Amazon now accepting consumers’ FSA, HSA payments

Amazon’s latest step in the healthcare space is an announcement that it will now accept flexible spending account (FSA) or health savings account (HSA) cards on its site for medical supplies.

Amazon started rolling out the program in early March, which coincides with the company adding more health and wellness products to its website.

Healthcare analysts say this is a smart move by Amazon as it gives the e-commerce giant more data on consumer purchasing behavior as it moves further into the space, perhaps even eyeing prescription drugs at some point. (CNBC)

https://www.fiercehealthcare.com/payer/roundup-amazon-now-accepting-consumers-fsa-hsa

Fully Legalized US Cannabis Market Could Reach $59-78B, Rival Alcohol: Roth

Roth Capital analyst, Scott Fortune, sees the States Act as the tipping point to cause valuation resets for cannabis U.S. Multi-State Operators (MSOs). With 33 medical states and 10 recreational states already legal, favorable public sentiment (66%, source: Pew Research) now supports full legalization of cannabis. The favorable view by the public should bring this to the forefront of the legislative agenda generating Bipartisan Congressional support to de-criminalize cannabis in the coming years.

Decriminalization, in the form of the States Act, is likely to be the impetus for institutional investment capital to enter into the U.S. cannabis and CBD industry and cause significant valuation resets for existing companies. This should shift the focus away from companies that have taken advantage of the capital friendly climate in Canada and refocus it on the larger market in the US. The analyst projects a $59-$78 billion total U.S. cannabis market today, that could in time rival the $200 billion U.S. alcohol industry.

There are already more than 20 cannabis companies with market caps above $500 million and the Multi-State Operators are likely to capitalize on 6 competitive advantages:

1) One-time conversion of a huge market from illegal to legal status;
2) High barriers to competition;
3) No need to supplant established incumbents;
4) Opportunity to create a high-end shopping experience that replaces low-end “mom and pop” settings;
5) A remarkable economics (measured in pre-tax margins) opportunity to supply one’s own high margin stores with one’s own high-margin products; and
6) Compelling new product opportunities, as cannabis discoveries continue to make news in the world’s leading medical journals – with no end in sight.

The passing of the STATES Act will exempt federal enforcement of individuals and corporations involved in cannabis operations in legal cannabis states. This removes the fear of persecution and opens up institutional capital and investment into legal cannabis states. We believe this catalyst will lead to an upside reset of the U.S. multi-state operators valuations. By simply assigning a similar 4.65x EV/Sales multiple to the cannabis TAM of $78 billion, there is a significant valuation opportunity for MSOs to total $360 billion in market capitalization. Currently the top 10 U.S. MSOs have an estimated total EV of ~$20B leaving a gap that amounts to an incremental ~$340 billion in enterprise value.

https://www.streetinsider.com/Analyst+Comments/Fully+Legalized+U.S.+Cannabis+Market+Could+Reach+%2459-%2478+Billion%2C+Rivaling+Alcohol+-+Roth+Capital/15268322.html

Anthem, Cigna await Delaware court ruling

Cigna claims that it’s owed around $16 billion as the injured party in the deal, while Anthem says it’s owed $20 billion after Cigna intentionally scuttled the deal.

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KEY TAKEAWAYS

The collapsed merger talks, suit, and countersuit exposed bitter fighting among top executives at both companies.

a Delaware chancery judge will decide which of the two health insurance companies will collect billions of dollars in damages.

Feuding Cigna Corp. and Anthem Inc. are waiting for a chancery court judge in Delaware to decide which of the two health insurance giants is owed billions of dollars in compensation after 2017’s collapsed merger bid, CT Mirrorreports.

In a trial that began Feb. 25, Cigna told Delaware Chancery Judge Travis Laster that it’s owed around $16 billion as the injured party in the deal, while Anthem says it’s owed $20 billion after Cigna intentionally scuttled the deal.

Although Cigna shareholders were expected to collect a 30% premium with the merger, Anthem alleged that Cigna CEO David Cordani sabotaged the deal because he would have had a reduced role as COO in the newly merged company, which would be led by Anthem CEO Joe Swedish, Bloomberg reported.

Anthem announced plans to acquire Cigna in 2015 for $49 billion in cash and stock, which if finalized would have created the largest health insurance company in the nation. However, the merger collapsed in 2017 after the Department of Justice successfully sued to block the deal after raising antitrust concerns.

