ACLA is in the forefront of efforts to raise concerns about abusive pathology arrangements known as “PODs” or “Condo Labs.” These are contractual agreements allowing non-pathology clinicians and physician groups to bill for pathology services, for their own patients, in which they do not have active involvement in the pathology services. The Centers for Medicare and Medicaid Services has incorporated concerns expressed by ACLA in proposed changes to the rules on reassignment. CMS proposed...
ACLA Achievements
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PDF versionThe American Clinical Laboratory Association (ACLA) is THE voice for clinical laboratories, and an effective advocate before federal and state government. Following are highlights of ACLA’s record of achievement on behalf of the laboratory industry.
Achievement_List
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A proposed rule by the Health and Human Services (HHS) Office of Inspector General (OIG) was withdrawn in June 2007 which would have potentially exclude Medicare providers, including labs, from the Medicare program for submitting claims containing “excessive charges.” Excessive charges could include a single CPT code for which Medicare pays more than 120 percent of customary and usual charges. ACLA led opposition to this rule on behalf of the laboratory industry and submitted comments on...
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On September 7, 2006, the Food and Drug Administration (FDA) published draft guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), requesting comments within 90 days. The guidance creates a new approach to “medical device” regulation for IVDMIAs, and FDA has said it will require premarket review for certain laboratory-developed tests that combine assays and algorithms to produce results tailored to a specific patient. ACLA successfully requested FDA to extend the...
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The final 2007 Physician Fee Schedule, published by the Centers for Medicare and Medicaid Services (CMS) on November 1, 2006, included a number of provisions affecting clinical laboratories and pathology services. Of particular note, CMS accepted all of ACLA’s recommendations for revisions to the technical component of flow cytometry services. This action partially restores payment for these critically important patient services (increases between 14 and 25 percent despite the imposition...
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The Medically Unbelievable Edits [now renamed Medically Unlikely Edits (MUEs)] program is intended to identify obvious billing errors and to prevent erroneous Medicare billing claims by placing a unit of service limitation on each CPT code. The Centers for Medicare and Medicaid Services (CMS) is implementing MUEs in multiple quarterly phases. When the MUE program was first announced in late 2005, ACLA was one of the first to meet with CMS to raise concerns, among them that the proposed...
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ACLA and a coalition of other health care providers were successful in including in the "Medicare Improvement for Patients and Providers Act of 2008" a provision extending the so-called “technical component grandfather clause” through the end of calendar year 2009 . Using the grandfather clause, Medicare has permitted independent laboratories to bill and receive direct payments from Medicare for both specimen preparation (also known as the technical component of the service) and the...
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ACLA was the leader in the successful battle to eliminate a 2003 legislative provision that would have cut the Medicare lab fee schedule by 20 percent and require labs to try to make up the loss by billing and collecting a 20 percent co-pay from Medicare beneficiaries. The provision passed the Senate and was on its way to passage in the House until ACLA mounted a major advocacy campaign to stop it. Congress dropped the provision in November 2003, and ACLA has successfully kept the...
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Florida
- A proposal by the Florida Agency for Health Care Administration (AHCA) to pick a single laboratory winner for Florida from the 100 laboratories providing services to Medicaid was withdrawn twice in the face of a May 2005 campaign by ACLA. ACLA led the opposition to the Invitation to Negotiate, filing administrative challenges to the proposal and coordinating a legislative advocacy campaign. ACLA led the challenges to the Florida proposal, and was the leader in the...
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ACLA Takes Lead Role for Lab Community
ACLA is a leader for the lab industry in promoting lab interests as the government and outside groups develop health care IT interoperability standards. ACLA is positioned on important health care IT boards and coalitions, as well as having a working relationship with key government officials.
Standards for Electronic Transmission of Health Data
In a public statement before the American Health Information...
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ACLA is an active participant in the development, revision and payment of CPT codes for laboratory tests. ACLA’s CPT Committee works with the Pathology Coding Caucus, which develops consensus recommendations for the AMA’s CPT Editorial Panel for new code applications. ACLA provides recommendations to CMS for payment for new CPT codes at a public meeting each summer and then comments on the payment recommendations from CMS.
ACLA is an active participant in all...
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In January 2005, the Medicare Payment Advisory Commission (MedPAC) passed a recommendation to Congress that would require labs to submit all laboratory values on claims submitted to Medicare. ACLA met with MedPAC Executive Director Dr. Mark Miller to express concerns, as well as sharing those concerns with key members of Congress. No further action of this nature has occurred.
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ACLA met in March 2006 with the Executive Director of the Medicare Payment Advisory Commission (MedPAC) to present the findings from an independent report on Trends in Medicare Laboratory Testing Services, which showed that any increase in laboratory utilization was consistent with medical practice guidelines. The report sponsored by ACLA and the American Association of Bioanalysts, the American Society for Clinical Laboratory Scientists, AdvaMed, and the Clinical Laboratory Management...
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ACLA successfully urged the removal of a costly “claims processing fee” from a September 2004 bill moving through the U.S. House that would have created a $5 fee for each Medicare claim returned for “completion or correction.”
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ACLA contacted CMS in January 2005 regarding a Change Request for “Independent Laboratory Billing for the Technical Component of Physician Pathology Services Furnished to Hospital Patients.” The notice appeared to change the application of the covered entity to the laboratory so that the individual laboratory would have needed to have the arrangement with the hospital. CMS advised ACLA that this was not their intention and rescinded the change request.
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Legislative History:
Senators Ted Kennedy (D-MA), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Senator Barack Obama (D-IL), member of the Senate HELP Committee, have introduced in the first session of the 110th Congress legislation that would strengthen oversight of laboratory developed tests (LDTs). ACLA opposed Senator Kennedy’s legislation (S.736) because of concerns that it would stifle innovation for patient care and supported...
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On July 15th, the House and Senate voted overwhelmingly to override the President’s veto of “The Medicare Improvement for Patients and Providers Act of 2008”. The law includes three key provisions sought by the laboratory community: Total repeal of the laboratory competitive bidding demonstration project, extension of the so called “TC grandfather clause” for 18 months and reversal of a 10.6% reduction in the physician fee schedule. ACLA led efforts in...
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Rescind Physician Signature Requirement
In November 2010, shortly after publication of the 2011 Medicare Physician Fee Schedule Final Rule, ACLA began building a coalition of supporters who also opposed CMS’ new physician signature requirement. Following pressure from these groups, CMS issued a three-month enforcement delay avoiding implementation of the policy January 1, 2011. ACLA worked tirelessly on a congressional sign-on letter to CMS to...