Monthly Legislative Newsletter June 2021

President Biden’s 2021 Budget

On May 28, 2021, President Biden released his Fiscal Year 2022 Budget. The budget, which is largely a messaging document, included a number of investments related to public health. Additionally, the foundations of the President’s budget are both the American Jobs Plan and the American Families Plan, which are both pieces of legislation that President Biden introduced in order to get back on track as the tide turns on the pandemic.

President Biden’s budget includes:

• Extending the expanded health insurance tax credits that were included in the American Rescue Plan o These credits lower premiums by an average of $50 per person and making them permanent will allow upwards of 4 million uninsured people to get coverage • $131.7 billion for HHS o $25 billion increase from Fiscal Year 2021 • A total of $51 billion for NIH o $9 billion increase from Fiscal Year 2021 • Launches the Advanced Research Projects Agency for Health (ARPA-H) o The budget provides $6.5 billion to launch ARPA-H o Will initially focus on research and development spending on cancer and other diseases such as diabetes and Alzheimer’s o Goal would be to speed up health breakthroughs • $7.6 billion for NCI o Includes $50 million for the Childhood Cancer Data Initiative as well as Cancer Moonshot funding • $8.7 billion in discretionary funding for CDC in order to better prepare for the next pandemic

You can view the full fact sheet HERE.

What Does the Biden Budget Mean for Congress?

While the President’s budget is largely a messaging document, its release officially kicks the congressional appropriations process into high gear. Over the coming weeks and months, congressional committees of jurisdiction will hold hearings to examine the President’s budget in order to develop their own spending proposals. On the House of Representatives side, these hearings have been going on for a number of weeks now in order to get a jump start on the process. The Senate however, has been slower to start the process with only a few budget hearings scheduled before the release of the Biden budget.

On Wednesday, May 26, 2021, the Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education and Related Agencies met to examine the National Institutes of Health’s FY22 Budget and the State of Medical Research. Relevant topics discussed are detailed in the congressional hearings section of the newsletter.

PRG will continue to provide updates on relevant congressional hearings as necessary.

Is H.R. 3 Dead?

On May 11, 2021, 10 moderate House Democrats indicated that they could potentially be in opposition to H.R. 3, the House’s sweeping drug pricing legislation. Recently, there has been talk that any large-scale infrastructure bill using reconciliation would include H.R. 3, despite President Biden not including drug pricing reform in either the American Jobs Plan or the American Families Plan. However, should moderate Democrats officially voice their opposition and state that they are unwilling to vote for a package that includes H.R. 3, Speaker of the House (D-CA) could be forced to drop any sort of drug pricing reforms.

The group of 10 Democrats called for a smaller, more modest plan that would “preserve our invaluable innovation ecosystem.” Additionally, conservative organizations and the drug lobby are spending millions in order to influence moderate Democrat opposition. In their targeted ads, they state that H.R. 3 is a “socialist prescription drug takeover” and will send drug innovation overseas. However, it is important to note that many Democrats want to pass H.R. 3 in order to put pressure on Senate Democrats to include comprehensive drug pricing legislation in their own negotiated infrastructure package.

Due to the Democrats’ slim control of the House, Speaker Pelosi can only afford to lose 2 Democrats should the package go forward requiring a party line vote.

A quick refresher as to what is included in H.R. 3.

H.R. 3- Elijah E. Cummings Lower Drug Costs Now Act (Reintroduced on April 27, 2021 with slight adjustments)

The Five Titles in the bill are:

• Lowering Prices Through Fair Drug Price Negotiation • Prescription Drug Inflation Rebates • Part D Improvements and Maximum Out-of-Pocket Cap for Medicare Beneficiaries • Drug Price Transparency • NIH, FDA, and Opioids Funding

What does the bill do?

-2- • The legislation has the Health and Human Services Department (HHS) directly negotiate the prices of the most expensive drugs, biological products, and insulin. • The measure would cap the prices of the selected drugs at 120 percent the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom. For reference, President Trump proposed a slightly less stringent price cap of 126 percent. • The bill would require drug manufacturers to pay rebates to Medicare for drug price increases that exceed inflation. • The legislation would create a $2,000 out-of-pocket cap for Medicare prescription drug plan beneficiaries.

How would price negotiations work?

• HHS would establish a Fair Price Negotiation Program that identifies “negotiation eligible drugs.” • In 2023, the first year of the plan, HHS would publish a list of 25 drugs and biological products, along with insulin, that will be subject to negotiations. • From 2024 onward, HHS will have to select at least 50 drugs to negotiate. • HHS would select drugs with the greatest potential to result in savings for the government or individuals. It would do this by comparing the drug’s price in the US versus its average international price. • Drugs subject to negotiation would be selected from a list of 125 drugs with the greatest net spending under Medicare Advantage, Medicare Part D, and an additional list of 125 drugs with the greatest overall spending in the US. • HHS would then negotiate a “maximum fair price,” which is not to exceed 120 percent of the average international price. The maximum fair price would consider the manufacturer’s research and development (R&D) costs, unit costs of production and distribution, and comparison to existing therapeutic alternatives. • If a drug lacks international price information, the maximum fair price would be capped at no more than 85 percent of the average manufacturer price. • If a manufacturer sells above the maximum fair price, it would be subject to a civil monetary penalty equal to ten times the difference between the price they charged and the maximum fair price amount. Additionally, each violation of a fair price agreement could be subject to a civil penalty not to exceed $1 million. • If manufacturers do not enter an agreement with HHS, H.R. 3 would impose a non- deductible excise tax on the company for the days they sell the selected drug outside of an agreement.

How does this affect brain tumor drugs?

The bill would cap the prices of the most expensive drugs sold in the US. To the extent that brain tumor drugs qualify as such, then H.R. 3 would reduce their prices. The bill applies to Medicare plans, which cover cancers drugs through parts B and D—both would be subject to negotiation.

Drug manufacturers will argue that lower drug prices will undermine the innovation necessary to find new breakthrough drugs to treat conditions like brain cancer. Consumer advocates will say that the bill increases access to life-saving medicine. With regard to the claim that the bill

-3- would hurt new drug development, the legislation contains provisions that account for R&D costs and innovation when negotiating the maximum fair price. This combined with the fact that manufacturers sell the same drug for less abroad undermines the claim that high prices are necessary for innovative drug development. Consequently, do not expect research into brain tumor drugs to suffer as a result of lower drug prices.

The Congressional Budget Office estimated that the 116th Congress plan would lower spending by $456 billion over ten years with the inflation rebates saving another $36 billion. But it would also result in eight fewer new drugs being introduced to the US market over that same period. CBO has yet to score the 117th Congress legislation.

