WellCare ‘mailing error’ exposes health information of kids on Missouri Medicaid

A contractor that administers Missouri Medicaid plans says it accidentally exposed the personal health information of 19,570 children.

A vice president for WellCare Health Plans Inc. said in a letter to The Star that the company learned on July 25 that a “mailing error” caused reminders about well-child visits for the company’s Missouri Care members to be sent to the wrong addresses.

“The letters contained personally identifiable health information including (the) child’s name, age and provider name,” said the letter from Ted Webster, WellCare’s VP and chief security and privacy officer.

Webster’s letter, which he said he was required to send by law, was postmarked Aug. 23.

It says there is no evidence suggesting the exposed information was misused, but WellCare is nonetheless offering members one year of free credit monitoring from Experian.

The letter also advises Missouri Care members to keep an eye on credit card bills, monitor bank accounts for unauthorized activity and not answer “emails asking for personal details or other information.”

“As we continue to investigate the scope of the incident, we are taking steps to prevent something like this from happening again,” Webster’s letter says. “Missouri Care is deeply committed to protecting our members’ privacy, and we apologize for any inconvenience this incident may have caused.”

Julie Roth, a lawyer with Spencer Fane in Overland Park and an expert on medical privacy laws, said the information WellCare exposed doesn’t sound too sensitive in comparison to some other breaches, but it could still be a violation of the Health Insurance Portability and Accountability Act, or HIPAA.

“This isn’t a situation where diagnoses were disclosed or account information, or full clinical reports (were disclosed),” Roth said. “So it’s more limited in nature, but I agree, personally, with their decision to notify individuals.”

Roth said health care organizations do a risk assessment after identifying potential data breaches to determine whether they should self-report them. WellCare notified the media because of the size of the breach, she said.

“You always notify the individuals (affected),” Roth said. “In cases where more than 500 individuals are involved in a jurisdiction, then you also notify the media at the same time.”

Missouri Care plans cover about 275,000 people throughout the state and focus mainly on children and pregnant women.

It’s the second straight year that a mailing error has exposed the data of Missouri Care members. Last August the company reported a similar breach of 1,223 members’ information that the company blamed on a subcontractor, O’Neil Printing. No health information was exposed in that breach, but names, dates of birth and Medicaid account numbers were.

WellCare also offered one year of free credit monitoring after that incident.

“Often that’s about the only thing that you can do,” Roth said. “Clearly in cases where there’s been Social Security Numbers disclosed or financial account numbers disclosed the credit monitoring is, in my opinion, always appropriate. But even here, with the child’s name, age and provider, it looked to me like they were offering credit monitoring to essentially mitigate any harmful effect that might occur.”

Missouri’s Medicaid program, MO HealthNet, also informed more than 25,000 members in 2013 that their personal information, including full Social Security numbers in some cases, was mailed to incorrect addresses by another contractor, InfoCrossing Inc. A “software programming error” was blamed for that breach.

https://bit.ly/2MZCZhf

Chugai Publishes Results of Phase 3 Study on Hemophilia A Med

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) today announced that results of the HAVEN 3 study (NCT02847637), the global phase III study evaluating hemophilia A treatment, HEMLIBRA^® (generic name: emicizumab [genetical recombination]), were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM).
Article: https://www.nejm.org/doi/full/10.1056/NEJMoa1803550
Quick video summary by NEJM: https://www.nejm.org/do/10.1056/NEJMdo005333/full/

The study evaluated the efficacy and safety of HEMLIBRA subcutaneous injection, once a week and once every two weeks, in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII. Detailed results of the study were presented at the World Federation of Hemophilia (WFH) 2018 World Congress held in Glasgow, Scotland on May 21, 2018.

“This is the third time that the clinical data of HEMLIBRA have been published in NEJM, following the results of the phase I/II studies and the first phase III study. It demonstrates a high medical value that the drug may bring to the treatment of hemophilia A,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “We are committed to deliver HEMLIBRA which has been created with our proprietary bispecific antibody technologies, as a new treatment option to people with hemophilia A without inhibitors as early as possible in cooperation with Roche.”

