A new report by the Office of Inspector General at the U.S. Department of Health and Human Services (HHS) reaffirms concerns with a regulatory decision that undermines the health and well-being of America’s seniors.
In an abrupt reversal of long-standing policy, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare Advantage health plans can impose “step therapy” requirements on patients who need drugs covered under Medicare Part B.
The new directive – which affects more than one-third of all Medicare beneficiaries – will force some patients to fail first on a medicine preferred by their insurance companies before they can receive the therapy prescribed by their doctors.
More than 230 patient and provider groups have warned the new policy “could put patients’ health at risk” and impose greater administrative burdens on physicians.
But what does this have to do with the HHS Inspector General? Well, in a new report, the independent watchdog reveals that patients are often wrongly denied care by health plans participating in the Medicare Advantage program. According to the report:
The “central concern” is that health plans may put profits before patients. The report notes “potential incentives” that encourage health plans to “inappropriately deny access to services and payment in an attempt to increase their own profit.”
Health plans routinely deny coverage, forcing patients to file appeals or forego the medical care they need. In fact, 75 percent of all coverage or payment denials issued by health plans were overturned at the first stage of the appeal process, which strongly suggests the insurance industry is taking a “deny first” approach to caring for America’s seniors.
Seniors face a “confusing and overwhelming” appeals process, which may explain why only 1 percent of coverage denials are actually appealed.
The often inaccurate denials of coverage by health plans are particularly worrisome for seniors who rely on Medicare Advantage and “may be especially burdensome for beneficiaries with urgent health conditions.”
These startling facts do not bode well for seniors, particularly as the Trump administration provides these same health plans new tools to restrict seniors’ access to prescription medicines.
And now UnitedHealth-the largest insurance carrier in the Medicare Advantage program-is rushing to impose the flawed fail first approach on millions of seniors starting next year. As the Society for Women’s Health Research cautioned in a recent letter, the current approach is flawed because it “lacks basic beneficiary protections and agency oversight that should be fundamental to any utilization management policy.”
The Trump administration should reverse course and withdraw this harmful policy. At the very least, it should not allow insurance companies to rush forward until basic safeguards are in place that ensure seniors aren’t wrongly denied the medicines they need.
As the stock market continued its volatile swings this week, investors at the BIO Investor Forum-which wrapped up today in San Francisco-seemed to take it all in stride and remain focused on the long-term promise of advancements and breakthroughs in the life sciences.
Attendance was up over previous years and included attendees from 34 countries, giving the event a distinctly international flavor. Many were drawn to the conference’s expertly led panel sessions and the opportunity to seek and find collaborators and partners.
Some topics covered in the educational sessions were not on the horizon five years ago. One panel covered investments in microbiome-related companies which have accelerated over the past three years, demonstrating high investor expectations for a myriad of applications beyond gut and digestion-related therapies. Other sessions looked at the ever-increasing digital space, exploring the benefits from the collaboration of biopharma and digital therapy providers, new analytical techniques utilizing digital health care records and applying artificial intelligence to improve therapy development.
A record number of meetings scheduled through BIO One-on-One Partnering-over 3,000! -reflected the enthusiasm for the great science that is fueling investment in biotech start-ups. Partnering increased nine percent over last year.
The event attracted the most investors in 10 years. Over 320 qualified private equity and public investors from around the world, particularly Asia, attended the conference this year. Interest from the investment community is on the rise for rapidly evolving areas of scientific and medical discoveries like gene therapy, cell therapy, genome editing and other innovative technologies.
But don’t take our word for it. These attendees shared their #BIF18 experience with us during the last two days.
BIO’s buzz center hosted interviews with thought-leaders focused on breakthrough technologies and the investment climate for biotechnology.
A gallery of photos highlights the networking that may lead to the next advancements in life-saving treatments.
The Conference program offered provocative and thought-provoking sessions on attracting Chinese investors, new CFIUS review regulations, investment strategies, new research on Alzheimer’s treatments and more.
