Supreme Court will hear 7 challenges to contraceptive mandate


The Supreme Court agreed to hear the challenges of seven religious non-profits against the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) contraceptive mandate. The challenges seek a decision from the Supreme Court overturning the ACA requirement that non-profit groups take action to opt out of the mandate, allowing them to benefit from the blanket exclusion granted to churches and other religious institutions.

Contraceptive mandate before the Supreme Court

This will mark the second time in three years that the contraceptive mandate has come before the Supreme Court. In June 2014, the Court held in Burwell v. Hobby Lobby Stores, Inc. that HHS regulations requiring employer-sponsored health plans to include FDA-approved contraceptives among the preventive services covered without cost sharing could not be applied to for-profit corporations with religious objections to some of the contraceptive methods (see Closely-held ‘corporate Christians’ win crusade against contraceptive coverage, July 2, 2014). The Court reasoned that the regulations violate the Religious Freedom Restoration Act (RFRA) (42 U.S.C. § 2000bb), which requires federal government requirements substantially burdening religious freedom to serve a compelling interest and be the least restrictive means of furthering that interest.

Non-profits object to accommodation process

The non-profit organizations in this challenge seek a ruling that would allow them to be exempt from the requirement to provide objectionable contraceptive coverage without having to undertake the accommodation process, which requires the filing of additional paperwork stating the organizations’ objection to the provision of contraceptives. The accommodation itself, the organizations argue, is a substantial burden on their religious exercise.

The following seven cases, originating in the Third, Fifth, Tenth, and District of Columbia Circuits, will be consolidated for hearing before the Court:

While several of these cases were consolidated at the appellate court level, all seven filed separate petitions for writ of certiorari. The Court will rule on whether the mandate and the accommodation violate RFRA but refused specifically to hear claims under RFRA and the First Amendment that the government discriminated among those allowed an exemption and those not.

Whistleblowers rake in heart-stopping $38M in cardiac device FCA settlements

Almost 500 hospitals have agreed to pay the United States over $250 million to resolve allegations that they violated the False Claims Act (FCA) (31 U.S.C. §3729 et seq.) by implanting cardiac devices in violation of Medicare coverage requirements. The Department of Justice announced the agreements, which involve 70 settlements and 457 hospitals spanning across 43 states, and represent one of the largest whistleblower suits and most significant FCA recoveries in the country. The settlements arose from a single lawsuit filed by two whistleblowers who have received a whopping $38 million under the FCA’s whistleblower provision.

Cardiac devices

The settlements involve the implantable cardioverter defibrillator (ICD), which is an electronic device that connects to the heart. The ICD detects and treats life-threatening heart rhythms, known as fibrillations, by delivering a shock to the heart to restore the heart’s normal rhythm. It is similar to an external defibrillator, but it is small enough to be implanted in a patient’s chest. Only certain patients who have specific clinical characteristics and risk factors qualify for Medicare coverage for an ICD.

Medicare coverage

A National Coverage Determination (NCD) governs whether the device, which costs approximately $25,000, will be covered by Medicare. CMS implemented the NCD based on clinical trials and guidance from various cardiac health care providers, professional cardiology organizations, and device manufacturers. According to the NCD, there should be a waiting period before ICDs are implanted in patients who recently suffered a heart attack or who had heart bypass surgery or angioplasty. The purpose of the waiting period is to allow the heart the opportunity to improve function on its own so that an ICD may not be required.

Qui tam lawsuit

The hospitals were alleged to have implanted ICDs from 2003 to 2010 during periods that were prohibited by the NCD. Most of the hospitals involved in the settlements were named in a qui tam lawsuit brought by two individuals under the whistleblower provision of the FCA (31 U.S.C. §3730), which allows private citizens to file lawsuits on behalf of the government for violations of the statute and to share in any resulting recovery.

POM Wonderful challenges FTC decision, seeks High Court review

POM Wonderful, LLC, is seeking Supreme Court review of a decision by the U.S. Court of Appeals in Washington, D.C., which affirmed an FTC determination that a series of ads touting the benefit of POM’s pomegranate-based products were deceptive. In its petition, POM argues that the First Amendment entitles the beverage company to de novo review, and therefore reversal, of the Commission’s January 2013 determination.


The Commission, in 2013, affirmed an administrative law judge’s (ALJ’s) finding of liability under the FTC Act. While the ALJ found that 19 of POM’s advertisements and promotional materials contained implied claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction and that those claims were unsubstantiated, the majority of the commissioners found that 36 of POM’s ads and promotional items made false or misleading claims.