President Biden Finally Gets His CMS Pick

On May 27, 2021, Secretary of Health and Human Services officially swore in Chiquita Brooks-LaSure as Administrator of the Centers for Medicare and Medicaid Services after the Senate confirmed her nomination on May 25, 2021 with a vote of 55-44. This comes after over a month of delay due to Senate Republicans holding up her confirmation vote because of the Biden administration’s decision to withdraw Texas’s Medicaid waiver on the grounds that the Trump administration did not hold a public comment period before approving the waiver in January of 2021. Senator (R-TX) used a parliamentary procedure to put a hold on Brooks-LaSure’s nomination until a solution to the waiver issue could be reached with the Biden administration.

Brooks-LaSure is an Obama administration veteran and with her confirmation, becomes the first Black woman to lead CMS.

Telehealth Update

On May 25, 2021, Senators (D-DE) and John Cornyn (R-TX) introduced legislation that would help states expand telehealth options for low-income Americans called the Telehealth Improvement for Kids’ Essential Services (TIKES) Act of 2021. The legislation would provide federal guidance on how to integrate telehealth services into states’ Medicaid and Children’s Health Insurance Program. Additionally, the legislation would research how telehealth expansion can impact health care access, utilization, and cost.

This legislation comes as telehealth expansion continues to be a popular subject in Congress after its effective expansion and use during the pandemic. Currently, expanded telehealth access is only in effect due to the public health state of emergency, however there has been bipartisan calls to make telehealth expansion permanent after the pandemic’s conclusion. In order to make telehealth expansion permanent, there will likely need to be a legislative fix that includes solutions to problems such as Medicare reimbursement, practicing medicine across state lines, and broadband.

In a recent KEF Analysis study, it was found that 56% of telehealth visits by Medicare beneficiaries in the U.S. took place via telephone rather than computer or smart device. Under current law, telehealth visits must be conducted via two-way audio and video communications. However, the COVID-19 public health emergency temporarily relaxed those rules so that some

-4- audio-only visits could occur. These new findings could prove useful as new telehealth legislation is being brought up in both the House and Senate. It is widely thought that allowing audio-only telehealth access could provide more opportunity for seniors and underserved communities.

This new information comes as Reps. Jason Smith (R-MO) and Josh Gottheimer (D-NJ) introduced H.R. 3447, the Permanency for Audio-Only Telehealth Act. The legislation would establish coverage for providers who connect via phone or audio-only telehealth platforms with patients. Additionally, it would remove some of the geographic and originating site restrictions that are currently on Medicare coverage.

CURES 2.0 is on the Horizon

It is being reported that CURES 2.0 is expected to be released to the public in the coming weeks. Reps Diana DeGette (D-CO) and (R-MI), who led the first iteration of the 21st Century Cures Act, stated that this latest version will focus on delivering treatments to patients, expedite drug and device approvals, and help ensure that the federal government is more prepared for future health crisis.

PRG will continue to monitor CURES 2.0 and provide updates where needed.

What’s Going on With President Trump’s Flurry of Final Rules?

Former President Trump issued a number of health related rules and regulations in of his administration. On President Biden’s first day in office, he issued an Executive Order that stopped, or put a pause, on any regulation that was finalized in the final days of the Trump administration. Consequently, there are a number of health related regulations that are currently in limbo, with the Biden administration having not made a decision as to whether they will move forward. Below you will find relevant health related regulations and their current status.

Regulation encouraging primary-care coordination for seriously ill Medicare beneficiaries

The model was originally set to kick off on April 1, 2021.

Status: Delayed as of March 8.

Regulation establishing an alternative payment model for rural health

Status: Application deadline extended through May 11, 2021.

Regulation barring PBMs from keeping Medicare Part D drug rebates

Status: On pause. The rule now won't fully take effect until at least Jan. 1, 2023.

Regulation cutting 340B drug discounts

-5- Status: On pause as of March 19. The rule was slated to take effect Mar. 22. But the Biden administration delayed its effective date until July 20.

Regulation changing outpatient drug prices

Status: No action yet.

Regulation expanding value-based drug pricing

Status: No action yet.

Regulation covering breakthrough medical devices

Status: On pause until May 15, 2021. The Biden administration will continue to take comments on the proposed rule until April 17, 2021.

You can find the full list of regulations and more information about each HERE.

(Updated June 2, 2021)

Recent Congressional Hearings

Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education and Related Agencies

National Institutes of Health’s FY22 Budget and the State of Medical Research

May 26, 2021

Relevant Opening Statements

Senator Roy Blunt (R-MO)

“RADx, Warp Speed, I think put us in a different place than we would have been two years ago in thinking about how we can look at some of our research efforts in another way. That's why I want to work with the administration to support the ARPA-H initiative. This will be a new institute or is proposed to be a new institute and I think that that's what should be the case. It will have the flexibility and tools necessary to both nimbly and innovatively respond to both the next pandemic and also some of the big health issues we face today. This is a critical moment in a rapidly changing health care world. Finding those things that a -- the kind of Warp Speed, Shark Tank, RADx relationship could enhance in cancer, in Alzheimer's, in every disease where there's an opportunity where you -- where we see that moment and know that this is something that doesn't necessarily call for a five-year research grant but some sort of partnership different than that that moves toward a real conclusion sooner than we might be otherwise be able to do that. ARPA-H should not do what the other institutes do but it should do what the other institutes can't do in a crosscutting way that goes throughout the institutes looking for opportunities, frankly, in the other institutes where there's a breakthrough moment

-6- that we could look at differently. I think we can help fill gaps here that otherwise would not be filled and look forward to that discussion. Now, also as someone working with Senator Murray for the last eight years to increase the funding and the focus in what NIH has been doing, I clearly want to be sure that this somehow doesn't take away from the solid research that proves so effective in getting this ready for what we just saw. So, Dr. Collins, I look forward to working with you and Chair Murray, in making -- and the administration in making ARPA-H a reality. I think there's a moment that's ready for that; I think that because of what's happened in the last two years NIH is ready for that. And look forward to the discussion today.”

