ON-THE-RECORD PRESS CALL
BY HHS SECRETARY ALEX AZAR,
CMS ADMINISTRATOR SEEMA VERMA,
HRSA ADMINISTRATOR TOM ENGELS,
AND DPC DIRECTOR JOE GROGAN
PREVIEWING NEW KIDNEY HEALTH PROPOSED RULES
Via Telephone
9:04 A.M. EST
MR. CANTRELL: Thank you, Operator. Good morning, everyone. And thank you for joining this morning's briefing to preview new health proposed -- kidney health proposed rules.
This briefing will be on the record and conducted by Health and Human Services Secretary Alex Azar, Administrator for the Centers for Medicare and Medicaid Services Seema Verma, Acting Administrator of the Health Resources and Services Administration Tom Engels, and Director of the Domestic Policy Council Joe Grogan.
If a subject-matter expert speaks during the briefing, he or she will be on background, attributable to a senior administration official.
We will begin with opening statements and, as time allows, will follow with question and answer. All information is embargoed until the conclusion of the call.
With that, we will begin with DPC Director Joe Grogan.
DIRECTOR GROGAN: Thank you. The Trump administration continues to deliver on the President's vision for great health for Americans as we unveil an important milestone in the delivery of the President's July 10 executive order to reform kidney care.
The Trump administration is committed to ensuring the world’s best healthcare for all Americans and confronting problems in the healthcare system that other administrations ignored -- in many cases, for decades.
Each month, 3,000 people are added to the kidney waitlist and hundreds pass away while waiting for a transplant. This is unacceptable. When President Trump signed the Executive Order on Advancing American Kidney Health in July, he prioritized the 95,000 candidates who are on the waitlist as of today, hoping for a life-giving kidney transplant. Not since President Nixon expanded Medicare coverage to Americans with end-stage renal disease in 1972 has a President advanced kidney health like President Trump to ensure that no American is forgotten.
The Organ Procurement Organization -- OPO -- proposed rule modernizes the Centers for Medicare and Medicaid Services Conditions for Coverage with measures to evaluate OPO performance that are objective and enforceable. This change will support kidney donation, reduce waste, and shorten transplant wait times for years to come.
Almost 7,000 of the 36,000 organ transplants performed this year came from living organ donors, about one-sixth of transplants. We are aiming to increase the number of living donors by reducing the barriers to giving an organ. The Living Donor proposed rule ensures that people generous enough to undergo surgery and give an organ to those in need do not bear the financial expenses alone.
The Health Resources and Services Administration, HRSA, proposes to allow expenses to be reimbursed by living -- when those expenses are incurred by living donors such as lost wages, childcare, and elder care that result from their organ donation.
These proposed rules stand to particularly benefit African Americans, the largest minority group in need of organ transplants. While only 13 percent of the U.S. population is African American, they represent approximately one-third of the candidates on the U.S. waitlist for kidneys. Increasing the supply of kidneys for transplants will help communities disproportionately affected by kidney disease.
These proposed rules build on the President's vision and plan to provide all Americans great healthcare through bold initiatives that battle major diseases and save American lives. We are working on behalf of all those Americans on the organ waitlist to ensure an ample supply of transplants.
We will always be on the side of patients, and this shift in health vision helps patients get the transplant they need to live.
The President’s vision for the American health system requires us to widen the aperture from an obsession with Obamacare to a broad commitment to help Americans lead healthy lives. We are building a healthcare system that delivers more options, better health, longer lives, at lower cost.
Thank you.
SECRETARY AZAR: Hello, everyone. Alex Azar here. Thank you for joining us on this call today.
We’re excited to be announcing proposals today that have the potential to save and transform the lives of thousands of Americans in need of organ transplant.
Better health is the ultimate goal of President Trump’s healthcare vision. Tackling impactable health challenges is one of the key areas where we’re delivering on that vision, alongside reforming financing and delivering better value in healthcare.
There are few more transformative interventions for someone’s health than by replacing a failing organ with a healthy one, and that’s what we’re aiming to make much more common with our proposals today.
