Recent Changes — Healthcare Delivery

SAMHSA published the 42 C.F.R. Part 8 OTP Final Rule (89 Fed. Reg. 7528) on February 2, 2024 with effective date April 2, 2024 and compliance October 2, 2024. The rule codifies COVID-era flexibilities permanently — take-home doses up to 28 days methadone for stable patients and 14 days for less stable; telehealth screening for buprenorphine initiation; audio-only and audio-visual telehealth platforms for buprenorphine treatment subject to HIPAA-compliance; in-person components of full exam scheduled within first 14 days. Removes all language and rules pertaining to DATA Waiver per CAA 2023 § 1262 (the MAT Act, which eliminated the federal requirement for practitioners to submit Notice of Intent to prescribe buprenorphine for OUD treatment). Correction effective February 23, 2026 (91 Fed. Reg. 7456). Combined with the DEA-HHS permanent telemedicine flexibility for buprenorphine prescribing finalized 2025, the federal architectural simplification operates at meaningful magnitude reducing workforce-access bottleneck for office-based buprenorphine prescribing.

Affects: Behavioral Health & SUD Delivery.

The Tri-Agencies (DOL, HHS, Treasury) issued a joint non-enforcement statement May 9-15, 2025 covering portions of the September 9, 2024 MHPAEA Final Rule applicable for plan years on or after January 1, 2025 and January 1, 2026 — including the new comparative-analysis content requirements, meaningful benefits standard, prohibitions on discriminatory factors and evidentiary standards, and relevant data evaluation requirements. ERIC v. DOL/HHS/Treasury filed January 17, 2025 in U.S. District Court for the District of Columbia (Judge Timothy J. Kelly) challenging the Final Rule; case in abeyance May 12, 2025; non-enforcement applies until final decision in ERIC litigation plus 18 months. The 2013 Final Rule plus CAA 2021 NQTL comparative-analysis obligations plus the statute itself remain operative. EO 14219 cited as policy basis. March 3, 2026 Tri-Agencies Fourth Annual Report to Congress documents DOL "not as active as previously" with state enforcement growing.

Affects: Behavioral Health & SUD Delivery · ACA & Commercial.

OBBBA was signed July 4, 2025 (P.L. 119-21) with approximately $1 trillion Medicaid cuts phased over 10 years. Section 71107 establishes 6-month eligibility redeterminations effective December 2026; Section 71109 noncitizen Medicaid restrictions effective October 1, 2026; Section 71115 provider-tax safe-harbor stepdown from 6.0% to 5.5% beginning FY 2028 and to 3.5% by FY 2032; Section 71117 MCO-tax tightening (effective July 4, 2025 with three-year CMS transition); Section 71119 community-engagement work requirements effective January 1, 2027 (80 hours/month); Section 71401 Rural Health Transformation Fund $10 billion annually FY 2026-2030 ($5B equal-state allocation plus $5B rurality-and-application-based; first distributions in 2026; December 29, 2025 initial state-application decisions). CBO projects approximately 11.8 million coverage losses by 2034; 9.1 million Medicaid recipients affected by provider-tax provisions by FY 2034; $11.9 billion annual federal Medicaid funding decline across 18 expansion states once caps fully implemented. CMS administratively names OBBBA as "Working Families Tax Cut" (WFTC). Implementation chronology: November 18, 2025 CMCS Informational Bulletin (eligibility/financing); December 8, 2025 Community Engagement Bulletin (Section 71119); early February 2026 CMS Final Rule "Preserving Medicaid Funding for Vulnerable Populations" (statistical-test tightening; CBO $35B FY 2026-2034); January 29, 2026 CMS Fact Sheet ($600M Medicaid Technology pledges); $200M Government Efficiency Grants FY 2026; CMS Interim Final Rule due June 1, 2026; beneficiary outreach must begin no later than December 31, 2026; retroactive coverage reduction to 60 days traditional / 30 days expansion effective January 1, 2027. CCBHCs, FQHCs, and RHCs exempted from new cost-sharing. IMD exclusion unchanged. Reentry continuity preserved (CAA 2023 § 5121 youth Medicaid continuity plus CAA 2024 suspension-not-termination requirement effective 2026 — both unchanged).

Affects: Medicaid · Hospital · FQHC & Safety-Net · Behavioral Health & SUD Delivery · ACA & Commercial · Specialty.

