DEPARTMENT OF HEALTH
and
DEPARTMENT OF STATEApplication of Abortion Control Act to Abortions Induced by Drugs [30 Pa.B. 6278] Notice is hereby given that Commonwealth agencies under the Governor that have responsibility under the Abortion Control Act (ACA) (18 Pa.C.S. §§ 3201--3220) to interpret those provisions of the ACA that pertain to abortions, for which they are responsible to satisfy or implement, to apply to abortions induced by drugs.
An ''abortion'' is defined in the ACA as follows:
''Abortion.'' The use of any means to terminate the clinically diagnosable pregnancy of a woman with knowledge that the termination by those means will, with reasonable likelihood, cause the death of the unborn child except that, for the purpose of the [ACA], abortion shall not mean the use of an intrauterine device or birth control pill to inhibit or prevent ovulation, fertilization or the implantation of a fertilized ovum within the uterus. 18 Pa.C.S. § 3203.
This definition must be read to implicitly include an intent requirement under American College of Obstetricians and Gynecologists, Pennsylvania Section v. Thornburgh, 737 F.2d 283 (1984), aff'd, 476 U.S. 747 (1986).
With respect to abortions induced by drugs, the Department of Health (DOH) and the Department of State (DOS) interpret provisions of the ACA that pertain to abortions, for which they are responsible to implement, as follows:
Department of Health 18 Pa.C.S. § 3207. Abortion facilities.
This section gives DOH the authority to adopt regulations with respect to the performance of abortions and with respect to facilities in which abortions are performed. A physician who intends to perform an abortion by providing or prescribing drugs must do so only in a facility that is registered with DOH to perform abortions. This section also requires any entity that chooses to operate a facility at which abortions will be performed to first file a report with DOH as described in that section. DOH has labeled the report form the ''Abortion Facility Registration Form.''
18 Pa.C.S. § 3208. Printed information.
This section requires DOH to prepare and distribute printed materials that, except in the case of a medical emergency, in the course of securing informed consent to an abortion must be made available to a woman and, unless judicial bypass procedures are followed, must also be made available to other persons such as a parent or guardian when the woman is adjudicated to be incapacitated or is under 18 years of age and not emancipated.
The United States Food and Drug Administration (FDA) recently approved the use of mifepristone to induce an abortion. The FDA approval is accompanied by several restrictions. One of the restrictions is that mifepristone may not be provided under a prescription; it may only be dispensed. DOH will supplement the printed material it has already developed with materials developed by the FDA pertaining to the use of mifepristone to induce an abortion and the medical risks commonly associated with that use. DOH will distribute those materials to all facilities registered with DOH to perform abortions and any other person who requests those materials from DOH. These and other materials developed by the FDA which are pertinent to the use of mifepristone to induce abortions may be accessed at http://www.fda.gov/cder/drug/infopage/mifepristone/.
18 Pa.C.S. § 3213. Prohibited acts.
Subsection (c) of this section provides that DOH is to adopt regulations to assure that prior to the performance of an abortion the maternal Rh status shall be determined and that anti-Rh sensitization prophylaxis shall be provided to a woman at risk of sensitization unless she refuses. DOH has adopted 28 Pa. Code § 29.33(6) and (7) to address these matters. These provisions are to be satisfied before a drug is provided to or prescribed for a woman for the purpose of inducing an abortion, except as otherwise permitted under subsection (c).
18 Pa.C.S. § 3214. Reports.
This section requires the filing of various reports with DOH. They include:
Report of Induced Termination of Pregnancy
(18 Pa.C.S. § 3214(a) and (b))A facility is required to file a report with DOH for every abortion performed. This applies to an abortion that is performed as the result of a physician providing or prescribing a drug for a woman at the facility. As needed, DOH will update the form and instructions for completing the form and will send the updates to all hospitals and all freestanding facilities registered with DOH to perform abortions.
