Difference between revisions of "Physician office laboratory"
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==POLs in the United States== | ==POLs in the United States== | ||
In December 2013, the [[Centers for Medicare and Medicaid Services]] (CMS) reported nearly half of all [[Clinical Laboratory Improvement Amendments|CLIA]]-certified laboratories in the United States (120,399) were physician office laboratories.<ref name="CMSDec13Count">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf |format=PDF |title=Laboratories by Type of Facility |publisher=Centers for Medicare and Medicaid Services |date=December 2013 |accessdate=3 April 2014}}</ref> However, | |||
===History=== | |||
Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent<ref name="GallivanPhys">{{cite journal |url=http://www.ncbi.nlm.nih.gov/pubmed/3899902 |journal=Hospitals |title=Physician offices invade clinical laboratory market |author=Gallivan, Mary |volume=59 |issue=20 |date=16 October 1985 |pages=84, 89, 92–4 |pmid=3899902 |accessdate=4 April 2014}}</ref>, likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.<ref name="CuminsInOff">{{cite journal |url=http://www.ncbi.nlm.nih.gov/pubmed/10267706 |journal=Computers in Healthcare |title=The In-Office Laboratory: Benefits for You and Your Patients |author=Cumins, L. |volume=5 |issue=9 |year=September 1984 |pages=60–2 |pmid=10267706 |accessdate=4 April 2014}}</ref> The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.<ref name="GallivanPhys" /> By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.<ref name="WilkinsonAre">{{cite journal |url=http://www.ncbi.nlm.nih.gov/pubmed/3557409 |journal=Hospitals |title=Are physician labs a competitive threat? |author=Wilkinson, Richard |volume=61 |issue=8 |date=20 April 1987 |pages=96, 98 |pmid=3557409 |accessdate=4 April 2014}}</ref> | |||
In December 2013, the [[Centers for Medicare and Medicaid Services]] (CMS) reported nearly half of all [[Clinical Laboratory Improvement Amendments|CLIA]]-certified laboratories in the United States (120,399) were physician office laboratories.<ref name="CMSDec13Count">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf |format=PDF |title=Laboratories by Type of Facility |publisher=Centers for Medicare and Medicaid Services |date=December 2013 |accessdate=3 April 2014}}</ref> However, as of December 2010 POLs only processed about eight percent of all clinical laboratory tests.<ref name="CarlsonPhys">{{cite web |url=http://www.genengnews.com/gen-articles/physician-office-lab-diagnostic-market/3493/ |title=Physician Office Lab Diagnostic Market |work=GEN |author=Carlson, Bruce |publisher=Genetic Engineering & Biotechnology News |date=1 December 2010 |accessdate=3 April 2014}}</ref> | |||
==References== | ==References== | ||
Revision as of 17:12, 4 April 2014
A physician office laboratory (POL) is a physician-, partnership-, or group-maintained laboratory that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.[1][2] The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a clinical laboratory and is thus regulated by federal, state, and/or local laws affecting such laboratories.[2][3]
In early 2011, researchers estimated the worldwide market for in vitro diagnostic company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.[4]
POLs in the United States
History
Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent[5], likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.[6] The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.[5] By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.[7]
In December 2013, the Centers for Medicare and Medicaid Services (CMS) reported nearly half of all CLIA-certified laboratories in the United States (120,399) were physician office laboratories.[8] However, as of December 2010 POLs only processed about eight percent of all clinical laboratory tests.[9]
References
- ↑ "Chapter 16 - Laboratory Services" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 20 June 2013. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf. Retrieved 3 April 2014.
- ↑ 2.0 2.1 "Physician Office Laboratory Evaluation Program (POLEP)". Wadsworth Center New York State Department of Health. http://www.wadsworth.org/labcert/polep/. Retrieved 3 April 2014.
- ↑ "Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration" (PDF). California Department of Public Health. May 2008. http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf. Retrieved 3 April 2014.
- ↑ "Healthcare Cost Worries Boost Physician Office Lab Market". Thomson Reuters. 10 February 2011. http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210. Retrieved 3 April 2014.
- ↑ 5.0 5.1 Gallivan, Mary (16 October 1985). "Physician offices invade clinical laboratory market". Hospitals 59 (20): 84, 89, 92–4. PMID 3899902. http://www.ncbi.nlm.nih.gov/pubmed/3899902. Retrieved 4 April 2014.
- ↑ Cumins, L. (September 1984). "The In-Office Laboratory: Benefits for You and Your Patients". Computers in Healthcare 5 (9): 60–2. PMID 10267706. http://www.ncbi.nlm.nih.gov/pubmed/10267706. Retrieved 4 April 2014.
- ↑ Wilkinson, Richard (20 April 1987). "Are physician labs a competitive threat?". Hospitals 61 (8): 96, 98. PMID 3557409. http://www.ncbi.nlm.nih.gov/pubmed/3557409. Retrieved 4 April 2014.
- ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. December 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 3 April 2014.
- ↑ Carlson, Bruce (1 December 2010). "Physician Office Lab Diagnostic Market". GEN. Genetic Engineering & Biotechnology News. http://www.genengnews.com/gen-articles/physician-office-lab-diagnostic-market/3493/. Retrieved 3 April 2014.
