S. 5475: Timely Access to Coverage Decisions Act

This bill would change how Medicare contractors make and review local coverage determinations (LCDs), which are the rules that decide whether Medicare will cover certain items or services in a particular area.

What it would require

• Faster initial screening of requests: If someone submits a formal request for a new or revised LCD, the Medicare contractor would have to decide within 60 days whether the request is complete or incomplete.
• Notice for incomplete requests: If the request is incomplete, the contractor would have to send written notice within that same 60-day period explaining exactly what information is missing.
• Deadline for complete requests: If the request is complete, the contractor would have to finish the LCD decision process within 1 year of receiving it.

Reconsideration requests

The bill would create similar deadlines for requests to reconsider a finalized LCD:

• Contractors would have to decide within 60 days whether a reconsideration request is complete.
• If incomplete, they would have to explain what additional information is needed.
• If complete, they would have to complete the reconsideration process within 1 year.

Review by the Secretary

If an interested party asks, the Secretary of Health and Human Services would have to review a final reconsideration decision. That review would look at whether the contractor:

• used or interpreted evidence correctly,
• used language that went beyond the intended purpose of the decision,
• made the right judgment about whether the item or service is reasonable and necessary,
• clearly described the clinical conditions used for coverage decisions,
• applied the determination to the items or services it was meant to cover, or
• conflicted with other laws, rules, regulations, or national coverage determinations.

New process for certain LCDs

For certain new or substantially revised LCDs, the bill would require a more public process before the policy can take effect:

• The contractor would have to post a draft determination, related billing/coding information, the rationale, and the evidence it relied on.
• Within 60 days, it would have to hold one or more open public meetings, allow remote attendance, and post the agenda at least 14 days in advance.
• It would have to accept public comments and consult an expert panel that includes physicians, contractor advisory committee members, and patient advocates.
• It would have to post a record of the meetings afterward.
• There would be at least a 30-day public comment period.
• Before the final determination takes effect, the contractor would have to post its response to comments, the comments themselves, its final rationale, any additional qualifying evidence it considered, and an effective date at least 45 days after posting.

Limits on final decisions

The final LCD would have to be a logical outgrowth of the draft version, meaning the final rule could not be so different that it was not fairly foreshadowed by the draft.

Definitions

The bill defines formal requests as documents that identify themselves as formal LCD requests or formal reconsideration requests. It also defines “interested party” to include certain Medicare beneficiaries, providers, suppliers, and others the Secretary recognizes.

When it would take effect

The changes would apply starting one year after enactment.

Relevant Companies

None found