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Welcome to this month’s ADVOCATE BRIEF

September rewarded everyone with a seat at the table. Patients need not apply

Four deals moved in the same month, and patients signed none of them. Twenty-six drugmakers struck private White House agreements that may exempt their medicines from Medicare's new price models. Phase two of the 100 percent drug tariffs took effect on September 29 with an exit door reserved for companies that signed those deals. Medicare Advantage insurers cut thousands of plans for 2027 and raised what seniors pay. Hospitals and insurers pointed artificial intelligence at each other and billed the cost of the fight to the system.

A Lancet cohort study found that exempting the deal-making companies would erase 71.3 percent of the projected Medicare savings from most-favored-nation pricing. The Wall Street Journal reported that 92 percent of providers now encourage or require payment before care, up from 81 percent a year earlier. Healthcare Dive found average maximum out-of-pocket limits in Medicare Advantage rising 10 percent for 2027 and Part D deductibles rising 30 percent, two weeks before open enrollment starts on October 15.

I have sat in enough negotiating rooms to know who those rooms leave out, and September left out the same person every time. Each side deal resolved into the two questions a patient actually asks, which are whether the drug arrives and what it costs, and nobody at the table answered for the person asking.

Four storylines ran through September, and they share one mechanism. Institutions cut deals with each other, and the patient absorbs the terms through prepayment, paperwork, and algorithms. Organizations that want a different outcome need to sit in those rooms before the fourth quarter locks 2027 budgets, not after the open enrollment letters arrive.

Paperwork remains the barrier…

POLICY PULSE: POLITICAL

Washington spent September writing side deals and calling them reform. The pattern runs through drug pricing, trade, surprise billing, and Medicaid, and the people who take the drugs sat outside every room.

  • The Lancet analyzed 195 brand-name drugs representing 87.9 billion dollars in Medicare spending and projected 5.2 billion dollars in savings under the GLOBE model and 6.4 billion dollars under GUARD. Exempting manufacturers with separate White House agreements would erase 71.3 percent of those savings. STAT reports that 26 drugmakers signed deals with terms nobody outside the companies and the administration has seen, and the proposed GLOBE and GUARD rules never put those exclusions out for public comment. Lead author Thomas Hwang of Brigham and Women's put it plainly: implementation will be confounded by side deals with zero transparency.

  • The second phase of the 100 percent tariff on patented drugs took effect September 29, and Axios reports that companies signing voluntary MFN deals and committing to on-shoring receive three-year exemptions while on-shoring alone still draws a 20 percent tariff until 2030. Brookings' Marta Wosińska estimates more than 100 firms face the duties without the resources to move production. PhRMA answered the moment by naming former House Majority Leader Eric Cantor as CEO, effective November 9. The deal machine now has a dealmaker running the trade group.

  • The courts keep closing the other exit. Health Affairs reports the Fifth Circuit rejected PhRMA's constitutional challenges to Medicare drug price negotiation, eliminating the circuit split industry hoped would reach the Supreme Court, and the DC Circuit upheld CMS against Teva on the definition of a qualifying drug. Expect the next wave of litigation to target CMS rules and guidance under the Administrative Procedure Act.

  • Regulators projected about 17,000 No Surprises Act arbitration disputes a year. Providers filed 2.5 million in 2025 and 1.4 million more in the first five months of 2026, and Georgetown researchers put the extra spending above 22 billion dollars. Arbiters collect a fee per eligible dispute, and two of them rule for providers more than 90 percent of the time. Frank Pallone opened an investigation, which gives patient organizations a live docket for their members' surprise bill stories.

  • The Urban Institute puts 2.3 million young adults at risk of losing Medicaid expansion coverage, even though nearly 9 in 10 of them already meet the work requirement. The National Bleeding Disorders Foundation told its community the biggest threat after January 1, 2027 comes from paperwork, with twice-yearly eligibility reviews and 80 hours a month of documented activity. Coverage will turn on whether states can verify what enrollees already do.

  • The Wall Street Journal reports a new customs rule routes FDA-regulated mail through private processors that check every parcel against FDA criteria. More than two million Americans buy prescriptions abroad to save money. One Dallas patient profiled pays about 10 dollars a week for Xifaxan from Canada and faces 1,100 dollars a week domestically, and patients already describe plans to cut doses or skip pills.

