67th Legislature HB 171.1
1 HOUSE BILL NO. 171
2 INTRODUCED BY S. GREEF, B. BROWN, C. FRIEDEL, S. HINEBAUCH, D. HOWARD, D. KARY, T.
3 MANZELLA, K. REGIER, D. SALOMON, C. SMITH
4
5 A BILL FOR AN ACT ENTITLED: “AN ACT ADOPTING THE MONTANA ABORTION-INDUCING DRUG RISK
6 PROTOCOL ACT; PROVIDING REQUIREMENTS FOR PROVIDING ABORTION-INDUCING DRUGS TO
7 PREGNANT WOMEN; PROHIBITING PROVIDING ABORTION-INDUCING DRUGS IN SCHOOLS AND ON
8 SCHOOL GROUNDS; REQUIRING INFORMED CONSENT; PROVIDING FOR THE REPORTING OF
9 CHEMICAL ABORTIONS AND ADVERSE EVENTS AND COMPLICATIONS; PROVIDING DEFINITIONS;
10 AND PROVIDING PENALTIES, CIVIL REMEDIES, AND PROFESSIONAL SANCTIONS.”
11
12 WHEREAS, in September 2000, the U.S. Food and Drug Administration (FDA) approved the
13 distribution and use of mifepristone (brand name Mifeprex), originally referred to as “RU-486”, an abortion-
14 inducing drug, under the authority of 21 C.F.R. 314.520, also referred to as “Subpart H”, which is the only FDA
15 approval process that allows for postmarketing restrictions. Specifically, the Code of Federal Regulations
16 provides for accelerated approval of certain drugs that are shown to be effective but “can be safely used only if
17 distribution or use is restricted”. The approved FDA protocol for Mifeprex/mifepristone was modified in March
18 2016; however, the FDA still requires that the distribution and use of Mifeprex/mifepristone be under the
19 supervision of a qualified health care provider who has the ability to assess the duration of pregnancy, diagnose
20 ectopic pregnancies, and provide surgical intervention or who has made plans to provide surgical intervention
21 through another qualified physician; and
22 WHEREAS, court testimony by Planned Parenthood and other abortion providers has demonstrated
23 that providers routinely and intentionally failed to follow the September 2000 FDA-approved protocol for
24 Mifeprex/mifepristone. See, e.g., Planned Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626 (S.D. Oh.
25 2006); and
26 WHEREAS, the use of Mifeprex/mifepristone presents significant medical risks, including but not limited
27 to uterine hemorrhage, viral infections, abdominal pain, cramping, vomiting, headache, fatigue, and pelvic
28 inflammatory disease. Medical evidence demonstrates that women who use abortion-inducing drugs risk four
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1 times more complications than those who undergo surgical abortions. At least 3% to 8% of medical abortions
2 fail to evacuate the pregnancy tissue and require surgical completion. One percent will fail to kill the fetus. If
3 surgical completion is required after a failed medical abortion, the risk of premature delivery in a subsequent
4 pregnancy is more than three times higher. Failure rates increase as gestational age increases. The gestational
5 age range of 63 to 70 days has been inadequately studied. The 2016 FDA gestational age extension was
6 based on only one study worldwide of little more than 300 women; and
7 WHEREAS, a woman’s ability to provide informed consent depends on the extent to which the woman
8 receives information sufficient to make an informed choice. The decision to abort “is an important, and often a
9 stressful one, and it is desirable and imperative that it be made with full knowledge of its nature and
10 consequences”. Planned Parenthood v. Danforth, 428 U.S. 52, 67 (1976); and
11 WHEREAS, in recent years, physicians have developed a method to potentially reverse the effects of
12 Mifeprex/mifepristone. This abortion pill reversal or “rescue” process has been discussed in a peer-reviewed
13 study and is based on decades of the safe use of progesterone to stabilize and continue pregnancies.
14 Progesterone has been used safely in pregnancies for decades and is used in in vitro fertilization, infertility
15 treatments, and high-risk pregnancies, including those experiencing preterm labor. Using progesterone to
16 reverse the effects of Mifeprex/mifepristone is a targeted response that is safe for the woman; and
17 WHEREAS, abortion “record keeping and reporting provisions that are reasonably directed to the
18 preservation of maternal health and that properly respect a patient’s confidentiality and privacy are permissible”.
