Seton Hall Law’s John Jacobi Testifies Before the New Jersey Legislature on the Obama Fix
Filed under: Health Reform, Insurance Companies
Last week, John V. Jacobi, the Dorothea Dix Professor of Health Law & Policy at Seton Hall University School of Law—and a contributor to this blog—testified before the New Jersey legislature at a hearing on the New Jersey insurance commissioner’s decision to allow insurers to renew recently-cancelled plans for an additional year.
Professor Jacobi responded to a number of issues, including whether New Jersey, rather than simply permitting insurers to renew policies out of compliance with the Affordable Care Act (as President Obama requested) could instead mandate such renewals. Jacobi explained that such a mandate would violate specific terms of the ACA, and therefore be unlawful. The permissive renewals, in contrast, can be seen simply as an exercise of administrative discretion by both federal and New Jersey officials.
Jacobi also, however, suggested that insurers might not be fully protected were they to renew these technically noncompliant policies. While administrative officials have agreed not to enforce the law, people covered by the insurance have entered into no such agreement. They could, then, if the renewed policy failed to cover services mandated by the ACA, insist on the coverage as a matter of federal statutory law.
In an article at NJ Spotlight, Andrew Kitchenman writes the following:
Seton Hall University health law professor John V. Jacobi raised a separate point – the possibility of legal challenges over coverage being denied in plans that are extended but don’t comply with the ACA.
Jacobi put forward the hypothetical example of a child of a worker at a small business that offers an insurance plan that is extended but would otherwise have been cancelled because it didn’t comply with the ACA. Jacobi said that if that child were to become sick and be denied coverage that would be mandated by the ACA, the child’s family would be in a strong position to challenge that denial.
For example, pediatric dental care and treatment for some mental illnesses aren’t covered by current health plans, but must be covered under ACA-compliant plans.
“While the employer and maybe even the employee may have agreed to this lesser coverage, the statute still requires that those services be covered,” Jacobi said.
Read Kitchenman’s entire article, Insurers Face Tough Decisions on Whether to Extend Health Plans, here.
Checking in on PPACA’s Protections for Pumping Moms
Filed under: Insurance Companies, Women's Health Issues
Cross-Posted at Bill of Health
For most women who work outside the home—Gisele Bundchen excepted—breastfeeding on the job is not an option. Pumping breast milk during the work day is more likely to be a realistic, if often challenging, choice.
As I blogged about here, Section 4207 of the Patient Protection and Affordable Care Act amended the Fair Labor Standards Act to require that employers provide their non-exempt employees with reasonable unpaid breaks to express breast milk, and “a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public” in which to do it. Employers with less than 50 employees are relieved of the requirement to the extent that it “would impose an undue hardship by causing the employer significant difficulty or expense when considered in relation to the size, financial resources, nature, or structure of the employer’s business.” In addition, under the Health Resources and Services Administration guidelines implementing PPACA’s women’s preventive services mandate, insurance plans must cover “costs for renting breastfeeding equipment” such as breast pumps and related supplies.
According to news reports (e.g., here, here, and here), new mothers have had some difficulty turning PPACA’s promise of a breast pump into a reality. Many insurers require that women go through a durable medical equipment provider, but many durable medical equipment providers do not stock breast pumps. In addition, insurers vary in what type of pump they cover. Writing in the Winston-Salem Journal late last month, neonatal nurse practitioner Tinisha Lambeth reports that:
“Some mothers of premature infants qualify for a manual breast pump, while some mothers of full-term babies qualify for (unnecessary) hospital-grade electric pumps. Still others will get a dual electric pump, which are not as effective as a hospital-grade electric pump for an extended period of time, but are adequate for supplying full-term babies. It all depends on your coverage.”
The breastfeeding advocacy groups the United States Breastfeeding Committee and the National Breastfeeding Center recommend that the cost of renting a powerful hospital-grade electric pump be covered upon a showing of medical necessity and that the cost of buying a regular electric pump be covered upon a showing that a nursing mother expects to be separated from her infant on a regular basis or for an extended period of time.