Relevant Q&A

Senator Roy Blunt (R-MO)

Well, Dr. Sharpless one of the things the president, of course, talks about in this issue -- in this topic is more rapidly moving toward ending cancer. Obviously we want to do that. We also want to make a point that that's not the only thing that ARPA-H would be focused on, nor would it just be a cancer or Alzheimer's. But on that topic, how do you envision the ARPA-H role in cancer research? And what might you be able to do with ARPA-H that you're not able to do in the traditional restraints of the institute? Dr. Sharpless: Yes, as the president has said, ending cancer as we know is a top domestic priority for this administration. Obviously the cancer research community is galvanized by this notion and very excited. I think as you know the National Cancer Institute -- National Cancer Institute has done some things really well. We fund basic foundational science very well, we can do clinical trials quite well. But there are some areas where we're challenged, where we have struggles and I think the scale and nimbleness and the ability to interact with industry is very appealing about APRA-H for certain kinds of cancer projects. I think a good example of that is this blood base cancer detector technology, that Dr. Collins mentioned in his opening statements, where you can find cancers at a very early stage and otherwise asymptomatic healthy people and that could have a profound effect on cancer mortality. So getting up a huge trial of the technology as quickly as possible is the kind of thing that I think would be a good fit for our reach.

Senator Jack Reed (D-RI)

I have to commend Dr. Sharpless for his efforts on childhood cancer. I was teamed up with Senator Capito and we passed a Childhood Cancer STAR Act. We have been funding it, thanks to the Chairwoman, at $30 million a year. And I want to commend NIH on its renewed emphasis on childhood cancer, not only treatments but also gathering data about these victims as they age so that we can see if there's any interventions that we can use later on. So thank you Dr. Sharpless and thank you panelists, thank you very much.

Senator Roy Blunt (R-MO)

On vaccines -- actually on maybe more on mRNA than vaccines, what do we think as it relates to cancer, to HIV; we'll start, Dr. Fauci, with you. Can we look at the flu shot in a different way and what do we think the mRNA impact, now that we know this different use for it may have on other healthcare settings?

-7- Dr. Fauci: I believe and many of my colleagues believe that the mRNA technology, as it has been so spectacularly successful with SARS-CoV-2 to develop a vaccine against COVID-19 is already being pursued for other infections including HIV and including influenza. So there are a couple of things that are going on now even as we see the successes with COVID-19. Is using the mRNA technology for the development, for example, of universal flu vaccines as well as now having HIV vaccine researchers now looking at the possibility of an mRNA platform technology to use for HIV. So it's already happening. Dr. Sharpless, on mRNA, I mean we know the impact in just the last half dozen years immunotherapy on cancer treatment. What about this mRNA intervention and how it might impact the way we look at fighting cancer? Dr. Sharpless: Yes, this is a very exciting topic. People interested in this space have been working on this long before the pandemic so using mRNA for cancer therapy has many potential applications. Because you can really get to body to make a protein and that protein could have a desirable affect against cancer -- is for cancer therapy in a lot of ways. The furthest advance, as you mentioned, is the use of mRNA vaccines, cancer vaccines and generally they tend to be highly personalized. The idea you can sequence someone's own tumor and then make the vaccine to their very own tumor in a way that won't cause them autoimmune side effects. And this is an idea to augment other kinds of autoimmune cancer -- anti-immune (ph) cancer therapies. So it's a very promising area, it's in clinical trials. And we just need to see how this develops.

House Energy and Commerce Committee, Subcommittee on Health

Fiscal Year 2022 HHS Budget

May 12, 2021

Opening Statements – Cancer and Drug Pricing Mentions

Chairman of the Full Committee Frank Pallone (D-NJ)

“Now, the Biden administration's budget request would also expand cross-agency research capabilities to combat life-threatening diseases through the National Institutes of Health that would establish the Advanced Research Projects Agency Health or ARPA-H, a research agency that would initially focus on diseases such as cancer, diabetes, and Alzheimer's. I look forward to learning more about how the proposed agency's activities may build off NIH's existing research, the five life-saving drugs. I know the president talked about this in his address.”

“And we also have to take action to lower the costs of prescription drugs. The President mentioned it in his address by passing H.R. 3, the Elijah Cummings lower drug costs now. And we have to make permanent the enhanced premium tax credits that we enacted into law on a temporary basis in the American Rescue Plan.”

Ranking Member of the Full Committee Cathy McMorris Rodgers (R-WA)

“Rather than modernize our health care system to empower patients to catch up to the 21st century, Medicare For All would take us -- would take back the clock to an outdated, politically

-8- influenced government takeover of our health care system. Just -- just like Speaker Pelosi's drug price control scheme, single payer will destroy innovation for new cures and breakthrough medical treatment.”

Secretary of Health and Human Services Xavier Becerra

“To support innovation and research the budget increases funding for NIH by $9 billion, $6.5 billion of which will go to establish the Advanced Research Projects Agency for Health, ARPA- H. With an initial focus on cancer and other deadly diseases. This major investment in federal research and development will speed transformational innovation in health research and speed application and implementation of health breakthroughs.”

Question and Answer – Cancer and Drug Pricing Mentions

Chairwoman Anna Eshoo (D-CA)

You mentioned ARPA-H and I'm glad that you did. The president's budget contains $6.5 billion in it to create this new independent agency. Tell me what you -- what the rational is to have this in NIH. This is modeled, DARPA and ARPA-E and it doesn't seem to me that as extraordinary as NIH is and the work that they do, that successful independence, that is the imprimatur of DARPA and ARPA-E, is really there. So, that's -- that's my -- I know that you support the sub- agency but if you could comment on where you think it needs to be. Two other things, our subcommittee was the first in the Congress to have a hearing on long-COVID. We had powerful testimony, Mr. Secretary from -- from patients. When I asked both the CDC and NIH because they both testified, when I asked them who was leading the coordinated whole of government response to what is taking place with long-COVID we were told there was no such leader or coordinator at HHS. So, we need you to tell us, you know, what you're going to do about that. We need a coordinated response from the government and we need someone to lead that. On the $6 billion provided for HHS for therapeutics in the American Rescue Plan, I think that we need a strategy for supporting the development of an effective therapeutic. It's been over a year since we've been -- the pandemic has visited us and the current monoclonal antibody therapies on the market really have not been as successful as we'd hoped. But newer monoclonal antibodies are being developed that could be delivered outside of a hospital setting, which is really important. And -- and I think could be effective against variants. So, I'd like you to tell us how you're going to spend that $6 billion. And on the provider relief fund, I think maybe someone mentioned that in their opening statement, I think that the Trump Administration failed at managing this. The money went out too slowly and it wasn't a transparent process. So, can you clarify for the subcommittee how much money remains in the provider relief fund and when you plan to disperse it and is there priority order for who receives it next? And my last question is, I think that we need more resources in the FDA for inspections both domestic and foreign. The foreign inspectors, actually their work is voluntary. And I think that we have a long, long way to go on this. The American people depend on these inspections, look what happened at Emergent, I mean, it's a national disgrace. So, those were all my questions, Mr. Secretary, and you have two minutes to answer. And if you can't answer all of them, of course, you'll respond in writing. So, welcome and thank you. Sec. Becerra: Madam Chair, thank you. I was actually going to take two minutes to just say thanks for having me, and great to be with you, so I'll try to cut that out and go right to the questions. First on ARPA-H, Madam Chair and members, I think what

