CMS 14-Day Rule Revisions Ease Precision Medicine Access for Patients, Stakeholders Say

NEW YORK (GenomeWeb) –The Centers for Medicare & Medicaid Services released a final rule this week for public comment revising its controversial 14-day rule that has long hindered molecular diagnostics labs from directly billing the government payor when tests are ordered within two weeks of an outpatient’s discharge from the hospital.

CMS’ 14-day rule, or the Date of Service Regulation, has been in place for around a decade to ensure that hospitals get paid for services they provide to patients while they’re at the hospital, including lab tests. The rule allows molecular diagnostics labs to bill CMS only for tests that are ordered at least 14 days after patient discharge. If the test is ordered earlier, only the hospital can bill CMS, and the lab would have to seek payment from the hospital.

This has proven administratively challenging for labs. There is also accumulating data suggesting that the policy may be negatively impacting patient care, particularly in the cancer setting where large genomic sequencing panels are increasingly used and timely access to test results can impact the treatments patients receive.

In the Hospital Outpatient Prospective Payment final rule, which the public can comment on until Dec. 31, CMS this week

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