NOTICES
Update of List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[31 Pa.B. 4498] In accordance with 31 Pa. Code §§ 89.806(a) and 89.907(b) (relating to coverage of child immunizations; immunizing agents, doses and AWPs), the Department of Health, Bureau of Communicable Diseases, Division of Immunization (Department) is updating 31 Pa. Code §§ 89.801--89.809, Appendix G (relating to ACIP recommendations prescribing child immunization practices) and Appendix H (relating to immunizing agents and doses). The Department has primary responsibility for the interpretation and the implementation of 31 Pa. Code §§ 89.806 and 89.807. See 31 Pa. Code § 89.801(b).
Health insurance policies are required by the Childhood Immunization Insurance Act (40 P. S. §§ 3501--3508) and regulations promulgated thereunder (see 31 Pa. Code §§ 89.801--89.809 (relating to childhood immunization insurance)) to include coverage for certain childhood immunizations, unless the policies are exempted by the act and 31 Pa. Code § 89.809 (relating to exempt policies). The childhood immunizations covered are those that meet Advisory Committee on Immunization Practices (ACIP) standards in effect on May 21, 1992 (see 31 Pa. Code § 89.806(a)). A list of the MMWR publications containing ACIP recommendations issued under the ACIP standards in effect on May 21, 1992 appears in 31 Pa. Code §§ 89.801--89.809, Appendix G.
The Department is required to update the list of these MMWR publications appearing in 31 Pa. Code §§ 89.801--89.809, Appendix G. See 31 Pa. Code § 89.806(a). The additions to the list are as follows, the remainder of the list at Appendix G remains in full force and effect:
''Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children,'' MMWR, March 28, 1997/Vol. 46/No. RR-7.
''Prevention of Pneumococcal Disease,'' MMWR, April 4, 1997/Vol. 46/No. RR-8.
''Measles, Mumps, and Rubella--Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps,'' MMWR, May 22, 1998/Vol. 47/No. RR-8.
''Human Rabies Prevention--United States, 1999,'' MMWR, January 8, 1999/Vol 48/No. RR-1.
''Prevention of Varicella Updated,'' MMWR, May 28, 1999/Vol. 48/No. RR-6.
''Prevention of Hepatitis A Through Active or Passive Immunization,'' MMWR, October 1, 1999/Vol. 48/No. RR-12.
''Poliomyelitis Prevention in the United States,'' MMWR, May 19, 2000/Vol. 49/No. RR-5.
''Prevention and Control of Meningococcal Disease and Meningococcal Disease and College Students,'' MMWR, June 30, 2000/Vol. 49/No. RR-7.
''Preventing Pneumococcal Disease Among Infants and Young Children,'' MMWR, October 6, 2000/Vol. 49/No. RR-9.
''Use of Diphtheria Toxoid-Tetanus Toxoid-Acellular Pertussis Vaccine as a Five-Dose Series,'' MMWR, November 17, 2000/Vol. 39/No.13.
''Prevention and Control of Influenza,'' MMWR, April 20, 2001/Vol 50/No. RR-4.
