For the past several years, policymakers and industry have been exploring ways to improve the quality of health care furnished to individuals while promoting efficiency and value. As I have discussed in the past, I believe that medical technology companies can be a key playerin these coordinated care efforts in light of their specialized clinical knowledge, economic expertise, data analytics proficiency, and supply chain management capability. Unfortunately, various regulatory roadblocks stand in the way of the medtech industry’s full participation in the shift to more coordinated care.

That is why I am so pleased to have been invited to represent the Advanced Medical Technology Association (AdvaMed) at a June 7, 2018 Department of Health and Human Services (HHS) “Regulatory Reform Listening Session” on “Barriers to Coordinated Care.” This session, called by Deputy Secretary Eric Hargan, is designed to allow HHS leadership to hear the perspectives of impacted stakeholders as the Department examines its regulatory reform agenda.

My key message for HHS is that medtech companies can be a full partner in efforts to facilitate coordinated care, but the federal anti-kickback statute (AKS) and its narrow and outdated regulatory safe harbors are inhibiting meaningful engagement by medtech companies. I offer more details on my message below.

Medtech Companies Offer Solutions

AdvaMed’s medtech company members no longer just produce devices; rather, they produce solutions. That is, our innovative companies offer combinations of technology and services to deliver targeted outcomes. This gives us the capacity to partner with providers in detecting, treating, and managing disease — and to be able to share accountability for both achieving better outcomes and managing costs.

Anachronistic Policies Discourage Health Innovation

In many cases, the health management solutions offered by medtech companies do not fit squarely within one of the existing regulatory safe harbors to the AKS, which were developed in contemplation of a fee-for-service and fee-for-product (volume-based) model rather than a coordinated care paradigm. For example, the discounts safe harbor contains provisions that could be interpreted as excluding from protection various value-based pricing arrangement discounts involving bundles of items and services. Other coordinated-care/value-based arrangements that may not be fully protected under the AKS include some rebates based on clinical/economic outcomes, payment for corrective services if targeted clinical outcomes are not achieved, and the provision of services under risk-based compensation models.

Proposed Value-Based Safe Harbors

To encourage coordinated care, AdvaMed has submitted to the HHS Office of the Inspector General proposals for two new value-based safe harbors to the federal Anti-Kickback Statute that would enable meaningful participation in outcomes-based arrangements with appropriate safeguards. First, the proposed Value-Based Pricing Arrangements Safe Harbor would allow for price adjustments based on whether specified clinical or cost outcome targets were achieved.

Second, the proposed Value-Based Warranties Safe Harbor would allow manufacturers to make certain clinical and/or outcome assurances and provide an appropriate remedy if such outcomes are not achieved. In other words, the outcome warranty would allow a manufacturer to share risk by providing a payment, item, or service when a targeted clinical or economic outcome is not realized.

Truly achieving coordinated care and value-based medicine will take the contributions of all segments of the health industry, including medtech companies. To that end, my number one request of HHS is to prioritize OIG’s development of value-based safe harbors, with allocating of the resources necessary for OIG to accomplish this.

I look forward to filling you in on my lessons learned from the listening session.

Learn more about AdvaMed’s proposals to advance value-based health care.

A Response to 2017 JAMA Oncology Study:

Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing

Recently, researchers at Brigham and Women’s Hospital published an article in JAMA Oncology that sought to compare the performance of FDA-approved companion diagnostics (FDA-CDs) and laboratory-developed tests (LDTs). In recent years, public debate and scrutiny has intensified regarding the oversight paradigm for diagnostics as well as the highly disparate treatment of tests that are the same from the perspective of patient risk and safety.

While papers such as these represent an important contribution to an area that has come under intense scrutiny, the overall study methodology invites a number of questions that warrant further review, and extrapolation of the paper’s conclusions without acknowledging the limitations could pose serious health risks to patients.

