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The Office of Inspector General of HHS, or the OIG, first issued formal compliance guidance for laboratories in 1997, and then modified that guidance in 1998 through its “Compliance Program Guidance For Clinical Laboratories.” The OIG’s guidance, key parts of which are summarized below, covers a variety of issues that

are important to laboratories, including, but not limited to, medical necessity, notices to physicians, billing, and pricing to physicians.

In this guidance, the OIG takes the position that even though laboratories do not themselves make medical necessity determinations, they should advise physicians that Medicare will only pay for services that are medically necessary. The OIG believes that it is important for laboratories to design their test ordering forms in a manner that promotes the conscious ordering of tests by physicians or other authorized individuals. According to the OIG, the ordering form should include a statement that Medicare does not cover routine screening tests and laboratories should also provide notices to physicians on an annual basis that include the following: (i) any national and local medical review policies for laboratory testing, (ii) a statement that organ and disease panels will only be paid when all components are medically necessary; and (iii) a copy of the applicable Medicare fee schedule and a statement that Medicaid reimbursement will usually be equal to or less than that amount. Additional information is required for “custom” profiles, i.e. profiles that are put together for the convenience of particular physicians. The purpose of these disclosures is to provide physicians with greater information in making their determinations as to what testing is medically necessary.

The OIG’s guidance also includes a discussion of the use of Advance Beneficiary Notice of Noncoverage, or ABNs, by laboratories. Where it is likely that a test will not be covered by Medicare, the laboratory may request that the beneficiary sign an ABN indicating the beneficiary’s consent to be financially liable if payment is denied. The laboratory may ask the ordering physician to obtain the ABN, but it is the laboratory’s responsibility to produce it, when necessary. According to the OIG, routine use of ABNs, or merely stating that denial of payment is possible, or that it is impossible to know when payment will be denied, is forbidden. The ABN must be in writing, must identify a specific service, and must explain the reasons that payment is believed likely to be denied.

According to the OIG, laboratories should also monitor test ordering to ensure that test ordering is not excessive, and the OIG’s guidance set out methods for performing this analysis. The OIG also believes that laboratories should take steps to ensure that the CPT/HCPCS codes provided accurately describe the services furnished. Laboratories should not alter the physician’s order in any way, either increasing or decreasing the number of services performed. According to the OIG, laboratories should ensure that the laboratory can support tests billed to Medicare with documentation from the physician ordering the test or other authorized person. According to the OIG, laboratories should not: (i) use information provided by the physician from earlier dates of service (other than standing orders); (ii) create diagnosis information that has triggered reimbursement in the past; (iii) use computer programs that automatically insert diagnosis codes without receipt from the ordering physician or other authorized person; or (iv) make up diagnosis information. Laboratories may, however, contact the ordering physician or other authorized person to obtain information if it was not provided and accurately translate narrative diagnoses obtained from the physician or other authorized person.

Where a test order is ambiguous, the OIG indicates that laboratories should not bill for testing until they have verified the tests that the physician actually wished to order. Similarly, where the test cannot be performed because of an accident or insufficient specimen, then the laboratory may not bill for the testing. The OIG’s guidance includes a discussion of reflex testing (i.e. additional testing that is testing performed

be an inducement to charge physicians a price below fair market value for their non-federal health care program testing.

We seek to conduct our business in compliance with all statutes and regulations applicable to our operations. To this end, we conduct in-depth reviews of procedures, personnel and facilities to ensure regulatory compliance throughout our operations. In addition, because compliance with government rules and regulations is a significant concern throughout our industry, in part due to evolving interpretations of these rules and regulations, we have established and maintain an internal compliance program. We provide periodic and comprehensive training programs to our personnel, which are intended to promote the strict observance of our policies designed to ensure compliance with the statutes and regulations applicable to our operations.

While current law does not expressly require laboratories to have a compliance program, the Affordable Care Act authorizes the Department of Health and Human Services, or HHS, to require certain providers and suppliers to establish a compliance program as a condition of enrollment in Medicare, Medicaid and other federal healthcare programs. HHS, in consultation with the HHS Office of Inspector General, is to establish the core elements of the required compliance plan and the implementation dates. HHS has not yet issued any final regulations but has issued detailed guidance on compliance requirements for nursing facilities, Medicare Advantage plans and Medicare prescription drug plans.