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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What’s missing from National Heart Month?

National Heart Month

Last October, advocates of Breast Cancer Awareness Month encouraged women to get mammograms. The rationale: early detection saves lives. This past November marked the first time advocates of National Lung Cancer Awareness Month could encourage those at risk for lung cancer to request a low-dose CT scan of the lungs from their doctors. Since the CMS decision to cover lung screening for Medicare patients early in 2015, the test is now widely used to achieve—you guessed it—early detection of lung cancer.

But what test are the advocates of American Heart Month advising? The American Heart Association wants you to “learn the warning signs for heart attack and stroke.” Million Hearts® is “challenging men to start one new, heart-healthy behavior.” AHA’s Go Red For Women® wants you to “end heart disease and stroke in women” by wearing a red dress on February 5.

Do you honestly believe the actions of these non-profits during American Heart Month will have any effect on the rate of heart disease and heart attacks in the United States? Consider the fact that heart disease is a costly epidemic in America, currently responsible for 17% of national health expenditures and projected to triple in cost by the year 2030. Consider that by 2030, 40.5% of the U.S. population is projected to have some form of cardiovascular disease according to the American Heart Association’s own forecast.* Although some might point to a recent decline in heart disease deaths among seniors, mortality rates for women and those under 55 are not improving. What’s more, one-third of all first heart attacks are fatal.

Suspiciously absent from the dialog is the recommendation of any test that could achieve the early detection of heart disease. But one exists, and it’s been largely ignored by the greater medical community for more than two decades.

In 1993, San Francisco-based Imatron, Inc. made available to the public an ultrafast electron beam CT scanner capable of accurately imaging a beating heart, with a low radiation dose and a highly accurate picture of coronary artery calcification. Dr. Arthur Agatston—the cardiologist who would subsequently write the best-selling book The South Beach Diet—was instrumental in the early research on the coronary calcium score and developed the calculations assigned to the density of calcification in the coronary arteries.

In 2005, St. Francis Heart Hospital in Roslyn, New York, released the results of what became known as the St. Francis Heart Study in the July 5 edition of the Journal of the American College of Cardiology. The study of nearly 5,000 healthy patients demonstrated that the coronary calcium score predicted coronary “events” such as heart attack independently of, and more accurately than, conventional risk factors such as age, smoking, blood pressure, cholesterol and C-reactive protein.

Calcium ScoreIn August of 2012, a new study of intermediate risk patients lead by Dr. Joseph Yeboah, assistant professor of internal medicine-cardiology at Wake Forest Baptist Medical Center, found that widespread use of the coronary calcium score would have accurately “reclassified” 25% of individuals from intermediate to high risk, and another 40% would have been reclassified to low risk.

This meant that the current “gold standard” of coronary risk stratification—the Framingham score—was incorrect in its classification of more than half of people labeled as having intermediate risk.

Translated into English: The coronary calcium score works far better than the Framingham model at identifying those at risk of heart disease. These studies—and dozens more like them—proved that the coronary calcium score was the best non-invasive test for the early detection of heart disease in otherwise healthy individuals.

So why isn’t this test embraced and recommended by the medical establishment? Why doesn’t your primary care doctor recommend the heart scan to men over 40 and women over 45 every few years?

“CAC scoring is a poor bargain with high costs and real harms,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic Foundation. “Calcium scoring has become a cult. It is widely advertised, and in Southern California there were once billboards encouraging people to go in and get their coronary arteries scanned, which can expose them to other risks, such as high levels of radiation. Yet there are absolutely no data [showing] that screening people for calcium with CT scanning affects their outcome in terms of survival.”

Calcium score naysayers like Nissen say that there are no randomized clinical trials that demonstrate that tests like the heart scan will ultimately reduce the number of heart attack deaths. He’s technically correct. However…there are also no randomized clinical trials that demonstrate the stress test will reduce the number of heart attack deaths—and that test is widely accepted as a “gold standard.” Nor are there such studies for many other lifesaving medical tests, such as breast MRI.

In fact, there is no randomized clinical trial that demonstrates jumping out of an airplane without a parachute causes death. But when we apply common sense, we see that we don’t really need such a study.

“For so long we’ve been doing it wrong,” says Matt Budoff, M.D., a cardiologist affiliated with UCLA Medical Center and one of the nation’s leading advocates of the calcium score. “There’s a very famous Chinese saying from the very first medical text that says that superior doctors prevent the disease, inferior doctors treat the full blown disease. I think we have been inferior doctors in cardiology for quite a long time. We have been waiting for heart attacks, we’ve been waiting for chest pain, we have been waiting for patients literally to suffer sudden death to jump in there with guns blazing and catheters interacting and trying to save them rather than getting to them earlier before the first event.”

Budoff’s research was instrumental in helping to achieve new American College of Cardiology (ACC) guidelines—released in 2013—that call for the use of calcium scoring to help better stratify risk in patients.

“The studies suggest that we may have been underestimating the value of calcium scoring for detecting and managing patients with known or suspected coronary disease,” says Kima Allan Williams Sr., M.D., vice president of the ACC and chief of cardiology at Rush University Medical Center in Chicago.

So, if the calcium score is a far better test to achieve early detection of heart disease than any other available test—cholesterol, blood pressure, etc—or risk stratification model, such as Framingham, why are organizations like the ACC so late to the game in advocating it?

Ironically, Dr. Steven Nissen was heavily involved with the ACC throughout the last decade, even serving as president of the organization. In 2007, Time magazine named him one of the 100 Most Influential People in the World. With that kind of clout and respect from the establishment, it’s safe to say that his opposition to the test—despite its clinical viability—has had an effect.

Still, you’ll find that many hospitals, diagnostic imaging centers and large cardiology practices offer the coronary calcium score test—usually at a cost of about $100.

My advice to you during American Heart Month is to pony up that C-note and get yourself screened so that you can achieve early detection if you have heart disease. Isn’t that the whole point of an awareness month anyway?

 


 

*Forecasting the Future of Cardiovascular Disease in the United States. A Policy Statement From the American Heart Association

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