Clinical Laboratory Information for 2004

Update to Fees
In accordance with §628 of the Medicare Prescription Drug, Improvement, and Modernization Act (DIMA) of 2003, the annual update to the local clinical laboratory fees for 2004 is 0 percent. Section 1833(a)(1)(D) of the Act provides that payment for a clinical laboratory test is the lesser of the actual charge billed for the test, the local fee, or the national limitation amount (NLA). For a cervical or vaginal smear test (Pap smear), §1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount (described below). However, for a cervical or vaginal smear test (Pap smear), payment may also not exceed the actual charge. The Part B deductible and coinsurance do not apply for services paid under the clinical laboratory fee schedule.

National Minimum Payment Amounts
For a cervical or vaginal smear test (Pap smear), §1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount. Also, payment may not exceed the actual charge. The 2004 national minimum payment amount is $15.14 ($14.76 plus 2.6 percent update for 2004). The affected codes for the national minimum payment amount are 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166, 88167, 88174, 88175, G0123, G0143, G0144, G0145, G0147, G0148, and P3000.

National Limitation Amounts (Maximum)
For tests for which NLAs were established before January 1, 2001, the NLA is 74 percent of the median of the local fees. For tests for which NLAs are first established on or after January 1, 2001, the NLA is 100 percent of the median of the local fees in accordance with §1833(h)(4)(B)(viii) of the Act.

Internet Access
Internet access to the 2004 clinical laboratory fee schedule data file should be available after November 20, 2003, at http://www.cms.hhs.gov/paymentsystems. Medicaid State agencies, the Indian Health Service, the United Mine Workers, Railroad Retirement Board, and other interested parties should use the Internet to retrieve the 2004 clinical laboratory fee schedule. It will be available in multiple formats: Excel, text, and comma delimited.

Public Comments
On July 28, 2003, CMS hosted a public meeting to solicit input on the payment relationship between valid 2003 codes and new 2004 Current Procedural Terminology (CPT) codes. The meeting announcement was published in the Federal Register on June 27, 2003, pages 38370-38371 and on the CMS Web site. Recommendations were received from many attendees, including individuals representing laboratories, manufacturers, and medical societies. CMS posted a summary of the meeting and the tentative payment determinations on its Web site at http://www.cms.hhs.gov/paymentsystems. Additional written comments from the public were accepted until September 27, 2003.

Comments after the release of the 2004 laboratory fee schedule can be submitted to the following address so that CMS may consider them for the development of the 2005 laboratory fee schedule. A comment should be in written format and include clinical, coding, and costing information. To make it possible for CMS and its contractors to meet a January 5, 2005 implementation date, comments must be submitted before August 1, 2004.

Centers for Medicare & Medicaid Services (CMS)
Center for Medicare Management
Division of Ambulatory Services
Mailstop: C4-07-07
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Pricing Information
The 2004 laboratory fee schedule includes separately payable fees for certain specimen collection methods (codes G0001, P9612, and P9615). The fees have been established in accordance with §1833(h)(4)(B) of the Act.

Instructions on separately payable fees for traveling to perform a specimen collection for either a nursing home or homebound patient were issued in June 1999. There are two codes: P9603 for a per mileage trip basis or code P9604 for a flat rate trip basis where the average round trip is generally less than 20 miles (or an average of 10 miles per leg of the trip). To bill either code requires documentation of the number of specimens performed per trip (for both Medicare and non-Medicare patients) to compute the Medicare prorated fee. Code P9604 requires the laboratory to determine the appropriateness of billing on an average round trip basis for all trips during a one-year time period. Thus, payment for travel under code P9604 is made to reasonably pay on average for a varying range of trip miles so that the laboratory should not also require payment with another basis (e.g., code P9603). The payment for codes P9603 and P9604 reflects personnel and transportation costs. For dates of service January 1, 2004 through December 31, 2004, the personnel payment is $.45 per mile. For dates of service January 1, 2004 through December 31, 2004, the standard mileage rate for transportation costs is $0.375. The 2004 payment for code P9603 is $.825 and for code P9604 is $8.25. The standard mileage rate can also be found at the Web site www.irs.gov.