The 43-day federal government shutdown ending January 30, 2026 was the longest in U.S. history. Direct healthcare-delivery effects included extension of the Community Health Center Fund prior authorization from September 30, 2025 to January 30, 2026 via the budget act ending the shutdown, then through December 31, 2026 via the 2026 Consolidated Appropriations Act (with CHCF FY 2026 at $4.6 billion — the largest annual increase in a decade per NACHC). Medicare telehealth waiver expired September 30, 2025; restored via November 12, 2025 continuing resolution through January 30, 2026; further extended through December 31, 2027 by CAA 2026 (signed February 3, 2026). NHSC $350M FY 2026; THCGME $225M scaling to $300M by FY 2029 over five years.

Affects: FQHC & Safety-Net · Specialty.

The Inflation Reduction Act of 2022 Enhanced Premium Tax Credits — which removed the 400% FPL eligibility cliff and capped premium at 8.5% of household income across all bands — expired December 31, 2025 per Congress's non-extension. The 2026 Pennie open-enrollment cycle showed average premium increase of 102%; 85,000 enrollees terminated coverage during OE 2026; additional 60,000+ dropped coverage between OE close and May 1, 2026; cumulative cancellations exceeded 145,000; Pennie enrollment fell from approximately 500,000 in 2025 to 452,525 as of May 1, 2026; new enrollments during OE 2026 totaled approximately 80,000 (12% decrease vs. 2025 OE). 19,571 PA enrollees earning less than 150% FPL dropped coverage (16.7% of the income-band total). The U.S. House passed H.R. 1834 "Health Subsidies Extension Measure" January 8, 2026 (230-196) for a 3-year EPTC extension; 17 Republicans crossed party lines including PA-1 Fitzpatrick, PA-7 Mackenzie, and PA-8 Bresnahan; remaining PA Republican delegation voted against. Senate alternative CARE Act ("Consumer Affordability and Responsibility Enhancement Act"; 2-year extension plus minimum premium payments plus income caps plus lawfully-present-noncitizen exclusion) draft circulating since January 2026 but not advanced. December 2025 Senate proposals S. 3385 and S. 3386 failed to clear the 60-vote threshold. 2026 unsubsidized premium for a 60-year-old couple reported at $2,000-$3,000/month, up from $500-$600 in 2025.

Affects: ACA & Commercial · Hospital · FQHC & Safety-Net.

IRA Round 1 prices took effect January 1, 2026 for 10 Part D drugs: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and NovoLog/Fiasp. Negotiated discounts range 38%-79% off list. CMS projects approximately $6 billion Medicare net Year-1 savings plus approximately $1.5 billion beneficiary OOP savings. The IRA coverage requirement means all Part D plans cover all 10 selected drugs at the negotiated maximum fair price. The Part D annual OOP cap is $2,100 in 2026 (up from $2,000 in 2025) per the CY 2026 Part D Redesign Program Instructions issued April 7, 2025. Round 2 (15 drugs) takes effect January 1, 2027 with MFPs announced approximately late November 2025; Round 3 selections in early 2026 were affected by the OBBBA orphan-drug exclusion expansion. Trump EO 14273 (April 15, 2025) directs program modifications without dismantling.

Affects: Medicare · Specialty (oncology, cardiology specialty pharmacotherapy).

Community Health Center Fund authorized through December 31, 2026 at $4.6 billion FY 2026 via the 2026 Consolidated Appropriations Act — the largest annual increase in a decade per NACHC. The 43-day federal shutdown earlier in FY 2026 extended prior authorization from September 30, 2025 to January 30, 2026, then through December 31, 2026. NACHC has requested multi-year reauthorization at $5.8 billion per year for at least 3 years; this is the chronic short-term extension pattern — CHCF has not been multi-year reauthorized since 2019. Companion FY 2026 provisions: NHSC $350M base; THCGME $225M scaling to $300M by FY 2029 over five years; Medicare telehealth flexibilities extended through December 31, 2027.

Affects: FQHC & Safety-Net · Specialty.

The Consolidated Appropriations Act 2026 (signed February 3, 2026) extended Medicare telehealth flexibilities through December 31, 2027 — home-based telehealth without geographic restriction; audio-only non-behavioral telehealth; FQHCs and RHCs as distant-site providers via HCPCS code G2025; expanded distant-site practitioner list (physical therapists, occupational therapists, speech-language pathologists, audiologists, marriage and family therapists, mental health counselors); behavioral / mental telehealth without in-person visit requirement (grandfather provision for beneficiaries who began services on or before January 30, 2026). CY 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F, October 31, 2025) finalized permanent provisions: direct supervision via real-time two-way audio-visual telecommunications; virtual teaching physician presence; removal of telehealth frequency limits on subsequent inpatient and nursing facility visits; behavioral / mental health audio-only telehealth permanent under certain conditions.

Affects: Specialty · Medicare · Behavioral Health & SUD Delivery.