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The collapsed merger talks, suit, and countersuit exposed bitter fighting among top executives at both companies.

During the DOJ antitrust trial in late 2016, transcripts obtained by The Wall Street Journal revealed details about the continuing antagonism between Anthem and Cigna’s top executives.

Cordani confirmed to the court that Cigna had stopped participating in some merger activities, saying he worried that Anthem’s integration strategy could damage Cigna’s network and value, the Journal reported.

Swedish testified that when Cigna stopped cooperating with the merger plan, Anthem created a confidential team to complete the task without Cigna’s knowledge, according to the documents.

DOJ attorneys expressed concern that the rift could cause the merger to fall apart even if the court allowed the plans to proceed, and that such a failure could harm both companies’ customers.

That prompted the U.S. District Judge Amy Berman to question the insurers’ promises of a smooth consolidation. “How do you work on integration without talking to the person you’re integrating with?” Jackson asked.

https://www.healthleadersmedia.com/strategy/anthem-cigna-await-delaware-courts-ruling

Ochsner, Pfizer building ‘digital superhighway’ for clinical trials

The alliance employs FHIR to quickly transmit data from the EHR with the hope of enhancing access to experimental therapies for patients and clinicians.

Construction of a “digital superhighway” for clinical trials is underway at New Orleans-based Ochsner Health System using HL7‘s Fast Healthcare Interoperability Resources (FHIR)—possibly the first time this technological solution has been successfully employed to transmit such data from Electronic Health Records (EHR) via FHIR to a study sponsor, in this case, Pfizer Inc.

The first phase of the experiment, transfer of mock data, has been completed, laying the groundwork for faster and more effective data capture and transfer between organizations. Ultimately, this alliance between Ochsner and Pfizer aims to enhance clinician and patient access to experimental therapies.

While FHIR has grown in prominence in recent years, in February the solution leapt to the spotlight when the Proposed Ruling on Interoperability of Electronic Health Information issued by the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology specified FHIR as the standard by which developers certify their application program interfaces (APIs).

Using the framework as a solution for clinical research data transfer builds on a foundation Ochsner has created through innovationOchsner (iO), an innovation company founded by Ochsner Health System in 2015 to reimagine and revolutionize the delivery and experience of healthcare and health.

“This initiative is trying to create a seamless digital trial experience,” says Aimee Quirk, CEO of iO. “For the last several years, we’ve been using digital tools to connect with patients in the clinical environment and engage them in improving their health. Some of the lessons we’ve learned are going to aid us in this research initiative we have with Pfizer.”

IMPACT AND IMPLICATIONS FOR HEALTH SYSTEMS

The impact and implications of this model could be broad-ranging, and, according to Quirk, could encompass the following outcomes:

• Enhance recruitment to clinical trials via digital submissions through the EHR
• Accelerate speed to more efficiently run clinical trials
• Avoid delays and prevent mistakes in data transfer
• Incorporate vital data generated by apps, wearables, trackers, and home monitoring devices into studies
• Reduce patient travel to participate in clinical trials
• Seamlessly transfer data to the study sponsor, pursuant to patient consent
• Share progress reports and information back to the patients about how they’re performing in trials
• Bring new therapies to the community

One key development could be a model or tool to push out information about clinical trials to physicians. It is difficult for clinicians to stay abreast of all potential and experimental therapies for patients and determine if they are eligible for a trial, explains Quirk. Not only would such a tool enhance access for patients, but it also might result in larger pools of eligible patients for those conducting the study.

Integrating EHR data into clinical trial databases has been a long-term goal of research institutions, industry, and regulators. “Such integration would reduce the burden of manual data entry, save time, decrease cost, and accelerate clinical trials,” according to a news release issued by Ochsner and Pfizer. “The ongoing challenge has been exchanging data between healthcare systems and clinical trial systems, because each uses different technology platforms and data standards.”

While many health apps use FHIR data standards, those involved in the Ochsner-Pfizer initiative say the solution has yet to be adopted for data exchange in industry-sponsored clinical trials.

“We’re pleased that we succeeded in transferring core data types collected in healthcare provider electronic health records to Pfizer’s clinical trial data capture system using FHIR standards,” says Rob Goodwin, vice president of operations at Pfizer’s center of excellence for product development in the release. “To the best of our knowledge, this is a first for our industry. There is more work ahead, but this is a significant step forward in simplifying data capture for clinical trials, and the first of many pioneering solutions we hope to develop through our partnership with Ochsner.”

