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Wednesday, September 26, 2018

Anthem returning to ObamaCare exchange in Ohio in 2019


Anthem will be once again selling individual health insurance plans next year in Ohio after its dramatic exit from the Obamacare exchanges during 2018.
The insurance company will sell plans in 25 counties in the state including Warren and Butler counties, according to filings with the Ohio Department of Insurance, which regulates the exchanges.
Open enrollment for coverage next year begins Nov. 1. and runs through Dec. 15.
Most counties in the region will have more options to choose from next year, signaling the market is starting to stabilize.
In 2018, eight companies sold health insurance products on the exchange in Ohio and 42 counties had just one insurer with an additional 20 counties having only two.
But for next year, 10 companies have filed rates and forms for the department to review and all 88 counties will have at least one insurer. Preliminary filings show 16 counties with just one insurer and 33 counties with two.
Miami County will have two insurance carriers next year selling individual plans instead of one. This year the only individual plan in the county — sold by CareSource — is not in-network with Upper Valley Medical Center, the only hospital in the county.
Molina and Medical Mutual are entering new counties and health insurance startup Oscar Health is expanding into the Columbus metro.
“I think what it tells me on the surface is that carriers are slightly more optimistic about what the exchange could offer,” said Scott McGohan, CEO of insurance benefits brokerage firm McGohan Brabender.
Costs of individual plans are still rising, though subsidies offset those spikes for some people.
The average premium in Ohio for individual plans will increase 8.2 percent, according to early cost estimates submitted to Ohio Department of Insurance.
In 2018, the weighted average premium for an individual plan was $5,798.83. For 2019, companies are proposing to sell products an an average $6,274.08 premium, up 8.2 percent.
While the increase still outpaces employer-sponsored insurance, the rates are rising at a slower pace than last year when premiums rose an average of 34 percent.
About 11 percent of the increase was because the Ohio Department of Insurance required insurance companies to assume they would lose federal subsidies that help lower costs.

UnitedHealth: Optum backs startup that uses AI to aid in medical diagnosis


A venture fund at Minnetonka-based UnitedHealth Group is part of a $33 million fundraising round for an Iowa startup that’s developing an autonomous diagnosistic system featuring artificial intelligence (AI).
Called IDx, the company this year received clearance from the Food and Drug Administration to market the first medical device using AI to detect greater than a mild level of the eye disease diabetic retinopathy in adults with diabetes.
The startup on Wednesday announced fundraising that’s intended to accelerate market adoption of the technology and development of related products. It includes money from Optum Ventures, which UnitedHealth Group launched last year.
“We expect this investment to accelerate the adoption of IDx-DR, a unique and much-needed solution for the 30 million people with diabetes in the U.S. alone who need to be tested for diabetic retinopathy each year,” said Stefan Abrams, vice chairman at IDx, in a news release.
Optum is the UnitedHealth Group division for health care services including information technology, direct patient care and pharmaceutical benefits management. Last year, the company launched Optum Ventures, a series of domestic and international funds meant to invest in digital care, consumer care and health analytics with artificial intelligence, big data and machine learning.
Company officials said in April that Optum Ventures has $600 million to invest. Last year, UnitedHealth listed among the venture fund’s first four investments a startup called Mindstrong Health, which uses machine learning and artificial intelligence to analyze a patient’s smartphone interactions. The goal is “to help diagnose and treat neuropsychiatric and neurodegenerative disorders such as depression, schizophrenia and post-traumatic stress disorder,” UnitedHealth Group said in a news release.
The financing announced Wednesday was led by venture capital firm 8VC, where founding partner Drew Oetting said in a statement that IDx leveraged expertise at University of Iowa Health Care “to develop a clinically-inspired AI — not a black box.”
Sarah London, senior principal at Optum Ventures, said in the news release: “The health care industry needs to accelerate its adoption of AI to reduce costs and drive efficiencies. We are confident that IDx will transform health care by increasing patient access to early disease detection.”

Epizyme: FDA Lifts Partial Clinical Hold on Tazemetostat Clinical Program


Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration(FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.
Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.
Epizyme’s formal response to the FDA included a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat, which took into account both published literature and the company’s clinical experience to date. This followed a report of a single case of T-LBL in its tazemetostat pediatric study. Epizyme provided a thorough assessment of efficacy and safety data across all of its trials in hematological malignancies and solid tumors, in both adults and children, and convened a panel of external scientific and medical experts who reviewed and validated the findings.
‘The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL,’ said Robert Bazemore, president and chief executive officer of Epizyme. ‘We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program. We remain steadfast in our commitment to bringing this potential therapeutic option to cancer patients in need of safe and effective new treatments.’
Epizyme will now engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries. The company is also working closely with its study partners to reach a similar resolution for their respective trials in which tazemetostat is being studied in combination with other therapies.