The Department is also required to update information relating to immunizing agents and doses that the Department has extracted from ACIP recommendations issued under the standards in 31 Pa. Code § 89.806(a). See 31 Pa. Code § 89.807(b). The Department is also to periodically list the average wholesale price (AWP) for immunizing agents. Id. This information currently appears in 31 Pa. Code §§ 89.801--89.809, Appendix H. The updated information is as follows, the remainder of the information in Appendix H remains in full force and effect:
Vaccine Type Company Pct Name Product Name NDC Purchase No. Unit Dose AWP/Dose Diphtheria Tetanus acellular Pertussis Vaccine (DtaP): Aventis Pasteur Tripedia 49281-0288-10 10 x 1 0.5 ml $23.97 GlaxoSmithKline Infanrix 58160-0840-11 10 x 1 0.5 ml $22.05 Diphtheria Tetanus pediatric Vaccine (DT pediatric): Aventis Pasteur DT Pediatric 49281-0275-10 5.0 ml 0.5 ml $9.28 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DtaP-HIB):
Aventis Pasteur TriHIBit 49281-0557-05 5 x 1 0.5 ml $42.64 Tetanus Diphtheria adult Vaccine (Td adult): Aventis Pasteur Td Adult syringe 49281-0271-10 10 x 1 0.5 ml $11.21 Aventis Pasteur Td Adult 49281-0271-83 5.0 ml 0.5 ml $9.28 Haemophilus Influenzae B Vaccine (HIB): Wyeth-Lederle HibTITER 0005-0104-32 5 x 0.5 0.5 ml $28.38 Aventis Pasteur ActHIB 49281-0545-05 5 x 1 0.5 ml $25.10 Merck & Co. Pedvax HIB 0006-4897-00 10 x 0.5 0.5 ml $23.42 Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):
Aventis Pasteur IPOL 49281-0860-51 1 x 1 0.5 ml $28.95 Aventis Pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $23.31 Aventis Pasteur IPOL 49281-0860-52 10 x 1 0.5 ml $28.95 Measles Mumps Rubella Vaccine (MMR): Merck & Co. MMR II 0006-4749-00 0.5 ml 0.5 ml $41.51 Merck & Co. MMR II 0006-4681-00 10 x 0.5 0.5 ml $36.16 Measles Vaccine (Rubeola):
Merck & Co. Atenuvax 0006-4709-00 0.5 ml 0.5 ml $16.60 Merck & Co. Atenuvax 0006-4589-00 10 x 0.5 0.5 ml $13.34 Mumps Vaccine (Mumps):
Merck & Co. Mumpsvax 0006-4753-00 0.5 ml 0.5 ml $19.13 Merck & Co. Mumpsvax 0006-4584-00 10 x 0.5 0.5 ml $17.21 Rubella (German Measles):
Merck & Co. Meruvax II 0006-4747-00 0.5 ml 0.5 ml $17.39 Merck & Co. Meruvax II 0006-4673-00 10 x 0.5 0.5 ml $14.84 Hepatitis A Vaccine Pediatric (HEP-A): Merck & Co. VAQTA 0006-4831-00 0.5 ml 0.5 ml $32.78 Merck & Co. VAQTA 0006-4831-38 5 x 0.5 0.5 ml $30.93 Merck & Co. VAQTA syringe 0006-4845-00 0.5 ml 0.5 ml $32.78 Merck & Co. VAQTA syringe 0006-4845-38 5 x 0.5 0.5 ml $30.93 GlaxoSmithKline Havrix 58160-0836-01 0.5 ml 0.5 ml $29.75 GlaxoSmithKline Havrix 58160-0837-01 0.5 ml 0.5 ml $29.75 GlaxoSmithKline Havrix 58160-0837-11 10 x 0.5 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0837-26 25 x 0.5 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0837-35 5 x 0.5 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0837-56 25 x 0.5 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0837-58 25 x 0.5 0.5 ml $29.75 Hepatitis A Vaccine Adult (HEP-A):
