WIGGINS, Justice.
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
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.
On our de novo review, we find the following facts.
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.
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:
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.
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
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.
On June 28, the Board held a public meeting and discussed the proposed rule. Three members of the public spoke at the meeting, Daniel McConchie, Vice President of Government Affairs for Americans United for Life, spoke in favor of the rule; Tom Ross, M.D., a doctor at Planned Parenthood, spoke against the rule; and Kelly Larson, a registered nurse at InnerVisions HealthCare, spoke in favor of the rule. After hearing the public comments, board member Allison Schoenfelder, M.D., moved to accept the petition and begin the rulemaking process. The Board voted eight to two to accept the petition.
The Board held a public hearing on the proposed rule on August 28, and the public had thirty-five days to submit written comments on the proposed rule. The Board heard testimony from twenty-eight individuals at the public hearing and received 244 written comments from both individuals and organizations. The Board heard from many doctors both for and against the rule.
Dr. Sean Kenney, a practicing obstetrician and gynecologist from Lincoln, Nebraska, spoke in favor of the rule. Dr. Daniel Grossman, an obstetrician and gynecologist from Oakland, California, spoke against the rule. The Board also received public comment from the Iowa Medical Society and the Iowa Osteopathic Medical Association, both of which expressed concern regarding the procedures used to implement the rule and opposed the rule itself. Other physicians also testified the Planned Parenthood clinics follow the standard of care used for medication abortions, whether the physician performs the procedure at an in-clinic visit or by telemedicine.
On August 30, the Board held a meeting to determine whether it should adopt the rule. The Board passed the rule, again with an eight to two vote. The Board announced it would publish the adopted rule on October 2, and it would become effective November 6.
On September 27, the Board issued a statement regarding the adoption and filing of the rule. The Board listed its principal reasons in support of the rule as follows:
The Board also provided its reasons for overruling the objections to the rule.
Iowa Admin. Code r. 653-13.10.
Planned Parenthood appealed and asked us to stay the enforcement of the rule pending the resolution of its appeal. We entered a stay and retained the appeal.
Planned Parenthood raised a number of issues before the district court challenging both the rulemaking process and the constitutionality of the rule. 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 other than Planned Parenthood's claim the rule is unconstitutional and violates Iowa Code section 17A.19(10)(a). Under the Code, we can provide appropriate relief when the agency action is "[u]nconstitutional on its face or as applied or is based upon a provision of law that is unconstitutional on its face or as applied." Iowa Code § 17A.19(10)(a).
Planned Parenthood did not challenge the ruling regarding provisions (1) and (5) of rule 653-13.10. Therefore, we will affirm the district court judgment regarding rule 653-13.10(1) and 13.10(5).
We review Planned Parenthood's constitutional claims de novo. Gartner v. Iowa Dep't of Pub. Health, 830 N.W.2d 335, 344 (Iowa 2013).
Many states considering this issue under their state constitutions have found their state constitutions provide such a right. See, e.g., Valley Hosp. Ass'n, Inc. v. Mat-Su Coal. for Choice, 948 P.2d 963, 967-69 (Alaska 1997); Comm. to Defend Reprod. Rights v. Myers, 29 Cal.3d 252, 172 Cal.Rptr. 866, 625 P.2d 779, 784 (1981); In re T.W., 551 So.2d 1186, 1192-93 (Fla.1989); Hope Clinic for Women, Ltd. v. Flores, 372 Ill.Dec. 255, 991 N.E.2d 745, 760 (2013); Moe v. Sec'y of Admin. & Fin., 382 Mass. 629, 417 N.E.2d 387, 398-99 (1981); Women of the State of Minn. by Doe v. Gomez, 542 N.W.2d 17, 27 (Minn.1995); Pro-Choice Miss. v. Fordice, 716 So.2d 645, 653 (Miss.1998); Reprod. Health Servs. of Planned Parenthood of St. Louis Region, Inc. v. Nixon, 185 S.W.3d 685, 692 (Mo.2006) (en banc) (per curiam); Armstrong v. State, 296 Mont. 361, 989 P.2d 364, 374-75 (1999); Hope v. Perales, 83 N.Y.2d 563, 611 N.Y.S.2d 811, 634 N.E.2d 183, 186 (1994); Planned Parenthood of Middle Tenn. v. Sundquist, 38 S.W.3d 1, 15 (Tenn.2000). But cf. Taylor v. Kurapati, 236 Mich.App. 315, 600 N.W.2d 670, 687 (1999) ("This Court has held that the Michigan Constitution does not provide a right to end a pregnancy."); Mahaffey v. Att'y Gen., 222 Mich.App. 325, 564 N.W.2d 104, 111 (1997) ("We merely hold that the Michigan Constitution does not guarantee a right to abortion that is separate and distinct from the federal right."); MKB Mgmt. Corp. v. Burdick, 855 N.W.2d 31, 31-32, 52, 64, 89, 91, 98 (N.D.2014) (per curiam) (upholding the constitutionality of amendments to the state abortion control act that limited medication abortions where two justices determined the law violated the North Dakota Constitution, two justices concluded the law did not violate the state constitution, three justices determined the statute violated the Federal Constitution, one justice concluded the law did not violate the Federal Constitution, and one justice concluded the federal constitutional issue was not properly before the court because there was not a sufficient majority of the court that agreed the law was unconstitutional). However, in this case, we need not decide whether the Iowa Constitution provides such a right, and if so, whether regulations affecting that right must pass strict scrutiny.
