The Regulator

60 days: that is how long people in the hurricane zone have to enroll in or change Obamacare coverage after the federal disaster period ends, under flexibilities the Centers for Medicare & Medicaid Services (CMS) announced October 15. HHS Secretary Robert F. Kennedy, Jr. declared public health emergencies on October 13 for Florida (effective October 6) and Alabama (effective October 7) after Hurricane Isaias. CMS says people in HealthCare.gov states who missed an enrollment window because of the disaster may qualify for a Special Enrollment Period (SEP), requested through the Marketplace Call Center at 1-800-318-2596. Medicare beneficiaries who lost or damaged durable medical equipment, prosthetics, orthotics or supplies can get replacements, and Part D drug plans must reimburse out-of-network pharmacy fills for displaced enrollees up to the usual plan allowance and drop “refill too soon” edits for people who lost medications. Blanket 1135 waivers (which relax Medicare, Medicaid and CHIP rules during emergencies) apply to affected providers in both states, and CMS activated its kidney emergency program for dialysis patients. The alert names no counties and gives no dollar figure, so the number of people covered is not stated. Confidence: High on the announced flexibilities; Low on how many people use them. Sources: CMS news alert, public health emergency in Alabama and Florida.

January 16, 2027: that is the date the Food and Drug Administration (FDA) starts rejecting drug and biologic applications that fail eight new electronic-format checks. A Federal Register notice published October 16 says FDA’s drug and biologics centers will reject submissions in the Electronic Common Technical Document (eCTD) format that fail newly designated “high-severity” validations: two for version 3.2.2 (numbers 2024 and 2025) and six for version 4.0 (eCTD4-084, eCTD4-085 and US-eCTD4-561 through 564). Companion notice, same day: FDA begins supporting forward compatibility for eCTD 4.0 submissions on October 16. Who it hits: any drug sponsor or regulatory-affairs vendor whose publishing software has not been updated, since a rejection means the submission is not accepted for review. The notice states no cost estimate and takes comments at any time. Confidence: High. Sources: Federal Register, eCTD validation notice (2026-21195), Federal Register, eCTD 4.0 forward compatibility notice (2026-21197).

Alignment Healthcare is suing CMS over its 2027 Medicare Advantage Star Ratings, saying the drop costs it more than $200 million in 2028 payments. The insurer filed in federal court in Washington on October 9 (case 1:26-cv-03550, assigned to Judge Christopher R. Cooper), one day after CMS posted the ratings. It argues CMS again used 10 quality measures that were never put through formal rulemaking, the same theory that won Clover Health a ruling earlier this year, and asks the court to vacate its 2027 ratings and order a recalculation before the 2028 selling season. Per Healthcare Dive’s reporting on the complaint, the share of Alignment members in plans rated 4 stars or higher fell from 98% to 25%, and CMS denied a pre-suit request on October 7. CMS has not publicly responded and no court ruling has been posted. Star Ratings set quality bonus payments, so a win for Alignment could invite copycat suits from other insurers. Confidence: High on the filing; Med on the figures, which come from the complaint and press reports. Sources: Alignment Healthcare complaint, October 9, 2026, supplemental: Healthcare Dive.

CMS sent $78 million in Rural Health Transformation money to 216 rural providers in Texas, announced October 15. The “Rural Texas Strong” awards go to chronic disease prevention (diabetes, heart disease, chronic respiratory disease, obesity), recruiting and keeping doctors and emergency medical staff, and replacing aging equipment and facilities. The release describes the $78 million as part of a larger fiscal year 2026 Texas award without stating that total, and gives no split by category or provider. Nationally the program is a $50 billion fund. Confidence: High on the announced figure. Sources: CMS press release, Texas.

The Centers for Disease Control and Prevention (CDC) extended its order suspending the right to introduce certain people into the United States from countries where a quarantinable disease exists. The order was issued October 11, published in the Federal Register October 15, and runs through 4:59 p.m. Eastern on November 10, 2026 unless the CDC Director amends or ends it sooner. It rests on sections 362 and 365 of the Public Health Service Act. We could not retrieve the full text, so the countries and diseases covered are not confirmed here; check the notice before relying on its scope. Confidence: Med on the dates (from the notice abstract); Low on scope. Sources: Federal Register, CDC order continuing the suspension (2026-21036).