The study presents a comparison of FDA-CDs to FDA-CD’s with some degree of modification, rather than to true LDTs that are designed and manufactured in a laboratory setting and never submitted for FDA review. While the study does not describe the types of modifications that were made — another inherent limitation in the methodology — the analysis clearly better supports the finding that FDA-approved tests are well-performing technologies that are helping to drive drug delivery and patient care in a high-risk space.

Second, the study authors selected well-established FDA-approved tests rather than novel tests — an important factor in truly assessing appropriately validated tests — thus we cannot theorize the results are applicable to other, more involved tumor tests. In fact, the increasing development of Next Generation Sequencing (NGS)-based testing — with significantly more complex workflows covering much larger numbers of genes and variants — highlights the importance of risk based framework to ensure appropriate oversight. The inference of equivalence between LDTs and FDA-CDs should also not be extrapolated to encompass any and all higher risk tests.

Finally, the paper represents a comparison of test results, not the tests or the laboratories themselves, and not all data was reported. All FDA-CD devices must undergo a rigorous set of analytical and clinical validation studies before approval for which there is transparency regarding performance claims. This remains a risk for tests that have not undergone FDA review. In this study, more transparency to better understand reporting mechanisms as well as why participants omitted results is needed to truly assess the study’s value.

The introduction and expanding use of molecular diagnostic tests to detect cancer and manage cancer care mark a major milestone and herald future progress in the fight against the disease. These tests are relied upon by doctors and patients to guide critical health care decisions in cancer treatment, however, they have grown increasingly complex over the last decade. Consistent and effective oversight of all diagnostics, including those developed by both manufacturers and laboratories, under a risk-based approach with sufficient transparency about known risks and limitations for tests while still promoting public health and innovation is the only path forward. Overly general comparisons for limited studies that make limited conclusions do not help advance patient care.

Most people are familiar with the saying, “Big things come in small packages.” What most may not realize is that some of the biggest innovations in medical technology come from small companies. These “up and coming” businesses in medical technology are often the drivers of disruptive innovation, job creation, and economic expansion.

In honor of National Small Business Week (April 30-May 6), here are examples of five groundbreaking medical technology innovations that are making people’s lives better every day — each of which is thanks to a small business:

A system that prevents epileptic seizures at their source. Seizures start in the brain. Neurons in the brain release electrical signals that tell a body what to do. These electrical signals, or brain activity, can be observed on an electroencephalogram (EEG). Occasionally, these brain signals can suddenly misfire and cause seizures. Other than surgery, most epilepsy therapies do not directly treat the source of seizures. Antiseizure medications and other medical devices deliver therapy whether or not a seizure is occurring — which can cause chronic side effects that negatively impact quality of life. The RNS® System developed by NeuroPace is a medical device that is smart enough to respond to what’s happening in the brain to stop seizures at their source. It automatically delivers treatment when it’s needed. Learn more.

A wearable breast pump. All mothers want to give their babies the best start in life, and for many, that means breast milk. Willow™ is the first all-in-one breast pump that cuts the cords, ditches the dangling bottles, and fits easily inside a bra. Mobile, discreet, and hands-free, Willow allows women to achieve their breastfeeding goals without pressing pause on their own lives. Willow’s design completely re-imagines the breast pump, bringing humanity and dignity to the pumping experience, so women no longer need to be tethered to the wall and undressed while they pump. Willow is smart and connected to an app that syncs data from each pump, enabling mothers to track their milk expression in real time while the pump stays hidden inside their bra. Learn more.

A connected ecosystem that automates the delivery of insulin. Bigfoot Biomedical is a startup founded by those with a personal connection to Type 1 Diabetes (T1D), with over 250 years of T1D across their small team. Tying together components like a Bluetooth-enabled insulin pump, continuous glucose monitor, and a smartphone mobile app, Bigfoot is developing a closed loop automated insulin delivery system (sometimes referred to as an “artificial pancreas” in the media) as part of a monthly subscription service, upending the traditional durable medical equipment business model and aiming to deliver a Class III medical device with the elegance of consumer technology and the reliability of enterprise software. Having completed initial clinical trials, Bigfoot is on target to complete a pivotal trial and submit its solution to FDA in 2018. The company’s focus is on making solutions that are simple for health care providers to prescribe, simple and affordable for people to use, and that improve quality of life. Learn more.