Abortions: Pathological Examinations
(18 Pa.C.S. § 3214(c) and (d))Tissue that is removed when an abortion is performed or induced is to be subjected to a pathological examination and a report to DOH may be required. Pathological examination and reporting requirements differ based upon whether the abortion is performed during or after the first trimester of pregnancy. When a drug is used to induce an abortion, fetal and other tissue may be expelled by the woman at a place other than the abortion facility. If no tissue is removed by the physician there is no duty to file a report. However, the reporting requirement does apply if tissue is removed by the physician following an abortion or attempted abortion induced by mifepristone or any other drug.
Abortions: Quarterly Facility Reports
(18 Pa.C.S. § 3214(f))A facility is required to file a quarterly report with DOH of all abortions performed in the facility. This applies to an abortion that is performed as the result of a physician providing or prescribing a drug for a woman at the facility.
Report of Maternal Death
(18 Pa.C.S. § 3214(g))This report is to be filed with DOH for all maternal deaths that occur in this Commonwealth arising out of pregnancy, childbirth or abortion. The reporting requirement applies when a drug induces the abortion as well as to a maternal death arising from continued pregnancy or childbirth and occurring after an induced abortion has been attempted but not completed.
Abortions: Report of Complications
(18 Pa.C.S. § 3214(h))A physician is to file this report with DOH if the physician provides medical treatment or care to a woman due to a complication resulting, in the good faith judgment of the physician, from the woman having undergone an abortion or attempted abortion. The reporting requirement applies when the abortion or attempted abortion was induced by a drug.
Department of State The following provisions apply to licensed health care professionals. Violations of these provisions constitute unprofessional conduct and may lead to the imposition of disciplinary sanctions by the appropriate licensing board in the Department of State.
18 Pa.C.S. § 3204. Medical consultation and judgment.
This section provides that an abortion shall be performed only by a physician, and only after the physician has either determined in the physician's best clinical judgment that the abortion is necessary, or receives what the physician reasonably believes to be a written statement signed by another physician (hereinafter called the ''referring physician'') certifying that in that physician's best clinical judgment the abortion is necessary.
Except in a medical emergency where there is insufficient time before the abortion is to be performed, the physician who is considering performing the abortion or the referring physician is to have a private medical consultation with the woman upon whom the abortion may be performed, in a place and at a time and or a duration reasonably sufficient to determine whether, based upon the physician's best clinical judgment, the abortion is necessary.
In complying with the aforementioned requirements, in determining whether an abortion is necessary the physician's best clinical judgment may be exercised in light of all factors relevant to the well-being of the woman, but an abortion sought solely because of the sex of the unborn child shall not be considered a necessary abortion.
The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the requirements of this section.
A physician who violates this section is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
18 Pa.C.S. § 3205. Informed consent.
This section prohibits a physician from performing or inducing an abortion without securing the voluntary and informed consent of the woman upon whom the abortion is to be performed. Certain exceptions to securing the informed consent of the woman upon whom the abortion is to be performed are afforded under 18 Pa.C.S. § 3206 (relating to parental consent) for a woman who is adjudicated to be incapacitated or is less than 18 years of age and is unemancipated.
Except in the case of a medical emergency, the consent is voluntary and informed only if the following are satisfied:
1. At least 24 hours prior to the abortion the physician who is considering performing the abortion or the referring physician has orally informed the woman of the probable gestational age of the unborn child at the time the abortion would be performed; the medical risks associated with carrying her child to term; and the nature of the proposed procedure or treatment and of those risks and alternatives to the procedure or treatment that a reasonable person would consider material to the decision of whether or not to undergo the abortion.
2. At least 24 hours prior to the abortion, the physician who is considering performing the abortion or the referring physician, or a qualified physician assistant, health care practitioner, technician or social worker to whom the responsibility has been delegated by either physician, has informed the woman that DOH publishes written materials that describe the unborn child and list agencies that offer alternatives to abortion and that she has a right to review the printed material and that a copy will be provided to her free of charge if she chooses to review it; that medical assistance benefits may be available for prenatal care, childbirth and neonatal care, and that more detailed information on the availability of such assistance is contained in the printed materials published by DOH; and that the father of the unborn child is liable to assist in the support of her child, even in instances where he has offered to pay for the abortion (in cases of rape this information may be omitted).
