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# HHS skips 2026 penalty adjustment
- URL: https://members.americanhealthintel.com/2026-10-21-regulator/
- Published: 2026-10-21T10:17:42.000Z
- Updated: 2026-10-21T10:17:42.000Z
- Description: Plus: FDA approves Hibsago for hepatitis B. The day's rules, money, and enforcement, sourced and tiered below.
- Author: American Health Intel

Plus: FDA approves Hibsago for hepatitis B. The day's rules, money, and enforcement, sourced and tiered below.

| American Health Intel Rules · Money · Medicine · Decoded daily The Regulator Wednesday, October 21, 2026 HHS skips 2026 penalty adjustment Plus: FDA approves Hibsago for hepatitis B. The day's rules, money, and enforcement, sourced and tiered below. ![](https://americanhealthintel.com/email/pulse-divider.png) Rule Confidence: High HHS will not raise its civil monetary penalty amounts for 2026\. Federal penalties on health care providers and plans stay at 2025 levels, per a notice in today's Federal Register. The notice cites Office of Management and Budget guidance from April 17 saying there is no cost-of-living adjustment this year. It does not change False Claims Act damages or settlement practice. Why it matters Federal penalty ceilings for health care violations stay where they were last year. Watch whether the full notice lists which penalty categories are covered. Sources: [Federal Register](https://www.federalregister.gov/documents/2026/10/21/2026-21524/no-adjustment-to-hhs-civil-monetary-penalty-amounts-for-2026?ref=members.americanhealthintel.com) Approval Confidence: High The FDA approved GSK's Hibsago, the first antisense drug for chronic hepatitis B. In trials, 24% of patients could stop their existing antiviral medicine versus none on placebo. A 24-week injection added to current therapy. 19% still had the virus controlled 24 weeks after stopping all treatment. Boxed warning for liver reactions and low platelets. No price or patient count released. Why it matters This is the first antisense drug approved for chronic hepatitis B and aims at a treatment-free period, which is new. Price and U.S. patient count are not yet public, so watch for both. Sources: [FDA](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment?ref=members.americanhealthintel.com) Also today FDA final guidance on drug apps [Read](https://americanhealthintel.com/editions/2026-10-21-regulator/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition#fda-drug-companion-app-final-guidance) First generic Climara Pro patch [Read](https://americanhealthintel.com/editions/2026-10-21-regulator/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition#fda-first-generic-climara-pro-patch) Virginia Negril Medicaid settlement [Read](https://americanhealthintel.com/editions/2026-10-21-regulator/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition#va-negril-medicaid-fca-settlement-1-8m) 1043Records$62.4BEnforcement44Deadlines297Rules [Read this issue + the trackers](https://americanhealthintel.com/editions/2026-10-21-regulator/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition) Pick your field on the site and every story tells you what it means for you. Reply to this email and tell us what you want covered. We read everything. We show our work. We score our own calls. [Track record](https://americanhealthintel.com/ledger/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition) · [Calendar](https://americanhealthintel.com/calendar/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition) · [Enforcement](https://americanhealthintel.com/enforcement/?utm%5Fsource=newsletter&utm%5Fmedium=email&utm%5Fcampaign=edition) · [X](https://x.com/amhealthintel?ref=members.americanhealthintel.com) · [LinkedIn](https://www.linkedin.com/company/american-health-intel?ref=members.americanhealthintel.com) News and analysis, not legal, medical, coding, or investment advice.You subscribed at americanhealthintel.com · [Unsubscribe](%%{unsubscribe%5Furl}%%) |
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