Archive for the ‘Policy’ Category

February 2018 Life Sciences Luncheon – 2018 Public Policy Overview

February 27, 2018

Public policies are impacting the life sciences sector dynamically, with many changes at the state and federal levels targeting manufacturers. Please join us as we hear the latest on the 2018 session of the Indiana General Assembly and delve into current public policy issues for the medical device and bio-pharmaceutical sectors. This month’s program will feature an Indiana legislative leader sharing thoughts on the current session and the direction state policy makers are heading in support of innovation. This will be followed by a moderated discussion featuring local industry leaders. This is a great time to reach out – please invite your legislators to attend with you!

 

 

PANELISTS
Anne HathawayExecutive Director, Indiana Medical Device Manufacturers’ Council (IMDMC)
Michael O’ConnorSenior Director, State Government Affairs, Eli Lilly and Company
MODERATOR
Kristin JonesPresident and CEO, IHIF

 

About the Series: The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in the life sciences. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the industry. We hope you will join us.

 

To learn about upcoming lunch programs, please visit us on-line.

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Hollingsworth Passes Bill to Cut Red Tape, Help Hoosier Companies Making Life-Saving Breakthroughs

February 15, 2018
FOR IMMEDIATE RELEASE Contact: Katie Webster
February 14, 2018 (202) 225-5315
 

 

WASHINGTON, D.C. – Today, the U.S. House of Representatives passed H.R. 1645, the Fostering Innovation Act, introduced by Rep. Trey Hollingsworth (R-IN) and Rep. Krysten Sinema (D-AZ), as part of a bipartisan legislative package to provide financial regulatory relief to Americans. H.R. 1645 helps ensure that costly regulations don’t stand in the way of successful biopharmaceutical research.

 

“This country has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Hollingsworth. “The Fostering Innovation Act will right-size the regulatory environment that detracts from advancements, enabling America to develop the next generation of cures to combat illnesses that plague Hoosiers.”

 

Read the full text of the legislation, here.

 

The bioscience and biotechnology sector in Indiana has expressed strong support of the Fostering Innovation Act:

 

Kristin Jones, President and CEO, Indiana Health Industry Forum: “While the Fostering Innovation Act will be of broad benefit to companies in the bioscience sector across the country, Hoosier companies and patients also stand to benefit.  By eliminating a costly administrative burden, pre-revenue biotech companies will be able to focus more of their scarce investment funding on developing new therapies and adding high-wage jobs, instead of paying for expensive internal audits.  As more Indiana bioscience companies mature and look to IPOs as a viable fundraising option, we expect the benefits of the Act to accrue quickly.  We commend Rep. Hollingsworth for his leadership on this issue.”

 

Jeff Schwegman, Ph.D., Founder & CEO of AB BioTechnologies, Inc. (Bloomington, IN): “The Fostering Innovation Act eliminates the costly burdens of extensive audits to many of our clients, allowing them to invest further in drug development in Indiana. Ultimately these savings will be passed on to patients which benefits the community as a whole. Thanks to Representative Hollingsworth’s depth of understanding of the life sciences sector in Indiana, he was able to pass meaningful legislation that will provide a benefit to Hoosiers at all levels.”

 

 

Background

 

Currently, emerging growth companies (EGCs) are exempt from certain regulatory requirements for the first five years after their IPO.  One of the requirements EGCs are exempt from is Sarbanes-Oxley Section 404 (b) – which requires public companies to obtain an external audit on the effectiveness of their internal controls for financial reporting.  This reporting requirement is both costly and unnecessary because management is still required to assess internal controls, and these EGCs have limited public exposure.

 

H.R. 1645 is a narrowly-tailored fix that temporarily extends the Sarbanes-Oxley Section 404(b) exemption for an additional five years for a small subset of EGCs with annual revenue of less than $50 million and less than $700 million in public float. This legislation does not prohibit an external audit if the company or the majority of shareholders determine an audit is benefit.

