U.S.
Legislative/Regulatory News
1. CLMA & ASCLS Applaud Representatives Stupak and Burgess for Introducing Legislation to Modernize the Clinical Laboratory Fee Schedule
The Clinical Laboratory Management Association (CLMA) and the American Society for Clinical Laboratory Science (ASCLS) applaud the leadership of Representatives Bart Stupak (D-MI) and Michael Burgess (R-TX) for introducing key legislation that will modernize the clinical diagnostic laboratory fee schedule. The Clinical Laboratory Diagnostic Fee Schedule Modernization Act of 2008, which was introduced July 31, 2008, requires the Secretary of Health and Human Services to convene a negotiated rulemaking committee to develop a modernized, consensus-driven clinical laboratory fee schedule.
The current clinical laboratory fee schedule that provides Medicare Part B reimbursement for clinical laboratory services was adopted in 1984 based on 1983 local prevailing charge data. Since that time, the cost of clinical diagnostic laboratory tests, laboratory equipment, supplies, and medical professional staff has increased exponentially. This legislation establishes a consensus driven process by which the laboratory fee schedule will be modernized to reflect these increased costs.
"The inadequacy of the current Medicare Clinical Laboratory Fee Schedule has been a primary concern of CLMA because of its adverse impact on our patients, the clinical laboratory industry, and our members,” said CLMA President, JoAnne Milbourn. “CLMA believes strongly that this legislation will provide for a mechanism that will result in a better payment system serving all stakeholders and Medicare patients in the future. It is our deepest wish that the clinical laboratory community and government work together to achieve a much needed step forward for the benefit of the patients receiving clinical laboratory services.”
In recent years, laboratories have suffered real reductions in their Medicare Part B reimbursement levels - not just reductions in the rate of increase as has been experienced by other health care services. The current Medicare fee schedule does not fully reflect changes in cost, technology, complexity and delivery of clinical laboratory services over the past two decades.
The legislation was referred to the Committee on Energy and Commerce for consideration. If the negotiated rulemaking committee fails to reach consensus, the Congress, or the Secretary of Health and Human Services (if the Congress fails to act), must implement a modernized fee schedule within a specified time period.
To contact your Representative, please use CLMA’s “one-click” advocacy software, CapWiz. The link below will connect you to an action alert with a template letter asking your Representative to co-sponsor HR 6761. Your letter will automatically be emailed to your Representative based on zip code match.
House Letter to Co-sponsor HR 6761: http://capwiz.com/clma/issues/alert/?alertid=11739601.
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2. Implementation of the "Medicare Improvements for Patients and Providers Act of 2008 (HR 6331) (MIPPA)"
On July 15, 2008, the House and Senate voted to override President Bush’s veto of the “Medicare Improvements for Patients and Providers Act of 2008 (HR 6331) (MIPPA).” HR 6331 is now law and permanently repeals the competitive bidding demonstration project for clinical laboratory services.
CLMA wishes to sincerely thank and congratulate all of our members who participated in the grassroots campaign to support the repeal of competitive bidding. The repeal would not have been passed as part of HR 6331 without your outstanding efforts!
Please take a moment to thank your Senators and Representatives who voted in support of HR 6331 and the repeal of competitive bidding.
To see if your Senators voted to override the veto of HR 6331, please visit:
http://www.senate.gov/legislative/LIS/roll_call_lists/vote_menu_110_2.htm
Scroll down and click on “00177.”
To see if your Representative voted to override the veto o HR 6331, please visit
http://clerk.house.gov/evs/2008/roll491.xml.
To thank them please use CLMA’s “one-click” advocacy software, CapWiz. The links below will connect you to action alerts with a template letter for both your Senators and Representative. The links below represent separate letters to your two Senators and to your Representative. Please click on each link separately in order to contact both the Senate and the House. Your thank you letter will automatically be emailed to your Members of Congress.
Senate Competitive Bidding Thank You Letter: http://capwiz.com/clma/issues/alert/?alertid=11707976.
House Competitive Bidding Thank You Letter: http://capwiz.com/clma/issues/alert/?alertid=11707706.
