The Biden Transition and His Team

On November 23, 2020, the General Services Administration formally allowed critical transition funds and activities to be made available to President-Elect Biden and Vice President-Elect Kamala Harris, thus officially beginning the transition process to the new administration. This comes nearly two weeks after most major news outlets had already declared Joe Biden the winner of the election and despite the Trump campaign continuing to contest results in many states including Pennsylvania, Arizona, and Wisconsin.

What does this mean? It means that President-Elect Biden can begin sending teams to meet and observe current agency personnel, make personnel and Cabinet appointment decisions, obtain security clearances for incoming personnel, and start making policy and management agendas. For more information on the details of a Presidential transition, you can read the Partnership for Public Services 2020 transition guide HERE.

President-Elect Biden’s transition team is made up of hundreds of individuals from across the nation who are various subject and policy matter experts. Additionally, President-Elect Biden tapped longtime friend and former Chief of Staff while Biden was in the Senate, Ted Kaufman, to lead the transition.

Below you will find more information on President-Elect Biden’s Department of Health and Human Services Transition team.

HHS Agency Review Team

Name Most Recent Employment Source of Funding

Chiquita Brooks-

LaSure, Team Lead

Manatt, Phelps and Phillips, LLP Volunteer

Robert Gordon, Team Lead

State of Michigan, Department of Health & Human Services

Volunteer

Kathryn Alvarez The Aspen Institute Volunteer John Auerbach Trust for America’s Health Volunteer Lisa Barclay Boies Schiller Flexner, LLP Volunteer Jonathan Blum Health Management Associates Volunteer Lu Borio In-Q-Tel Volunteer Perrie Briskin University of California,

Berkeley Volunteer

Monthly Legislative Newsletter December 2020

-2-

Ken Choe Hogan Lovells, LLP Volunteer Henry Claypool Self-employed Volunteer Jose Cordero University of Georgia Volunteer Sarah Despres Pew Charitable Trusts Volunteer Eliot Fishman Families USA Volunteer Cristal Gary AMITA Health Volunteer Mina Hsiang Devoted Health Volunteer Tom Inglesby Johns Hopkins University Volunteer David C. Kaslow PATH Volunteer Natalie Kates Alloy Volunteer Jeremy Konyndyk Center for Global Development Volunteer Anna Martinez State of New Jersey,

Department of Children and Families, Division on Women

Volunteer

Sarah Nolan Service Employees International Union

Volunteer

Yngvild Olsen Institutes for Behavior Resources, Inc.

Volunteer

Edwin Park Georgetown University Volunteer Sharon Parrott Center on Budget and Policy

Priorities Volunteer

Chuck Peck Guidehouse, Inc. Volunteer Anne Reid Co-Equal Volunteer Geoff Roth Self-employed Volunteer Meena Seshamani MedStar Health Volunteer Cyrus Shahpar Resolve to Save Lives, an

initiative of Vital Strategies Volunteer

Mary Wakefield University of Texas at Austin Volunteer Sonya Bernstein NYC Health + Hospitals Transition Sarah Bianchi Evercore ISI Volunteer Elizabeth Cameron Nuclear Threat Initiative Volunteer Danielle Carnival I AM ALS Volunteer Mark Greenberg Migration Policy institute Volunteer Rebecca Katz Georgetown University Volunteer David Kessler University of California, San

Francisco Volunteer

Tim Manning Research Corporation of the University of Hawaii – Pacific Disaster Center

Volunteer

Julie Morgan Roosevelt Institute Volunteer Vivek Murthy Self-employed Volunteer

-3-

Sherice Perry Biden for President Transition Natalie Quillian BFPCC, Inc. Volunteer Marcella Nunez-Smith Yale University Volunteer Jeff Zients The Cranemere Group Volunteer

As you can see from the list above, Biden has tapped academics, health professionals, healthcare executives, and former Obama Administration officials to help lead his transition. This experienced group of individuals will start the process of transitioning from the Trump HHS to the Biden HHS and this effort will continue all the way up until inauguration day.

While it is very possible that some of the transition team will take on roles within HHS and the administration, that is not guaranteed. Much of this group will go back to their rolls in academia and the private sector once the transition concludes. Additionally, much of the staffing of HHS will be left to the HHS Secretary, who has yet to be nominated.