A Virtual Attendee Package including panels, therapeutic sessions and fireside chats from the 2018 Investor Forum is available for purchase .
BIO sponsors meetings and conferences throughout the year that support industry-wide success. The full list of events is on the BIO website.
Despite some recent market volatility, the industry is well positioned for long-term growth and success.
That was the underlying theme of the opening Plenary Luncheon and Fireside Chat at the 2018 BIO Investor Forum (BIF).
The fireside chat featured an informative and wide-ranging conversation with industry investing veteran Ed Hurwitz, managing director at MPM Capital. The discussion was moderated by Susanne Mulligan, managing director, life sciences banking, at BMO Capital Markets.
BIO President & CEO Jim Greenwood kicked off the lunch by discussing how the fundamentals of the industry are strong and how our understanding of human biology continues to advance at a breathtaking pace. Greenwood highlighted how this increased understanding of the science gives investors more confidence to provide key financing for companies throughout their growth cycle.
Hurwitz echoed this point during the fireside chat, noting that our improvedunderstanding of science has changed the trends in investing.
Because of advances in science, more companies today can attract the capital they need to motor through tough times and bad markets.
In his remarks, Greenwood noted how this trend is playing out by highlighting some key data points:
Initial public offerings in 2018 are much stronger than in years’ past: 39 so far this year – compared to 24 for all of last year and just 22 in 2016.
U.S. companies have pulled in $3.8 billion in IPOs and are on track for the second highest amount raised in a decade.
More preclinical-stage companies are going public than any other year in a decade.
There have been more than 800 secondary offerings since 2013. These offering have raised more than $100 billion for biotech companies.
2018 could be a record year for VC investment in this sector, beating last year’s record of $7.6 billion for U.S. companies.
Globally, data from Evaluate Pharma shows a record $13.2 billion into biopharma in 2018. That’s ahead of last year’s record $12.2 billion.
We can expect more than 40 novel drug approvals this year.
“As an industry, we’ve gone from talking about our potential to realizing it,” said Greenwood.
MPM Capital has played an important role in making this success possible. As Mulligan noted in her comments, MPM Capital has about $1.5 billion under management; launched 22 start-ups since 2010; 35 of their portfolio companies have gone public since 2005; and there have been 46 drug approvals from companies that the firm has invested in. The firm continues to be a leader in the oncology space and has one of the most experienced leadership teams in the business.
During the fire side chat, Hurwitz talked about the MPM entrepreneurial engine, its deep bench of expertise and the role it plays in helping turn great ideas into well-capitalized, well-run companies.
Access business panels, therapeutic sessions, and fireside chats from the 2018 Investor Forum by purchasing a Virtual Attendee Package .
Today marks the 17th opening of the BIO Investor Forum-a place where emerging biotech companies, researchers and investors mull over opportunities to advance innovations in medicines and treatments with their sights trained on bringing products to the market. The conference has attracted over 300 qualified private equity and public investors from around the world, particularly Asia. Their presence here reflects the enthusiasm around the rapidly evolving areas of scientific and medical discoveries like gene therapy, cell therapy and genome editing.
“As a life-science venture capitalist, I am looking to discover the most novel therapies and the companies that are developing them” noted Vinay Bhaskar, Principal at MPM Capital and a member of the BIO Investor Forum Advisory Committee. “To do this, I have to stay ahead of pack in both my scientific and industry knowledge. The BIO Investor Forum lets me do both. It features cutting-edge speakers and panels and provides me with the tools to quickly connect with the types of companies I’m looking to invest in.”
During this year’s conference BIO’s President and CEO, Jim Greenwood, will deliver an address during the lunch session on Oct 17th the that will recognize BIO’s 25th anniversary and reflect with pride on the role the organization has played in shaping policy to save lives and promote the planet’s health. He will point to current trends in biotechnology and what attendees can expect at the conference.
With thought leaders and investment powerhouses scheduled to speak on panels and in Fireside Chats, the discussions will be robust, informative and stimulating.
