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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 1 of 31
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`ADVOCATE CHRIST MEDICAL CENTER
`4440 West 95th Street
`Oak Lawn, IL 60453
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`ADVOCATE ILLINOIS MASONIC MEDICAL
`CENTER
`836 West Wellington Avenue
`Chicago, IL 60657
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`ADVOCATE LUTHERAN GENERAL HOSPITAL
`1775 Dempster Street
`Park Ridge, IL 60068
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`ADVOCATE TRINITY HOSPITAL
`2320 East 93rd Street
`Chicago, IL 60617
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`ALAMANCE REGIONAL MEDICAL CENTER
`1240 Huffman Mill Road
`Burlington, NC 27215
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`AMITA HEALTH MERCY MEDICAL CENTER
`AURORA
`1325 North Highland Avenue
`Aurora, IL 60506
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`AMITA HEALTH SAINT FRANCIS HOSPITAL
`EVANSTON
`355 Ridge Avenue
`Evanston, IL 60202
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`AMITA HEALTH SAINTS MARY AND
`ELIZABETH MEDICAL CENTER SAINT MARY
`CAMPUS
`2233 West Division Street
`Chicago, IL 60622
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`AMITA HEALTH ST. ALEXIUS MEDICAL
`CENTER HOFFMAN ESTATES
`1555 Barrington Road
`Hoffman Estates, IL 60169
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 2 of 31
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`AMITA HEALTH ST. MARYS HOSPITAL
`KANKAKEE
`500 West Court Street
`Kankakee, IL 60901
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`ASCENSION ALL SAINTS HOSPITAL - SPRING
`STREET CAMPUS
`3801 Spring Street
`Racine, WI 53405
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`ASCENSION COLUMBIA SAINT MARY'S
`HOSPITAL MILWAUKEE
`2301 North Lake Drive
`Milwaukee, WI 53211
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`ASCENSION NORTHEAST WISCONSIN SAINT
`ELIZABETH CAMPUS
`1506 South Oneida Street
`Appleton, WI 54915
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`ASCENSION SACRED HEART HOSPITAL
`PENSACOLA
`5151 North Ninth Avenue
`Pensacola, FL 32504
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`ASCENSION SAINT JOHN HOSPITAL
`22101 Moross
`Detroit, MI 48236
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`ASCENSION SE WISCONSIN HOSPITAL - ST.
`JOSEPH CAMPUS
`5000 West Chambers Street
`Milwaukee, WI 53210
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`ASCENSION SETON MEDICAL CENTER AUSTIN
`1201 West 38th Street
`Austin, TX 78705
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`ASCENSION SETON NORTHWEST
`11113 Research Boulevard
`Austin, TX 78759
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`ASCENSION ST. FRANCIS HOSPITAL
`3237 South 16th Street
`Milwaukee, WI 53215
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 3 of 31
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`ASCENSION ST. MARY'S HOSPITAL
`800 South Washington Avenue
`Saginaw, MI 48601
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`ASCENSION VIA CHRISTI HOSPITAL IN
`PITTSBURG
`1 Mount Carmel Way
`Pittsburg, KS 66762
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`ASCENSION VIA CHRISTI HOSPITAL ST.
`FRANCIS
`929 North Saint Francis
`Wichita, KS 67214
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`ATHENS-LIMESTONE HOSPITAL
`700 West Market Street
`Athens, AL 35611
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`AURORA SAINT LUKE'S MEDICAL CENTER
`2900 West Oklahoma Avenue
`Milwaukee, WI 53215
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`AURORA SHEBOYGAN MEMORIAL MEDICAL
`CENTER
`2629 North Seventh Street
`Sheboygan, WI 53083
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`AURORA WEST ALLIS MEMORIAL HOSPITAL
`8901 West Lincoln Avenue
`West Allis, WI 53227
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`AVERA MCKENNAN HOSPITAL & UNIVERSITY
`HEALTH CENTER
`1325 South Cliff Avenue
`Sioux Falls, SD 57117
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`BAPTIST EASLEY HOSPITAL
`200 Fleetwood Drive
`Easley, SC 29640
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`BAYHEALTH HOSPITAL, KENT CAMPUS
`640 South State Street
`Dover, DE 19901
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 4 of 31
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`BAYHEALTH HOSPITAL, SUSSEX CAMPUS
`100 Wellness Way
`Milford, DE 19963
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`BEAUMONT HOSPITAL – DEARBORN
`18101 Oakwood Boulevard
`Dearborn, MI 48124
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`BEAUMONT HOSPITAL – FARMINGTON HILLS
`28050 Grand River Avenue
`Farmington Hills, MI 48336
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`BEAUMONT HOSPITAL – GROSSE POINTE
`468 Cadieux Road
`Grosse Pointe, MI 48230
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`BEAUMONT HOSPITAL – ROYAL OAK
`3601 West Thirteen Mile Road
`Royal Oak, MI 48073
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`BEAUMONT HOSPITAL – TAYLOR
`10000 Telegraph Road
`Taylor, MI 48180
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`BEAUMONT HOSPITAL – WAYNE
`33155 Annapolis Street
`Wayne, MI 48184
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`BECKLEY ARH HOSPITAL
`306 Stanaford Road
`Beckley, WV 25801
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`BETSY JOHNSON REGIONAL HOSPITAL
`800 Tilghman Drive
`Dunn, NC 28335
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`BON SECOURS SAINT FRANCIS HOSPITAL
`2095 Henry Tecklenburg Drive
`Charleston, SC 29414
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`BROCKTON HOSPITAL
`680 Centre Street
`Brockton, MA 02302
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 5 of 31
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`BRONXCARE DR. MARTIN LUTHER KING, JR.
