HHS' health tech arm wants input on how to accelerate adoption of AI in clinical care

By Heather Landi - The Department of Health and Human Services' (HHS') health tech arm wants to hear from the healthcare industry about ways to speed up the adoption of artificial intelligence in medical treatment. The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) released a request for information (PDF) seeking public feedback on the actions it can take to establish a "forward-leaning, industry-supportive, and secure approach to accelerate the adoption and use of as part of clinical care." Read Full Article…

HVBA Article Summary

1. Call for Public Input on AI in Clinical Care: The U.S. Department of Health and Human Services (HHS) has issued a Request for Information (RFI) aimed at gathering input from a wide range of stakeholders—including developers, healthcare providers, and potential users of AI tools in clinical settings. This effort is intended to help shape how HHS leverages its policy levers—regulation, reimbursement, and research—to encourage responsible AI adoption in healthcare, reduce barriers to innovation, and build public trust in AI applications.

2. Focus Areas: Regulation, Reimbursement, and R&D: HHS is concentrating on three major areas to support the integration of AI into clinical care. These include establishing clear and balanced regulations that support innovation while addressing risk, exploring updates to reimbursement policies to incentivize adoption of effective AI tools, and investing in research and development, including through public-private partnerships. The department aims to align incentives and modernize outdated systems to meet the evolving needs of the healthcare ecosystem.

3. Broad Scope of Feedback Sought: The RFI invites feedback on a wide range of topics beyond policy levers, such as the evaluation of AI tools (especially non-medical devices), industry-led accreditation and certification practices, and real-world challenges in healthcare that AI could help solve. HHS also seeks insights into legal and governance concerns, including issues of liability, privacy, and security. Patients, healthcare professionals, and industry voices are all encouraged to contribute their perspectives within 60 days of the RFI’s publication in the Federal Register.

SIIA Government Relations Update 12.19.2025

By SIIA - In our September Newsletter, we were right when we you told you that the “debate” over extending the Affordable Care Act’s (ACA’s) “enhanced premium subsidies” would reach a fever-pitch once the September 30 th government funding deadline hit. But, what we did not quite fathom is that the “debate” over extending the “enhanced premium subsidies” would be the root-cause for the longest Government Shutdown in history. Now that we are on the other side of the historic Government Shutdown, what’s next? ANSWER: Political “messaging” and “campaigning.” Read Full Article…

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1. Pharmacy Benefit Manager (PBM) Transparency Measures: Recent House legislation includes robust PBM Disclosure Requirements aimed at increasing transparency in how prescription drug benefits are managed. Although part of a Republican “messaging” bill, these provisions are expected to resurface in a future bipartisan compromise. The requirements would mandate PBMs to regularly report detailed data to group health plans, including drug pricing, rebates, utilization rates, pharmacy channels, and formulary restrictions. The goal is to shed light on opaque pricing practices and ensure cost accountability throughout the healthcare system.

2. Regulatory Debate over Stop-Loss Insurance Protections: The Self-Insurance Protection Act (SIPA), included in the House health care bill, seeks to prevent federal regulators from reclassifying stop-loss insurance as traditional health insurance. It would also limit states from imposing restrictions that block employers from securing stop-loss coverage. While SIPA is unlikely to pass in its current form, it highlights ongoing tensions between federal oversight and state-level regulation. Stakeholders such as SIIA support federal protections but caution against preempting state authority unnecessarily.

3. ERISA Fiduciary Expansion for PBMs: A policy proposal under discussion would designate PBMs as fiduciaries under the Employee Retirement Income Security Act (ERISA). This change would impose legal duties requiring PBMs to act in the best interest of plan participants, minimize conflicts of interest, and maintain transparency in drug pricing and benefit management. While not yet formal legislation, the measure signals a growing legislative interest in regulating PBM practices under existing employer-sponsored health plan law.

