May 16, 2019 - Issue: Vol. 165, No. 82 — Daily Edition116th Congress (2019 - 2020) - 1st Session
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MARKETING AND OUTREACH RESTORATION TO EMPOWER HEALTH EDUCATION ACT OF 2019; Congressional Record Vol. 165, No. 82
(House of Representatives - May 16, 2019)
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[Pages H3853-H3876] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov] MARKETING AND OUTREACH RESTORATION TO EMPOWER HEALTH EDUCATION ACT OF 2019 General Leave Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and add extraneous material on H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. The SPEAKER pro tempore (Mr. Trone). Is there objection to the request of the gentleman from New Jersey? There was no objection. The SPEAKER pro tempore. Pursuant to House Resolution 377 and rule XVIII, the Chair declares the House in the Committee of the Whole House on the state of the Union for the consideration of the bill, H.R. 987. The Chair appoints the gentleman from Rhode Island (Mr. Langevin) to preside over the Committee of the Whole. {time} 1229 In the Committee of the Whole Accordingly, the House resolved itself into the Committee of the Whole House on the state of the Union for the consideration of the bill (H.R. 987) to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, with Mr. Langevin in the chair. The Clerk read the title of the bill. [[Page H3854]] The CHAIR. Pursuant to the rule, the bill is considered read the first time. General debate shall not exceed 90 minutes, with 60 minutes equally divided and controlled by the chair and ranking minority member of the Committee on Energy and Commerce, and 30 minutes equally divided and controlled by the chair and ranking minority member of the Committee on Education and Labor. The gentleman from New Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each will control 30 minutes, and the gentleman from Virginia (Mr. Scott) and the gentlewoman from North Carolina (Ms. Foxx) each will control 15 minutes. The Chair recognizes the gentleman from New Jersey. Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise to speak in favor of H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. This legislation, Mr. Chairman, is a big step in our commitment to delivering on our promise to make healthcare and prescription drugs more affordable. It brings together seven bills that passed out of the Energy and Commerce Committee last month. Taken together, these bills will strengthen our Nation's healthcare system, reverse the Trump administration's sabotage of the Affordable Care Act, and help lower the costs of healthcare and prescription drugs. The first title of this bill contains three bipartisan measures intended to address high prescription drug costs by promoting greater competition in our pharmaceutical marketplace. One of the most effective ways to bring down the cost of prescription drugs is to ensure that generics can come to market as soon as possible. The first proposal would address so-called exclusively parking, a practice where a first-time generic is blocking the approval of other generics from entering the market. The second proposal prohibits the use of pay-for-delay agreements between brand and generic drug manufacturers that delay generic entry into the market. And finally, the third drug pricing measure would address situations where some brand drug companies are delaying or impeding generic entry by denying generic drug manufacturers access to samples or to single, shared system REMS. By eliminating these three barriers, we will prevent some manufacturers from manipulating the system to extend their monopolies at the expense of consumers, and this will make prescription drugs more affordable for all Americans. Now, the second title of this bill, Mr. Chairman, will help lower Americans' healthcare costs, protect people living with preexisting conditions, and reverse some of the most harmful actions the Trump administration has carried out to sabotage the Affordable Care Act. Two of the proposals will restore funding for the navigator program and outreach and enrollment efforts that help provide consumers with the support and information that they need to make the right healthcare decisions for their families. Restoring this funding is critical, considering that the Trump administration gutted funding for consumer outreach and marketing by 90 percent. It cut navigator funding by 80 percent, leaving huge swaths of the country without access to fair and unbiased enrollment help. H.R. 987 will also provide States with funding to establish their own State-based marketplaces, which will help make healthcare more affordable. In 2018, premiums in these State marketplaces were 17 percent lower than in the federally facilitated marketplace, and enrollment was higher for the State plans. And, finally, Mr. Chairman, H.R. 987 will reverse the Trump administration's regulation to expand junk insurance plans, known as short-term limited duration health insurance. The Trump administration expanded these junk plans from the current 3-month term and made these plans available for up to 3 years. These junk plans are exactly that, Mr. Chairman: They are junk. They discriminate against people with preexisting conditions. They set higher premiums for people based on age, gender, and health status. They deny access to basic benefits like prescription drugs, maternity care, and mental health and substance abuse treatment, and they set arbitrary dollar limits for healthcare services leading to huge surprise bills for consumers. This legislation would prevent the administration's expansion of these plans from taking place. In closing, Mr. Chairman, I believe this is an important bill that will lower healthcare and prescription drug costs, protect people with preexisting conditions, and end some of the administration's ongoing sabotage of our Nation's healthcare system. Mr. Chairman, I urge my colleagues to support this bill, and I reserve the balance of my time. Mr. WALDEN. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, The Washington Post said it best. Allow me to quote this headline from yesterday: ``Democrats Are Putting a Political Pothole in the Way of Bipartisan Drug Pricing Bills.'' It didn't have to be this way. Americans want us to come together, work together, solve problems. This is a big one. I hear about it every time I am home, and I have done more townhalls than anybody in this House--20 of them so far this year. Drug pricing is a big issue. We actually agreed. We worked it out. We passed these bills out of committee, unanimously. And then somewhere along the path to the House floor, they jammed our bipartisan efforts to lower drug costs with clearly partisan bills. The chairman didn't mention those bills came out of committee on a partisan vote. To bail out ObamaCare, Democrats are once again putting politics and partisanship over what could have been bipartisan public policy. Republicans and Democrats have been working together on bipartisan legislation to bring generic drugs to market faster by incentivizing more competition and ensuring patients get the earliest possible access to more affordable prescription drugs. We agree on that, just as we did in the last Congress when I was chairman. We led the effort to revamp every part of the FDA and how they can get drugs to market sooner. As a result of our work there and in our bipartisan work before that on 21st Century Cures, we really ramped up the ability of the FDA to get competition and new drugs into the market. They set a record last year in getting generics to market as a result of our bipartisan work. We could have had that, today, on this floor. The first measure that we do agree upon would ensure branded drug makers do not withhold samples that are needed to get generic drugs approved; the second would ban pay-for-delay agreements; and the third would limit first-approved generic makers' ability to stall another rival's launch. So we put a stop to what I would say are bad behaviors in that process. Together, these bills would help patients actually get access to more affordable prescription drugs, and those bills are bipartisan. Just how bipartisan? Two of the bills passed the Energy and Commerce Committee by voice vote, and the third passed unanimously on a 51-0 vote. Now, Mr. Chair, this is how the American people expect us to get our work done, but, sadly, House Democrats once again could not pass up a chance to play gotcha politics. So what did they do? They packaged these agreed-to bipartisan drug pricing proposals with a bailout of ObamaCare that passed out of committee on a purely partisan vote. Now here is what that bill contains: First, $200 million a year in taxpayer funding for States to establish ObamaCare marketplaces. This funding expired 5 years ago, albeit not before hundreds of millions of Federal taxpayer resources were wasted, including in my own State that finally had to give up on that and go with a national plan. New Jersey has recently expressed an interest in creating a new State exchange, and they say they can do it without new Federal taxpayer money; they can do it without us. If a State decides to create an exchange, then they shall be allowed to do so, but we don't need to create new Federal grants for things that States say they have the capacity to do themselves. [[Page H3855]] Second, $100 million a year--$100 million a year--to fund the navigator program. Now, for plan year 2017, navigators received a total of $62.5 million in grants, and they enrolled 81,426 individuals. That means it cost $767 per person that they enrolled, and that accounted for less than 1 percent of the total enrollees. Now, it is important to understand, by contrast, agents and brokers assisted 42 percent of those in the enrollment year of 2018. Do you know what it cost for them to do it? $2.40. Yet, under this law, you can't use the funds for the navigators to actually pay for those folks, the brokers and agents, to do this work that they do very efficiently. $767 per enrollee versus $2.40. Third, the bill reverses the administration's efforts to allow more State-regulated insurance plan options for consumers who, frankly, are getting priced out of the market and are looking for choices that fit them and their lives. I want to set the record straight on these plans. The plans you heard described earlier were actually legal under ObamaCare and the Obama administration, and they are legal under the Trump administration. They provide choices to people in between jobs or people who can't afford these exploding premiums. You know, the promise that your premium is going to go down 2,500 bucks kind of evaporated as soon as the bill became law, so people are stuck with ever-increasing premiums, enormous deductibles, and saying: Could we please allow our States to put together options for us that still have to go through a State insurance regulator? And they certainly care about their systems. CBO projected premiums for these plans could be as much as 60 percent lower than the cheapest Federal mandated plan, 60 percent, and, even more, States can regulate these plans. In fact, in the chairman's home State of New Jersey, they are simply banned. That is New Jersey's choice. They should have that choice. In my home State of Oregon, they are limited to 90 days. That is what we have chosen. This is kind of federalism at its best. But in their Washington-knows-best mentality, the bills brought before us today strip away this option for longer term plans, and that is wrong and it is unfair. Fourth, the bill spends $100,000,000 a year to market the Federal plans. They couldn't stop there. Instead of educating patients on all the plans' options available to them, their legislation actually places a gag order on the promotion of more affordable choices, specifically association health plans, known as AHPs, and the short-term limited duration insurance plans. You can't even tell consumers about that. Oh, no. We are going to have a gag order from Washington. So there is simply no reason to combine these bills with our bipartisan, I would say unanimously approved, bills to deal with drugs. Energy and Commerce Republicans put forth an alternative bill that includes all of H.R. 987's bipartisan drug provisions I referenced earlier but removes the partisan, the strictly gotcha provisions. Our pragmatic plan replaces these partisan provisions with language extending funding for community health centers, the National Health Service Corps, and other public health extenders for a year. Now, these public health extenders should be a top bipartisan priority for the Congress, as they must be done before the end of the fiscal year, the end of September, and they deserve the attention of Congress. Let me go back to the navigators for a minute. The Wall Street Journal reported: ``One grantee took in $200,000 to enroll a grand total of one person.'' They went on to write: ``The top 10 most expensive navigators collected $2.77 million to sign up 314 people.'' If you take that $2.77 million that they want to give to these navigators--they are the most expensive operators on the planet--to sign people up for insurance and gave that to our community health centers, do you know how many people they could cover with $2.77 million? One estimate is 20,000 patients--20,000 patients. So Republicans are saying let's take that money and actually get it out to help patients through our community health centers rather than spend it on navigators that can take $200,000 and enroll one person, or $767, on average, versus $2.40 when agents and brokers do this enrollment. We think we have a better way. Our bill, H.R. 2700, is called the Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act. It is pretty straightforward. It is an honest title. We should take this bill up now, Mr. Chairman, because the majority, unfortunately, has decided to put politics before us today with our bipartisan efforts to lower drug costs. The bill before us right now is going nowhere in the Senate. They have said that. The White House has weighed in, so they don't like it either. We should take up the alternative to move our bipartisan work forward and take care of our responsibilities to ensure our community health centers and other public health priorities are funded. That has always been a bipartisan effort. Finally, just to further the point on the blatant and unnecessary partisanship on display here today, House Democrats made 26 amendments in order on this bill--26. One of those amendments, just one, was authored by a Republican. Now, they control everything around here, and they said in the opening days they are going to open up this process. Ninety-two percent of the amendments allowed to be brought to the floor so far this year have been from Democrats. When we were in charge, 45 percent--45 percent--were the minority's amendments that came to the floor. So, so much for openness. Just one was authored by a Republican. So it is unfortunate we find ourselves here today. It didn't have to be this way. {time} 1245 These are measures, especially on the drug side, we are already all in agreement on. If they were separated out, you would have passage. It would go right to the President from the Senate. I think they would take them up and pass them to become law. So, when the majority is ready to make law, let us know. In the meantime, we have a better way to take care of our community health centers, our patients, and those seeking more choices and more affordable rates for an insurance product than what the Federal Government is mandating. Mr. Chairman, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from South Carolina (Mr. Clyburn), our distinguished whip. Mr. CLYBURN. Mr. Chairman, I thank the gentleman for yielding me the time. Mr. Chairman, today, I stand for the American people and the voters of South Carolina's Sixth Congressional District who spoke loud and clear last November, demanding that Congress defend and uphold the right to have access to affordable care. This is an effort to dismantle the Affordable Care Act, and we stand ready to defend every aspect of this legislation. We will not stop our efforts to hold this administration and my Republican colleagues accountable as they continue misrepresenting and undermining the Affordable Care Act. The work of this body, a coequal branch of our government, to conduct legitimate and lawful oversight in order to protect Americans' access to healthcare will not be deterred. Today, this House will vote on a package of seven bills that will halt the administration's sabotage of the Affordable Care Act, improve the act's implementation, and lower the cost of prescription drugs. This legislative package, titled the Strengthening Health Care and Lowering Prescription Drug Costs Act, prevents the substitution of junk policies that take advantage of unsuspecting citizens, and it protects against discrimination for preexisting conditions. The CHAIR. The time of the gentleman has expired. Mr. PALLONE. Mr. Chairman, I yield an additional 30 seconds to the gentleman from South Carolina. Mr. CLYBURN. Mr. Chairman, this legislation takes meaningful steps to control prescription drug costs by expanding access to generic drugs so patients don't have to choose between [[Page H3856]] lifesaving medications and other necessities, like rent or food. Mr. Chairman, Democrats are addressing crucial healthcare needs. We stand to protect the healthcare of American citizens. Mr. WALDEN. Mr. Chairman, I yield 2 minutes to the gentleman from Kentucky (Mr. Guthrie), a very accomplished member of our committee. Mr. GUTHRIE. Mr. Chairman, I rise today in opposition to H.R. 987, the supposed Strengthening Health Care and Lowering Prescription Drug Costs Act. I wish I wasn't giving this speech. As many of my colleagues know, I have a bipartisan track record here in the House. I have been proud to work with many of my Democrat colleagues on a number of issues that impact Kentuckians and people across the country, such as Alzheimer's, the opioid crisis, and workforce development. Last Congress, I had 10 bipartisan bills signed into law, and I had two additional bipartisan bills pass the House. I hope my colleagues on both sides of the aisle know that I take bipartisanship and our responsibility to get things done for our constituents very seriously. That is why I am extremely disappointed that I will have to vote against H.R. 987 today. Wherever I go in my district, I hear from Kentuckians about how drug prices are simply too high. This an issue that affects everyone, and it is one of the few big issues these days that Republicans and Democrats can all agree on. And President Trump has made this a priority. As ranking member of the Oversight and Investigations Subcommittee, I have launched, with Chair Diana DeGette from Colorado, an investigation on rising insulin prices. I was proud to support bipartisan legislation in the Health Subcommittee and the full Energy and Commerce Committee. Sadly, Mr. Chairman, Democrats have loaded up what was previously a bipartisan drug pricing legislative bill with political land mines that they know we, as Republicans, will never support. They made a bipartisan drug pricing bill into an ObamaCare bailout bill. They know that this bill is dead on arrival in the Senate and that President Trump will never sign it. My colleagues are playing games to score cheap political points in the short term at the expense of Americans across the country who are paying too much at the pharmacy counter. I urge my colleagues on the Democratic side not to make lowering drug prices another partisan fight. I am willing to work with any of my colleagues to fix this problem, and I urge all my colleagues to do the same. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Illinois (Mr. Rush), the sponsor of the pay-for-delay legislation. Mr. RUSH. Mr. Chairman, I thank the full committee chairman for giving me this time. Mr. Chairman, I am proud, on behalf of the people of the First District of Illinois, to rise today in support of H.R. 987, which includes my legislation, the Protecting Consumer Access to Generic Drugs Act. My legislation included in today's package prohibits the practice of pay-for-delay where brand-name companies compensate generics to prevent the entry of cheaper drugs into the market. I have long stood against these anticompetitive deals that limit competition and force consumers to pay more for their medications. This disgraceful and deceptive practice ends now. I stand with my colleagues to stop drug companies from continuing to rig the system in an attempt to take advantage of hardworking Americans. My legislation will take a meaningful step toward bringing this behavior to a screeching halt and holding drug companies accountable once and for all. With today's package of prescription drug bills, we are making progress toward addressing the skyrocketing cost of prescription drugs and are making good on our promise that no American should be forced to make the choice between paying their bills and buying their pills. Mr. WALDEN. Mr. Chairman, I yield 4 minutes to the gentleman from Texas (Mr. Burgess), our top Republican on the Health Subcommittee, a former chairman of the subcommittee, and a distinguished member of the Rules Committee. Mr. BURGESS. Mr. Chairman, I thank the gentleman for yielding, and I do rise today to speak in opposition to H.R. 987. Mr. Chairman, I am concerned that the Democrats are using bipartisan drug pricing bills to pay for partisan politics. Look, these bills are proof that we can work together across the aisle and do what is best for constituents. Unfortunately, as The Washington Post so eloquently said yesterday in ``The Health 202,'' ``Democrats are putting a political pothole in the way of bipartisan drug pricing bills.'' The Democrats have decided to use $5 billion in savings to fund State-based ACA marketplaces, the federally facilitated marketplace navigator program. This morning, a publication called STAT published an article titled, ``In Washington, a partisan approach to lowering drug costs leaves Democrats doubting their own party leadership.'' As this article reported, even House Democrats do not understand why the Speaker of the House and party leadership have decided to politicize bipartisan bills that enjoy widespread support. The chairwoman of the Energy and Commerce Health Subcommittee is on record as saying she was ``not a fan of what happened.'' Republicans stand ready to work on solutions. Congressman Mark Meadows, the chairman of the Freedom Caucus, told STAT that the Democrats' political stunt is a wasted political opportunity. He continued, ``You have got the chairman of the Freedom Caucus willing to work with Democrats on making real, structural reforms on prescription drug prices. And what do they do? They put a poison pill in, trying to augment a failing healthcare-delivery system.'' I ask my friends on the other side of the dais, why are you intent on tanking good legislation that can deliver real results for real people? You say you want to lower drug prices, but your actions speak loudly otherwise. Fortunately, I am not just here to complain. I also have a solution to the scenario we are facing on the floor today. On Tuesday night at the Rules Committee, I offered an amendment that would take these three drug policies and the $5 billion in savings from those policies, and I introduced H.R. 2700, the Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act. H.R. 2700 couples the bipartisan drug pricing policies with reauthorization programs, such as Community Health Centers and Special Diabetes Programs. Look, reauthorizations are tough. I know. I was chairman of the Health Subcommittee in the last Congress. September seems like a long way away. Many of these programs expire at the end of the fiscal year, but the time to get these things done is now. We have taken no specific action toward reauthorization of these programs. Again, September seems far away, but we have to account for the time it takes to move through regular order. On the other issues that we are facing today, the short-term, limited duration rule repeal, according to the Congressional Budget Office and the Joint Committee on Taxation, the policy to repeal the Trump administration's short-term, limited duration insurance rule would result in 500,000 individuals becoming uninsured. Is this what you want? Isn't it better that people have some form of insurance than none at all? I take meetings in my office back home in my district with families that cannot afford the high premium, high deductible plans that they have been forced to buy off the ACA exchange. These individuals need lower cost options, and that is exactly what these limited duration plans provide. States already regulate these plans and have the authority to disallow them at the State level, if they so choose. This is a case for federalism. I want to quote from the Congressional Budget Office report: ``CBO and JCT estimate that enacting the legislation would result in roughly 1.5 million fewer people'' participating in insurance plans. The CHAIR. The time of the gentleman has expired. [[Page H3857]] Mr. WALDEN. Mr. Chairman, I yield the gentleman from Texas an additional 30 seconds. Mr. BURGESS. Mr. Chairman, I thank the gentleman. Of those, more than 500,000 would instead participate in nongroup coverage through the marketplaces established by the Affordable Care Act, and 500,000 would become uninsured. The drug policies contained in both H.R. 987 and my bill, H.R. 2700, are commonsense bipartisan measures to lower drug prices for our constituents. I am disappointed they have been rolled into a partisan package that will be dead on arrival in the Senate. We were able to work together in the committee and subcommittee to ensure these policies would improve access to generics for American patients. I hope the Democratic leadership would consider the bipartisan nature of the policies when moving the packages to the floor in the future. The CHAIR. Members are reminded to address their remarks to the Chair. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ to the gentlewoman from Illinois (Ms. Schakowsky), who chairs our Consumer Protection and Commerce Subcommittee. Ms. SCHAKOWSKY. Mr. Chairman, the real political grandstanding that we are hearing today is from the Republican side of the aisle, which for nearly 10 years has been fighting against the Affordable Care Act. Over 60 times, they voted against the Affordable Care Act. Maybe it is because some people call it ObamaCare. We know that millions and millions of people have gotten healthcare because of it. It is time to stop and to say let's work together to make the Affordable Care Act even better and extend access. The fact is that the Affordable Care Act and affordable prescription drugs are two pillars of healthcare access. They really cannot be separated. I am proud that we have an opportunity today to do what was impossible while the Republicans were in charge of the Congress. Today, we are voting on making impactful, lasting change in lowering the cost of healthcare, including prescription drugs, for Americans nationwide. Democrats are at the table and ready to pass this legislation. {time} 1300 We are ready to improve all aspects of healthcare from healthcare affordability, to prescription drug affordability. Instead of offering amendments in bad faith, we need to pass this bill. Mr. Chair, I urge all of my colleagues to reject the amendment by Mr. Bucshon and support the passage of H.R. 987 in its entirety. Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume. Mr. Chair, before I recognize our pharmacist, Mr. Carter from Georgia, I just want to say I have been on the floor a lot in the last few weeks on this issue, and we keep getting the same refrain about Republicans voting 60 times to repeal ObamaCare. What is never said is that 30 of those bills, my friends on the other side of the aisle voted for, and President Obama signed them into law-- I'm sorry. Twenty-one of those bills were signed into law by President Obama. So it is 21 of the 30 were signed into law by President Obama. So my point being is, ObamaCare had problems. We came together and tried to address those problems with this legislation, repealing the unsustainable CLASS Act, the co-ops, the Cadillac and medical device taxes we voted to delay, the Independent Payment Advisory Board, and on and on. My friends on the other side of the aisle voted with us and we with them to fix those sorts of things. So don't come down here and tell me it is only Republicans who voted to do things on ObamaCare. We also support these drug bills. There is no question about that, because we want to get lower-cost drugs and stop bad behaviors that prevent generics from coming to market sooner. Mr. Chair, I yield 3 minutes to the gentleman from Georgia (Mr. Carter), a pharmacist. Mr. CARTER of Georgia. Mr. Chair, I thank the gentleman for yielding. Mr. Chair, I come before you today a very disappointed person; a disappointed Member of Congress; a disappointed pharmacist. I am disappointed that my Democratic colleagues have decided to prioritize politics over patients by packaging together bipartisan bills to lower drug costs with partisan bills to bail out ObamaCare. They are two completely different subjects. Republicans and Democrats have worked hard to create strong, bipartisan bills that will increase the amount of generic drugs entering the marketplace, bringing more affordable choices to patients. Now, House Democrats have chosen to use these bipartisan bills to pay for partisan ObamaCare bills. This bill includes major drug pricing proposals like the CREATES Act, and the pay for delay, which both seek to increase the ability of lower-cost generic drugs getting to the market quickly, providing patients with more affordable choices. We had long, hard-fought negotiations with our Democratic counterparts in multiple markups that ran until midnight over these two proposals, but we were eventually able to come to an agreement. The other drug-pricing bill in this package is a bill that I have worked on with my friend, Representative Schrader from Oregon, the BLOCKING Act. This bill mirrors the proposal from President Trump's budget proposal to keep bad actors from clogging up our generic drug pipeline. Hear me, Mr. Chair, and hear me clearly. This bill is the picture- perfect definition of good bipartisan legislation. Democrats are throwing that work away by prioritizing politics over patients. All three of these bipartisan drug-pricing bills save money, so the Democrats are choosing to use their hard-fought savings and wish lists for partisan politics. The bill before us today will throw hundreds of millions of dollars at the failed ObamaCare marketplace and further restrict patient choice. The bottom line is, there is no need for this course. Drug pricing should not be a partisan issue. In all of my years of being a pharmacist, I have seen patients struggle with the high cost of prescription drugs. Now that I am in Congress, I hear about it all the time from my constituents back home. We all do. Voters across the country sent us up here to work together on issues, like drug pricing. The three drug-pricing bills in this package show that we can, in fact, do that. We can work together on important issues. When we work together, we can achieve real results that help patients. But once again, we are letting politics become the priority instead of helping people. Republicans want to work together on drug pricing. The people want us to work together on drug pricing. I call on my colleagues to do the right thing. Let's put patients before politics. Mr. Chair, this is important. Strike these partisan poison pills in this bill and send our excellent drug-pricing work over to the Senate and on to the President's desk and have him sign them into law. Mr. PALLONE. Mr. Chair, I yield 1 minute to the gentleman from Maryland (Mr. Hoyer), our distinguished majority leader. Mr. HOYER. Mr. Chair, if you put patients before politics, you will vote for this bill because patients care about prescription drugs, but they also care about access to affordable, quality healthcare. Now, you sent a bill to the President--or you didn't really send it to him because it didn't pass the Senate--and you went down to the White House and you exalted about the bill you had passed, and the President said: This is a good bill. Then he had the opportunity to, perhaps, have his advisers tell him what was in the bill, and 10 days later he said: This is a mean bill because it shortchanged patients for politics. Mr. Chair, last week the House passed H.R. 986, a bill to protect coverage for those with preexisting conditions, and the Republicans said: No, it doesn't do that. They wanted to change the name of the bill. Not only did they want to vote against it, they wanted to change the name of the bill. Why? Because they want to tell the public we [[Page H3858]] are for protecting you against preexisting conditions. We just don't vote that way. This week House Democrats are continuing to strengthen access to affordable healthcare by passing H.R. 987, an additional package of bills aimed at strengthening our healthcare system and lowering prescription drug costs because patients don't just worry about prescription drugs, they worry about their health coverage. As a matter of fact, it is hard to separate the two. This effort is critical because the Trump administration, in its campaign and from its very first day, and congressional Republicans, have been working tirelessly to sabotage healthcare access and undermine the reforms of the Affordable Care Act. They voted against it and, yes, they voted over, and over, and over again to repeal it. With all due respect to my friend, we didn't vote for those bills. Now, we may have voted for some bills to improve the Affordable Care Act, but we certainly didn't vote for any of your bills which had the effect of repealing ObamaCare, because we believe it is in the best interest of the American public, and so does the majority of the American public. Last year, 1.1 million Americans lost health coverage after years of gains in coverage. This shows us, dangerously, that the Trump administration's administrative sabotage is having its intended adverse effect, from limiting access to open enrollment, to allowing junk plans. Let me say something about junk plans because the gentleman says: Well, some people can't afford it. Yes, they get a plan and they think they have health coverage, and by the way, it doesn't cover something when they get really ill, or they have lifetime limits, or annual limits. They don't have this covered. They don't have the other covered. Not only that, but guess what happens to the insurance pool? It becomes riskier. And guess what happens then? The price goes up. You don't have to be a genius or know much about the insurance business to know that that is the case. From repealing votes in Congress, to anti-ACA lawsuits in the courts, Republicans have been trying to undermine the Affordable Care Act. From shortening enrollment periods, to cutting funding for outreach to let people know what is available to them and what is the best policy for them. Advice and counsel, they don't have to take any of it, but they ought to have that available to them. This sabotage is hurting access to affordable, quality healthcare coverage for the people. That is what we are here for. For the people. And that is what this legislation is for. For the people. The legislation before the House today would push back on these efforts that sabotage in several ways: first, we are banning junk plans that don't provide adequate coverage and raise premiums for comprehensive health plans. Next, we are taking action to bring generic drugs to market more quickly, helping to lower the cost of prescription drugs. I appreciate the fact that my Republican colleagues support those bills. I appreciate the gentleman who knows full well as a pharmacist the crisis that confronts people when they can't afford lifesaving and health- enhancing prescription drugs. But they also are facing real problems on the availability of health insurance should they have to have health providers, whether they are doctors, or hospitals. Finally, H.R. 987 increases funding for outreach, enrollment, and navigators to help Americans find the right healthcare plan. That is for the people, to help the people understand, and to have access, and to be secure in knowing they have adequate healthcare for them and their families. It also provides States with additional funding to establish State- based marketplaces. Innovation. Our legislation will provide insurers, providers, and patients alike with greater certainty that the Affordable Care Act will continue to make healthcare available and affordable to Americans with preexisting conditions. I am pleased that my Republican colleagues are supporting the prescription drug titles of this bill. Perhaps we will send it over to the Senate, and maybe that is all they will send back. But the fact of the matter is, we have a broader responsibility than just prescription drugs. Democrats are committed to bringing healthcare costs down and making sure more Americans can access quality, affordable coverage. Mr. Chair, I want to thank Representatives Cicilline, Rush, Schrader, Castor, Kim, and Blunt Rochester for their leadership in the component parts of this bill, which will make the security for healthcare better for the people. They have introduced the constituent parts of this bill. Of course, I want to thank my good friend, Frank Pallone. Nobody has worked harder for a longer period of time to enhance the healthcare of Americans. Nobody has worked harder in committee, both initially on the Affordable Care Act, of which he was a very significant part of the authorship, and since then in protecting it and trying to enhance it. This bill is important for us to pass to do just that. That is why I urge my colleagues on both sides of the aisle to join us in standing up for the Affordable Care Act and its benefits; not undermining the law and its reforms. Having agreement on prescription reforms, bringing prices down, and making generics more available is an important step. But it is not the only step that we need to take. This is not the final step. This is a step. It is an important step. I hope that Republicans and Democrats would support this bill overwhelmingly because, as I said, it is for the people. The CHAIR. Members are reminded to address their remarks to the Chair. Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume. I want to make a couple of points before I introduce the author of the CREATES Act. The gentleman that just spoke, Mr. Hoyer, voted 21 times, on 21 of the bills that were signed into law to repeal parts of ObamaCare. The gentleman voted for it because those parts were unworkable. So when you hear about 60 times, remember the leader, the distinguished leader, my friend, actually voted for 21 of those, as did I. When we talk about the people, let me read you a little statement from Tom from Medford who wrote me in October of last year. He said, ``Greg, I just received a letter from the insurance company stating their monthly premium next year will go up nearly 40 percent, from $632 to $883 per month, and that is with the plan more or less staying the same, but without any out-of-network healthcare.'' {time} 1315 That is not affordable. That is why we think States should have options. When it comes to the navigators that they want to dump all this money into, remember agents and brokers in the private sector cost about $2.40 for them to sign somebody up. The navigators would cost, based on 2017 numbers, $767 per enrollee. And for the $2.7 million that was spent to sign up 314 people, if you put that money--as Republicans want to do--into community health centers, one estimate is you could cover 20,000 people with that $2.77 million. Mr. Chairman, I yield 2 minutes to the gentleman from Wisconsin (Mr. Sensenbrenner). My friend is the former chairman of the Judiciary Committee and the former chairman of the Science, Space, and Technology Committee, and a leader on this CREATES effort legislation on bringing drug prices down. Mr. SENSENBRENNER. Mr. Chairman, I rise in opposition to H.R. 987, the ObamaCare bailout act. One of the things that has frustrated me in the almost 5 months that the Democrats have controlled this Chamber is that anything that is good, bipartisan, and for the people they turn into a partisan screaming contest. That is exactly what they have done with the CREATES Act, which will bring down prescription drug prices and has strong bipartisan support in both Houses and, as a standalone bill, would have a very good chance of being signed into law. So we can talk today about all of these things about ObamaCare that the other side of the aisle wants to put more money into, but that is going nowhere. I think what we should do is look at what we can accomplish, and we can accomplish changing the way that drugs are priced through the CREATES Act. [[Page H3859]] At a time when everything is a dramatic political battle, lowering prescription drug prices is one of the few opportunities where it seemed like Republicans and Democrats could get something meaningful done for the American people. Just a few weeks ago, the Judiciary and Energy and Commerce Committees worked across the aisle unanimously reporting out several bills to that end. My friend, the gentleman from Rhode Island (Mr. Cicilline), and I are sponsors of one of those bills, the CREATES Act. Our commonsense legislation would allow consumers to access cheaper generic drugs sooner, driving down costs and saving taxpayers money. According to CBO estimates, our bill would save the American taxpayer $3.9 billion over 10 years. This bill has the kind of bipartisan support to become law. However, instead of letting this body vote on our commonsense bill in standalone form, the Democratic leadership has tacked it on to this ObamaCare bill. The CHAIR. The time of the gentleman has expired. Mr. WALDEN. Mr. Chairman, I yield an additional 30 seconds to the gentleman from Wisconsin. Mr. SENSENBRENNER. The ObamaCare bailout package has no chance of passing in the Senate. The majority leader just admitted that. This is a missed opportunity, and it is highly disappointing. The American people want us to work in a bipartisan manner. The American people want us to accomplish things, and this is a poison pill that will make sure that this bill never sees the light of day in the Senate and will never become law. When they take up this bill, I hope they strip out all the ObamaCare bailout--free of poison pills--and pass the bipartisan drug pricing bills so the House will be able to reconsider them in a more bipartisan fashion. Mr. WALDEN. Mr. Chairman, I yield myself such time as I may consume to reinforce what the gentleman from Wisconsin said. This is from The Washington Post: ``The Health 202: Democrats Are Putting a Political Pothole in the Way of Bipartisan Drug Pricing Bills.'' That is all you need to know. It didn't have to be this way. These bills came out of the committee individually. The Democratic leadership put them together knowing full well they could put a poison pill into a drug reform bill and delay consumers' ability to get more affordable drugs sooner, because this legislation could move through the Senate and down to the President much more quickly if it didn't have these provisions. Mr. Chairman, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1 minute to the gentlewoman from California (Ms. Matsui). Ms. MATSUI. Mr. Chairman, I rise today as a proud cosponsor of H.R. 987, legislation that advances Democrats' commitment to rein in the soaring costs of healthcare for consumers. I am pleased that we are taking important steps forward to address an issue I hear from constituents almost daily: the rising cost of prescription medicines. Just recently, I heard from Mary, who is living with a lifelong chronic condition. The cost of her medication has skyrocketed in recent years to the point that it has forced her to cancel prescriptions and forgo treatment. This is really unacceptable. The bills before us today represent an opportunity to make progress by allowing lower cost generic drugs to come to market sooner. Furthermore, these efforts aim to make healthcare more affordable for patients with preexisting conditions by reversing the Trump administration's relentless and ongoing sabotage of the ACA. This is critical for people like Charis, a constituent in my district who fears that, without the ACA, she would have to hide her rare disease in order to get adequate medical care. No patient should have to live with such a worry. I am pleased to be able to support these patient protections on the floor today, and I remain committed to keeping the pressure on tackling prescription drug and insurance costs and working to defend Americans' rights to quality and affordable healthcare. Mr. WALDEN. Mr. Chairman, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Vermont (Mr. Welch). Mr. WELCH. Mr. Chairman, this legislation is going to help make healthcare more affordable and more accessible. There are two things: One, we finally are attacking the explosion in the cost of prescription drugs, and I thank my Republican colleagues for participating in that effort. In Vermont, we just had a 16 percent rate increase for requests from Blue Cross Blue Shield, and 9 percent of that is attributable to the increase in pharma costs. This is happening because pharma has been ripping us off for far too long. This bill does two things: One, it ends their abusive, outrageous practice of paying generic companies to delay bringing their lower cost drug to the market. There is no excuse for that. This bill ends it. The second thing it does is deny pharma the opportunity to withhold samples so that generic companies can come up with a competitive product. That is tremendous, it is overdue, and it is just the beginning. Second, this makes healthcare more accessible by funding