Who will be Secretary of HHS?

President-Elect Biden has yet to disclose who he will choose to run the Department of Health and Human Services. However, there are a number of names floating around that he is likely to choose from. Below you will find the most likely candidates with a brief biography.

Governor of New Mexico Michele Lujan Grisham – Before serving as Governor of New Mexico, Lujan Grisham was a former New Mexico Congresswoman, giving her experience with the ins and outs of working in Washington, DC and establishing relationships on Capitol Hill. Additionally, before Congress, she was the New Mexico Secretary of Health, giving her valuable experience running a large state-wide governmental agency. She also co-chairs Biden’s transition team.

Dr. Vivek Murthy – Dr. Vivek Murthy is a former U.S. Surgeon General during the Obama administration, former Vice Admiral in the Public Health Service Commissioned Corps, and founder of Doctors for America. With Dr. Murthy being widely respected in the medical world, his appointment could be particularly interesting in the middle of a pandemic.

Dr. Mandy Cohen – Dr. Cohen is the current North Carolina Secretary of Health and professor at the University of North Carolina at Chapel Hill. Additionally, during the Obama administration, she served as Chief Operating Officer and Chief of Staff at the Centers for Medicare and Medicaid Services.

While any of these three individuals could be nominated by President-Elect Biden, there is no guarantee they will be confirmed should Republicans maintain control of the Senate. However, many Republican Senators have indicated they will support President-Elect Biden’s nomination should they not be too far left on the political spectrum.

Appropriations Update

-4-

As of right now, the government will run out of funding on December 11th, thereby creating a government shutdown. However, both Majority Leader Mitch McConnell (R-KY) and Speaker of the House Nancy Pelosi (D-CA) have indicated that they would like to reach an agreement, avoiding a government shutdown and preventing the need for a Continuing Resolution. All of that being said, there is no guarantee that President Trump would sign the omnibus package. He has used shutdowns for political purposes in the past and as he continues to challenge the results of the election, he could attempt to use a government shutdown for some sort of political gain. COVID-19 Stimulus Update On December 1st, 2020, another COVID-19 stimulus package was dropped by a bipartisan and bicameral group of lawmakers including Senator Joe Manchin (D-WV), Senator Lisa Murkowski (R-AK), and Senator Mitt Romney (R-UT). The bill totals $908 billion in COVID-19 related relief and includes:

$35 billion for the Healthcare Provider Relief Fund $160 billion for states and cities $180 billion for unemployment insurance $288 billion for the Paycheck Protection Program $16 billion for vaccine development and distribution Provides short-term federal protection from COVID-19 related lawsuits

In order for the relief measure to pass, there would have to be buy-in from party leadership on both sides of the aisle. At this point, that is no guarantee of either party’s leadership giving the okay as the top line cost is more than double Majority Leader McConnell’s proposal previous proposal and less than half the amount of the House Democrat’s HEROES Act. There is also a possibility that additional COVID-19 relief be included in the appropriations omnibus bill that could potentially be passed before the government runs out of funding on December 11th. Will Surprise Billing Finally be Fixed?

This week, there is a renewed effort to fix surprise billing. A bipartisan group of lawmakers across multiple committees are meeting to find a legislative fix to the issue, which has plagued Congress for years. Specifically, the pressure is mounting on House Speaker Nancy Pelosi (D-CA) and Majority Leader Mitch McConnell (R-KY). As of now, they are reluctant to come out and approve a fix because they do not want to cross the powerful hospital and doctor lobbies at this point in time. Additionally, any legislative fix would have to work around House Ways and Means Committee Chairman Richard Neal (D-MA) who successfully derailed the efforts to fix surprise billing earlier this year. However, should either Speaker Pelosi or Majority Leader McConnell approve a fix, the other would be forced to at least bring the issue up for a vote.

-5-

PRG will continue to monitor the developments on the surprise billing issue.