-9- President Biden is saying is we know what basic research can do for us. It leads to some of the greatest scientific discoveries. But sometimes we got to move it faster because for some people contracting a disease is a death sentence, and it's a quick death sentence. So, what President Biden simply said is let's accelerate this, if we see something innovative, something promising and it works let's jump on it. And I applaud President Biden for wanting to devote energies. We can't do it with every particular condition or disease but we can focus. We've mentioned cancer, we've talked about some of the deadly diseases; we can any number of them. But what he's saying is we're going to partner with the private sector. But where do you want to put it? Where -- what's your view as to where this should be? Sec. Becerra: Well, I -- certainly, we know that NIH continues to do the basic research. I think we have any number of places that we could feel comfortable with it. But NIH continues to be the basic research. If we want to just lift that up and launch faster, we could talk -- discuss that. But the -- the important thing is that we launch and not let issues about bureaucratically where we're going to locate ARPA-H in the way of a great idea because there are communities out there clamoring for us to help them find that next discovery that keeps their loved on alive. Let me -- should I move on to some of the other questions.

Ranking Member Brett Guthrie (R-KY)

So switching to drug pricing, weall want lower drug pricing. All Americans want lower drug pricing. Though the President said in the State of the Union, as we talked about that if we can't agree on everything, let's at least pass the things that we agree on. We have a bill, H.R.19 that has 36 I think unanimous bipartisan bills that will make an effect on drug pricing. Some people say it's small. Well it's not. If you reform Medicare Part D it's every American over 65. And so, can we not proceed on areas in which we agree, which would be H.R.19 that does make a difference, and if we go with H.R.3 we had a hearing the other day, and the witness on the Democrat side gets to talking about it would just be 10 to a dozen pills and pills that have been around, I mean pills or drugs that have been around for a long time and therefore really wouldn't affect innovation because they've been around for a long time, but we all know that in any business you take your previous revenues and put them into your research to move forward. So I do think that was very dismissive of the problem of H.R.3 to cause and moving forward. So one, can we not work together on what we agree on? And two, if H.R.3 is part of a package, it -- let's hope it's not going to be paid for by other priorities. For instance, these are people's premiums, people's payroll taxes that they put in. We want to make sure that money -- can you commit that money will stay in Medicare?. Sec. Becerra: So Congressman, let me first agree with you. We need to work together, and I hope that you will test us at HHS if you need technical assistance, if our team can be of any service in helping you noodle through a particular issue as we try to tackle what I think every American agrees with, and that is that we have to lower drug prices. Then hopefully we'll -- not only will the working together produce results but will do it quickly. And so, I can guarantee you that if you give us an assignment we'll take it on, and if you give us dollars to make it happen we'll keep that money where it's supposed to say. We will follow the law. Whatever you all decide to pass we will implement it and make sure we comply with whatever the prescriptions are within that legislation that you passed to have become law.

-10- Chairman of the Full Committee Frank Pallone (D-NJ)

I don't want to take on Mr. Guthrie, but I don't think he accurately portrayed what happened at the H.R.3 hearing or what happened at the border. I mean, it's clear that President Trump's administration forcibly separated kids from their families at the border and caused terrible damage to the kids and to the ORR program. You know, I don't want to debate that here, but I mean, to suggest otherwise I just don't think it's accurate. Also it -- the president said in his joint address that he wanted to have legislation pass this year to lower the price of prescription drugs by giving his administration the power to negotiate prices, and specifically said that that money should be a pay for, for healthcare programs. I mean, I don't think there's any question that that should be used for things like ACA, Medicare, Medicaid. That's the president's position and that's certainly my position. But I wanted to get into quickly if I could, Mr. Secretary, ask about negotiated prices, about public health infrastructure, and then finally mention the Provider Relief Fund. So let me quickly get into this. On the prescription drug issue and H.R.3, I just want your opinion. The testimony at the hearing last week was that in order to effectively reduce prescription drug costs we have to have a comprehensive solution like H.R.3 that includes negotiated prices. And so, from your perspective is empowering the secretary to negotiate drug prices an essential tool to lowering drug prices? Sec. Becerra: Chairman, absolutely. I think the president's made that very clear, and I'll restate that absolutely if we want to lower those drug prices we have to have the ability to negotiate.

Ranking Member of the Full Committee Cathy McMorris Rodgers (R-WA)

I wanted to ask specifically regarding quality, what is the policy of a quality adjusted life year and I wanted to ask if there would be any provisions in your budget that would give you, as Secretary, the authority to set prices based upon foreign drug prices that are established using quality adjusted life years? Sec. Becerra: Congresswoman, let me say this. I know that the team at HHS can probably give you some particulars on this. I won't profess to be the expert. And so what I will do this, I will take this matter back to the folks at HHS and I look forward to being able to respond with you as quickly as possible. OK. Sec. Becerra: Again, if it involves drug prices we're going to do something. OK. Well, we all -- we all are committed to bringing down drug prices, prescription drug prices for patients. One of my biggest concerns with the proposal right now that is before this committee is that in a -- in a -- in an effort to bring down prescription drug prices it includes a reliance on foreign drug prices developed using qualities. So, foreign drug prices that use -- that measure quality adjusted life years, so they're determining the value of an individual, especially an individual with disabilities. And so, that's one issue that we really need to address.

Representative G.K. Butterfield (D-NC)

I would like to focus must a few minutes of my time on the investments in biomedical research put forward in this proposal. For decades publicly funded research has laid the foundation for the treatment and cures patients use today. NIH, which has long enjoyed bipartisan, bicameral support, is the largest public funder of biomedical research in the world. And the positive impact of this agency is clear. Heart disease and stroke and diabetes are less deadly. Cancer

-11- mortality rates also overall are on the decline. Americans are living longer and healthier. Yet, there's always more we can do to support the health of our constituents. And so I applaud the administration for investing more resources into biomedical research. And I'm really interested in learning more about the proposed Advanced Research Project Agency, we call it ARPA. I'm interested to learn more about this. Mr. Secretary the funding request put forward $6.5 billion for the creation of ARPA-H, which I understand is part of a larger $51 billion request for NIH. Can you talk about the responsibilities for this new agency? Sec. Becerra: Congressman, absolutely. And great to see you. We'll consider this a five minute chat. What I will tell you is that ARPA-H is meant to complicate, not compete with NIH's basic research. And what we will do is hopefully be the springboard to take some of those budding ideas and actually start them off on a fast track. And we're going to partner far more with the private sector, because we know that they're incubating some of these things as well. But if you don't have a dedicated source of funding for that, with a -- an agency that has a proven track record, as you said, of success, it's hard to get the private sector to believe that they should make the same investment to try to do this. COVID-19 is now being attacked by successful vaccines. Why? Because it was a partnership and we did everything to accelerate those vaccines as much as we could while still maintaining safety. And so ARPA-H gives us a chance to say, on something in the future, we're going to do the same thing.