The 2004 laboratory fee schedule also includes codes that have a ‘QW’ modifier to both identify codes and determine payment for tests performed by a laboratory registered with only a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

For 2004, the clinical laboratory fee schedule will continue to include code G0001, Routine venipuncture for collection of specimen(s), and laboratories should continue to bill code G0001 for Medicare payment of venous blood collection by venipuncture. CPT code 36415 for Collection of venous blood by venipuncture and code 36416, Collection of capillary blood specimen (e.g., finger, heel, ear stick), remain invalid for Medicare purposes.

Based on comments, the mappings have been revised for codes 80157, 83663, 83664, 87046, 87071, 87073, 87254, 87300, and 88400. Mappings have been established for 82274 and 82274QW. Mappings have also been established for new codes G0328 and G0328QW. Code G0328’s long descriptor is colorectal cancer screening; fecal-occult blood test, immunoassay, 1-3 simultaneous determinations. The short descriptor is fecal blood screening immunoassay.

Complete Blood Count (CBC) Testing
A complete blood count consists of measuring a blood specimen for levels of hemoglobin, hematocrit, red blood cells, white blood cells, and platelets. Also, a differential white blood cell (WBC) count measures the percentages of different types of white blood cells. This hematology testing is commonly ordered by physicians to diagnose and treat a wide array of disorders such as liver, heart, and pulmonary disease, hemorrhage, dehydration, and infections.

CPT codes representing component tests of CBC testing (with differential WBC testing) include:

If additional CBC component test(s) are medically necessary, only the medically necessary components (e.g., hemoglobin (Hgb) or hematocrit (Hct)) should be ordered and performed. Billing modifiers can assist in reporting additional medically necessary CBC component test(s) or bundling testing service for the same patient on the same date of service, such as modifier -91, repeat clinical laboratory test.

Organ or Disease Oriented Panel Codes
Similar to prior years, the 2004 pricing amounts for certain organ or disease panel codes and evocative/suppression test codes were derived by summing the lower of the fee schedule amount or the NLA for each individual test code included in the panel code. The national limitation amount field on the data file is zero-filled.

Mapping Information for New and Revised Codes

Gap-Fill Payments for New Laboratory Tests
In accordance with §531(b) of the Benefits Improvement and Protection Act of 2000 (BIPA), CMS solicits public comments on determining payment amounts for new laboratory tests. As described earlier, CMS hosts an annual public meeting to allow parties the opportunity to provide input to the payment determination process. The CMS employs one of two approaches to establishing payment amounts for new laboratory test codes, crosswalking and gap-filling. After considering public input regarding the new test codes, CMS determines which approach is most appropriate for each new test code. In determining gap-fill amounts, the sources of information carriers should examine, if available, include: charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payers; and charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant. Carriers may consider other sources of information as appropriate including clinical studies and information provided by clinicians practicing in the area, manufacturers, or other interested parties.

After determining a gap-fill amount, a carrier may consider if a least costly alternative (LCA) to a new test exists (see Pub. 100-08, PIM Chapter 13, §5.4). Joint Signature Memorandum RO-2256 issued August 29, 2003 states that the method of implementing a LCA is through the Local Medical Review Policy (LMRP) process. If a carrier determines LCA, the carrier may adopt the payment amount of the LCA test code as the gap-fill amount for the new test code. However in this case, the carrier must report two payment amounts, the gap-fill amount prior to determination of LCA and the payment amount that the carrier has determined to be LCA.

For 2004, there are no new test codes to be gap-filled.

2004 Clinical Lab Fee Schedule New York
2004 Clinical Lab Fee Schedule New Jersey

Reference: Transmittal 20, Change Request 2959, Pub. 100-20

Posted: 11/21/2003