On day one, Ed Hurwitz, an accomplished biotech executive, investor and Managing Director at MPM Capital, will take questions from the moderator and the audience in a noon-time Fireside Chat.
Day two’s Fireside Chat will host Rowan Chapman of Johnson & Johnson Innovation, CA. As the head of this division, Rowan manages a co-investments spanning all three sectors of Johnson & Johnson
The program will cover everything from artificial intelligence applications in biopharma drug development to the growth of Chinese investment in biotechnology to the implications of regulatory policy on the industry to new therapeutics in the pipeline. It will close with a session on the market outlook.
Partnering at #BIF18
The popularity of BIO One-on-One Partnering™ can be seen in the surge in participation which is up 27 percent over last year with more than 3000 one-on-one meetings expected. New this year:
Meeting requests can be made from the One-on-One mobile app
Companies can be filtered by their in-licensing and out-licensing goals
Resources like pitch decks and one-pagers can be linked to specific meeting requests with companies to better showcase an offering.
Warm-up for JPM Week!
BIO Investor Forum attendees can get a jump-start on using BIO’s One-on-one Partnering™ during 2019 JPM week, January 6 – 10, 2019 in San Francisco. Come to the Yorkshire Room on Wednesday (10/18) at 2:30 to learn how to use this versatile system to request meetings with thousands of biopharmas, investors, in-licensors, academics, research institutes and patient groups at no cost. Those who join this session will receive expedited registration for JPM week.
Check out the BIO Buzz Center
The BIO Buzz Center hosts industry leaders and invites them to share their perspectives on key industry trends during two to three-minute video interviews. Which will be conducted in the “California West” room. Here is the schedule of interviews for this year’s Buzz Center:
To all our attendees, welcome to the BIO Investor Forum!
Every October 16th the world celebrates World Food Day, honoring the founding of the Food and Agriculture Organization of the United Nations.
Established in 1945, the UN’s Food and Agricultural Organization is focused on leading international efforts to defeat hunger. And in today’s world, hunger is an increasingly critical issue that the UN is closely watching.
In fact, the UN has been sounding the alarm that we must double food production to feed the world’s growing population – a population that will swell to 9 billion people by 2050. Compounding this, the UN recently issued a sobering report on the progress to curb climate change, noting more work needs to be done. Because of Earth’s rising temperatures and its exponentially increasing population, the mission of UN’s Food and Agricultural Organization is more important than ever.
So, in honor of #WorldFoodDay, let’s explore how biotechnology can help the UN in its mission to feed a growing, warmer world.
Ag Microbials
As we covered in September’s 25th Anniversary blog, ag microbials are products that can be applied directly to a seed to enhance the natural microbes found in soil – that is the tiny organisms like bacteria and fungi that provide plants the nutrients they need. Ag microbials can be applied to seeds to make plants grow more efficiently, such as making them drought tolerant (requiring less water), able to absorb nitrogen from the atmosphere (reducing the need for nitrogen fertilizers) or able to protect themselves from pests and diseases (reducing the need for pesticides).
By applying certain ag microbials to crops, farmers can increase yields without using resources that exacerbate the world’s food security issue by being harmful to the environment.
Precision Agriculture
In the UN report on climate change, the intergovernmental organization alluded to the need for new technologies to meet the goals in the Paris Agreement. Precision agriculture is the overarching term for a plethora of new farming technologies that have enhanced farming practices in the computer age. Many of these technologies allow farmers to grow food more efficiently, reducing resources and preventing harm to the environment. Two technologies advancing precision agriculture include:
Variable rate technology, or VRT, allows farmers to control the amount of inputs they apply to a specific crop. Instead of spraying an entire field from a crop duster plan, VRT allows farmers to apply precise doses of treatments at the base of the plant, cutting down on resource waste. These deliberate inputs can also lead to higher yields as individual crops will get treatments specific to their needs as opposed to relying on an overhead, inaccurate crop dust.
