A history of executive orders that impacted healthcare

executive order

On his first day in office, President Donald Trump signed an executive order instructing federal agencies to minimize the burden of the Affordable Care Act, pending congressional repeal. According to the language, it is intended to “minimize the unwarranted and regulatory burdens of the Act, and prepare to afford the States more flexibility and control to create a more free and open healthcare market.”

Executive orders that impact the healthcare industry are not new, although the majority of them have been issued during the last three administrations. Some have become famous, such as President Reagan’s executive order in 1987 that led to the President’s Commission on the Human Immunodeficiency Virus Epidemic, and which officially recommended “HIV infection” as appropriate to replace the obsolete term “AIDS.”

Some executive orders have had a significant impact on healthcare providers and researchers, perhaps even more so than the general public. A few noteworthy examples include:

On May 19, 1992, President George H.W. Bush signed executive order 12806 that established a human fetal tissue bank to be administered by the Department of Health and Human Services. It is believed that fetal stem cell research is critical to developing therapies for diseases such as Parkinson’s, diabetes and certain inherited disorders. It was also assumed that the bank would eliminate the “medico-ethical tangle” by making fetal tissue available to researchers from a “non-controversial” source, according to Dr. James Mason, HHS Assistant Secretary of Health at the time.

President William Clinton’s March 7, 2000, executive order established a White House Commission on Complementary and Alternative Medicine Policy. The commission’s mandate was “to develop legislative and administrative recommendations that would help public policy maximize potential benefits, to consumers and American health care, of complementary and alternative medicine (CAM) therapies – chiropractic, acupuncture, massage, herbs, and nutritional and mind-body therapies, as well as a host of other approaches.” This executive order helped pave the way for insurance coverage of CAM therapies, as well as to help legitimize such therapies throughout the greater healthcare establishment.

Another executive order signed by Clinton in September 1996 established an Advisory Commission on Consumer Protection and Quality in the Health Care Industry. This led to the now-famous “consumer bill of rights” concerning health care. Basic tenets of the health care bill of rights include information disclosure, choice of providers and plans, access to emergency services, participation in treatment decisions and confidentiality of health information.

On September 18, 2014, President Barack Obama signed an executive order entitled Combating Antibiotic-Resistant Bacteria. Considered to be one of the greatest healthcare concerns of the modern era, antibiotic-resistant bacteria renders antibiotic drugs obsolete in a short period of time. This executive order lead to the development of a National Action Plan for Combating Antibiotic-Resistant Bacteria. The plan called for the enhancement of domestic and international capacity to prevent and contain outbreaks of antibiotic-resistant infections, maintain the efficacy of current and new antibiotics and a call to develop and deploy next-generation diagnostics, antibiotics, vaccines and other therapeutics.

Looking back at the past several administrations, it is clear that executive action has been used as a tool for broadly impacting healthcare in the U.S. While President Trump’s Affordable Care Act executive order has no immediate statutory effect, it clears the way for legislative action on the sale of health insurance policies across state lines and for the elimination of the individual mandate, one of the act’s most unpopular tenets.


Healthcare-related executive orders since 1980 include:

July 30, 2015 – Implementing the National HIV/AIDS Strategy for the United States for 2015–2020

September 18, 2014 – Combating Antibiotic-Resistant Bacteria

July 15, 2013 – HIV Care Continuum Initiative

August 31, 2012 – Improving Access to Mental Health Services for Veterans, Service Members and Military Families

October 31, 2011 – Reducing Prescription Drug Shortages

March 24, 2010 – Patient Protection and Affordable Care Act’s Consistency with Longstanding Restrictions on the Use of Federal Funds for Abortion

December 30, 2009 – Medical Countermeasures Following a Biological Attack

April 8, 2009 – Establishing the White House Office Of Health Reform

March 6, 2007 – Establishing a Commission on Care for America’s Returning Wounded Warriors and a Task Force on Returning Global War on Terror Heroes

January 13, 2006 – Designating the Global Fund to Fight Aids, Tuberculosis and Malaria as a Public International Organization Entitled to Enjoy Certain Privileges, Exemptions, and Immunities

May 28, 2001 – President’s Task Force to Improve Health Care Delivery for Our Nation’s Veterans

May 10, 2000 – Access to HIV/AIDS Pharmaceuticals and Medical Technologies

March 7, 2000 – White House Commission on Complementary and Alternative Medicine Policy

September 5, 1996 – Advisory Commission on Consumer Protection and Quality in the Health Care Industry