The women’s preventive services mandate did not go into effect until last August, and many women did not benefit until January of this year. Some of the issues with coverage of breast pumps may be resolved as insurers and durable medical equipment suppliers gain experience with the new requirements. At some point, though, HHS may need to step in and lend further specificity to the phrase “breastfeeding equipment”. A hand pump or other equipment that cannot be used to express sufficient milk will not meet the Institute of Medicine’s criteria for preventive services—that they “improve well-being and/or decrease the likelihood or delay the onset of a targeted disease or condition.”
Turning to the new rule protecting time taken to pump at work, it is primarily enforced by the Department of Labor. Individual plaintiffs can only sue if their efforts to take advantage of the rule lead to retaliation. Caselaw is still sparse. In a per curiam decision issued on December 26, 2012, the Eleventh Circuit affirmed the trial court’s grant of judgment as a matter of law in favor of the defendant in a case in which the plaintiff testified that she was given the breaks she needed to pump and that she had access to a private place in which to do so. The plaintiff’s claim that she was retaliated against failed because an email that she sent asking where she could pump on a day when she would not have access to her own office did not constitute “fil[ing a] complaint.” In a case brought in district court in the Northern District of Iowa, by contrast, the plaintiff survived a motion to dismiss, alleging, among other things, that the room in which she was told she could pump had an operating video camera in it.
The plaintiff in a case filed by the ACLU last month in Pittsburgh has a very compelling story, alleging that she was shunted from the bathroom, to a first aid room where she was subjected to harassment by her co-workers, and to “an old locker room that was furnished with nothing but a single chair on a filthy floor with dead bugs.” When the plaintiff complained, “she was moved from the day shift to a rotating schedule that frequently required her to work an overnight shift, which disrupted her ability to breastfeed or produce enough milk for her baby.” It will be interesting to track the progress of this case and others that give courts the opportunity to apply and interpret PPACA’s requirement of reasonable breaks in an appropriate place.
Monday Morning Recap: The Week in Drug & Device Law & Policy
What follows is a weekly feature here at Health Reform Watch. Each Monday morning, we provide a recap of the drug and device (and, this week, breast milk and bone marrow) law and policy developments over the previous week that caught our eye and made us think. Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.
1. FDA Commissioner Margaret Hamburg kicked off the week with a blog post heralding the passage of the Drug Quality and Security Act which will empower FDA to regulate compounded drugs and enhance the security of the drug supply chain. Commissioner Hamburg writes that ”[w]hile the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress.”
2. At FDA Law Blog, Allyson Mullen and Jeffrey Gibbs provide helpful analysis of the FDA’s final guidance on in-vitro diagnostics that are labeled for research or investigational use only. Mullen and Gibbs note that the final guidance was modified in response to manufacturers’ vociferously-voiced complaints that the draft guidance wrongly equated a manufacturer’s knowledge that a research-only diagnostic is being used for clinical purposes with the manufacturer’s intent that it be so used. Nonetheless, Mullen and Gibbs conclude that ”it is clear that FDA expects commercially available RUO and IUO products to be an area of focus for FDA enforcement.”
3. At NJ Spotlight, Andrew Kitchenman writes about legislation pending in New Jersey that would “increase public awareness of the potential dangers of informal [breast] milk sharing and require state licensure of milk banks.” As interest in donating and selling breast milk grows, so does interest in regulating its exchange. Kitchenman notes that “the health concerns are backed up by research studies, including a recent one published by the journal Pediatrics, which found that human milk purchased via the Internet exhibited high overall bacterial growth and was frequently contaminated with pathogenic bacteria due to poor collection, storage, or shipping”, but he also quotes an advocate who calls the risk of disease transmission “theoretical”.
4. At Bill of Health, Michelle Meyer offers an exhaustive set of arguments against an HHS proposal to ”criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized[.]“ Meyer also suggests a seemingly-promising alternative approach to increasing bone marrow donation, as follows: “If a major stumbling block is getting people into the registry, which is a stage at which dying patients are for many prospective registrants merely “statistical lives,” then maybe what we should be doing — all without violating [the National Organ Transplant Act], even as interpreted by the Department — is to pay people to join the registry.”
5. Finally, discussion about the FDA and 23andMe continued this week. I recommend this post by Leila Jamal at the Berman Institute’s blog, in which she argues that the fact that “most individual genetic markers have poor predictive power” is not a reason to restrict consumers’ access to tests for those markers. Jamal contends that “responsible and user-friendly DTC genomics could still be a powerful antidote to dangerous, reductionist notions about genomics….This is why we must keep the big picture in sight, and not let a tiff between the FDA and 23andMe hinder creative new ways of communicating and teaching about human genomics.”