The U.S. District Court for the District of Maine vacated and remanded the 340B Rebate Model Pilot Program in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me., February 10, 2026) — vacating the August 1, 2025 Application Notice (90 Fed. Reg. 36,163), the August 7, 2025 Corrected Application Notice (90 Fed. Reg. 38,165), and manufacturer-application approvals announced October 30 - November 14, 2025. HRSA published the Request for Information in the Federal Register February 17, 2026 (91 Fed. Reg. 7,287; HHS Docket No. HRSA-2026-03042) drawing 5,576 comments; comment period closed April 20, 2026; ICR period closed April 27, 2026. HRSA notice contemplates potential expansion of the rebate model to 13 manufacturers (those subject to 2026 and 2027 Medicare negotiated discounts). H.R. 7391 Community Health Center Drug Pricing Protection Act introduced February 5, 2026 by Reps. Jack Bergman (R-MI) and Jake Auchincloss (D-MA); 35 cosponsors by late February 2026; PA cosponsors include Rep. Rob Bresnahan (PA-8), Rep. Madeline Dean (PA-4), and Rep. Lloyd Smucker (PA-11) per PACHC. No Senate companion bill identified. Senate "Bipartisan Gang of Six" working group on broader 340B reform (SUSTAIN 340B discussion draft) circulating. HHS reconsidering whether to implement rebate model "consistent with its statutory authority"; no NPRM issued. HHS FY 2026 proposed budget would move 340B oversight from HRSA to CMS.

Affects: FQHC & Safety-Net · Specialty.

The Title X family planning program (PHSA 42 U.S.C. §§ 300 to 300a-6) experienced a sustained Trump-administration administrative-disruption sequence operating alongside continuing $286.5M FY 2025 and $286M FY 2026 enacted appropriations. (a) April 1, 2025 administration withholding of 16 grantees / 22 Title X grants / $65.8M / approximately 842,000 patients (~30% of Title X patient population) affected; Pennsylvania named among partially-affected states. (b) NFPRHA lawsuit filed April 24, 2025 in U.S. District Court, District of Columbia. (c) December 2025 HHS restoration of year-4 funds; NFPRHA litigation dropped. (d) March 13, 2026 HHS guidance with one-week response window removing "Quality Family Planning" standards and equity/inclusion programmatic goals. (e) April 1, 2026 OPA continuation grant total $261 million announced to 86 organizations including Planned Parenthood affiliates. (f) April 3, 2026 Trump White House FY 2027 budget contains no Title X funding; new Title X grant guidelines posted same day requiring grantees to end DEI policies, protect parental rights in religious upbringing, enforce Hyde Amendment, and ensure funds do not benefit "illegal aliens." Pending: 2019 "Protect Life Rule" formal reinstatement not yet completed via NPRM. Congressional response: March 16, 2026 Democratic Women's Caucus plus Reproductive Freedom Caucus letter signed by 128 Members to HHS Secretary Kennedy demanding one-year full funding extension. White House spokesperson statement: "current Title X grants to Planned Parenthood will be the last" per Ms. Magazine.

Affects: Specialty · FQHC & Safety-Net (Title X / FQHC intersection).

The Infrastructure Investment and Jobs Act (P.L. 117-58; "Bipartisan Infrastructure Law") signed November 15, 2021 authorized $1.2 trillion total / $550 billion new investment FY 2022-FY 2026. IIJA expires September 30, 2026. As of May 2026, no reauthorization bill has been introduced. CRS R47573 (April 14, 2026) projects 5-year FY 2027 reauthorization gap $166 billion; 6-year gap $199 billion; HTF balance projected at ~$45 billion end FY 2026 (~7 months of average outlays); CBO projects HTF depleted by 2028 with cumulative shortfall reaching $280 billion by 2034 per AGC. House T&I Committee has held over a dozen hearings since beginning of 2025 with Reps. David Rouzer (R-NC; T&I Subcommittee on Highways and Transit Chair) and Rick Larsen (D-WA; T&I Ranking Member) leading bipartisan effort. September 2025 House T&I announcement of intent for "bipartisan, multi-year surface transportation reauthorization." BASICS Act H.R. 7437 introduced February 9, 2026 by Reps. Bresnahan (R-PA) and McDonald Rivet (D-MI) is bipartisan bridge-repairs-and-safety-improvements legislation but not the master reauthorization vehicle. ASCE infrastructure report card upgraded overall infrastructure grade from C- to C in 2025. Trump Administration FY 2027 budget preparing for reauthorization not maintaining IIJA funding levels. Healthcare-delivery-adjacent infrastructure (SEPTA transit to academic medical centers; FHWA road infrastructure affecting EMS routing) faces planning-horizon disruption. Cross-reference D13 SD7 G13-SD7-01 PRINCIPAL ANCHOR.

Affects: Specialty.