Complication Plans for Certain Drug- and Chemically-Induced Abortions by Physicians via Hospitals

PURPOSE: This rule establishes the standards governing complication plans required by section 188.021, RSMo, for abortions induced by physicians via hospitals. This rule also explains the process for submitting such complication plans to the Department of Health and Senior Services for approval. (1) For purposes of this rule, the following terms mean: (A) Abortion—The act of using or prescribing any instrument, device, drug, or any other means or substance resulting in the intentional destruction of an embryo or fetus in a woman’s uterus or the intentional termination of a pregnancy of a woman with intent other than to increase the probability of a live birth or to remove a dead or dying embryo or fetus; (B) Hospital—As such term is defined in section 197.020, RSMo; (C) Complication—Includes, but is not limited to, incomplete abortion, excessive hemorrhage, endometritis, parametritis, pyrexia, pelvic abscess, uterine perforation, failed abortion, retained products, cervical lacerations, or psychiatric issues; (D) Department—The Missouri Department of Health and Senior Services; (E) Drug—A drug or chemical used to induce an abortion for which the federal Food and Drug Administration (FDA) label includes any clinical study in which more than one percent (1%) of those administered the drug required surgical intervention after its administration; (F) OB/GYN— 1. A physician who is board-certified or board-eligible by the American Osteopathic Board of Obstetrics and Gynecology, or who is in a residency approved by that board; or 2. A physician who is board-certified by the American Board of Obstetrics and Gynecology (ABOG); or who is an ABOG Registered Residency Graduate or an ABOG Active Candidate; or who is in an ABOG-approved residency; (G) Physician—A person licensed to practice medicine pursuant to Chapter 334, RSMo. (2) Complication plans for certain drug- and chemicallyinduced abortions. (A) A physician shall not prescribe or administer a drug without first obtaining written approval from the department of a complication plan applicable to the physician’s prescription or administration of the drug. (B) A physician may obtain approval of a complication plan applicable to the physician prescribing or administering drugs via a hospital. In the alternative, a hospital may obtain approval of a complication plan applicable to a physician prescribing or administering drugs via the hospital. (C) Each hospital shall take reasonable measures to ensure that no physician prescribes or administers drugs via the hospital in the absence of a complication plan as required by these rules. Each hospital shall also take reasonable measures to ensure that physicians prescribing or administering drugs via the hospital comply with this rule. (D) To ensure the safety of all patients, a primary objective of complication plans shall be to recognize the importance of the physician-patient relationship by providing for continuity of care and ensuring communication among the physician who induced the abortion and all subsequent health care providers DIVISION—10 OFFICE OF THE 19 CSR 10-15 DEPARTMENT OF HEALTH DIRECTOR AND SENIOR SERVICES involved in treating the patient’s complication. (E) Every complication plan shall provide that an OB/GYN is on-call and available twenty-four hours a day, seven days a week (24/7) to treat complications related to drugs prescribed or administered by the physician via the hospital. To ensure this required twenty-four hours a day, seven days a week (24/7) coverage, the complication plan for each physician who will prescribe or administer drugs shall include a written agreement between the physician and an OB/GYN or group of OB/GYNs to treat complications, or in the alternative, a written agreement between the hospital and an OB/GYN or group of OB/GYNs to treat complications. (F) If the physician who will prescribe or administer drugs is an OB/GYN, that physician’s complication plan may provide that the physician treats complications, but the physician and/ or the hospital must have a written agreement with an OB/GYN or group of OB/GYNs to ensure the required twenty-four hours a day, seven days a week (24/7) coverage when the physician is unavailable to treat complications. (G) Every complication plan shall provide that the OB/GYN with whom there is a written agreement or member of the group of OB/GYNs with which there is a written agreement, or the physician who prescribes or administers drugs if he or she is an OB/GYN, shall: 1. Personally treat all complications, including those requiring surgical intervention, except in any case where doing so would not be in accordance with the standard of care, or in any case where it would be in the patient’s best interest for a different physician to treat her; and 2. Assess each patient suffering a complication individually, and shall not, as a matter of course, refer all patients to the emergency room or other facilities or physicians unless the patient is experiencing an immediately life-threatening complication. 3. This regulation does not prohibit screening or triage of patients by a nurse or physician to determine whether or when it is necessary to contact the OB/GYN. (H) Every complication plan shall provide that, in any case where it would not be in accordance with the standard of care or would not be in the patient’s best interest for the OB/GYN to personally treat the complication (e.g., surgery in a hospital is required, and it is not in the patient’s best interest to travel to a hospital where the OB/GYN has privileges), the OB/GYN shall arrange for hand-off of the patient to an appropriately-qualified physician and shall fully brief such physician regarding the patient at the time of hand-off. (I) Every complication plan shall require that the OB/GYN treating a patient’s complication shall prepare a complication report as required by section 188.052, RSMo and ensure that it is submitted to the department. (J) The physician shall ensure that before discharge, every patient who receives a drug also receives the phone number, in writing, for the OB/GYN or OB/GYN group providing complication coverage. The phone number given may be for the on-call service rather than the OB/GYN’s direct number. (K) The physician or hospital shall submit complication plans to the department for approval in writing using the complication plan submission form provided by the department. The form shall require at least the following information: 1. The full name of each physician whose prescription or administration of drugs via the hospital will be covered by the plan; 2. The full name of the OB/GYN who will provide complication coverage, or if a group of OB/GYNs will provide coverage, the full legal name of the group and the full name of each OB/GYN who is part of the group; and 3. A description of how the complication plan meets each requirement in this regulation, including treating complications requiring surgical intervention. (L) With the completed complication plan forms, the facility shall also submit: 1. Documents establishing that each OB/GYN who will provide complication coverage under the plan is board-eligible or board-certified by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology; and 2. A copy of the executed written agreement between the physician(s) whose prescription or administration of drugs will be covered by the plan (and/or the hospital) and the OB/GYN or group of OB/GYNs that will provide the complication coverage. The written agreement shall cite this regulation and specify that complication coverage under the written agreement shall be provided in compliance with this regulation. (M) If any change occurs that prevents full compliance with a complication plan as approved by the department, the physician or hospital shall immediately notify the department in writing, providing details regarding the change. If the change results in the physician being unable to provide twenty-four hours a day, seven days a week (24/7) OB/GYN coverage for complications as required by this regulation, the physician shall ensure that no drugs are prescribed or administered until 1) full compliance with the plan is achieved and the physician or hospital has so notified the department in writing, or 2) a new or revised complication plan has been submitted to and approved by the department in writing. (N) The physician shall ensure that each complication plan approved by the department and currently in use is on file at the physician’s office or hospital. The physician or hospital shall maintain copies of complication plans no longer in use for seven (7) years following the last use. The physician or hospital shall make current and past complication plans available to patients or the department for review upon request. (3) Pursuant to section 188.021.2, RSMo, no complication plan is required where the patient is administered the drug in a medical emergency at a hospital and is then treated as an inpatient at a hospital under medical monitoring by the hospital until the abortion is completed. AUTHORITY: sections 188.021 and 197.225, RSMo Supp. 2017.* Emergency rule filed Oct. 24, 2017, effective Nov. 3, 2017, expired May 1, 2018. Original rule filed Oct. 24, 2017, effective April 30, 2018. *Original authority: 188.021, RSMo 2013, amended 2017 and 197.225, RSMo 1975, amended 1986, 2017.