8 min reading time

“Nobody knew that health care could be so complicated,” President Trump conceded last week.

He should have asked members of the Medical Devices Group! Many of you are intimately familiar with the complexities of the U.S. health care system.

As you know, Republicans want to “repeal and replace” the Affordable Care Act. But not the whole thing.

The New York Times summarized the proposed changes at

To save you a click, here are the broad categories:

REPEAL
Mandates (Individual and Employer): People will not have to pay a penalty if they go without insurance. Larger companies won’t be mandated to provide affordable insurance.

CHANGE
Subsidies: Will be distributed by using age, instead of income, as a way to calculate subsidies.

Medicaid Expansion: Reduces the reimbursement states would get. Changes Medicaid from an entitlement program, where the funding grows based on need, to a block grant or a per capita allotment.

Health Savings Accounts: Would lift the limit of tax-free individual contributions.

KEEP
Dependent coverage until age 26

Pre-existing conditions policy: Requires insurers to cover people regardless of pre-existing medical conditions, and bars the companies from charging more based on a person’s health history.

Restrictions on charging more for older Americans: Plans can charge their oldest customers only three times the prices charged to the youngest ones.

Essential health benefits: All insurers must offer 10 essential health benefits, including maternity care and preventive services.

Prohibitions on annual and lifetime limits: Bars insurers from setting any limit on how much they have to pay to cover someone.

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If enacted, do you think this plan will help or hurt the medical device industry?

Related: “5 ways Trump is making things uncertain for medtech” by my friend Chris Newmarker at http://medgroup.biz/uncertain

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FEATURING THREE ENTREPRENEURS

At the 10x Medical Device Conference, we have three open spots to pitch well-known portfolio manager Jeffrey Kraws from Crystal Research. See http://medgroup.biz/10x

I’d very much like to feature the entrepreneurs in this group.

If you are raising capital and have a solid pitch you feel good about, reach me at JHage@MedicalDeviceEvents.com if you’re interested to pitch on May 3 in San Diego.

We can discuss details when you contact me and, apologies in advance, I won’t be able to accommodate everyone who has an interest so please reply quickly. I’ll also set up a waiting list in case someone drops out.

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Just Released: The MedForce 2017 Agenda

MedForce is an interactive conference for sales and marketing executives from medical device and diagnostics manufacturers. Join us this June 20 – 22 at Nashville, TN and innovate with an audience of 50% marketing and 50% sales.

Speakers Include:
William C. Weldon, Former CEO, Chairman, Johnson & Johnson
Jocelyn Johnson, Chief Marketing Officer, GE Healthcare
Greg Nesbitt, Vice President, National Accounts, Philips Healthcare

I went last year. It’s a worthwhile event!

Download the agenda to learn more: http://medgroup.biz/medforce2017

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. The video replay, slides, and transcript for the “Checking Your Patents for Loopholes Webinar” are all available for immediate access at http://medgroup.biz/check-patent. Thanks to Doug Limbach from Shay Glenn for the enlightening session!

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Julie Omohundro
Principal Consultant at Class Three, LLC
So, Trump would seem to be one of those people who thinks that what they know and don’t know is what “everybody” knows and doesn’t know. If this is legit, and not just political tap dancing, it’s particularly discouraging to hear it in reference to healthcare, since I know virtually know one who doesn’t see healthcare as one of the most complicated things there is (not “could be”). It suggest that, in the world of “everybody,” his knowledge of things falls far on the low end of the spectrum.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Mr. Christensen, an excellent presentation at the 2016 10x Medical Device Conference!

Robert Christensen
Medical Consultant
Oh yeah. Read my book, FDA You Were WRONG! Let’s cut their budget by 20% the first year and then 5% each year for three more years.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Three things:
(1.) At the 10x Medical Device Conference, I am sure that the presenters will have much to say about the AHCA and its interaction with the medical device industrial. One more thing to look forward to at the 10x.
As one of the many who lost their insurance, I listen with much interest. Very glad that the share plans available are so very effective at providing my family with coverage.
(2.) Joe, really summary.
(3.) Also Joe, funny headline. As a long time past New Jersey resident, I know “Who knew.” is an expression of speech, just as “Bless your heart!” is an expression in my beloved South. If someone says, “Bless your heart!” to you in the South, that was not a nice thing they just said to you. But “Who knew.” in NY is actually just humor.

I really hope President Trump will listen on this subject as well as he clearly listened with his FDA pick, Scott Gottlieb. He should ask us, if he is not already doing so.

Wendy O’Donovan Phillips
CEO, Big Buzz Brands
A clean, easy dissemination of the information. Thanks, Joe!

Larry Brewton
AXON-II HELPS DOCTORS SOLVE CHRONIC PAIN PROBLEMS
I truly hope we can solve this riddle. We have the means.

Larry Brewton
AXON-II HELPS DOCTORS SOLVE CHRONIC PAIN PROBLEMS
Very interesting that he (Mr. Trump) phrased it THAT way. Sounds like he dived into a swimming pool filled with alligators without looking first.

Steve Anderson
CEO at Preceptis Medical
Since we have all been watching the healthcare reforms in Europe over the past 20 years, we know how difficult it can be. But, a reminder that the US is far more complicated than Europe. One key to a single payer system is efficiency gained. However, the largest EU country is Germany has a population of 86M while the USA is 320M. So, not even close to an apples to apples comparison. As the German system is decentralized to its 16 Lenders. Finally, most healthcare reform in the EU was not done by parliament but by Blue Ribbon Commissions. The politicians knew that they had neither the political guts or knowledge to succeed. Lots of lessons to be learned, both positive and negative. The big question is what the GOP has been doing on this topic since they won the mid-terms 2 years ago. They should have had multiple plans ready for discussion.