June 14, 1995 – Presidential Advisory Council on HIV/AIDS

May 26, 1995 – Presidential Advisory Committee on Gulf War Veterans’ Illnesses

January 15, 1994 – Advisory Committee on Human Radiation Experiments

May 19, 1992 – Establishment of a Fetal Tissue Bank

November 13, 1989 – Establishment of the President’s Drug Advisory Council

June 24, 1987 and July 16, 1987 – Presidential Commission on the Human Immunodeficiency Virus Epidemic

September 15, 1986 – Drug-Free Federal Workplace

December 22, 1983 – Revised list of quarantinable communicable diseases



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Repealing Obamacare: What it could mean for medical device companies

Affordable Care Act

Since its inception, there has been much debate about the consequences of repealing the Affordable Care Act (ACA), and the effect it could have on low income families, those with preexisting conditions and the previously uninsured. But how will it affect the medical device companies who develop and market the equipment, tests and devices that healthcare professionals use to diagnose and treat those patients?

The ACA included a medical device excise tax of 2.3% that was imposed starting in January of 2013. On the surface, a 2.3% tax doesn’t sound like much… these companies can afford it, right?

A common misperception is that the medical device industry is comprised mainly of massive companies such as Stryker, General Electric and Johnson & Johnson. But just like the rest of America, the medical device industry is 80% small business—companies with 50 or fewer employees.

Here’s another problem. An excise tax is not a sales tax—which means it cannot be applied to equipment sales the way sales tax is applied to your purchase of a new car, a new piece of furniture or a bottle of wine—as a pass-through cost to the end customer. The excise tax is calculated on gross sales, not profits.

Many companies operating in a competitive marketplace must operate lean with thin margins. This tax has the potential to not only reduce profitability, but eliminate it altogether. Having already been hammered by reductions in reimbursements resulting from the ACA,hospitals and health systems vehemently opposed this tax being passed onto them.1 In order to continue selling to their customers, device companies would have to eat the tax themselves.

To illustrate, let’s say a small breast biopsy device manufacturer sells $1 million worth of biopsy systems. The profit resulting from these sales is 5%, or $50,000. The excise tax is calculated by multiplying the $1 million in gross sales by 2.3%, or $23,000. This is the amount that the manufacturer now has to pay the IRS. In this case, the tax effectively halved the company’s profits. Even if a company posted a loss, it would still have to pay taxes on gross sales of its medical devices.

A new medical device faces hurdles that are simply not experienced by companies in other industries. The extensive regulatory process and FDA approvals take many years, and adoption by the medical community is agonizingly slow. By forcing manufacturers to pay the excise tax on gross sales (during the initial unprofitable years), their path to profitability is now longer and less certain, and thus much less attractive to investors.

According to the Joint Committee on Taxation (JCT), revenues collected from this tax were $1.7 billion in FY 2013. So, what effect did this tax have on the medical device industry?

New taxes do have a real impact on businesses, on jobs and on the economy. In anticipation of the excise tax, device manufacturers started eliminating jobs. A 2014 AdvaMed survey2 of device and diagnostics manufacturers revealed that as of December 2013, 14,000 jobs had been eliminated. 30% of respondents reported a reduction in R&D spending, and 10% of respondents said that they had moved manufacturing abroad.

Those who still question whether or not new “modest” taxes devastate entire industries need only look back the 1990 Omnibus Budget Reconciliation Act, better known as George H.W. Bush’s broken “read my lips” promise to veto any new tax legislation. A new luxury tax imposed by Congress that year would be placed upon yachts, private airplanes, expensive automobiles and jewelry. The tax, we were assured, would result in an additional $30 million in revenue. Best of all, we were told, the tax wouldn’t affect the average consumer, because it was only “the rich” who purchased these products.

The tax destroyed more than 300 jobs in jewelry manufacturing and 1,400 jobs in the aircraft industry during the first year alone. Hardest hit was the boating industry, which saw sales plummet 77% the first year with 45,000 jobs lost.3 Over the next two years, the United States shifted from a net exporter of boats to a net importer of them, as many U.S. companies either went bankrupt or relocated overseas. Instead of earning the treasury millions, job losses cost the U.S. government more than $24 million in unemployment benefits and untold amounts lost in the corporate taxes of relocated companies.

The tax was repealed three years later.

Fortunately, there are those on both sides of the political aisle who realize this, and in a rare instance of bipartisanship during December 2015, Congress passed and President Obama signed an agreement to suspend the medical device excise tax for two years. Ironically, the suspension went into effect three years after the tax was instituted.