navigators. My colleagues disregard that, but, in fact, navigators help people make the complicated decision about what is the best healthcare plan for them. It also provides money for outreach. We want folks to know what is available for them, make the best choice, and have the security of healthcare. Finally, there will be protection for the auto enrollment program. Everybody is busy. If the default position is you are back in the plan you had, that is good. There is security in that. People can make options to get out or to change their plan. We want them to shop. This makes healthcare affordable and more accessible. Mr. WALDEN. Mr. Chairman, I yield myself such time as I may consume to thank the gentleman from Vermont for not only his comments here on the floor, but his comments publicly about what we agree with, which is these issues should have remained separate and not lumped together. Mr. Chairman, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Florida (Ms. Castor). Ms. CASTOR of Florida. Mr. Chairman, Democrats are doing everything that we can to lower the cost of healthcare and prescription drugs, so I strongly support the act that is on the floor today. It contains two bills that I authored. First is H.R. 1010, which prohibits the expansion of these junk insurance plans. Junk insurance plans are the ones that do not cover preexisting conditions. You can often be tricked into buying one of these plans and find out it doesn't even cover the trip to the hospital. In fact, I asked Secretary Azar, in committee, about this. I asked him: You are aware that these junk plans do not cover preexisting conditions? He said: That is correct. The bill also contains another section that I authored, the ENROLL Act, to restore funds to our independent navigators who are helping American families choose the right health insurance options for them. Agents and brokers are important, but they are no substitute for independent navigators who are trusted in the community. We have got to pass these bills today to lower healthcare costs for families all across the country and lower prescription drug costs. I am very proud to have authored two portions of this. Let's not let them expand these junk plans and leave you on the hook. Let's make sure that families have the independent advice that they need to choose what makes the most sense for them. Mr. WALDEN. Mr. Chairman, I will say that the State of Florida actually allows State-regulated plans to go up to 364 days to give Floridians an opportunity to have choice. When it comes to association health plans that allow small businesses like I used to own to get together and offer more affordable health insurance, they put a gag order on so that you can't tell America's patients they might have that option. So, Mr. Chairman, I don't know that I would fully trust all these navigators. According to The Wall Street Journal, one grantee took in $200,000 of your tax dollars and enrolled one person. The [[Page H3860]] top 10 most expensive navigators collected $2.77 million to sign up 314 people. If you put that $2.77 million into our community health centers, as the Republicans would prefer, to spend that money, then you would cover 20,000 patients, according to one estimate. Mr. Chairman, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Oregon (Mr. Schrader), who is the sponsor of the BLOCKING Act, one of the generic competition bills. Mr. SCHRADER. Mr. Chairman, I rise today in favor of the package of bills before us that includes efforts to stabilize the marketplace and address drug prices, a win-win for America. I am particularly proud to rise in support of one bill in the package, my bill, cosponsored with my good friend from Georgia, Buddy Carter, H.R. 938, the BLOCKING Act. As we are all too well aware, the rising cost of drug prices is deeply impacting every American. At the same time, addressing this issue does not have one big silver bullet solution. The BLOCKING Act is one of many that will address this larger problem. It takes action to ensure that generic drugs reach the market as quickly as possible. Generic drugs save patients tens of billions of dollars every year. The more competition we have in the generic space, the more savings we see. It is with that knowledge that we provide generic manufacturers that incentive of 180 days of exclusivity. Unfortunately, in the current system, some generic manufacturers delay bringing their drugs to market by parking their applications, once being awarded the exclusivity, and not actually bringing their drug to market. Doing so does not allow others to come to the market and extends their hold, to the disadvantage of the American consumer. That being said, a solution is quite simple. We need to prevent loopholes that decrease competition and inadvertently keep drug prices high. I remain committed to working to lower drug prices and urge others to support passage of this package of bills that will assist in addressing this critical issue for America. Mr. WALDEN. Mr. Chairman, my friend from Oregon is right on the drug pieces, and like other Democrats I know, there are a lot of people who think that we should keep these bills separately and they would zoom on through here, but not package them up the way they are. Mr. Chairman, I yield 2 minutes to the gentlewoman from Washington State (Mrs. Rodgers). Mrs. RODGERS of Washington. Mr. Chairman, I thank our Republican lead on the Energy and Commerce Committee for yielding. I appreciate the gentleman's leadership on this important issue. Mr. Chairman, I rise today to voice my support for true bipartisan efforts to reduce prescription drug costs. Seniors, patients, and families in my district and all across America are counting on us so that they can afford their medication and have the certainty that they need. On the Energy and Commerce Committee, we have led. Republicans and Democrats on our committee have been working together on provisions to bring generic drugs to the market faster by incentivizing more competition among generic manufacturers. We recently passed three drug-pricing bills with overwhelming, bipartisan support. These are three solutions that President Trump stands ready to sign, and we should send them to his desk. This is an opportunity to build on the bipartisan work from the last Congress to lower drug costs and keep our promises to the American people. Remember, just last fall, President Trump signed our bipartisan bill to ban the gag clauses so patients can save on prescriptions and trust they are getting the best price. Again, we should build on that work. That is what the people elected us to do; that is what they expect; and that is what they deserve. {time} 1330 So, what has changed, and where are we today? The new majority--at the expense of patients, seniors, and families-- is playing politics with lowering the costs of prescription drugs. H.R. 987 includes our bipartisan bills, but my colleagues across the aisle have packaged them with very partisan bills to bail out ObamaCare. These partisan proposals would restrict access to healthcare coverage and stop the administration's work to reduce wasteful spending on programs that aren't working. The Washington Post called these poison bills a political pothole. We don't need any more political potholes. We need real reforms that the President will sign. This is a ploy, and it is just the latest. The Energy and Commerce Committee has historically been the most bipartisan committee in the House, putting more bipartisan legislation on the President's desk than any other. I am disappointed that we have found ourselves here. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from New Hampshire (Ms. Kuster), who is the sponsor of our Protecting Americans With Preexisting Conditions Act that we passed last week. Ms. KUSTER of New Hampshire. Mr. Chair, I thank Chairman Pallone for yielding and for his guidance and leadership on the Energy and Commerce Committee as we advance critical legislation this week to stabilize the Affordable Care Act and drive down prescription drug costs for all Americans. Mr. Chair, I rise today in support of H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. I rise hand in hand with Granite Staters and all Americans who have been denied care or have been charged more for care because of preexisting conditions. Asthma, allergies, Alzheimer's, cancer, diabetes--you can go right through the alphabet--having a child, these are preexisting conditions. And I believe people should not suffer more when they are at their most vulnerable. Patients should not be discriminated against or treated unfairly when they need help the most. I am committed to reversing the Trump administration's continuous, unrelenting sabotage of the Affordable Care Act that allows and encourages junk health plans. H.R. 987 invests in access to quality care while lowering prescription drug prices. It ensures that generics can come to market as soon as possible so that seniors are not skipping the medication they need because they cannot afford it. I support this legislation because it puts patients first. I thank Representative Lisa Blunt Rochester for her leadership on this bill, and I encourage my colleagues to vote ``yes'' on H.R. 987. Mr. WALDEN. Mr. Chairman, at this point I would reserve the balance of my time to close. Mr. PALLONE. Mr. Chairman, I yield 1 minute to the gentlewoman from California (Ms. Pelosi), our dynamic leader, our Speaker. Ms. PELOSI. Mr. Chair, congratulations. What a joy to see the gentleman in the chair. I thank Chairman Pallone for his extraordinary leadership as chair of the Energy and Commerce Committee and Congresswoman Anna Eshoo, chair of the Health Subcommittee. I thank them so much for all their hard work to bring us to this series of bills today, in addition to the bills of last week. I commend our colleague who just spoke, Ann Kuster, for her important legislation to preserve the benefit of preexisting conditions not being a barrier to access to care and insurance, and also to Lisa Blunt Rochester for her leadership on the legislation before us today to lower the cost of prescription drugs. Mr. Chairman and colleagues, on Sunday we marked Mother's Day, a special tribute to our mothers and also a somber reminder of the days when being a mother--when being a woman--was a preexisting medical condition. As a mother of five, I can speak from some experience as to what an obstacle that could be to access to insurance. Last week, we took action to block the administration's cynical efforts to drag our country back to the dark days of discrimination in healthcare coverage by passing the Protecting Americans With Preexisting Conditions Act. Again, I salute Congresswoman Kuster for her leadership on this, and also our chairman. [[Page H3861]] This is not a fight about legislation that we are gathered about here today. This is about a fight for our lives, the lives of many people affected. I want to take the opportunity to salute a hero, a hero who testified last week on healthcare at the Rules Committee, Mr. Ady Barkan. Ady Barkan is a hero to us. He is a man who suffers from ALS, but, in speaking out for better healthcare, with courage, he testified before the committee 2 weeks ago. Ady said: I was healthy a year ago. I was running on the beach. I am 33 years old. I have an 18-month-old son, Carl. And, out of nowhere, I was diagnosed with ALS, which, as you know, has a life expectancy of 3 to 4 years. No treatment, no cure. Like so many others, Rachael--that is his wife--and I have had to fight with our insurers, which has issued outrageous denials instead of covering the benefits we paid for. We have so little time left together, yet our system forces us to waste it dealing with bills and bureaucracy. That is why I am here today urging you to build a more rational, fair, efficient, and effective system. That was Ady testifying 2 weeks ago. Since then, Ady lost his grandmother, Dina Abramov, and our sympathy goes out to him. Our congratulations to her for having such a magnificent and courageous grandson. But Ady has been here so many times with our Little Lobbyists who have preexisting conditions, with many of the communities that represent people with diagnoses that need prescription drugs and cannot afford them. So, in the coming weeks and months, Democrats will continue our action to strengthen health protections for people like Ady, the Little Lobbyists, and others, because this is life or death. It certainly is quality of life. And now, our Democratic House, today, is proud to pass the Strengthening Healthcare and Lowering Prescription Drug Costs Act, with Congresswoman Blunt Rochester. With this legislation, we are further reducing the price of prescription drugs by promoting competition with generics and reversing the Republican sabotage that we have seen. Mr. Chair, when we passed the Affordable Care Act, it was absolutely necessary that we do so. Even if everyone in our country approved and loved their insurer and was happy with their healthcare--which was not the case, but even if they did--it was essential that we pass the Affordable Care Act because we could not sustain the costs of healthcare in our country at the time: the cost to an individual; to a family; to a small business; to corporate America, who was paying a big part of the bill; and to the public sector, was a tremendous burden. With the Affordable Care Act, we were able to lower the rate of increase of healthcare costs in our country. But one sector, one segment of the healthcare arena that we did not conquer was the cost of prescription drugs, which continues to contribute to the increase of healthcare costs in our country. That is the main reason healthcare costs rise: the cost of prescription drugs. So, I salute the chairman and the committee and Anna Eshoo, chair of the subcommittee, and our distinguished chairman of the full committee for his legislation today which helps to lower the cost of prescription drugs to people, to individuals, to families, to everyone who has a part in funding the good health of the American people. This is really essential. And it is a fight. And it is a fight, but we are taking it one piece at a time. The reason it had to be combined with other bills is so that it could be paid for. Our Republicans salute the first part of the bill where we encourage competition among generics and this, that, and the other, but want to walk away from the part of the bill that is essential for paying for the legislation. So, we want to be very, very responsible in all of this. One of our colleagues on the floor earlier said that this bill was going to go die in hell or someplace. I don't know where. Actually, the distinguished--well, not so in this case, but the Republican leader of the Senate has said that he is the grim reaper and all these bills will die, designating the Senate a graveyard for legislation that would help the good health of the American people, lower costs for them, improve their lives. But he talked about everything that we passed here. I have some news for the distinguished leader in the Senate, the Republican leader, Mr. McConnell. The support for this legislation, these bills, is alive and well among the American people, and he will be hearing from them, because this legislation, these bills, are a matter of life and death and, certainly, quality of life for America's working families. So we will never limit the aspirations and meeting the needs of the American people to what might be legislatively acceptable in the mind of a person in the United States Senate, but we will recognize our responsibility to not only pass the boldest common denominator, but to do so in a way that honors what President Lincoln told us: Public sentiment is everything. With public sentiment, you can pass almost anything; without it, practically nothing. But, in order for the public sentiment to weigh in, the public has to know. And passing legislation of this kind is a strong message. And our advocates, whether it is the Little Lobbyists; whether it is those who are affected by so many aspects that the Republican leadership is out to sabotage, that the Trump administration is out to sabotage, whether in the Congress or in the courts--well, we will take it to the court, as we are in the Supreme Court. We will fight them in the Supreme Court, but we will also fight them in the court of public opinion. This is very, very important to, not only the health, but also the financial well-being of America's working families. So, I salute the chairman for this legislation, and I urge everyone to vote for it. And I know that there is bipartisan support for some parts of the bill. I hope that will apply to all of it so that it really can work. Mr. WALDEN. Mr. Chairman, may I inquire as to how much time remains on each side, please. The CHAIR. The gentleman from Oregon has 2 minutes remaining. The gentleman from New Jersey has 11\1/2\ minutes remaining. Mr. WALDEN. Mr. Chair, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from California (Ms. Barragan). Ms. BARRAGAN. Mr. Chair, I rise today on behalf of the millions of Americans who are struggling to afford their lifesaving medications. Every day, millions face the tough decision of having to pay for their prescriptions or other basic costs of living like groceries and rent, Americans like Victoria Stuessel from Los Angeles, a mother of three who was just diagnosed with MS. Because of the high cost of her medications which she uses to delay the progress of her disease, she was forced to skip doses. But this is just one of many stories of people like Victoria who ration their care or stop taking their medication altogether. Not only is this dangerous, but it could result in death. The Strengthening Healthcare and Lowering Prescription Drug Costs Act is the first step to stop the rigging of the system so there is no delay to get generics to consumers faster. That will increase competition, and it will keep drug prices down for consumers. While there is still much more work that needs to be done to drive down the price of prescription drugs, this bill is a strong first step in ensuring that all Americans can afford the medication they need. Let's pass this bill and move forward in helping consumers. Mr. WALDEN. Mr. Chair, I continue to reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Delaware (Ms. Blunt Rochester). {time} 1345 Ms. BLUNT ROCHESTER. Mr. Chairman, I thank Chairman Pallone for yielding and for his leadership. Mr. Chairman, I rise in strong support of H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. This legislative package is comprised of commonsense proposals that will advance important gains made by the Affordable Care Act and further improve our healthcare [[Page H3862]] system by, one, lowering the cost of prescription drug prices and, two, increasing access to care. Included in this package is my bill, the MORE Health Education Act, which will restore funding to the Affordable Care Act's marketing and outreach programs and, according to the CBO, help an additional 5 million Americans get health coverage. Educating Americans about when they can enroll and what their options are gets more people covered, creates a better risk pool, brings down some of the cost of high premiums, and gets us one step closer to stabilizing the individual marketplace. ACA outreach not only boosts enrollment, but is also cost effective. The private sector spends between $250 and $1,000 per enrollment; however, it costs the government just $29 to enroll someone in the individual marketplace using TV ads--$29. The goal of affordable, accessible, and high-quality healthcare is not a D or an R, it is an A for American. I urge my colleagues to vote ``yes'' on this bill. Mr. WALDEN. Mr. Chair, I continue to reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Texas (Mr. Doggett), who chairs the Ways and Means Health Subcommittee. Mr. DOGGETT. Mr. Chairman, I am here to wade through the pool of crocodile tears being shed by Republicans who, for eight long years, have done nothing meaningful to address prescription price gouging. This bill provides some protection from anticompetitive pharmaceutical practices. And while it fails to lower drug prices immediately as we need, it offers great hope for the future. Key provisions are substantially the same as legislation I have introduced twice before. Big Pharma depends on monopoly power to spike prices. Taxpayers finance much of the drug development; then the government grants a monopoly and, too often, that patent monopoly is extended wrongfully by buying off the competition in what are called pay-for-delay contracts. Big Pharma claims that it has to price-gouge in order to solve and provide cures for the future. What it is really innovative about is not cures, but maintaining its monopoly position. Today's modest action is very important, but it will not fulfill our Democratic promise to deliver on lowering drug costs until we use the full power of the Federal Government, its purchasing power, to directly negotiate drug prices, much the way that the Veterans Administration gets lower prices for our veterans. Big Pharma will not yield its monopoly prices willingly. It will take more than a cry of, ``Kumbaya.'' It will take enough Members here with the intestinal fortitude to stand up to one of the most powerful lobbies in America and provide genuine relief. Let's do that. Mr. WALDEN. Mr. Chairman, I continue to reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1 minute to the gentleman from New Jersey (Mr. Kim), who is the sponsor of the legislation that encourages State exchanges. Mr. KIM. Mr. Chairman, I rise today in support of taking action to lower healthcare and prescription drug costs. In each of my townhalls, I heard from my neighbors that they are tired of the politics; they can't afford the partisanship; and they need Congress to be the adults in the room and to act now. I am proud that my bill, the SAVE Act, has been incorporated into the bill that we will be voting on today. The SAVE Act came from a conversation, a single conversation, as I reached across the aisle to Congressman Brian Fitzpatrick, put aside our parties, and worked together to help the people we wake up every day committed to serve. Congress needs more conversations like that. Congress needs bold action like the one we will be taking today. I call on our colleagues in the House to recognize that our neighbors need healthcare relief, and I call on our colleagues in the Senate to recognize that our neighbors cannot wait for that relief to come. This is our moment to act to lower healthcare costs. This is our moment to get something done for the American people. Mr. WALDEN. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Georgia (Mr. Austin Scott). Mr. AUSTIN SCOTT of Georgia. Mr. Chairman, as I have listened, again, I want to point out the same thing I pointed out the other day, that they act as if you go to the doctor and the doctor says you have a dreaded disease, that you can go out the next day and get an insurance contract. That is simply not true. Affordable Care Act contracts are not available until January 1 of next year. You can sign up for them starting in November, but you will not have coverage until the first of next year. And if you think healthcare was expensive and insurance was expensive before the Affordable Care Act, you sure ought to look at it now, because it is significantly more. I just want to point out that there is a lot of good stuff in this legislation, there really is. I commend both the Democrats and the Republicans on the committee for the work that is done to help the American citizens on the prescription drug issue. But as a Representative who has 24 counties, in over half the counties that I represent, they have only one insurance carrier--only one insurance carrier. I can tell you these skinny plans are important. If you lose your coverage, where we live, it is, in many cases, the only thing that is available to you. Is it what people want to have? Is it what we want people to have? I would tell you, no, it is not, but it is sure better than nothing. So I hope that, as things move forward, we will be able to get some things done on the prescription drugs. But again, 24 counties that I represent, half of them only have one insurance option. Those insurance carriers, exempt from the antitrust laws of the country--that is the way they wrote the Affordable Care Act. They left them exempt from the antitrust laws of the country. Mr. PALLONE. Mr. Chairman, I yield 1 minute to the gentlewoman from Minnesota (Mrs. Craig). Mrs. CRAIG. Mr. Chairman, I join my colleagues today in strong support of the Strengthening Health Care and Lowering Prescription Drug Costs Act. Healthcare is the number one issue I hear about from the families that I represent, and we must do the right thing for the American people and finally focus on lowering the cost of healthcare. As a child, in my own family, we struggled at times to afford health insurance. I know directly that, if healthcare isn't affordable, it isn't accessible. That is why I have cosponsored bills in this package to lower prescription drug costs and stabilize the Affordable Care Act. It is unacceptable that 29 percent of Americans ration lifesaving medicine because they cannot keep up with the cost. We need to stop brand-name drug companies from keeping affordable generic alternatives from the market and support efforts to develop lower cost options for families. These efforts have bipartisan support, and I am proud to support them. Mr. WALDEN. Mr. Chairman, may I inquire again about the amount of time on each side. The CHAIR. The gentleman from Oregon has 30 seconds remaining. The gentleman from New Jersey has 5 minutes remaining. Mr. WALDEN. Mr. Chair, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 1 minute to the gentleman from Colorado (Mr. Neguse). Mr. NEGUSE. Mr. Chairman, across the State of Colorado and across my district, the cost of healthcare is an urgent concern to so many of my constituents. That is why I am proud to support the legislation championed by our chairman today. Today's legislation will provide much-needed reforms to lower the cost of healthcare, protect people with preexisting conditions, and lower the cost of prescription drugs--and these reforms are urgently needed. We know for a fact that American consumers pay far more for prescription drugs than it costs to manufacture them. In Colorado, over half a million people each year don't fill a prescription because of the cost--half a million people. The burden has led to heartbreaking stories across my State and [[Page H3863]] across the Nation of individuals forced to choose between feeding their loved ones and taking life-sustaining medications. Today's legislation will provide much-needed reforms, will lower prescription drug costs by ending the tactics used by so many drug manufacturers to keep less expensive drugs off the market, and will bring generics to market faster. I urge passage of the provisions on the floor today to ensure that no American has to skip doses of lifesaving medication because of the cost and no American goes bankrupt paying for their healthcare. I thank the chairman again for his leadership in championing this legislation. Mr. WALDEN. Mr. Chair, I continue to reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from New York (Mr. Jeffries), the Democratic Caucus chair. Mr. JEFFRIES. Mr. Chairman, I thank the distinguished chair for his leadership on this critically important issue. The reckless and reprehensible Republican assault on healthcare is un-American, unconscionable, and unacceptable. This administration wants to take away healthcare protection from tens of millions of Americans. This administration wants to impose an age tax on people between 50 and 64, which will dramatically increase premiums, copays, and deductibles. This administration wants to take away protections for those with preexisting conditions, adversely impacting more than 100 million Americans. Here is the Democratic response: Keep your hands off of the healthcare of everyday Americans. Our legislation will strengthen the Affordable Care Act, protect people with preexisting conditions, lower healthcare costs, and drive down the high costs of lifesaving prescription drugs because Democrats believe that, in this great country, no American should ever have to choose between putting food on the table, paying the rent, or getting access to lifesaving medication. We believe that healthcare is a right; it is not a privilege. We are not going backward; we are just going to move forward. This is the wealthiest country in the history of the world. Every single American should have access to high-quality and affordable healthcare, and we are taking a substantial step in that direction today. I thank the chair and the tremendous members of the relevant committees for their great work. Mr. Chairman, I urge a ``yes'' vote. Mr. WALDEN. Mr. Chairman, I continue to reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I think I am prepared to close, but I just want to ask about the time on each side once more. The CHAIR. The gentleman from New Jersey has 2 minutes remaining. The gentleman from Oregon has 30 seconds remaining. Mr. WALDEN. Mr. Chairman, I yield myself the balance of my time, as I have no other speakers. I would just like to point out, make clear for the Record and for all our colleagues, Republicans supported and worked closely with our Democratic colleagues on the drug reform bills here to get lower cost prescriptions and more generics into the market sooner. There is no light between our shoulders on those issues. If those bills were brought here independently as they came out of committee independently, they would be headed to the Senate and likely to the President, and we would be moving forward. But, instead, Democrats merged in bills they know Republicans oppose. When it comes to navigators, the actual number is $767 per individual the navigators signed up; agents and brokers cost $240 per enrollee. Mr. Chairman, we would rather take that money and put it into community health centers. That would take care of 20,000 patients, just at $2.7 million. Mr. Chairman, I urge opposition to the bill, and I yield back the balance of my time. {time} 1400 Mr. PALLONE. Mr. Chair, I yield myself such time as I may consume. Mr. Chair, I want to acknowledge the many Members who wanted to lend their strong support to this legislation but were unable to add themselves as cosponsors due to this package being combined for floor consideration as part of the Rules Committee proceedings. Those Members include the sponsors of the individual bills incorporated into this package, as well as Members like Representative Sheila Jackson Lee who strongly support our efforts to make healthcare more accessible and affordable. Let me say, Mr. Chairman, in closing, as Democrats, we promised, and we will fulfill the promise, that we are going to make healthcare more affordable, that we are going to bring down the costs of prescription drugs, that we are going to make sure people who have preexisting conditions are protected, and that we are offering robust, comprehensive plans with all the essential benefits as part of the package. That is what this bill is about. That is what the bill last week was about as well, guaranteeing that if you have a preexisting condition, you will get affordable health coverage, and saying that in the case of prescription drugs, 90 percent of prescription drugs now have or could have a generic alternative to bring down costs. They bring them down considerably, but the brand-name drug companies have conspired, in many cases, to make it more difficult for generics to come to market and delayed them coming to market. That drives up the costs of prescription drugs. We have watched this Trump administration sabotage the Affordable Care Act and put out junk plans so people don't have comprehensive coverage and people with preexisting conditions have trouble finding affordable coverage. They have made it more difficult for people to even know what to buy in the marketplace by cutting back on navigators and the outreach that makes people aware. They have also made it so that many people, unfortunately, don't even have options. We are going to do whatever we can. Republicans may like some bills, and they may not like others, but we are going to move forward with a package today and also in the future on whatever we can to make premiums more affordable and to bring down drug prices. Mr. Chair, I urge support for these bills for those reasons, and I yield back the balance of my time. The CHAIR. The gentleman from Virginia (Mr. Scott) and the gentlewoman from North Carolina (Ms. Foxx) each will control 15 minutes. Mr. SCOTT of Virginia. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise today in support of this bill to improve access to quality health coverage, protect the Affordable Care Act, and cut prescription drug costs for consumers. Unfortunately, Mr. Chairman, the administration has consistently undermined quality, affordable coverage that Americans have come to expect. House Republicans actually passed a bill last year that CBO concluded would provide coverage for over 20 million fewer people, would increase premiums 20 percent the first year, would cover less, and would jeopardize protections for those with preexisting conditions. We can do better. Mr. Chairman, I want to speak on one important provision of H.R. 987 that reverses the administration's attempt to proliferate junk insurance plans. Mr. Chairman, for healthier, younger Americans, short-term junk plans may sound like a good idea. Unfortunately, those policies will fail to cover essential benefits and will lack consumer protections. They may not provide decent coverage for when they get sick. The major problem with the proliferation of junk plans is the fact that they allow insurance companies to sell plans to healthy people only, meaning that everybody else would be in an insurance pool that is sicker than they are today. While a privileged few may pay less, everybody else will pay more. In fact, one study showed that the combination of all these junk plans and lack of mandates and other sabotage of the Affordable Care Act could result in thousands of dollars more for everybody else to pay. These plans will raise costs for most Americans, and that is a step in the wrong direction. [[Page H3864]] Mr. Chairman, we should be reducing the cost of insurance for most Americans, not increasing the cost. Mr. Chair, this bill will prevent the administration from going in the wrong direction, so I urge my colleagues to support H.R. 987. Mr. Chair, I reserve the balance of my time. Ms. FOXX of North Carolina. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise as leader of the Republicans on the committee of jurisdiction over employer-sponsored healthcare, the House Committee on Education and Labor. We have a vital stake in this debate because that is how most Americans get their healthcare, through their employer. Our focus should be on improving those options. Instead, we are here so our Democratic colleagues can grind an ax against the few remaining healthcare options they don't get to control. Among its many choice-eliminating, freedom-limiting provisions, this legislation would eliminate short-term, limited-duration insurance plans. These plans are an obvious potential solution for millions of Americans, working or not, who may find themselves between jobs or unable to afford rising premiums in the already expensive individual market. If any of my colleagues on the other side of the aisle claim to be champions for hardworking Americans or the unemployed, their support for this provision is proof that those claims are empty. It is worth noting for the Record that short-term, limited-duration plans were legal under the Obama administration and that States still have the authority to regulate these plans both under the Obama administration and under the current rules. If States choose to limit or prohibit the sale of these plans, they are free to do so. By considering this bill, House Democrats are once again defaulting to their standard uncreative, blind support for one-size-fits-all Federal mandates instead of respecting the judgment of State lawmakers and authorities, as well as individuals, to act in their States' and their own best interests. Republicans on the Education and Labor Committee have been and remain fully dedicated to protecting Americans with preexisting conditions and unleashing new customizable, affordable, workable healthcare options that take into account the changing needs of all Americans at all stages of life. The bill before the House today will not lower drug prices, will not protect anyone from surprise billings, will not lower premiums, will not cut any out-of-pocket costs, and will not provide one cent of tax relief. Its failure to achieve any of those objectives makes it simply unacceptable for us as Republicans. Mr. Chair, I reserve the balance of my time. Mr. SCOTT of Virginia. Mr. Chairman, I yield 2 minutes to the gentlewoman from Pennsylvania (Ms. Wild). Ms. WILD. Mr. Chairman, I thank Mr. Scott for yielding. Mr. Chair, I rise in support of H.R. 987. I am proud that we are about to follow through on key campaign promises: lowering drug costs by removing barriers to generic drugs coming to market, reversing the sabotage of the ACA, and rescinding the administration's rule to expand junk plans. As we all know, Congress sometimes engages in hyperbole, but this is not hyperbole: These plans are truly junk. They are not required to include essential benefit coverage requirements of the ACA. They can deny consumers coverage or charge more based on age, gender, or health status. They come with no guarantees for basic benefits like maternity care, mental healthcare, prescription drug coverage, and other preventive services. They are not subject to the out-of-pocket limitations of the ACA that are designed specifically to protect consumers. I know a bit about these junk plans because I spent time over Mother's Day weekend desperately helping my 26-year-old son find insurance coverage. In March, he turned 26 and found himself uninsured. He is in a sandwich situation between his 26th birthday and when he will again become eligible for employer-provided healthcare. Only because I have read countless insurance policies over the years of my legal career did my son avoid the trap of paying $6,000 for a policy that would afford him almost no coverage with a $10,000 deductible. That deductible would have applied even to his prescription drugs, of which he needs one. Just as important, my son is exactly the kind of person we need in the marketplace. Let's encourage robust participation in marketplace plans, which was the intent of the Affordable Care Act. These junk plans lure young, healthy people away from the ACA pool of plans, resulting in more expensive premiums for the rest of Americans. Let's pass this bill. Ms. FOXX of North Carolina. Mr. Chairman, I yield 3 minutes to the gentleman from Virginia (Mr. Cline). Mr. CLINE. Mr. Chairman, well, here we go again, another bait and switch by the Democrats. We have a great bill, the CREATES Act, that allows consumers to access cheaper generic drugs, driving down costs, saving Americans $3.9 billion over 10 years. What have they done with it? They have stuck in poison pills designed to take choice away from Americans when it comes to their health insurance plans. As lawmakers, we owe it to Americans to protect their rights to make their own decisions, particularly as it relates to healthcare. The fact that we are here debating even further reducing these options available to Americans proves that we are not keeping up our end of the bargain. ObamaCare created a healthcare paradigm that aimed to take away options from Americans and give that authority to the government. As a result, premiums are skyrocketing, with the highest in the country being in my home State of Virginia. President Trump, thankfully, has stepped in to allow flexible, short- term, limited-duration plans to help those in my district, where my constituents are pleading for more choices in health insurance. This administration is simply trying to give more options to Americans in this desert of choice. We should be creating an environment that encourages more choices for individuals and families. This includes a more individualized market, particularly with regard to employer-sponsored health insurance. It also means increasing pricing transparency at the point of sale to avoid surprise medical billing, which the President championed last week. Finally, we should address consolidation in the healthcare system through increased enforcement from the FTC and the DOJ under the Sherman Antitrust Act. This legislation is the height of arrogance. Government knows best, yet again. The American people know nothing about their own choices when it comes to health insurance. To double down on ObamaCare and take away the few options that are left for constituents, and giving those choices to those who caused this failure in the first place, the Federal Government, is beyond offensive to American citizens. Mr. Chair, I urge my colleagues to join me in rejecting this legislation. Reject this idea that government knows best, and stand up for affordable and accessible health insurance for all Americans. Mr. SCOTT of Virginia. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from North Carolina (Ms. Adams). Ms. ADAMS. Mr. Chairman, I thank the gentleman from Virginia for yielding and for his support on this issue. Mr. Chair, I rise today in strong support of H.R. 987. We must reverse the administration's attempt to sabotage the Affordable Care Act. Healthcare should not be a partisan issue. It doesn't matter if you are a Democrat, Republican, or unaffiliated. If you get sick, you need to see a doctor. Your body certainly doesn't make the distinction about what your politics are. The ACA has given millions of Americans, including 500,000 in my home State of North Carolina, access to quality and affordable care. That is huge because people need healthcare. No one should worry about losing access to quality, affordable health insurance because of a preexisting condition. We all have them. [[Page H3865]] Black women shouldn't have to worry about dying in childbirth because they don't have equal access to healthcare. I am proud to support H.R. 987 to invest in quality healthcare for the American people, a healthcare system that works for everyone. {time} 1415 Ms. FOXX of North Carolina. Mr. Chairman, I yield 3 minutes to the gentleman from Tennessee (Mr. David P. Roe), the distinguished ranking member of the Veterans Affairs' Committee. Mr. DAVID P. ROE of Tennessee. Mr. Chairman, I rise today in opposition to H.R. 987, the Democrats' ObamaCare bailout act. This legislation includes three bipartisan bills that could help lower the cost of prescription drugs. Unfortunately, the majority has decided to package these positive bills with four bills that double down on trying to force ObamaCare on people who don't want it and can't afford it. We are back on the floor again using valuable time to consider legislation that will not pass the Senate. Make no mistake: If House Democrats wanted to accomplish something, they could have put their three drug pricing bills on the floor by themselves today and they would have passed. Everyone needs to understand that. Instead of working together to find ways to bring down the costs of healthcare, House Democrats are acting to eliminate affordable options that many folks across the country rely upon for covering their family's healthcare needs. One provision in this bill would be to limit the availability of short-term limited duration plans to no more than 3 months. This change by President Obama went into effect January of 2017 and overturned 20 years of regulations that had been in place since Bill Clinton was in office, including the entirety of President Obama's administration. These plans are for essential health benefits chosen by the individual consumer, not the Federal Government. We have different needs at different points in our life. Unfortunately, the ACA does not allow for plans to be sold as ``compliant'' unless they contain government approved what you need, not what you and your family decide what is in your best interest and can afford. If my colleagues want to get rid of junk plans, they can start by working with us to get rid of ObamaCare. In my district, while the individual mandate was in effect, there were 20,000 people who purchased their coverage through the exchange and about 15,000 who paid the penalty. Many of those people who paid the penalty were able to find a plan that was affordable through the Tennessee Farm Bureau or the Christian sharing ministries. I have said it before and I will say it again: ObamaCare is a good deal for you if you get a subsidy, of which about 90 percent do. But these subsidies hide the true cost of the care, and for people who don't receive a subsidy, it is unaffordable. When the Education and Labor Committee marked up the short-term bill last month, I heard the argument that these short-term plans were too difficult to understand, that consumers don't know what they are getting. This is offensive to me. This is saying, just because patients don't choose plans that Washington bureaucrats think are good for them, they don't have enough sense to figure it out on their own. They do. I trust the American people. Why on earth when we do something using common sense and creating association health plans that allow small groups to get together-- Washington State does that, hardly a conservative State. They have had AHPs for over 20 years, and they are working well. If my friends across the aisle want to engage in a good faith effort to find solutions to high healthcare costs, I am all in, Mr. Chairman. I want to help. But the point is that people are finding ways outside of ObamaCare to best access coverage for their families. The CBO initially said there would be 27 million people in the exchanges