Technology that biologically heals rotator cuff disease. From the time Rotation Medical was founded in 2009, it has worked in partnership with leading clinical experts to address the limitations of current treatments for rotator cuff disease. Traditional approaches focus on biomechanical repair, but do not address the underlying biology of the tendon. This can lead to unpredictable results, disease progression and a high rate of re-tears. In addition, patients require lengthy rehabilitation and face disruption to quality of life. In contrast, the Rotation Medical Rotator Cuff Repair System incorporates a breakthrough technology and technique that balances biomechanics and biology to enhance the body’s natural healing response. The bioinductive implant technology enables tendons to heal by inducing growth of new tendon-like tissue, offering the potential to prevent tear progression and reduce the incidence of re-tears. Learn more.

A device that completely replaces the human heart. Heart Failure is a devastating disease that affects more than 11 million people in the United States and Europe, with an incidence of 1.1 million new cases per year. Furthermore, current growth rates predict a 25 percent increase in the incidence of heart failure by 2030. According to the U.S. National Institutes of Health (NIH), 100,000 patients could immediately benefit from a ventricular assist device or total artificial heart (TAH), and the European market is similarly sized. Without intervention, patients with severe heart failure have a bleak outlook. For these patients, drug therapy is a limited, relatively ineffective option. Although a heart transplant would meet their needs, only 4,000 donor hearts are available globally each year. Thanks to Bivacor, a start-up founded in 2008, implantation of a Total Artificial Heart is a treatment option for patients with end-stage heart failure who need support while on a heart transplant waiting list or who do not qualify for a transplant. Removal of the native ventricles allows the device to completely replace the function of the native heart. The BiVACOR TAH is designed to be a long-term device that can replace the total function of the patient’s native heart. The small, compact device uses proven rotary blood-pump technology to provide the required cardiac output. Learn more.

This piece has been updated to include a fifth example from BiVACOR.

As any parent has experienced when their child is sick, it may seem like the right course of action to visit the pediatrician and request an antibiotic for what ails them. But the truth is they may not always need an antibiotic, and their misuse is fueling one of the world’s most alarming health crises: The rise of antibiotic-resistant organisms, or so-called ‘superbugs’.

Antibiotics are one of the world’s greatest advances in health care, providing effective, life-saving treatments for infections that throughout human history have been often fatal or debilitating, including strep throat, bacterial meningitis, ear infections, tuberculosis, whooping cough, and pneumonia. It turns out, however, that the widespread, and sometimes indiscriminate, use of antibiotics is driving the prevalence and spread of bacteria that are resistant to many or all of the antibiotics currently available.

Infectious bacteria that are impervious to antibiotics are increasingly a global threat — so much so that public health authorities are taking notice. Based on current trends, antibiotic resistance is projected to cause 10 million deaths annually by 2050, accompanied by $100 trillion in lost global economic productivity over that period.

A recently published study in the Journal of the Pediatric Infectious Diseases Society illustrates this alarming trend. Between 2007 to 2015, there was more than a seven-fold increase in the percentage of hospitalized children whose bacterial infection was resistant to multiple types of antibiotic drugs.

To address decreasing treatment options and encourage research and development of new antibiotics, the World Health Organization (WHO) recently came out with a first-of-its-kind list of priority pathogens that pose the greatest threat to human health, identifying 12 families of bacteria. While this priority attention and the development of new antibiotics are critical elements in the fight against this growing epidemic, they are only part of the equation.

Diagnostic tests play a critical role in fighting antibiotic resistance, but are underappreciated and underutilized. These tests support patient treatment and public health by identifying, monitoring, tracking and preventing antibiotic resistance. Diagnostics can often identify the organism causing infections and provide insights into the host’s immune response, thereby helping providers determine which infections do and don’t need antimicrobial treatment — and which antibiotics will be most effective against a particular organism.