`HEALTH CENTER
`1276 Fulton Avenue
`Bronx, NY 10456
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`CAPE FEAR VALLEY HOKE HOSPITAL
`210 Medical Pavilion Drive
`Raeford, NC 28376
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`CAPE FEAR VALLEY MEDICAL CENTER
`1638 Owen Drive
`Fayetteville, NC 28304
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`CLIFTON SPRINGS HOSPITAL AND CLINIC
`2 Coulter Road
`Clifton Springs, NY 14432
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`COLUMBUS REGIONAL HOSPITAL
`2400 East 17th Street
`Columbus, IN 47201
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`COMMUNITY HOSPITAL ANDERSON
`1515 North Madison Avenue
`Anderson, IN 46011
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`COMMUNITY HOSPITAL EAST
`1500 North Ritter Avenue
`Indianapolis, IN 46219
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`COMMUNITY HOSPITAL NORTH
`7150 Clearvista Drive
`Indianapolis, IN 46256
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`COMMUNITY HOWARD REGIONAL HEALTH
`3500 South Lafountain Street
`Kokomo, IN 46902
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`COOKEVILLE REGIONAL MEDICAL CENTER
`1 Medical Center Boulevard
`Cookeville, TN 38501
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`D. W. MCMILLAN MEMORIAL HOSPITAL
`1301 Belleville Avenue
`Brewton, AL 36426
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 6 of 31
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`DALLAS COUNTY HOSPITAL DISTRICT
`5200 Harry Hines Boulevard
`Dallas, TX 75235
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`DAY KIMBALL HOSPITAL
`320 Pomfret Street
`Putnam, CT 06260
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`DENVER HEALTH
`777 Bannock Street
`Denver, CO 80204
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`EAST ALABAMA MEDICAL CENTER
`2000 Pepperall Pkwy
`Opelika, AL 36801
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`EAST ALABAMA MEDICAL CENTER–LANIER
`4800 48th Street
`Valley, AL 36854
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`EPHRAIM MCDOWELL REGIONAL MEDICAL
`CENTER
`217 South Third Street
`Danville, KY 40422
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`FIRELANDS REGIONAL MEDICAL CENTER -
`MAIN CAMPUS
`1111 Hayes Avenue
`Sandusky, OH 44870
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`FISHER-TITUS MEDICAL CENTER
`272 Benedict Avenue
`Norwalk, OH 44857
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`FORREST GENERAL HOSPITAL
`6051 U.S. Highway 49
`Hattiesburg, MS 39401
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`FRANCISCAN HEALTH HAMMOND
`5454 Hohman Avenue
`Hammond, IN 46320
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`FRANCISCAN HEALTH LAFAYETTE EAST
`1701 South Creasy Lane
`Lafayette, IN 47905
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 7 of 31
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`FRANCISCAN HEALTH MICHIGAN CITY
`3500 Franciscan Way
`Michigan City, IN 46360
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`FRANCISCAN HEALTH OLYMPIA FIELDS
`CAMPUS
`20201 South Crawford Avenue
`Olympia Fields, IL 60461
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`FRANKLIN WOODS COMMUNITY HOSPITAL
`300 MedTech Parkway
`Johnson City, TN 37604
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`FROEDTERT HOSPITAL
`9200 West Wisconsin Avenue
`Milwaukee, WI 53226
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`GOOD SAMARITAN REGIONAL MEDICAL
`CENTER
`3600 Northwest Samaritan Drive
`Corvallis, OR 97330
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`GREENVILLE MEMORIAL HOSPITAL
`701 Grove Road
`Greenville, SC 29605
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`GREER MEMORIAL HOSPITAL
`830 South Buncombe Road
`Greer, SC 29650
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`GUNDERSEN LUTHERAN MEDICAL CENTER
`1900 South Avenue
`La Crosse, WI 54601
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`HARLAN ARH HOSPITAL
`81 Ball Park Road
`Harlan, KY 40831
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`HAZARD ARH REGIONAL MEDICAL CENTER
`100 Medical Center Drive
`Hazard, KY 41701
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`HELEN KELLER HOSPITAL
`1300 South Montgomery Avenue
`Sheffield, AL 35660
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 8 of 31
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`HIGHLANDS ARH REGIONAL MEDICAL
`CENTER
`5000 Kentucky Route 321
`Prestonburg, KY 41653
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`HILLSDALE HOSPITAL
`168 South Howell St.