4. Federal Push to Preempt State AI Laws in Healthcare: An Executive Order from President Trump directs federal agencies to challenge state-level AI regulations that conflict with national policy or hinder innovation. This includes creating an “AI Litigation Task Force” under the Department of Justice to address potential legal conflicts. As AI becomes more integrated into healthcare operations, this order may influence how AI is regulated and harmonized across state and federal jurisdictions — particularly concerning patient data, automation, and compliance systems.

Trump administration proposes stronger insurer price transparency requirements

By Sydney Halleman – Boosting price transparency requirements has been a priority of the Trump administration since its first term, when the HHS finalized rules requiring insurers and hospitals to post machine-readable files of pricing information for healthcare services starting in January 2021. The administration said it hoped the rules would encourage patients to compare options and visit lower-priced facilities, which would incentivize providers to lower costs. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Hospital vs. Insurer Compliance Varies: Compliance with healthcare price transparency rules has been uneven, particularly among hospitals, where adherence has been spotty. In contrast, insurers and health plans have shown stronger compliance, often publishing negotiated price data more consistently. However, this assessment comes from Turquoise Health, which noted that true compliance can only be determined by federal or state regulators, not independent researchers.

2. Current Regulations Create Data Challenges: Existing regulations lack clear guidance on how insurers should link posted pricing data to specific networks within national, regional, or state-level plans. As a result, insurers tend to include vast amounts of information in their data files. This approach has led to the creation of massive, machine-readable files that are difficult for both consumers and insurers to navigate, reducing the practical usefulness of the data.

3. Proposed Rule Seeks to Improve Usability and Access: A proposed rule introduced by the Trump administration aims to address these challenges by streamlining and clarifying reporting requirements. Key changes include reducing the frequency of reporting from monthly to quarterly, eliminating data for services unlikely to be performed by certain providers, and organizing rate files by provider network rather than by plan. Additionally, it mandates that pricing information be available via phone or paper to ensure accessibility for patients without internet access.

Trump administration inks pricing deals with 9 drugmakers

By Ella Jeffries - The Trump administration finalized agreements Dec. 19 with nine pharmaceutical manufacturers to offer U.S. patients prescription drug prices aligned with the lowest rates paid by other developed nations. The companies — Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi — agreed to provide “most-favored-nation” pricing on various therapies, including treatments for cancer, Type 2 diabetes, rheumatoid arthritis, HIV, hepatitis B and C, and asthma. Read Full Article…

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1. Nationwide Medicaid Access to Deep Pharmaceutical Discounts: Medicaid programs in all 50 states will now benefit from newly established pricing arrangements that offer steep discounts on a range of prescription drugs. Notable reductions include Sanofi’s Plavix dropping from $756 to $16, Gilead’s Epclusa from $24,920 to $2,425, and Novartis’ Mayzent from $9,987 to $1,137. Additionally, Sanofi’s insulin products will be priced at $35 per month. These savings will be accessible through direct-to-patient sales platforms such as TrumpRx, aiming to make critical medications more affordable to vulnerable populations.

2. Pharmaceutical Companies Commit $150 Billion to U.S. Manufacturing and API Donations: As part of the agreements, nine pharmaceutical companies have pledged a combined $150 billion investment into U.S.-based manufacturing facilities. They have also agreed to donate key active pharmaceutical ingredients (APIs) to the Strategic Active Pharmaceutical Ingredients Reserve. These contributions include 98.8 kilograms of albuterol from GSK, 6.5 tons of apixaban from Bristol Myers Squibb, and 3.5 tons of ertapenem from Merck—supporting both national health security and supply chain resilience.

3. Drug Pricing Agreements Reinforce Broader Federal Cost-Reduction Efforts: These deals build on prior arrangements with companies like Pfizer, Eli Lilly, and Novo Nordisk, all of which committed to most-favored-nation pricing and expanded domestic investment. A notable milestone was reached in November, when Eli Lilly and Novo Nordisk agreed to cap Medicare prices for GLP-1 diabetes and obesity medications at $245 per month starting in 2026. These agreements align with Centers for Medicare & Medicaid Services (CMS) proposals to tie drug reimbursement rates for Medicare Part B and D to international price benchmarks, with the goal of lowering prescription drug costs and improving patient affordability nationwide.

