PLANNED PARENTHOOD OF THE HEARTLAND, INC. and JILL MEADOWS, Appellants,
IOWA BOARD OF MEDICINE, Appellee
Appeal from the Iowa District Court for Polk County, Jeffrey D. Farrell, Judge. Providers appeal a district court judgment upholding a rule by the Iowa Board of Medicine establishing standards of practice for physicians who prescribe or administer abortion-inducing drugs.
AFFIRMED IN PART AND REVERSED IN PART.
Alice Clapman of Planned Parenthood Federation of America, Washington, D.C., Sharon K. Malheiro of Davis, Brown, Koehn, Shors & Roberts, P.C., Des Moines, and Roger Evans of Planned Parenthood Federation of America, New York, New York, for appellant.
Thomas J. Miller, Attorney General, Jeffrey S. Thompson, Solicitor General, and Julie J. Bussanmas and Meghan L. Gavin, Assistant Attorneys General, for appellee.
Paige Fiedler of Fiedler & Timmer, P.L.L.C., Urbandale, and Holly A. Harrison, Lynn D. Fleisher, Ph.D., Patrick E. Croke, Daniel C. Craig, and Andrew Chinsky of Sidley Austin LLP, Chicago, Illinois, for amicus curiae American College of Obstetricians and Gynecologists.
Roxanne Barton Conlin of Roxanne Conlin & Associates, P.C., Des Moines, for amici curiae Iowa Coalition Against Sexual Assault, Iowa Coalition Against Domestic Violence, and National Women's Law Center.
Joe Austen of Austen Law Office, PLLC, West Des Moines, and Rita Bettis of ACLU of Iowa, Des Moines, for amicus curiae American Civil Liberties Union of Iowa.
Mailee R. Smith of Americans United for Life, Washington, D.C., and Arthur F. Gilloon of Gilloon, Wright & Hamel PC, Dubuque, for amici curiae Physicians for Life, National Association of Pro Life Nurses, Christian Medical Association, National Association of Catholic Nurses, and The National Catholic Bioethics Center.
Timm Reid of Galligan & Reid, P.C., Des Moines, and Michael J. Norton and Natalie L. Decker of Alliance Defending Freedom, Greenwood Village, Colorado, for amici curiae American Association of Pro-Life Obstetricians & Gynecologists, Donna Harrison, M.D., Iowa Right to Life, and Susan Thayer.
Matthew F. Heffron and Christine F. Delgado of Brown & Brown, P.C., L.L.O., Omaha, Nebraska, Patrick D. Smith of Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, and Thomas Brejcha of Thomas More Society, Chicago, Illinois, for amici curiae Catholic Medical Association, Catholic Medical Association--Des Moines Guild, Catholic Medical Association--St. Thomas Aquinas Guild of the Quad Cities, Iowans for Life, and Women's Choice Center of the Quad Cities.
WIGGINS, Justice. Zager, J., takes no part.
In 2013, the Iowa Board of Medicine passed a rule establishing standards of practice for physicians who prescribe or administer abortion-inducing drugs. These standards require the physician to personally perform a physical examination and to be physically present when the abortion-inducing drug is provided. It is not disputed the rule would have the effect of prohibiting telemedicine abortions in Iowa.
Planned Parenthood of the Heartland, Inc. and Dr. Jill Meadows, M.D. (collectively Planned Parenthood) challenge the rule as both improperly enacted and violative of the Iowa Constitution. For purposes of this appeal, we will assume the Board properly enacted the rule and did not violate any of the procedural or rulemaking provisions of Iowa Code chapter 17A (2013), other than Planned Parenthood's claim the rule violates section 17A.19(10)( a ), which provides an agency's
action is invalid when " substantial rights of the person seeking relief have been prejudiced" and the action is " [u]nconstitutional on its face or as applied." Iowa Code § 17A.19(10)( a ). We will therefore focus on the constitutional question.
The Board has conceded the Iowa Constitution provides a right to an abortion that is coextensive with the right available under the United States Constitution. Planned Parenthood argues the Iowa Constitution affords a broader right, and we should therefore apply a strict scrutiny analysis under the Iowa Constitution to the rule. We need not resolve this question because we conclude, for the reasons stated herein, that the Board's rule violates the controlling " undue burden" test announced by the United States Supreme Court as the federal constitutional test. See Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 878-79, 112 S.Ct. 2791, 2821, 120 L.Ed.2d 674, 715-16 (1992) (plurality opinion) and Gonzales v. Carhart, 550 U.S. 124, 146, 158, 127 S.Ct. 1610, 1626-27, 1633, 167 L.Ed.2d 480, 502, 509-10 (2007). Thus, the contested rule violates the Iowa Constitution under the less stringent Iowa constitutional standard advanced by the Board. We therefore reverse the decision of the district court as to the contested portions of the rule.
I. Background Facts and Proceedings.
On our de novo review, we find the following facts.
A. Medication Abortions. In 2000, the United States Food and Drug Administration (FDA) approved the distribution and use of mifepristone in the United States. Mifepristone, also known as RU-486, is a prescription drug that terminates a pregnancy by detaching the gestational sac from the uterine wall. In the clinical trials, the woman returned two to four days later and took a second medication, misoprostol, which induced contractions to complete the medication abortion.
Consistent with the clinical trial documents submitted in support of the application for approval of the drug, the FDA label indicated the appropriate treatment regimen was to administer 600 mg of mifepristone orally, followed two days later by 0.4 mg of misoprostol administered orally. Additionally, the label indicated the patient should take the mifepristone within the first seven weeks of pregnancy.