In adopting the test, the Supreme Court recognized that even though a woman has a liberty interest in deciding whether to terminate a pregnancy, the right to do so is limited. Id. at 869, 112 S.Ct. at 2816, 120 L.Ed.2d at 709-10. The limitation imposed by the Supreme Court is the state's "important and legitimate interests in preserving and in protecting the health of the pregnant woman" and "in protecting the potentiality of human life." Roe, 410 U.S. at 162, 93 S.Ct. at 731, 35 L.Ed.2d at 182. The Court balanced a woman's right to terminate her pregnancy against the legitimate interests of the state by developing the undue burden test. Casey, 505 U.S. at 876, 112 S.Ct. at 2820, 120 L.Ed.2d at 714.
In the most recent case, Gonzales v. Carhart, the Court — considering a ban on late term abortions — stated the undue burden test as
Carhart, 550 U.S. at 158, 127 S.Ct. at 1633, 167 L.Ed.2d at 509-10.
The Court applies the undue burden test differently depending on the state's interest advanced by a statute or regulation. If the state's interest is to advance fetal life, "[a]n undue burden exists, and therefore a provision of law is invalid, if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability." Casey, 505 U.S. at 878, 112 S.Ct. at 2821, 120 L.Ed.2d at 715.
On the other hand, if the state's interest is to further the health or interest of a woman seeking to terminate her pregnancy, "[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the
In contrast to the Seventh and Ninth Circuits, the Fifth and Sixth Circuit Courts of Appeals have applied Casey differently to measures passed by their state to promote the health or interest of a woman seeking to terminate her pregnancy. The Fifth and Sixth Circuits do not weigh the strength of the state's justifications against the burden placed on women. Under the Fifth Circuit's approach, once the state sets forth a justification for an abortion regulation sufficient to pass rational basis review, it is not necessary to consider the strength of the state's justification in its analysis. Planned Parenthood of Greater Tex. Surgical Health Servs. v. Abbott, 748 F.3d 583, 593-99 (5th Cir.2014). The Sixth Circuit took the same approach as the Fifth Circuit when it decided its case without considering the strength of the state's justification in its analysis. See Planned Parenthood Sw. Ohio Region v. DeWine, 696 F.3d 490, 513-18 (6th Cir.2012).
Like the Seventh and Ninth Circuits, we believe the "unnecessary health regulations" language used in Casey requires us to weigh the strength of the state's justification for a statute against the burden placed on a woman seeking to terminate her pregnancy when the stated purpose of a statute limiting a woman's right to terminate a pregnancy is to promote the health of the woman.
1. Substance of Iowa Administrative Code rule 653-13.10. The rule creates a standard of practice for physicians who perform medication abortions. Planned Parenthood is challenging rule 653-13.10(2) through 13.10(4). The crux of this rule is to require greater physician involvement in the termination of a pregnancy than is now provided by Planned Parenthood for medical terminations of pregnancies.
Rule 653-13.10(2) requires a physician to perform a physical examination of the woman for the purposes of determining the gestational age and intrauterine location of the pregnancy. Iowa Admin. Code r. 653-13.10(2). Rule 653-13.10(3) requires the physician to be physically present in the room and give the medications to the woman. Id. r. 653-13.10(3). Finally, rule 653-13.10(4) requires the physician to schedule a follow-up visit with the woman at the same facility where the physician dispensed the medication to confirm the termination of the pregnancy and to evaluate the woman's medical condition. Id. r. 653-13.10(4). Planned Parenthood challenges the rule as applied to medication abortions done with the physician present or by telemedicine.