3. A copy of the DOH-printed materials has been provided to the woman if she chooses to view them.
4. The woman certifies in writing, prior to the abortion, that the information required to be provided to her pursuant to the preceding paragraphs has been provided.
In addition to the informed consent requirements, this section requires that when a medical emergency compels the performance of an abortion, the physician is to inform the woman, prior to the abortion if possible, of the medical indications supporting the physician's judgment that an abortion is necessary to avert the woman's death or a substantial and irreversible impairment of a major bodily function of the woman.
The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the requirements of this section, except as expressly stated in this section.
A physician who violates this section is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license. No physician shall be guilty of violating this section for failing to furnish the information required to secure the informed consent of the woman to an abortion if the physician can demonstrate, by a preponderance of the evidence, that the physician reasonably believed that the furnishing of the information would have resulted in a severely adverse effect on the physical or mental health of the patient.
18 Pa.C.S. § 3206. Parental consent.
This section provides that in addition to the informed consent requirements of 18 Pa.C.S. § 3205 (relating to informed consent), when a woman is adjudged to be an incapacitated person under 20 Pa.C.S. § 5511, or is less than 18 years of age and unemancipated, a physician may be required to secure the informed consent of an additional person. The duty to secure that additional informed consent does not apply in the case of a medical emergency and under other circumstances explained in this section. Also, if judicial bypass procedures afforded by this section are pursued, neither the informed consent of the woman who is adjudged to be an incapacitated person or is less than 18 years of age and unemancipated, nor of any other person, will be required if the court determines that the woman is not mature and capable of giving informed consent or if the woman does not claim to be mature and capable of giving informed consent, and the court determines that the performance of the abortion would be in the best interests of the woman.
The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the informed consent requirements of this section, except as expressly stated in this section or 18 Pa.C.S. § 3205.
A physician who performs an abortion upon an unemancipated woman less than 18 years of age or a woman adjudged to be incapacitated, either with knowledge or reckless disregard that she is an unemancipated woman less than 18 years of age or a woman adjudged to be incapacitated, and who intentionally, knowingly or recklessly fails to perform any of the requirements of this section imposed upon the physician is guilty of unprofessional conduct and the license of the physician shall be suspended for at least three months under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a second offense the State Board of Medicine or the State Board of Osteopathic Medicine shall also suspend the physician's license for at least 90 days. For a third offense the board shall revoke the physician's license.
18 Pa.C.S. § 3210. Determination of gestational age.
This section provides that except in a case of a medical emergency that prevents compliance with the section, no abortion is to be performed or induced unless the physician who is considering performing or inducing the abortion or the referring physician has first made a determination of probable gestational age of the unborn child. In making that determination, the physician is required to make such inquiries of the patient and perform or cause to be performed such medical examination and tests as a prudent physician would consider necessary to make or perform in making an accurate diagnosis of gestational age.
If an abortion occurs, the physician who performs or induces the abortion is to report on forms provided by DOH the type of inquiries made and the type of examinations and tests utilized to determine the gestational age of the unborn child and the basis for the diagnosis or gestational age. The form DOH provides for this purpose is the Report of Induced Termination of Pregnancy form.
The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the requirements of this section, except as expressly stated in this section.
A physician who violates this section is guilty of unprofessional conduct and the license of the physician shall be suspended for at least 3 months under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a second offense, the State Board of Medicine or the State Board of Osteopathic Medicine shall also suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
18 Pa.C.S. § 3213. Prohibited acts.
Subsection (c) of this section provides that DOH is to adopt regulations to assure that prior to the performance of an abortion the maternal Rh status shall be determined and that anti-Rh sensitization prophylaxis shall be provided to a woman at risk of sensitization unless she refuses. DOH has adopted 28 Pa. Code § 29.33(6) and (7) to address these matters.