Entasis Therapeutics opens at $13.45, IPO priced at $15.00 per share


Entasis Therapeutics (ETTX) priced 5M shares at $15.00. The deal size was increased to 5M shares from 4.1M shares and priced below the $16.00-$18.00 range. Credit Suisse and BMO Capital acted as joint book running managers for the offering.

Piper says Amag goal to add 174 patients to trial by 2019 ‘may be a tall order’


Piper Jaffray analyst Christopher Raymond noted that Amag Pharmaceuticals announced it has taken over development of digoxin immune Fab for the treatment of severe preeclampsia from Velo Bio and seeks to add an additional 174 patients by the end of 2019, which he believes “may be a tall order.” As he waits to see how enrollment progresses for this trial, he continues to have concerns with Amag’s current franchise as Makena, which makes up over 70% of revenue, recently began facing generic competition, Raymond tells investors. The analyst maintains a Neutral rating on Amag shares and says he is still “comfortable on the sidelines.”

Alphatec Wins OsseoScrew® FDA Clearance


Alphatec Holdings, Inc.  (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew® System, making it available for clinical use for the first time in the United States.
“I am exceptionally pleased that OsseoScrew has been cleared for the U.S. market,” said Pat Miles, Chairman and Chief Executive Officer. “The system will create new market opportunities for ATEC by uniquely addressing an unmet need for an underserved patient population.  We are building an organic innovation machine and today’s announcement represents another significant step toward creating a clinically distinguished portfolio.”

Carpenter to Retire as Chair, CEO of LifePoint; President, COO Dill to CEO


LifePoint Health (NASDAQ: LPNT) and its Board of Directors announced today that current Chairman and Chief Executive Officer (CEO) William F. Carpenter III (Bill) will retire upon completion of the Company’s pending merger with RCCH HealthCare Partners, which is anticipated to occur later this year. Following his retirement, Carpenter will join the merged organization’s Board of Directors. David Dill, the Company’s current president and chief operating officer (COO), will assume the role of CEO for LifePoint upon Carpenter’s retirement.
Carpenter has served as CEO since 2006 and was appointed the additional position as chairman of the Board in 2010. He is a founding employee of LifePoint, which was established in 1999. Carpenter led the strategic process that resulted in the transaction that will merge LifePoint with RCCH HealthCare Partners and transition LifePoint to a privately-held company.
“It has been an absolute privilege to lead LifePoint for nearly 13 years, and to be a part of the team since the company’s inception almost 20 years ago. I am incredibly proud of all the organization has accomplished during that time,” said Carpenter. “We’ve grown from 23 hospitals in 9 states, to nearly 70 hospitals in 22 states today, to a footprint that will soon span coast to coast, pending completion of our merger with RCCH HealthCare Partners. We’ve forged partnerships and innovations within the industry that were first of their kind, such as being the only investor-owned system selected by CMS to participate in the Partnership for Patients initiative as a Hospital Engagement Network, and our joint venture partnership with Duke University Health System, Duke LifePoint Healthcare. With David’s leadership, I’m confident that LifePoint will continue to advance its mission of Making Communities Healthier in even more remarkable ways. I cannot think of a better leader to take LifePoint into the future and am pleased to have the opportunity to stay engaged through my participation on the Board.”
Dill joined LifePoint as executive vice president and chief financial officer in 2007. He was named COO in 2009 and appointed president and COO in 2011. Under Dill’s leadership, the Company grew its revenues from $2.6 billion in 2007 to more than $6 billion projected for 2018 and enhanced quality and patient safety across its hospitals, most notably by launching the Company’s National Quality Program in collaboration with Duke University Health System.
“It is a tremendous honor to be named CEO of LifePoint Health. When I joined this organization more than 10 years ago, I was attracted to the mission – Making Communities Healthier. Today, I continue to be energized by our mission and the potential to make a positive impact in communities across the country. I thank and commend Bill for his years of leadership,” remarked Dill. “I believe that LifePoint is better positioned than ever to be the leader in non-urban healthcare, and to help define what the delivery of community-based healthcare looks like in the future. I am fortunate to be surrounded by one of the most talented teams in the industry that will help take us there. Additionally, I am excited about the opportunity to work with the team at RCCH HealthCare Partners as we embark on the next chapter for the combined company.”
Dill will be the first CEO of the merged LifePoint and RCCH HealthCare organization, which will operate under the LifePoint Health name. Following the close of the transaction, LifePoint will operate a diversified portfolio of healthcare assets, including approximately 85 non-urban hospitals in 30 states, regional health systems, physician practices, outpatient centers and post-acute service providers, with leading market positions as the sole community healthcare provider in the majority of the regions it serves.