In May 2018, HEMLIBRA was launched in Japan for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) with factor VIII inhibitors. An application for an additional indication of the treatment of hemophilia A without factor VIII inhibitors has been filed in April in Japan. Applications for the same additional indication have also been filed in the United States and Europe. In the U.S., the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation in April, and Priority Review in June, for this line extension. In Europe, the review by the EU Committee for Medicinal Products for Human Use (CHMP) is ongoing.

https://bit.ly/2MBnuwy

Oppco Bullish On Weight Watchers Margin Expansion Opportunities

Major changes are afoot at Weight Watchers International, Inc. WTW 2.04%, and one Wall Street analyst believes Weight Watcher’s explosive 2018 growth is just the beginning of the long-term story.

The Analyst

Oppenheimer analyst Brian Nagel initiated coverage of Weight Watchers with an Outperform rating and $98 price target.

The Thesis

Weight Watchers’ new strategies have the company on the path to long-term growth and margin expansion.

“Under the leadership of new CEO Mindy Grossman and her team, WTW is now tactfully introducing improved programming upon an enhanced digital infrastructure, so as to better connect with a larger and more diverse audience of subscribers,” Nagel wrote in a note on Wednesday.

Nagel said the pullback off of recent highs is mostly technical in nature and serves as a buying opportunity.

Oppenheimer projects EPS of $3.00 in 2018, on the high end of the company’s guidance range. Looking ahead, Nagel forecasts EPS to grow to $3.86 in 2019 and $4.90 in 2020, slightly ahead of consensus analyst estimates.

In the most recent quarter, Weight Watchers reported a 28-percent uptick in digital subscribers, which reached 4.5 million. Nagel says the retention rate of subscribers is also climbing higher, up from between eight and nine months in early 2017 to nearly 10 months today.

From 2018 to 2020, Nagel projects Weight Watchers will generate about $220 million in free cash flow, which is can use to de-lever and de-risk its balance sheet.

https://bit.ly/2PLYCQR

Why Raymond James Is Bullish On Deciphera, Dova Pharmaceuticals

Raymond James launched coverage of two pharmaceutical names Tuesday afternoon with bullish ratings.

Deciphera Pharmaceuticals, Inc. DCPH 1.72% is a clinical-stage biopharmaceutical company that addresses key mechanisms of tumor drug resistance. Dova Pharmaceuticals Inc DOVA 3.62% focuses on treatment of rare diseases with a high unmet demand.

The Analyst

Raymond James’ Laura Chico initiated coverage of Deciphera Pharmaceuticals with an Outperform rating and $47 price target. Chico initiated coverage of Dova Pharmaceuticals with an Outperform rating and $44 price target.

Deciphera Pharmaceuticals

One of the more notable trends in the biotechnology sector is the growth of gene therapy, CAR-T and other novel treatment modalities, Chico said in the initiation note. (See her track record here.)

“Easy to overlook” kinase inhibitor companies like Deciphera Pharmaceuticals are operating in the sector, the analyst said. The company boasts a unique approach through its switch pocket inhibition strategy, she said.

Deciphera’s lead asset DCC-2618 for the treatment of gastrointestinal stromal tumors is “encouraging,” Chico said. The therapy is undergoing Phase 3 studies and should come to the market by 2020 and generate $341 million in U.S. revenue by fiscal 2026, the analyst said.

The company’s switch-pocket inhibitor platform gives management the opportunity to design novel and differentiated candidates, Chico said.

Deciphera is looking to begin a second Phase 3 study of DCC-2618 in earlier lines of treatment in a head-to-head design to compare the therapy to Sutent, she said.

The candidate demonstrates a strong potency with encouraging readouts and the potential to surpass rival products, including Sutent and Stivarga, Chico said. From a technical perspective, the stock looks attractive in the low $30s given a bear-case scenario downside target of $15 and an upside bull-case target of $60, she said.

Dova Pharmaceuticals

The bullish case for Dova Pharmaceuticals is justified now that the company’s Doptelet is approved for a domestic commercial launch, Chico said in the initiation note.

Firs hand checks and conversations suggest a disconnect between investor expectations for “modest” performance versus conversations with physicians who are aware of the recent approval and likely to prescribe the therapy over the next six months, the analyst said.