The next phase on the initiative will include development of new ways to digitize the patient and clinician experience in clinical trials, with attention to patient preferences on access to and use of their health data and with an overarching goal of enhancing the quality and value of clinical research interactions for all participants.

“We’re beginning to think about digitizing that patient journey,” says Quirk, “and ultimately creating a digital superhighway for clinical trials.”

https://www.healthleadersmedia.com/innovation/ochsner-and-pfizer-constructing-digital-superhighway-clinical-trials

Syneos Health reports Q4 EPS 95c, consensus 81c

Reports Q4 revenue $1.15B, consensus $1.15B. Adjusted EBITDA for the three months and year ended December 31, 2018 under ASC 605 increased to $186.1M and $636.3M , or 22.3% and 20.0%, of adjusted service revenue, respectively, compared to $156.2M and $580.7M, or 20.3% and 18.7%, of adjusted service revenue and combined company adjusted service revenue during the three months and year ended December 31, 2017, respectively.

https://thefly.com/landingPageNews.php?id=2880783

PolarityTE down on SEC probe

Thinly traded micro cap PolarityTE (PTE -13.4%) slumps on almost 25% higher volume in apparent response to its disclosure that, on March 4, it received a formal order of investigation from the SEC concerning possible violations of federal securities laws (2018 annual report, page 48).

On September 7, 2018, the SEC filed a complaint in a New York court accusing former CFO and CIO Barry Honig, the owner of 5% of PolarityTE, of manipulating the price of three public companies (not including PolarityTE), amended on March 8.

PolarityTE received an SEC subpoena on March 1 requesting additional documents related to communications between the company and others, including Mr. Honig, Johns Stetson and Michael Brauser, the Majesco transaction, its current regenerative medicine business, including SkinTE, and any promotion of the company or its securities.

Previously: SEC charges Frost and Honig with stock promotion schemes; OPKO down 18% (Sept. 7, 2018)

https://seekingalpha.com/news/3443626-polarityte-13-percent-sec-investigation

Competition doesn’t always drive down drug prices

https://graphics.axios.com/2019-03-15-drugs-list/2019-03-15-drugs-list.html?initialWidth=797&childId=av-2019-03-15-drugs-list-RCCVJ&parentTitle=Competition%20doesn%27t%20always%20drive%20down%20drug%20prices%20-%C2%A0Axios&parentUrl=https%3A%2F%2Fwww.axios.com%2Fcompetition-doesnt-always-drive-down-drug-prices-1552681111-dabcef4c-229c-4626-b990-aae24c5eb303.html

Data: Centers for Medicare & Medicaid Services; Chart: Harry Stevens/Axios*

Competition doesn’t always lead to lower drug prices, at least in the class of drugs administered by a doctor, according to new Medicare payment data. Most of the drugs with the biggest price increases from 2016 to 2017 had at least 2 versions on the market.

Why it matters: This data only captures one year of price changes, but casts doubt on the idea that competition is a foolproof way to constrain drug prices.

Yes, but: Most drugs with more than 5 competing products did see price decreases in 2016.

• Of the 17 drugs covered by Medicare Part B with more than 10 competing products on the market, just 5 of them — or 29% — saw price increases. And only 35% of the drugs with 6-10 competing products saw a price increase.
• By contrast, of the 162 drugs with just 1 product on the market, 69%, saw price increases from 2016 to 2017. And of the 125 drugs with 2-5 products, prices increased for 58% of them.
• This analysis excludes drugs that were used by fewer than than 300 patients. It also doesn’t take into account drugs picked up at the pharmacy counter, or price decreases that may have occurred when competition for a drug first entered the market, as it looks at only one year of data.

While some of these drugs cost mere pennies per dosage, each insurance claim can include multiple doses.

• Insulin delivered through a pump — which had 16 competitors — cost on average $9.45 per dosage in 2017, but the average claim was $958.65.

The bottom line: Drugs with monopoly power aren’t the only ones that can raise their prices.

• Even with competition, “you can’t count on continual price decreases,” said Vanderbilt’s Stacie Dusetzina after reviewing the data.

https://www.axios.com/competition-doesnt-always-drive-down-drug-prices-1552681111-dabcef4c-229c-4626-b990-aae24c5eb303.html