Medical necessity practices are well established for laboratory services. The Centers for Medicare and Medicaid Services (CMS) and many third-party payers require a medical diagnosis to justify performing laboratory tests. In order to facilitate obtaining effective diagnostic information, Align Laboratories is providing you a link to the current National Coverage Decisions (NCDs), as well as the Local Coverage Determinations that specify covered diagnosis for specific tests.

If you order a test that has a specific NCD or LCD, Please verify the diagnosis code for that test to ensure that the diagnosis information you are providing to Align Laboratories meets medical necessity criteria determined by CMS. If the patient’s diagnosis does not meet medical necessity criteria determined by CMS, you should notify the patient that Medicare or Medicaid is not likely to pay for the services and request them to sign a waiver of responsibility, known as an Advanced Beneficiary Notice (ABN). This waiver serves as a notice to the patient that if CMS does not cover the services due to frequency or medical necessity that the patient is responsible for the charges for those lab tests. This notice must be given to the patient prior to the specimen collection thus allowing the patient the options provided by CMS. If the patient refuses to sign the ABN, thus choosing not to take responsibility or indicates that they do not want this testing, then the physician must weigh the necessity for the test.

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Due to the enormous amount of change with the introduction and changes to ICD-10, the NCD/LCD Manual is not printed due to size and volume. However the links will take you to the most current information for your convenience. In addition, a link for the interactive preventive or screening services site is also provided.

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This information is provided to assist you in making the best possible decisions for your patient. As always, we value your trust in Clinical Pathology Laboratories and appreciate your business.