According to the Centers for Disease Control and Prevention, 50 percent of all antibiotics prescribed in U.S. are either unnecessary or inappropriate and could be reduced by better use of existing diagnostic tests, especially where they’re often overused — in outpatient and point-of-care settings. The benefits are clear that these tests can help reduce drug misuse, decrease health care costs, revitalize drugs that have been otherwise abandoned and, ultimately, save lives.

Yet, diagnostic tests are a lesser known or used tool for medical professionals. Despite the value of diagnostic tests, there are various reasons why they are underutilized:

· Access to tests vary widely around the world and infections are often treated empirically.

· Antimicrobial drugs are prescribed before the source of the infection has been identified and treatments aren’t always adjusted afterward.

· Diagnostics tests aren’t consistently used to confirm or modify treatments.

· Certain health care systems value the simple practice of prescribing antibiotics over using these tests, which may seem expensive and burdensome.

For these reasons, AdvaMedDx has launched an initiative to optimize the use of diagnostic tests to address antibiotic resistance and educate key stakeholders. This past January, AdvaMedDx unveiled a commitment at the World Economic Forum in Davos-Klosters, Switzerland, signed by 33 organizations, that serves as a framework for collaborative action. Groups that have signed on agree to build the economic case for diagnostics; establish public-private partnerships to increase systems and access to tests; ensure effective use of the tests globally; and advocate for R&D investments and simplified processes and policies to encourage development of innovative tests.

We hope this effort will help to reduce the threat of antibiotic resistance and improve the quality of care for affected patients around the world. No child should suffer needlessly when there are solutions within reach — diagnostics tests are an essential part of the world’s arsenal in this fight and must be fully utilized.

Operating as a division of AdvaMed, the Advanced Medical Technology Association, AdvaMedDx is the only advocacy organization dedicated exclusively to issues facing diagnostic manufacturers in the United States and abroad.

This year alone, more than 12 million people around the world will be diagnosed with cancer, and 8 million people will die from the disease. While cancer continues to be a major worldwide health concern, and as World Cancer Day approaches, it is important to remember how far we’ve come in the fight against the disease and to shed light on current treatment options that can maximize a person’s chance of recovery and preserve their quality of life.

As the newly elected Chair of AdvaMed’s Radiation Therapy Sector, I want to highlight a cutting-edge cancer treatment that is proven to be safe and effective, yet is often misunderstood — radiotherapy. Also commonly referred to as radiation therapy, the technology uses different types of high-energy radiation to damage or kill cancer cells so they can’t reproduce, making it an innovative, life-saving tool in the treatment of people with cancer. What’s more, radiotherapy is a lower cost alternative to other cancer treatments.

Millions of people worldwide could benefit from radiotherapy yet there are still misconceptions and fears surrounding this life-saving treatment. Here are the most common questions I hear about radiotherapy:

Is radiotherapy a safe treatment option?

While radiotherapy has been around since the early 1900s, advances in medical technology starting in the 1960s — such as linear accelerators, imaging technologies, diagnostic devices and sophisticated hardware and software — have made this form of treatment extremely targeted and highly effective. Today, doctors can deliver radiation beams with sub-millimeter precision to target tumors, and can change the size, shape, direction and strength of treatment beams to individualize treatment to each patient. All of this means that doctors can carefully measure and precisely deliver radiation to the tumor while minimizing healthy tissue exposure and side-effects.

Today, radiation therapy is well tolerated by most patients, and it isn’t typically associated with the side effects of chemotherapy or surgery. While side effects such as fatigue, the most common one, can occur, their severity and frequency are lessened greatly by the precision of advanced, image-guided approaches to radiation delivery.

When is radiotherapy used?

Radiotherapy can be an effective part of a patient’s cancer treatment regimen. It can be used as a front-line cancer treatment, although it is not always thought of that way. That’s because doctors often wait to refer their patients to a radiation oncologist as a last resort or as part of end-of-life cancer treatment. Radiation therapy can actually be used as a curative treatment in place of or in combination with surgery or chemotherapy, or to shrink a tumor before surgery so it’s safer to remove.