in 2019. That number is 8 million. Competition works. I hope my colleagues oppose this legislation, and I am ready to work in a bipartisan way to solve these problems. Ms. FOXX of North Carolina. Mr. Chairman, may I inquire as to the amount of time left. The Acting CHAIR (Mr. Sablan). The gentlewoman from North Carolina has 6\1/2\ minutes remaining. The gentleman from Virginia has 10 minutes remaining. Mr. SCOTT of Virginia. Mr. Chairman, I yield 2 minutes to the gentleman from Rhode Island (Mr. Cicilline). Mr. CICILLINE. Mr. Chairman, every day in kitchens and living rooms all across America, working men and women sit down and try to figure out how to pay for their prescription drugs. That is because 25 percent of the people in this country can't afford the medicine they have been prescribed. Seniors are choosing between COPD and their the groceries. People with cancer are being forced to delay their treatment, cut pills in half, or even forgo treatment altogether. This is happening in the richest, most powerful nation in the history of the world. It is a disgrace. If government is going to work for the people, then the people who serve in government need to end this crisis, and Democrats are committed to doing just that. We are taking on the big pharmaceutical companies and their lobbyists, and we are going to get the job done. That is why I am proud that my legislation, the CREATES Act, is included in this legislative package. The CREATES Act will save taxpayers $3.9 billion, according to the CBO, and bring down the cost of some prescription drugs by as much as 85 percent. The CREATES Act does this by directly addressing the abusive delay tactics that big drug companies use to block or delay generic competitors from entering the market. Over the past decade, some of the biggest drug companies have abused regulatory protocols so they can prevent the sale of affordable drugs. This lets them maintain their control of the marketplace, pull in monopoly profits, and keep their prices at inflated levels. If it is signed into law, the CREATES Act will create a tailored path for generic drug competitors to obtain the samples that are necessary for regulatory approval of their lower cost formulations. I am proud that this bill is not only backed by many of our colleagues, but it also has the support of a diverse coalition of healthcare providers, patient groups, and public interest organizations, including AARP and Public Citizen. And I am proud it is included in this package today. The majority leader in the Senate likes to describe himself as the grim reaper for Democratic legislative proposals. I hope that won't be the case here. He needs to put the interests of the American people ahead of his obsession with fighting Democrats every step of the way. The CREATES Act and these other proposals that are contained in this package deserve an up-or-down vote in the United States Senate. The American people deserve relief from these outrageous prescription drug prices, and this legislation will achieve that. Ms. FOXX of North Carolina. Mr. Chairman, I yield 3 minutes to the gentleman from Michigan (Mr. Walberg), the distinguished Republican leader on the Subcommittee on Health, Employment, Labor and Pensions. Mr. WALBERG. Mr. Chairman, I rise today in opposition to H.R. 987, and I truly lament the fact that the other side is once again, under their leadership's direction, trying to score political points instead of truly solving problems. Republicans and Democrats agree on the need to tackle out-of-control prescription drug costs. It is an issue that touches all of our districts. People are struggling and in need of relief. All of the names mentioned today, the illustrations, from the Speaker of the House on to my colleagues, names that were mentioned of people who are hurting and need relief from drug costs, are being let down by the Democrat leadership today. Up until today, we have been working together on solutions. On the Energy and Commerce Committee on which I sit, as well, we passed three drug pricing bills with overwhelming bipartisan support: The CREATES Act, the Protecting Consumer Access to Generic Drugs Act, and the Bringing Low-cost Options and Competition while [[Page H3866]] Keeping Incentives for New Generics Act. These bills would foster greater competition and help bring generic drugs to market as soon as possible and at more affordable prices. Once again, they all had bipartisan support. They were bills that were good bills. Unfortunately, the Democrats turned this bipartisan issue into a political football by adding several partisan provisions to this bill package, and they let down everyone that they have talked about today who needs affordable prescription drugs. They are costly provisions that bail out failed ObamaCare programs and strip away affordable healthcare options for families. The Democrats also rejected a number of commonsense amendments, including one I offered to protect expanded access to association health plans. These association health plans give more affordable options to workers and small businesses to purchase healthcare that fits their needs. We should be encouraging these options, not removing them. But most of all, today should be a moment of bipartisanship, a moment of meaningful results. We had an opportunity to get something done today on behalf of our constituents who are struggling with skyrocketing costs of prescription drugs. Instead, politics got in the way and we missed that opportunity. The American people deserve better than that, and I think most of us are better than that. We stand ready to work on lowering prescription drug costs. I hope our colleagues on the other side of the aisle will talk to their leadership and put politics aside and join us in that effort. I believe we and they are better than that and that, by standing up to leadership that wants to make it political, if they do that, we can get this done. I stand ready to work. I hate to do this, Mr. Chairman. I want to keep talking about this and get a solution, but my time is up. Mr. SCOTT of Virginia. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Texas (Ms. Jackson Lee). Ms. JACKSON LEE. Mr. Chairman, I am pleased to rise and support, enthusiastically, H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. This omnibus bill combines three key bills to lower drug costs by promoting generic competition--long overdue--and four key bills to strengthen healthcare, reverse the GOP sabotage, and rescind the Trump administration's devastating junk plan rule. I know full well what happens when individuals are impacted by junk plans, and they don't have the courage they need. I encourage my good friends on the other side of the aisle to drop politics and join with us to pass this legislation. This omnibus bill invests most of the savings of $13.8 billion created by its cracking down on junk plans into strengthening healthcare, which will fund about 500,000 additional enrollees into non-group coverage and Medicaid. Let me say to you, in 2017, due to the direct interference by the Trump administration, the number of uninsured people increased by 700,000, the first increase since implementation of the Affordable Care Act. I know full well that Texas, which is the number one State in the number of uninsured, is experiencing the devastation of not having the expanded Medicaid and the Affordable Care Act at its fullest. We had a roundtable discussion with people who experience diabetes. Insulin is going through the roof. These people are suffering. The average uninsured resident in my congressional district pays 23 times more for a form of insulin than people living in Australia, 15 times more than they would in the United Kingdom, and 13 times more than they would in Canada. Let's protect those with preexisting conditions, and let's pass this bill to bring down these drugs and save the lives of our constituents. Mr. Chair, I rise in strong support of H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Cost Act. This is an omnibus bill that includes the: H.R. 938, The BLOCKING (Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics) Act; H.R. 1499, Protecting Consumer Access to Generic Drugs of 2019; H.R. 965, The CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act; and H.R. 1010, Rescinding Trump Administration's Final Rule Promoting Junk Insurance Plans. This omnibus bill invests most of the savings of $13.8 billion created by its cracking down on junk plans into strengthening health care, which will fund about 500,000 additional enrollees in nongroup coverage and Medicaid. Health care should be a fundamental right for all Americans. This is why I introduced the Breath of Fresh Air Act, which establishes a Department of Education grant program to be used by local education agencies for the purchase of nebulizers for use in elementary and secondary schools and secured passage of Amendments to the Commerce Justice State spending bills that preserve and expand upon green spaces needed to reduce the worse symptoms of respiratory illnesses. Each Congress I have secured adoption of amendments to Department of Defense Appropriations and Authorization Bills that increase funding for triple negative breast cancer research and treatment. I am an original sponsor of H.R. 366, the Insulin Access for All Act of 2019, which addresses the extreme financial hardship most vulnerable Americans face and too many may face untimely deaths due to insulin rationing. Last month, I held a forum in my Congressional district in Houston Texas that engaged physicians, patients, public health officials in a discussion about the high cost of insulin. The Affordable Care Act (ACA) led to historic gains in health insurance coverage by extending Medicaid coverage to many low-income individuals and providing Marketplace subsidies for individuals below 400 percent, of poverty. The number of uninsured nonelderly Americans decreased from over 44 million in 2013, the year before major provisions of the ACA went into effect, to just below 27 million in 2016. Unfortunately, the Trump Administration has been doing all that it can to undermine the ACA and deny deserving Americans access to affordable health insurance. In 2017, due to direct interference by the Trump Administration the number of uninsured people increased by nearly 700,000 people, the first increase since implementation of the ACA. One of the most difficult challenges are the hurdles to healthcare created by lack of health insurance and the expense of prescription medication. In 2017, private health insurance coverage continued to be more prevalent than government coverage, at 67.2 percent and 37.7 percent, respectively. Of the subtypes of health insurance coverage, employer-based insurance was the most common, covering 56 percent of the population for some or all of the calendar year, followed by Medicaid (19.3 percent), Medicare (17.2 percent), direct-purchase coverage (16.0 percent), and military coverage (4.8 percent). Unfortunately, the state of Texas remains the state with the most uninsured persons at 17 percent because it refuses to accept federal Medicaid funding to cover the poorest residents of the state. According to the Kaiser Family Foundation, one in four people taking prescription drugs report difficulty affording their medication. In 2017, diabetes contributed to the death of 277,000 Americans--and was the primary cause of death for 85,000 of those individuals. That same year diagnosed diabetes cost the United States an estimated $327 billion--including $237 billion in direct medical costs and $90 billion in productivity losses. Diabetes drugs, including insulin and oral medications that regulate blood sugar levels, play a critical role in helping people with diabetes manage their condition and reduce the risk of diabetes-related health complications. After the Democrats took control of the House in January we got to work on a report on the high cost of insulin and we determined that the Americans with diabetes are in crisis. Insulin--used by approximately 7.5 million Americans to treat their diabetes--was discovered nearly a century ago by Canadian researchers Frederick Banting, Charles Best, J.B. Collip, and J.J.R. Macleod, who assigned their patent to the University of Toronto with the goal of making the medication widely available. The researchers charged $3.00 to transfer ownership of insulin to the University of Toronto. Even though analog insulin has been on the market for nearly 30 years, it has no meaningful generic competition. Over the past two decades, manufacturers have systematically and dramatically raised the prices of their insulin products by more than tenfold--often in lockstep. These prices dwarf manufacturing costs. One study found manufacturers could charge as little as $7 to $11 per month for insulin and still make a profit. [[Page H3867]] In recent years, the high prices of diabetes drugs have placed a tremendous strain on diabetes patients as well as the federal government, which provides diabetes medications to more than 43 million Medicare beneficiaries. Reva Verma, is a type 1 diabetic who faces firsthand the struggles of managing diabetes in an era of skyrocketing insulin prices. Diabetes is a life-threatening disease that disproportionately affects communities of color. Diabetes is associated with serious health problems, including heart disease and stroke, kidney failure, and blindness. There are 15,000 Medicare beneficiaries in the Eighteenth Congressional District who have been diagnosed with diabetes. These individuals are my constituents and I know that on average, each of them pay 4.8 times the cost of similar medication in Australia, 3.6 times the cost in the United Kingdom, and 2.6 times the cost in Canada. Additionally, in the Eighteenth Congressional District, there are 191,000 uninsured residents in this district and, because they lack insurance, they often pay significantly more than their insured counterpart, or any patient overseas. The average uninsured resident in my congressional district pays 23 more times for a form of insulin than people living in Australia, 15 more times than they would in the United Kingdom, and 13 more times than they would in Canada. The consequences of these staggering costs are not benign. Many patients often speak of having to make heart-wrenching decisions about what to buy with the commonly fixed incomes attendant to seniors. Many medical professionals indicate that the high prices for prescription drugs are a function of a lack of competition, and authorizing Medicare to create a program to negotiate drug prices may be an estimable way to lower the cost of prescription drugs. All told this reflects a disturbing trend: in our country, the cost of branded drugs tends to go up, whereas in other countries, the costs tend to go down. These high prices lead many people to ration or stop taking their medications, which can result in serious health complications and even death, as the Energy and Commerce Committee heard in direct testimony earlier this year. The prices of diabetes medications--and insulin in particular--are far higher in the United States than they are overseas, in part because certain federal programs lack the authority to negotiate directly with drug manufacturers. The Democratic majority came into office with a promise to the American people, to make sure that they had affordable and dependable healthcare. Today, we are delivering on that promise, not just for persons with diabetes but for all Americans who have pre-existing conditions that require medication management. Ms. FOXX of North Carolina. Mr. Chairman, I yield 3 minutes to the gentleman from Idaho (Mr. Fulcher). Mr. FULCHER. Mr. Chair, I rise in opposition to H.R. 987, as well, for a number of reasons; but one in particular that has been raised already is the provision that it terminates the short-term limited duration insurance provision. Now, these are a good thing, and they have been good for Idaho. Idaho has been one of the States that has been leading on this front. Mr. Chairman, before the Affordable Care Act, the average premium in our State was $1,915. After the Affordable Care Act, that premium average went to $5,267. And that is, from what I understand, not unlike what has happened in other States, because the young and the healthy left the plans. That left the older, less healthy who were remaining in those plans, and it has driven those costs up. The younger and the more healthy have gone out of the plan altogether or they have joined a Medi-Share. But the point is that it has driven those numbers up significantly. In my State, the legislature passed a 3-year provision for short-term plans, and it is good for everyone. If you are in between those jobs or if you are in between coverage for some reason or you need to maintain continuity among the plans, it allows for that. Mr. Chairman, I have heard a couple of times these referred to as junk. If they were junk, there wouldn't be such demand for it. I would reframe that argument to say that junk would be better described to the system that has driven those prices up from $1,915 to $5,267. We want to draw that younger constituency into those plans. Everyone wins. We all win when that is the case. Mr. Chairman, again, H.R. 987 strikes that provision, and for that reason, I will oppose it, and I ask my colleagues to do the same. {time} 1430 Mr. SCOTT of Virginia. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from New York (Ms. Clarke). Ms. CLARKE of New York. Mr. Chairman, I would like to, first of all, thank the gentlewoman from Delaware (Ms. Blunt Rochester) for introducing this very important legislation, and thank Chairman Scott for yielding me time and for his leadership and support in continuing to provide access to quality healthcare for working families. As vice chair of the House Committee on Energy and Commerce, I am happy to stand with my colleagues on the Education and Labor Committee to urge my colleagues to support the Strengthening Healthcare and Lowering Prescription Drug Costs Act. While H.R. 987 is not a panacea to the many challenges that we face in our Nation's healthcare delivery system, it is sound legislation that will reduce drug pricing and increase market competition to bring generic drugs to the market sooner. It improves the lives of Americans by lowering the cost of premiums and out-of-pocket expenses and that presents real financial hardships to Americans who have to struggle with limited resources and ask themselves, Do I pay for medication, or do I purchase food, or school fees, or transportation to and from work? While my home State of New York has banned the sale of short-term health insurance plans, they are legal in other states and often do not provide a comprehensive level of healthcare insurance and coverage in the event of an emergency. Mr. Chairman, let's do the right thing and enact legislation that will lower the skyrocketing cost of prescription drugs and give protections to the consumers of health insurance coverage, lifting the burden of access and affordability from the American people. Ms. FOXX of North Carolina. Mr. Chairman, I reserve the balance of my time. Mr. SCOTT of Virginia. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Delaware (Ms. Blunt Rochester). Ms. BLUNT ROCHESTER. Mr. Chairman, I thank the gentleman from Virginia (Mr. Scott), the chairman of the committee. According to the Merriam-Webster Dictionary, ``sabotage'' is, an act or process intended to hurt or hamper. I am a person who is really particular about words, and I have heard this word used a lot. And when I look at what has happened to the Affordable Care Act over the past few years, the administration has slashed the enrollment period, we scrubbed the ACA from government websites, we have cut in-person assistance, and eliminated almost all of the educational outreach for the open enrollment period. All of the administration's actions were intended to deliberately damage the ACA and hamper American's access to affordable, quality healthcare. I don't question people's motivations. I think we all want the same thing. We all want healthcare for Americans. But this bill, H.R. 987, is intended to do two things. Number one, lower the cost of prescription drugs, and number two, strengthen this historic legislation, the ACA. Today, we have an opportunity to reverse the administration's relentless sabotage of the healthcare system and lower prescription drug prices. And as I think about individuals in my State, I think about a woman who came to me crying because of the cost of her prescription drugs. Every one of us in here wants to see something happen. Today, we have the opportunity to make that happen. Mr. Chairman, I urge my colleagues to support H.R. 987. Ms. FOXX of North Carolina. Mr. Chairman, I reserve the balance of my time. Mr. SCOTT of Virginia. Mr. Chairman, I yield 2\1/2\ minutes to the gentlewoman from Florida (Ms. Shalala). Ms. SHALALA. Mr. Chairman, this amendment expresses the sense of Congress that the secretary should not do anything that prohibits State insurance commissioners from allowing for so-called silver loading. [[Page H3868]] Let me walk you through how we got to this point. Because while silver loading has worked to keep costs on the exchange lower for folks who get subsidies, it has only been used because the President was actively trying to kill the Affordable Care Act. In 2017, the President decided to stop reimbursing health insurance companies for what are called cost-sharing reductions, or CSRs. CSRs are payments that health insurance companies are required to make to help low- and moderate-income people afford healthcare. Under the Affordable Care Act, the health insurance companies must help people that have more affordable, and, possibly, no co-pays or deductibles. The Federal Government was supposed to reimburse insurance providers for making these payments; however, in October of 2017, the administration stopped making these payments. This was a deliberate attempt to make health insurance on the exchange unaffordable, and undermine, weaken, and attack the Affordable Care Act. In response to this, States let health insurance plans do what is now called silver loading. State insurance regulators, in a desperate and creative attempt to stabilize the insurance marketplaces, allowed insurance companies to bill the unpaid CSR costs into their silver plans on the exchange. This was a very creative attempt to stabilize the insurance market. This wasn't the solution that anyone wanted, but it is a solution that has worked and has created some stability and predictability in the insurance market in the face of an administration that seeks chaos. Because the tax credits are benchmarked to the silver plan, silver loading has meant that most who receive subsidies did not see an increase in their health insurance premiums. In fact, new data shows that 2.6 million healthcare.gov consumers are now paying lower premiums as a result of silver loading. States that allowed for silver loading as a way to cope with the manufactured chaos that the