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The Regulator · Thursday, July 16, 2026

The Regulator

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A U.S. House committee voted 42-0 to force Medicare Advantage insurers to speed up and disclose their prior authorization decisions, one of seven bipartisan health bills the same committee advanced in a single markup. The House Ways and Means Committee, chaired by Rep. Jason Smith, marked up seven bills July 15, 2026. The lead bill, the Improving Seniors’ Timely Access to Care Act of 2025 (H.R. 3514), passed 42-0 and would require Medicare Advantage plans, which cover roughly 34 million seniors, to build an electronic prior authorization system and publicly report how often they delay or deny care for services including surgeries. The other six bills would expand rural reimbursement for remote patient monitoring (H.R. 3108, the Rural Patient Monitoring Access Act) and anesthesiology (H.R. 9642, the Medicare Access to Rural Anesthesiology Act), create new caregiver protections (H.R. 9641, the Essential Caregivers Act of 2026), change long-term care hospital payment rules (H.R. 9468, the STAR Act), require Medicare Advantage insurers to report medical loss ratio data (H.R. 9644), and expand hospital and insurer price transparency requirements (H.R. 9645, the Health Care Price Certainty for All Americans Act). Confidence: High on the markup date and the 42-0 vote on H.R. 3514; Low on whether the full package reaches a House floor vote this year or what it would cost, since the committee did not release a consolidated score. Sources: Markup of H.R. 9641, H.R. 3108, H.R. 9642, H.R. 9468, H.R. 3514, H.R. 9644, and H.R. 9645, House Committee on Ways and Means, Chairman Smith Opening Statement, House Committee on Ways and Means.

The Trump administration filed its defense July 15 against a 26-state lawsuit seeking to block a Medicaid rule that narrows who counts as “medically frail” and exempt from new work requirements, with a ruling still pending before the rule’s July 31 effective date. In Commonwealth of Massachusetts et al. v. Oz et al. (D. Mass. No. 1:26-cv-12962), Massachusetts and 25 other states argue the interim final rule violates the Administrative Procedure Act and the Spending Clause by imposing documentation burdens that could strip Medicaid coverage from people with disabilities and chronic illness who should qualify for the frailty exemption. HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz filed their response to the states’ preliminary injunction motion on the July 15 deadline set by the court; the case now awaits a ruling on whether the rule takes effect as scheduled July 31, 2026, or is blocked while litigation continues. Per Georgetown’s Health Care Litigation Tracker; the underlying court filings were not independently retrieved this run. Source: Commonwealth of Massachusetts et al. v. Oz et al., Health Care Litigation Tracker, Georgetown University O’Neill Institute.

Forty-eight states forced generic drug maker Glenmark Pharmaceuticals to pay 29.6 million dollars July 15 over allegations it conspired with competitors to fix prices on generic drugs sold nationwide for a decade. The multistate settlement resolves claims that Glenmark colluded with other manufacturers between May 1, 2009 and December 31, 2019 to inflate prices and divide markets for numerous generic prescription drugs, part of a long-running generic-drug price-fixing investigation that has already produced settlements with dozens of companies. New York Attorney General Letitia James said her office secured more than 29 million dollars of the total; the agreement also requires Glenmark to cooperate against the 33 remaining corporate defendants and 25 individual executives still facing the litigation and submit to at least seven years of court-ordered antitrust compliance monitoring. Consumers who purchased Glenmark or other implicated companies’ generic drugs during the conspiracy period may be eligible for compensation once a claims process opens. Confidence: High on the settlement amount and states involved; Low on how much individual consumers will recover, since the claims process has not yet opened. Sources: Attorney General James Secures More Than $29 Million From Glenmark Pharmaceuticals for Illegal Scheme to Inflate Drug Prices, New York Attorney General, Attorney General Tong Announces Settlement with Glenmark Over Conspiracy to Inflate Prices, Connecticut Attorney General.

Labcorp will pay 14.5 million dollars to resolve claims it billed Medicare for years of unnecessary urine drug tests, after admitting it improperly stacked two billing codes on the same lab panel. The Department of Justice announced July 15, 2026 that Laboratory Corporation of America agreed to the settlement to resolve False Claims Act allegations that from January 1, 2018 through November 22, 2023, it billed Medicare Part B for medically unnecessary urine drug testing under its ToxAssure Comprehensive panel by improperly billing CPT code 80307 and HCPCS code G0483 together on the same test. Labcorp admitted the improper billing practice, has since stopped it, and received credit under Justice Department guidelines for voluntarily disclosing the conduct, cooperating with the investigation, and remediating it; the government made no separate liability finding. Confidence: High on the settlement amount and billing codes; Low on how many individual patients or claims were affected, since the announcement does not break out claim volume. Source: Labcorp Agrees to Pay $14.5 Million for Testing Fraud, U.S. Attorney’s Office for the District of Massachusetts.

HHS is reopening the federal rules governing every clinical laboratory in the country for the first time since they were implemented in 1992, and wants industry input before it rewrites them. The Centers for Medicare and Medicaid Services published a Request for Information on the Clinical Laboratory Improvement Amendments (CLIA) regulations in the Federal Register July 16, 2026, seeking public comment on updating decades-old rules covering breath testing, laboratory processes and procedures, and emergency preparedness and biosafety requirements, citing how far laboratory testing technology has advanced since 1992. Comments are due September 14, 2026; CMS has not proposed specific rule changes, so the RFI is a first step toward a future rulemaking rather than a rule labs must comply with today. The timing lands the same week Labcorp agreed to its 14.5 million dollar settlement over improper lab billing, underscoring how much has changed in lab oversight since CLIA’s rules were last written. Confidence: High on the publication date and comment deadline; Low on what CMS will actually change, since the RFI does not propose specific regulatory text. Source: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations, Federal Register.

The DEA’s historic hearing on whether to reschedule marijuana closed its evidentiary record July 15, moving the decade-long rescheduling fight to written briefs and a judge’s recommendation. The hearing began June 29, 2026 to examine whether cannabis should move from Schedule I to Schedule III of the Controlled Substances Act; testimony concluded July 15 after the final witnesses were heard. Parties will now submit post-hearing briefs and proposed findings, after which the administrative law judge issues a recommended decision, both sides get 20 days to file exceptions, and the full record moves to the DEA Administrator for a final rule, a process that could stretch into late 2026 or early 2027. The hearing follows an April 23, 2026 order that already placed FDA-approved marijuana products and state-licensed medical marijuana products in Schedule III; this hearing covers the broader plant-level rescheduling question affecting the wider cannabis industry and state-legal markets. Confidence: High on the hearing closing and its scope; Low on when or whether the DEA Administrator ultimately reschedules marijuana, since the recommended decision and final rule are still pending. Source: Marijuana Rescheduling Regulatory Actions, Drug Enforcement Administration.

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