A risk always exists of physicians overestimating use, Chico said.

Under a conservative assumption, Dova Pharmaceuticals will likely see $11 million in Doptelet sales, and the figure should grow to $1.037 billion by 2026, Chico said. Even assuming sales peak at $400 million by 2026, the downside case for the stock is to $18 per share given the company’s net cash position of $5 per share, she said.

The upside case is in the $60 per share range and can be achieved if Doptelet gains a better-than-expected share of the market, expanded use or if investors merely assign a higher multiple to the stock.

https://bit.ly/2omnCkY

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FDA Accepts Resubmission Of Ortho/Bausch Psoriasis Med Application

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for DUOBRII^TM1 (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis. The FDA accepted the application as a Class 2 resubmission, with a PDUFA action date of February 15, 2019.

“We are confident in our NDA resubmission for DUOBRII and unwavering in our commitment to bring this new treatment option to patients,” said Bill Humphries, president, Ortho Dermatologics. “We have worked closely with the FDA to answer their questions regarding pharmacokinetic data, and we look forward to continued collaboration with the Agency through the remainder of the review process.”

If approved, DUOBRII will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.

https://bit.ly/2wqdTyu

Commissioner Gottlieb on FDA support to exempt coffee from Cal. cancer warning

Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the U.S. Food and Drug Administration. Consumers deserve accurate information about the food they eat and how it can affect their health and nutrition. That’s why Congress entrusted the FDA to serve as the nation’s expert on food safety and labeling and to craft predictable, uniform federal requirements on matters within our jurisdiction. Consistent with that authority, we work to provide the best advice possible to Americans about the foods they eat based on the most recent scientific information, taking into account the food’s benefits in addition to any potential health risks.

Part of our mission in this space means ensuring that food product labeling doesn’t contain false or misleading statements about safety or nutrition. This includes statements that food manufacturers make on their own initiative. But it also includes statements that may be compelled under state law.

Simply put, if a state law purports to require food labeling to include a false or misleading statement, the FDA may decide to step in.

That’s why we were deeply concerned when a court recently ruled that a California law – known as Proposition 65 – may require coffee sold in California to be labeled with a cancer warning because of the presence of a chemical called acrylamide. Under Proposition 65, California requires that certain products contain cancer warnings if they will expose consumers to chemicals that California health authorities have identified as causing cancer. But requiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them.

Acrylamide can form in many foods during high-temperature cooking, such as frying, roasting and baking. Acrylamide in food forms from sugars and an amino acid that are naturally present in food. It doesn’t come from food packaging or the environment. In coffee, acrylamide forms during the roasting of coffee beans. Although acrylamide at high doses has been linked to cancer in animals, and coffee contains acrylamide, current science indicates that consuming coffee poses no significant risk of cancer. This finding was reflected in a comprehensive report by the World Health Organization’s International Agency for Research on Cancer.

The good news is that, based on this science, the California agency that administers Proposition 65 has proposed a regulation to exempt coffee from a Proposition 65 cancer warning.

The FDA strongly supports this proposal.

As a science-based agency, the FDA is committed to ensuring that information being presented on a food’s label is accurate and not misleading. That’s why today the FDA sent a letter to the California Office of Environmental Health Hazard Assessment expressing our support of this proposed regulation that would exempt coffee from a Proposition 65 cancer warning.

We’ve taken this position because we too have carefully reviewed the most current research on coffee and cancer and it does not support a cancer warning for coffee. In fact, as our letter to California states, such a warning could mislead consumers to believe that drinking coffee could be dangerous to their health when it actually could provide health benefits. Misleading labeling on food violates the Federal Food, Drug, and Cosmetic Act. No state law can require food to bear a warning that violates federal law.

Strong and consistent evidence shows that in healthy adults moderate coffee consumption is not associated with an increased risk of major chronic diseases, such as cancer, or premature death, and some evidence suggests that coffee consumption may decrease the risk of certain cancers. To this end, current dietary guidelines published by the U.S. Department of Health and Human Services and the U.S. Department of Agriculture state that moderate coffee consumption (three to five cups a day or up to 400 mg/day of caffeine) can be incorporated into healthy eating patterns.