administration tried to inflict on the market, actually saw an increase in enrollment in the exchanges. The Acting CHAIR. The time of the gentlewoman has expired. Mr. SCOTT of Virginia. Mr. Chairman, I yield an additional 30 seconds to the gentlewoman from Florida. Ms. SHALALA. Mr. Chairman, the administration must stop trying to sabotage the Affordable Care Act. My amendment expresses that it is the sense of Congress that the secretary of Health and Human Services shall not do anything to prohibit the use of silver loading, a program designed by the States to stabilize the health insurance marketplace. Ms. FOXX of North Carolina. Mr. Chairman, I continue to reserve the balance of my time. Mr. SCOTT of Virginia. Mr. Chairman, may I inquire as to how much time each side has remaining. The Acting CHAIR. The gentleman from Virginia has 45 seconds remaining. The gentlewoman from North Carolina has 1 minute remaining. Mr. SCOTT of Virginia. Mr. Chairman, do I have the right to close? The Acting CHAIR. The gentleman enjoys the right to close. Mr. SCOTT of Virginia. Mr. Chairman, I am ready to close, and I reserve the balance of my time. Ms. FOXX of North Carolina. Mr. Chairman, I yield myself the balance of my time. Mr. Chairman, Republicans predicted all the bad things that have resulted from the so-called Affordable Care Act. It has not been affordable and has actually increased the cost of health insurance and care. Unfortunately, our colleagues are so invested in supporting this legislation that they blame Republicans for its failure. The legislation has failed because it is hopelessly flawed and cannot be fixed. Mr. Chairman, the piece of legislation before us, as I said earlier, is a choice-limited, freedom-limiting bill, and should not pass. I would also like to make one more observation. My colleagues have made repeated references to junk plans. Every time they do that, they are insulting the person who has chosen that plan for one reason or another due to individual circumstances or preferences. Just because a product isn't something I would buy, or you would buy, does that make it junk? No. Dismissing less expensive and more flexible health plans as junk isn't taking up for anyone, it is actually putting them down. That is not the way we should be in this country. Mr. Chairman, I yield back the balance of my time. Mr. SCOTT of Virginia. Mr. Chairman, I yield myself the balance of my time. Mr. Chairman, I just want to say a final word about these junk plans. The problem with them is that you allow them to screen for preexisting conditions and have lower benefits. That might be a good idea for the person buying the plan, but what happens is under the Affordable Care Act everybody pays an average. If you let healthy people buy these junk plans, everybody else's premium will go up. This sabotage has been estimated with this and the other sabotage, thousands of dollars more for everybody else left behind. So I rise today in support of the bill, which will improve access to quality health coverage, protect the Affordable Care Act and cut prescription drugs cost. Mr. Chairman, I yield back the balance of my time. Mr. CARSON of Indiana. Mr. Chair, last November, the American people elected us to this body because of the urgent need to shore up our health care system and bring down the cost of prescription drugs. Today, we are making good on that promise to the country by passing another critically-important piece of legislation. H.R. 987, the Strengthening Health Care and Prescription Drugs Act helps protect the Affordable Care Act from the sabotage of the Trump Administration. In particular, this bill bans the use of ``junk'' health care plans that harm people with pre-existing conditions; it also helps provide states with more resources to increase health care coverage. Second, this legislation helps increase generic prescription drug competition which will help bring down prices for patients. In particular, this legislation includes a bill that I cosponsored that makes it illegal for prescription drug manufacturers to use a practice called ``pay-for-delay.'' This anti-competitive practice delays generic manufacturers from bringing cheaper drugs to market. This bill will prohibit this practice and help increase drug competition. This bill will not solve every problem ailing our health care system, nor will it immediately fix our prescription drug prices problems. But the American people deserve these needed reforms without delay. This bill's passage today will help us build additional policies to shore up our health care system and further bring down the cost of prescription drugs. I encourage all of my colleagues to support it. Ms. BLUNT ROCHESTER. Mr. Chair, I would like to revise my remarks made during general debate of the underlying measure, H.R. 987. In my remarks, I stated that the marketing and outreach provision under Title II of H.R. 987 would increase enrollment into health plans by five million over the ten year period as estimated by the Congressional Budget Office. Due to the methodology adopted by the Congressional Budget Office to estimate the enrollment effect of the underlying measure, the figure is more appropriately represented as increasing enrollment by about 500,000 each year over the ten year period. The Acting CHAIR. All time for general debate has expired. In lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce, printed in the bill, an amendment in the nature of a substitute consisting of the text of the Rules Committee Print 116-14, shall be considered as adopted and shall be considered as an original bill for purpose of further amendment under the 5-minute rule. The bill, as amended, shall be considered as read. The text of the bill, as amended, is as follows: H.R. 987 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Strengthening Health Care and Lowering Prescription Drug Costs Act''. SEC. 2. TABLE OF CONTENTS. The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. [[Page H3869]] TITLE I--LOWERING PRESCRIPTION DRUG COSTS Subtitle A--Bringing Low-cost Options and Competition While Keeping Incentives for New Generics Sec. 101. Change conditions of first generic exclusivity to spur access and competition. Subtitle B--Protecting Consumer Access to Generic Drugs Sec. 111. Unlawful agreements. Sec. 112. Notice and certification of agreements. Sec. 113. Forfeiture of 180-day exclusivity period. Sec. 114. Commission litigation authority. Sec. 115. Statute of limitations. Subtitle C--Creating and Restoring Equal Access to Equivalent Samples Sec. 121. Actions for delays of generic drugs and biosimilar biological products. Sec. 122. REMS approval process for subsequent filers. Sec. 123. Rule of construction. TITLE II--HEALTH INSURANCE MARKET STABILIZATION Sec. 201. Preserving State option to implement health care marketplaces. Sec. 202. Providing for additional requirements with respect to the navigator program. Sec. 203. Federal Exchange outreach and educational activities. Sec. 204. Short-term limited duration insurance rule prohibition. TITLE III--BUDGETARY EFFECTS Sec. 301. Determination of budgetary effects. TITLE I--LOWERING PRESCRIPTION DRUG COSTS Subtitle A--Bringing Low-cost Options and Competition While Keeping Incentives for New Generics SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLUSIVITY TO SPUR ACCESS AND COMPETITION. Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended-- (1) in subclause (I), by striking ``180 days after'' and all that follows through the period at the end and inserting the following: ``180 days after the earlier of-- ``(aa) the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant; or ``(bb) the applicable date specified in subclause (III).''; and (2) by adding at the end the following new subclause: ``(III) Applicable date.--The applicable date specified in this subclause, with respect to an application for a drug described in subclause (I), is the date on which each of the following conditions is first met: ``(aa) The approval of such an application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. ``(bb) At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant. ``(cc) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii). ``(dd) No application for the drug submitted by any first applicant is approved at the time the conditions under items (aa), (bb), and (cc) are all met, regardless of whether such an application is subsequently approved.''. Subtitle B--Protecting Consumer Access to Generic Drugs SEC. 111. UNLAWFUL AGREEMENTS. (a) Agreements Prohibited.--Subject to subsections (b) and (c), it shall be unlawful for an NDA or BLA holder and a subsequent filer (or for two subsequent filers) to enter into, or carry out, an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement-- (1) a subsequent filer directly or indirectly receives from such holder (or in the case of such an agreement between two subsequent filers, the other subsequent filer) anything of value, including a license; and (2) the subsequent filer agrees to limit or forego research on, or development, manufacturing, marketing, or sales, for any period of time, of the covered product that is the subject of the application described in subparagraph (A) or (B) of subsection (g)(8). (b) Exclusion.--It shall not be unlawful under subsection (a) if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection (a)(1) is compensation solely for other goods or services that the subsequent filer has promised to provide. (c) Limitation.--Nothing in this section shall prohibit an agreement resolving or settling a covered patent infringement claim in which the consideration granted by the NDA or BLA holder to the subsequent filer (or from one subsequent filer to another) as part of the resolution or settlement includes only one or more of the following: (1) The right to market the covered product that is the subject of the application described in subparagraph (A) or (B) of subsection (g)(8) in the United States before the expiration of-- (A) any patent that is the basis of the covered patent infringement claim; or (B) any patent right or other statutory exclusivity that would prevent the marketing of such covered product. (2) A payment for reasonable litigation expenses not to exceed $7,500,000 in the aggregate. (3) A covenant not to sue on any claim that such covered product infringes a patent. (d) Enforcement by Federal Trade Commission.-- (1) General application.--The requirements of this section apply, according to their terms, to an NDA or BLA holder or subsequent filer that is-- (A) a person, partnership, or corporation over which the Commission has authority pursuant to section 5(a)(2) of the Federal Trade Commission Act (15 U.S.C. 45(a)(2)); or (B) a person, partnership, or corporation over which the Commission would have authority pursuant to such section but for the fact that such person, partnership, or corporation is not organized to carry on business for its own profit or that of its members. (2) Unfair or deceptive acts or practices enforcement authority.-- (A) In general.--A violation of this section shall be treated as an unfair or deceptive act or practice in violation of section 5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 45(a)(1)). (B) Powers of commission.--Except as provided in subparagraph (C) and paragraphs (1)(B) and (3)-- (i) the Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this section; and (ii) any NDA or BLA holder or subsequent filer that violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act. (C) Judicial review.--In the case of a cease and desist order issued by the Commission under section 5 of the Federal Trade Commission Act (15 U.S.C. 45) for violation of this section, a party to such order may obtain judicial review of such order as provided in such section 5, except that-- (i) such review may only be obtained in-- (I) the United States Court of Appeals for the District of Columbia Circuit; (II) the United States Court of Appeals for the circuit in which the ultimate parent entity, as defined in section 801.1(a)(3) of title 16, Code of Federal Regulations, or any successor thereto, of the NDA or BLA holder (if any such holder is a party to such order) is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) or an approved application that is deemed to be a license for a biological product under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148; 124 Stat. 817) is submitted to the Commissioner of Food and Drugs; or (III) the United States Court of Appeals for the circuit in which the ultimate parent entity, as so defined, of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) is submitted to the Commissioner of Food and Drugs; and (ii) the petition for review shall be filed in the court not later than 30 days after such order is served on the party seeking review. (3) Additional enforcement authority.-- (A) Civil penalty.--The Commission may commence a civil action to recover a civil penalty in a district court of the United States against any NDA or BLA holder or subsequent filer that violates this section. (B) Special rule for recovery of penalty if cease and desist order issued.-- (i) In general.--If the Commission has issued a cease and desist order in a proceeding under section 5 of the Federal Trade Commission Act (15 U.S.C. 45) for violation of this section-- (I) the Commission may commence a civil action under subparagraph (A) to recover a civil penalty against any party to such order at any time before the expiration of the 1-year period beginning on the date on which such order becomes final under section 5(g) of such Act (15 U.S.C. 45(g)); and (II) in such civil action, the findings of the Commission as to the material facts in such proceeding shall be conclusive, unless-- (aa) the terms of such order expressly provide that the Commission's findings shall not be conclusive; or (bb) such order became final by reason of section 5(g)(1) of such Act (15 U.S.C. 45(g)(1)), in which case such findings shall be conclusive if supported by evidence. (ii) Relationship to penalty for violation of an order.-- The penalty provided in clause (i) for violation of this section is separate from and in addition to any penalty that may be incurred for violation of an order of the Commission under section 5(l) of the Federal Trade Commission Act (15 U.S.C. 45(l)). (C) Amount of penalty.-- (i) In general.--The amount of a civil penalty imposed in a civil action under subparagraph (A) on a party to an agreement described in subsection (a) shall be sufficient to deter violations of this section, but in no event greater than-- (I) if such party is the NDA or BLA holder (or, in the case of an agreement between two subsequent filers, the subsequent filer who gave the value described in subsection (a)(1)), the greater of-- (aa) 3 times the value received by such NDA or BLA holder (or by such subsequent filer) that is reasonably attributable to the violation of this section; or (bb) 3 times the value given to the subsequent filer (or to the other subsequent filer) reasonably attributable to the violation of this section; and (II) if such party is the subsequent filer (or, in the case of an agreement between two subsequent filers, the subsequent filer who received the value described in subsection (a)(1)), 3 times [[Page H3870]] the value received by such subsequent filer that is reasonably attributable to the violation of this section. (ii) Factors for consideration.--In determining such amount, the court shall take into account-- (I) the nature, circumstances, extent, and gravity of the violation; (II) with respect to the violator, the degree of culpability, any history of violations, the ability to pay, any effect on the ability to continue doing business, profits earned by the NDA or BLA holder (or, in the case of an agreement between two subsequent filers, the subsequent filer who gave the value described in subsection (a)(1)), compensation received by the subsequent filer (or, in the case of an agreement between two subsequent filers, the subsequent filer who received the value described in subsection (a)(1)), and the amount of commerce affected; and (III) other matters that justice requires. (D) Injunctions and other equitable relief.--In a civil action under subparagraph (A), the United States district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate. (4) Remedies in addition.--Remedies provided in this subsection are in addition to, and not in lieu of, any other remedy provided by Federal law. (5) Preservation of authority of commission.--Nothing in this section shall be construed to affect any authority of the Commission under any other provision of law. (e) Federal Trade Commission Rulemaking.--The Commission may, in its discretion, by rule promulgated under section 553 of title 5, United States Code, exempt from this section certain agreements described in subsection (a) if the Commission finds such agreements to be in furtherance of market competition and for the benefit of consumers. (f) Antitrust Laws.--Nothing in this section shall modify, impair, limit, or supersede the applicability of the antitrust laws as defined in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12(a)), and of section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent that such section 5 applies to unfair methods of competition. Nothing in this section shall modify, impair, limit, or supersede the right of a subsequent filer to assert claims or counterclaims against any person, under the antitrust laws or other laws relating to unfair competition. (g) Definitions.--In this section: (1) Agreement resolving or settling a covered patent infringement claim.--The term ``agreement resolving or settling a covered patent infringement claim'' means any agreement that-- (A) resolves or settles a covered patent infringement claim; or (B) is contingent upon, provides for a contingent condition for, or is otherwise related to the resolution or settlement of a covered patent infringement claim. (2) Commission.--The term ``Commission'' means the Federal Trade Commission. (3) Covered patent infringement claim.--The term ``covered patent infringement claim'' means an allegation made by the NDA or BLA holder to a subsequent filer (or, in the case of an agreement between two subsequent filers, by one subsequent filer to another), whether or not included in a complaint filed with a court of law, that-- (A) the submission of the application described in subparagraph (A) or (B) of paragraph (9), or the manufacture, use, offering for sale, sale, or importation into the United States of a covered product that is the subject of such an application-- (i) in the case of an agreement between an NDA or BLA holder and a subsequent filer, infringes any patent owned by, or exclusively licensed to, the NDA or BLA holder of the covered product; or (ii) in the case of an agreement between two subsequent filers, infringes any patent owned by the subsequent filer; or (B) in the case of an agreement between an NDA or BLA holder and a subsequent filer, the covered product to be manufactured under such application uses a covered product as claimed in a published patent application. (4) Covered product.--The term ``covered product'' means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g))), including a biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)). (5) NDA or bla holder.--The term ``NDA or BLA holder'' means-- (A) the holder of-- (i) an approved new drug application filed under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) for a covered product; or (ii) a biologics license application filed under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product; (B) a person owning or controlling enforcement of the patent on-- (i) the list published under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) in connection with the application described in subparagraph (A)(i); or (ii) any list published under section 351 of the Public Health Service Act (42 U.S.C. 262) comprised of patents associated with biologics license applications filed under section 351(a) of such Act (42 U.S.C. 262(a)); or (C) the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any entity described in subparagraph (A) or (B) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities. (6) Patent.--The term ``patent'' means a patent issued by the United States Patent and Trademark Office. (7) Statutory exclusivity.--The term ``statutory exclusivity'' means those prohibitions on the submission or approval of drug applications under clauses (ii) through (iv) of section 505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) through (iv) of section 505(j)(5)(F) (5-year and 3-year exclusivity), section 505(j)(5)(B)(iv) (180-day exclusivity), section 527 (orphan drug exclusivity), section 505A (pediatric exclusivity), or section 505E (qualified infectious disease product exclusivity) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 360cc, 355a, 355f), or prohibitions on the submission or licensing of biologics license applications under section 351(k)(6) (interchangeable biological product exclusivity) or section 351(k)(7) (biological product reference product exclusivity) of the Public Health Service Act (42 U.S.C. 262(k)(6), (7)). (8) Subsequent filer.--The term ``subsequent filer'' means-- (A) in the case of a drug, a party that owns or controls an abbreviated new drug application submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) or a new drug application submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 355(b)(2)) and filed under section 505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or has the exclusive rights to distribute the covered product that is the subject of such application; or (B) in the case of a biological product, a party that owns or controls an application filed with the Food and Drug Administration under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) or has the exclusive rights to distribute the biological product that is the subject of such application. (h) Effective Date.--This section applies with respect to agreements described in subsection (a) entered into on or after the date of the enactment of this Act. SEC. 112. NOTICE AND CERTIFICATION OF AGREEMENTS. (a) Notice of All Agreements.--Section 1111(7) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note) is amended by inserting ``or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making, using, offering to sell, selling, or importing into the United States a biological product that is the subject of a biosimilar biological product application'' before the period at the end. (b) Certification of Agreements.--Section 1112 of such Act (21 U.S.C. 355 note) is amended by adding at the end the following: ``(d) Certification.--The Chief Executive Officer or the company official responsible for negotiating any agreement under subsection (a) or (b) that is required to be filed under subsection (c) shall, within 30 days of such filing, execute and file with the Assistant Attorney General and the Commission a certification as follows: `I declare that the following is true, correct, and complete to the best of my knowledge: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification-- `` `(1) represent the complete, final, and exclusive agreement between the parties; `` `(2) include any ancillary agreements that are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to, the referenced agreement; and `` `(3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.'