP) maximum fair prices (MFPs). In October 2025, the Colorado PDAB capped the price of Enbrel at $600 per dose, slightly higher than the MFP for that product. In 2026, Maryland has set two UPLs—for Jardiance and Ozempic—both tied to MFPs. Other states with UPL authority ( Minnesota , Washington ) are earlier in the process. To date, no UPL has taken effect anywhere in the c
2026 Dyslipidemia Guideline Signals a New Standard for Cardiovascular Risk Management
Aug 3, 2026 · original
The 2026 Playbook: Screening Smarter, Treating Earlier, and Measuring What Matters Earlier this year, the American College of Cardiology (ACC), American Heart Association (AHA), and nine other associations see Appendix) jointly released the 2026 Guideline on the Management of Dyslipidemia , replacing the 2018 guideline. The 2026 clinical practice guideline (CPG) addresses the evaluation, management, and monitoring of individuals with dyslipidemias. Unlike the 2018 version, which heavily emphasized high blood cholesterol, the 2026 update encompasses a broader evidence base with new treatment targets, treatment options, earlier intervention, and personalized risk assessment for cholesterol, hypertriglyceridemia, and elevated lipoprotein(a) (Lp(a)). Key recommendations include the identification and treatment of cardiovascular disease (CVD) with tailored recommendations for pediatric, elder
Negotiated Part B Drug Effectuation Proposals: Four SDRA Approaches and Key Tradeoffs
Jul 30, 2026 · original
Background Under the Medicare Drug Price Negotiation Program (MDNP), the Centers for Medicare & Medicaid Services (CMS) negotiates a maximum fair price (MFP) for selected drugs and requires manufacturers to make that price available to providers treating Medicare beneficiaries in the applicable Initial Price Applicability Year (IPAY). The process by which the manufacturer ensures that a provider can access a selected drug at the MFP is coined “effectuation”. CMS’s July 16 Draft Guidance on Manufacturer Effectuation of the MFP in 2028 under the MDNP sets forth proposed policies for manufacturer effectuation of MFPs in IPAY 2028 for selected drugs payable under Part B and/or covered under Part D. IPAY 2028 will be the first year in which MFPs apply to selected Part B drugs. Differences in underlying data and payment flows between Part B and Part D mean that manufacturers effectuation MFPs
2027 NAMBA Signals Continued Market Pressures in Part D
Jul 29, 2026 · original
On July 28, the Centers for Medicare & Medicaid Services (CMS) released the Part D national average monthly bid amount (NAMBA) and base beneficiary premium (BBP) for contract year (CY) 2027, providing one of the early indicators of the financial pressures continuing to shape the Part D market into the 2027 plan year. The NAMBA, which represents the average of Part D plan bids for providing the basic Part D benefit, will increase by 24%, to $296.05, in 2027. This is an increase of more than 750% (from $34.71 in 2023) above pre-Inflation Reduction Act (IRA) plan bids, reflecting the higher expected costs of providing the standard Part D benefit following implementation of IRA benefit redesign. The significant increase in the NAMBA indicates that both Medicare Advantage Prescription Drug plans (MA-PDs) and standalone Prescription Drug Plans (PDPs) are continuing to face rising benefit costs
New Analysis Highlights Opportunities to Improve MPPP Uptake
Jul 28, 2026 · original
Following the first year of implementation of the Inflation Reduction Act’s (IRA) redesigned Part D benefit, Avalere Health analyzed 2025 Medicare Part D claims to examine beneficiary out-of-pocket (OOP) spending patterns and enrollment in the MPPP during the first year of implementation. The analysis found that most beneficiaries in the study population (defined as beneficiaries not receiving the low-income subsidy and not enrolled in Employer Group Waiver Plans) had relatively low annual OOP spending, with nearly 72% (more than 22.7 million beneficiaries) spending less than $120 total OOP in 2025. However, even among the remaining beneficiaries with higher OOP exposure who could benefit from the MPPP, enrollment in the program was very limited. Overall, just 1% of beneficiaries (approximately 333,000) in the entire study population enrolled in the MPPP in 2025. Enrollment in the MPPP I
What Does Another USPSTF Meeting Cancellation Mean for Preventive Care Recommendations?
Jul 16, 2026 · original
Overview The US Preventive Services Task Force (USPSTF) is an independent panel of nationally recognized experts in prevention and evidence-based medicine that develops recommendations for clinical preventive services delivered in primary care settings. USPSTF recommendations influence clinical practice guidelines, preventive care quality initiatives, and insurance coverage. Under the Affordable Care Act, most commercial health plans must cover preventive services receiving an A or B recommendation without patient cost sharing. Recent administrative developments, including multiple canceled Task Force meetings, early termination of Vice-Chair terms, and uncertainty surrounding future appointments, have created questions regarding the pace of recommendation development and the long-term direction of the Task Force. Although there has been no formal announcement indicating changes to USPST
Navigating Medicaid Work Rules: Strategies for Uncertain Terrain
Jul 14, 2026 · original
Tune in to our latest episode of On the Record . To get notified about new episodes in this series, subscribe to our Federal and State Policy insights . The post Navigating Medicaid Work Rules: Strategies for Uncertain Terrain appeared first on Avalere Health Advisory .
Navigating State Variability in Medicaid Work Requirements
Jul 10, 2026 · original
On June 1, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule with comment period (IFC) on Medicaid work requirements (what it calls “community engagement requirements”) to be implemented on January 1, 2027. Per the One Big Beautiful Bill Act (OBBBA), adults in states with Medicaid expansion or similar 1115 waivers must demonstrate 80 hours per month of qualifying “community engagement” activities to qualify for coverage. The interim final rule establishes a federal framework for the requirements, but delegates key implementation decisions to states, creating conditions for significant variability in how the requirement is operationalized across the country. While the OBBBA requires states to implement work requirements by 2027, several states have announced earlier implementation dates, and Nebraska and Montana have already implemented their programs. Wher

Discovered by the rss-feed-index crawler, which checks each feed at most once a month.

Same record as JSON: https://api.agentalog.com/api/feeds/fd_advisory_avalerehealth_com_e0f2423ff534834f. More from this site: advisory.avalerehealth.com in the Feeds tab.