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Medicare Reimbursement: New HOPPS Date of Service Rules for ADLTs & Molecular Pathology Tests Take Effect

by | Jul 31, 2018 | Essential, Lab Compliance Advisor, Reimbursement-lca

Here’s what labs that bill Medicare for outpatient lab tests need to know about the new CMS rules exempting advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests from Hospital Outpatient Prospective Payment System (HOPPS) laboratory 14-day date of service rules. General Rules The date of specimen collection is normally the date of service (DOS) for outpatient lab services. Exception: The DOS is the date the test is performed if: The doctor orders the test at least 14 days after a patient is discharged from the hospital; The specimen is collected during a hospital surgical procedure; Collecting the sample at another time would be medically inappropriate; Test results don’t guide treatment provided during the hospital stay; and The test is reasonable and necessary for treating an illness. When the “14-day rule” applies, the test is paid separately under Part B; in all other cases, it’s bundled into the payment for the hospital stay. CRITERIA FOR DIRECT BILLING OF OUTPATIENT ADLTs Criterion 1: The test: Analyzes multiple biomarkers of DNA, RNA or proteins; When combined with an empirically derived algorithm, yields a result predicting the probability of an individual patient’s development of a certain condition(s) or response to a particular therapy(ies); […]

Here's what labs that bill Medicare for outpatient lab tests need to know about the new CMS rules exempting advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests from Hospital Outpatient Prospective Payment System (HOPPS) laboratory 14-day date of service rules.

General Rules
The date of specimen collection is normally the date of service (DOS) for outpatient lab services. Exception: The DOS is the date the test is performed if:

  • The doctor orders the test at least 14 days after a patient is discharged from the hospital;
  • The specimen is collected during a hospital surgical procedure;
  • Collecting the sample at another time would be medically inappropriate;
  • Test results don't guide treatment provided during the hospital stay; and
  • The test is reasonable and necessary for treating an illness.

When the "14-day rule" applies, the test is paid separately under Part B; in all other cases, it's bundled into the payment for the hospital stay.

CRITERIA FOR DIRECT BILLING OF OUTPATIENT ADLTs

Criterion 1: The test:

  • Analyzes multiple biomarkers of DNA, RNA or proteins;
  • When combined with an empirically derived algorithm, yields a result predicting the probability of an individual patient's development of a certain condition(s) or response to a particular therapy(ies);
  • Provides new clinical diagnostic information that can't be obtained from any other test or combination of tests; and
  • May include other assays

Criterion 2: The test is cleared or approved by the FDA.

The ADLT & Molecular Pathology Test Exception
Under the new rules, the DOS for roughly 300 molecular pathology tests and ADLTs is the date of testing provided the tests are both:

  • Excluded from OPPS packaging rules; and
  • Ordered less than 14 days after a patient's hospital discharge.

Impact
The new CMS rule enables labs to bill Medicare for exempted ADLTs and molecular pathology tests directly under the Clinical Laboratory Fee Schedule.

Implementation
Although the new rules officially took effect on Jan. 1, 2018, CMS didn't begin implementing them until July 2. To give labs leeway to get used to the rules, the agency will exercise enforcement discretion until Jan. 2, 2019.

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