`Hillsdale, MI 49242
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`HOLSTON VALLEY MEDICAL CENTER
`130 West Ravine Road
`Kingsport, TN 37660
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`INDIAN PATH COMMUNITY HOSPITAL
`2000 Brookside Drive
`Kingsport, TN 37660
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`IU HEALTH BALL MEMORIAL HOSPITAL
`2401 West University Avenue
`Munice, IN 47303
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`IU HEALTH BLOOMINGTON HOSPITAL
`601 West Second Street
`Bloomington, IN 47403
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`IU HEALTH METHODIST HOSPITAL
`1701 North Senate Boulevard
`Indianapolis, IN 46202
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`JOHNSON CITY MEDICAL CENTER
`400 North State of Franklin Road
`Johnson City, TN 37604
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`LAKELAND MEDICAL CENTER, SAINT JOSEPH
`1234 Napier Avenue
`St. Joseph, MI 49085
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`LEHIGH VALLEY HOSPITAL - CEDAR CREST
`1200 South Cedar Crest Boulevard
`Allentown, PA 18103
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`LEHIGH VALLEY HOSPITAL - HAZLETON
`1700 East Broad Street.
`Hazleton, PA 18201
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 9 of 31
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`LEHIGH VALLEY HOSPITAL - POCONO
`206 East Brown Street
`East Stroudsburg, PA 18301
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`LEHIGH VALLEY HOSPITAL-SCHUYLKILL S.
`JACKSON STREET
`420 South Jackson Street
`Pottsville, PA 17901
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`LENOX HILL HOSPITAL
`100 East 77th Street
`New York, NY 10075
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`LONESOME PINE HOSPITAL
`1990 Holton Avenue
`Big Stone Gap, VA 24219
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`LONG ISLAND JEWISH MEDICAL CENTER
`270-05 76th Avenue
`New Hyde Park, NY 11040
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`LOWELL GENERAL HOSPITAL - MAIN CAMPUS
`295 Varnum Avenue
`Lowell, MA 01854
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`MADISON HEALTH
`210 North Main Street
`London, OH 43140
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`MARSHALL MEDICAL CENTER SOUTH
`2505 US Highway 431
`Boaz, AL 35957
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`MEMORIAL HOSPITAL
`615 North Michigan Street
`South Bend, IN 46601
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`MEMORIAL HOSPITAL AT GULFPORT
`4500 Thirteenth Street
`Gulfport, MS 39501
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`METHODIST HOSPITAL
`1305 North Elm Street
`Henderson, KY 42420
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 10 of 31
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`MIAMI VALLEY HOSPITAL
`One Wyoming Street
`Dayton, OH 45409
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`MIDDLESBORO ARH HOSPITAL
`3600 West Cumberland Avenue
`Middlesboro, KY 40965
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`MIDMICHIGAN MEDICAL CENTER - GRATIOT
`300 East Warwick Drive
`Alma, MI 48801
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`NORTH SHORE UNIVERSITY HOSPITAL
`300 Community Drive
`Manhasset, NY 11030
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`NORTON COMMUNITY HOSPITAL
`100 15th Street Northwest
`Norton, VA 24273
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`NORTON HOSPITAL
`200 East Chestnut Street
`Louisville, KY 40202
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`OUR LADY OF LOURDES MEMORIAL HOSPITAL
`169 Riverside Drive
`Binghamton, NY 13905
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`PARKVIEW HUNTINGTON HOSPITAL
`2001 Stults Road
`Huntington, IN 46750
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`PARKVIEW NOBLE HOSPITAL
`401 Sawyer Road
`Kendallville, IN 46755
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`PARKVIEW REGIONAL MEDICAL CENTER
`11109 Parkview Plaza Drive
`Fort Wayne, IN 46845
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`PARKVIEW WHITLEY HOSPITAL
`1260 East State Road 205
`Columbia City, IN 46725
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 11 of 31
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`PENN STATE HEALTH MILTON S. HERSHEY
`MEDICAL CENTER
`500 University Drive
`Hershey, PA 17033
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`PENN STATE HEALTH SAINT JOSEPH - MAIN
`CAMPUS
`2500 Bernville Road
`Reading, PA 19605
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`PHELPS MEMORIAL HOSPITAL CENTER
`701 North Broadway
`Sleepy Hollow, NY 10591
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`PRINCETON COMMUNITY HOSPITAL
`122 Twelfth Street
`Princeton, WV 24740
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`PRISMA HEALTH RICHLAND HOSPITAL
`5 Richland Medical Park Drive
`Columbia, SC 29203
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`PUNXSUTAWNEY AREA HOSPITAL
`81 Hillcrest Drive
`Punxsutawney, PA 15767
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`REGIONAL MEDICAL CENTER