A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?
Cross-Posted at Bill of Health
At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information.
Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]“ Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach. In a Tweet commenting on Gaffney’s article, Patricia Zettler–a Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges.
Commercial speech is only protected under the First Amendment if it is not false or–perhaps more relevant in the context of direct-to-consumer advertising–misleading. In Christopher Robertson’s recent essay in the Boston University Law Review, he argues that when the truth about a claim is known, as it likely the case with an on-label direct-to-consumer advertisement, it is sensible to put the burden on the government to “prov[e] that the true speech is misleading…given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation.”
As I discussed previously here, courts called upon to decide whether an advertisement or form of advertising is true, false, or misleading are permitted “to look to the facts to determine ‘the actual effect speech will have.’” In Florida Bar v. Went for It, for example, the Supreme Court relied on the government’s “106-page summary of its 2-year study of lawyer advertising and solicitation to the District Court,” as well as an “anecdotal record . . . noteworthy for its breadth and detail” in upholding a thirty-day moratorium on direct-mail solicitation of accident victims and their families by personal injury lawyers. In Bronco Wine Company v. Jolly, a California appeals court held that a legislative finding that the descriptor “Napa” was inherently misleading was adequately supported by “the regulatory history of brand names of geographic significance,” hearing testimony, and a survey. By contrast, in Edenfield v. Fane, the Supreme Court invalidated a ban on in-person solicitation by accountants on the grounds that the Board of Accountancy failed to ”validate [its] suppositions[.]“
Commercial speech doctrine does not precisely specify the level of deception, or the form or degree of proof, necessary to justify speech-restrictive regulations like those that limit direct-to-consumer prescription drug advertising. The government might have to show that such advertising is more often deceptive than not. Or, as in Lanham Act false advertising cases, it might have to show that a substantial percentage (typically fifteen to twenty percent) of a company’s customers is misled by it. Or, a significant risk of deception might be sufficient. Notwithstanding this uncertainty, FDA is wise to prepare to defend (and even fend off) future First Amendment challenges to the laws and regulations governing direct-to consumer prescription drug advertising by building up the evidence base underlying them.
Monday Morning Recap: The Week in Drug and Device Law and Policy
Welcome back from what I hope was a restorative break in the routine! What follows is a weekly feature here at Health Reform Watch. Each Monday morning, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think. Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.
1. Last week, the warning letter that the FDA sent to 23andMe on November 22, 2013 ordering the company to stop marketing its 23andMe Saliva Collection Kit and Personal Genome Service was heavily debated. Here’s a link to a radio show on the FDA’s action featuring Nita Farahany, Hank Greely, and others.
2. At Scientific American, Dina Fine Maron reports that “[a] new process, in which the FDA approves cancer drugs on the basis of which malfunctioning growth pathways they target rather than on [the part of the body where a malignancy begins], has been quietly batted about on the sidelines of conferences or over drinks among oncologists for the past couple years. Although the FDA has not formally proposed any such change, the agency’s cancer czar, Richard Pazdur, floated the idea at a public conference on cancer care earlier this month in Washington, D.C., suggesting the idea may be gaining official traction.”
3. In an editorial in JAMA, epidemiologist Jennifer Robinson makes the case for statins for primary prevention. She writes: “Critics give several reasons to avoid statin therapy, including concerns about adverse effects, lack of a total mortality benefit, cost, and a philosophical aversion to drug therapy. However, the passage of time has allowed sufficient evidence to accumulate to refute each of these concerns.”
4. Health Affairs issued a new Health Policy Brief on specialty pharmaceuticals. The authors note that the debate over co-pay coupons, which I blogged about here, is especially heated with regard to these more expensive drugs.
5. Finally, in an editorial in the American Journal of Obstetrics and Gynecology, Anthony Vintzileos and Cande Ananth provide an alternate explanation for data demonstrating a link between oxytocin, used to induce or augment labor, and autism. The authors conclude that “the most recent evidence (birth years 1995-1998) indicates that when the appropriate diagnostic criteria for autistic disorders are applied, there was no increase in autism from baseline or any association between induced or augmented childbirth and autism.” The search for a cause continues.