Next abortion legislation arguments will use mixed evidence on fetal pain

Reproductive health issues have long been controversial, and one law professor believes that the next wave of abortion restriction legislation and court cases will take a new approach by discussing the effects of abortion on the fetus. In an article published in the New England Journal of Medicine, Professor R. Alta Charo projects that, because the recent arguments supporting abortion restrictions focusing on women’s safety were shot down due to medical evidence, the focus will turn to the effects on the fetus.

New focus on evidence

The recent U.S. Supreme Court decision Whole Woman’s Health v. Hellerstedt shot down a Texas law requiring physicians performing abortions to have admitting privileges at local hospitals while reasoning that the procedures have become so safe that such a requirement is not necessary. This reasoning signals a shift in court thinking and a new willingness to dive into the medical evidence surrounding the issue rather than defer to the legislature on factual issues. Charo pointed out that in 2007, when the Supreme Court upheld a statute banning dilation and extraction based on the legislature’s findings that such a procedure is not necessary to protect a woman’s health, the Gonzales v. Carhart opinion accepted the legislature’s factual findings because of mixed evidence. Even so, the opinion indicated that the court had a duty to review the facts underlying decisions involving constitutional rights.

Next steps

Charo believes that a shift will occur because medical evidence does not support the argument that abortion is unsafe and presents significant health risks to women. This shift will involve claims that a fetus can feel pain about 20 weeks after conception, based on fetal movement and hormonal activity in response to stimuli and stress. Charo observed that there are growing efforts to require fetal anesthesia, outlaw second-trimester use of dilation and evacuation, and prevent abortion starting at 20 weeks following conception. The opportunity arises for a legislature to state that medical opinion is mixed in light of studies showing that a fetus cannot feel pain due to the development timeline until almost 30 weeks. Charo believes that the Gonzales decision prioritized fetal concerns over women’s health and that that the opportunity may arise again. However, Whole Woman’s Health presents the possibility that the court will consider further evidence rather than deferring to the legislature’s fact finding.

Florida health care provider settles monopolization, conspiracy claims

Health First, Inc. and its subsidiaries have settled allegations that they attempted to establish a vertically integrated, self-reinforcing, illegally-maintained health care monopoly in Southern Brevard County, Florida. Just days after denying Health First’s motion for summary judgment, the federal district court in Orlando dismissed the antitrust claims with prejudice.

Omni Healthcare, Inc. and other physicians and physician practice groups filed suit against “fully integrated” health care corporation Health First, Inc. and three of its wholly owned subsidiaries: Holmes Regional Medical Center, Inc.; Health First Health Plans, Inc., and Health First Physicians, Inc. Omni alleged that Health First engaged in an anticompetitive scheme to monopolize Southern Brevard County’s interrelated health care markets for years and that the scheme has largely been successful.

The court denied Health First summary judgment on August 13, 2016, finding that Omni and other physicians and physician groups created genuine issues of material fact in whether Health First monopolized, attempted to monopolize, and conspired to monopolize the markets for physician services, Medicare Advantage, and ancillary services.

Anthem first to respond to merger challenges, government opposes quick trial

Two large insurance mergers–Cigna-Anthem and Aetna-Humana–have been hot topics since the deals were proposed. The latest hurdle, suits filed by the Department of Justice (DOJ), may be a bigger issue than anticipated, as the government argued against Anthem, Inc.’s request for a speedy trial. The DOJ argued that the issues at hand are more complex than other cases, requiring more time than the 88-day scheduling range Anthem requested.

The inevitable lawsuit 

On July 21, 2016, the DOJ filed lawsuits challenging both the Cigna-Anthem merger and the Aetna-Humana merger. Attorney General Loretta Lynch stated that the mergers would eliminate too much competition and, therefore, the motivation for insurers to lower their premiums and offer better benefits. Aetna and Humana both stated they would contest the suit, arguing that the deal would actually improve options for Medicare patients. These companies are two of the four largest Medicare Advantage providers. According to the DOJ, an Anthem-Cigna merger would result in only three insurers with networks that would sufficiently serve the country’s largest employers.

Cigna’s response to the suit was less robust, stating that if the deal closed at all, it would be sometime next year. The company is reviewing the merger agreement, which may require defense of the deal, and analyzing its options. Anthem took the position that the suit was a “step backwards” for consumers, but seemed open to a settlement.  A joint statement from Aetna and Humana suggested that some divestitures could preserve competition, but the government was doubtful.

The American Hospital Association (AHA) and the American Medical Association (AMA) believe that the suit protects consumers, and that fewer coverage options would undermine innovation. The Center for Healthcare Research & Transformation director noted that even if the deals reduced prices insurers pay to providers, consumers may not see any savings. She believes that the suits will be difficult for the companies to win. Failure would be costly for Aetna and Anthem, as the agreements state that Anthem would pay Cigna $1.85 billion and Aetna would pay Humana $1 billion in termination fees.

State responses

States are taking action on the suits as well. Eleven states, plus the District of Columbia, joined the DOJ’s challenge against the Cigna-Anthem merger, while eight states and D.C. joined to fight Aetna-Humana. Other state actions are pending as well, such as the New Hampshire Insurance Department’s is review of the Cigna-Anthem proposal. An AMA analysis found that the  merger would result in control of 64 percent of the state’s insurance market. According to the state, the two proceedings are separate, and the insurance commissioner still has the authority to act in the event that the lawsuit does not succeed. The state department is not yet prepared to hold hearings, and will wait to take action until the lawsuit is resolved.