Representative Doris Matsui (D-CA)

I wanted to take a minute to raise an issue that I know you are familiar with -- the ongoing actions that drug companies chosen to rewrite the 340B program to deny discounts on drugs dispensed through coverage and contract pharmacy. As you know, HHS has issued an advisory (inaudible) concluding that these actions are illegal yet drug companies admit that they do not intend to comply with the law. I along with over 220 of my House colleagues wrote a letter to you earlier this year outlining our strong opposition to these actions. The 340 B is essential to providing access to care to low-income and rural patients. I encourage you to take swift enforcement action to put a stop to these efforts to undermine the program. That's my comment to you.

Representative Peter Welch (D-VT)

Mr. Secretary, I have a question for three areas. One is the 340B Program. Two is the ARPA-H Program. And three is prescription drug price negotiation. I know your concern about access to healthcare in community health centers and community hospitals. And I've been alarmed as my local hospitals and community health centers have been that six pharmacy companies, I believe illegally, are not passing on the discounts that are required under the 340B Program. Is it the -- your intention to enforce continued access to the discounts for community hospital and community health centers? Sec. Becerra: Congressman first, great to see you. Secondly, we are on this one. As we know that vulnerable populations are at risk and so everyone -- I've been saying all along, we have to follow the law, everyone has to follow the law. OK, thank you. Second, we're all excited about President Biden's $50 billion program ARPA-H. And of course that is going to focus on cures for Alzheimer's, diabetes and cancer. Is there any consideration to including Lou Gehrig's disease, dubbed ALS, and research that would be benefited by that fund?

-12- Sec. Becerra: Congressman, that is where we're going to be working with you and the to make sure we know how to focus the money. We certainly could use more than $6 billion to address all these deadly diseases, but we're going to try let the science drive us there, because that's the best way to ensure that we'll have not just a good result, but one that people will trust. Thank you. Finally, on prescription drug pricing, there is a dispute here that pharma companies do not want the U.S. to be involved in price negation, yet we just had a recent example where negotiation was very successful. Our government worked in partnership with pharma, they got the vaccine that was agreed upon at a price of $19.50 per dose. Pfizer executives now saying after the pandemic they may go up to $175 per dose. My concern about healthcare in general is the cost is too high and not sustainable. It hurts tax payers, it hurts private employers trying to provide access. Pharma is concerned about price negotiation is that the government won't be fair. Now, pharma is happy with government providing tax protection, providing a market through the Part D program, providing tax payer funding through Medicare and Medicaid. You would play a major role that any kind of price negotiations plans occur. How would you address the reported concern that if the government negotiated so that we did not continue to pay three times, four times, what other countries pay we would still be the leader of innovation? Sec. Becerra: Great question Congressman. What I will tell you is first and foremost, failure is not an option here in dropping drug prices. We have to do better, especially when we see the rest of the world paying less than we do for some of these same drugs. So, President Biden has made it very clear he wants to see negotiations of these prices. We can make this a win-win for everyone, including the pharmaceutical industry. We have to make sure that we're partnering with them. We have to have them sitting them at the table, but we have to make sure we're moving. There's no reason why America should be paying this much for their -- for their prescription medication. And so, whether it's tough love or sitting down and collaborating one way or the other, we're going to have to drop the prices of drugs and we want to have everyone who is a stakeholder be at the table when we do it.

Representative Nanette Diaz Barragan (D-CA)

I was excited to hear that the president discussed ending cancer as we know it during his joint address to Congress. I wish to take a moment to highlight one form of cancer, multiple myeloma. Unfortunately, my sister who is only a year older than me, last November, was diagnosed with multiple myeloma. It was pretty devastating for me, and my family, and of course to her and her family. This is a cancer that forms - a type of a blood cancer - let me back up here. Multiple myeloma is a cancer that forms in a type of white blood cell and accumulates in the bone marrow. In 2021 it is estimated that that there will be 34,920 new cases of myeloma, and an estimated 12,410 people will die of this disease. Unfortunately large social, economic, geographic, and racial disparities exist in myeloma treatment, which can greatly impact patient outcomes. Among these disparities includes a late diagnosis, stem cell utilization rates, limited access to new therapies, and access to clinical trials. I just wanted to put this on your radar, Mr. Secretary, so that we can make sure we're looking at things like multiple myeloma when we're looking at where to invest this $6.5 billion. And I also want to applaud the administration and you for looking at and making sure that we are looking at this as a public health crisis and addressing that as well.

Representative Lisa Blunt Rochester (D-DE)

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Today, I want to focus on an issue that has disproportionately affected communities of color - - climate change. For decades, policy decisions at the federal, state and local levels have led black, brown and indigenous communities living near toxic and polluted environments, even though the link between these conditions -- air pollution and increased rates of illness, like cancer and asthma -- is well documented. The administration's funding request proposes establishing a new Office of Climate Change and Health Equity to reduce disparities in communities of color, low wealth households, tribal communities and other marginalized groups overburdened by the health impacts of climate change. Mr. Secretary, can you discuss how this office will differ from existing HHS agency efforts around climate change, such as the NIH climate change and human health and the CDC climate and health programs? Sec. Becerra: Congresswoman, thank you for the question, and I absolutely appreciate the chance to respond to that. We are going to focus directly now, as a result of these resources, on climate change. By the way, I should mention that as Attorney General, I established the Environmental Justice Bureau in our department because we know -- you -- as you've sort of said, it is our communities of color that are first and worst hit by climate change. And so we want to get there before the hit gets there, and in order to do that, we have to have the resources to start letting people know about clean water, about asthma when you have dirty air, about those toxic sites that might be built in your community, about the impact of building a large warehouse right next to a school and residential communities, where you're going to have semi-trucks driving 24/7 right by all of those communities, spewing diesel gas -- diesel exhaust. And so we're going to get out there and work with communities to make sure we provide equity, but more importantly, we need to fight to protect the health of these communities.