DOH regulations 28 Pa. Code § 29.33(6) and (7) apply to a physician providing or prescribing for a woman a drug to induce an abortion.
Except in the case of a medical emergency or when in the judgment of the physician there exists no possibility of Rh sensitization, a physician who intentionally, knowingly, or recklessly fails to conform to 28 Pa. Code § 29.33(6) and (7) is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
18 Pa.C.S. § 3214. Prohibited acts.
This section requires the filing of various reports with DOH. They include:
Report of Induced Termination of Pregnancy
(18 Pa.C.S. § 3214(a) and (b))A facility is required to file a report with DOH for every abortion performed. This applies to an abortion that is performed as the result of a physician providing or prescribing a drug for a woman at the facility.
A physician's duty to file this report and provide information necessary for the completion of the report will vary depending upon the type of facility involved. For example, a physician who engages in medical practice as a sole proprietor and registers his or her office with DOH to provide abortion services will have full responsibility for completing and filing the form, while a physician who performs an abortion in a hospital will only have responsibility for providing certain information needed to complete the form.
A physician who willfully fails to file this report, keep records necessary to complete the report or supply information that is required to complete the report, when the physician has an obligation to file the report, keep such records or supply such information, is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
Abortions: Pathological Examinations
(18 Pa.C.S. § 3214(c) and (d))Tissue that is removed when an abortion is performed or induced is to be subjected to a pathological examination and a report to DOH may be required.
The requirements of subsections (c) and (d) apply if tissue is removed by the physician following an abortion or attempted abortion induced by mifepristone or any other drug.
A physician who willfully fails to file a required pathological report, keep records necessary to complete the report or supply information that is required to complete the report, when the physician has an obligation to file the report, keep such records or supply such information, is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
Abortions: Quarterly Facility Reports
(18 Pa.C.S. § 3214(f))A facility is required to file a quarterly report with DOH of all abortions performed in the facility.
This report is to include abortions induced by a drug if the physician secures the information that is needed for the physician to conclude that an abortion has occurred.
A physician's duty to file this report and provide information necessary for the completion of the report will vary depending upon the type of facility involved. For example, a physician who engages in medical practice as a sole proprietor and registers his or her office with DOH to provide abortion services will have full responsibility for completing and filing the form, while a physician who performs an abortion in a hospital will only have responsibility for providing certain information needed to complete the form.
A physician who willfully fails to file this report, keep records necessary to complete the report or supply information that is required to complete the report, when the physician has an obligation to file the report, keep such records or supply such information, is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
Abortions: Report of Complications
(18 Pa.C.S. § 3214(h))A physician is to file this report with DOH if the physician provides medical treatment or care to a woman due to a complication resulting, in the good faith judgment of the physician, from the woman having undergone an abortion or attempted abortion.
The reporting requirement applies when the abortion or attempted abortion was induced by a drug.
A physician who willfully fails to file this report, keep records necessary to complete the report or supply information that is required to complete the report, when the physician has an obligation to file the report, keep such records or supply such information, is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense, the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense, the board shall suspend the physician's license for at least 90 days. For a third offense, the board shall revoke the physician's license.
A person with a disability who wants to obtain a copy of this notice in an alternative format (that is, large print, audiotape or Braille) should contact the Office of the Deputy Secretary for Quality Assurance, Department of Health, 805 Health and Welfare Building, P. O. Box 90, Harrisburg, PA 17108-0090, (717) 783-1078. Speech or hearing impaired persons may use V/TT (717) 783-6514, or the Pennsylvania AT&T Relay Services at (800) 654-5984 [TT].
ROBERT S. ZIMMERMAN, Jr.,
Secretary
Department of HealthKIM PIZZINGRILLI,
Secretary
Department of State[Pa.B. Doc. No. 00-2078. Filed for public inspection December 1, 2000, 9:00 a.m.]
