APPENDIX D
Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaived Test Status, 1996–1998, 1999-Early 2000



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Medicare Laboratory Payment Policy: Now and in the Future APPENDIX D Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaived Test Status, 1996–1998, 1999-Early 2000

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Medicare Laboratory Payment Policy: Now and in the Future TABLE D.1 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1996 Facility Type Number of Laboratories Waived Test Volume Nonwaived Test Volume Total Test Volume Hospital 8,888 91,883,111 2,886,279,172 2,978,162,283 Independent 5,751 15,886,008 1,529,300,443 1,545,166,451 Physician Physician office 89,432 119,593,903 402,642,748 522,236,651 Community clinic 5,016 15,104,518 46,914,077 62,018,595 Health maintenance organization 959 6,879,396 58,602,448 65,481,844 Other practitioner 2,135 3,353,899 34,017,314 37,371,213 Total Physician 97,542 144,931,716 542,176,587 687,108,303 Other 11,216 64,978,527 235,688,932 300,667,459 Blood bank 338 9,037,496 108,378,714 117,416,210 Insurance 38 953,783 88,211,516 89,165,299 Ambulatory surgery center 1,160 1,892,906 24,881,423 26,774,329 Comp. outpatient rehabilitation facility 60 152,069 344,189 496,258 Ancillary test site in health facility 2,254 21,152,745 54,292,331 75,445,076

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Medicare Laboratory Payment Policy: Now and in the Future End-stage renal dialysis facility 1,919 7,034,302 3,698,366 10,732,668 Health fair 213 452,066 8,433,499 8,885,565 Home health agency 8,676 9,193,602 734,261 9,927,863 Hospice 596 377,998 2,020,628 2,398,626 Industrial 1,343 1,006,668 6,516,089 7,522,757 Intermediate care facility 626 419,097 1,570,654 1,989,751 Mobile unit 718 1,166,534 596,277 1,762,811 Pharmacy 288 150,911 142,638 293,549 School or student health service 1,175 1,072,946 3,797,719 4,870,665 Skilled nursing or nursing facility 13,933 37,638,543 5,968,203 43,606,746 Tissue bank 29 92,580 5,519,625 5,612,205 Rural health clinic or federally qualified health centerb Ambulanceb Total Other 44,582 156,772,773 550,795,064 707,567,837 Total, All Facility Types 156,763 409,453,608 5,508,551,266 5,918,004,874 aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1996 CLIA Provider Files. Health Care Financing Administration.

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Medicare Laboratory Payment Policy: Now and in the Future TABLE D.2 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1997 Facility Type Number of Laboratories Waived Test Volume Nonwaived Test Volume Total Test Volume Hospital 8,766 95,533,576 2,890,447,242 2,985,980,818 Independent 5,246 16,010,004 1,694,570,874 1,710,580,878 Physician Physician office 91,979 125,431,118 531,817,599 657,248,717 Community clinic 5,667 16,507,804 56,348,445 72,856,249 Health maintenance organization 872 6,139,609 59,289,436 65,429,045 Other practitioner 2,113 3,087,842 38,034,249 41,122,091 Total Physician 100,631 151,166,373 685,489,729 836,656,102 Other 12,190 65,765,571 329,945,790 395,711,361 Blood bank 341 8,984,653 112,267,650 121,252,303 Insurance 36 953,348 106,422,639 107,375,987 Ambulatory surgery center 1,474 1,906,826 22,801,571 24,708,397 Comp. outpatient rehabilitation facility 86 120,763 313,722 434,485 Ancillary test site in health facility 2,629 22,165,830 57,195,905 79,361,735

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Medicare Laboratory Payment Policy: Now and in the Future End-stage renal dialysis facility 2,343 7,916,703 7,394,763 15,311,466 Health fair 262 536,936 8,229,977 8,766,913 Home health agency 11,202 10,594,655 759,040 11,353,695 Hospice 829 301,566 1,587,633 1,889,199 Industrial 1,375 993,481 19,482,917 20,476,398 Intermediate care facility 700 543,964 1,658,198 2,202,162 Mobile unit 1,074 1,403,132 2,871,039 4,274,171 Pharmacy 677 312,452 149,426 461,878 School or student health service 1,372 1,155,195 4,430,107 5,585,302 Skilled nursing or nursing facility 14,389 39,749,678 3,916,131 43,665,809 Tissue bank 33 93,830 5,492,474 5,586,304 Rural health clinic or federally qualified health centerb Ambulanceb Total Other 51,012 163,498,583 684,918,982 848,417,565 Total, All Facility Types 165,655 426,208,536 5,955,426,827 6,381,635,363 aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1997 CLIA Provider Files. Health Care Financing Administration.

