New focus, more funding for improving transplant process, organ viability

A number of organizations, including the White House, have united to improve the process for organ transplants in hopes of reducing the time recipients must wait for the life-saving opportunity they so desperately need.  At the White House Organ Summit, the administration announced what steps these organizations will take to improve the donor process, which includes a $160 million program led by the Department of Defense to develop cell repair and replacement techniques.

Registration: Is opt-in the best strategy?

Although 95 percent of the American population supports organ donation, only half are registered as organ donors. This is one thing the united organizations hope to change. Over 120,000 hopeful recipients are on the waiting list, with nearly 100,000 of those needing kidneys. The wait is deadly, taking 22 lives per day.

The registration process, as it stands, leaves something to be desired. Donors must opt in at their Department of Motor Vehicles (DMV). In other countries, opt-out policies result in much higher registration levels. Although some have expressed concern about presuming consent, the high support rate indicates that most would not object to such a change. Social media companies have committed to a campaign to encourage people to declare themselves donors online instead of through the DMV.

Maintaining viability

One way to increase the successful use of donated organs is coming up with ways to preserve viability during transport. Toting an organ in a cooler packed with ice, as seen on television shows, is not the best strategy. A device that monitors the organ while maintaining its temperature and infusing it with oxygenated blood can help the organ to start functioning almost as soon as it is transplanted.

Cooling the organ slows its natural processes down, but the approach of keeping it warm allows it to continue functioning. Trials established the safety of the technique for hearts and lungs, but it had not been proven for the liver–yet a successful transplant indicates that it will work. Many potential donor hearts are unusable because putting them on ice would cause too much damage. A study is currently underway to determine if warm transport will alleviate this issue.

The device, developed by TransMedics, is a plastic box that can be manipulated as needed. It can attach to a cart or be removed to fit into a transport vehicle. Warmed blood and nutrients are pumped through while sensors monitor functions. Various conditions can be altered on a control screen. The device is awaiting FDA approval for commercial use, but it is already being used in the other parts of the world. Even if this option is successful, however, the device may be prohibitively expensive for payers.

In  the meantime, other efforts to improve the entire process are underway. Over 30 transplant centers have agreed to share data about kidney transplants, while Johns Hopkins University and the National Institute of Allergy and Infectious Disease are working together to expand HIV-positive donor options. The FDA and the American Society of Nephrology will work together to create alternatives to kidney dialysis. The government is also improving the online platform for matching, labeling, and tracking organs in order to reduce the burden on hospitals and speed up the process.

Creating an organ

Another approach to the organ shortage is developing new organs altogether. The Pentagon is creating the Advanced Tissue Biofabrication Manufacturing Innovation Institute to develop a process for generating new human cells and tissues. The National Cell Manufacturing Consortium and others are collaborating to best decide how to develop this technology. The idea of tissue engineering is not a new one, and the National Institutes of Health (NIH) has been involved in research to create tissues and expand human application. The new institute will hopefully build on these efforts and result in many more lives saved.

DMEPOS suppliers accept adjusted fee schedule rates

Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers in non-competitive bidding program areas are accepting adjusted payment rates that were phased in beginning in 2016. CMS posted quarterly monitoring data suggesting that the adjusted rates are adequate to cover the costs of furnishing DMEPOS and have had no negative impact on beneficiary access. The fully adjusted billing rates will take effect in non-competitive bidding areas beginning July 1, 2016.

Competitive bidding program

CMS has operated the DMEPOS competitive bidding program (CBP) since January 2011 to improve upon the prior DMEPOS fee schedule, which was based on historic supplier charges from the 1980s and resulted in excessive payments. Medicare saved more than $580 million upon the completion Round 1’s three-year contract period, which lasted from 2011 through 2013. After the first two years of Round 2 and the national mail-order programs, which began in July 2013, it saved approximately $3.6 billion.

Non-CBP areas

Section 1834(a)(1)(F) of the Social Security Act requires CMS to adjust fee schedule amounts for durable medical equipment (DME) on January 1, 2016, in non-CBP areas. Section 1842(s)(3)(B) authorizes adjustments to the fee schedule amount for enteral nutrients, equipment and supplies based on information from CBPs. To combat stakeholder concerns that the adjustment might negatively impact quality and access to items and services, CMS decided to phase in the adjustments to the fee schedule amounts for claims with dates of service January 1, 2016, through June 30, 2016, with each fee schedule amount based on a blend of 50 percent of the fee schedule amount that would have gone into effect on January 1, 2016, if not adjusted based on information from the CBP, and 50 percent of the adjusted fee schedule amount.