Each year, almost 8,000 Americans die waiting for a kidney or other organ transplant. Almost 100,000 Americans are on the waiting list for a kidney. Yet there are thousands of organs that could be available for use, and many Americans who might be willing to become a generous living donor.
Unfortunately, today, and for decades, we haven’t done everything we can to procure organs from deceased donors, and we haven’t been providing enough support for living donors.
These challenges around organ donation have been recognized for some time, but they’ve never gotten the full attention they need from the decision-makers in Washington. President Trump is changing that. The President is not going to let viable organs be wasted and see lives thrown away.
Today, under Administrator Verma’s leadership, CMS is proposing to reform how we measure the work of organ procurement organizations -- the federally funded, nonprofit organizations that run organ procurement. Today, many of these OPOs -- “O-P-Os” -- are doing a great job, but some of them are not.
Rather than allowing OPOs to report on their own performance, we’re proposing objective, consistent criteria that will hold them accountable. The President’s proposed OPO reforms have the potential to give tens of thousands of Americans a chance at a better, longer, and healthier life.
We’re also proposing another rule to support people who become living donors. Many Americans may be interested in being living donors, like the incredibly generous kidney donor that saved my father’s life, but financial constraints stand in the way.
So, today, under the leadership of Administrator Engels, through the Health Resources and Services Administration, we are proposing bold steps to break down barriers to living donation by reimbursing for a broader range of expenses, such as lost wages and, potentially, childcare. When an American wishes to become a living donor, we don’t believe their financial situation should limit their generosity.
These two new proposals supplement the work already underway at HHS to advance American kidney health, under the President’s executive order, like the work of KidneyX, a public-private initiative designed to drive innovation in kidney care, including measures to improve dialysis and develop an artificial kidney.
Today’s proposals reflect President Trump’s commitment not only to improving the health of all Americans, but also to tackling neglected health challenges where we have the chance to make a real difference.
The initiative to advance American kidney health is a broad, HHS-wide effort, and we would not be making the historic progress that we’re seeing without the contributions of leadership and civil servants from across HHS. So I want to thank everyone involved in this effort for their dedication to this lifesaving work.
With that, I'd like to turn things over to Administrator Seema Verma to explain the reforms CMS has proposed for OPOs.
Administrator Verma?
ADMINISTRATOR VERMA: Thank you, Mr. Secretary. And thanks for joining us.
We are here to announce some major improvements for patients who need lifesaving organ transplants, and we’re doing it (inaudible) President Trump’s visionary leadership. He's doing everything in his power to repair a broken healthcare system that stands between patients and cures that medical science discovered long ago, realigning government incentives to drive quality and cut red tape.
The President’s historic executive order on American kidney health is a key part of this vision, and today’s announcement delivers on that directive. Today’s announcement also is the culmination of President Trump’s historic effort to cut the red tape, which is reflected in major CMS initiatives like Patients over Paperwork and Meaningful Measures.
Today, CMS is unveiling a bold new rule that aims to increase the short supply of available organs. You just heard the numbers on our lengthy transplant waiting lists. To make matters worse, someone is added to one every 10 minutes, and 20 people die every day because they can’t get an organ. Government’s misaligned regulatory incentives aren’t procuring enough kidneys, hearts, lungs, and other organs to fulfill the demand. But those 20 deaths each day can be avoided. And today, CMS takes the first step towards preventing them.
Our proposals, if finalized, would increase the number of organs by completely and totally overhauling the organ procurement system. So before we discuss it, it’s important to first understand the status quo and its flaws.
Organ Procurement Organizations, or OPOs, are not-profit entities that act as an essential link between organ donors and organ recipients. They procure organs from donors in hospitals and deliver them to transplant centers, where they can save lives. My agency, CMS, establishes quality metrics for OPOs, which we use to assess them every four years to decide if they will be recertified for participation in Medicare. There are three current metrics, of which OPOs must meet two.
Unfortunately, these current measures disincentivize OPOs from trying hard to procure every possible organ in their service areas. They are also based on self-reported data that is tough to validate and can vary from one OPO to another.
Finally, the metrics are riddled with exclusions. They may exclude all but organs from perfect candidates, so OPOs have little incentive to seek imperfect organs -- meaning organs from donors who are less-than-ideal candidates because of a health condition.
