By Michael D.I. Siget, JD, MPA, PAMED's Legislative & Regulatory Counsel
By a vote of 5-0, the Pennsylvania Independent Regulatory Review Commission approved the Department of Health's regulations regarding school immunizations on Oct. 20, 2016. At the hearing, the Pennsylvania Department of Health (DOH) indicated that the regulations were published in March 2017 so that they are in effect for the 2017-2018 school year.
Read five things key changes that came out of the new immunization regulations.
The regulatory package is voluminous in its scope, as it includes DOH's responses to the various comments (almost 300) that it received on its proposed regulations that were issued in April 2016. Under the law, DOH was required to answer each comment it received with an explanation why it was or was not revising its proposed regulations based upon the comments received.
In total, DOH's preamble, which includes its reasons for making changes to the proposed regulations, totals 331 pages. DOH's Regulatory Analysis Form, which includes de-identified school immunization data, totals 85 pages.
Five-day provision period remains; no change to religious or philosophical exemptions (Preamble Part 2 starting on pg. 238)
One of the major changes DOH is seeking to make is the reduction of the eight-month provisional period.
Currently, children may be provisionally admitted to school for up to an eight-month period if the child has a plan for the completion of required immunizations in the child's school health record or, in the case of a multiple dose vaccine, if the child has received one dose and there is a plan for completion of the remaining doses in the child's health record.
In its proposed regulations, DOH sought to reduce this provisional period to five days, with requirements that differ for single-dose and multiple-dose vaccines. If a child does not have a requisite single-dose vaccine, the child would be excluded from school.
For multiple dose vaccines, one of the following requirements would apply:
- A child would be excluded from school for lack of the first dose of a multiple dose vaccine.
- A child would be provisionally admitted to school for a five-day school period if a child receives the final dose of a multiple dose vaccine within five school days of the child's first day of school.
- If a child has the first dose of a multiple dose vaccine series, is scheduled to and does receive the next dose during the five-school-day provisional period, and provides a medical certificate scheduling the remaining doses, the child may attend school so long as he/she adheres to the medical certificate schedule.
- If a child needs additional doses of a multiple dose vaccine series to meet the requirements, but the next dose is not medically appropriate during the five school days, the child's parent or guardian must provide a medical certificate scheduling those additional doses on or before the fifth school day.
This provision elicited the most comments by far, both for and against. After reviewing all of the comments, DOH decided to keep the five-day provisional period. DOH is not proposing to make any changes to its regulations concerning religious or philosophical exemptions.
Comments regarding school nurse access to immunization data from physicians (Preamble Part 1 starting on pg. 90)
In this section, DOH answered comments received by school nurses who stated that doctors' offices refuse to provide immunization records to school nurses by claiming doing so would be a HIPAA violation. DOH noted that it cannot change the HIPAA requirements because that is federal law.
However, DOH indicated that HIPAA has an exception for public health programs, including reporting programs. Therefore, if DOH were to add a section to the Department's regulations relating to communicable and non-communicable diseases (28 Pa. Code Ch. 27) requiring reporting of vaccine administration to DOH's Statewide Immunization Information System (SIIS), this could address concerns raised by school nurses.
Such an action would require a separate rulemaking by DOH in the future.
The IRRC hearing is scheduled for Oct. 20, 2016 at 333 Market Street, 14th Floor Conference Room, Harrisburg, Pa., 17101. The hearing is open to the public.
At that meeting, IRRC Commissioners will hear testimony from DOH and vote up or down on the regulations.
If you cannot attend the hearing but would like to comment
on DOH's final-form regulations, you may do so up to 48 hours prior to the
beginning of the IRRC public meeting. The 48-hour embargo period begins at
10:00 a.m. on October 18. The email address is email@example.com.
You may also send written comments to the address listed
above. Be sure to indicate that your comments are related to DOH's school
immunization regulations that are being considered on Oct. 20. Comments
may also be submitted to DOH by contacting Cynthia Findley, Director, Division
of Immunization, Department of Health, 625 Forster St., Harrisburg, PA
17120. Any comments submitted to DOH should also be submitted to IRRC via
the email address or mailing address above.
Please note that all
correspondence and documents relating to a regulation submitted to DOH and IRRC
are a matter of public record and appear on IRRC’s Web site.