 

 

 

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Office of Representative Trey Hollingsworth  |  1641 Longworth House Office Building, Washington, DC 20515

P: (202) 225-5315 |  www.hollingsworth.house.gov

Senator Joe Donnelly Recognized as IHIF 2017 Legislator of the Year

January 16, 2018

September 14, 2017 – (Indianapolis, IN) –  The Indiana Health Industry Forum (IHIF) presented Senator Joe Donnelly with its 2017 Legislator of the Year Award at the group’s Annual Meeting held in Indianapolis in September.  As the Senate was in session, he accepted the award via a video shown to the attendees and was later presented with the award plaque at a meeting in Washington, D.C.. The recognition is given annually to state and federal legislators who demonstrate a commitment to excellence in public health policy and service to Indiana’s health science business community.

 

“Since being elected to the Senate in 2012, Senator Donnelly has been an outstanding advocate for patients and their right to access innovative medicines and therapies”, said Kristin Jones, president and CEO of IHIF.  “He understands the impact that this industry makes both economically to the state and to the lives of Hoosiers”.

 

In a year that saw a tremendous volume of healthcare policy negotiations and votes, Senator Donnelly stood by Hoosier veterans and Medicare recipients, sought ways to proactively address the nation’s opioid crisis, showed intense interest in learning how new medicines and devices are developed and brought to market, and strongly supported Indiana’s bioscience industry.

 

“Senator Donnelly joins a long line of previous award recipients at the state and federal levels,” said Jones. “While many legislators understand the importance of the bioscience industry to Indiana’s economy, we are delighted to be able to recognize those special champions who go the extra mile to help Hoosier patients.  It is a privilege to be able to include Senator Donnelly among our honorees”.

 

About IHIF

IHIF is a statewide trade association representing Indiana’s health science business community.  The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry.  Our mission is to connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation. To learn more, please visit www.ihif.org.

Letter to the Editor – 1/14/18

January 16, 2018

The following letter was published in the Sunday edition of the Indianapolis Star (1/14/18)

Protect Medicare Prescription Drug Program

The Medicare prescription drug program has been a remarkable success for seniors and taxpayers, despite what a Jan. 4 op-ed claims. Ninety percent of seniors are satisfied with the program and it has cost $349 billion less than originally expected. The program also helped reduce seniors’ hospital admissions and premiums are going down.

The success of the program is market-based competition — not government price controls. The private insurers who administer the Medicare drug program negotiate aggressively with drugmakers for discounts and rebates, often securing better deals than what’s available in the private market.

Dismantling the program would be detrimental to seniors and do nothing to lower drug costs. In fact, more than 200 patient-advocacy groups urged Congress to reject government interference in Medicare because it could “jeopardize beneficiaries’ access to comprehensive, affordable” medicines.

To get health care costs under control, policymakers should take a close look at the entire system. Hospital and physician services make up 42% and 43% of all Medicare spending, respectively, and they are expected to grow by $552 billion over the next decade. Let’s tackle the real drivers of health care spending and preserve a prescription drug program that is working well for everyone.

 

-Kristin Jones

Indianapolis

BIO Action

June 6, 2017

IHIF members are encouraged to learn about a new effort that the Biotechnology Innovation Organization (BIO) has launched as part of its state and federal advocacy efforts – called BIO ACTION.  In 2017 the potential of biotechnology to heal, fuel, and feed the world has never been more promising – yet some policymakers are proposing ideas that could grind innovation to a halt.

That is why BIO is launching a new grassroots advocacy initiative called BIO ACTION.  This advocacy program will keep you informed of emerging policy issues and threats to biotechnology innovation.  BIO ACTION will ask for your voice when needed to encourage lawmakers to enact policies to further innovation and stop harmful policies from passing.

We know you care about the future of biotechnology from your past support of IHIF.  But now we need your help – and your voice – more than ever before.

