2008 MPFS Final Rule Highlights Lab Changes: DOS for TC of Pathology and Reconsideration Process

The 2008 final Medicare physician fee schedule (MPFS) includes two sections related to the clinical laboratory fee schedule. More details about the new policies can be found in the MFPS sections noted.

TC of Physician Pathology Services
In the 2007 Medicare physician fee schedule (PFS) final rule with comment period, the Centers for Medicare & Medicaid Services (CMS) added §414.510 to the Code of Federal Regulations (CFR) to address the laboratory date of service (DOS) for specimens. In the 2008 MPFS final rule, CMS announced that this provision also should apply to the technical component (TC) of physician pathology services, and effective January 1, 2008, it will be added.

As CMS explained, the collection date for both types of services is similar.

Expanding this rule will "improve claims processing and adjudication in relation to the clarity of dates of service, accuracy of payment, and detection of duplicate services."

In response to a comment from a member of the public, CMS also provided a billing guideline in Section II.G.1: It noted that the technical component (TC) and the professional component (PC) of a laboratory test should be on separate line items on the same claim when two different DOS are involved, even when both services are performed by the same independent laboratory. One-line global billing is not appropriate in this instance. Program instructions on this issue will be forthcoming, CMS stated.

Payment Reconsideration Process
CMS finalized its proposal to establish a new formalized process for reconsiderations and appeals with data transparency. This process, in part, will help CMS determine the basis for, and amount of, payment for any new clinical diagnostic laboratory test for which a new or substantially revised HCPCS code is assigned on or after January 1, 2008. This is CMS' attempt to balance additional opportunities for public input against the necessity for establishing final fees for new clinical laboratory test codes.

Those interested in knowing all of the details about the new reconsideration process should read through Section II.G.2 in the MPFS final rule. As you do, you may wonder just how this process differs from the one that CMS currently uses to establish payment for new codes. In fact, it is similar but the one currently used has never been stated as an official policy. This inclusion in the final rule now gives the lab community a specific way it can submit requests for reconsideration, and CMS will review these requests and provide detailed responses about its payment decisions.

In contrast to several other payment systems, which have been significantly revised in the last several years, the procedures for operating the clinical laboratory fee schedule have remained relatively static. Implementation of a reconsideration process would be a significant step in helping to assure reasonable pricing decisions for new tests. CMS sees this as an "opportunity to revisit payment determinations for clinical laboratory test codes and foster accurate payment levels for new tests."

Laboratory DOS for Clinical Laboratory and Pathology Specimens
As stated in the story above, the following is taken from §414.510 of the Code of Federal Regulations. The 2008 revisions made are underlined.

The date of service for either a clinical laboratory
test or the technical component of physician pathology service is as follows:

(a) Except as provided under paragraph (b) of this section, the date of service of the test must be the date the specimen was collected.
(b)(1) If a specimen was collected over a period that spans 2 calendar days, then the date of service must be the date the collection ended.
(2) In the case of a test performed on a stored specimen, if a specimen was stored for-
(i) Less than or equal to 30 calendar days from the date it was collected, the date of service of the test must be the date the test was performed only if-
(A) The test is ordered by the patient's physician at least 14 days following the date of the patient's discharge from the hospital;
(B) The specimen was collected while the patient was undergoing a hospital surgical procedure;
(C) It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
(D) The results of the test do not guide treatment provided during the hospital stay; and
(E) The test was reasonable and medically necessary for the treatment of an illness.
(ii) More than 30 calendar days before testing, the specimen is considered to have been archived and the date of service of the test must be the date the specimen was obtained from storage.
(3) In the case of a chemotherapy sensitivity test performed on live tissue, the date of service of the test must be the date the test was performed only if-
(i) The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge;
(ii) The specimen was collected while the patient was undergoing a hospital surgical procedure;
(iii) It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
(iv) The results of the test do not guide treatment provided during the hospital stay; and,
(v) The test was reasonable and medically necessary for the treatment of an illness.
(4) For purposes of this section, "chemotherapy sensitivity test" means a test identified by the Secretary as a test that requires a fresh tissue sample to test the sensitivity of tumor cells to various chemotherapeutic agents. The Secretary identifies such tests through program instructions.

Randy Wiitala, BS, MT (ASCP)
Senior Healthcare Consultant
One of MedLearn's original consulting professionals, Randy conducts CPT coding and chargemaster assessments, reviews provider operations for regulatory agency compliance, evaluates administrative policies and procedures, and assists in the development of quality-assurance programs. He's also a frequent seminar presenter, speaking to hospitals, corporations, clinics, state hospital associations and professional organizations. These educational programs cover a variety of areas, such as coding, regulatory compliance and reimbursement for laboratories; chargemaster system
management; and APCs. Randy contributes to a number of MedLearn books, as well as the Laboratory Compliance Manager newsletter.

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