2. Purpose of Iowa Administrative Code rule 653-13.10. The Board did not pass this rule to advance the state's interest in advancing fetal life. Rather,
3. The strength of the Board's justification of the rule. The underpinning of the Board's rule is that competent medical care to promote the health of a woman seeking to terminate her pregnancy requires a physician to do a physical examination. In its explanations for overruling the reasons presented in opposition to the rule, the Board said:
However, the weight of the record evidence indicates that a pelvic examination prior to administering the mifepristone does not provide any measurable gain in patient safety.
Dr. Kenney was the only actively practicing doctor who opined that a doctor should give a patient seeking a medical termination of a pregnancy a physical exam that includes a pelvic exam before proceeding with the termination.
The physician reads the ultrasound images before giving the patient the medication. The physician uses the ultrasound images to determine the location of the gestational sac. If the ultrasound images are of poor quality or do not clearly show the gestational sac, the physician does not dispense the medication to the woman. If the gestational sac is located outside the uterus, the woman may have an ectopic pregnancy. The physician will not dispense the medication if the patient is experiencing an ectopic pregnancy. The physician
The physician also reviews the patient's medical history, blood work, and vital signs. The physician reviews the history taken by the medical provider who takes the history in-person and asks further questions of the patient as needed. A person other than a physician draws the patient's blood and a lab processes it. These results are reviewed by the physician, who can order further blood work if necessary. Finally, the physician reviews the vital signs, which a person other than the physician normally takes. If the doctor has any questions regarding a patient's vital signs, the physician can have a vital sign retaken.
The next justification for the presence of a physician was the off-label use of the medications by Planned Parenthood. However, studies have shown that the off-label protocol is safer and more effective than the FDA approved protocol for administering the drugs. The method presently used by Planned Parenthood conforms to the present medical standard of care for administering the drug.
An additional reason for the rule prohibiting telemedicine abortions is that a patient may never meet face-to-face with the physician prescribing the medication. The Board determined a face-to-face meeting was important in promoting the health or interest of a woman seeking to terminate her pregnancy. However, an increasing number of medical procedures are being performed today by telemedicine. Studies have shown medical termination of pregnancies can be "provided safely and effectively by nonphysician clinicians." Medical Management of First-Trimester Abortion, Practice Bulletin No. 143 (Am. Coll. of Obstetricians & Gynecologists, Wash., D.C.) Mar. 2014, at 11 (hereinafter ACOG Bulletin). Second, studies have shown that telemedicine abortions pose no further risk of complications to the woman than medication abortions done with the physician present. Daniel Grossman, et al., Effectiveness and Acceptability of Medical Abortion Provided Through Telemedicine, 118 Obstetrics & Gynecology 296, 302 (2011).
Based on these studies, ACOG issued a practice bulletin. A practice bulletin is
ACOG Bulletin at 1. The ACOG Bulletin recommends that the off-label use of mifepristone and misoprostol are superior to the FDA protocol. Id. at 11. In addition, the bulletin recommends that "[m]edical abortion can be provided safely and effectively via telemedicine with a high level of patient satisfaction; moreover, the model appears to improve access to early abortion in areas that lack a physician health care provider." Id. at 12.
The rule also requires the physician's physical presence with the woman at the time the physician provides the drug to terminate the pregnancy. The record does not show the necessity of this part of the rule to promote the woman's health. In fact, when a speaker asked a physician board member whether it was her practice to be present when she dispensed drugs, the board member did not answer.
The final part of the Board's rule requires the physician to schedule a follow-up visit with the woman at the same facility where the physician dispensed the medication to confirm the termination of the pregnancy and to evaluate the woman's medical condition. The purpose of the follow-up visit is to make sure the termination of the pregnancy was complete. The record, however, established that a clinic equipped to detect and examine women for signs of pregnancy could make this determination.
4. The burden on a woman seeking to terminate her pregnancy. Planned Parenthood urges that the telemedicine rule imposes a substantial burden on a woman seeking to terminate her pregnancy because it only has physicians at its clinics in Des Moines, Iowa City, and Ames. This means that a woman seeking a medication abortion in Iowa potentially would have to drive hundreds of miles. Additionally, requiring two visits to the same clinic would cause a working mother to potentially miss two to four days of work and incur additional childcare expense. Planned Parenthood claims these additional costs are a significant financial strain on low-income women and their families, and for some individuals these costs are prohibitive. Finally, it asserts that increased travel means a greater possibility that an abusive spouse, partner, or relative could find out the woman is terminating her pregnancy. This may cause the woman to lose the ability to make the abortion decision privately and discretely. See Casey, 505 U.S. at 887-98, 112 S.Ct. at 2826-31, 120 L.Ed.2d at 721-28 (striking down a spousal notification requirement as an undue burden because it was "likely to prevent a significant number of women from obtaining an abortion").