President Trump’s Drug Import Plan One of President Trump’s biggest promises during the 2016 campaign was to bring down the price of prescription drugs for everyday Americans. Thus far, he has been unable to do so. His last major proposal, his drug importation plan, which allows for the importation of certain European countries and Canada, is currently grabbing headlines. The rule, which has yet to take effect, is already starting to be challenged in court by the pharmaceutical companies who believe that the action will hurt research and development of new drugs and hurt American businesses. However, there is another issue that is starting to take shape. Canada has issued an order that bans mass exports of pharmaceuticals to the United States, citing potential drug shortages. Additionally, Canada only accounts for 2% drug sales and actually imports 68% of their own drug supply from abroad. It is very unlikely that President Trump’s plan will take effect before President-Elect Biden is sworn into office in January. Even if it does, there is no guarantee that then President Biden will continue the policy. PRG will continue to monitor this issue as it developments. Promising Pathways Act

A bill titled the Promising Pathways Act, was introduced by Senator Mike Braun (R-IN), Senator Lisa Murkowski (R-AK), and Senator Martha McSally (R-AZ) on June 3rd, along with a companion bill in the House of Representatives introduced by Representatives Mike Quigley (D-IL), Eric Swalwell (D-CA), Bruce Westerman (R-AR), and Mike Gallagher (R-WI). The bill would allow for 2-year provisional approves with the possibility to renew for up to six years. Additionally, under this legislation, pharmaceutical companies would not need to conduct confirmatory clinical trials. In the legislation, provisionally approved drugs can win full approval if there’s a “15 percent improvement in an important endpoint compared to standard therapies.” However, it is unclear what “important” means at this point in time. This legislation is a natural extension of the Right to Try legislation that was passed in 2018 and differs from the FDA Accelerated Approval Program because the Promising Pathways Act does not require a confirmatory trial. At this point in time, there is no plan for either the Senate nor the House to vote on this legislation. However, PRG will continue to monitor and provide updates as they become available.

CURES 2.0

Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released an initial concept paper to start guiding the CURES 2.0 discussion. As of now, they’re hoping for passage prior to the end of 2020, meaning the end of the 116th Congress. They also left the window open to potentially attaching the clinical trial/COVID-19 components to a 4th or 5th COVID response package.

-6-

You can view the concept paper HERE.

The concept paper identifies six major buckets of Cures 2.0, including pandemic surveillance and response:

Improving pandemic surveillance and testing capabilities, commercializingantimicrobial resistance products, and expanding vaccine education and surveillance.

Creating educational and training programs for caregivers.

Increasing diversity in clinical trials.

Empowering patients’ decision-making with better health literacy and access to health information.

Modernizing the FDA by providing grants for innovative clinical trial design and patient-focused drug development to improve science in these areas.

Finding ways for the CMS to keep pace with technological and scientific advances suchas potentially curative therapies that have one time administration costs that can reach the millions.

Up to Date List of Drug Related Legislation

● H.R.8546 - Fair Drug Prices for Kids ActIntroduced by Rep. Susan Wild (D-PA) on October 6, 2020, this bill amends titles XIX and XXI of the Social Security Act to give States the option to extend the Medicaid drug rebate program to the Children’s Health Insurance Program, and for other purposes.

● H.R.8588 - Improving the American Drug Supply Chain Act of 2020Introduced by Rep. Richard Hudson (R-NC) on October 13, 2020, this bill provides for a study on the current and historical production of drugs in the United States and in foreign countries, and for other purposes.

● H.R. 8138 - Patient Access to Medical Foods ActIntroduced by Rep. Andy Biggs (R-AZ) on September 1, 2020, this bill amends the Orphan Drug Act with respect to the definition of medical food, and for other purposes.

● H.R. 8139 - SUPPLIES Act of 2020Introduced by Rep. Gus Bilirakis (R-FL) on September 1, 2020, this bill amends title XIX of the Social Security Act to remove direct sales of drugs near expiration during the COVID–19 emergency from the calculation of certain pricing metrics under the Medicaid program.

● H.R. 8177 - RAISE ActIntroduced by Rep. Tom O'Halleran (D-AZ) on September 4, 2020, this bill amends title XVIII of the Social Security Act to remove from the list of drugs excluded from coverage under the Medicare prescription drug program prescription oral vitamins and mineral products indicated for the treatment of iron deficiency anemia in individuals with chronic kidney disease.

● S.4674

-7-

Introduced by Sen. Amy Klobuchar (D-MN) on September 23, 2020, this bill amends title XIX of the Social Security Act to clarify that drugs and biologicals used for medication-assisted treatment under Medicaid are subject to the requirements of the Medicaid Drug Rebate Program.