To learn about some of the issues BIO ACTION will be actively working on, please visit the BIO ACTION advocacy portal at https://www.bio.org/become-advocate-biotechnology.  Here you can also find the new BIO ACTION online tool that makes it easy for you to contact your federal, state and local public officials.  Our voices must be HEARD – lend yours to help biotechnology heal, fuel, and feed the world!

Please take a moment and help make the biotech industry’s voice heard –  join BIO ACTION!

BioAction block

AdvaMed Statement on House Reconciliation Legislation

March 7, 2017

FOR IMMEDIATE RELEASE                                                                                                                   March 7, 2017

 

AdvaMed Statement on House Reconciliation Legislation

 

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after introduction of reconciliation legislation in the U.S. House of Representatives:

 

“AdvaMed commends the House Ways and Means Committee for moving forward with legislation that will permanently repeal the medical device excise tax. Bipartisan majorities in both the House and Senate are on record in support of repeal of this onerous tax, which has been associated with a significant loss of American jobs. Recent data from the U.S. Commerce Department showed that the medical technology industry experienced a decline of nearly 29,000 U.S. jobs while the tax was in effect. Conversely, an analysis by the American Action Forum demonstrated that permanent repeal of the tax could result in excess of 53,000 additional industry jobs, compared to what would occur if the tax remains in effect. Repealing the tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generation of breakthroughs in patient care and treatment. We urge the House and Senate to act expeditiously to pass this important legislation.”

 

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

 

 

 

Drug Cost Facts: Your comprehensive guide to the drug cost ecosystem

March 6, 2017

March 3, 2017

BIO Logo Horizontal RGB

The Biotechnology Innovation Organization (BIO) today launched DrugCostFacts.org, a new interactive web tool designed to help healthcare stakeholders gain a better understanding of the true facts surrounding drug costs, spending and value.

 

The site features a series of commonly asked questions—ranging from “Why are some drugs expensive?” to “What role do PBMs, insurance companies and wholesalers play in determining what patients pay for their drugs?”—and then answers these questions using infographics, videos and interactive tools. The site also has additional research and reading materials for those who want to dive deeper into these issues. The tool is mobile responsive, allowing users to access information on their phones and tablets.

 

The goal of the site is to provide information—drawn from independent studies, news articles and outside research—that policymakers, the media and the public can rely on when writing or engaging in discussions about issues relating to drug costs and spending. The site also features a “Follow the Debate” section, where users can get more information on topics ranging from drug importation to government negotiations in Medicare that are making headlines and that are part of the current policy and public debate.

 

Below are highlights of some of the elements of the site:

 

(Note: The interactive tools were developed based on publically-available data and each tool includes an explanation of how the calculations were determined.)

 

Understanding Your Drug Costs: Follow the Pill

 

Understanding Your Drug Costs: Follow the Pill is designed to give users a better understanding of how prescription drug costs are really determined and where the pharmaceutical dollar actually goes. The whiteboard video begins with a typical transaction at your local pharmacy. It then traces that purchase back through a series of complex transactions that occur throughout the pharmaceutical distribution and insurance chain. The video breaks down the differences between the list price and the net price of a medicine, explains how the various actors (e.g., pharmacy benefit managers (PBMs), wholesalers, insurance companies, etc.) in the health care ecosystem operate to deliver medicines to patients and at what cost, and demonstrates why it is that a biopharmaceutical company has very little power to determine what a patient ultimately pays for his or her medicine.

Insurance Calculator

The Insurance Calculator is an interactive tool that allows you to explore how changes on the front end of insurance benefit design (e.g., to your deductible or required cost-sharing for drugs) ultimately impact what you pay each month for premiums and other out-of-pocket costs.

 

The calculator allows you to get a better understanding of how insurance design impacts patient out-of-pocket costs. The tool starts you off with two pre-set plans (i.e., an Affordable Care Act Silver Family Plan and a Large Corporate Individual Plan) to give you examples of what common deductible and co-payment amounts can be. Once you gain more familiarity with how to use the tool, choose the “customize” option to explore all of the various elements of a plan benefit. Users are encouraged to experiment with the different parameters, keeping a close eye on “Total Monthly Out-Of-Pocket Costs” on the left-hand side to see just what elements of your insurance plan’s structure impact the costs you bear the most.