`106 Blanca Avenue
`Alamosa, CO 81101
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`RHODE ISLAND HOSPITAL
`593 Eddy Street
`Providence, RI 02903
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`RIVERSIDE REGIONAL MEDICAL CENTER
`500 J. Clyde Morris Boulevard
`Newport News, VA 23601
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`RMC ANNISTON
`400 East Tenth Street
`Anniston, AL 36202
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`ROCHESTER GENERAL HOSPITAL
`1425 Portland Avenue
`Rochester, NY 14621
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 12 of 31
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`SAINT CATHERINE HOSPITAL
`4321 Fir Street
`East Chicago, IN 46312
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`SAINT JOSEPH'S UNIVERSITY MEDICAL
`CENTER
`703 Main Street
`Paterson, NJ 07503
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`SAINT MARY'S HOSPITAL AT AMSTERDAM
`427 Guy Park Avenue
`Amsterdam, NY 12010
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`SAINT TAMMANY PARISH HOSPITAL
`1202 South Tyler Street
`Covington, LA 70433
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`SAINT THOMAS RIVER PARK HOSPITAL
`1559 Sparta Road
`McMinnville, TN 37110
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`SAINT VINCENT ANDERSON
`2015 Jackson Street
`Anderson, IN 46016
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`SAINT VINCENT EVANSVILLE
`3700 Washington Avenue
`Evansville, IN 47750
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`SAINT VINCENT INDIANAPOLIS HOSPITAL
`2001 West 86th Street
`Indianapolis, IN 46260
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`SAMARITAN ALBANY GENERAL HOSPITAL
`1046 Southwest Sixth Avenue
`Albany, OR 97321
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`SANFORD BISMARCK MEDICAL CENTER
`300 North Seventh Street
`Bismarck, ND 58501
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`SANFORD MEDICAL CENTER FARGO
`5225 23rd Avenue South
`Fargo, ND 58104
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 13 of 31
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`SANFORD USD MEDICAL CENTER SIOUX
`FALLS
`1305 West 18th Street
`Sioux Falls, SD 57117
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`SCHNECK MEDICAL CENTER
`411 West Tipton Street
`Seymour, IN 47274
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`SOUTHSIDE HOSPITAL
`301 East Main Street
`Bay Shore, NY 11706
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`SPECTRUM HEALTH UNITED HOSPITAL
`615 South Bower Street
`Greenville, MI 48838
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`STATEN ISLAND UNIVERSITY HOSPITAL
`475 Seaview Avenue
`Staten Island, NY 10305
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`TALLAHASSEE MEMORIAL HEALTHCARE
`1300 Miccosukee Road
`Tallahassee, FL 32308
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`TAYLOR REGIONAL HOSPITAL
`1700 Old Lebanon Road
`Campbellsville, KY 42718
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`THE MOSES H. CONE MEMORIAL HOSPITAL
`1200 North Elm Street
`Greensboro, NC 27401
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`THE UNIVERSITY OF TOLEDO MEDICAL
`CENTER
`3000 Arlington Avenue
`Toledo, OH 43614
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`TUG VALLEY ARH REGIONAL MEDICAL
`CENTER
`260 Hospital Drive
`South Williamson, KY 41503
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`TWIN LAKES REGIONAL MEDICAL CENTER
`910 Wallace Avenue
`Leitchfield, KY 42754
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 14 of 31
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`UMASS MEMORIAL HEALTHALLIANCE –
`CLINTON HOSPITAL – LEOMINSTER CAMPUS
`60 Hospital Road
`Leominster, MA 01453
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`UMASS MEMORIAL MARLBOROUGH HOSPITAL
`157 Union Street
`Marlborough, MA 01752
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`UMASS MEMORIAL MEDICAL CENTER –
`UNIVERSITY CAMPUS
`55 Lake Avenue North
`Worcester, MA 01655
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`UNION HOSPITAL
`1606 North Seventh Street
`Terre Haute, IN 47804
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`UNIONTOWN HOSPITAL
`500 West Berkeley Street
`Uniontown, PA 15401
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`UNITED MEMORIAL MEDICAL CENTER
`127 North Street
`Batavia, NY 14020
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`UNITY HOSPITAL
`1555 Long Pond Road
`Rochester, NY 14626
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`UNIVERSITY OF ILLINOIS MEDICAL CENTER
`1740 West Taylor Street
`Chicago, IL 606012
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`UNIVERSITY MEDICAL CENTER AT
`BRACKENRIDGE
`601 East 15th Street
`Austin, TX 78701
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`WAKE FOREST BAPTIST MEDICAL CENTER
`Medical Center Boulevard
`Winston-Salem, NC 27157
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`WEIRTON MEDICAL CENTER
`601 Colliers Way
`Weirton, WV 26062