● H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act Introduced by Rep. Nita Lowey (D-NY) on September 22, 2020, this bill includes covered outpatient drugs used for medication-assisted treatment in the Medicaid Drug Rebate Program.

● H.R. 8399 Introduced by Rep. Abby Finkenauer (D-IA) on September 25, 2020, this bill amends the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs.

S.4448 - Fair Drug Prices for Kids Act Introduced by Sen. Mark Warner (D-VA) on August 5th, 2020, this bill amends titles XIX and XXI of the Social Security Act to give States the option to extend the Medicaid drug rebate program to the Children's Health Insurance Program, and for other purposes.

S.4490 Introduced by Sen. Bernie Sanders (I-VT) on August 6th, 2020, this bill imposes an emergency tax on the increase in wealth of billionaires during the COVID-19 pandemic in order to pay for all of the out-of-pocket healthcare expenses of the uninsured and under-insured, including prescription drugs, for one year.

S.4492 - Safe Drugs Act Introduced by Sen. Gary Peters on August 8th, 2020, this bill provides the Food and Drug Administration with mandatory recall authority for all drug products.

H.R.8139 Introduced by Rep. Gus Bilirakis (R-FL) on September 1st, 2020, this bill amends title XIX of the Social Security Act to remove direct sales of drugs near expiration during the COVID-19 emergency from the calculation of certain pricing metrics under the Medicaid program.

H.R.7877 - Lowering Drug Costs for Seniors Act of 2020 Introduced by Rep. John Katko (R-NY) on July 30th, 2020, this bill amends title XVIII of the Social Security Act to provide Medicare part D beneficiaries with certain offset payments and reduce the growth rate of the Medicare part D out-of-pocket cost threshold, and for other purposes.

S.4199 - Prescription Drug Pricing Reduction Act of 2020 Introduced by Sen. Chuck Grassley (R-IA) on July 2nd, 2020, this bill amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes.

-8-

S. 4295 Introduced by Sen. Rand Paul (R-KY) on July 23, 2020, this bill amends title XVIII of the Social Security Act to ensure access to certain drugs and devices under the Medicare program.

S.4225 - Safeguarding Therapeutics Act of 2020 Introduced by Sen. Mike Enzi (R-WY) on July 20, 2020, this bill establishes authority to destroy counterfeit devices offered for import, and for other purposes.

S.4175 - Pharmaceutical Supply Chain Defense and Enhancement Act Introduced by Sen. Elizabeth Warren (D-MA) on July 2nd, 2020, this bill secures the supply of drugs in the United States, and for other purposes.

H.R. 7767 Introduced by Rep. Brad Wenstrup (R-OH) on July 23, 2020, this bill amends the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment.

H.R. 7838 Introduced by Rep. Doris Matsui (D-CA) on July 29, 2020, this bill provides for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes.

H.R.7104 Introduced by Rep. Ann Kuster (D-NH) on June 4, 2020, this bill directs the Secretary of Health and Human Services to award contracts, grants, and cooperative agreements to expand and enhance manufacturing capacity of vaccines and vaccine candidates to prevent the spread of SARS-CoV-2 and COVID-19.

H.R.7296 Introduced by Rep. Jan Schakowsky (D-IL) on June 22, 2020, this bill 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.

H.R.7113 and S. 3847 - COVID-19 Emergency Manufacturing Act of 2020 Introduced by Rep. Jan Schakowsky (D-IL) on June 4, 2020, this bill amends the Public Health Service Act to establish an Emergency Office of Manufacturing for Public Health, and for other purposes.

S. 4010 Introduced by Senator Bob Casey (D-PA) on June 18, 2020, this bill amends the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.

S.3872 - Promising Pathway Act

-9-

Introduced by Senator Mike Braun (R-IN) on June 3, 2020, this bill 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.

H.R.6457 and S.3576 - Disaster and Emergency Pricing Abuse Prevention ActIntroduced by Rep. Emmanuel Cleaver (D-MO) and Sen. Amy Klobuchar on April 7, 2020, this bill is to clarify that the Federal Trade Commission Act prohibits excessive and unjustified price increases in the sale of certain products and services when an emergency or disaster results in abnormal disruptions of the market, and for other purposes.