 

For example, increasing deductibles may not have as much of an impact on your premiums as you may think. In addition, you’ll see that increasing brand drug cost-sharing by patients does little to lower your premium, but has a major impact on your out-of-pocket costs.

 

Like the tool discussed below, this insurance calculator is not meant to provide exact data on your individual plan or an individual patient’s costs—instead, it uses real-world data to map the relationship between insurance benefit design of a plan like yours and out-of-pocket costs to demonstrate the effect that one has on the other.

 

How Much Does the Cost of an Innovative New Drug Impact Overall Health Care Costs?

 

When an innovative new medicine becomes available on the market, insurance companies often raise concerns that covering the drug will put upward pressure on health care costs. To take a deeper look at this issue, BIO developed an interactive tool that simulates the impact of adding a new innovative drug on average health care costs across a hypothetical insurance market. The site allows you to enter the monthly cost of a new medicine and the number of people who would take the drug to determine what an approximate monthly impact would be on health care costs if the cost were distributed equally nationwide. What you will see is that, even in the case of more expensive drugs, the incremental cost across all insured individuals is modest. This is important information to know when the alternative is restricting access to these new medicines, and in turn, restricting the potential benefits they would have for patients.

 

Here are a few scenarios you can try: Take your typical statin, which would cost about $10 per month. The population taking this drug would be about two million people. As the calculator shows, the incremental impact on each individual’s health care costs would be about $0.11 a month. Remember, these numbers are not meant to be exact for any particular plan or individual, but instead to demonstrate the magnitude of the impact of covering medicines on health care costs.

 

Another scenario would be a novel therapy costing $1,000 per month and taken by 100,000 patients, which could be the case for a new medicine that treats a certain type of cancer or a specific form of cardiovascular disease. Ensuring coverage of this drug for all patients that need it would have a monthly impact of just $0.56. Or, for example, if a more expensive rare disease drug cost $25,000 per month, and is utilized by 2,000 patients, the monthly impact would be $0.28.

 

Try it out yourself to see how both common and rarer medicines impact the insurance system. We think you’ll quickly see how easy it is for insurance plans to provide robust drug coverage for patients who need new medicines without fear of significant cost increases.

 

Additional Tools

 

In addition to these tools, the site includes an animated video that follows a molecule from the lab through the drug development process, and it features a range of downloadable infographics on topics – from where new drugs are being developed to the role of private sector R&D in drug development.

 

With this resource, BIO has created a one-stop shop for factual information and answers to some of the most hotly debated questions regarding the role of drugs in our nation’s health care system.

January 2017 -Understanding 21st Century Cures for Drugs and Devices

February 1, 2017

This month we’ll discuss the 21st Century Cures Act – a $6.3 billion, nearly 1,000-page, comprehensive legislation package that passed the U.S. House and Senate in late December 2016. 21st Century Cures overhauls the way drugs and devices will be coming to market; the legislation offers grant funding to states to help fight the opioid epidemic and addresses mental health laws and resources. It also places a big emphasis on research funding – especially for cancer and neurodegenerative diseases – and patient rights. All of these factors are expected to change the research-to-commercialization pathway. Please join us as we learn more about the act and its impact on patients, regulators, and large and small companies.

Presenters:

Jeanne Haggerty, Senior Vice President, Federal Government Relations
BIO

Lynn Tyler, Partner
Barnes & Thornburg LLP

Moderator:

Kristin Jones
Indiana Health Industry Forum

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

For more information on upcoming programs, please visit www.ihif.org/pages/lifescience

Follow us on Twitter @IHIF1 #LifeScienceLunch @BTLawNews

2015 Advocacy Efforts

November 30, 2016

 

October 2015

Moderated afternoon session of Rep. Susan W. Brooks, “Connecting Classrooms and Careers” program.