In addition to permanently repealing the competitive bidding demonstration project for clinical laboratory services, HR 6331 also contains a provision that reduces the Consumer Price Index (CPI) payment update for clinical laboratory services by 0.5 percent for the next five years, in exchange for including competitive bidding repeal. With the passage of HR 6331 starting in 2009, clinical laboratories will receive a partial CPI update for the first time since 2004.
The 2009 physician fee schedule proposed rule formerly announced that beginning January 1, 2009; the freeze on the CPI update for services paid under the clinical laboratory fee schedule (CLFS) will expire. By law, fees are to be updated based on the CPI for All Urban Consumers (CPI-U). The 2009 CLFS will be updated by the percentage increase in the CPI-U using the 12-month period ending on June of the previous year. According to a recent data released by the Bureau of Labor Statistics (BLS), the unadjusted CMS percentage increase in the CPI-U using the 12-month period ending June 30, 2008 is 5.0 percent.
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3. The CPI Update for Clinical Laboratories for 2009 Will Therefore Be Approximately 4.5 Percent.
The adjusted CPI-U could vary by a few percentage points. CMS will announce the official update factor through a Change Request (CR) and on the CMS Clinical Laboratory Fee Scheduled Web site in November 2008.
With the passage of HR 6331, the “Grandfather Clause” is now extended for 18 months. The Grandfather Clause allows Medicare reimbursement for the technical component (TC) for pathology services provided to a “covered” hospital to continue to be paid to the laboratory providing the service instead of the hospital. “Covered hospitals” are defined as those having an arrangement with an independent laboratory that was in effect as of July 22, 1999.
On July 25, 2008, CMS published Transmittal 1561, CR 6042 officially implementing the extension through December 31, 2009. CMS will continue to allow independent laboratories covered under the “Grandfather Clause” to bill the carrier or MAC for the TC of physician pathology services provided to a hospital inpatient or outpatient, retroactive for services on or after July 1, 2008.
To read Transmittal 1561, CR 6042, “Medicare Improvements for Patients and Providers Act of 2008-Legislative Change Concerning Independent Laboratory Billing for the Technical Component of Physician Pathology Services,” please visit http://www.cms.hhs.gov/transmittals/downloads/R1561CP.pdf.
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4. CLMA Presents Payment Recommendations for New 2009 CPT Codes
On July 14, 2008, the Centers for Medicare and Medicaid Services (CMS) held a public meeting to discuss payment determinations for new 2009 Current Procedural Terminology (CPT) codes for clinical laboratory tests.
The purpose of the meeting was for stakeholders to make recommendations on the assignment of payment levels for new CPT codes to be included in the 2009 clinical laboratory diagnostic fee schedule, effective for services from January 1 through December 31, 2009. These coding changes have been developed by the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel.
The list of new codes for 2009 is:
Pathology and Laboratory
Chemistry
8372X Myeloperoxidase (MPO)
8395X Oncoprotein; des-gamma-carboxy-prothrombin (DCP)
Hematology and Coagulation
85XXX Coagulation and fibrinolysis, functional activity, not otherwise specified (e.g., ADAMTS-13), each analyte
Immunology
Microbiology
879XX Infectious agent enzymatic activity other than virus (e.g., sialidase activity in vaginal fluid)
In Vivo (e.g., Transcutaneous) Laboratory Procedures
8872X Bilirubin, total, transcutaneous
8874X1 Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin (For in vitro carboxyhemoglobin measurement, use 82375)
8874X2 Hemoglobin, quantitative, transcutaneous, per day; methemoglobin (For in vitro quantitative methemoglobin measurement, use 83050)
(88400 has been deleted. To report, use 8872X)
The majority of presenters did not comment on the new transcutaneous codes; CPT 8874X1 Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin (For in vitro carboxyhemoglobin measurement, use 82375), and CPT 8874X2 Hemoglobin, quantitative, transcutaneous, per day; methemoglobin (For in vitro quantitative methemoglobin measurement, use 83050). Masimo Corporation, the manufacturer of the new tests recommended a cross-walk for each to CPT 88400, Bilirubin, total, transcutaneous with an NLA of $7.02. CPT 88400 will be deleted for 2009 and replaced with CPT 88872X Bilirubin, total, transcutaneous at the same NLA of $7.02.
