ACLA Questions CMS Policies on Lab Tests Included in ESRD Bundle

A recent transmittal issued by the Centers for Medicare and Medicaid Services (CMS) related to the end-stage renal disease (ESRD) prospective payment bundle has generated concern from the lab industry over lab tests that are being included in the bundle. Several provisions in CMS Transmittal 171 (CR 8261, issued June 7, 2013) appear to constitute new or significantly revised CMS policy with regard to laboratory tests included in the ESRD prospective payment system (PPS), says the American Clinical Laboratory Association (ACLA) in a letter to Laurence Wilson, director of the Chronic Care Policy Group at CMS. When the ESRD PPS was implemented, CMS properly included diagnostic laboratory services that are furnished for the treatment of ESRD, notes ACLA. In fact, the ESRD PPS final rule, issued in 2010, contained a table (Table F) that listed the lab tests that were purported to be included in the ESRD bundle. ACLA strongly supported the establishment of a clearly defined list of lab tests to be included in the bundle since the “absence of such specificity would create uncertainty and chaos.” Recent guidance from CMS, including the June 7 transmittal, “deviates from the clearly defined ESRD PPS lab list in a way that makes unclear whether the lab list remains the definitive guidance on which laboratory tests are included in, and excluded from, the ESRD PPS.” Specifically, the June 7 transmittal contains the following provision: “The distinction of what is considered to be an ESRD-related laboratory test is a clinical decision determined by the ESRD patient’s ordering practitioner. If a laboratory test is ordered for an ESRD-related condition, then the laboratory test is considered to be renal dialysis services and is not paid separately.” This statement implies that for every laboratory test ordered for an ESRD beneficiary, the ordering practitioner is required to determine on an individual test-by-test basis whether the test is ESRD-related. “Leaving such determinations to the discretion of individual practitioners will have the effect of causing a great deal of confusion, inconsistent billing practices, and potential overuse of the AY modifier,” says ACLA. Other Issues ACLA also notes that CMS added the lipid panel (CPT code 80061) to the ESRD PPS through a change request and without proper notice and opportunity for comment. However, none of the three components of the lipid panel were determined to be “furnished for the treatment of ESRD” by the deliberative group that developed the original list of lab tests, and these lipid tests were not included in Table F of the 2010 ESRD PPS final rule. As a result, the dialysis facility (and the contracted laboratory) are put in the position of using the AY modifier for the vast majority of lipid tests to justify payment as they are not furnished for the treatment of ESRD. “Had the renal community been given the opportunity to articulate its position and concerns about adding lipid testing prior to the inclusion of these tests in the ESRD PPS through appropriate notice and comment rulemaking, this situation could have been avoided,” says ACLA. ACLA also raises concerns about terminology used to describe services included in the ESRD PPS, as well as concerns about post-payment audit liability and additional revisions to lab tests in the PPS. ACLA is urging CMS to take the following actions:

• »Clarify that the only clinical laboratory tests included in the ESRD PPS are those CPT codes on the list of “Labs Subject to ESRD Consolidated Billing”;

• »Implement a periodic review process that includes various stakeholders to evaluate current standards of clinical care for ESRD beneficiaries, including new lab tests that may be determined to be furnished for the treatment of ESRD;

• »Consistent with the requirements under the Administrative Procedure Act, follow notice and comment rulemaking procedures when seeking to issue changes or additions to items and services in the ESRD PPS;

• »Remove uncertainty and requirements for ordering practitioners to determine on a test-by-test basis what is considered to be furnished for the treatment of ESRD and revise guidance documents accordingly; and

• »Revise manual guidance to be consistent with the statutory requirement that clinical laboratory tests in the ESRD PPS are “furnished for the treatment of ESRD” and eliminate terms such as “ESRD-related” and “renal related.”

Takeaway: CMS has created confusion regarding which lab tests are included in the ESRD bundle. ACLA is requesting that the agency use its original list of tests published with the ESRD PPS final rule.