Steve Anderson
CEO at Preceptis Medical
Congress is not capable of handling this task.

Steve Anderson
CEO at Preceptis Medical
The GOP should have been working on options for discussion since the mid-term elections in 2014. Frustrating but typical that they were not ready for the moment.

Erica Heath, CIP
Retired – available for small human subject protection, informed consent consulting jobs
I’m sorry… it all makes sense in a perverted kind of way. If we do away with FDA regulations asking for efficacy and we take away health care opportunities, we end up with some really awful natural experiments. We can get new control data for how long it takes for xyz to develop if left untreated. Ok, yes, I am crying. We all know it is complicated and for some pretty good reasons.

Thomas Fare
Director Strategic Alliances at PlanetConnect
Was anyone advising the administration? Do a little history and summary? Never mind.

Thomas Fare
Director Strategic Alliances at PlanetConnect
Was anyone advising this administration? Providing background? (Rhetorical, admittedly)

Andy Silber
IoT Program Manager at T-Mobile via Protingen
Or he could have asked someone who doesn’t get insurance from work. Or a doctor having to pay someone just to handle billing. Or someone struggling to understand the difference between all of the tax advantaged saving accounts and why some people get to deduct certain costs, but not everyone.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
There’s one thing missing: The federal and or state governments that funded the research should be required to gain a certain percentage of ownership of the patents. The proceeds obtained can go to fund other new research and FDA
and or no repayment be required but the resultant product has a price cap affordability requirement for it’s approval.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Sorry to all, it appears the order or the approved comments I have made here are not necessarily in order as I submitted them. Hopefully each will have its own merit.

Mike Hagerty
President of Cuna Supply
Joe,
The US healthcare delivery system is a disaster, and this “reform” is only making it worse. We may all be rugged individualists when we’re well, but when sick or injured, we all want and need an adequate and available source of healthcare. The only sure cure is a single-payer system with an opt-out provision for high-wealth, high-income individuals who can afford to pay their own way.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
The largest costs in health care are drugs and medical devices and yet these may yield the most benefit and overall reduce the total costs of medical care,

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Medications and Medical devices approved to market in USA that results from taxpayer funded academic research should either have cost effective price caps or a % of profits returned to the government to use for new research grants, FDA and helping low income persons afford proper and full medical care.

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
No matter how good the replacement program is, it will get worse over time. There is only one way that social programs work successfully and that is MAKE THE COOK EAT THE FOOD. Mandate every elected person funded by tax dollars to enroll in the cheapest plan available in the geography where he/she is elected from. Do this for Medicare, Social Security, Health Insurance and any other government program. Our politicians are too entitled and showered with benefits and all they do is bicker and point fingers rather than do work for their electorate.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Often these insurance suggest “approved other treatments” that may have increased patient safety risks or may be less effective allowing disease progression with increased morbidity and mortality.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Ultimately, the costs of requiring ineffective treatment and or treatments that have patient safety risks must be considered. If the patient suffers additional injury or adverse effects from the insurance company prescribed pre-requisite treatment thus, morbidity that increases the costs of extended treatment which has 1 of 2 possible patient outcomes no matter the cost….life or death

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Most other countries were shocked to realize that before AHC plan U.S. Citizens did not have national health insurance. It is considered by many countries as a given right of the working class people. A healthy workforce is known to be more productive GNP and Exported goods rates are higher in countries ensuring a healthy population.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Skyrocketing Health Care costs at at the heart of the matter. Its all due to a combination of several key factors I will share here:
1. In some states major health insurance companies are under Non-Profit status thus, avoiding taxes, obtaining non-profit discounts, even receiving federal and or state grant funding. There are however, no caps on salaries of President, CEO and upper management and really none at all, thus, the sky is the limit. Yet these insurance companies dictate to doctors of what medical devices and what medications they will approve and pay for.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Even in discussions today doctors lament of how they try to prescribe what they know based upon experience and their professional training is the best treatment for a patient only to have that prescribed be denied and refused for payment. Often instead the health insurance will recommend/specify lower cost devices or medication that they do approve and stipulate that these must be tried first before they will consider approving the physician requested one.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Another important cause of skyrocketing health costs is lack of Health Safety and Sanitary Education. Ignorance is not bliss it means earlier death and higher medical cost debts for patients. There should be mandatory Health Safety and Sanitary Education programs that required in all high schools for graduation.
These would provide basic information involving hygiene, cleanliness, food handling safety for prevention of foodborne illnesses, First Aid, CPR and when to promptly seek medical care.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Lastly, numerous complain about the very high costs of medicines and medical devices. Yet federal and sometimes state taxpayer money is spent funding academic research, these include NIH and other federal grant fundings. But when a patent is obtained it can be sold off to one or more of the principle investigators for a very low price, they start up a Biopharma get SBIR grants & further NIH grants. Or they can sell off the patent to any company or even foreign country companies and the principle investigators profit.

NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Great excellent comment Anil

Greg Shipp, MD
Director, Global Medical Devices/Clinical Evaluation Group at Bausch Health Companies Inc.
I am so afraid that Julie O. Is correct…

JoAnn Wilkinson
Director, Quality Assurance/Regulatory Compliance at BD Biosciences
RE Larry’s comment: Trump may have looked in the pool but his alternative fact was that the critters swimming there are Koi.