UnitedHealth commits to changes after independent review

By Rebecca Pifer – UnitedHealth has pledged to make a range of improvements in response to the first outside reviews of its business practices as the healthcare behemoth works to improve waning consumer trust. The independent analyses, completed by FTI Consulting and the Analysis Group in November and released on Friday, didn’t find a smoking gun that UnitedHealth is leveraging its control of the industry in order to inflate profits, as some critics allege. Read Full Article...

HVBA Article Summary

1. Independent Reviews Validate Compliance but Reveal Gaps in Oversight and Communication: External audits found UnitedHealth’s operations in Medicare Advantage, utilization management, and PBM practices to be broadly compliant with industry standards. However, the reviews highlighted issues such as unclear policy ownership, outdated documents, and disorganized coding procedures. For example, some materials hadn’t been reviewed in over a year, and it was often unclear which policies applied to which divisions. Greater clarity and more consistent oversight were recommended to improve transparency and accountability.

2. UnitedHealth Pledges 23 Action Plans and Process Reforms by March Deadline: UnitedHealth has announced 23 specific reform actions to be completed by the end of March. These include annual policy reviews, improved governance structures, and audit tracking systems with escalation protocols. The company acknowledged that in 9 out of 62 audits, corrective actions were not documented. It also plans to release findings from a review of its HouseCalls program, which critics claim contributes to upcoding.

3. Investigations and Industry Scrutiny Continue Amid Promised Reforms: UnitedHealth is under criminal and civil investigation by the DOJ for allegedly inflating Medicare Advantage risk scores, a claim it denies. Meanwhile, Optum Rx faces scrutiny for its rebate practices as one of the three largest PBMs in the U.S. Lawmakers are concerned PBMs prioritize high-cost drugs to maximize rebates and retain a greater share of savings. Although audits confirmed Optum passes discounts to clients, lack of transparency continues to raise concerns.

Anthem’s 62% Profit Margin in Federal Employees Health Benefits Contract

By Chris Deacon - When the Office of Inspector General (OIG) audited Anthem Blue Cross and Blue Shield insurance plans for federal employees recently, auditors appeared to be conducting a typical contract compliance review. While they may not have been looking for a smoking gun, they stumbled upon one. Read Full Article…

HVBA Article Summary

1. OIG Found Potential Contract Violations Through Related-Party Transactions: The U.S. Office of Inspector General (OIG) discovered that Anthem (now part of Elevance Health) contracted subrogation services to its affiliate Carelon and charged the Federal Employees Health Benefits Program (FEHBP) fees as medical claims rather than administrative costs. This structure circumvented caps on administrative expenses and potentially allowed excessive profits in violation of federal contract rules, particularly because the service was provided by a related entity.

2. Auditors Faced Non-Cooperation and Withheld Evidence: Throughout the audit, Anthem resisted oversight by refusing to provide key documentation, including a full Deloitte valuation report used to justify fees. The company also denied the existence of internal cost data, only to inadvertently reveal it during a meeting. These actions obstructed the OIG’s ability to assess the true extent of unallowable profit and raised serious concerns about transparency and accountability in federal contracting.

3. Systemic Oversight Weaknesses Enable Contractor Overreach: Despite identifying a profit margin potentially as high as 62%—in a program that legally prohibits such profits—the audit is unlikely to result in enforcement due to structural weaknesses. The federal Office of Personnel Management’s deferential stance and a lack of congressional scrutiny suggest that contractors like Anthem can exploit the system with minimal consequence, raising broader concerns about governance and taxpayer protection in federal health programs.

