The Regulator

The Centers for Medicare and Medicaid Services proposed a rule that raises Medicare’s shared savings rate for some accountable care organizations while retroactively imposing a new spending guardrail that delays those same organizations’ 2025 reconciliation payments until November 2026. CMS published the calendar year 2027 Physician Fee Schedule proposed rule, docket CMS-1848-P, in the Federal Register July 16, 2026, proposing to raise the Medicare Shared Savings Program’s Basic Level E shared savings rate from 50 percent to 60 percent, cut the Enhanced track’s positive regional adjustment weight from 50 percent to 35 percent, and raise the prior savings adjustment scaling factor from 50 percent to 75 percent, changes that reshape how the government’s largest accountable care program, covering hundreds of physician organizations nationwide, splits savings with Medicare. The rule also creates a new guardrail capping how far an accountable care organization’s projected spending can diverge from national growth trends, applies it retroactively to Performance Year 2025, and delays that year’s reconciliation payments to implement it. Comments are due September 14, 2026. Confidence: High on the proposed provisions and comment deadline, since CMS’s own fact sheet confirms them; Low on whether the retroactive guardrail or reconciliation delay survives into the final rule, since the comment period has just opened. Sources: CY 2027 Medicare Physician Fee Schedule Proposed Rule, Federal Register, Calendar Year (CY) 2027 Medicare Physician Fee Schedule Proposed Rule, Centers for Medicare and Medicaid Services.

A House committee will vote Monday on 29 bills that would force hospitals and insurers to disclose prices, tighten oversight of Medicare Advantage prior authorization, and speed biosimilar drugs to market. The House Energy and Commerce Committee, chaired by Rep. Brett Guthrie, announced July 16, 2026 a full committee markup scheduled for July 20 at 5 p.m. in Rayburn 2123, covering bills including the Lower Costs, More Transparency Act of 2026, the Prices on the Wall Act of 2026, the Premium Transparency Act, the Prior Authorization Accountability Act, the Expedited Access to Biosimilars Act, and a companion version of the Improving Seniors’ Timely Access to Care Act the Ways and Means Committee already advanced July 15. The session is open to the public and press and will stream online; no floor vote is scheduled. Confidence: High on the markup date and bill list, corroborated across the committee’s own announcement and independent legislative trackers; Low on which bills clear committee or reach the House floor. Sources: Full Committee Markup of Health Bills, House Committee on Energy and Commerce, House Energy and Commerce Committee Schedules Markup of 29 Bills, Traders Union.

The Food and Drug Administration approved the first pill combination targeting both the PI3K and mTOR cancer-growth pathways, short for phosphoinositide 3-kinase and mechanistic target of rapamycin, for a common form of metastatic breast cancer, cutting the risk of disease progression or death by up to 76 percent in a late-stage trial. The FDA approved gedatolisib, brand name Revtorpyk and made by Celcuity, on July 14, 2026, for use with fulvestrant, with or without palbociclib, in adults with hormone receptor-positive, HER2-negative, PIK3CA-wild-type locally advanced or metastatic breast cancer whose disease progressed after prior treatment. The approval rests on the VIKTORIA-1 trial, which showed the three-drug combination reduced the risk of progression or death by 76 percent, and the two-drug combination by 67 percent, compared to fulvestrant alone. Confidence: High on the approval and trial results, since FDA’s approval and the sponsor’s investor disclosure align; Low on how quickly insurers, including Medicare Part D plans, will cover the drug, since coverage decisions have not been announced. Sources: FDA Approves Gedatolisib for HR-Positive, HER2-Negative Breast Cancer, U.S. Food and Drug Administration, Celcuity Announces FDA Approval of Revtorpyk (gedatolisib), Celcuity Investor Relations.

A federal watchdog gave its first favorable opinion on a health center’s practice of giving produce boxes and grocery vouchers to chronically ill, low-income patients, a program that would otherwise risk running afoul of the law barring healthcare providers from giving patients anything of value tied to referrals. The Department of Health and Human Services Office of Inspector General posted Advisory Opinion 26-16 on July 14, 2026, concluding that a federally qualified health center’s produce-box and produce-voucher program for patients with certain diagnosed health conditions would not trigger sanctions under the federal Anti-Kickback Statute or Civil Monetary Penalties Law. The opinion legally binds only the requesting health center, whose identity OIG’s summary does not disclose, but it is the first published OIG opinion to bless a “food as medicine” program outright, a signal other health systems building similar nutrition interventions are likely to cite. Confidence: High on the opinion’s existence, date, and favorable conclusion; Low on the exact eligibility rules for the underlying program, since the full opinion text was not independently reviewed for this issue. Source: OIG Advisory Opinion No. 26-16, U.S. Department of Health and Human Services Office of Inspector General.

An Arkansas pathology lab and its owners will operate under five years of federal compliance monitoring after paying 30 million dollars to settle allegations they paid kickbacks to gastroenterology practices and ordered medically unnecessary tissue testing. The HHS Office of Inspector General posted the resulting Corporate Integrity Agreement for Advanced Pathology Solutions, based in North Little Rock, on July 14, 2026; the agreement took effect June 17, 2026 and runs through 2031. The Department of Justice said the lab, its management company APS MSO, and owners Kevin Hannah, Donell Burkett, and Daniel Hunter Pledger violated the False Claims Act from 2015 through July 2022 by setting up “lean labs” inside gastroenterology practices nationwide that automatically ordered special stains on biopsy specimens before a pathologist determined they were needed, and by paying a separate individual illegal volume-based commissions from 2018 to 2020. Confidence: High on the settlement amount, conduct period, and compliance agreement terms, since DOJ’s announcement and OIG’s posted agreement corroborate each other; Low on how many individual patients or claims were affected, since neither announcement breaks out claim volume. Sources: Arkansas Pathology Laboratory and Its Owners Pay $30M to Settle Allegations of Kickbacks and Unnecessary Medical Testing, U.S. Department of Justice, Corporate Integrity Agreement: Advanced Pathology Solutions, HHS Office of Inspector General.

A New Jersey pharmacy owner was sentenced to 30 months in prison and his technician to 24 months for fabricating audit documents and prescription pickup records to cover up more than 1.1 million dollars in fraudulent billing to Medicare and private insurers. The U.S. Attorney’s Office announced July 16, 2026 that Kirtan Patel, 34, of Jersey City, falsified records submitted to a health insurer during a 2020 audit, making it appear medical providers had authorized prescriptions they had not, and separately submitted fraudulent pickup records claiming customers had picked up prescriptions that were never dispensed; technician Christopher Lugo, 36, was separately convicted for his role. Patel was ordered to pay 620,000 dollars in restitution and forfeit another 620,000 dollars; Lugo must pay back more than 565,000 dollars. Confidence: High on the sentences and financial penalties, since they come from DOJ’s own announcement; Low on additional case details, since the underlying scheme’s full scope was not independently verified beyond DOJ’s summary. Source: Pharmacy Owner and Technician Sentenced for Falsifying Audit Documents and Submitting Fraudulent Claims, U.S. Department of Justice.