AdvaMed Applauds Introduction of FDA Reform Legislation

News from AdvaMed:   

Oct. 14, 2011    WASHINGTON, DC –

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement today upon the introduction of the “Saving
American Jobs and Saving American Patients” legislative package in the U.S. House of Representatives that would reform the FDA device review process:Continue reading

FDA reform package announced

 

 

 

Press Release:  House Energy and Commerce Committee [Republican]

Committee Members Introduce FDA Reform Package to Protect American Patients, Jobs, and Medical Innovation

After Detailed Committee Review, Members Offer Ten Specific Solutions to Top Ten Challenges in Current Review Process that Slow Access to Vital DevicesContinue reading

AZBio writes to Congress on Medicare Part B and ASP+6


To:  The Members of the Arizona House Delegation

From: The Members of the Arizona Bioscience Industry

RE:   Proposed lowering of the ASP percentage from 6% to 4% could have dangerous side effects and information in support of the Lance/Pascrell letter that is being circulated. 

We have a lot of things that need fixing at the moment as the financial burden our country bears comes under further review and adjustments.  Many of our systems are broken, but some are working.  ASP and Medicare Part B is a case in point.

In keeping with the Arizona BioIndustry Association’s commitment to monitor key issues and to share key information on areas that affect our community, our state and our nation, the following points are offered to assist you on how best to control healthcare costs and protect jobs while serving the best interests of millions of Americans and tens of thousands of Arizonans who are touched directly or indirectly by the current ASP rates and the Medicare Part B Program.

HISTORY/BACKGROUND:  ASP and Biologics:

 Biologics are used to treat some of the most serious diseases.  Many of these products are infused directly  into the patients’ blood stream and require administration in a physician’s office because of their  complexity and the need to monitor how the patient is responding.  Medicare pays for these products under Part B of the statute and pay for the product at the average sales price plus a physician add-on that covers the handling and administration of the product.  This system was created as a replacement to the old system in order to better reflect the cost of the products.  The change in the program is estimated to have saved $16 billion since the MMA was implemented in 2005.

ASP+6%  is working well and there is no policy argument for reducing the add-on payment down to 3%.  MedPac, which makes recommendations to Congress on CMS policy, has found that the 6% is an adequate payment level.  The only reason to dial down the % is to save the government money, approximately $3 billion but is unlikely to be a true savings as these costs will reappear in other places.

Some providers, especially in rural areas, are already struggling.  Many of these providers are small businesses that provide lifesaving medical services in their communities.   Passing the cost burden to these small companies could result in curtailment of their service offerings in their communities.  As services are cut back, jobs are lost.

Dialing down the percentage has the potential to really disrupt the delivery system, creating potential access problems for patients and ultimately costing the government more as these patients end up in the hospital for either the initial treatment or complications caused by limited access to these treatments and
services that land them in the hospital with more serious problems later.

In addition, the regulatory changes that would be needed to implement this change may face significant hurdles in implementation during the Regulatory Flexibility Review.  As you know, The Regulatory Flexibility Act, which was created in 1980 and amended in 1996, requires federal agencies to assess the economic impact of proposed and existing regulations on small businesses.  Rules found to be too burdensome must be replaced with alternatives.   A government mandated profit margin that falls below the operating costs of these small businesses will effectively drive small business providers out of the market as they would not be able to sustain operations at this level or compete with large businesses that have other areas where they can shift costs to keep their operations solvent.

The 6% is not all profit for these providers.  Within that they have to deal with numerous factors critical for their business model including the prompt pay discount, bad debt, handling and administration and others. Lowering the add-on will force certain providers to no longer take Medicare patients, forcing them into the hospital setting which is more expensive and less convenient.

This sort of disruption, to a system that is working, for a cost saving estimated at $3 billion over 10 years will have dangerous side effects for little to no real benefit.  This is basically a rounding error in the larger healthcare cost and budget debate and once the unintended consequences to small businesses, jobs, and patient access are added in potentially a net increase healthcare costs and yet another hurdle for businesses of all sizes as we strive for economic recovery.

As I shared in the beginning, ASP and Medicare Part B is Working. It has allowed us to reduce healthcare costs and through the products it covers stimulate innovation and create jobs.  The current 6% level offers a slim but manageable profit margin for small business providers.  Fixing a system that is not
broken could negatively impact thousands of Arizonans and millions of Americans.   I know you have a lot on your plate in solving the financial challenges our country is facing.   Perhaps it is time to take changes to the ASP+6% Rate  and Medicare Part B off the “fix it list” and  use our scarce resources to address other challenges that can truly use the help.

On behalf of the Arizona BioIndustry and our community, I thank you for taking the time to read this letter and for doing what is best for all of us.

Sincerely,

 Joan Koerber-Walker
President and CEO
AZBio – The Arizona BioIndustry Association
SkySong, 1475 N. Scottsdale Road, Scottsdale, AZ 85257

 

Want To Move Forward Faster? Activate The Collaborative Gene

clip_image002Arizona biosciences sector demonstrates how to accelerate innovation and job growth and offers insight on how Washington can keep things moving forward faster by activating its “collaborative gene.”

These days tales of economic vitality are few and far between making Arizona’s bioscience sector an inspiration to all as the nation focuses on jobs and economic recovery.

Thanks to a coordinated plan developed in 2002 and supported by leaders from Arizona’s healthcare industry, corporations, government, and universities that has been led by the Flinn Foundation with support from Battelle, Arizona is moving forward faster in economic development, job creation and bioscience research.Continue reading

AZBio Comments on the FDA 510K

 as submitted to the FDA on September 23, 2011

RE: Docket No. FDA-2011-N-0556

[Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years”; Request for Comments]
 

On behalf of the Arizona BioIndustry Association (AZBIO), I appreciate the opportunity to submit  comments to the Food and Drug Administration’s (FDA’s) Center for Devices and  Radiological Health (CDRH) on the Institute of Medicine’s (IOM’s) report,  “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at  35 Years” (Docket No. FDA-2011-N-0556).Continue reading

Study: Medical Device Tax Could Cost Jobs, Stifle Innovation

WASHINGTON,D.C. –The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm U.S. competiveness, according to a study released today by the Advanced Medical Technology Association (AdvaMed).  The new study, “Employment Effects of the New Excise Tax on the Medical Device Industry,” by Manhattan Institute senior fellow Diana Furchtgott-Roth and Hudson Institute senior fellow Harold Furchtgott-Roth, outlines a number of economic harms likely to result from the tax.Continue reading

Tips on Writing Powerful Public Comment Letters Regarding Proposed Regulations

By: Michael T. Hull – Managing Director, InVent Life Sciences   mhull@inventls.com  (Former Regional Advocate for the U.S. SBA Office of Advocacy)

The federal government proposes and finalizes approximately 4,000 new rules every year. In general approximately 800-1,000 will directly affect small business. A 2008 study by the U.S. Small Business Administration’s Office of Advocacy estimated that the cost of complying with federal rules and regulations exceeds $1.75 trillion per year with small businesses spending approximately 36% more per employee than their large business counterparts.Continue reading

The FDA When There’s An App For That

There is a lot happening on the medical device front these days around MDDS (Medical Device Data Systems) and the FDA is paying close attention with new regulations, guidance and requests for comment. 

With the  April 2012 compliance deadline less than 8 months away, AZBio Member John C. Hoffman of QMR is paying close attention too and keeping our community in the loop via the AZBio  Resource Network Group on LinkedIn.  If you and your team are working in the MDDS space, you’ll want to get connected and join the discussion.

Continue reading