Trump admin payment tests aim to lower Medicare drug prices

By Maya Goldman and Caitlin Owens - The Trump administration on Friday proposed two new programs aimed at saving Medicare billions of dollars on seniors' drugs by pegging what the government pays to prices in other developed countries. Why it matters: While President Trump's deals with drugmakers have focused primarily on getting Medicaid and direct-to-consumer drug prices in line with peer countries, the new efforts focus on Medicare. Read Full Article…

HVBA Article Summary

1. Projected Savings for Medicare and Seniors: Two new Medicare drug pricing initiatives—the Global Benchmark for Efficient Drug Pricing Model (Part B) and the Guarding U.S. Medicare Against Rising Drug Costs Model (Part D)—are expected to generate $14.1 billion and $11.9 billion in savings respectively for Medicare between 2026 and 2031. Additionally, Medicare enrollees are projected to save approximately $6.2 billion in out-of-pocket expenses for outpatient drugs during this same timeframe, as the programs aim to limit excessive drug prices by referencing international benchmarks.

2. Potential Cost Increases for Seniors: While the programs are designed to lower costs overall, Medicare officials project that seniors could still experience a $3.6 billion increase in prescription drug costs between 2028 and 2033. This increase is anticipated because pharmaceutical companies may respond to the pricing reforms by raising prices on drugs not included in the programs—particularly those selected for Medicare's separate price negotiation initiative—in an effort to compensate for potential revenue losses from the new rebate requirements.

3. Program Mechanisms and Industry Pushback: Both initiatives aim to control drug prices by requiring manufacturers to pay rebates if their prices exceed a calculated international benchmark, which is based on drug prices in other developed countries. Enrollees’ out-of-pocket costs would also be aligned with these benchmarks. However, the pharmaceutical industry strongly opposes the proposals, claiming that such government-imposed pricing structures could harm innovation and reduce investment in U.S. medical research. The proposals are currently in the public comment phase, with feedback accepted until February 23.

2025 Year in Review: From the GLP-1 boom to the One Big Beautiful Bill Act

By Lucy Peterson – The year 2025 was marked by major developments across health care, retirement, and corporate policy, shaping the landscape for employers, patients, and consumers alike. The health care sector saw significant shifts, including the rapid adoption of GLP‑1 weight‑loss therapies, which raised both hopes for long-term health improvements and concerns over rising pharmacy costs. Pharmaceutical distribution also evolved, with companies like Eli Lilly, Novo Nordisk, Humana, and Mark Cuban’s Cost Plus Drugs exploring direct-to-employer models to increase transparency and affordability. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Healthcare and Insurance Industries Faced Heightened Regulatory, Legal, and Antitrust Scrutiny: Numerous legal and regulatory actions reshaped the healthcare ecosystem. High-profile settlements involving UnitedHealth and Blue Cross Blue Shield highlighted systemic concerns around claim denials and anticompetitive practices. Legislative efforts like the Patients Over Profits Act aimed to counter insurer consolidation and its effects on access, cost, and quality of care. Federal and state interventions—including scrutiny from DOGE and antitrust lawsuits—signaled a growing push for accountability and transparency across the industry.

2. Pharmaceutical Market Experienced Disruption Through Direct Models and Policy Shifts: New business models emerged in the pharmaceutical sector, with companies like Eli Lilly, Novo Nordisk, and Mark Cuban’s Cost Plus Drugs bypassing traditional pharmacy benefit managers (PBMs) to sell directly to employers and consumers. Initiatives such as TrumpRx and bipartisan legislative proposals for drug importation aimed to increase price transparency and reduce drug costs. These trends signal a move toward greater consumer choice and a challenge to entrenched pricing and distribution systems.

3. Federal Policy Changes and Executive Actions Drove Uncertainty and Innovation in Benefits Management: Major federal actions—including the One Big Beautiful Bill, mass layoffs, and “cash-for-coverage” proposals—introduced new dynamics in employee benefits, affordability, and regulatory enforcement. Employers and insurers were forced to adapt quickly to evolving tax codes, telehealth expansions, dependent care rules, and administrative slowdowns from government shutdowns. These developments emphasized the challenge of aligning innovation with compliance amid ongoing political and policy turbulence.