19 Planned Parenthood v. Danforth, 428 U.S. 80 at 52, 79-81 (1976).
20
21 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
22
23 NEW SECTION. Section 1. Short title. [Sections 1 through 14] may be cited as the "Montana
24 Abortion-Inducing Drug Risk Protocol Act".
25
26 NEW SECTION. Section 2. Legislative findings and purpose. The purpose of [sections 1 through
27 14] is to further the important and compelling state interests of:
28 (1) protecting the health and welfare of a woman considering a chemical abortion;
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1 (2) ensuring that a medical practitioner examines a woman prior to dispensing an abortion-inducing
2 drug in order to confirm the gestational age of the unborn child, the intrauterine location of the unborn child, and
3 that the unborn child is alive because the routine administration of an abortion-inducing drug following
4 spontaneous miscarriage is unnecessary and exposes the woman to unnecessary risks associated with the
5 abortion-inducing drug;
6 (3) ensuring that a medical practitioner does not prescribe or dispense an abortion-inducing drug after
7 70 days have elapsed since the first day of a woman's last menstrual period;
8 (4) reducing the risk that a woman may elect an abortion only to discover later, with devastating
9 psychological consequences, that the woman's decision was not fully informed;
10 (5) ensuring that a woman considering a chemical abortion receives comprehensive information on
11 abortion-inducing drugs, including the potential to reverse the effects of the drugs if the woman changes the
12 woman's mind, and that a woman submitting to an abortion does so only after giving voluntary and fully
13 informed consent to the procedure; and
14 (6) promoting the health and safety of women by adding to the sum of medical and public health
15 knowledge through the compilation of relevant data on chemical abortions performed in the state as well as
16 data on all medical complications and maternal deaths resulting from these abortions.
17
18 NEW SECTION. Section 3. Definitions. As used in [sections 1 through 14], the following definitions
19 apply:
20 (1) "Abortion" means the act of using or prescribing an instrument, medicine, drug, or any other
21 substance, device, or means with the intent to terminate the clinically diagnosable pregnancy of a woman, with
22 knowledge that termination by those means will with reasonable likelihood cause the death of the unborn child.
23 The term does not include an act to terminate a pregnancy with the intent to:
24 (a) save the life or preserve the health of the unborn child;
25 (b) remove a dead unborn child caused by spontaneous abortion;
26 (c) remove an ectopic pregnancy; or
27 (d) treat a maternal disease or illness for which the prescribed drug is indicated.
28 (2) "Abortion-inducing drug" or "chemical abortion" means a medicine, drug, or any other substance
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1 provided with the intent of terminating the clinically diagnosable pregnancy of a woman with knowledge that the
2 termination will with reasonable likelihood cause the death of the unborn child. This includes the off-label use of
3 drugs known to have abortion-inducing properties, which are prescribed specifically with the intent of causing
4 an abortion, such as mifepristone, misoprostol, and methotrexate. The term does not include drugs that may be
5 known to cause an abortion that are prescribed for other medical indications.
6 (3) "Adverse event" means an untoward medical occurrence associated with the use of a drug in
7 humans, whether or not considered drug related. The term does not include an adverse event or suspected
8 adverse reaction that, had it occurred in a more severe form, might have caused death.
9 (4) "Associated medical practitioner" means a person authorized under 50-20-109 to perform an
10 abortion who has entered into an associated medical practitioner agreement.
11 (5) "Complication" means an adverse physical or psychological condition arising from the
12 performance of an abortion, including but not limited to uterine perforation, cervical perforation, infection, heavy
13 or uncontrolled bleeding, hemorrhage, blood clots resulting in pulmonary embolism or deep vein thrombosis,
14 failure to actually terminate the pregnancy, incomplete abortion, pelvic inflammatory disease, endometritis,
15 missed ectopic pregnancy, cardiac arrest, respiratory arrest, renal failure, metabolic disorder, shock, embolism,
16 coma, placenta previa in subsequent pregnancies, preterm delivery in subsequent pregnancies, free fluid in the
17 abdomen, hemolytic reaction due to the administration of ABO-incompatible blood or blood products, adverse
18 reactions to anesthesia and other drugs, subsequent development of breast cancer, death, psychological
19 complications such as depression, suicidal ideation, anxiety, and sleeping disorders, and any other adverse
20 event.
21 (6) "Last menstrual period" or "gestational age" means the time that has elapsed since the first day of
22 the woman's last menstrual period.
23 (7) "Medical practitioner" means a person authorized under 50-20-109 to perform an abortion in this
24 state.
25 (8) "Pregnant" or "pregnancy" means the female reproductive condition of having an unborn child in
26 the uterus.
27 (9) "Provide" mean any act of giving, selling, dispensing, administering, transferring possession to, or
28 otherwise providing or prescribing an abortion-inducing drug.
