677 Update of the list of citations to ACIP recommendations prescribing child immunization practices and immunizing agents and doses
Update of the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses [36 Pa.B. 1949] In accordance with 31 Pa. Code §§ 89.806(a) and 89.807(b) (relating to coverage of child immunizations; and immunizing agents, doses and AWPs), the Department of Health, Bureau of Communicable Diseases, Division of Immunization (Department) is updating 31 Pa. Code Chapter 89, Appendices G and H (relating to ACIP recommendations prescribing child immunization practices; and 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) (relating to authority and purpose; implementation).
Health insurance policies are required by the Childhood Immunization Insurance Act (act) (40 P. S. §§ 3501--3508) and regulations promulgated thereunder, 31 Pa. Code Chapter 809, Subchapter L (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 Morbidity and Mortality Weekly Report (MMWR) publications containing ACIP recommendations issued under the ACIP standards in effect on May 21, 1992 appears in 31 Pa. Code Chapter 89, Appendix G.
The Department is required to update the list of these MMWR publications in 31 Pa. Code Chapter 89, Appendix G. See 31 Pa. Code § 89.806(a). The additions to the list are as follows. The remainder of the list in 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:
The Department is required to update the list of these MMWR publications in 31 Pa. Code Chapter 89, Appendix G. See 31 Pa. Code § 89.806(a). The additions to the list are as follows. The remainder of the list in 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:
September 2, 2005/Vol. 54/No. 34
* Update: Influenza Vaccine Supply and Recommendations for Prioritization During the 2005-06 Influenza Season
September 16, 2005/Vol. 54/No. 36
* Direct and Indirect Effects of Routine Vaccination of Children with 7-Valent Pneumococcal Conjugate Vaccine on Incidence of Invasive Pneumococcal Disease--United States, 1998-2003
* Update: Influenza Activity--United States and Worldwide, May 22--September 3, 2005, and 2005-06 Season Vaccination Recommendations
October 14, 2005/Vol. 54/No. 40
* Guillain-Barre Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine--United States, June--July 2005
* Notice To Readers: FDA Approval of VAQTA® (Hepatitis A Vaccine, Inactivated) for Children Aged > 1 Year
* QuickStats: Rate of Hospitalizations for Pertussis Among Infants Aged < 6 Months--United States, 1994-1998 and 1999-2003
December 2, 2005/Vol. 54/No. 47
* Notice to Readers: Licensure of a Combined Live Attenuated Measles, Mumps, Rubella, and Varicella Vaccine
February 3, 2006/Vol. 55/No. 4
* Childhood Influenza Vaccination Coverage--United States, 2003-04 Influenza Season
January 6, 2006/Vol. 54/Nos. 51 and 52
* MMWR QuickGuide Recommended Childhood and Adolescent Immunization Schedule--United States, 2006
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 Chapter 89, Appendix H. The updated information is as follows:
2006 List of Immunizing Agents and Average Wholesale Prices Product Name, Company Brand/Product Name NDC Number Unit Dose AWP/