But advancements in medical science have shown us that many organs from individuals with certain conditions can, in fact, be transplanted, resulting in better and longer lives for patients who are struggling through organ donation alternatives like dialysis. Imperfect organs shouldn’t be discarded when they can save lives and improve quality of life.
For example, the current rules could exclude a potential kidney donor who’s a bit older than the ideal donor. These kidneys would be imperfect, but usable. The current metrics could also exclude an older potential heart donor with a history of high blood pressure. But again, while that heart is imperfect, it can save a life.
Moreover, the current measures have encouraged OPOs to seek donors who are donating multiple organs and avoid single organ donors, discarding some potentially transplantable organs.
These examples show it’s critical that we’re focusing on the right quality measures. And that’s why CMS has been so focused on our Meaningful Measures initiative. Whether we’re talking about holding physicians accountable for outcomes or ensuring that imperfect but usable organs aren’t needlessly discarded, it’s critical to patients that we’re measuring what matters: outcomes.
Our proposed rule represents a fundamental shift in the way we assess OPOs. It would scrap this inefficient system, replacing the old measures with two simple, vigorous measures calculated with independent data from the CDC. While this data will exclude potential donors with conditions that would totally preclude them from donation -- like most types of cancer, infectious disease, and sepsis -- it will ensure that imperfect organs are considered for procurement, organs that may be wasted under the current system.
Using this objective data, we would calculate two simple measures. The first is an OPO’s donation rate, meaning the percentage of possible donors who become actual donors. The second is the transplantation rate, meaning the percentage of organs transplanted after procurement.
These simple yet powerful outcome measures eliminate today’s perverse incentives, and will instead incentivize OPOs to seek as many organs as possible -- perfect and imperfect alike. Needless to say, patients retain their right to receive robust information on the quality of the organ they are receiving, and the final decision on whether to use a given organ will remain with them and their doctors. But for countless patients, an imperfect organ is better than no organ at all. And for someone on a waitlist, that may be the difference between life and death.
CMS also intends, in the spirit of transparency, to make outcome measures public at each assessment, highlighting OPOs that fall outside of the top 25 percent in donation and transplantation rates. This system would help OPOs identify weaknesses and give them an opportunity to take swift action to improve in between each four-year recertification cycle. This increased accountability -- to the public and to CMS alike -- promises to spur OPOs to procure and transplant more organs.
And, finally, because of the unique statutory limitations on OPOs, our proposed rule does much to ensure that no areas of the country are left without one. At the end of each recertification cycle, poor performing OPOs could be decertified, but they’d be replaced by better performing one -- a better performing one preventing gaps in service for patients who are in need of organs.
We hope and expect that key stakeholders -- patient advocates, OPOs, transplant surgeons, nephrologists, and more -- to be pleased with this proposal. We are eager to hear their feedback so we can collaborate with them to finalize policies that strengthen our organ procurement system.
Because, today, it is simply not meeting the needs of thousands of American patients that stand in need of new organs. And, once again, President Trump is tackling longstanding -- a longstanding problem in the American healthcare system, because no life-saving organ should go to waste.
ADMINISTRATOR ENGELS: Good morning. I’m Tom Engels and I'm the Administrator of the Health Resources and Services Administration, or HRSA.
Today, I'm excited to announce that the Trump administration has taken a major step to remove financial barriers for a living organ donation by expanding the scope of reimbursable expenses for living organ donors to include lost wages, and children childcare, and eldercare expenses.
Today’s notice of proposed rulemaking is a result of the President’s Executive Order on Advancing American Kidney Health, which emphasized that supporting living organ donors can help address the current demand for kidney transplants.
Living organ donation is an important option for thousands of people on the national transplant waiting list. Approximately 96,000 individuals are on the national waiting list awaiting an available kidney. This proposed rule will increase living organ donation by removing financial disincentives for living organ donors.
It is important to note that living organ donation provides a number of advantages. Recipients often receive a better quality organ in a shorter time period, which often results in improved survival rates of organ recipients. In general, recipients of kidney transplants from living organ donors have better clinical outcomes than those who continue on dialysis or those who receive a deceased donor kidney transplant.
