CMS issues final Medicare outpatient payment rule for 2027

The rule includes new device pass-through payments, a hospital drug acquisition cost survey, and a request for information on standardizing price transparency data.

By Theo Adeyemi, Regulation and biotech correspondent
. 2-minute read.
Illustration: CMS headquarters Baltimore
Illustration: Clinical Observer

CMS published a final rule with comment period in the Federal Register on November 6, 2026, setting Medicare payment policies for hospital outpatient departments and ambulatory surgical centers for calendar year 2027. The rule also updates the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Program, includes a request for information on strengthening the standardization and comparability of hospital price transparency data, and addresses prior authorization, EMTALA deeming, and notices of closure of teaching hospitals.

The final rule grants transitional device pass-through payments under an alternative pathway for several devices. According to the rule, the MY01 Continuous Compartmental Pressure Monitor, RemeOs Screw LAG Solid, and WiSE CRT System were approved effective October 1, 2025. The SetPoint System and the TOUCH CMC 1 Prosthesis received approval effective January 1, 2026. The Esprit BTK Everolimus Eluting Resorbable Scaffold System received approval effective April 1, 2026, and the TOPS System received approval effective July 1, 2026. The rule includes these devices in the CY 2027 spending estimates.

On drug acquisition costs, the rule includes discussion of a CMS survey. Legal analyses cited in the rule advised hospitals that they could respond to the survey solely to assert that their costs are not minimal and that the difficulties of responding prevent them from providing the full data CMS wants. Bloomberg Law reported on April 22, 2026, that hospitals rebuffed the request, quoting a K&L Gates partner as saying, "CMS truly got an anemic response." A K&L Gates analysis cited in the rule said that if many hospitals choose not to respond, the law would stop CMS from using the survey results to reduce payment to 340B-covered entities.

The rule also describes a methodology for identifying outliers in reported drug acquisition costs using an interquartile range approach, with thresholds at 1.5 times the IQR above the third quartile and below the first quartile. The rule notes that using the minimum average sales price rather than the mean produces an overall 340B margin of 31.8 percent, as opposed to 33.4 percent.

For quality reporting, the rule includes measures such as appropriate follow-up interval for normal colonoscopy, the rate of hospital visits within seven days after outpatient colonoscopy that are risk-standardized, and advance care planning. The rule notes that the term "Super Intelligence" is used in the rule to refer to what was formerly called Artificial Intelligence, and it cites Executive Order 14434, "Inaugurating the Era of Super Intelligence."

Theo AdeyemiRegulation and biotech correspondent

Theo Adeyemi covers drug regulation and the biotech industry for Clinical Observer. He writes from regulators' notices, company filings and published reporting.

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