Appellate court

The appellate court determined that the Commission properly found POM’s efficacy and establishment claims to be deceptive due to inadequate substantiation. In particular, the Commission had examined the studies put forth by POM to substantiate the ads and concluded that the studies failed to qualify as randomized controlled clinical trials (RCTs) of the kind that could afford adequate substantiation. The court acknowledged that RCTs might be costly, but noted that an advertiser can always assert a health-related claim backed by medical evidence falling short of an RCT if it includes an effective disclaimer disclosing the limitations of the supporting research. The court additionally rejected POM’s argument that the substantiation standard applied by the FTC to POM’s establishment and efficacy claims amounted to a new legal rule adopted in violation of the Administrative Procedure Act’s (APA’s) notice-and-comment requirements for rulemaking, reasoning that the FTC did not amend a regulation, but “validly proceeded by adjudication.”


“The decision that the FTC’s ban can be upheld without de novo First Amendment review is a plain and critical error of law,” POM argued, noting that the Supreme Court has “expressly held that the very kind of predicate finding the FTC made here—namely, that a particular instance of commercial speech implies a misleading message—must be reviewed de novo in order to give compass to First Amendment protections.” Otherwise, according to POM, “the scope of the First Amendment would be essentially left to the censor’s discretion, because it would always be free to decide that truthful speech implied some misleading message—and to ban it on that theory—subject only to highly deferential, APA review.”

Little Sisters is perfect vehicle for resolving RFRA dispute

The Little Sisters of the Poor Home for the Aged, Denver, Colorado (Little Sisters) filed a reply brief in its challenge to the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) contraceptive mandate and accommodation before the Supreme Court. The petition identifies Little Sisters v. Burwell as “an ideal vehicle to resolve the [Religious Freedom Restoration Act (RFRA) (42 U.S.C. §2000bb)] question that HHS now concedes warrants this court’s review.”


Under Section 1001 of the ACA, employer-sponsored health insurance plans offered by employers with 50 employees or more must meet certain coverage requirements. In particular, those plans must cover all FDA-approved contraceptive methods without copays or deductibles. While some religious employers are exempt from those requirements, others religious entities—ones that do not qualify for the exemption—may receive an accommodation. The accommodation is designed to allow such an employer to relieve itself of the ACA mandate by certifying to HHS that it is opposed to providing coverage for contraception services. As a result of that certification, a third-party administrator provides for the coverage of the objectionable contraceptives.

Procedural history

Previously, the Little Sisters challenged the accommodation before a circuit court, which denied its request for a preliminary injunction to allow it to avoid the accommodation. The Tenth Circuit upheld the denial, reasoning that the accommodation did not violate the RFRA, as it did not constitute a substantial burden on the Little Sisters’ religious exercise because it would not have to provide, pay for, or facilitate contraceptive coverage (see Prayers for injunctions go unanswered in appellate review of contraceptive accommodation, Health Reform WK-EDGE, July 15, 2015).

The Little Sisters then filed a petition with the U.S. Supreme Court, and the Tenth Circuit entered an order stating that the organization did not have to comply with the accommodation while the Supreme Court decision was pending (see Little Sisters granted relief from the heat, Health Reform WK-EDGE, August 26, 2015). The Tenth Circuit, following a poll of the circuit’s active judges, entered an order denying rehearing. The dissent criticized the decision of the court, saying “the opinion of the panel majority is clearly and gravely wrong—on an issue that has little to do with contraception and a great deal to do with religious liberty” (see Judges call majority ‘clearly and gravely wrong’ in contraception mandate case, Health Reform WK-EDGE, September 9, 2015).

Reply brief

In the government’s response to the Little Sisters petition, it argued that Roman Catholic Archbishop of Washington v. Burwell was the “most suitable vehicle” for resolving the contraceptive mandate issue and that the Supreme Court should grant the petition for writ of certiorari in that case instead of Little Sisters. In its reply brief, the Little Sisters argued, “After impermissibly trying to pick and choose which religious groups to exempt from the contraceptive mandate, HHS should not now be allowed to pick and choose its opponent or which questions it must confront in defending its actions.” The Little Sisters further argue that there is no clearer violation of the Constitution’s religion clauses than a regulation that is specifically designed to protect houses of worship but that leave out equally religious organizations, even though they assert the exact same religious objection with the exact same religious conviction.