Also, after surgery, radiotherapy can target remaining cancer cells to prevent cancer from returning. Additionally, radiotherapy is frequently employed in the treatment of metastatic and recurrent cancer, and in many cases it can provide months and even years of high-quality life. When it is used near the end of life it is an effective and efficient means of managing the pain which may accompany progressive cancer.

Today, as patients live longer with cancer and because of the recurring nature of many forms of the disease, some advanced radiation technologies can also be used to retreat patients who have been previously treated. This is a result of the extreme precision of some of these advanced radiation therapy treatments.

Who has access to radiotherapy?

By 2035, 12 million patients worldwide will need radiation therapy, however, many of them won’t have access to it. That’s because this important cancer treatment is not readily available across the globe; only 40 percent to 60 percent of patients with cancer currently have access to radiation therapy. Shortages of equipment, trained staff and facilities, most common in rural areas but also occurring in some high-income countries, have contributed to this problem. Globally, the lack of access is even more startling: 90 percent of the population in low-income countries lack access to this treatment.

How can we increase radiotherapy access worldwide?

To realize both the patient benefits and health system savings radiation therapy can bring to society, we need to continue to advocate for policies that recognize the clinical and economic benefits of radiotherapy, both in the U.S. and around the world. According to a report published in the Lancet, in low- and middle-income countries, with a $97 billion upfront investment, the economic benefits and cost savings are sizable: between $278 billion to $365 billion over the next 20 years. More importantly, these policies and investments would positively impact people living with cancer. It is estimated that if all patients had access by 2035, radiation therapy would prevent cancer from progressing in 2.5 million people and it would lead to an overall survival benefit for 950,000 people.

Accuray is proud to play a leadership role in enabling more people to be aware of cancer treatment options and the role of radiation therapy, and the company is committed to doing its part to enable patients to have access to this important technology. To that end, we recently committed to joining a new worldwide program with the Union for International Cancer Control (UICC), AdvaMed and fellow radiotherapy companies Elekta and Varian Medical Systems. The C/Can 2025: City Cancer Challenge is a new initiative designed to reduce the number of premature deaths and economic burden resulting from cancer. Learn more about the initiative here and more about the value of radiotherapy here. More information on the side effects of treatment with radiotherapy is here.

Josh Levine is President and CEO of Accuray, a company that develops innovative tumor treatment solutions designed to help patients live longer, better lives.

The data cited in this article can be found in the article titled, “Expanding global access to radiotherapy,” which appeared in the September 2015 issue of the Lancet Oncology. The article abstract can be found here.

Enactment of the 21st Century Cures Act represents the culmination of more than two years of bipartisan work by members of the House and Senate — led by House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Committee Member Diana DeGette (D-CO), and Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA). I am proud of the role that AdvaMed played as a leader in the development and advancement of this important legislation from the very beginning.

The final legislation is very positive for the medtech community. It includes a number of important FDA regulatory reforms from AdvaMed’s Innovation Agenda, led by the breakthrough pathway provision that will improve use of the FDA Expedited Access program. There are also provisions to: raise the humanitarian device exemption cap; establish a process for FDA recognition of international standards; improve selection of experts on FDA advisory panels; update the Class I/II exemption list; allow for the use of central IRBs for device trials; require FDA to update its CLIA-waiver guidance; reinvigorate FDA’s use of the Least Burdensome principle in conducting reviews; clarify FDA regulation of software and certain digital health technologies; and improve the regulation of combination products. The package also provides for $500 million in discretionary appropriations for FDA to implement these and other provisions of the legislation.

There are also delivery system reforms, including language to require greater transparency in local coverage decisions (LCDs), which is a positive step forward on AdvaMed’s work to improve the LCD process. While the legislation includes the expected offset that would move up the effective date of the application of Medicare durable medical equipment (DME) rates to the Medicaid program to Jan. 1, 2018, it also includes a constructive retroactive delay of the application of competitive bidding rates to non-competitively bid areas for DME through the end of this year. This delay mirrors legislation introduced by Rep. Tom Price (R-GA) and Sen. John Thune (R-SD), which AdvaMed has supported.