Suppliers in non-CBP areas are not required to accept assignment of Medicare claims for items subject to competitive bidding and may instead collect the extra money needed to cover their costs directly from the beneficiary. However, the data for 2016 show that suppliers in non-CBP areas have accepted the new, adjusted rates as payment in full. Overall, there was no change in the rate of assignment for the first four months of 2015 (99.87 percent) compared to the first four months of 2016 (99.88 percent). The data are also broken down by geographic regions, rural versus non-rural classification, and DMEPOS item category. CMS will continue to monitor data for the second quarter of 2016 and after the fully adjusted payment rates are implemented beginning in the third quarter.

PEEK supplier settles monopoly charges with FTC

Invibio, the first company to sell the high-performance polymer polyetheretherketone (PEEK) used by medical device makers to construct spinal, orthopedic, and other human implants, has agreed to enter into a proposed consent agreement with the Federal Trade Commission (FTC) settling charges that it violated federal antitrust law by using long-term exclusive contracts to impede competitors and retain a 90 percent monopoly of PEEK sales worldwide.

According to a draft administrative complaint by the FTC, Invibio and Invibio Limited, along with their corporate parent, Victrex plc (Invibio) is the dominant supplier of implant-grade PEEK. Invibio’s only competitors are Solvay Specialty Polymers LLC (Solvay) and Evonik Corporation (Evonik). The complaint further alleged that:

  • Solvay and Evonik each began to sell PEEK after Invibio had established market dominance, offering prices significantly below the prices charged by Invibio.
  • Invibio supplies PEEK to medical device makers primarily pursuant to long-term supply contracts, which it employed both before and after market entry by Solvay and Evonik, and which included exclusivity terms.
  • Invibio employed various strategies to coerce or induce device makers to accede to exclusivity terms, including threatening to discontinue PEEK supply or to withhold access to regulatory support.
  • Invibio’s insistence on exclusivity terms was a deliberate and successful strategy to hinder its competitors and to maintain its monopoly power.
  • In 2014, years after entry by Solvay and Evonik, and despite Solvay’s and Evonik’s lower prices, Invibio still accounted for over 90 percent of PEEK sales worldwide. A substantial majority of these sales were foreclosed from Solvay and Evonik due to the exclusivity terms in Invibio’s long-term supply contracts.

The complaint concluded that due to Invibio’s conduct, Solvay and Evonik have been hampered in their efforts to compete against Invibio, including in developing valuable customer relationships that would bolster the entrants’ reputations, and in realizing sufficient returns to justify further investment in the business. As a result, the FTC alleged that purchasers of PEEK were deprived of a meaningful choice among suppliers and denied the full benefits of competition.

Proposed consent agreement

Under a proposed consent agreement, Invibio will be prevented from entering into exclusive supply contracts and from keeping current customers from using an alternate source of PEEK in new products. The agreement also requires the following:

  • Invibio must allow current customers to modify existing contracts to eliminate the requirement that the customer purchase PEEK for existing products exclusively from Invibio.
  • Invibio is barred from using pricing terms in new contracts that could effectively result in an exclusive arrangement between Invibio and a device maker. These prohibited terms include (1) setting minimum purchase requirements, (2) conditioning discounts or important services on a device maker’s purchase from Invibio of a specified percentage of its PEEK requirements, and (3) providing retroactive volume discounts.
  • Invibio must establish an antitrust compliance program for its employees and officers.

Effect of the consent agreement

The proposed consent agreement is entered into for settlement purposes only and does not constitute an admission by Invibio that it has violated the law as alleged in the administrative complaint, or that the facts as alleged in the complaint, other than jurisdictional facts, are true. The consent agreement is only effective upon execution by the parties and acceptance by the Commission. According to a press release from the FTC’s Bureau of Competition, a Commission vote to issue the administrative complaint and accept the proposed consent agreement for public comment was 3-0.

The proposed agreement package will be published in the Federal Register shortly and subject to public comment for 30 days. The FTC has made available to the public an analysis of the agreement to aid the public in commenting. After the close of the comment period, the Commission may then issue its final decision and order or withdraw its acceptance of the agreement if it deems appropriate.