The pattern across all six holds. Money and coverage moved through agreements, rules, and fee structures written for institutions, and the patient voice showed up only after the terms were set. A comment letter, a member story handed to a congressional investigator, or a state-level paperwork playbook costs an advocacy organization far less than the coverage its community stands to lose.

Patients are continued to ask to pay before they get care.

COST OF CARE: ECONOMIC

The cost story in September came down to one word: first. Patients now pay first, prove eligibility first, and absorb plan cuts first, and every one of those shifts lands before a claim exists.

  • Healthcare Dive read the 2027 Medicare Advantage landscape and found total plan counts barely moved, from 5,553 to 5,532, while Centene cut about 3,000 plans, Humana about 2,400, and UnitedHealthcare about 690. Premiums stay roughly flat, but average maximum out-of-pocket limits rise 10 percent and Part D deductibles rise 30 percent, and Clover raised its Part D deductible 192 percent. Insurers project enrollment falling about 2 million to 34 million. Mass General Brigham Health Plan had already dropped Dana-Farber from its Medicare Advantage network on October 1. Oncology teams should map which networks their patients depend on before open enrollment closes.

  • The Wall Street Journal reports 92 percent of providers now encourage or require prepayment or keep a payment method on file, up from 81 percent a year earlier, and about half of patient cost-sharing remains unpaid a year after care. Providers in most states can refuse nonemergency procedures without payment upfront. Hub and copay programs built around the claim now face a gate that swings shut before anyone files a claim.

  • The Commonwealth Fund found one-third of privately insured adults carry medical debt, and 30 percent of them delayed needed care while another 30 percent cut back on food, heat, or rent. Hospital care drove nearly two-thirds of the debt. Affordability programs that track only copays miss the debt that keeps patients from coming back.

  • In Health Affairs, Joey Mattingly documents what happens to companies that price low. Merck launched Zepatier 42 percent below Harvoni, watched sales fall 73 percent, and exited hepatitis C after a 2.9 billion dollar impairment. Viatris had to nearly triple its insulin glargine list price before Express Scripts would prefer it. Every link in the chain, from PBM rebates to 340B spread to Part B add-on payments, rewards the higher list price, and patients on coinsurance pay that difference.

  • A Pioneer Institute white paper funded by CancerCare compared 3,999 hospitals and found 340B hospitals reported charity care at 2.16 percent of operating expenses against 2.82 percent for non-340B hospitals, though they served more Medicaid patient days. The authors acknowledge the analysis runs unadjusted, and defenders of 340B will push on that point. The paper still hands policymakers the auditable charity care standard they have asked for, and it arrived from a patient organization.

Cost now reaches patients before care begins and long after it ends. Advocacy organizations hear those stories first, which gives them the evidence payers and policymakers keep saying they lack.

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COMMUNITY LENS: SOCIOCULTURAL

The advocacy lesson of September stings. Patients who go public get answers, and patients who follow the process wait.

  • Sally Nix published her Blue Cross NC denial letter, Mark Cuban shared it, and the CEO's office called within days. Her argument runs structural: the insurer folded the trigeminal nerve block code into a migraine injection policy in 2020, and annual policy reviews trail the clinical evidence. No patient should need a billionaire's feed to earn a fair review.

  • KFF Health News reported on a young man with a rare brain tumor whose PBM denied Lynparza as "not approved for the diagnosis provided," leaving an 8,700 dollar monthly bill, and an independent nonspecialist reviewer backed the denial. AstraZeneca shipped the drug the day after his mother posted publicly and tagged the company. Rare cancers account for roughly a quarter of US cancers, and label-bound coverage rules leave those families to fight alone. His mother said it best: she had to become a PBM, an insurer, and a research expert while trying to be his mother.

  • STAT reports Novo Nordisk logged 7 million prescriptions for its Wegovy pill this year with 90 percent of sales running direct to consumer, and the company now talks about customers rather than patients. The STOP Obesity Alliance and clinicians warn that retail positioning undercuts years of advocacy for obesity coverage parity, and cash prices of 400 to 450 dollars a month turn access into a question of means. Commercial teams celebrating DTC growth should count who that model leaves out.

  • University of Colorado Denver sociologist Jennifer Reich has spent two decades talking with parents who decline vaccines, and she told STAT that many started out pro-vaccine before rushed pediatric visits, which average 11 to 16 minutes, pushed them toward peer groups that listened. A culture that tells parents to research everything and then dismisses them for doing it loses the conversation that could change minds.

