College of American Pathologists
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February 18, 2010  •  Volume 26, Number 4
Next Issue: March 4, 2010
© 2010 College of American Pathologists

In This Issue:

Photo: Womack Army Medical Center Hosts Lab Tour
Fate of SGR, TC Grandfather Continue to Loom
CMS Clarifies EHR Rules Under CLIA

Photo: Womack Army Medical Center Hosts Lab Tour

Photo: Womack Army Medical Center Hosts Lab Tour

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Fate of SGR, TC Grandfather Continue to Loom

Physician payment and other time sensitive or expiring Medicare provisions which were likely to be extended in health care reform legislation are yet to be addressed by Congress, despite mounting pressure from all quarters of the medical community.

The massive bi-partisan jobs bill, announced early last Thursday by Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) attempted to solved the problem with $10 billion in Medicare “extender provisions” that would have, among other things, delayed a 21 percent Medicare pay cut for physicians until December 31, 2010, and extended the Technical Component (TC) “grandfather”, for another for another year retroactive to January 1, 2010.

However, shortly after the bill was announced by the Senate Finance Committee, Senate Majority Leader Harry Reid (D-NV) revealed he would break up the $85 billion bill into four smaller bills, starting with a much-simplified, less controversial $15 billion jobs-only package to be voted on February 22, one day after the Senate reconvenes following a week-long President’s Day recess.

The Majority Leader’s failure to state how, when, or if the Medicare extenders would be addressed is causing considerable dismay in the physician community, particularly with a looming March 1 deadline for Medicare physician payment to be cut 21%.

The problem now appears to be a matter of timing and priority. Congressional Democrats, particularly Senate Democrats, are under pressure to deliver legislation that will help middle-class Americans through the country’s financial crisis. This has moved healthcare reform, including physician payment, to a position of less importance in the eyes of Congress. The best hope was to attach the Medicare extenders to other legislation, such as the jobs bill, that would be voted on before March 1.

With little other legislation likely to be voted on before the March 1 deadline, some Washington insiders have begun speculating that Congress will try to address the issue in early March, and have it be effective retroactive to March 1, so no cut would actually be felt. Since CMS can legally hold claims for 15 days, this is a possibility. CAP and others have already begun urging Congress to address expired Medicare policies now.

In a letter to Congressional leaders on February 11, CAP joined a broad coalition of provider, patient, and healthcare professional groups urging Congress to take immediate action to extend several extenders, including the physician payment freeze and the TC Grandfather.

The College is also working with leaders of the House Rural Health Care Coalition, specifically Representatives Earl Pomeroy (D-ND) and Jerry Moran (R-KS) to send a letter urging House and Senate leadership to pass legislation that would, among other things, extend the TC “grandfather” for another year retroactive to January 1, 2010.

The College will continue to advocate on these important issues, and will keep CAP members informed as events unfold.

CMS Clarifies EHR Rules Under CLIA

CMS Division of Laboratory Services Director Judith Yost announced her office will be issuing new CLIA interpretive guidance for Electronic Health Records (EHR) and clarified a number of common misconceptions regarding CLIA regulations on EHR and laboratory test reporting at last week’s meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC).

While new rules and regulations are in development to expand the reach of Health Information Technology and interoperability, Yost said current CLIA regulations are still applicable to the present state of EHRs.

Citing CLIA Section 493.1105, Yost said misconceptions persist regarding specific formats for reporting and storing results. In clarification she said, No specific format is required for retrieving or saving test results, but all required elements of the EHR must be transmitted accurately, reliably, confidentially, and timely. She also said CLIA specifies that only 1 copy be saved and does not require a certain method (paper vs. electronic).

Citing CLIA Sections 493.1241 and 493.1291, Yost said State law determines whether patients may be allowed to receive test results or whether the authorized person may request a copy for the patient or a Health Information Exchange when ordering the test. CLIA places no restriction on this.

Also under section 493.1291, Yost said laboratories are responsible for getting the results to the authorized person who ordered the test, and once they reach the authorized person, the lab’s CLIA responsibility is discharged. Yost also said CLIA does not specify the mechanism or frequency to check result transmission, but that all EHR interfaces at all locations must be checked and verified. Such a requirement will require laboratories using the same software and protocols at multiple locations are required to ensure their data integrity and verification systems at each location.

CMS Feedback on Latest Proposed EHR Regulations

CMS also provided testimony to the CLIAC on recently published U.S. Department of Health and Human Services (HHS) proposed regulations designed to support national electronic health records (EHRs) and provide incentives to non-hospital based physicians to adopt certified electronic health records and to “meaningfully” use those systems. CMS highlighted several “Business Impediments” affecting independent laboratories’ ability to support the national effort to adopt EHR’s. The identified challenges included:

  • Cost of developing, implementing and testing the necessary customized laboratory information system (LIS) interfaces
  • Number of interfaces required to support multiple current and potential business relationships; and
  • Ability of payers to direct laboratory business.

By CMS’s own estimates, independent laboratories would have to bear the cost of $5,000K to $15,000 per required LIS interface. Given that laboratories have multiple business relationships, business costs will be significant and could result in the inability of small/independent laboratories to compete with larger commercial laboratories. This could be seen as an unintended and undesirable consequence of the proposed Meaningful Use rule.

CMS observed that additional costs would be imposed on each laboratory to manually update the compendiums of multiple data exchange vocabularies and nomenclatures necessary to support each business relationship’s LIS interface. CMS’ cost estimates did not consider or include the cost to support the interoperability requirements necessary for pathologist’s to access each business partners EHR system, which is necessary to further coordination of care activities.

CMS also discussed the need for national and uniform standards for laboratory data transmission; compendiums and vocabularies; methods to identify patients, and the ability to integrate LIS legacy systems.

The College provided testimony in October on the issues related to the electronic exchange of laboratory information and electronic laboratory reporting.

CAP will continue to advocate on behalf of pathologists and the patient medical information required to provide accurate diagnosis services.

CLIAC is the body chartered by Congress to provide scientific and technical advice and guidance to the Secretary and the Assistant Secretary for Health regarding the need for, and the nature of, revisions to the standards under which clinical laboratories are regulated; the impact on medical and laboratory practice of proposed revisions to the standards; and the modification of the standards to accommodate technological advances.


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