There is no question the rule imposes some burdens that would not otherwise exist and did not exist before the rule was adopted. Planned Parenthood provides telemedicine abortions at clinics in Burlington, Cedar Falls, Council Bluffs, Dubuque, the Quad Cities, and Sioux City. Clearly, those services would end and women in those communities would have to travel — in many cases hundreds of miles — to obtain abortions from Planned Parenthood if the rule took final effect.
Even opponents did not dispute the rule would impose some burdens on women seeking abortion services. Their contention was that a woman who wants an abortion, even if she was indigent, would overcome these burdens.
The Board has several responses to Planned Parenthood's position regarding burden. First, it points out that the twenty-four-hour waiting period in Casey resulted in additional trips and therefore additional driving, but was upheld. See id. at 885-87, 112 S.Ct. at 2825-26, 120 L.Ed.2d at 720-21.
Id. at 874, 112 S.Ct. at 2819, 120 L.Ed.2d at 712. Third, the Board notes that in Casey, the Supreme Court upheld a requirement that a physician provide the informed consent form to the patient. It argues that if a physician can be required to obtain informed consent, a physician also can be required to perform a physical exam. The Board directs us to this passage from Casey:
Id. at 884-85, 112 S.Ct. at 2824, 120 L.Ed.2d at 719-20 (citation omitted).
Lastly, the Board argues that undue burden should not be determined by the decisions and circumstances of a single provider. The rule does not mandate that Planned Parenthood close clinics. If Planned Parenthood could deploy physicians in more communities, its clients would not have to travel as far. An additional noteworthy point is that telemedicine abortions have existed in Iowa only since 2008 and do not exist in the vast majority of states. Thus, as compared to the situation before 2008 or in many other states, the Board's rule does not have a significant adverse effect.
5. Weighing the strength of the Board's justification for its rule against the burden placed on a woman seeking to terminate a pregnancy. Consistent with United States Supreme Court precedent, we must now weigh the health benefits of rule 653-13.10(2) through 13.10(4) against the burdens they impose on a woman who wishes to terminate a pregnancy. As the foregoing indicates, the record evidence showed very limited health benefits. While undoubtedly at an abstract level everyone would prefer to see a doctor in person every time they have a medical issue, the reality of modern medicine is otherwise. In this case, the record indicates the physician plays an important role in reviewing the ultrasound images and dispensing the prescribed medications, but those roles can be performed without the physician being personally present. The record also provides almost no medical support for the necessity of a pelvic exam prior to dispensing the medication. At the same time, the record indicates that the telemedicine rule would make it more challenging for many women who wish to exercise their constitutional right to terminate a pregnancy in Iowa to do so.
A general concern we have with the Board's appellate arguments is that they are not "context-specific." See Planned Parenthood Ariz., 753 F.3d at 914 (indicating "the undue burden test is context-specific, and ... both the severity of a burden and the strength of the state's justification can vary depending on the
Given the strongly held beliefs on both sides of the issue, it is not surprising that the Board received many thoughtful comments expressing a variety of viewpoints. While the commenters vigorously disagree as to the extent of the burden imposed by the rule, there was little discussion in medical terms as to how the rule was medically necessary to protect a woman's health. Whenever telemedicine occurs, the physician at the remote location does not perform a physical examination of the patient. It is difficult to avoid the conclusion that the Board's medical concerns about telemedicine are selectively limited to abortion.
Most significantly, as noted above, the Board has adopted a rule that generally approves of the use of telemedicine, recognizing the existence of "technological advances [that] 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." Iowa Admin. Code r. 653-13.11. The rule authorizes the use of telemedicine in accordance with "evidence-based" guidelines and standards. Id. r. 653-11(2). As the Seventh Circuit observed in the somewhat different circumstances presented in Van Hollen, "An issue of equal protection of the laws is lurking in this case." 738 F.3d at 790. The Board appears to hold abortion to a different medical standard than other procedures.
After careful consideration, we hold that rule 653-13.10(2) through 13.10(4) places an undue burden on a woman's right to terminate her pregnancy as defined by the United States Supreme Court in its federal constitutional precedents. Because the Board agrees the Iowa Constitution protects a woman's right to terminate her pregnancy to the same extent as the United States Constitution, we find the rule violates the Iowa Constitution.
For the foregoing reasons, we find Iowa Administrative Code rule 653-13.10(2) through 13.10(4) is unconstitutional. Therefore, we reverse that part of the district court's judgment finding rule 653-13.10(2) through 13.10(4) constitutional. We affirm the district court's judgment as to rule 653-13.10(1) and 13.10(5). We also lift our stay as to the Board's enforcement of rule 653-13.10(1) and 13.10(5).
ZAGER, J., takes no part.