The 21st Century Cures Act is a win for patients and for medical innovation. Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new life-saving, life-enhancing devices and diagnostics for patients.

I am proud to have served our country as a sailor in the United States Navy for twenty years. Today, I am proud to serve people in need as a product support specialist in the medical technology industry.

The skills I honed in the Navy as an aviation electronics technician translated well into my current role. During my naval career, I managed software systems and learned how to maintain, troubleshoot and repair sophisticated equipment. In my current role at a medical technology company that is pioneering innovative solutions for treating cancer, I provide real-time, virtual technical support to leading medical institutions to ensure cancer patients get the radiotherapy treatments they need. Since 50 to 60 percent of people with cancer will need radiotherapy at some point during their treatment, this is a critical job.

It wasn’t just the technical skills I gained in the Navy that gave me an edge, however. I was exposed to diverse cultures and people, which helped me recognize and respect where people are coming from and how to maximize their strengths. The military also taught me how to stay calm in high-pressure situations and get issues resolved. When a life is at stake, patience and level-headed thinking are critical.

I am lucky; my job is fulfilling and rewarding. And I work in an industry that is committed to hiring transitioning military veterans into good-paying jobs, into roles that are not just for scientists or engineers, but for people with skills in human resources, finance, logistics and the supply chain, among others. Veterans can fill any role, from entry level all the way up to the CEO.

But many of my fellow veterans aren’t so lucky. According to a CareerBuilder study conducted last year, nearly a third of employed U.S. veterans say they are underemployed or in a low-paying job. That’s unfortunate; veterans can and do make significant contributions to the American workplace, every day. While I am encouraged by the meaningful efforts — by our government and businesses across the country — to recruit and hire former members of our military, I would argue that’s only half the battle. It is equally important to help veterans find positions that not only effectively leverage their skills, but also offer opportunities to advance in their post-military careers.

In addition to the technical skills we bring to the table, research indicates that members of the military possess important soft skills that make us valuable and productive members of just about any business organization, including high levels of resiliency, advanced team building skills, and strong organizational commitment. However, these skills are often harder to communicate with prospective employers.

We need to do more to support programs offered by organizations like MVPvets (MedTech and BioTech Veterans Program), a group that assists and prepares transitioning military veterans for meaningful employment in the life sciences industry. These types of programs help prospective employers evaluate those soft skills — like critical thinking, team-building and leadership — and match veterans like me with mentors, jobs and career resources. To date, more than 1,450 veterans have participated in the MVPvets program and have either gained employment in high-quality jobs within the life sciences industry or have improved their current employment situation and job readiness post military transition.

Today, I have a job that matters. I am proud to work at a company that recognizes what I can contribute, and it is my hope that government and business leaders here in our region and across the country will emulate what the medical technology industry has been able to do by putting greater emphasis on placing veterans in positions that make the most of their skills and experiences. This is a battle we can most definitely win.

Kenneth Morton served in the U.S. Navy for 20 years. He is a product support specialist at Elekta in Atlanta, Ga. More information on MVPvets can be found here: http://www.mvpvets.org/.

In recognition of October as National Breast Cancer Awareness Month, it’s important to remember that advancements in medical technology in recent decades have helped save the lives of millions of cancer patients, perhaps even some who are close to you. Radiation therapy — also known as radiotherapy — is one such advancement that is helping more patients live longer, healthier lives every day.

Radiotherapy is integral to the management of most cancers, including the three most common cancers in the world — breast, prostate, and lung cancers. But what many people may not know is that, given the profound toll that cancer takes on individuals, families, societies, and economies, much of the world’s population lacks access to radiotherapy services.