Remote sensing technology allows farmers to monitor various components of cropland, from the soil’s moisture content to factors that could be stressing the plant. Think of remote sensing technology like an MRI scan for humans. From this, farmers can make more calculated decisions to manage crop health and growth, thus reducing resource waste. Additionally, remote sensing technology allows farmers to be better stewards of cropland, allowing them to monitor and make changes to guarantee the land’s health into the future.
Gene Editing
Perhaps the most-exciting, or most newsworthy, technology that can help feed the growing, warmer world is gene editing. Unlike GMOs, gene editing allows us to make edits to a plant’s DNA without using a vehicle like bacteria to transfer genes from one plant to another. Like GMOs, however, gene editing can lead to countless traits that will help farmers grow food in various challenging conditions. From crops that are drought tolerant, enabling them to grow in arid climates, to high oleic soybeans, which will increase supply of heart-healthy fats in certain malnourished regions, gene editing technologies like CRISPR hold tremendous promise to feed a growing and warmer world.
See what others are talking about for #WorldFoodDay by following the conversation on Twitter here.
A guided walk is a great way to take in the city’s architectural and cultural riches
‘It’s not just the history but the sheer chutzpah of these buildings that fascinates me,” announces Trevor Newton, my guide to Liverpool, as we meet under the looming portico of the Town Hall. An artist and architectural historian, Newton, 59, grew up here before heading south to work in London as a topographical artist in the early 1980s. He’s returned to launch Magnificent Liverpool, idiosyncratic tours of a city that’s captivated him since childhood.
“There’s still an outdated view of Liverpool which dates back to the Toxteth riots and declining docks of the 1980s,” says Newton, “but the city has changed hugely since then. The architecture is spectacular – it has the most listed buildings of any city outside London – and the vibrant indigenous culture is open to all. You can go on tours themed around football or the Beatles, but I wanted to offer something that draws on my background as an architectural historian and a Liverpudlian. I’ve known this city all my life, now I’ve come back to share it with other people.
Here’s a statistic you might not have known: an estimated 700,000 people die each year due to the growing number of infections resistant to treatment. Known as antimicrobial resistance (AMR), this “silent killer” and looming public health threat has severe social and economic consequences that could have a lasting impact on families, individuals and communities across the globe.
How best to tackle that problem will be the subject of the World Antimicrobial Resistance Congress later this month. Now in its fourth year, the Congress will take place October 25-26, 2018 here in Washington, DC, where over 400 stakeholders from around the world will discuss strategies and commercial approaches to combat AMR.
This year’s event will consist of three streams on Antibiotic R&D, Diagnostics, and Antimicrobial Stewardship, as well as a fourth stream called Innovation Showcase where antibiotic biotech companies and diagnostics innovators will be pitching to investors.
One of the highlights of this year’s show will be the keynote panel entitled Coordinated Pull, where our panelists will discuss how to make tangible “pull” incentives a reality. Dr. Gregory Frank, BIO’s director of infectious diseases policy, will be moderating the panel. He will be joined by:
Mark Jones, Head of Clinical Development and Preclinical Development, Basilea Pharmaceutica
Jeremy Knox, Policy and Advocacy Lead, Drug-Resistant Infections Programme, Wellcome Trust
Amanda Jezek, Senior Vice President, Public Policy and Government Relations, Infectious Diseases Society of America (IDSA)
Silas Holland, Director of Infectious Diseases Policy, Merck
Christine Årdal, Senior Advisor, Norwegian Institute of Public Health, and Co-Lead, DRIVE-A
These leaders will analyze different commercial models, mainly market entry rewards, transferable vouchers, and FDA proposed licensing model, from a multi stakeholder approach.
Since 2015, the World Antimicrobial Resistance Congress has been the go-to global meeting for AMR stakeholders, and this year’s event is supposed to be the best yet! More information and registration details may be found here.
Writing for The Hill, Steve Forbes, Forbes Media Chairman and Editor in Chief, delivered a simple message to the American people about the implications of drug importation: “Your health could be put in unnecessary danger soon.”