If the suspension (scheduled to expire at the end of 2017) were to become permanent through a full or partial repeal of the ACA, it would likely free up capital for medical device manufacturers to start hiring again and invest in innovation.

The excise tax on medical devices is just one component of many contained within the Affordable Care Act. If nothing else, repealing this one tax—this one provision out of thousands—can have a very real and positive effect on jobs and the kind of innovation that can save lives and/or improve the quality of our lives.

That’s why this tax needs to go.

  1. Medical device excise tax: Is it being passed on to your hospital? Healthcare News & Insights March 5, 2013
  2. Impact of the Medical Device Excise Tax: A Status Report from AdvaMed January 2015
  3. The Bottom Line/Christopher Byron New York, May 4, 1992


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Radiologists, travel agents and whale oil salesmen

radiologist

Recently, the Department of Veterans Affairs (VA) proposed a stunning new rule that would allow certified nurse practitioners (CNPs) to “order, perform, supervise and interpret complex imaging studies,” such as MRI and CT, without physician oversight and regardless of state law.

James Borgstede, M.D., (Professor of Radiology-Diagnostics at the University of Colorado at Denver) warned of this more than eight years ago at the RSNA 2007 Annual Meeting. In “Radiology: Commodity or Specialty?” Borgstede claimed that the profession of radiology requires the integration of four linked components:

  1. Pre-examination evaluation for necessity and appropriateness,
  2. Monitoring of exam quality,
  3. Interpretation of exam results and,
  4. A post-examination consultation with the referring physician.1

 
In many hospital imaging departments and IDTFs, radiologists perform only the interpretation and have little or no involvement (or interest) in the remaining three responsibilities. Combine this with the growing trend toward outsourced teleradiology on nights and weekends along with radiologist’s lack of visibility to both referring physician and patient, and it’s no wonder the “commodity perception” exists.

Borgstede also claimed that technology is “driving the radiology specialty toward commoditization through digitization, increased bandwidth, picture archiving and communications systems, computer-assisted detection, and improved transfer software.”

There is no doubt that the advent of technology has and will continue to transform industries. The light bulb and cheap electricity rendered gas lighting obsolete, which in turn had replaced the various derivatives of whale oil, lard, coal and alcohol used for burning in the mid-1800s. The internet gave rise to self-serve travel websites which decimated the ranks of travel agents as consumers found they could do just as good a job at booking their own travel, while saving themselves money in the process.

Yet, obsolescence need not to be the destiny of the radiologist. Those in the know understand that their work is too valuable to be left up to less experienced clinicians whose skills and training simply cannot compare, and which would negatively impact quality.

According to Paul Ellenbogen, M.D., former Chairman of the Board of Chancellors of the American College of Radiology, “radiologists should focus more on consulting with patients and referring physicians, assessing the appropriateness of imaging requests before doing the studies, controlling utilization management, serving on hospital committees and boards, and participating in conferences and grand rounds of other specialties.”2

In other words, you need to become more useful to physicians and improve you visibility.

However, becoming more “visible” with a heavy workload can be challenging. That’s where marketing comes into play.

With marketing, you can educate referring physicians, inform them of new services relevant to their practice, communicate positive changes within your organization, postulate opinions and much more. Marketing serves as the radiologist’s voice within the physician community, and can help overcome misperceptions or clarify issues that negatively impact your profession.

Marketing also represents and opportunity for you to build awareness and credibility among patient populations. For too long, radiologists have ignored this extremely important audience, as patient demand can actually shape and influence physician referral patterns. Put simply, if you haven’t given your patients an explanation as to why you are a critical part of their care, why should they care who reads their study?

 


 

  1. Radiology: Commodity or Specialty, James P. Borgstede, MD, From the Department of Radiology, University of Colorado at Denver and Health Sciences Center, 12401 E 17th Ave, Aurora, CO 80045. From the 2007 RSNA Annual Meeting. Received December 19, 2007; accepted January 7, 2008; final version accepted January 10
  2. Ellenbogen P . The “P word.” J Am Coll Radiol. 2012;9:603

 



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Pokémon™ GO, Augmented Reality and the Benefits to Medical Marketers

Pokemon-GO-584212396You might have heard of “augmented reality” in the past couple years and how it could help your business, but by-and-large, it hasn’t been fully understood or adopted as a marketing tool by most businesses. This might be due to its cost or the inability to imagine how the technology could be used to drive business to a company or practice.