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 15 of 31
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`Plaintiffs,
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`vs.
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`WHITESBURG ARH HOSPITAL
`240 Hospital Road
`Whitesburg, KY 41858
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`XAVIER BECERRA
`Secretary of the United States Department of Health
`and Human Services
`Room 700-E
`200 Independence Avenue, S.W.
`Washington, D.C. 20201
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`Defendant.
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`COMPLAINT
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`The above-captioned 151 Plaintiff hospitals (“Plaintiffs” or “Hospitals”), by and through
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`their undersigned counsel, bring this action against Xavier Becerra, in his official capacity as the
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`Secretary of the Department of Health and Human Services, and allege the following:
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`NATURE OF ACTION
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`1.
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`Plaintiffs bring this action under the Social Security Act, 42 U.S.C. §§ 1395, et seq.
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`(the “Medicare Act”) and the Administrative Procedure Act, 5 U.S.C. §§ 551, et seq. (the “APA”)
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`to challenge provisions of final rules issued on November 1, 2017, November 1, 2018, November
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`1, 2019, and December 4, 2020 by the Centers for Medicare and Medicaid Services (“CMS”). See
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`82 Fed. Reg. 52,356, 52,493–511, 52,622–25 (Nov. 13, 2017); 83 Fed. Reg. 58,818, 58,981 (Nov.
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`21, 2018); 84 Fed. Reg. 61,142, 61,317–27 (Nov. 12, 2019); and 85 Fed. Reg. 85,866, 86,038
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`(Dec. 29, 2020). The final rules concern the Hospital Outpatient Prospective Payment System
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`(“OPPS”) and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs for
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`Calendar Years (“CYs”) 2018, 2019, 2020 and 2021. The portions of the challenged rules reduced
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`by nearly 30% Medicare reimbursements to certain public and not-for-profit hospitals and clinics
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 16 of 31
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`for prescription drugs purchased by those institutions on a discounted basis under section 340B of
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`the Public Health Service Act (the “340B Program”). The 2020 Rule expanded the covered entities
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`subject to the reduction to include non-excepted off-campus provider-based departments, and the
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`2021 Rule continues that policy. The Secretary, in exceeding his scope of authority under the
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`Medicare Act and by reducing reimbursement payment for drugs purchased under the 340B
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`Program, unlawfully infringed on the Plaintiffs’ efforts to care for low-income and vulnerable
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`patients, in contravention of Congress’s intent in enacting the 340B Program. The challenged rules
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`took effect on January 1, 2018;January 1, 2019; January 1, 2020; and January 1, 2021.
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`2.
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`Congress enacted the 340B Program in 1992 and through the Program lowered the
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`cost of drugs purchased by certain public and not-for-profit hospitals and federally funded clinics
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`serving large numbers of low-income patients. By lowering hospitals’ purchase costs for patient
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`drugs, Congress enabled these hospitals to “stretch scarce Federal resources as far as possible,
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`reaching more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-
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`384(II), at 12 (1992). See also 82 Fed. Reg. at 52,493 & n.18 (quoting House report and noting
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`that “[t]he statutory intent of the 340B Program is to maximize scarce Federal resources as much
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`as possible, reaching more eligible patients”).