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Medicare Laboratory Payment Policy: Now and in the Future TABLE D.3 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Non-waiveda Test Status, 1998 Facility Type Number of Laboratories Waived Test Volume Nonwaived Test Volume Total Test Volume Hospital 8,644 94,196,474 2,861,419,809 2,955,616,283 Independent 4,871 15,272,621 1,380,135,459 1,395,408,080 Physician Physician office 93,763 129,153,794 363,417,570 492,571,364 Community clinic 5,535 15,390,658 42,097,551 57,488,209 Health maintenance organization 751 5,042,666 30,487,001 35,529,667 Other practitioner 2,004 2,984,083 24,256,184 27,240,267 Total Physician 102,053 152,571,201 460,258,306 612,829,507 Other 11,995 64,685,709 217,678,933 282,364,642 Blood bank 316 8,595,502 96,113,181 104,708,683 Insurance 36 952,898 88,346,869 89,299,767 Ambulatory surgery center 1,507 1,933,819 20,287,811 22,221,630 Comp. outpatient rehabilitation facility 91 130,747 313,462 444,209 Ancillary test site in health facility 2,384 21,546,469 34,021,429 55,567,898

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Medicare Laboratory Payment Policy: Now and in the Future End-stage renal dialysis facility 2,386 7,742,580 5,875,977 13,618,557 Health fair 270 656,215 5,622,353 6,278,568 Home health agency 10,859 10,245,942 423,745 10,669,687 Hospice 847 305,926 1,415,242 1,721,168 Industrial 1,363 963,861 6,030,475 6,994,336 Intermediate care facility 665 520,100 624,787 1,144,887 Mobile unit 1,094 1,131,722 280,678 1,412,400 Pharmacy 773 447,319 110,149 557,468 School or student health service 1,379 1,214,093 3,648,558 4,862,651 Skilled nursing or nursing facility 14,008 38,971,818 3,006,791 41,978,609 Tissue bank 31 93,830 5,416,065 5,509,895 Rural health clinic or federally qualified health centerb Ambulanceb Total Other 50,004 160,138,550 489,216,505 649,355,055 Total, All Facility Types 165,572 422,178,846 5,191,030,079 5,613,208,925 aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1998 CLIA Provider Files. Health Care Financing Administration.

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Medicare Laboratory Payment Policy: Now and in the Future TABLE D.4 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1999-Early 2000 Facility Type Number of Laboratories Waived Test Volume Nonwaived Test Volume Total Test Volume Hospital 8,560 95,931,042 2,862,826,492 2,958,217,534 Independent 4,936 15,057,780 1,499,093,551 1,514,151,331 Physician Physician office 96,357 133,563,773 347,739,610 481,303,383 Community clinic 5,978 18,360,107 40,200,559 58,560,666 Health maintenance organization 717 4,768,920 79,774,094 84,543,014 Other practitioner 2,037 3,350,368 28,679,024 32,029,392 Total Physician 105,089 160,043,168 496,393,287 656,436,455 Other 12,605 66,900 265,612,004 265,678,904 Blood bank 340 9,044,389 74,538,000 83,582,389 Insurance 44 961,946 79,440,076 80,402,022 Ambulatory surgery center 1,943 2,239,255 19,114,207 21,353,462 Comp. outpatient rehabilitation facility 107 317,250 450,541 767,791 Ancillary test site in health facility 2,650 22,437,640 4,116,747 26,554,387

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Medicare Laboratory Payment Policy: Now and in the Future End-stage renal dialysis facility 2,804 8,628,068 2,386,960 11,015,028 Health fair 315 501,270 12,732,801 13,234,071 Home health agency 8,461 17,570,371 326,868 17,897,239 Hospice 897 1,028,376 1,733,518 2,761,894 Industrial 1,428 954,110 6,224,404 7,178,514 Intermediate care facility 696 538,212 944,477 1,482,689 Mobile unit 1,203 1,663,769 2,140,582 3,804,351 Pharmacy 1,450 910,779 81,794 992,573 School or student health service 1,526 1,314,250 3,666,849 4,981,099 Skilled nursing or nursing facility 14,695 43,496,738 3,056,795 46,553,533 Tissue bank 41 99,930 7,633,868 7,733,798 Rural health clinic or federally qualified health centerb 233 699,531 431,327 1,130,858 Ambulanceb 79 20,360 - 20,360 Total Other 51,517 112,493,144 484,631,818 597,124,962 Total, All Facility Types 170,102 382,985,134 5,342,945,148 5,725,930,282 aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: March 2000 CLIA Provider Files. Health Care Financing Administration.

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