This is not the first time the FDA has expressed concerns about Proposition 65 warnings based on the presence of acrylamide in foods. The FDA previously wrote to California stating our concerns about acrylamide warnings for foods because such warnings may mislead consumers about the risks posed by foods containing acrylamide and encourage consumers to alter their diets in ways that may not benefit their health. A prime example is whole grain foods. We recognize that some of these products may contain acrylamide. But we also know that consumption of whole grains is beneficial for health and nutrition. Labeling whole grain foods with a cancer warning may cause American consumers to avoid foods that would have a benefit to their health, including avoiding foods that may reduce cancer risks.

The FDA has undertaken a number of activities on acrylamide since the discovery of acrylamide in foods in 2002, including performing toxicology research, conducting food surveys and exposure assessments and issuing guidance for industry on mitigating the formation of acrylamide during food production. Given the widespread presence of acrylamide in foods, it isn’t feasible to completely eliminate acrylamide exposure.

Removing any one or two foods from your diet would not have a significant effect on overall exposure to acrylamide. This is why the FDA’s best advice is that consumers adopt a healthy diet, consistent with the Dietary Guidelines for Americans (2015-2020). It emphasizes fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products; includes lean meats, poultry, fish, beans, eggs, and nuts; healthy oils, and limits saturated fats, trans fats, sodium, and added sugars.

Assuring that consumers have access to transparent science-based nutrition information is a pivotal element of the FDA’s public health mission. These goals are encompassed in the multi-year Nutrition Innovation Strategy that we announced in March. This Innovation Strategy involves a series of synergistic actions intended to modernize the FDA’s approach to nutrition, help reduce the burden of chronic disease that stems from poor nutrition, including obesity, diabetes, heart disease and a variety of cancers, and to remove barriers to industry innovation.

In line with our Nutrition Innovation Strategy, we strongly support exempting coffee from a cancer warning. The scientific community has conducted a substantial amount of research on the issue of whether coffee causes cancer, and the totality of that research has found inadequate evidence to establish that coffee causes cancer and suggests that coffee may even reduce the risk of some cancers.

We’re dedicated to providing science-based information to consumers in an effort to benefit health and nutrition. And we remain committed to ensuring product labeling provides the most factual, easy-to-understand information needed to inform diet selections.

For more information:
FDA: Acrylamide information
FDA: Guidance for Industry: Acrylamide in Foods
FDA: Nutrition Innovation Strategy

https://bit.ly/2oiNJJs

Statement, Netflix’s ‘The After Party’ by Philip Gattone, CEO, Epilepsy Foundation

Members of our community have expressed concerns about the inappropriate and negative portrayal of people with epilepsy and seizures in the new Netflix film, “The After Party.” The main character is nicknamed “Seizure Boy” and everyone makes fun of him because he has a seizure. The film inaccurately portrays seizures and people who experience seizures. Epilepsy is a neurological disorder and people with epilepsy may experience hundreds of seizures a day.

Making fun of someone having a seizure is bullying at its worst. When such responses are portrayed as acceptable behavior – even in movies – it is demeaning and hurtful to our epilepsy community and all of us. In fact, such treatment can put real people who have seizures at increased risk of injury and death. If someone is ridiculed for a medical problem, such as seizures, they are more likely to hide their illness and less likely to seek medical care or the help of others.

While we welcome opportunities to portray real stories of people with epilepsy in movies and in the media, it is a serious affront to our community when so-called entertainment mocks or jokes about having epilepsy or seizures.

For decades, and in partnership with the U.S. Centers for Disease Control and Prevention for 17 years, the Epilepsy Foundation has developed and activated nationwide programs to promote public education about epilepsy, seizure recognition and how to administer Seizure First Aid.

Unfortunately, the film does not educate people about seizures or provide information on what to do if someone sees a person having a seizure. The way seizures are portrayed in the film only adds to the ignorance, misunderstanding and fear that exist about seizures. This Netflix film harkens back into the Dark Ages.

We have reached out to Netflix and hope to work with them to ensure that seizures are accurately depicted in future projects and that Netflix includes an education component about seizure recognition and Seizure First Aid.

https://bit.ly/2PNkACV