Speedy trial

Anthem, the only company that has filed an answer in the lawsuits, requested that the judge provide a trial within 88 days, with a decision on the injunction coming within 35 days of the trial’s conclusion. The government strongly opposes such a quick timeline, as the case comes against the largest health care merger ever to be proposed. The DOJ finds that the case is more complex than another recent coal antitrust suit that was quickly resolved, which Anthem relied upon as an example in its answer.

After denying cert in health law cases, SCOTUS ends term

The Supreme Court concluded its 2015 term by cleaning house and disposing of many pending petitions for writ of certiorari. In doing so, the High Court declined to hear—and thereby, affirmed the lower court rulings in—a number of health law cases in its order lists of June 27 and June 28, 2016. The Court denied petitions in cases regarding health care employees, the False Claims Act (FCA) (31 U.S.C. §3729 et seq.), and a Washington state law requiring the timely delivery of all prescription medications by licensed pharmacies that was challenged pharmacists with religious objections to certain medications. In wake of the Court’s decision in Whole Women’s Health v. Hellerstedt, it also denied certiorari in two Targeted Regulation of Abortion Providers (TRAP) law challenges.

Health care workforce

The Court denied petitions in both Prime Healthcare Services, Inc. v. Service Employees International Union (Dkt. 15-1448) and Home Care Association of America v. Weil (Dkt.15-683). Prime Healthcare appealed the Ninth Circuit’s unpublished decision finding that it failed to sufficiently allege harm to competition or monopoly power in favor of a conspiracy and monopolization claims against Kaiser Permanente, Kaiser-affiliated companies, and two unions (for more information on this case, see Court dismisses antitrust lawsuit against Kaiser Foundation entities and United Healthcare Workers unions, Health Law Daily, July 29, 2013). In Home Care, the Court’s denial upholds the D.C. Circuit’s decision that the Department of Labor’s revised domestic worker regulations (78 FR 60453, October 1, 2013) that extended minimum wage and overtime protections to home care workers was a reasonable interpretation of the Fair Labor Standards Act due to changes in the long-term home care industry.

False Claims Act

In PharMerica Corporation v. U.S. ex rel. Gadbois (Dkt. 15-1309), PharMerica asked the Court to review its 2015 decision in Kellogg Brown & Root Services, Inc. v. U.S. ex rel Carter, which found that the FCA’s first-to-file rule does not bar subsequent relator claims if earlier lawsuits were dismissed (see Nothing to fear: whistleblower action timeline not suspended during war, Health Law Daily, May 27, 2015). Based on that decision, the First Circuit allowed a whistleblower to revive an earlier case brought against PharMerica that was originally barred under the first-to-file rule (see PharMerica requests Supreme Court review of FCA’s first-to-file bar, Health Law Daily, April 28, 2016; FCA action dismissed under first-to-file bar may get another chance on remand, Health Law Daily, December 17, 2015).

Religious pharmacists

In Stormans, Inc. v. Weisman (Dkt. 15-862), a divided Court denied cert, leading to a dissent from Justice Alito, joined by the Chief Justice and Justice Thomas. Washington state medication prescribing rules require the timely delivery of all prescription medications by licensed pharmacies; an individual pharmacist may refuse to deliver a prescription due to religious objections, so long as another pharmacist working for the pharmacy provides timely delivery. If there is no other pharmacist to provide timely delivery, pharmacists and pharmacy owners must deliver the prescription even in the face of religious objections. The Ninth Circuit determined that the state law is neutral and of general application, and is rationally related to a legitimate government purpose, and therefore does not violate the Constitutional protections of the Free Exercise, Due Process, or Equal Protection clauses (see Prescribing rules withstand religious attacks, patient safety takes the higher ground, Health Law Daily, July 24, 2015).

In his dissent, Justice Alito suggested that the law will make religious pharmacists “unemployable” and notes that the facts in the case show that the pharmacy in question, Ralph’s Thriftway, does not stock emergency contraceptives, but rather uses the practice of facilitated referrals, sending customers to other nearby pharmacies, to ensure timely delivery. The dissent also argued that the law in question is not neutral, because there is evidence to suggest that it was passed predominantly to “‘stamp out the right to refuse’ to dispense emergency contraceptives for religious reasons.”

TRAP laws

The Court also denied certiorari in a pair of TRAP law cases. In Currier v. Jackson Women’s Health Organization (Dkt. 14-997), the Fifth Circuit upheld a preliminary injunction preventing the enforcement of a Mississippi law requiring abortion facility physicians to have admitting privileges at a local hospital and staff privileges to replace the on-staff physicians at local hospitals (see Admitting privileges requirement for abortion clinics put on hold, Health Law Daily, July 31, 2014). Similarly, in Schimel v. Planned Parenthood of Wisconsin (Dkt. 15-1200), the Seventh Circuit affirmed a permanent injunction against a Wisconsin law requiring a physician performing an abortion to have admitting privileges at a hospital no more than 30 miles from the clinic where the abortion is performed (see Court terminates enforcement of Wisconsin law requiring admitting privileges for abortion doctors, Health Law Daily, November 24, 2015). These two Circuit Court decisions align with the Court’s decision released the previous day in Whole Women’s Health, which found that a Texas abortion law requiring physicians at abortion clinics to have admitting privileges at a nearby hospital and obligating clinics to meet ambulatory surgical center standards violated the Constitution by creating an undue burden on access to abortion services (see High Court strikes down Texas abortion restrictions as unconstitutional burdens, Health Law Daily, June 27, 2016).