Let’s rewind to July, when Health and Human Services Secretary Alex Azar directed Food and Drug Administration (FDA) Commissioner Scott Gottlieb to establish a drug importation working group. Azar stated that he was open to a variety of solutions, as long as they are “effective, safe for patients and respect choice, innovation, and access.” But as the facts show, importing medicines from abroad do not meet any of these requirements.
As Forbes points out, four former FDA commissioners who served under both President Bush and President Obama had a front row seat into the dangerous, counterfeit global medicine marketplace which is alarmingly deceptive.
“[The] vast majority of internet sites that advertise as being Canadian are actually based in South America, Eastern Europe and Russia,” the group stated.
It’s often assumed that buying drugs from highly developed Western countries like Canada poses little to no safety risks. This claim, however, cannot be further from reality.
Sure, the Canadian government works to ensure the safety and authenticity of medicines entering their market that are intended for use by patients in Canada, but they do not apply those standards for medicines intended only for export. The Canadian government has even stated, “Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.”
These concerns are also backed by a number of current and former law enforcement officials who have sounded similar alarms about allowing drugs from foreign countries to flow into our communities.
The National Sheriff’s Association stated that importing medicines from abroad would “jeopardize law enforcement’s ability to protect the public health; threaten the safety of our drug supply; and endanger law enforcement officers, their canines, and other first responders across America.”
Louis Freeh, former director of the Federal Bureau of Investigation, added that drug importation could “force law enforcement agencies to make tough prioritization decisions that leave the safety of the U.S. prescription drug supply vulnerable to criminals seeking to harm patients.”
To put the risks in perspective, the Wall Street Journal recently shared the story of a young man who lost his life after taking a counterfeit medicine to help him fall asleep. The medication in question was purchased on the black market and laced with a deadly dose of fentanyl.
“All risk with no reward does not sound like great policy,” Forbes concluded. “If patients cannot trust and rely on the safety of their treatments, the cost benefit of importing these risky medications, or the hope of innovative medical discoveries, then what good is importation as policy anyway?”
In 1984, President Ronald Reagan used the phrase “It’s Morning in America” as a now famous campaign message to reassure American’s that his economic policies were working. Fast forward nearly 25 years later and it is now past midnight in America – at least for those who contribute to the U.S. biobased economy and rely on key Farm Bill energy titles.
Brent Erickson, BIO’s Executive Vice President, Industrial and Environmental
As Brent Erickson, BIO’s Executive Vice President for the Industrial and Environmental section, explains in an op-ed for Biofuels Digest, because the Farm Bill expired as the calendar turned to October funds for critical Farm Bill energy title programs that many in rural America rely on are now in jeopardy. These programs, representing a drop in the bucket in terms of overall Farm Bill spending, have become substantial sources of federal support for companies at the core of the burgeoning biobased economy – an economy that BIO estimates is valued at $205 billion, generating 1.665 million jobs.
And while the bill’s energy title programs cost little, the positive impacts are real. Erickson argues that the Senate’s version of the Farm Bill energy title should be passed to continue building on the positive gains.
Read the full piece below, or at Biofuels Digest by clicking here.
On September 30th, the 2018 Farm Bill officially expired. And while both chambers of Congress passed their respective bills, the final version of the legislation that supports the agricultural sector in the U.S. is still being negotiated between House and Senate leaders in conference committee. Now it appears efforts to finalize the legislation will be delayed until after the election. If Congress does not pass a new bill by the end of the year, they risk having to go back to the drawing board after a new Congress is sworn in January 3rd– a Congress that could look significantly different.
Because of this, Congress should pass the Senate version of the Farm Bill energy title without delay to ensure funding for these programs so manufacturers – many based in Rural America – can continue strengthening the burgeoning biobased economy.