.''. SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ``section 111 of the Strengthening Health Care and Lowering Prescription Drug Costs Act or'' after ``that the agreement has violated''. SEC. 114. COMMISSION LITIGATION AUTHORITY. Section 16(a)(2) of the Federal Trade Commission Act (15 U.S.C. 56(a)(2)) is amended-- (1) in subparagraph (D), by striking ``or'' after the semicolon; (2) in subparagraph (E), by inserting ``or'' after the semicolon; and (3) by inserting after subparagraph (E) the following: ``(F) under section 111(d)(3)(A) of the Strengthening Health Care and Lowering Prescription Drug Costs Act;''. SEC. 115. STATUTE OF LIMITATIONS. (a) In General.--Except as provided in subsection (b), the Commission shall commence any administrative proceeding or civil action to enforce section 111 of this Act not later than 6 years after the date on which the parties to the agreement file the Notice of Agreement as provided by section 1112(c)(2) and (d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note). (b) Civil Action After Issuance of Cease and Desist Order.--If the Commission has issued a cease and desist order under section 5 of the Federal Trade Commission Act (15 U.S.C. 45) for violation of section 111 of this Act and the proceeding for the issuance of such order was commenced within the period required by subsection (a) of this section, such subsection does not prohibit the commencement, after such period, of a civil action under section [[Page H3871]] 111(d)(3)(A) against a party to such order or a civil action under subsection (l) of such section 5 for violation of such order. Subtitle C--Creating and Restoring Equal Access to Equivalent Samples SEC. 121. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL PRODUCTS. (a) Definitions.--In this section-- (1) the term ``commercially reasonable, market-based terms'' means-- (A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-3a(c)(6)(B)); (B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and (C) no additional conditions are imposed on the sale of the covered product; (2) the term ``covered product''-- (A) means-- (i) any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262); (ii) any combination of a drug or biological product described in clause (i); or (iii) when reasonably necessary to support approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or section 351 of the Public Health Service Act (42 U.S.C. 262), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and (B) does not include any drug or biological product that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e), unless-- (i) the drug or biological product has been on the drug shortage list in effect under such section 506E continuously for more than 6 months; or (ii) the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage. (3) the term ``device'' has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); (4) the term ``eligible product developer'' means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); (5) the term ``license holder'' means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) for a covered product; (6) the term ``REMS'' means a risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1); (7) the term ``REMS with ETASU'' means a REMS that contains elements to assure safe use under section 505-1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)); (8) the term ``Secretary'' means the Secretary of Health and Human Services; (9) the term ``single, shared system of elements to assure safe use'' means a single, shared system of elements to assure safe use under section 505-1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)); and (10) the term ``sufficient quantities'' means an amount of a covered product that the eligible product developer determines allows it to-- (A) conduct testing to support an application under-- (i) subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or (ii) section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); and (B) fulfill any regulatory requirements relating to approval of such an application. (b) Civil Action for Failure To Provide Sufficient Quantities of a Covered Product.-- (1) In general.--An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms. (2) Elements.-- (A) In general.--To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence-- (i) that-- (I) the covered product is not subject to a REMS with ETASU; or (II) if the covered product is subject to a REMS with ETASU-- (aa) the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and (bb) the eligible product developer has provided a copy of the covered product authorization to the license holder; (ii) that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms; (iii) that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder; and (iv) that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms-- (I) for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and (II) for a covered product that is subject to a REMS with ETASU, by 31 days after the later of-- (aa) the date on which the license holder received the request for the covered product; or (bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B). (B) Authorization for covered product subject to a rems with etasu.-- (i) Request.--An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU. (ii) Authorization.--Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of-- (I) development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or (II) development and testing that involves human clinical trials, if the eligible product developer has-- (aa)(AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or (BB) otherwise satisfied the Secretary that such protections will be provided; and (bb) met any other requirements the Secretary may establish. (iii) Notice.--A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product. (3) Affirmative defense.--In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence-- (A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- (i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and (ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms; (B) that-- (i) the license holder sells the covered product through agents, distributors, or wholesalers; (ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and (iii) the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or (C) that the license holder made an offer to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- (i) for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or (ii) for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder. (4) Methods for transmission of requests for covered products.--A written request for a covered product, offer to sell a covered product, or acceptance of such an offer between the eligible product developer and the license holder shall be made by-- (A) certified or registered mail with return receipt requested; (B) personal delivery; or (C) electronic means. (5) Remedies.-- (A) In general.--If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall-- (i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms; (ii) award to the eligible product developer reasonable attorney's fees and costs of the civil action; and (iii) award to the eligible product developer a monetary amount sufficient to deter the license [[Page H3872]] holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence-- (I) that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or (II) that the license holder failed to comply with an order issued under clause (i). (B) Maximum monetary amount.--A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period-- (i) beginning on-- (I) for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or (II) for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of-- (aa) the date on which the license holder received the request; or (bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and (ii) ending on the date on which the eligible product developer received sufficient quantities of the covered product. (C) Avoidance of delay.--The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award. (c) Limitation of Liability.--A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer. (d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the following new subsection: ``(l) Provision of Samples Not a Violation of Strategy.-- The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 121(a) of the Strengthening Health Care and Lowering Prescription Drug Costs Act) shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug.''. (e) Rule of Construction.-- (1) Definition.--In this subsection, the term ``antitrust laws''-- (A) has the meaning given the term in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12); and (B) includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent that such section applies to unfair methods of competition. (2) Antitrust laws.--Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws. SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS. Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), as amended by section 121, is further amended-- (1) in subsection (g)(4)(B)-- (A) in clause (i) by striking ``or'' after the semicolon; (B) in clause (ii) by striking the period at the end and inserting ``; or''; and (C) by adding at the end the following: ``(iii) accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug.''; (2) in subsection (i)(1), by striking subparagraph (C) and inserting the following: ``(C)(i) Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) may use-- ``(I) a single, shared system with the listed drug under subsection (f); or ``(II) a different, comparable aspect of the elements to assure safe use under subsection (f). ``(ii) The Secretary may require a drug that is the subject of an application under section 505(j) and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).''; (3) in subsection (i), by adding at the end the following: ``(3) Shared rems.--If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 505(j), the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 505(j) or 505(b) that references the same listed drug.''; and (4) by adding at the end the following: ``(m) Separate REMS.--When used in this section, the terms `different, comparable aspect of the elements to assure safe use' or `different, comparable approved risk evaluation and mitigation strategies' means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy.''. SEC. 123. RULE OF CONSTRUCTION. (a) In General.--Nothing in this subtitle, the amendments made by this subtitle, or in section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), shall be construed as-- (1) prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle; or (2) in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 505-1, with respect to such covered product. (b) Definitions.--In this section, the terms ``covered product'', ``eligible product developer'', ``license holder'', and ``REMS with ETASU'' have the meanings given such terms in section 121(a). TITLE II--HEALTH INSURANCE MARKET STABILIZATION SEC. 201. PRESERVING STATE OPTION TO IMPLEMENT HEALTH CARE MARKETPLACES. (a) In General.--Section 1311 of the Patient Protection and Affordable Care Act (42 U.S.C. 18031) is amended-- (1) in subsection (a)-- (A) in paragraph (4)(B), by striking ``under this subsection'' and inserting ``under this paragraph or paragraph (1)''; and (B) by adding at the end the following new paragraph: ``(6) Additional planning and establishment grants.-- ``(A) In general.--There shall be appropriated to the Secretary, out of any moneys in the Treasury not otherwise appropriated, $200,000,000 to award grants to eligible States for the uses described in paragraph (3). ``(B) Duration and renewability.--A grant awarded under subparagraph (A) shall be for a period of two years and may not be renewed. ``(C) Limitation.--A grant may not be awarded under subparagraph (A) after December 31, 2022. ``(D) Eligible state defined.--For purposes of this paragraph, the term `eligible State' means a State that, as of the date of the enactment of this paragraph, is not operating an Exchange (other than an Exchange described in section 155.200(f) of title 45, Code of Federal Regulations).''; and (2) in subsection (d)(5)(A)-- (A) by striking ``operations.--In establishing an Exchange under this section'' and inserting ``operations.-- ``(i) In general.--In establishing an Exchange under this section (other than in establishing an Exchange pursuant to a grant awarded under subsection (a)(6))''; and (B) by adding at the end the following: ``(ii) Additional planning and establishment grants.--In establishing an Exchange pursuant to a grant awarded under subsection (a)(6), the State shall ensure that such Exchange is self-sustaining beginning on January 1, 2024, including allowing the Exchange to charge assessments or user fees to participating health insurance issuers, or to otherwise generate funding, to support its operations.''. (b) Clarification Regarding Failure to Establish Exchange or Implement Requirements.--Section 1321(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18041(c)) is amended-- (1) in paragraph (1), by striking ``If'' and inserting ``Subject to paragraph (3), if''; and (2) by adding at the end the following new paragraph: ``(3) Clarification.--This subsection shall not apply in the case of a State that elects to apply the requirements described in subsection (a) and satisfies the requirement described in subsection (b) on or after January 1, 2014.''. SEC. 202. PROVIDING FOR ADDITIONAL REQUIREMENTS WITH RESPECT TO THE NAVIGATOR PROGRAM. (a) In General.--Section 1311(i) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(i)) is amended-- (1) in paragraph (2), by adding at the end the following new subparagraph: ``(C) Selection of recipients.--In the case of an Exchange established and operated by the Secretary within a State pursuant to section 1321(c), in awarding grants under paragraph (1), the Exchange shall-- ``(i) select entities to receive such grants based on an entity's demonstrated capacity to carry out each of the duties specified in paragraph (3); ``(ii) not take into account whether or not the entity has demonstrated how the entity will provide information to individuals relating to group health plans offered by a group or association of employers described in section 2510.3-5(b) of title 29, Code of Federal Regulations (or any successor regulation), or short-term limited duration insurance (as defined by the Secretary for purposes of section 2791(b)(5) of the Public Health Service Act); and ``(iii) ensure that, each year, the Exchange awards such a grant to-- ``(I) at least one entity described in this paragraph that is a community and consumer-focused nonprofit group; and ``(II) at least one entity described in subparagraph (B), which may include another community and consumer-focused nonprofit group in addition to any such group awarded a grant pursuant to subclause (I). In awarding such grants, an Exchange may consider an entity's record with respect to waste, fraud, and abuse for purposes of maintaining the integrity of such Exchange.''. [[Page H3873]] (2) in paragraph (3)-- (A) in subparagraph (C), by inserting after ``qualified health plans'' the following: ``, State medicaid plans under title XIX of the Social Security Act, and State child health plans under title XXI of such Act''; and (B) by adding at the end the following flush left sentence: ``The duties specified in the preceding sentence may be carried out by such a navigator at any time during a year.''; (3) in paragraph (4)(A)-- (A) in the matter preceding clause (i), by striking ``not''; (B) in clause (i)-- (i) by inserting ``not'' before ``be''; and (ii) by striking ``; or'' and inserting ``;''; (C) in clause (ii)-- (i) by inserting ``not'' before ``receive''; and (ii) by striking the period and inserting ``; and''; and (D) by adding at the end the following new clause: ``(iii) maintain physical presence in the State of the Exchange so as to allow in-person assistance to consumers.''; and (4) in paragraph (6)-- (A) by striking ``Funding.--Grants under'' and inserting ``Funding.-- ``(A) State exchanges.--Grants under''; and (B) by adding at the end the following new subparagraph: ``(B) Federal exchanges.--For purposes of carrying out this subsection, with respect to an Exchange established and operated by the Secretary within a State pursuant to section 1321(c), the Secretary shall obligate $100,000,000 out of amounts collected through the user fees on participating health insurance issuers pursuant to section 156.50 of title 45, Code of Federal Regulations (or any successor regulations) for fiscal year 2020 and each subsequent fiscal year. Such amount for a fiscal year shall remain available until expended.''. (b) Effective Date.--The amendments made by subsection (a) shall apply with respect to plan years beginning on or after January 1, 2020. SEC. 203. FEDERAL EXCHANGE OUTREACH AND EDUCATIONAL ACTIVITIES. Section 1321(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18041(c)), as amended by section 201(b)(2), is further amended by adding at the end the following new paragraph: ``(4) Outreach and educational activities.-- ``(A) In general.--In the case of an Exchange established or operated by the Secretary within a State pursuant to this subsection, the Secretary shall carry out outreach and educational activities for purposes of informing individuals about qualified health plans offered through the Exchange, including by informing such individuals of the availability of coverage under such plans and financial assistance for coverage under such plans. Such outreach and educational activities shall be provided in a manner that is culturally and linguistically appropriate to the needs of the populations being served by the Exchange (including hard-to- reach populations, such as racial and sexual minorities, limited English proficient populations, and young adults). ``(B) Limitation on use of funds.--No funds appropriated under this paragraph shall be used for expenditures for promoting non-ACA compliant health insurance coverage. ``(C) Non-ACA compliant health insurance coverage.--For purposes of subparagraph (B): ``(i) The term `non-ACA compliant health insurance coverage' means health insurance coverage, or a group health plan, that is not a qualified health plan. ``(ii) Such term includes the following: ``(I) An association health plan. ``(II) Short-term limited duration insurance. ``(D) Funding.--Out of any funds in the Treasury not otherwise appropriated, there are hereby appropriated for fiscal year 2020 and each subsequent fiscal year, $100,000,000 to carry out this paragraph. Funds appropriated under this subparagraph shall remain available until expended.''. SEC. 204. SHORT-TERM LIMITED DURATION INSURANCE RULE PROHIBITION. The Secretary of Health and Human Services, the Secretary of the Treasury, and the Secretary of Labor may not take any action to implement, enforce, or otherwise give effect to the rule entitled ``Short-Term, Limited Duration Insurance'' (83 Fed. Reg. 38212 (August 3, 2018)), and the Secretaries may not promulgate any substantially similar rule. TITLE III--BUDGETARY EFFECTS SEC. 301. DETERMINATION OF BUDGETARY EFFECTS. The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled ``Budgetary Effects of PAYGO Legislation'' for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage. The Acting CHAIR. No further amendment to the bill, as amended, shall be in order except those printed in House Report 116-61. Each such further amendment may be offered only in the order printed in the report, by a Member designated in the report, shall be considered read, shall be debatable for the time specified in the report, equally divided and controlled by the proponent and an opponent, shall not be subject to amendment, and shall not be subject to a demand for division of the question. Amendment No. 1 Offered by Mr. Pallone The Acting CHAIR. It is now in order to consider amendment No. 1 printed in House Report 116-61. Mr. PALLONE. Mr. Chairman, I have an amendment at the desk. The Acting CHAIR. The Clerk will designate the amendment. The text of the amendment is as follows: Page 28, strike lines 8 through 11 and insert the following: (iii) that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder and such request-- (I) was sent to a named corporate officer of the license holder; (II) was made by certified or registered mail with return receipt requested; (III) specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual; and (IV) specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product; and Page 32, strike lines 15 through 18 and insert the following: (C) that the license holder made an offer to the individual specified pursuant to paragraph (2)(A)(iii)(III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- Page 33, strike lines 13 through 22. Page 33, line 23, strike ``(5)'' and insert ``(4)''. The Acting CHAIR. Pursuant to House Resolution 377, the gentleman from New Jersey (Mr. Pallone) and a Member opposed each will control 5 minutes. The Chair recognizes the gentleman from New Jersey. Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I have an amendment sponsored by myself and the ranking member of the full committee, Mr. Walden. We have been considering the CREATES Act and legislation like it for years, and it has long been one of my top priorities. So I was pleased to announce a bipartisan amendment that gained the support of our Republican colleagues during the Energy and Commerce Committee's consideration of the CREATES bill. There was only one outstanding concern still to be resolved after that amendment was adopted. And I am pleased now to offer a bipartisan solution to address that concern today. The concern raised during our full committee markup was that there was a lack of specificity in the provisions that describe the communication requirements related to the request and the delivery of the requested samples between the eligible product developer and the license holder. This bipartisan amendment filed by myself and my colleague, the ranking member of the Energy and Commerce Committee, Mr. Walden, will provide the additional needed clarity to ensure that communication requirements in these negotiations are understood so that there is certainty for both parties. So I think we have found agreement with our colleagues across the aisle around a shared goal of discouraging anti-competitive conduct and providing certainty to both brand and generic manufacturers about the sample requests and delivery process. I appreciate the ranking member and his staff for working with me in good faith on this legislation and urge all my colleagues to vote in support of this amendment. Mr. Chairman, I reserve the balance of my time. {time} 1445 Mr. SHIMKUS. Mr. Chairman, I claim the time in opposition, although I do not oppose this amendment. The Acting CHAIR. Without objection, the gentleman from Illinois is recognized for 5 minutes. There was no objection. Mr. SHIMKUS. Mr. Chair, the chairman of the full committee is correct. We appreciate his help and support in working through these technical corrections. We don't oppose them, and with that, I yield back the balance of my time. Mr. PALLONE. Mr. Chairman, I appreciate the comments from the gentleman from Illinois. [[Page H3874]] Again, this is an effort to try to make sure that when a patent expires that the samples or formula are given to generic, so they can develop a generic alternative. That is what the CREATES Act is all about. I would urge support for my amendment, and I yield back the balance of my time. The Acting CHAIR. The question is on the amendment offered by the gentleman from New Jersey (Mr. Pallone). The amendment was agreed to. Amendment No. 2 Offered by Mr. McKinley The Acting CHAIR. It is now in order to consider amendment No. 2 printed in House Report 116-61. Mr. McKINLEY. Mr. Chairman, I rise as the designee of the gentleman from Indiana (Mr. Bucshon), and I have an amendment at the desk. The Acting CHAIR. The Clerk will designate the amendment. The text of the amendment is as follows: Strike title II (and redesignate the subsequent title and update the table of contents accordingly). The Acting CHAIR. Pursuant to House Resolution 377, the gentleman from West Virginia (Mr. McKinley) and a Member opposed each will control 5 minutes. The Chair recognizes the gentleman from West Virginia. Mr. McKINLEY. Mr. Chairman, the bills to recognize lower drug prices passed the Energy and Commerce Committee with unanimous bipartisan support. They were genuine efforts to address the most expensive component of healthcare, but Democrats have packaged these bipartisan drug-pricing solutions with controversial, ideologically driven legislation that will not be taken up by the Senate. Shame on them. So here we go again. According to The Washington Post, in so doing, the Democrats have put a pothole in the path of drug pricing. We have all seen the charts and seen the quotes here earlier in the day. Mr. Chairman, as the 11th-most bipartisan Member of the House, I recognize the importance of playing nice in the sandbox and putting good legislation before politics. This combination fails that test. My amendment is simple. It would strike the most controversial portions from the bill, leaving those areas that allow us to lower the cost of prescription drugs. Therefore, if your goal is to lower the cost of prescription drugs, I would encourage my friends and colleagues to vote ``yes'' on this amendment. But if you want to play politics with the healthcare of Americans and see this bill stopped in the Senate, then vote ``no,'' and you will see what happens. Mr. Chair, I reserve the balance of my time. Mr. PALLONE. Mr. Chairman, I claim the time in opposition to the amendment. The Acting CHAIR. The gentleman from New Jersey is recognized for 5 minutes. Mr. PALLONE. Mr. Chair, I yield myself 2 minutes. Mr. Chairman, I am very disappointed that my Republican colleagues want to strike all of the ACA stabilization measures that we passed through our committee. These are important bills that should have strong bipartisan support, but, unfortunately, my Republican colleagues continue to be unwilling to work together on commonsense proposals that would lower healthcare costs for consumers. Funding for outreach and marketing, why is this even controversial to my Republican colleagues? Outreach and advertising are critical to ensuring that people know about the option to enroll in comprehensive coverage. We know that last year just one in four uninsured people who buy their own insurance were aware of the open enrollment season and the deadline to enroll in coverage. Another commonsense proposal to lower healthcare costs is to provide funds to States to set up State-based marketplaces. Again, why is this controversial? Over the last few years, State-based marketplaces have had lower premiums and better enrollment than the Federal marketplace. Enrollment on healthcare.gov has declined due to the Trump administration's sabotage. Enrollment in the State-based marketplaces has actually increased. The navigator funding provisions the Republicans are trying to strike from the bill, again, this is a program to help hard-to-reach individuals sign up for comprehensive coverage. Finally, the Republicans want to remove protection that would block the Trump administration's expansion of junk insurance plans that discriminate against people with preexisting conditions. I really can't understand why my Republican colleagues who claim to support protections for preexisting conditions want to defend these plans that discriminate against preexisting conditions and put consumers at extreme financial risk, other than the fact this is a Trump administration initiative, so they don't want to oppose it. In addition to discriminating against people with preexisting conditions, these junk plans exclude coverage for many important benefits, such as maternity care. And even when you think you are covered, if you get sick while you are on one of these, the insurance companies find a way to avoid paying the bill. So in closing, this amendment demonstrates what we all know clearly: that Republicans don't want to do anything to actually help lower healthcare costs for Americans or safeguard preexisting condition protections. Mr. Chair, I urge opposition to this amendment, and I reserve the balance of my time. Mr. McKINLEY. Mr. Chairman, this is the third time today I have heard the word ``sabotage'' so that must be the new operative word coming from my colleagues across the aisle. I would submit to you, I will turn the table back because if there is someone trying to sabotage the effort of lowering healthcare prices, it is you. Our chairman on the other side, however, I think genuinely wanted to lower the healthcare prices when the bills came out in a nonpartisan fashion which was universally adopted by us. But someplace from the time they left Energy and Commerce to the time they came to the floor, they were put into something that the Senate has already indicated they have no appetite for. So if we truly want to lower healthcare prices in this vote, then it is a ``yes'' vote. But if you want to sabotage this legislation, you go right ahead and do what you have to do. So I know, Mr. Chairman, there were good efforts here, bipartisan efforts to try to get something done. It looks like something has crept in to cause a problem. Mr. Chair, I yield back the balance of my time. The Acting CHAIR. Members are advised to address their remarks to the Chair. Mr. PALLONE. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Florida (Ms. Castor). Ms. CASTOR of Florida. Mr. Chairman, we are trying to turn back the sabotage of the Trump administration on people's healthcare for the folks back home who we represent. The Trump administration has done everything they can to make it more expensive, whether we are talking about prescription drugs or that all-important health insurance policy. Don't just take it from me and my Democratic colleagues. Take it from folks who are on the side of our families day in and day out: the American Cancer Society Cancer Action Network, the American Diabetes Association, the American Heart Association, and the American Lung Association. I could go on and on. Mr. Chair, I include in the Record letters from over 20 health groups that represent our families back home who say: Pass this bill. May 15, 2019. Hon. Kathy Castor, House of Representatives, Washington, DC. Dear Representative Castor: The 23 undersigned organizations, representing millions of American patients, providers, and consumers, write today in strong support of H.R. 1010, To provide that the rule entitled ``Short-Term, Limited Duration Insurance ``shall have no force or effect,'' which is now included in H.R. 987. Our organizations strongly support providing protections for patients from short-term, limited-duration (STLDI or short-term) plans and support preventing action on implementing or enforcing the ``Short- Term, Limited-Duration Insurance'' final rule (83 FR 38212, published August 3, 2018). Our organizations remain concerned about this final rule which expands the maximum [[Page H3875]] duration of short-term health insurance plans from three months to 364 days. Previously, short term plans were available to fill a temporary gap in coverage, such as gaps in employment. However, since the rule was finalized, the growth and availability of these products continues to threaten patients with pre-existing conditions because insurers offering these policies can either deny coverage or charge higher premiums to individuals with pre-existing conditions. Expanding access to these policies could cause premiums in the marketplace to increase, as younger and healthier individuals choose to enroll in the short-term plans. This forces individuals with serious or chronic conditions into a smaller, sicker risk pool to obtain the coverage they need to manage their health. Premiums for these comprehensive plans would likely skyrocket, making insurance unaffordable. Short-term plans also lack patient protections guaranteed by the Affordable Care Act (ACA), severely impacting individuals with serious or chronic health conditions. Plan providers are permitted to consider pre-existing conditions in decisions to deny coverage, charge higher premiums, or not cover certain care and treatments. After enrolling in a short-term plan, providers are permitted to rescind or amend coverage based on new health issues. Short-term plans are not required to cover all of the Essential Health Benefits (EHBs) categories outlined in the ACA, potentially forcing individuals to pay out-of-pocket for expensive treatments. These plans can also impose lifetime and annual limits on coverage and do not require limits on out-of-pocket expenses and deductibles. H.R. 1010 would both protect patients and consumers from substandard insurance products and assist in stabilizing the marketplace. The decreased up-front costs of short-term plans may be more appealing to younger, healthier individuals, thus, dividing the individual marketplace risk pool. Segmenting the market in this way will result in increased premiums for comprehensive ACA-compliant plans in the marketplace, decreasing marketplace stability, and reducing affordable access to insurance. It is for these reasons we enthusiastically endorse your legislation and urge Congress to act swiftly to limit the sale of short-term insurance plans. People with pre-existing conditions need access to adequate, affordable health insurance. Again, our organizations thank you for your leadership on this critical issue for people with pre- existing conditions, and we support your efforts to expand access to affordable health insurance. Sincerely, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Arthritis Foundation, Cystic Fibrosis Foundation, Epilepsy Foundation, Hemophilia Federation of America, Leukemia & Lymphoma Society, Lutheran Services in America, March of Dimes, Mended Little Hearts, Muscular Dystrophy Association. National Alliance on Mental Illness, National Coalition for Cancer Survivorship, National Health Council, National Hemophilia Foundation, National Multiple Sclerosis Society, National Organization for Rare Disorders, National Patient Advocate Foundation, National Psoriasis Foundation, Susan G. Kamen, The ALS Association, Women Heart: The National Coalition for Women with Heart Disease. ____ May 15, 2019. Hon. Kathy Castor, House of Representatives, Washington, DC. Dear Representative Castor: The 23 undersigned organizations, representing millions of American patients, providers, and consumers, write today in strong support of H.R. 1386, Expand Navigator's Resources for Outreach, Learning, and Longevity (ENROLL) Act of 2019, which is now included as a provision in H.R. 987. Our organizations recognize the importance of navigator programs to assist potential enrollees with the open enrollment process. Your legislation will guarantee resources for navigators, allowing them to continue the important work of educating Americans about their coverage and enrollment options. In March 2017, we identified three overarching principles to guide and measure any work to further reform and improve the nation's health insurance system. Our core principles are that health insurance coverage must be adequate, affordable, and accessible. Together, our organizations understand what individuals and families need to prevent disease, manage health, and cure illness. Our organizations are deeply concerned about cuts to these services and the lack of reliable resources for consumers who have questions about how to enroll in coverage. We are pleased that this legislation represents a significant and meaningful step towards increasing access to services that help consumers enroll in high-quality health care, including Medicare and Medicaid. Cuts to navigators and outreach and enrollment activities since 2016 have taken away resources that help consumers understand and select health care coverage. Navigators and consumer assisters are critical to educating the public about their health insurance options and helping individuals enroll in appropriate coverage. Navigators conduct outreach and must provide fair, accurate, unbiased, and culturally appropriate information to individuals and families regarding eligibility and enrollment requirements for the marketplaces and other state health insurance programs. They are valuable allies to consumers seeking affordable coverage that meets their needs. Many navigators also provide in-person help to low-income and rural communities, consumers with limited English proficiency, people with disabilities, and other populations for whom such assistance is not often available. We strongly and enthusiastically support your legislation to preserve funding for navigator programs. Informed enrollees can choose plans that provide the coverage they need at prices they can afford. Research has shown that states that devote robust resources to marketing, outreach, and enrollment assistance programs experience higher rates of enrollment compared to those who do not. Providing resources to ease the enrollment process will help stabilize the marketplace and result in lower premiums for many enrollees. People with pre-existing conditions need access to adequate, affordable health insurance. In order to be accessible, potential enrollees need to understand open enrollment and coverage options. With the increase of coverage options that are not compliant with the Affordable Care Act (ACA), such as short-term, limited-duration insurance plans, navigator programs are particularly important to allow uninsured individuals to make informed decisions. This legislation will keep this information accessible to all. Again, our organizations thank you for your leadership on this critical issue for people with pre- existing conditions, and we support your efforts to expand access to affordable health insurance. Sincerely, American Cancer Society Cancer Action Network, American Diabetes Association, American Heart Association, American Lung Association, Arthritis Foundation, Cystic Fibrosis Foundation, Epilepsy Foundation, Hemophilia Federation of America, Leukemia & Lymphoma Society, Lutheran Services in America, Mended Little Hearts. Muscular Dystrophy Association, National Alliance on Mental Illness, National Coalition for Cancer Survivorship, National Health Council, National Hemophilia Foundation, National Kidney Foundation, National Multiple Sclerosis Society, National Organization for Rare Disorders, National Patient Advocate Foundation, National Psoriasis Foundation, Susan G. Komen, Women Heart: The National Coalition for Women with Heart Disease. Ms. CASTOR of Florida. Mr. Chair, I wanted to make one more important point. I have heard so much misinformation today from my colleagues on the other side of the aisle who have denigrated our navigators. They say agents and brokers can do the job of helping to sign up our neighbors for health insurance. Boy, that is not the case. Yes, agents and brokers are important, but we heard expert testimony in our committee that the navigators provide independent, trusted advice. They are our community-based folks at community health centers and groups like the American Cancer Society, who I mentioned, that understand how important it is. A lot of the agents and brokers send their customers over to navigators to sign up because the agents and brokers are not interested in going over to folks who rely on Medicaid, or the Children's Health Insurance Program. Mr. PALLONE. Mr. Chair, I yield 1\1/2\ minutes to the gentlewoman from Delaware (Ms. Blunt Rochester). Ms. BLUNT ROCHESTER. Mr. Chairman, I oppose this amendment because by stripping the ACA's stabilization bills from this package, we are reneging on the promise that we made to the American people: access to quality, affordable healthcare. This complete package of bills helps stabilize the ACA which will improve the risk pool, reduce premium cost, and lower the number of uninsured. The CBO found that my bill, the MORE Health Education Act would help 5 million Americans obtain high-quality health insurance created by the ACA. It is supported by AARP, the American Hospital Association, and a number of other organizations, as was mentioned before. From day one, there has been a concern that when we shorten the amount of time that people can enroll, when we tell them that we are not going to let them know what is even available to them, and then we take away the resources and the individuals that can help them get there, that is why we feel like we have been watching and witnessing the move backwards. What we want to do with this bill is move forward. So I urge my colleagues to reject this amendment and support the full legislative package for the people. Mr. PALLONE. Mr. Chair, I would just ask Members to oppose this amendment because it guts the effort to improve the Affordable Care Act. [[Page H3876]] Mr. Chair, I yield back the balance of my time. Ms. BLUNT ROCHESTER. Mr. Chair, I would like to revise my remarks made during debate of amendment No. 2 of H.R. 987, offered by Mr. McKinley. In my remarks, I stated that the marketing and outreach provision under Title II of H.R. 987 would increase enrollment into health plans by five million over the ten year period as estimated by the Congressional Budget Office. Due to the methodology adopted by the Congressional Budget Office to estimate the enrollment effect of the underlying measure, the figure is more appropriately represented as increasing enrollment by about 500,000 each year over the ten year period. The Acting CHAIR. The question is on the amendment offered by the gentleman from West Virginia (Mr. McKinley). The question was taken; and the Acting Chair announced that the noes appeared to have it. Mr. McKINLEY. Mr. Chair, I demand a recorded vote. The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further proceedings on the amendment offered by the gentleman from West Virginia will be postponed. Amendment No. 3 Offered by Mr. Welch The Acting CHAIR. It is now in order to consider amendment No. 3 printed in House Report 116-61. Mr. WELCH. Mr. Chairman, I have an amendment at the desk. The Acting CHAIR. The Clerk will designate the amendment. The text of the amendment is as follows: Add at the end of title II the following new section: SEC. 205. PROTECTION OF HEALTH INSURANCE COVERAGE IN CERTAIN EXCHANGES. In the case of an Exchange that the Secretary of Health and Human Services operates pursuant to section 1321(c)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18041(c)(1)), the Secretary may not implement any process that would terminate the health insurance coverage of an enrollee solely because such enrollee did not actively enroll during the most recent open enrollment period. The Acting CHAIR. Pursuant to House Resolution 377, the gentleman from Vermont (Mr. Welch) and a Member opposed each will control 5 minutes. The Chair recognizes the gentleman from Vermont. Mr. WELCH. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, this amendment, which I will describe in a moment, is about improving and preserving the Affordable Care Act. The word ``sabotage'' has been used here. We don't need that word. We have a very straightforward, very transparent difference of view. The Democrats supported and passed the Affordable Care Act. We have been defending it for years. The Republicans opposed it. President Trump made it a campaign pledge to get rid of it, and they came within a vote in the Senate, except for John McCain, of repealing the law altogether. We don't have to use words that are pejorative. We think we should have the Affordable Care Act. We think we should make it stronger, and my colleagues on the other side of the aisle want to vote against it and now want to repeal it. {time} 1500 One of the ways to make the Affordable Care Act effective is to have automatic reenrollment. If a family is in the Affordable Care Act and the time for reenrollment comes up, if they take no action, then they are automatically reenrolled in the plan that they are already in. If you take away the automatic reenrollment, folks fall off, oftentimes for no particular reason. They were doing other things; they didn't notice it; they didn't have the time; or they didn't get to a navigator. There are lots of things that come between automatic reenrollment and picking your own plan. By the way, studies have shown that automatic reenrollment, like automatic withdrawal to go into your retirement account, is very, very effective. The President has indicated a desire to get rid of the automatic reenrollment program. He hasn't done that yet. This amendment would prohibit him from doing so. There is a reason why the administration would like to get rid of automatic reenrollment. The evidence suggests that that would mean about 2 million Americans would then lose access to their healthcare because they hadn't reenrolled. We don't want that to happen. We want those American families who depend on the healthcare that they have to continue receiving that healthcare next year just like they received it this year. This amendment makes it very clear that that automatic reenrollment program would continue to be part of the Affordable Care Act. Keep in mind, it in no way limits the ability of a family or an individual to decide to get into a different plan or to affirmatively say they don't want to be in any plan. That can still happen. There is total and complete freedom of choice, but it gives security. It is going to be very beneficial to about 2 million American families. Mr. Chairman, I reserve the balance of my time. The Acting CHAIR. The Committee will rise informally. The Speaker pro tempore (Mr. DeSaulnier) assumed the chair. ____________________
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