Merck & Co. VAQTA 0006-4841-00 1.0 ml 1.0 ml $65.58 Merck & Co. VAQTA 0006-4841-38 5 x 1.0 1.0 ml $61.86 Merck & Co. VAQTA syringe 0006-4844-00 1.0 ml 1.0 ml $65.58 Merck & Co. VAQTA syringe 0006-4844-38 5 x 1.0 1.0 ml $61.86 GlaxoSmithKline Havrix 58160-0835-01 0.5 ml 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0835-32 1 x 0.5 0.5 ml $29.75 GlaxoSmithKline Havrix syringe 58160-0835-35 5 x 0.5 0.5 ml $29.75 Hepatitis B Vaccine (HEP-B):
Merck & Co. (1) Recombivax HB 00006-4980-00 0.5 ml 0.5 ml $27.70 Merck & Co. (1) Recombivax HB 00006-4981-00 10 x 0.5 0.5 ml $26.36 Merck & Co. (2) Recombivax HB 00006-4769-00 0.5 ml 0.5 ml $27.70 Merck & Co. (2) Recombivax HB 00006-4876-00 10 x 0.5 0.5 ml $26.36 Merck & Co. (2) Recombivax HB 00006-4849-00 5 x 0.5 0.5 ml $27.72 Merck & Co. (2) Recombivax HB 00006-4969-00 5 x 0.5 0.5 ml $27.72 Merck & Co. (3) Recombivax HB 00006-4773-00 3.0 ml 0.5 ml $33.96 Merck & Co. (3) Recombivax HB 00006-4775-00 1.0 ml 1.0 ml $67.98 Merck & Co. (3) Recombivax HB 00006-4872-00 10 x 1.0 1.0 ml $67.28 Merck & Co. (3) Recombivax HB 00006-4873-00 10 x 3.0 0.5 ml $33.65 Merck & Co. (3) Recombivax HB 00006-4848-00 5 x 1.0 1.0 ml $67.99 GlaxoSmithKline (4) Engerix-B 58160-0856-01 0.5 ml 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B 58160-0856-11 10 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-35 5 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-26 25 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-36 5 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-27 25 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-56 25 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-58 25 x 0.5 0.5 ml $24.20 GlaxoSmithKline (4) Engerix-B
syringe58160-0856-57 25 x 0.5 0.5 ml $24.20 GlaxoSmithKline (5) Engerix-B 58160-0857-01 1.0 ml 1.0 ml $24.20 GlaxoSmithKline (5) Engerix-B 58160-0857-16 25 x 1.0 1.0 ml $24.20 GlaxoSmithKline (5) Engerix-B
syringe58160-0857-35 5 x 1.0 1.0 ml $24.20 GlaxoSmithKline (5) Engerix-B
syringe58160-0857-26 25 x 1.0 1.0 ml $24.20 (1) Pediatric low risk formulation @ 5 mcg/ml
(2) Adolescent/infant high risk formulation @ 10 mcg/ml
(3) Adult formulation @ 10 mcg/0.5 ml
(4) Pediatric formulation @ 10 mcg/0.5 ml
(5) Adult formulation @ 20 mcg/mlHepatitis B/HIB
Merck & Co. COMVAX 0006-4843-00 0.5 ml 0.5 ml $52.28 Merck & Co. COMVAX 0006-4898-00 10 x 0.5 0.5 ml $49.50 Hepatitis A & Hepatitis B Vaccine: GlaxoSmithKline Twinrix 58160-0850-01 1.0 ml 1.0 ml $94.73 GlaxoSmithKline Twinrix 58160-0850-11 10 x 1.0 1.0 ml $94.73 GlaxoSmithKline Twinrix syringe 58160-0850-35 5 x 1.0 1.0 ml $94.73 Influenza (split virus) Vaccine: Aventis Pasteur Fluzone/syringe 49281-0364-11 10 x 0.5 0.5 ml $8.50 Evans Fluvirin 19650-0103-10 5.0 ml 0.5 ml $4.50 Evans Fluvirin/syringe 19650-0103-01 10 x 0.5 0.5 ml $5.60 Wyeth-Lederle Flu-Shield 0008-0986-01 5.0 ml 0.5 ml $6.62 Influenza (whole virus) Vaccine: Aventis Pasteur Fluzone 49281-0364-15 5.0 ml 0.5 ml $5.00 Rabies Vaccine:
Aventis Pasteur Imovax Rabies 49281-0250-10 1.0 ml 1.0 ml $151.38 Pneumococcal Vaccine:
Wyeth-Lederle Prevnar 0005-1970-67 5 x 0.5 0.5 ml $73.25 Wyeth-Lederle Pnu-Immune 23 0005-2309-31 5 x 0.5 0.5 ml $16.04 Wyeth-Lederle Pnu-Immune 23
syringe0005-2309-33 5 x 0.5 0.5 ml $17.99 Merck & Co. Pneumovax 23 0006-4793-00 2.5 ml 0.5 ml $13.06 Merck & Co. Pneumovax 23 0006-4943-00 10 x 0.5 0.5 ml $14.66 Merck & Co. Pneumovax 23
syringe0006-4894-00 5 x 0.5 0.5 ml $19.58 Meningococcal Vaccine:
Aventis Pasteur Menomune 49281-0489-05 5 x 0.5 0.5 ml $70.30 Aventis Pasteur Menomune 49281-0489-91 5.0 ml 0.5 ml $67.00 Varicella Virus Vaccine Live (Chickenpox):
Merck & Co. Varivax* 00006-4827-00 10 x 0.5 0.5 ml $59.52 Merck & Co. Varivax* 00006-4826-00 0.5 ml 0.5 ml $62.44 *Comes with a box of 10 vials of diluent (package B: 00006-4309-00)
Gamma Globulin/Immune Globulin (GG/IG):
Bayer Gamimune N 10% 0026-0648-12 10.0 ml 2.0 ml $90.00/g Bayer Gamimune N 10% 0026-0648-15 25.0 ml 2.0 ml $90.00/g Bayer Gamimune N 10% 0026-0648-20 50.0 ml 2.0 ml $90.00/g Bayer Gamimune N 10% 0026-0648-71 100.0 ml 2.0 ml $90.00/g Bayer Gamimune N 10% 0026-0648-24 200.0 ml 2.0 ml $90.00/g *Dosage will vary depending upon the weight of the child and the disease for which the child is being immunized. 150 Pct AWP/Dose is to be calculated based upon the dosage used. Hepatitis B Immune Globulin (HBIG):
NABI NABI-HB 59730-4402-01 1.0 ml 1.0 ml $175.00 NABI NABI-HB 59730-4403-01 5.0 ml 5.0 ml $700.00 Varicella-Zoster Immune Globulin (VZIG): Mass. PHBL VZIG 52769-0574-11 125 u 250 u* $125.00 Mass. PHBL VZIG 52769-0574-66 625 u 250 u* $562.50 *Dosage will vary depending upon the weight of the child. If any portion of a vial is used to immunize a child, and the remainder cannot be used to immunize another individual, the entire vial shall be considered as part of the dosage used. 150 Pct LST/Dose is to be calculated based upon the dosage used.
**LST (list price) is used instead of AWP. This product has no AWP. LST may fluctuate slightly, depending on where the product is purchased.Rabies Immune Globulin (RIG):
Aventis Pasteur Imogam Rabies-HT 49281-0190-10 10.0 ml 1.0 ml* $77.50 Aventis Pasteur Imogam Rabies-HT 49281-0190-20 2.0 ml 1.0 ml* $77.50 *Dosage will vary depending upon the weight of the child. Each 1.0 ml contains 150 IU units. If any portion of the vial is used to immunize a child, and the remainder cannot be used to immunize another individual, the entire vial shall be considered as part of the dosage used. 150 Pct AWP/Dose is to be calculated based upon the dosage used. Tetanus Immune Globulin (TIG): Bayer Baytet syringe 00260-0634-01 1.0 ml 1.0 ml $120.00 Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille), should contact Alice Gray, Director, Division of Immunization, Pennsylvania Department of Health, P. O. Box 90, Harrisburg, Pa 17108-0090 (717) 787-5681 or at V/TT: (717) 783-6154 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984 [TT].
ROBERT S. ZIMMERMAN, Jr.,
Secretary
[Pa.B. Doc. No. 01-1470. Filed for public inspection August 10, 2001, 9:00 a.m.]
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