# 42 CFR § 426.340: Procedures for review of new evidence

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-42-426.340

## Section

- **Citation:** 42 CFR § 426.340
- **Heading:** Procedures for review of new evidence
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 42—Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—MEDICARE PROGRAM > PART 426—REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE DETERMINATIONS > Subpart C—General Provisions for the Review of LCDs and NCDs

## Text

(a) The process for review of new evidence is initiated once the ALJ/Board completes the taking of evidence.
(b) If an aggrieved party has submitted new evidence pertaining to the LCD/NCD provision(s) in question, and the ALJ or the Board finds that evidence admissible, the ALJ or the Board reviews the record as a whole and decide whether the new evidence has the potential to significantly affect the ALJ's or the Board's evaluation of the LCD/NCD provision(s) in question under the reasonableness standard.
(c) If the ALJ or the Board determines that the new evidence does not have the potential to significantly affect the ALJ's or the Board's evaluation of the LCD/NCD provision(s) in question under the reasonableness standard, this evidence is included in the review record, and the review goes forward to a decision on the merits.
(d) If the ALJ or the Board determines that the new evidence has the potential to significantly affect the ALJ's or the Board's evaluation of the LCD or NCD provision(s) in question under the reasonableness standard, then the ALJ or the Board—
(1) Stays the proceedings and ensures that the contractor or CMS, whichever is appropriate, has a copy of the new evidence for its examination; and
(2) Allows the contractor/CMS 10 days, generally, to examine the new evidence, and to decide whether the contractor or CMS initiates a reconsideration.
(e) If the contractor or CMS informs the ALJ or the Board by the end of the 10 days that a reconsideration is initiated, and then the ALJ or the Board—
(1) Continues the stay in proceedings; and
(2) Sets a reasonable timeframe—
(i) For LCDs, of not more than 90 days, by which the contractor completes the reconsideration; or
(ii) For NCDs, in compliance with the timeframes specified in section 1862(1) of the Act, by which CMS completes the reconsideration.
(f) The ALJ or Board lifts the stay in proceedings and continues the review on the challenged provision(s) of the original LCD or NCD, including the new evidence in the review record, if the contractor or CMS—
(1) Informs the ALJ or Board that a reconsideration is not initiated; or
(2) Does not meet—
(i) For LCDs, the 90-day reconsideration timeframe; or
(ii) For NCDs, the reconsideration timeframe specified by the Board, in compliance with section 1862(l) of the Act.
(g) If an LCD or NCD is reconsidered and revised within the timeframe allotted by the ALJ or Board, then the revised LCD or NCD and any supplement to the LCD or NCD record is forwarded to the ALJ or the Board and all parties and the review proceeds on the LCD or NCD.
[68 FR 63716, Nov. 7, 2003, as amended at 70 FR 70335, Nov. 21, 2005; 71 FR 9461, Feb. 24, 2006]

## Nearby sections

- [42 CFR § 426.100 § 426.100 Basis and scope.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.100.md)
- [42 CFR § 426.110 § 426.110 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.110.md)
- [42 CFR § 426.120 § 426.120 Calculation of deadlines.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.120.md)
- [42 CFR § 426.130 § 426.130 Party submissions.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.130.md)
- [42 CFR § 426.300 § 426.300 Review of LCDs, NCDs, and deemed NCDs.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.300.md)
- [42 CFR § 426.310 § 426.310 LCD and NCD reviews and individual claim appeals.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.310.md)
- [42 CFR § 426.320 § 426.320 Who may challenge an LCD or NCD.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.320.md)
- [42 CFR § 426.325 § 426.325 What may be challenged.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.325.md)
- [42 CFR § 426.330 § 426.330 Burden of proof.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.330.md)
- [42 CFR § 426.340 § 426.340 Procedures for review of new evidence.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.340.md)
- [42 CFR § 426.400 § 426.400 Procedure for filing an acceptable complaint concerning a provision (or provisions) of an LCD.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.400.md)
- [42 CFR § 426.403 § 426.403 Submitting new evidence once an acceptable complaint is filed.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.403.md)
- [42 CFR § 426.405 § 426.405 Authority of the ALJ.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.405.md)
- [42 CFR § 426.406 § 426.406 Ex parte contacts.](https://www.frixlaw.com/law-library/statutes/ecfr-42-426.406.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-42-426.340. Check the current official text before relying on it. Not legal advice.