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`3.
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`Commencing January 1, 2018, CMS began reimbursing covered outpatient drugs
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`and biologicals acquired through the 340B Program at average sales price (ASP) minus 22.5%
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`when billed by a hospital paid under the OPPS. CMS continued this payment policy in CY 2019,
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`CY 2020, and CY 2021. Beginning with the 2020 OPPS Rule, CMS extended this payment policy
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`to non-excepted off-campus provider-based departments.
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`4.
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`As explained in comments to the CY 2018 OPPS Rule, see 82 Fed. Reg. at 52,499–
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`502, and by the United States District Court for the District of Columbia in the lawsuits that
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 17 of 31
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`followed its passage and application, the establishment of this improper rate exceeds the
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`Secretary’s authority, see Am. Hosp. Ass’n v. Azar, 348 F. Supp. 3d 62, 79-83 (D.D.C. 2018)
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`(“AHA I”) and Am. Hosp. Ass’n v. Azar, 385 F. Supp. 3d 1 (D.D.C. 2019) (“AHA II”) (holding that
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`the Secretary exceeded his authority when he reduced the 2018 and 2019 Medicare reimbursement
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`rate for pharmaceutical drugs covered by the “340B Program” by nearly 30%), consolidated on
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`appeal and rev’d, Am. Hosp. Ass’n v. Azar, 967 F.3d 818 (D.C. Cir. 2020), cert. petition pending,
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`No. 20-114 (U.S.).
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`5.
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`In accordance with this Court’s decisions in AHA I and AHA II, Plaintiffs bring this
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`action to seek relief from the Secretary’s prior actions and to secure injunctive relief from the 2021
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`OPPS Rule.
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`6.
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`As noted above and as discussed in this Court’s decisions in AHA I and AHA II, the
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`340B Program has lowered the cost of drugs purchased by certain public and not-for-profit
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`hospitals and federally funded clinics serving large numbers of low-income patients. In so doing,
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`Congress enabled these hospitals to “stretch scarce Federal resources as far as possible, reaching
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`more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-384(II),
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`at 12 (1992). The 340B Provisions of the 2018, 2019, 2020, and 2021 OPPS Rules specially target
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`the Medicare portion of this benefit of the Program for 340B hospitals that serve the poor. The
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`2018– 2021 OPPS Rules eliminate nearly all of the differential between national Medicare
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`reimbursement rates and the discounted purchase costs mandated for 340B hospitals, costing those
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`hospitals an estimated $3.2 billion, in violation of both the Secretary’s statutory authority under
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`the Social Security Act to reimburse hospitals for outpatient drugs and the purpose and design of
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`the Public Health Service Act provisions establishing the 340B Program.
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 18 of 31
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`7.
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`Plaintiffs have used the 340B Program to provide critical health care services to
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`their communities. Those hospitals and their poor and underserved patient populations have
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`suffered, and will continue to suffer, harm from the negation of the cost-reimbursement differential
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`through the 340B Provisions of the 2018–2021 OPPS Rules.
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`8.
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`Plaintiffs are entitled to declaratory and injunctive relief, including a preliminary
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`injunction setting aside the 340B Provisions of the 2021 OPPS Rule pending resolution of this
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`action.
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`PARTIES
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`9.
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`At all times relevant to this Complaint, Plaintiffs were qualified as Medicare-
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`participating providers under the Medicare Act and have participated in the 340B Program.
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`10.
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`Plaintiffs participate in the 340B Program and rely heavily on the price differential
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`created by Congress through that Program to generate resources that are used to provide critical
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`health care programs to the vulnerable populations they serve. Plaintiffs have been significantly
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`harmed by the elimination of this differential from Medicare payments in the 2018–2021 OPPS
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`Rules and will continue to be significantly harmed if those Rules remain in effect.
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`11.
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`The 340B Provisions of the 2018–2021 OPPS Rules severely threaten Plaintiffs’
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`ability to provide critical health care programs to their communities, including the underserved
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`populations in those communities, by depriving Plaintiffs of millions of dollars of savings
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`previously generated from the differential between Medicare reimbursements and 340B discounts.
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`12.
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`Defendant Xavier Becerra (“the Secretary”) is the Secretary of the Department of
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`Health and Human Services, the federal department which encompasses CMS. The Secretary, the
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`federal official responsible for the administration of the Medicare Program, has delegated to CMS
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`the responsibility to administer that program. Secretary Becerra is sued in his official capacity.
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 19 of 31
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`JURISDICTION AND VENUE
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`13.