FDA tackles postmarket medical device cybersecurity

By Kathryn Brown, DePaul University College of Law, WK Legal Scholar

Increasingly, medical devices may be accessed via wireless technologies which transform health care by improving patient mobility, enabling the remote programing of devices, and allowing remote access to and monitoring of patient data. Despite these apparent benefits, medical devices pose serious safety and security risks to patients and health care entities. Like other computer systems, medical devices are vulnerable to security breaches. The FDA stated, “[t]he failure to maintain the cybersecurity of medical devices can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or exposure of connected devices or networks to security threats.” This vulnerability has led to many concerns about potential harms that could arise via medical devices. For example, according to ABC News, Thomas Lewis, Partner-in-Charge at LBMC Information Security, stated that “[a] hacker attempting to get patient data could accidentally knock out medical devices connected to the Wi-Fi network, such as an MRI or X-ray machine.” Additionally, as an extreme example of the harm that device hackers could cause, The Washington Post reported that Former Vice-President Dick Cheney chose to disable the wireless function of his heart implant in fear that it could be hacked in an assassination attempt.

In response to growing concerns about the cybersecurity vulnerability of medical devices, the FDA issued a draft guidance entitled “Postmarket Management of Cybersecurity of Medical Devices.” This new draft guidance builds on the FDA’s prior cybersecurity guidance issued in October 2014, which encouraged medical device manufacturers to develop and incorporate cybersecurity controls into medical devices at the premarket design stage. The new draft guidance outlines recommendations to aid medical device manufacturers in monitoring, identifying, and addressing cybersecurity vulnerabilities in devices that have already entered the market. This guidance applies to medical devices that contain software or programmable logic, as well as software that qualifies as a medical device. It does not apply to experimental or investigational medical devices.

Overview of the Draft Guidance

The draft guidance provides overarching recommendations on assessing cybersecurity risk, as well as manufacturers’ remediation and reporting obligations. In order to determine whether their device vulnerability is controlled, the FDA encourages manufacturers to “define and document their process for objectively assessing the cybersecurity risk for their devices.” This process should be tailored to the device as well as the clinical performance and situation. The FDA’s draft guidance indicates that “critical components” of a cybersecurity surveillance program include:

  • Monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risk;
  • Understanding, assessing and detecting presence and impact of a vulnerability;
  • Establishing and communicating processes for vulnerability intake and handling;
  • Clearly defining essential clinical performance to develop mitigations that protect, respond, and recover from the cybersecurity risk;
  • Adopting a coordinated vulnerability disclosure policy and practice; and
  • Deploying mitigations that address cybersecurity risk early and prior to exploitation.

The FDA further advises manufacturers to exercise “good cyber hygiene” through routine device maintenance and the timely implementation of a comprehensive risk management program to mitigate cybersecurity risks and vulnerabilities. Manufacturers are reminded that they must report to the FDA any device vulnerability that poses an uncontrolled risk. As an additional security measure, the FDA suggests implementing the 2014 National Institute of Standards and Technology (NIST) Voluntary Framework for Improving Critical Infrastructure Cybersecurity.

Impact of the Draft Guidance

The FDA draft guidance is neither final nor codified; however, attorney Ronald Lee, as well as several of his colleagues, believe that the FDA has “essentially made cybersecurity vulnerability management throughout the lifecycle of medical devices a long-term and likely permanent aspect of regulatory compliance.” The proactive recommendations for device manufacturers demonstrate that medical device cybersecurity is a priority for the FDA. However, medical devices and cybersecurity threats are continually evolving; therefore, postmarket controls will not entirely eliminate these risks. Device manufacturers need to implement comprehensive cybersecurity risk management programs to address any device security vulnerabilities. The FDA accepted comments on the draft guidance until April 21, 2016, and will consider the comments before drafting the final version of the guidance. Whether or not these recommendations are codified, device manufacturers ought to be carefully assessing and evaluating the potential vulnerabilities that may appear throughout a device’s lifecycle, so as to better protect patient safety.

Kathryn Brown is pursuing her law degree from DePaul University College of Law. She completed her undergraduate degree summa cum laude from St. Ambrose University with a Bachelor’s Degree in Political Science and a concentration in International Politics. Kathryn is a Staffer on the DePaul Law Review, Fellow and Vice-Director of Programming for the Jaharis Health Law Institute, and a General Staff Writer for the Institute’s E-Pulse newsletter.