Category: Kate Greenwood

Checking in on PPACA’s Protections for Pumping Moms

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By Kate Greenwood

Cross-Posted at Health Reform Watch 

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.”

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A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?

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By Kate Greenwood

Cross-Posted at Health Reform Watch

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. Read More

The Co-Pay Coupon Controversy: Time for Detente?

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By Kate Greenwood

Cross-Posted at Health Reform Watch

At the end of last month, the Secretary of Health and Human Services Kathleen Sebelius made headlines when, in a letter addressed to Representative Jim McDermott (D-WA), she announced that “[qualified health plans], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act” were not “federal health care programs under section 1128B of the Social Security Act”.  One implication of the Secretary’s interpretation is that the “anti-kickback act”, which is found in Section 1128B, does not apply to qualified health plans.  And that, in turn, means, among other things, that individuals insured under those plans, unlike individuals on Medicare or Medicaid, will be able to use drug company coupons to defray the cost of their prescription drugs.

Prescription drug coupons have been a source of controversy, favored by branded manufacturers and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers.  Joseph Ross and Aaron Kesselheim studied a large number of coupons advertised on the website www.internetdrugcoupons.com and found that “62% (231 of 374) were for brand-name medications for which lower-cost therapeutic alternatives were available.”  Ross and Kesselheim argue that the coupons are costly at the population level, but also for individual patients.  This is because the coupons are nearly always time-delimited and the short-term savings do not typically outweigh the long-term cost of taking a branded drug.  On the other hand,  in an article in last week’s JAMA, Leah Zullig and colleagues pointed out that reducing co-payments has been proven to improve medication adherence, a problem which there “is an increasing business case for addressing[.]”

The coupon controversy has carried over into the courts.  On March 7, 2012, seven lawsuits were filed in district courts by third party payers against a number of drugmakers, alleging that prescription drug coupons violate antitrust, commercial bribery, and racketeering laws.  (This post at FDA Law Blog includes links to the seven complaints, and this one provides an update on the status of the litigation as of late June 2013.)

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Stillbirth: Still Not There*

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By Kate Greenwood

Cross-Posted at Health Reform Watch

As I have blogged about before, including in this post from 2010, and this one from 2009, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why.  An article by Robert Goldenberg and colleagues in this month’s issue of the American Journal of Perinatology suggests that the knowledge gap is likely to persist.

As Goldenberg explains, the three tests that provide the most information about what caused a stillbirth are (1) an autopsy, (2) an examination of the placenta, fetal membranes, and umbilical cord, and (3) a karyotype (a test for chromosome abnormality).  Of the members of the American College of Obstetricians and Gynecologists who responded to a 2011 survey, however, 23.3 reported that they infrequently ordered an autopsy when a stillbirth occurred (0.4 percent reported that they never did) and 24.8 percent reported that they infrequently ordered a karyotype (0.3 percent reported that they never did).  These results comport with the findings of a qualitative study published in 2012 in BMC Pregnancy & Childbirth.  The authors, Maureen Kelley and Susan Trinidad, reported that obstetrician-gynecologists in two focus groups “would not routinely offer an autopsy to the parents, but would conduct one if requested. Some would offer/order lab work on the placenta if the cause of the stillbirth were not known.”

A surprisingly high 30.2 percent of the doctors who responded to Goldenberg’s survey indicated that they frequently, but do not always, review the results of post-stillbirth testing; an additional 11.9 percent admitted that they infrequently review such results.  The survey also revealed that “the large majority of stillbirth certificates are filled out prior to the return of all test results”, some “by providers other than the physician”, “making it “highly likely that that the vital statistic cause of death reports are inaccurate.” Read More

Kaiser v. Pfizer and the Question of Who Pays When Fraudulent Pharmaceutical Promotion Has Its Intended Effect

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By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion.  The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the  appellate court upheld a jury verdict that, after trebling, came to $142 million.

Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.”  Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.”  In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”

Civil RICO claims cannot be predicated on “off-label promotion”, however.  To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud.  In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo.  On appeal, Pfizer did not contest the jury’s finding that it committed fraud.  This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.

There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Read More

Introducing Contributor Kate Greenwood

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Kate Greenwood is a Research Fellow & Lecturer in Law at the Center for Health & Pharmaceutical Law & Policy at Seton Hall University School of Law.  She also serves as Faculty Editor of Seton Hall Law’s Health Reform Watch blog.  Kate received her law degree from Georgetown University Law Center and her undergraduate degree from Swarthmore College. After law school, she was an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York, a law clerk to federal judges at the trial and appellate levels, and an associate at Covington & Burling in New York.  Her current research interests include maternal and child health policy, prescription drug and medical device regulation, and, especially, the intersection of the two.

Some of Kate’s recent publications include:

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