Over the past year, BIO has been working to improve upon the existing Farm Bill energy title programs and reauthorize them with mandatory funding. Because of our leadership, the Senate Farm Bill energy title expands eligibility to renewable chemicals and biobased products, with mandatory funding. Supporting these technologies is economically sound policy. The U.S. biobased economy has made significant strides due to the Farm Bill energy title. A recent U.S. Department of Agriculture (USDA) analysis found that biobased products contributed $393 billion to the U.S. economy, generating 4.223 million jobs. Support for these programs will ensure continued domestic growth of this sector.
One of the key energy title programs is the USDA BioPreferred Program®, which helps establish a market for companies developing renewable chemicals and biobased products by prioritizing the procurement of these products by federal agencies and their contractors. Additionally, the program issues a USDA certified renewable chemical and biobased label – ensuring the product is biobased – to manufacturers across the country, helping companies promote their products to consumers. As a result of BIO’s advocacy, the Senate bill strengthens the program to ensure certification of new renewable chemicals and biobased product processes and technologies, through the application of a biobased mass balance test method. This will increase the use of renewable feedstocks, benefitting the biobased sector and agricultural producers by making more feedstocks available for producers and creating an expanded value-added market.
By helping companies promote their renewable chemicals and biobased products, thus increasing sales, the Farm Bill’s BioPreferred Program supports millions of jobs in the renewable chemicals and biobased products industry across the country and gloablly. According to USDA, in Texas alone, the biobased products industry is valued at more than $6.8 billion and creates more than 88,000 jobs. Therefore, funding of the BioPreferred Program® is essential to generating job growth in the U.S.
The Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program is critical to the growth of the biobased economy and is also at risk if the Farm Bill is not finalized before the end of the year. Because of BIO’s advocacy, the Senate version of the program will support companies who are developing first-of-a-kind technologies to produce advanced biofuels, as well as standalone renewable chemicals and biobased manufacturers, by helping these companies secure financing from rural lenders.
Because of BIO’s efforts, more companies with innovative technologies will be able to secure funds through this program for commercial projects across the nation. The program enables companies to meet the increasing consumer demand for cleaner biofuels and greater and safer household and personal care products.
Additionally, BIO continues to advocate for the continued funding of the Biomass Crop Assistance Program (BCAP). The program provides matching payments to farmers growing dedicated energy crops to produce biofuels, biobased products and renewable chemicals. These payments provide certainty to manufacturers that dedicated feedstocks needed to produce bioproducts will be in steady supply. This certainty in the supply chain allows manufacturers to continue producing and developing the biofuels, biobased products and renewable chemicals that have become pillars of the biobased economy. Because of our efforts the Senate version of the energy title allows algae to qualify under BCAP and helps incentivize the collection of forest residue, helping remove hazardous fuels that lead to forest fires.
Of course, the ability of Congressional leaders to pass the Farm Bill will come down to dollars and cents. However, the bill’s Energy Titles barely represent a drop in the bucket. The Energy Title programs account for less than one-tenth-of-one-percent of total Farm Bill spending. For so much so success for such little funding, reauthorizing these programs with mandatory funding should be a priority, especially considering their minimal burden on the budget.
As Congressional leaders return to Washington post-election, BIO will be working to make sure their primary focus should be to pass a final Farm Bill with the Senate’s version of the energy title as soon as possible. By passing the Senate version, key programs that support the biobased economy, and thus many in rural America, will continue to be funded. If they wait until the new Congress is sworn in we could see a significant delay in reauthorizing the Farm Bill, jeopardizing funding and operation of these programs. Lack of funds for these programs would significantly impact the rapidly growing biobased economy that supports domestic manufacturing, jobs, renewable energy, rural communities, and agricultural producers across the country.
“As a life-science venture capitalist, I am looking to discover the most novel therapies and the companies that are developing them” noted Vinay Bhaskar, Principal at 
On day one, Ed Hurwitz, an accomplished biotech executive, investor and Managing Director at MPM Capital, will take questions from the moderator and the audience in a noon-time Fireside Chat.
Day two’s Fireside Chat will host Rowan Chapman of 