Representative Kim Schrier (D-WA)

Thank you for coming to this committee to talk with us about your priorities in the HHS budget. First, just as a pediatrician I want to thank you for prioritizing children in so many ways. But I wanted to talk about something else today, and I want to thank the Advanced Research Projects Agency for Health, ARPA-H, to focus on breakthrough research for diseases like cancer, diabetes, and Alzheimer's. We have just witnessed, with Operation Warp Speed, how quickly medical advances can happen when government targets investment and ameliorates that risk. And this keeps us right on the cutting edge of research and development to treat and cure some of our most devastating and dreaded diseases.

Up to Date List of Drug Related Legislation for the 117th Congress

• S. 1644 This bill, introduced by Sen. Mike Brain on May 13, 2021, amends the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.

• S. 1645 This bill, introduced by Sen. Mike Braun on May 13, 2021, provides for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries.

-14- • H.R. 3203 This bill, introduced by Rep. Doris Matsui (D-CA) on May 13, 2021, enables certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes.

• S. 1773 This bill, introduced by Sen. Bob Casey (D-PA) on May 20, 2021, amends title XI of the Social Security Act to establish internet website-based dashboards to allow the public to review information on spending for, and utilization of, prescription drugs and biologicals covered under the Medicare and Medicaid programs.

• H.R. 3437 This bill, introduced by Rep. Bobby Rush (D-IL) on May 20, 2021, requires the Secretary of Health and Human Services to guarantee BioBonds in order to provide funding for loans to eligible biomedical companies and universities to carry out clinical trials approved by the Food and Drug Administration, and for other purposes.

• H.R. 2344 This bill, introduced by Rep. Tim Ryan (D-OH) on April 1, 2021, requires the use of prescription drug monitoring programs.

• H.R. 2484 This bill, introduced by Rep. Katie Porter (D-CA) on April 13, 2021, amends title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes.

• S. 1124 This bill, introduced by Sen. Marsha Blackburn on April 14, 2021, preserves non-interference under the Medicare part D Prescription Drug Benefit program.

• H.R. 2608 This bill, introduced by Rep. Peter Welch (D-VT) on April 15, 2021, amends title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes.

• H.R. 2623 This bill, introduced by Rep. Josh Gottheimer (D-NJ) on April 16, 2021, amends the Internal Revenue Code of 1986 to restore the amount of the orphan drug tax credit, and for other purposes.

• H.R. 2706 This bill, introduced by Rep. Katie Porter (D-CA) on April 20, 2021, amends title XVIII of the Social Security Act to require drug manufacturers to pay a Medicare part B rebate for certain drugs if the price of such drugs increases faster than inflation.

-15- • H.R. 2829 and S. 1323 This bill, introduced by Rep. Peter Welch (D-VT) and Sen. Jeff Merkley (D-OR) on April 22, 2021, requires the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes.

• S. 1366 This bill, introduced by Sen. (D-MA) on April 26, 2021, secures the supply of drugs in the United States, and for other purposes.

• H.R. 2846 This bill, introduced by Rep. David McKinley (R-WV) on April 27, 2021, amends title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.

• H.R. 2853 This bill, introduced by Rep. Kurt Schrader (D-OR) on April 27, 2021, amends the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.

• S. 1425 This bill, introduced by Sen. (D-MN) on April 28, 2021, enables the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes.

• S. 1428 This bill, introduced by Sen. Amy Klobuchar (D-MN) on April 28, 2021, prohibits brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.

• H.R. 2868 This bill, introduced by Rep. G.K. Butterfield (D-NC) on April 28, 2021, amends title XIX of the Social Security Act to prohibit additional rebates under the Medicaid program for certain noninnovator multiple source drugs.

• H.R. 2870 This bill, introduced by Rep. Buddy Carter (R-GA) on April 28, 2021, amends the Public Health Service Act to provide for stockpiles to ensure that all Americans have access to generic drugs at risk of shortage, and for other purposes.

• H.R. 2883

-16- This bill, introduced by Rep. (D-NY) on April 28, 2021, enables the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes.

• H.R. 2891 This bill, introduced by Rep. (D-NY) on April 28, 2021, prohibits prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

• S. 1462 This bill, introduced by Sen. Bill Cassidy on April 29, 2021, amends the Federal Food, Drug, and Cosmetic Act to simplify the generic drug application process.

• S. 1463 This bill, introduced by Sen. Bill Cassidy on April 29, 2021, amends the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations.

• S. 1508 This bill, introduced by Sen. Roger Marshall (R-KS) on April 29, 2021, provides for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

• S. 1523 This bill, introduced by Sen. Mike Braun (R-IN) on April 29, 2021, amends title XI of the Social security Act and title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits.

• H.R. 2148 This bill, introduced by Rep. Ro Khanna (D-CA) on March 23, 2021, aims to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries.

• S. 909 This bill, introduced by Sen. (I-VT) on March 23, 2021, aims to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries.

• S. 898 This bill, introduced by Sen. Tammy Baldwin (D-WI) on March 23, 2021, requires reporting regarding certain drug price increases, and for other purposes.

-17- • S. 833 This bill, introduced by Sen. Amy Klobuchar (D-MN) on March 18, 2021, amends XVII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program.

• H.R. 597 This bill, introduced by Re. Jan Schakowsky (D-IL) on January 28, 2021, requires any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes.

• S. 141 This bill, introduced by Sen. (D-NH) on January 28, 2021, amends the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs.

• H.R. 153 This bill, introduced by Rep. Bobby Rush (D-IL) on January 4, 2021, prohibits brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.

In The

Politico (5/28/2021): IT’S BIDEN’S BUDGET DAY — The White House’s budget ask, expected to top $6 trillion overall, would pour billions of dollars into agencies like the CDC and NIH that have been at the center of the pandemic response.

Politico (5/27/2021): CMS PROPOSES DELAYING VALUE-BASED DRUG MEASURES — The agency wants to press pause on several provisions of a Trump-era drug rule meant to let states and manufactures pay for Medicaid drugs based on their effectiveness, Rachel writes.

Modern Healthcare (5/27/2021): CMS delays controversial best price requirement for drugmakers - CMS delayed the Medicaid drug rebate program requirements until July 2022. Drugmakers sued the federal government over them last week.

Politico (5/27/2021): FIRST IN PULSE: AFFORDABLE DRUG BILL REVIVED — Sen. Tina Smith (D- Minn.) this morning plans to introduce a bill to let Medicare negotiate drug prices, a long-sought Democratic priority that has been left out of the upcoming infrastructure package.