Some of you may never have even heard the term “augmented reality” before now.

Since the launch of Pokémon GO in July 2016, the nation is now paying full attention of how augmented reality can capture audiences, and for some smart businesses, capture sales.

To play the game, players use their mobile phone’s GPS to search the area for Pokémon characters—like Pikachu, Charmander or Bulbasaur—and try to “catch” them by bringing their GPS-enabled smart phone or device to their “location.” If a Pokémon is seen near your business, GO players will show up, too.

Here is where smart business owners have learned to use the game to their benefit. Instead of going out and hunting the neighborhood for Pokémon, the game allows you to attract Pokémon to your location for a short period of time by setting a lure. A lure module will attract rare and popular Pokémon for a half an hour to a specific location for only 100 Pokécoins (99 cents). While those rare Pokémon are “hanging out” around your lure, gamers will show up, too.

Businesses have seen increases of foot traffic and sales while these lures have been set. This foot traffic doesn’t have to just benefit pizza joints and coffee shops. Medical practices can benefit as well. Why not set a lure for a flu shot clinic? Or lure players towards a nearby screening event or educational seminar? The great thing about this game is that it gets consumers out of their houses and wandering around parts of their cities they may have never traveled to before. This is opening up a brand new demographic wandering into your part of town that might never have been there otherwise.

Augmented-Reality-528063708While Pokémon GO is a great example of augmented reality success, imagine the possibilities of how more focused augmented reality could be used in the medical field. In fact, it’s already being used.

Baxter used this technology at a medical conference to show prospects a new medical device in augmented reality 3D. Users held iPads in front of a static device, which effectively brought the device “to life” in order to demonstrate how it is used. Wright State University was able to better explain and differentiate its work in neuroscience with an engaging, interactive model of the brain. The Australian Breastfeeding Association used augmented reality to allow counselors to effectively “see” through the eyes of mothers while they breastfed at home.

The opportunities are endless, and medical providers and manufacturers are only scratching the surface of what’s possible with augmented reality.

Find out how augmented reality could benefit your company or practice, contact Jim Koehler at jim@armadamedical.com.



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The Powerful Elegance of Location-Based Advertising in Marketing Healthcare Products and Services

In today’s fast-paced medical marketing environment, location-based advertising (LBA) offers a powerful, hyper-targeted, low-cost way to generate qualified leads and improve the overall effectiveness of marketing campaigns. LBA uses native GPS-targeting technology to pinpoint prospects geographically, and then serves ad messages in-app to their mobile, tablet and desktop devices. LBA services offered by our agency include GeoFencing/Retargeting and IP Targeting, which can be used together or independently, depending on your marketing objectives.

GeoFencing/Retargeting

geo-fencing

GeoFencing is an elegant solution for marketers seeking to reach and influence physicians of all specialties, as well as their patients. Considering the difficulty reps face in obtaining face time with physicians, and the fact that so many doctors’ offices are now “rep-inaccessible,” GeoFencing puts key messages about your company right in the hands (literally!) of the people you seek to influence most.

Here’s how it works. We put a digital “fence” around each geographic area or address you wish to target…a medical office building, a hospital, a physician practice. When individuals within these locations access apps on their smart phone or tablet, your digital ads appear in-app, with a link to the landing page of your choice.

Your ads are seen by doctors, nurses, administrators and even patients sitting in waiting rooms. With retargeting, we continue to deliver your ads to these individuals long after they’ve left the targeted building, usually for a period of up to 30 days.

For equipment and medical device manufacturers, our agency leverages the power of GeoFencing/Retargeting to reach and influence clinicians and administrators at hospitals, medical centers and surgery centers—or the attendees at an influential medical conference—whether or not the manufacturer is even exhibiting!

An oncologist GeoFences competing practices to encourage a second opinion consultation. A bariatric surgeon GeoFences people within a Weight Watchers clinic. An orthopedic practice GeoFences professional and collegiate athletes within their practice facilities. The opportunities are endless!

 

IP Targeting

IP tracking

This tactic combines the power of location-based advertising with the preciseness of a qualified list of prospects. It is ideal for targeting individuals based on demographic and psychographic profiles, but without the high cost of traditional direct mail to reach them.

Once a mailing list is obtained, our technology is capable of identifying the individual IP addresses of about half of the mailing list. Then digital ad messages can be delivered to this audience on their devices again and again.