Dose*Diphtheria Tetanus acellular Pertussis Vaccine (DTaP): sanofi pasteur Tripedia 49281-0298-10 10 × 1 0.5 ml $26.18 sanofi pasteur Daptacel 49281-0286-10 10 × 1 0.5 ml $26.00 GlaxoSmithKline Infanrix 58160-0840-11 10 × 1 0.5 ml $24.70 GlaxoSmithKline Infanrix 58160-0840-46 5 × 0.5 0.5 ml $25.28 Tetanus Diphtheria acellular Pertussis Vaccine (TdaP): sanofi pasteur Adacel 49261-0400-10 10 × 1 0.5 ml $42.45 GlaxoSmithKline Boosterix 58160-0842-11 10 × 1 0.5 ml $41.85 GlaxoSmithKline Boosterix 58160-0842-46 5 × 1 0.5 ml $41.85 Diphtheria Tetanus pediatric Vaccine (DT pediatric): sanofi pasteur DT Pediatric 49281-0275-10 5.0 ml 0.5 ml $21.96 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB) sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $51.40 Tetanus Diphtheria adult Vaccine (Td adult): sanofi pasteur (1) Td Adult 49281-0271-83 5.0 ml 0.5 ml $22.70 sanofi pasteur (2) Decavac 49281-0291-10 10 × 1 0.5 ml $21.66 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV) GlaxoSmithKline Pediarix 58160-0841-11 10 × 1 0.5 ml $84.11 GlaxoSmithKline Pediarix 58160-0841-46 5 × 1 0.5 ml $84.12 Tetanus Toxoid sanofi pasteur Tetanus toxoid 49281-0820-10 10 × 5 0.5 ml $22.17 Haemophilus Influenzae B Vaccine (HIB): Wyeth Pharmaceuticals HibTITER 0005-0104-32 5 × 0.5 0.5 ml $25.54 Wyeth Pharmaceuticals HibTITER 0005-0104-10 10 × 1 100 mcg $25.68 sanofi pasteur ActHIB 49281-0545-05 5 × 1 0.5 ml $27.04 Merck & Co. Pedvax HIB 0006-4897-00 10 × 0.5 0.5 ml $27.17 Injectable Polio Vaccine Inactivated (Salk Enhanced IPV): sanofi pasteur IPOL 49281-0860-10 10 × 5 0.5 ml $27.35 sanofi pasteur IPOL 49281-0860-55 10 × 5 0.5 ml $31.45 Measles Mumps Rubella Vaccine (MMR): Merck & Co. MMR II 0006-4749-00 0.5 ml 0.5 ml $44.72 Merck & Co. MMR II 0006-4681-00 10 × 0.5 0.5 ml $48.00 Measles Vaccine (Rubeola): Merck & Co. Atenuvax 0006-4709-00 0.5 ml 0.5 ml $17.73 Merck & Co. Atenuvax 0006-4589-00 10 × 0.5 0.5 ml $17.73 Meninigococcal Vaccine (MCV4): sanofi pasteur Menactra 49281-0589-01 0.5 ml 0.5 ml $98.40 sanofi pasteur Menactra 49281-0589-05 5 × 1 0.5 ml $98.40 Mumps Vaccine (Mumps): Merck & Co. Mumpsvax 0006-4753-00 0.5 ml 0.5 ml $20.45 Merck & Co. Mumpsvax 0006-4584-00 10 × 0.5 0.5 ml $22.95 Rubella (German Measles): Merck & Co. Meruvax II 0006-4747-00 0.5 ml 0.5 ml $18.57 Merck & Co. Meruvax II 0006-4673-00 10 × 0.5 0.5 ml $19.76 Hepatitis A Vaccine Pediatric (HEP-A): Merck & Co. VAQTA 0006-4831-00 0.5 ml 0.5 ml $34.56 Merck & Co. VAQTA 0006-4831-41 10 × 0.5 0.5 ml $32.66 Merck & Co. VAQTA syringe 0006-4845-00 0.5 ml 0.5 ml $35.30 Merck & Co. VAQTA syringe 0006-4845-38 5 × 0.5 0.5 ml $33.31 GlaxoSmithKline Havrix 58160-0837-01 0.5 ml 0.5 ml $30.11 GlaxoSmithKline Havrix 58160-0837-11 10 × 0.5 0.5 ml $28.79 GlaxoSmithKline Havrix syringe 58160-0837-50 25 × 0.5 0.5 ml $28.79 GlaxoSmithKline Havrix syringe 58160-0837-46 5 × 0.5 0.5 ml $28.79 Hepatitis A Vaccine Adult (HEP-A): Merck & Co. VAQTA 0006-4841-00 1.0 ml 1.0 ml $76.06 Merck & Co. VAQTA 0006-4841-38 5 × 1.0 1.0 ml $66.64 Merck & Co. VAQTA 0006-4841-41 10 × 1.0 1.0 ml $71.93 Merck & Co. VAQTA syringe 0006-4844-00 1.0 ml 1.0 ml $70.60 Merck & Co. VAQTA syringe 0006-4844-38 5 × 1.0 1.0 ml $66.64 Merck & Co. VAQTA pediatric 0006-4831-00 1 × 5 0.5 ml $38.41 Merck & Co. VAQTA pediatric 0006-4831-41 10 × 5 0.5 ml $36.29 GlaxoSmithKline Havrix 58160-0835-01 1.0 ml 1.0 ml $66.50 GlaxoSmithKline Havrix 58160-0835-41 1.0 ml 1.0 ml $65.08 GlaxoSmithKline Havrix syringe 58160-0835-46 5 × 1 1.0 ml $65.08 Hepatitis B Vaccine (HEP-B): Merck & Co. (1) Recombivax HB 00006-4980-00 0.5 ml 0.5 ml $27.26 Merck & Co. (1) Recombivax HB 00006-4981-00 10 × 0.5 ml 0.5 ml $25.93 Merck & Co. (3a,b) Recombivax HB 00006-4995-00 1.0 ml 1.0 ml $33.49 Merck & Co. (3a,b) Recombivax HB 00006-4995-41 10 × 1.0 1.0 ml $33.15 Merck & Co. (3c) Recombivax HB 00006-4992-00 1.0 ml 1.0 ml $93.31 GlaxoSmithKline (4) Engerix-B pediatric 58160-0856-01 0.5 ml 0.5 ml $25.64 GlaxoSmithKline (4) Engerix-B 58160-0856-11 10 × 0.5 0.5 ml $25.64 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-46 5 × 0.5 0.5 ml $25.64 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-35 5 × 0.5 0.5 ml $25.64 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-50 25 × 0.5 0.5 ml $23.07 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-57 25 × 0.5 0.5 ml $23.07 GlaxoSmithKline (5) Engerix-B 58160-0857-01 1.0 ml 1.0 ml $61.51 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-46 5 × 1.0 1.0 ml $60.27 GlaxoSmithKline Engerix-B syringe 58160-0857-16 25 × 1 1.0 ml $99.92 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-50 25 × 1.0 1.0 ml $54.24 (1) Pediatric/Adolescent formulation (preservative-free) 5mcg/.5ml (3a) Adult formulation (preservative free) 10 mcg/1 ml (3b) Two dose regimen for 11 through 15 years of age (preservative free) (3c) Dialysis formulation (preservative free) 40mcg/1ml Hepatitis B / HIB Merck & Co. COMVAX 0006-4898-00 10 × 0.5 0.5 ml $54.07 Hepatitis A & Hepatitis B Vaccine: GlaxoSmithKline Twinrix 58160-0850-01 1.0 ml 1.0 ml $84.96 GlaxoSmithKline Twinrix 58160-0850-11 10 × 1.0 1.0 ml $92.89 GlaxoSmithKline Twinrix syringe 58160-0850-46 5 × 1.0 1.0 ml $93.20 Influenza Vaccine: sanofi pasteur Fluzone PF 49281-0373-25 10 × 0.5 0.25 ml $25.92 sanofi pasteur Fluzone 49281-0374-11 10 × 1 0.5 ml $12.27 sanofi pasteur Fluzone 49281-0374-15 10 × 1 0.5 ml $9.18 MedImmune Flumist 66019-0101-01 10 × 1 0.5 ml $16.20 sanofi pasteur Fluzone 49281-0005-10 10 × 0.5 0.5 ml $16.50 sanofi pasteur Fluzone 49281-0005-50 10 × 0.5 0.5 ml $16.50 sanofi pasteur Fluzone 49281-0376-15 10 × 0.5 0.5 ml $16.50 Pneumococcal Vaccine: Wyeth Pharmaceuticals Prevnar 0005-1970-67 5 × 0.5 0.5 ml $82.95 Wyeth Pharmaceuticals Prevnar 0005-1970-00 10 × 1 0.5 ml $170.00 Merck & Co. Pneumovax 23 0006-4739-00 2.5 ml 0.5 ml $142.25 Merck & Co. Pneumovax 23 0006-4739-50 10 × 2.5 ml 0.5 ml $159.65 Merck & Co. Pneumovax 23 0006-4943-00 10 × 0.5 0.5 ml $31.93 Merck & Co. Pneumovax 23 syringe 0006-4894-00 5 × 0.5 0.5 ml $19.30 Varicella Virus Vaccine Live (Chickenpox): Merck & Co. Varivax** 00006-4827-00 10 × 0.5 0.5 ml $80.02 Merck & Co. Varivax** 00006-4826-00 0.5 ml 0.5 ml $83.93 **Comes with a box of 10 vials of diluent (package B: 00006-4309-00) Measles, Mumps Rubella and Varicella Vaccine Merck & Co. ProQuad*** 00006-4999-00 10 × 0.5 0.5 ml $140.52 Merck & Co. ProQuad*** 00006-4984-00 0.5 ml 0.5 ml $147.30 ***Comes with a box of 10 vials of diluent (package B: 00006-4309-00) * Indicates the Estimated Acquisition Cost (EAC) as stated in the Department of Public Welfare, Office of Medical Assistance Programs, Medical Assistance Regulations at 55 Pa. Code § 1121.55 (relating to method of payment).
Persons with disability who require an alternative format of this notice (for example, large print, audiotape, Braille), should contact Alice Gray, Director, Department of Health, Division of Immunizations, Room 1026, Health and Welfare Building, Harrisburg, PA 17120, (717) 787-5681 or for speech and/or hearing impaired persons, V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
CALVIN B. JOHNSON, M. D., M.P.H.,
Secretary[Pa.B. Doc. No. 06-677. Filed for public inspection April 21, 2006, 9:00 a.m.]