Axios (5/26/2021): CMS head gets OK, but still no FDA pick - More than four months into President Biden's term, the Senate confirmed his pick of Chiquita Brooks-LaSure to lead Medicare and Medicaid. It's still unclear who will lead the FDA permanently.

-18- (5/26/2021): Drug discounts aren't always a good deal - Buying prescription drugs through GoodRx, Amazon and other alternative avenues does not guarantee patients are getting a good deal, Axios' Bob Herman writes.

Politico (5/26/2021) BIDEN’s BIG BILL STALLS IN SENATE — Hopes of a bipartisan deal on Biden’s next trillion-dollar spending bill are fading fast, POLITICO’s Marianne LeVine reports, meaning the White House’s legislative agenda — not to mention the president’s major health priorities — could be delayed until well into summer or beyond.

Politico (5/26/2021): HHS ADDS TO ITS SENIOR RANKS — Newly confirmed Deputy Secretary Andrea Palm has tapped Angela Botticella as her chief of staff, HHS said Tuesday. Botticella was previously chief of staff at the Catholic Health Association, but prior to that spent almost four years in the Obama-era HHS’ intergovernmental and external affairs office.

Modern Healthcare (5/26/2021): Drugmakers sue HHS over Medicaid drug rebate rule - The Pharmaceutical Research and Manufacturers of America said CMS didn't have the power to issue the rule and seemingly reversed course on the agency's longstanding interpretation of the law.

Modern Healthcare (5/25/2021): Congress wants permanent Medicare coverage of audio-only telehealth - The bipartisan bill would allow Medicare to permanently cover audio-only telehealth, which providers say has benefited patients in rural areas during the pandemic.

Modern Healthcare (5/25/2021): Laws to curb surprise medical bills might be inflating healthcare costs - Some researchers recently have raised alarms that doctors and other medical providers are leveraging state laws that rely on arbitration to increase in-network fees, thereby raising healthcare costs for everyone.

Politico (5/25/2021): CONFIRMATION OF BIDEN’S CMS PICK EXPECTED TODAY — The Senate will take its final vote on the nomination of Chiquita Brooks-LaSure to spearhead the trillion-dollar Medicare and Medicaid agency. She’s expected to be confirmed, and as the head of CMS, Brooks- LaSure would be charged with overseeing President ’s pledge to expand Obamacare and reverse Trump-era regulations, among other key parts of his agenda.

Politico (5/25/2021): BIPARTISAN PAIR ROLLS OUT SENATE BILL TO BOOST TELEHEALTH — Sens. Tom Carper (D-Del.) and John Cornyn (R-Tex.) on Tuesday introduced legislation aimed at expanding telehealth access for low-income children.

Politico (5/25/2021): BIDEN’S CMS PICK INCHES TOWARDS CONFIRMATION — The Senate will vote on a procedural hurdle to advance the nomination of Chiquita Brooks-LaSure to head the Medicare and Medicaid agency.

Axios (5/21/2021): Employers' dog in the drug pricing fight - Employers and their workers have hundreds of billions of dollars at stake in the fight over House Democrats' drug pricing bill, according to a new West Health Policy Center analysis.

Politico (5/21/2021): ELI LILLY CHALLENGES BIDEN’s 340B ORDER — The insurer is suing over HHS’ recent decision to restore drug discounts to contract pharmacies that work with hospitals in the federal program known as 340B, POLITICO’s Susannah Luthi reports.

-19- Axios (5/21/2021): Big money pours into drug fight - Millions of dollars are being poured into the fight over prescription drug costs — and not just from pharmaceutical companies and their allies. Consumer groups aren't letting up on the issue either, Axios' Caitlin Owens writes.

Politico (5/21/2021): WHAT BECERRA’s SENIOR TEAM SAYS ABOUT HHS’ PRIORITIES — The health secretary has added at least three new counselors to his front office in recent weeks, a build-out that reflects the range of challenges facing HHS and the concerted effort to find experienced staffers to tackle them.

Axios (5/20/2021): Telephones played a key role in pandemic telehealth - More than a quarter of all Medicare beneficiaries had a telehealth visit between the summer and fall of 2020 and, for more than half of them, that visit took place over an actual telephone, a KFF Analysis found.

Politico (5/20/2021): DEMOCRATS FACE MORE OUTSIDE PRESSURE ON DRUG PRICING — The progressive group Patients for Affordable Drugs Now will spend more than $1 million to urge House Democrats to support legislation allowing Medicare to negotiate drug prices, POLITICO’s Alice Miranda Ollstein reports.

The Hill (5/19/2021): Katie Porter brings her whiteboard to accuse pharma CEO of inflating drug prices - Rep. Katie Porter (D-Calif.) went viral on after she brought back her signature whiteboard during a Tuesday committee hearing in which she grilled drugmaker AbbVie’s CEO on allegations that the company has inflated drug prices.

Politico (5/18/2021): HOUSE PANEL SETS SIGHTS BACK ON DRUG PRICES — House Oversight Chair (D-N.Y.) is picking up where her late predecessor, Chair Elijah Cummings (D-Md.), left off, questioning AbbVie CEO Richard Gonzalez over the drugmaker’s pricing practices for two of its moneymakers, including the autoimmune medicine Humira.

The Hill (5/18/2021): Lawmakers press AbbVie CEO on increased US prices of two drugs - A group of mostly Democratic House lawmakers pressed drugmaker AbbVie’s CEO on Tuesday over the increased prices of anti-inflammatory drug Humira and cancer drug Imbruvica in the U.S. in the years since they first became available.

Politico (5/18/2021): CURES 2.0 COMING SOON — Expect the latest iteration of the 21st Century Cures Act to drop in the next few weeks, Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) said Monday during a “fireside chat” (let’s call it “Zoom-side”) hosted by the Alliance for Regenerative Medicine. The discussion draft will focus on delivering treatments to patients, DeGette said, and will aim to expedite drug and device approvals and to ensure federal agencies are better prepared for future health crises. The pair is also working with the White House to bring to life ARPA—H, a proposed health research agency modeled after similar ones for advanced energy and defense technologies.

Politico (5/18/2021): HHS ORDERS SIX DRUGMAKERS TO RESTORE 340B DISCOUNTS — The Biden administration on Monday ordered six pharmaceutical companies to restore discounts they had stopped providing to a federal drug discount program, likely resolving a long-running standoff between hospitals and the pharmaceutical industry, POLITICO’s Susannah Luthi reports.