The benefit of this approach is that you can zero in on specific customer profiles and reach them for a fraction of the cost of traditional direct mail. For example, you can use this method to target individuals in your city who have diabetes. Or you can get very granular in your approach, targeting African-American women 39-54 who have purchased at least one diet product in the past 12 months and who have a household income in excess of $100,000.

The advantage of this approach over traditional SEO or pay-per-click advertising is that it does not require the individual to be actively searching specific terms or visiting specific web properties in order to be able to identify them and serve them digitally.

As with any new marketing technology, large consumer brands have already realized the power of this medium and are exploiting it prodigiously, as are attorneys and pharmaceutical companies. But with most LBA campaigns priced at $20 or less CPM (cost per thousand impressions delivered), this approach is extremely cost effective for medical marketers and results in very little waste.

For more information on Location-Based Advertising, contact Jim Koehler at (303) 623-1190 x229 or email jim@armadamedical.com.



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Some legislation we can all get “behind” – CT Colonography Screening

CT Colonography Screening Bill

On February 25, a new bill with bipartisan support was introduced in Congress. If passed, H.R. 4632—also known as the CT Colonography Screening for Colorectal Cancer Act of 2016—would provide Medicare coverage for seniors who choose to be screened with CT colonography (virtual colonoscopy) instead of traditional colonoscopy.

“Early screening for colorectal cancer saves lives. Unfortunately, too many Americans fail to get screened because they feel current procedures are too invasive, or can’t for medical reasons. By covering an additional method of screening, Medicare can give seniors and physicians another tool for preventive and lifesaving care,” says Ben Wenstrup (R-OH), co-sponsor of the bill along with Danny Davis (D-IL).

It is widely known that 75% of those at risk for colon cancer fail to get screened; some speculate this is because of the invasive or embarrassing nature of the traditional colonoscopy. My theory is that the traditional screening is too complex and expensive. Unlike a mammogram or an ultrasound, where the individual can simply drive to the imaging center and then drive home an hour later, colonoscopy requires sedation, which forces the individual being screened to have to ask someone to drive them to and from the endoscopy center. The colon cleans prep is also heavier, and is commonly cited as the worst part of the entire procedure. The whole episode creates a major disruption to a person’s normal routine and diet. Finally, the price of a colonoscopy can range from $2,500 to more than $8,000. For individuals under 65 with high deductible plans, this can be expensive.

All of that adds up to…procrastination.

But CT colonography is a more practical test. Requiring only a light prep, it is essentially a CT scan of the colon. It can see areas of the colon the traditional colonoscope may not be able to reach (e.g. the cecum, which is the beginning of the colon). And it’s much less expensive, usually under $1,000.

In fact, a recent study* demonstrated that screening patients over 65 with CT colonography would cost 29% less than the traditional test and save up to $1.7 billion per screening cycle. Many private insurers now cover CT colonography, probably because at least 20 states have laws requiring them to do so.

Today, many of the individuals over 65 who undergo CT colonography are not able to have the traditional scope for various reasons. This could be due to their anatomy (which can make endoscopy challenging), or if they are on blood thinners (and are therefore at risk for internal bleeding).

Opponents—who typically consist of the greater gastroenterology community—complain that if CT colonography detects a polyp, it provides no means to remove it for testing as the traditional colonoscopy procedure does.

They’re missing the point. 90% of colon cancer death is preventable. Three-quarters of those at risk avoid their screenings, despite the best efforts of the medical community to inform patients. Clearly, another approach is needed.

What’s more, less than 8% of colonoscopies reveal polyps that would be considered suspicious. Wouldn’t it be better for an individual to actually get screened in the first place than worry about whether or not they will be inconvenienced by a follow-up test?

Here’s an idea for the GI community: Partner with your local imaging provider. We can assume that the majority of the unscreened (75% of people over 50) don’t actually have a gastroenterologist. But more widespread screening will reveal more patients at risk, and those patients will need a specialist. Instead of fighting this test, embrace it, and see it for the opportunity it really is—a chance to build your patient base while saving lives. How is that not a win-win situation all around?

March is colorectal cancer awareness month. What can you do? Write your representatives and tell them to support H.R. 4632. Let them know you’re behind this test. And together, we can do our part to eliminate colorectal cancer as a leading cause of death in the United States.

 


 

(*) Abdominal Imaging October 2015, Volume 40, Issue 8, pp 2966-2976 First online: 09 September 2015 Medicare cost of colorectal cancer screening: CT colonography vs. optical colonoscopy Bruce Pyenson, Perry J. Pickhardt, Tia Goss Sawhney, Michele Berris 10.1007/s00261-015-0538-1



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