Many potential living organ donors may be willing and available to donate an organ to a family member, friend, or an unknown recipient, but would be unable to afford the loss in income while out of work during the transplant process, which includes the pre-transplant evaluation, surgery, subsequent recovery time, and follow-up appointments. This proposed rule would remove this potential barrier to living organ donations.
This notice of proposed rulemaking makes clear that HHS and HRSA are committed to reducing the number of individuals on the organ transplant waiting list by increasing the number of organs available for transplant.
With that, I’ll turn it back to Austin.
MR. CANTRELL: Thank you. Operator, we can now take some questions.
Q Hi, this is (inaudible) with Politico. Thanks for taking my question. I was curious, on the OPO rule, if you guys had considered any penalties or fines for OPOs that are either, like, egregiously not meeting their performance metrics or some kind of penalty.
ADMINISTRATOR VERMA: There are no penalties proposed. But the way it would work is, right now, they're being assessed every four years, and what we're proposing here is that we would work with them every year to assess how they're doing on their outcome measures. And then if there are issues or problems, we would address it at that time -- not waiting every four years.
Q Hey, sorry about that. This is Anne Flaherty with ABC News. Can you tell us a little bit more about what does it look like for somebody to get reimbursed for lost wages if they donated a kidney? What exactly is the formula on that, and how does it work?
ADMINISTRATOR ENGELS: Well, currently HRSA has a program that reimburses the National Living Donor Assistance Center. The program currently provides reimbursement for up to $6,000 in expenses, including travel, lodging, meals, and incidentals related to the organ donation evaluation.
What we’re going to do is add the dis- -- take away a disincentive to include the lost wages, along with childcare and elder care expenses.
Q Yes, hi. Kimberly Kindy with the Washington Post. I was hoping that you could go over again how the new performance metrics would work. What would the measurements be?
ADMINISTRATOR VERMA: Okay, so before, we had three and now we’re going to be moving to two measures. One is the donation rate measure, and this is proposing that the donation rate would be the number of actual deceased donors as a percentage of a donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death. And that would not be an absolute contraindication to organ donation.
And the second one is the transplantation rate measure. And we’re proposing that the organ transplantation rate would be the number of organs transplanted as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death. And that would not be an absolute contraindication to organ donation.
Q Hi, this is Lauren Clason from CQ. Thanks for holding the call. I’m just curious, could you go over a couple more examples about an imperfect organ that might be -- that might now be used under these rules?
ADMINISTRATOR VERMA: Sure. So in the past, I think the rules were very strict and they focused on just procuring perfect organs. But I think the science tells us that we could potentially transplant an imperfect organ and the recipient would still have an increased quality of life and it would extend their life as well.
There are still exclusions. For example, we wouldn’t take an organ from a person that had cancer or some type of a bacterial or viral infection or sepsis. But we know that there are organs, for example, of somebody that's older in age or somebody that’s had hypertension, that those organs can be successfully transplanted.
So what we’ve done in this rule is reduce the number of exclusions of the organs that were previously discarded, because we know that we can use imperfect organs successfully.
SECRETARY AZAR: And for instance, an organ from an individual who has Hepatitis C -- because we can actually cure Hepatitis C -- would be eligible for transplantation because the recipient could be treated for that. And, of course, due to legislative change also, an organ from an individual who is HIV-positive could be transplanted to an individual who is also HIV-positive.
Obviously, all of this is done with full-informed consent and notification from the transplant surgeon to the recipient individual. But it just dramatically opens up the categories of organs available for transplantation, that we longer allow the perfect to be the enemy of the good when it comes to organ transplantation. These are individuals where even an imperfect organ can be life altering and life saving.
Q Hi. Joyce Frieden from MedPage Today. I’m wondering if you can talk about how many more organs you expect to be donated as a result of these changes. How much do you expect things to improve?
ADMINISTRATOR VERMA: We’re expecting almost 5,000 new organs to be successfully transplanted under the new rules.
MR. CANTRELL: Great. Thank you everyone. This will conclude our call. Again, remarks were on the record. As always, direct any further question to the corresponding press office.
Thank you everyone for joining us this morning.
END 9:28 A.M. EST