  • A DIA and Tufts CSDD benchmark and a Bayer Oncology case study on patient advisors reach one finding. Most sponsors buy the easy version of engagement, stipends and incentives, while few run patient steering committees or bring advisors in before protocols lock.

Engagement that works only under public pressure fails every patient who never goes viral. Trust gets built in the quiet years and spent in a single news cycle, which is exactly what ELAVAY measures every year.

AI bots fighting AI bots.

Technology outran accountability again in September. Medicare scaled two pilots, hospitals and insurers escalated an AI coding war, and an FDA panel weighed a cancer blood test with a serious false-positive problem.

  • STAT obtained documents showing CMS rushed its WISeR AI prior authorization pilot, and vendor Innovaccer warned it would go live without full functionality and auto-approved every request to avoid a backlog. Vendors earn 25 percent of the value of a denied claim, and an HHS OIG review of a Medicare Advantage program found 82 percent of patients never appeal. Providers reported canceled surgeries while approvals sat in a queue.

  • The New York Times reports a Blue Cross Blue Shield Association study found hospitals using AI coding tools added secondary diagnoses without evidence of different treatment, earning nearly 12,000 dollars more per case and adding close to 1 billion dollars in costs over two years. Insurers answer with their own AI to scan charts for denials, and benefit consultants cite the arms race among the drivers of employer cost increases of up to 11 percent next year. Patients sit in the middle of the bots fighting the bots.

  • CMS will expand its ACCESS chronic care model with new condition tracks in spring 2027, and 17 health plans covering 165 million people committed to aligned payment. Payment tops out at 420 dollars per patient per year for cardiovascular, kidney, and metabolic conditions, and Omada, Sword Health, and Hinge Health declined to join.

  • An FDA advisory panel voted 7 to 2 that the benefits of Grail's Galleri multi-cancer test outweigh its risks, but only 6 to 4 on effectiveness, after an FDA official told the panel that a third to half of positive results come back false and two of three cancers may be missed. Patient groups need plain-language guidance ready so nobody trades a colonoscopy or a mammogram for a blood draw.

  • FDA approved FAYUVI, the first treatment for Sanfilippo syndrome type A, after the asset nearly died for lack of funding. Cure Sanfilippo Foundation and National MPS Society leaders co-authored the approval statement, and decades of advocacy kept the therapy alive. The payer navigation fight starts now.

Every one of these tools shifts work onto patients unless someone builds patient review in from the first design meeting. Advocacy organizations hold that knowledge, and CMS keeps launching without it.

THE BOTTOM LINE

September 2026 proved that institutions now decide access in side agreements, fee structures, and plan landscapes rather than in statutes. Twenty-six private pharma deals could erase most of Medicare's projected MFN savings. Ninety-two percent of providers now want payment before care. Seniors open their 2027 Medicare Advantage letters this month to find higher out-of-pocket limits and steeper Part D deductibles. None of it produced a headline that survived the week, and all of it will shape access in 2028.

Pharma and biotech teams that connect advocacy insight to execution before 2027 budgets lock will lead the next two quarters. Patient advocacy organizations that file comments, hand member stories to investigators, and build paperwork playbooks before January 1 will decide what their communities can reach next year. The ones that wait for the open enrollment letters will spend 2027 explaining to their communities why the answer came back no.

Take the free Advocacy Influence Diagnostic at aid.elavay.com to evaluate your advocacy function's influence and get a real understanding of its impact within your organization.

Find every source cited in this brief, and the other articles our CEO, Matt Toresco, found valuable last month, at intelligence.archo.io.

Archo's 2025/2026 ELAVAY Oncology Advocacy Intelligence Report ranked Eli Lilly first in five of eight categories among 17 oncology companies, and no respondent ranked the Inflation Reduction Act as a top priority. For ELAVAY Intelligence briefings and Archo syndicated research on how patient advocacy organizations evaluate pharma and biotech companies, email [email protected].

The 2025/2026 ELAVAY report is available now, and fielding for the 2026/2027 cycle opens this month, which means inclusion decisions happen now. To request the findings or schedule a briefing, email Archo at [email protected].

For advocacy strategy consulting or advocacy function training to maximize your team's engagement and influence, reach Matt directly at [email protected].

Connect with the advocacy community and get access to patient and advocacy resources, check out advocatebridge.org and empwrdpatientfoundation.org.

SOURCE ARTICLES BY SECTION

Policy Pulse

Cost of Care

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ELAVAY

ALL SOURCED CAN ALSO BE FOUND AT https://intelligence.archo.io

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