September 2015

Signed on to a joint letter to the President urging him to focus on ag biotech issues in his upcoming meetings with President Xi Jinping of China.

August 2015

Participated with IMDMC in Legislative Roundtable, Indianapolis

July 2015

Participated in Hoosiers Work for Health/We Work for Health PhRMA Partnership Fly-In to Washington D.C.

June 2015

Requested Indiana Congressional Delegation to sign-on to bi-partisan letter encouraging fair and balanced patent reform consideration in HR 9.

Met with Rep. Susan W. Brooks at BIO Convention in Philadelphia, provided tour of Indiana booth in the conference exhibit hall

May 2015

Awarded Rep. Susan W. Brooks IHIF’s Legislator of the Year Award for outstanding service to Indiana’s health science sector

Signed on to joint-association letter supporting H.R. 1078, the FDA Safety Over Sequestration (SOS) Act

Participated in Hoosiers Work for Health Award to Rep. Susan W. Brooks

Signed on to Healthcare Leadership Forum letter to repeal IPAB

April 2015

Participated in the BIO Fly-In to Washington, D.C. – met with nine of Indiana’s eleven offices.

March 2015

Signed on to the Declaration Supporting Incentives for Medical Innovation in Trade Agreements organized by the Global Colon Cancer Association and the Information Technology and Innovation Foundation

February 2015

Indiana Expanding Exports and Creating Jobs – Fact Sheet with information on TTIP and TPA impacts on state.

Signed on to National Osteoporosis Foundation letter to Congress supporting Medicare Part D.

January 2015

IHF signed on to a letter to the Administration emphasizing the importance of strong IP and data protections for medicines.  Letter was initiated by the Global Colon Cancer Association and the Information Technology and Innovation Foundation.

IHIF co-hosted our 4th Annual Legislative Breakfast Briefing (agenda) on January 28th.  Co-Hosts include IMDMC and Hoosiers Work for Health/PhRMA

IHIF shared concerns over Senator Elizabeth Warren’s “Medical Innovation Act”.

IHIF provided informational testimony on HB 1065 – Use of investigational drugs, biologics, and devices.  Also expressed concern over SB 66.

IHIF signs on to letter encouraging US legislators to proceed with caution when considering making changes to patent legislation

IHIF signs on to letter to US legislators highlighting the success of Medicare Part D and urging Congress to reject any proposals that would undermine the current program’s success in holding down premiums and taxpayer costs, while still producing high satisfaction rates among enrollees.

2016 Advocacy Efforts

November 30, 2016

Recent Activities

October 2016

Signed on to letter  sponsored by the Healthcare Leadership Council in support of repeal of IPAB.

August 2016

Signed on to letter supporting intellectual property protections in current UN negotiations.

Signed on to BIO letter to SEC supporting re-examination of the definition of ‘Smaller Reporting Companies”.

June 2016

IHIF supports HWFH and opposition to Medicare Part B Demo

May 2016 

IHIF joins BIO and other state bioscience groups in supporting the Fostering Innovation Act – allowing growing bioscience companies to focus on R&D.  Read BIO’s statement on passage of the Act here

IHIF announces Legislators of the Year at 2016 Annual Meeting – Honoring Rep. Larry Bucshon, M.D. and Senator Patricia Miller

April 2016

IHIF attends BIO Fly-In to meet with entire Indiana federal delegation in Washington, D.C. – continuing focus on Medicare Part B reimbursement changes.

March 2016

Provided Letter of Support for HB 3320 – A Bill to Establish a Smart Card Pilot Program Under Medicare

Participated in Lilly 2016 Vendor Conference

Signed on to letter opposing CMS proposed changes to Medicare Part B

January 2016

IHIF testified in favor of HB 1176 – creating a Diabetes Incidence Study and Action Plan through IDOH.  The bill was held and DOH was requested to provide a study update to stakeholders within six months.

IHIF Legislative Breakfast featuring remarks by Rep. Ed Clere and Lt. Governor Sue Ellspermann.

Activity Archive