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`This action arises under Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395,
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`et seq., section 340B of the Public Health Services Act, 42 U.S.C. § 256b, and the Administrative
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`Procedure Act, 5 U.S.C. §§ 701–06.
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`14.
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`This Court has subject matter jurisdiction over this action under 42 U.S.C. § 405
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`and 28 U.S.C. § 1331.
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`15.
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`This judicial district is an appropriate venue pursuant to 28 U.S.C. § 1391(e),
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`42 U.S.C. § 405(g), and 42 U.S.C. § 1395ff(b)(2)(C)(iii).
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`STATUTORY AND REGULATORY BACKGROUND
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`A.
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`The 340B Program
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`16.
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`Congress established the 340B Program in 1992 as part of the Public Health Service
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`Act. The 340B Program provides certain hospitals serving a disproportionate share of low-income
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`individuals and federally-funded clinics (called “covered entities” in the statute) with outpatient
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`prescription drug discounts comparable to those that Congress had made available to state
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`Medicaid agencies in 1990. Under the 340B Program, private prescription drug manufacturers, as
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`a condition of having their outpatient drugs be reimbursable through state Medicaid programs, are
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`required to offer covered entities discounts calculated pursuant to a statutory formula. 42 U.S.C.
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`§ 256b(a)(1). The purpose of the Program is to enable eligible public and not-for-profit hospitals
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`and other covered institutions to use their scarce resources to reach more patients, and to provide
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`more comprehensive services.
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`17.
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`Since the 340B Program was first implemented, covered entities have retained all
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`savings generated through the program and have used those savings to provide additional critical
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`health care services for their communities, including underserved populations within those
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 20 of 31
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`communities. Those critical health care services include the provision of patient education
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`programs, translation services, transportation services and increased service locations.
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`18.
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`Recognizing the value of the 340B Program, Congress has increased the categories
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`of eligible “covered entities.” In 1992, when Congress first created the Program, “covered entities”
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`included federally-funded health centers and clinics providing services such as family planning,
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`AIDS intervention, and hemophilia treatment, as well as public and certain not-for-profit hospitals
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`serving a large proportion of low-income populations. See 42 U.S.C. §§ 256b(a)(4)(A)-(E),
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`(G), (L). In 2010, as a part of the Affordable Care Act, Congress expanded “covered entities” to
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`include certain children’s hospitals, free-standing cancer hospitals, critical access hospitals, and
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`sole community hospitals. See 42 U.S.C. § 256b(a)(4)(M)-(O). Pursuant to the 2020 OPPS Rule,
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`“covered entities” also include non-excepted off-campus provider-based departments. See 84 Fed.
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`Reg. at 61,181.
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`19.
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`Plaintiffs are “covered entities” under the 340B Program and are paid under the
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`OPPS system.
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`B. Medicare OPPS Reimbursement
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`20.
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`In 1997, Congress sought to control Medicare expenditures for outpatient services
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`and directed CMS to develop a hospital Outpatient Prospective Payment System (“OPPS”) for
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`Medicare to pay for services offered by hospitals’ outpatient departments. See 42 U.S.C. § 1395l.
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`CMS updates the OPPS payment rates annually.
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`21.
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`Beginning in 2004, Congress directed CMS to set reimbursement rates for
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`separately payable drugs, i.e., covered outpatient drugs that are not bundled into the price of an
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`outpatient service. These drugs include outpatient drugs covered under the 340B Program.
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`22.
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`The statute provides two avenues to CMS for setting Medicare reimbursement rates
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`for separately payable drugs in 2006 and subsequent years. Under Subclause I of the statute, CMS
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 21 of 31
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`must set rates based on the acquisition costs of these drugs, if specified statistically sound survey
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`data on acquisition costs are available for each drug. 42 U.S.C. § 1395l(t)(14)(A)(iii)(I). Under
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`Subclause II, if the specified acquisition costs data are not available, CMS is required to reimburse
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`based on average sales price (“ASP”)—a defined quantity under a different statutory provision—
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`plus 6%. 42 U.S.C. § 1395l(t)(14)(A)(iii)(II).
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`23.
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`In 2012, after concluding that it could not obtain the acquisition cost required in
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`order to reimburse under Subclause I based on acquisition cost, CMS adopted the reimbursement
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`method under Subclause II—the statutory default rate of ASP plus 6%—for all separately payable
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`drugs. This statutory default rate was applied without further adjustments for each subsequent
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`year, until January 1, 2018.
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`C.
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`CMS’s Reduction to Payment Rate for 340B Drugs
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`24.