According to data from the Lancet Oncology Commission, expanding access to radiotherapy in low- and middle-income countries would produce economic benefits ranging from $278 billion to $365 billion over the next two decades — all for an initial investment of $97 billion. More importantly, such an expansion could save 27 million life-years.

The radiotherapy shortfall we currently face will only increase in the wake of the world’s ever-growing cancer burden. To learn more about radiotherapy and the importance of global investment to expand patient access to this life-changing innovation, I invite you to read a recent op-ed I wrote on the subject here. I hope you enjoy it, and I welcome your feedback.

This past January, the Centers for Medicare and Medicaid Services began an aggressive timeline to phase in $4.4 billion in Medicare payment cuts for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) — without first understanding what impact these cuts would have on Medicare patients’ access to necessary medical equipment.

Among the life-sustaining medical devices at stake are home-based respiratory therapies, which are used to treat conditions such as chronic obstructive pulmonary disease, or COPD, and obstructive sleep apnea. These home oxygen and sleep therapies enable patients to live independently, remain at home with their families and maintain a high quality of life.

Until recently, provisions in Medicare law set fee schedules to pay for these products. Today, 100 of the largest metropolitan statistical areas instead participate in Medicare’s competitive bidding program for many of these products, which has already resulted in major market disturbances. For home respiratory therapies, for instance, the process has generated sizable payment cuts ranging from 30 percent to 50 percent.

To date, there has been little independent analysis of the competitive bidding program to evaluate if the program has restricted access to products for patients or compromised physicians’ decision-making when it comes to prescribing these types of products. That is why AdvaMed and the Council for Quality Respiratory Care have joined a chorus of lawmakers, patients and physicians to call on Congress to pass bipartisan and bicameral legislation that would temporarily delay the full phase-in of pricing policies for medical devices until there is enough evidence to understand the consequences.

Here are three reasons Congress should move forward with this legislation:

1. Six months is not enough time to monitor the disruption of Medicare beneficiaries’ access to medical equipment. Without comprehensive data, we just do not know if pricing changes have affected patient access.

2. If rural providers shut their doors or reduce services, access to some care could disappear, which would negatively impact traditionally underserved regions. Rural providers do not typically participate in the competitive bidding process, and we do not have much data to study the impacts.

3. Reducing reimbursement rates would stifle innovation. Respiratory therapy providers and product manufacturers would not have the ability to innovate and develop new processes and products that would improve the patient experience and, ultimately, patient outcomes. Improving patient outcomes would contribute to Medicare’s overall goals of reducing readmissions, and therefore costs, by keeping patients healthy in the home.

Read my op-ed in The Hill, co-written with Dan Starck, the chairman of the Council for Quality Respiratory Care, to learn more about why it is important for Congress to come together on this issue for Medicare patients.

America’s medical device and diagnostics industry helps deliver life-changing medical advancements to patients in need. These innovations allow people to live longer and healthier lives, yield savings across the health care system by replacing more invasive procedures and reducing hospital stays, and help create good-paying American jobs.

As president and CEO of AdvaMed, I know that to continue to advance the benefits of medical technology, we must have the right public policies to support investment, innovation and patient access. This includes permanent repeal of the U.S. medical device tax. Instituted in 2013, the 2.3 percent medical device tax has had a significant, adverse impact on medical technology investment, research and development. Fortunately, Congress has taken a great first step toward repeal of this onerous tax by implementing a two-year suspension late last year.

I applaud lawmakers from both sides of the isle who came together in a bipartisan effort to secure device tax relief in 2015. With the current suspension, our medical technology companies are investing recaptured revenue into important efforts such as increasing R&D and launching new products to advance patient care. Going forward, securing permanent repeal will be critical to strengthening these efforts, creating the kind of certainty that drives long-term planning and investment, and preserving America’s global leadership in medical technology.

To learn more about the importance of device tax repeal to economies in states across the country — including New York and Ohio — I invite you to read two recent articles I co-authored on the subject, here and here. I hope you enjoy them, and I welcome your feedback. For more information about the device tax and the importance of full repeal, please click here. Thank you for your support!