CLMA and the American Clinical Laboratory Association (ACLA) also made a request for reconsideration of the payment determination for CPT 80047, Basic Metabolic Panel (Calcium, Ionized).
During the July 16, 2007 Laboratory Public Meeting, for CPT 80047, Basic both CLMA and ACLA recommended a crosswalk to the Automated Test Panel 07 (ATP07) ($11.42) plus CPT 82330 Calcium, ionized ($19.09) for an NLA of $30.51. CMS originally agreed to the cross-walk when added CPT 80047 to the 2008 clinical laboratory diagnostic fee schedule.
However, on February 15, 2008, CMS published Transmittal 1451, Change Request 5874, announcing that ionized calcium (CPT 82330) would become an automated multichannel chemistry code (“AMCC”) effective July 1, 2008. This results in a payment rate for CPT 80047 of just $11.83 (ATP08) under the AMCC Panel Payment Algorithm. CMS also assigned ionized calcium as a composite rate test for End Stage Renal Dialysis (ESRD) patients.
It is CLMA’s position that designation of ionized calcium (CPT 82330) as an AMCC test is inconsistent with the underlying rationale initially adopted for establishment of the original 22 AMCC tests. The vast majority of hospital and independent laboratories must collect a patient specimen for seven of the AMCC tests included in CPT 80047 to test the specimen’s serum or plasma on an AMCC analyzer, and then collect the ionized calcium in a special collection tube and perform the ionized calcium test on a completely separate instrument. CLMA also questioned CMS’ assignment of ionized calcium as a composite rate test for ESRD patients because ionized calcium levels are not usually performed for dialysis patients.
Both CLMA and ACLA requested that CMS reconsider payment for CPT 80047, Basic Metabolic Panel (Calcium, Ionized), withdraw ionized calcium as an AMCC test, and not include ionized calcium in the composite rate for ESRD patients.
A summary of the new 2009 codes, the payment recommendations from the July 14, 2008 public meeting, and CMS’ tentative payment recommendations will be posted at http://www.cms.hhs.gov/ClinicalLabFeeSched by early September 2008. Final written comments on the tentative payment determinations will be accepted until September 19, 2008.
Final payment determinations will be posted on the CMS web site in October 2008.
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5. FDA Advisory Panel Considers CLIA Waiver for CBC with Diff
On July 18, 2008, the Hematology and Pathology Devices Advisory Panel held an Open Public Meeting to discuss and make recommendations to the Food and Drug Administration (FDA) on issues relevant to granting CLIA waiver status to the automated hematology complete blood count (CBC) with differential.
The panel provided recommendations on whether a device that performs an automated CBC with differential would be appropriate for use in a CLIA-waived setting, with specific recommendations regarding pre-analytical, analytical and post-analytical issues.
The meeting was open to the public and three speakers addressed the panel. The first speaker recommended that the panel not grant CLIA-waived status to the automated CBC with differential due to the potential harm to patients from performing the test in settings that are not subject to conventional laboratory controls or regulations. The next two presenters spoke of the value of having a waived automated CBC with differential because it would increase access to the important information the test provides.
Panel summary minutes are typically available 60-90 days after a meeting at http://www.fda.gov/cdrh/panel/.
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EDUCATION NEWS
6. Check out all of CLMA's recently scheduled audioLabs by clicking here.
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August 2008 audioLabs
Patient Safety audioLab Series
Module 2: Beyond MRSA: The Strategic Value of the Laboratory in the Control of Health Care Associated Infections.
Wednesday, August 27 / 3:00 PM - 4:30 PM, ET
Presenter: Dr. Michael Astion & Lucia Berte
UPDATE! NOTE: Change in DATE!!!
A Successful Collaborative Six Sigma Study Between
The Laboratory and Emergency Departments
(Converted from ThinkLab 2008 Session 631)
Wednesday, September 17, 2008: / 11:00 AM – 12:30 PM, ET
Presenter: Vince D'Mello
Full Scholarships Still Available!
Full Scholarships for the Siemens Healthcare Diagnostics Executive Management Program at the University of Notre Dame!
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Did you know?
CLMA offers credits from ASCP (CMLE), ASCLS (P.A.C.E.); California and Florida are also available. A Certificate of Attendance is also available to those who must submit proof of attendance to their professional association.
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