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1 (10) "Qualified medical practitioner" means a medical practitioner who has the ability to:
2 (a) identify and document a viable intrauterine pregnancy;
3 (b) assess the gestational age of pregnancy and inform the woman of gestational age-specific risks;
4 (c) diagnose ectopic pregnancy;
5 (d) determine blood type and administer RhoGAM if a woman is Rh negative;
6 (e) assess for signs of domestic abuse, reproductive control, human trafficking, and other signals of
7 coerced abortion;
8 (f) provide surgical intervention or who has entered into a contract with another qualified medical
9 practitioner to provide surgical intervention; and
10 (g) supervise and bear legal responsibility for any agent, employee, or contractor who is participating
11 in any part of a procedure, including but not limited to preprocedure evaluation and care.
12 (11) "Unborn child" means an individual organism of the species homo sapiens, beginning at
13 fertilization, until the point of being born alive as defined in 1 U.S.C. 8(b).
14
15 NEW SECTION. Section 4. In-person requirement. An abortion-inducing drug may be provided only
16 by a qualified medical practitioner following the procedures set forth in [sections 1 through 14]. A manufacturer,
17 supplier, medical practitioner, qualified medical practitioner, or any other person may not provide an abortion-
18 inducing drug via courier, delivery, or mail service.
19
20 NEW SECTION. Section 5. Distribution of abortion-inducing drugs. (1) Because the failure and
21 complication rates from a chemical abortion increase with advancing gestational age and because the physical
22 symptoms of chemical abortion can be identical to the symptoms of ectopic pregnancy and abortion-inducing
23 drugs do not treat ectopic pregnancies and are contraindicated in ectopic pregnancies, the qualified medical
24 practitioner providing an abortion-inducing drug shall examine the woman in person and, prior to providing an
25 abortion-inducing drug, shall:
26 (a) independently verify that a pregnancy exists;
27 (b) determine the woman’s blood type, and if the woman is Rh negative, be able to and offer to
28 administer RhoGAM at the time of the abortion;
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1 (c) inform the woman that the woman may see the remains of the unborn child in the process of
2 completing the abortion; and
3 (d) document in the woman’s medical chart the gestational age and intrauterine location of the
4 pregnancy and whether the woman received treatment for Rh negativity, as diagnosed by the most accurate
5 standard of medical care.
6 (2) A qualified medical practitioner providing an abortion-inducing drug must be credentialed and
7 competent to handle complications management, including emergency transfer, or must have a signed contract
8 with an associated medical practitioner who is credentialed to handle complications and must be able to
9 produce the signed contract on demand by the woman or by the department. Each woman to whom a qualified
10 medical practitioner provides an abortion-inducing drug must be given the name and phone number of the
11 associated medical practitioner.
12 (3) The qualified medical practitioner providing an abortion-inducing drug, or an agent of the qualified
13 medical practitioner, shall schedule a follow-up visit for the woman at approximately 7 to 14 days after
14 administration of the abortion-inducing drug to confirm that the pregnancy is completely terminated and to
15 assess the degree of bleeding. The qualified medical practitioner shall make all reasonable efforts to ensure
16 that the woman returns for the scheduled appointment. A brief description of the efforts made to comply with
17 this subsection, including the date, time, and identification by name of the person making the efforts, must be
18 included in the woman’s medical record.
19
20 NEW SECTION. Section 6. Prohibition on providing abortion-inducing drugs at elementary,
21 secondary, and postsecondary schools. An abortion-inducing drug may not be provided in an elementary,
22 secondary, or postsecondary school facility or on school grounds.
23
24 NEW SECTION. Section 7. Informed consent requirements for abortion-inducing drugs. (1) An
25 abortion-inducing drug may not be provided without the informed consent of the pregnant woman to whom the
26 abortion-inducing drug is being provided.
27 (2) Informed consent to a chemical abortion must be obtained at least 24 hours before the abortion-
28 inducing drug is provided to the pregnant woman, except when, in reasonable medical judgment, compliance
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1 with this subsection would pose a greater risk of:
2 (a) the death of the pregnant woman; or
3 (b) the substantial and irreversible physical impairment of a major bodily function, not including
4 psychological or emotional conditions, of the pregnant woman.
5 (3) A form created by the department must be used by a qualified medical practitioner to obtain the
6 consent required prior to providing an abortion-inducing drug.
7 (4) A consent form is not valid and consent is not sufficient unless:
8 (a) the woman initials each entry, list, description, or declaration required to be included in the
9 consent form as provided in subsection (5);
10 (b) the woman signs the consent statement described in subsection (5)(j); and
11 (c) the qualified medical practitioner signs the qualified medical practitioner declaration described in
12 subsection (5)(k).
13 (5) The consent form must include, but is not limited to the following:
14 (a) the probable gestational age of the unborn child as determined by both patient history and
15 ultrasound results used to confirm gestational age;
16 (b) a detailed description of the steps to complet