-20- The Hill (5/18/2021): House Democrats request FTC investigate AbbVie's pricing of Humira - Three House Democrats called on the Federal Trade Commission (FTC) to investigate drugmaker AbbVie for its pricing of Humira, the best-selling drug in the U.S. and internationally.

Politico Pro (5/13/2021): Biden’s full budget to debut May 27 - President Joe Biden will unveil his full budget request on May 27, a spokesperson for the Office of Management and Budget said Thursday.

Politico (5/13/2021): AMERICANS FAVOR BIG INVESTMENTS IN PUBLIC HEALTH — An overwhelming majority of Americans believe the government should be spending substantially more on public health programs, according to a new survey from the Harvard Opinion Research Program and Robert Wood Johnson Foundation.

The Hill (5/13/2021): White House unveils plan to spend $7B to hire public health workers - The White House announced Thursday that it is providing $7.4 billion of funding from the pandemic relief measure passed earlier this year to hire and train public health workers to respond to COVID- 19 and future crises.

Politico (5/13/2021): SENATE ADVANCES BIDEN’S CMS PICK — Chiquita Brooks-LaSure is one step closer to becoming Biden’s Medicare and Medicaid chief after the Senate on Wednesday narrowly agreed to advance her nomination in a 51-48 procedural vote, POLITICO’s Rachel Roubein writes.

Politico (5/12/2021): DEMOCRAT-ALIGNED GROUP LAUNCHES DRUG PRICING PUSH — Just as Pelosi begins to face resistance within her caucus, the health care advocacy group Protect Our Care will debut a national TV and digital ad campaign calling for the passage of drug price legislation like H.R. 3 (117).

Politico Pro (5/12/2021): Senate advances Brooks-LaSure's nomination to run CMS - Chiquita Brooks-LaSure is one step closer to becoming President Joe Biden's Medicare and Medicaid chief after the Senate on Wednesday narrowly agreed to advance her nomination in a procedural vote.

The Hill (5/12/2021): House moderates signal concerns with Pelosi drug pricing bill - A group of 10 moderate House Democrats is signaling concerns with Speaker Nancy Pelosi’s (D-Calif.) signature legislation to lower prescription drug prices, raising further doubts about the legislation’s path forward.

Politico (5/12/2021): PELOSI's DRUG PLAN STALLED BY CENTRIST DEMOCRATS — At least 10 Democrats are signaling opposition to the House’s sweeping drug price negotiation bill, Alice Miranda Ollstein and Susannah Luthi report. That’s more than enough votes to force Pelosi to drop her reforms from a relief package that leadership hope to pass along party lines.

The Hill (5/11/2021): Biden announces 1 million have enrolled in special ObamaCare sign-up period - President Biden announced on Tuesday that 1 million people have enrolled so far in coverage during a special sign-up period his administration created.

Politico Pro (5/11/2021): Senate confirms Biden's No. 2 HHS official - The Senate on Tuesday confirmed Andrea Palm in a 61-37 vote to serve as Health and Human Services' No. 2 official, a key post that would help oversee the department's daily operations.

-21- Politico (5/10/2021): SENATE TO VOTE ON KEY BIDEN HHS PICK — The Senate will vote to clear a procedural hurdle for the nomination of Andrea Palm to serve as deputy health secretary. Palm — who would run HHS’ daily operations as its No. 2 official — received bipartisan support in a 20-8 vote in the Senate Finance Committee vote last month.

Axios (5/7/2021): Democrats are still looking for a plan on drug prices - Democrats have no workable plan to tackle the cost of prescription drugs, even with full control of Washington and after campaigning on the issue for years.

Politico (5/6/2021): HALF OF AMERICANS FEAR RISING HEALTH COSTS — Some 53 percent of Americans say health care costs are rising to the point they’ll become unaffordable, according to a new Gallup poll conducted for the advocacy group West Health. A similar proportion — 52 percent — think the same about prescription drugs, POLITICO’s Susannah Luthi reports.

The Hill (5/6/2021): Gillibrand touts legislation to lower drug costs: This idea 'is deeply bipartisan' - Sen. (D-N.Y.) this week touted legislation aimed at lowering the cost of prescription drugs for Americans, calling it a "deeply bipartisan" issue.

Politico (5/5/2021): E&C tees up Becerra hearing - The health secretary will defend Biden’s budget request in front of a House Energy and Commerce subcommittee next week, where he’ll likely be grilled on both the pandemic response and the department’s care of rising numbers of unaccompanied immigrant minors.

Politico (5/5/2021): ANOTHER HOUSE COMMITTEE CONVENES ON DRUG COSTS — The House Education and Labor Committee meets today to discuss slashing high prices for medicines, a hearing that is sure to feature some of the same pitches for squeezing health care reform into the American Families Plan that we saw in Tuesday’s Energy and Commerce hearing on drug prices.

Politico (5/4/2021): ANTI-DRUG BILL CAMPAIGN LAUNCHES — Conservative advocacy group on Monday launched a new ad campaign aimed squarely at swing-state Democrats thinking of backing Pelosi’s H.R. 3.

The Hill (5/4/2021): Pallone commits to using 'whatever vehicle I can' to pass Democrats' drug pricing bill - House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) on Tuesday said he would use “whatever vehicle I can” to pass the Democrats’ drug pricing bill, known as H.R. 3, that would allow the federal government to negotiate for decreased prices on behalf of Medicare.

Politico (5/4/2021): CASSIDY, HASSAN JUMP INTO ‘SURPRISE’ BILLING WATCH — Sens. Bill Cassidy (R-La.) and (D-N.H) — whose alliance helped drive a more provider- friendly version of Congress’ recent ban on “surprise” medical bill — last week formally outlined their vision for the law’s implementation. Lobbying around the policy is heating up as officials work to finalize rules by the end of the year.

Politico (5/4/2021): HOUSE HEARING ON DRUG PRICES SPOTLIGHTS NEGOTIATION — One of the bills on today’s agenda before the House Energy and Commerce Committee will be H.R. 3 (117), House Speaker Nancy Pelosi’s sweeping measure to empower Medicare to bargain down the cost of hundreds of drugs, Alice Miranda Ollstein writes.

-22- Modern Healthcare (5/3/2021): Telehealth can increase nurses' workloads, study finds - Nurses performed about twice as many activities with telehealth patients compared to in-person patients.

Axios (5/3/2021): Telehealth utilization dropped in February - Telehealth utilization among those with private insurance fell by 16% from January to February this year, the first month-to-month drop since September, according to FAIR Health's Monthly Telehealth Regional Tracker.

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