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`On July 13, 2017, CMS issued its proposed rule on OPPS and Ambulatory Surgical
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`Center payment systems for the CY 2018. In addition to updating the OPPS with 2018 rates, CMS
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`proposed to change how Medicare pays certain hospitals for separately payable drugs purchased
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`under the 340B Program. 82 Fed. Reg. 33,558, 33,634 (July 20, 2017). Specifically, it proposed
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`to lower the Medicare reimbursement rate for such drugs from the previous rate of ASP plus 6%
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`to ASP minus 22.5%—a reduction of 28.5% in the reimbursement rate. Id. at 33,634.
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`25.
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`On November 13, 2017, CMS issued the final version of the 340B Provisions of
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`the 2018 OPPS rule, adopting the proposed rate of ASP minus 22.5% for drugs purchased under
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`the 340B Program. 82 Fed. Reg. at 52,362.
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`26.
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`This new reimbursement rate nearly eliminated the benefit of the 340B Program for
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`certain covered entities by eliminating the difference between the purchase price paid by hospitals
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`for those drugs and Medicare payments to hospitals for those drugs.
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 22 of 31
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`27.
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`For its authority to reduce the reimbursement rate for certain 340B drugs by nearly
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`30%, CMS purported to rely on 42 U.S.C. § 1395l(t)(14)(A)(iii)(II), which allows the Secretary to
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`“calculate” and “adjust” the statutory default rate of ASP plus 6%. See, e.g., 82 Fed. Reg. at 52,499
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`(noting that “calculate and adjust” authority gives the Secretary “broad discretion” to adjust
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`payments for drugs). The 340B Provisions of the 2018 OPPS Rule exceed the Secretary’s authority
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`because the reduction set forth in the Rule is expressly based on the estimated acquisition costs of
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`340B drugs, i.e., a variation of the cost-based methodology set forth under Subclause I of the
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`applicable statutory provision, 42 U.S.C. § 1395l(t)(14)(A)(iii)(I). See, e.g., 82 Fed. Reg. at
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`52,501. Because CMS, by its own admission, cannot now and has never been able to reliably
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`collect the statistically significant cost data for each drug required under the statute to invoke
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`Subclause I, it improperly sought to use aggregate acquisition costs as estimated by the Medicare
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`Payment Advisory Commission (“MedPAC”) as a proxy for that data in issuing the OPPS Rule –
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`even though payment under Subclause II expressly must be based on average sales price, not
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`acquisition costs. In doing so, the Secretary impermissibly invoked his authority under Subclause
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`II to circumvent the requirements under Subclause I.
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`28.
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`The Secretary’s authority under Subclause II of the applicable statutory provision,
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`42 U.S.C. § 1395l(t)(14)(A)(iii)(II), to “calculate” and “adjust” the ASP-plus-6% formula, does
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`not allow CMS to reduce the statutory rate by nearly 30%, depriving affected hospitals of drug-
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`price savings totaling an estimated $1.6 billion (CMS’s estimate). Rather, this authority only
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`permits the Secretary to calculate the ASP as set forth in the statute and to fine-tune the default
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`rate.
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`29.
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`The 340B Provisions of the 2018 OPPS Rule also exceed the Secretary’s authority
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`because they undermine the 340B Program by depriving eligible hospitals of a critical portion of
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`Case 1:21-cv-01651 Document 1 Filed 06/18/21 Page 23 of 31
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`the resources Congress intended to provide those hospitals through 340B discounts. Elimination
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`of these resources has and will continue to put public and not-for-profit covered entities into even
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`more precarious financial situations, curtailing their ability to provide essential health care services
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`and programs to their communities, including underserved populations within those communities.
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`This is inconsistent with the intent of the 340B Program, which was designed to help covered
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`entities stretch scarce federal resources to reach more eligible patients. CMS’s efforts in the 340B
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`Provisions of the 2018 OPPS Rule to “align” (82 Fed. Reg. at 52,495) the purchase price of 340B
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`drugs with reimbursements for those drugs is directly contrary to Congress’ intent to create a
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`differential between reimbursements and purchase prices and thereby to generate resources for
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`covered entities to use in their communities.
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`30.
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`The new payment rate set forth in the 340B Provisions of the 2018–2021 OPPS
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`Rules have substantially impacted the day-to-day operations of many covered entities, including
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`Plaintiffs. These Hospitals rely on the 340B savings, and the price differential Congress created
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`through that program, to provide vital health services to their communities, including vulnerable
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`and underserved populations within those communities. Elimination of the differential in
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`co