Once the FDA approves a drug, the FDA does not prohibit physicians from using the drug in a different manner than the label provides--otherwise known as " off-label" use. See U.S. Food & Drug Admin., " Off-Label" and Investigational Use of Marketed Drugs, Biologics, and Medical Devices-Information Sheet, available at www.fda.gov/regulatoryinformation/guidances/ucm126486 . Off-label use means the safety and effectiveness of the dosing regimen has not been established by the FDA.
Following FDA approval, additional studies led to the development of new protocols for administering these drugs. The new off-label method changed the dosage amounts of the drugs, lowering the amount of mifepristone from 600 mg to 200 mg and increasing the amount of misoprostol from 0.4 mg to 0.8 mg. The new method also changed the administration of misoprostol from oral ingestion to buccally--placing the pill between the cheeks and gums. The studies also showed this method was safe and effective for use within the first nine weeks of pregnancy. The American College of Obstetricians and Gynecologists (ACOG) accepts and approves of this off-label protocol as the standard of care to administer these drugs.
Since 2008, the medication abortions performed by Planned Parenthood in Iowa have involved 200 mg of mifepristone administered orally, followed one to four days later by 0.8 mg of misoprostol taken buccally. The clinic then instructs the patient to return to the clinic within two weeks after taking the misoprostol for a follow-up appointment. Planned Parenthood utilizes the same procedures for medication abortions if the patient is physically present in the doctor's clinic or if the procedure is being performed utilizing telemedicine.
Telemedicine is a method of practicing medicine in which the physician is at one geographical location, the patient is at a different geographical location, and the two communicate through a secure electrical audio-visual connection that complies with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). In Iowa, physicians and hospitals deliver a variety of health care and education services to Iowans living in rural communities through telemedicine. The Board has adopted a rule effective June 3, 2015, regarding the use of telemedicine by Iowa physicians. The regulations make the following findings:
1. The board recognizes that technological advances have made it possible for licensees in one location to provide medical care to patients in another location with or without an intervening health care provider.
2. Telemedicine is a useful tool that, if applied appropriately, can provide important benefits to patients, including increased access to health care, expanded utilization of specialty expertise, rapid availability of patient records, and potential cost savings.
3. The board advises that licensees using telemedicine will be held to the same standards of care and professional ethics as licensees using traditional in-person medical care.
Iowa Admin. Code r. 653-13.11.
The regulations also state that " [a] licensee who uses telemedicine shall utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes." Id. r. 653-13.11(2). The regulations further require the licensee to perform " a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient." Id. r. 653-13.11(8). They identify nine separate situations in which the licensee need not personally interview, examine, or diagnose the patient, including when " the patient has been examined in person by an advanced registered nurse practitioner or physician assistant or other licensed practitioner with whom the licensee has a supervisory or collaborative relationship." Id. r. 653-13.11(20)( e ).
Planned Parenthood has been utilizing telemedicine to perform medication abortions in Iowa since 2008. At all Planned Parenthood locations in Iowa, a trained staff member takes a medical history from the patient, checks the patient's vital signs, and gathers the patient's blood for tests to check for any medical reasons the woman should not undergo a medication abortion.
A trained staff member then performs an ultrasound on the woman to check for an ectopic pregnancy and obtain the gestational age of the pregnancy. An ectopic pregnancy occurs when the fertilized egg is implanted somewhere other than the uterus. An ectopic pregnancy is a contraindication for a medication abortion because
the drug regimen does not work when the fertilized egg is not located in the uterus. Thus, the doctor uses the ultrasound images to determine if the gestational sac containing the fertilized egg implanted somewhere other than inside the uterus. The ultrasound machine also estimates gestational age.
Prior to administering the mifepristone, the physician reviews the lab results, the ultrasound images, and medical history provided by the patient. After the physician determines there is no medical reason the woman cannot proceed with the procedure, the patient and physician speak to each other. Whether the physician is present in person or communicating remotely through telemedicine, the physician does not personally perform a physical exam on the patient. The standard of care developed by ACOG is that a physical examination by the physician before proceeding with a medical termination of a pregnancy is medically unnecessary.
Next, the physician informs the patient about the medication regime, potential complications, what to expect after ingesting the misoprostol, and answers questions the patient may have. After receiving informed consent from the patient that she wishes to go forward with the termination, the doctor provides the medications to the patient.
In telemedicine administration, the patient-physician communication occurs over a real-time two-way HIPAA secured teleconference audio-visual connection with a staff person in the room with the patient and the physician at a different clinical location. After receiving informed consent, the physician remotely releases a secure drawer containing the medications located in the patient's room.
Regardless of whether the physician dispenses the medications in person or by telemedicine, both the physician and the staff member watch the patient take the mifepristone (in the telemedicine situation, the physician watches over the two-way video). The clinic schedules a follow-up visit within two weeks. The woman then goes home, or to a location of her choosing, and takes the misoprostol twenty-four to forty-eight hours later.
The woman also receives a toll-free number that she may call to speak with medical staff or the physician regarding any complications or questions, as the actual uterine evacuation occurs while the woman is at home regardless of the location of the initial appointment. In the relatively uncommon case in which the physician feels the patient needs emergency care, the doctor refers the woman to the nearest hospital emergency room.
B. Administrative Proceedings. On June 25, 2013, the Board received a petition for rulemaking regarding the standards of practice for telemedicine medication abortions. The petition proposed the following rule:
653-13.10 - Standards of practice - chemical abortion.
This rule establishes the standards of practice for a physician or osteopathic physician who induces an abortion by an abortion-inducing drug.
13.10(1). Definition. As used in this rule, " abortion-inducing drug" means a drug, medicine, mixture, or preparation, when it is prescribed or administered with the intent to terminate the ...