If the regulations are approved, DOH has indicated that they will go into effect Aug. 1, 2017 in time for the 2017-2018 school year.
To simplify the regulatory package, listed below are the page numbers where each of DOH's discussion points starts. At the end of this article are links to the various documents that were submitted to IRRC.
- Purpose and Background – pg. 1
- Summary and Overview of General Comments – pg. 4
- General comments in support of rulemaking – pg. 5
- General comments, recommendations, and concerns – pg. 11
- Comments regarding costs and paperwork and affected persons section of the Preamble and Regulatory Analysis Form (RAF) to Proposed Rulemaking – pg. 22
- Comments regarding VFC (Vaccines for Children) Program – pg. 35
- Comments regarding Whistleblower lawsuit against Merck – pg. 37
- Relation of vaccines to autism, chronic disease, injuries, illness – pg. 40
- Home Schooling – pg. 64
- Comments regarding "herd" or community immunity, vaccine effectiveness and natural immunity – pg. 67
- Comments regarding number of required immunizations – pg. 81
- Comments regarding communication of amendments – pg. 88
- Comments regarding HIPAA and the sharing of information between physicians and schools – pg. 90
- Comments regarding insurance coverage for immunizations – pg. 95
- General comments – pg. 98
- Comments opposing imposition of school vaccine requirements in violation of parental and human rights – pg. 103
- General comments in opposition to vaccination and vaccine additives – pg. 122
- Comments regarding combination vaccines – pg. 131
- Comments regarding vaccine safety – pg. 142
- Comments regarding pharmaceutical companies and vaccines – pg. 148
- Comments regarding accuracy of electronic medical records – pg. 152
- Comments regarding specific sections of the rulemaking – pg. 153
B. Preamble, Part 2
- a. Definitions – pg. 153
- b. Immunization Requirements – pg. 153
- c. Required for attendance – pg. 158 – 166; Preamble Part 2 (167-202)
- d. Comments in support of the 12th grade MCV requirement – pg. 202
- e. Comments requesting addition of other meningitis vaccines – pg. 203
- f. Comments opposing the addition of an MCV requirement for cost and potential side effects – pg. 204
- g. Comments relating to vaccine "kick-backs" – pg. 221
- h. Comments relating to reporting and paperwork requirements – pg. 221
- i. Comments relating to college attendance – pg. 222
- j. Legislative action to require 12th grade dose – pg. 224
- k. Comments regarding the National Childhood Vaccine Injury Act and Program – pg. 226
- l. Application of 12th grade MCV requirements – pg. 232
- m. Responsibilities of schools and school administrators – pg. 238
- i. In Favor of 5-Day Provisional Period – pg. 251
- ii. Opposed to a 5-Day Provisional Period – pg. 253
- iii. 10-Day Provisional Period – pg. 265
- iv. 15-Day Provisional Period – pg. 265
- v. 30-Day Provisional Period – pg. 266
- vi. 60-Day Provisional Period – pg. 269
- vii. 90-Day Provisional Period – pg. 279
- viii. 30 to 60-Day Provisional Period – pg. 283
- ix. 60 to 70-Day Provisional Period – pg. 285
- x. 60 to 90-Day Provisional Period – pg. 286
- xi. 3 to 6-Month Provisional Period – pg. 289
- xii. 8-Month Provisional Period – pg. 290
- xiii. 9-Month Provisional Period – pg. 292
- xiv. Provisional Period in Kindergarten and 6th Grade – pg. 292
- xv. Elimination of Provisional Period – pg. 293
- n. Applicability – 30 Day Waiver if Transferring in to School in the Commonwealth – pg. 307
- o. Applicability – Waiver if the Child is in Foster Care – pg. 309
- p. Temporary Waiver – pg. 309
- q. Exemption to immunization requirements – pg. 310
- r. School reporting – pg. 315
- 23. Cost and Paperwork Estimate – pg. 318
- 24. Statutory Authority – pg. 326
- 25. Effectiveness/Sunset Dates – pg. 328
- 26. Regulatory Review – pg. 328
- 27. Contact Person – pg. 329
- 28. Findings – pg. 330
- 29. Order – pg. 330