S.3647 - Prevent Emergency and Disaster Profiteering Act of 2020Introduced by Sen. Cory Booker (D-NJ) on May 7, 2020. This bill rohibit price gouging for necessary products during federally declared national emergencies or disasters.

H.R.6472 - COVID-19 Price Gouging Prevention ActIntroduced by Rep. Janice Schakowsky (D-IL) on April 7. This bill prohibits price gouging in connection with the public health emergency resulting from COVID–19, and for other purposes.

H.R.6450 - Price Gouging Prevention ActIntroduced by Rep. Joe Neguse (D-CO) on April 3. This bill prevents price gouging during emergencies, and for other purposes.

H.R. 3- Elijah E. Cummings Lower Drug Costs Now ActOn December 12, the House passed the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3) in a party-line 230-192 vote, with two Republicans supporting the measure. The bill has been received in the Senate, where it is still not likely there will be a vote, given Majority Leader Mitch McConnell’s (R-KY) opposition. The content of the bill, however, is important to assess because it represents what could become the Democrats’ drug pricing policy should they sweep the 2020 election. Additionally, President Donald Trump has also made reducing pharmaceutical prices a priority, so elements of H.R. 3 could make their way into a bipartisan package. Included in the package are: H.R. 4663- Freedom from Price Gouging Act, H.R. 4619- Pharmaceutical Rebates for Excessive Pricing Above Inflation Act, H.R. 2296 - Fair Accountability and Innovative Research (FAIR) Drug Pricing Act

H.R.6264 – Preventing Pandemic Profiteering ActIntroduced by Rep. Jason Smith (R-MO) on March 12, 2020, this bill would prevent price gouging of necessary products during a state of emergency. The bill has been referred to the House Committee on the Judiciary.

S.3574Introduced by Sen. Thom Tillis (R-NC) on March 24, 2020, this bill prevents price gouging during national emergencies.

S.378 and H.R. 1093 – Stop Price Gouging ActIntroduced by Rep. Mark Pocan (D-WI) and Sen. Sherrod Brown (D-OH) on February 7, 2019, this bill is to establish an excise tax on certain prescription drugs which have been subject to a price spike that exceed the annual percentage increase in the Chained Consumer Price Index.

-10-

S. 637 and H.R. 4159 - Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act

Introduced by Rep. Chellie Pingree (D-ME) and Sen. Richard Blumenthal (D-CT), this bill is To prohibit price gouging in the sale of drugs- would require pharmaceutical companies to submit justification to HHS for any price increase of 10% or more over one year; 20% or more over 3 years; and 30% or more over 5 years. If HHS finds the price increase is unreasonable, it can penalize the company.

S. 1801 – Affordable Medications Act Introduced by Sen. Tina Smith (D-MN) on May 12, 2019, this bill is to ensure medications are affordable- including a provision to levy an excise tax on companies that spike drug prices (Sec. 202), among other provisions.

S. 2543 – Prescription Drug Pricing Reduction Act (PDPRA) On December 6, 2019, the Senate Finance Committee released a revised version of their drug pricing package that passed through the Committee in July. The updated package still includes its caps to out of pocket costs for Medicare Part D beneficiaries and the inflation rebate penalty. However, the penalty in this package does not go as far as provisions in H.R. 3. The legislation’s impact on drug prices is mostly indirect, see here. The CBO estimated over $10 billion in savings each for Medicare beneficiaries and the government. Other tweaks were made to details surrounding these two core provisions.

S. 1895- Lower Health Care Costs Act of 2019 In July 2019, this bill introduced by Chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) passed the Senate HELP Committee. The five titles of this bill aim to end surprise medical bills, reduce the price of prescription drugs, improve transparency in health care, enhance public health, and improve the exchange of health information. This package contains 14 proposals that aim to increase prescription drug competition.

S.1416- Affordable Prescriptions for Patients Act This legislation, introduced by Senators Cornyn (R-TX), Blumenthal (D-CT), Hawley (R-MO), and Kennedy (R-LA), would give the Federal Trade Commission more ability to go after pharmaceutical companies that file many patents on a drug or shift consumers onto slightly different, separately patented brand-name drugs when older patents run out, keeping prices and profits high. This bill is more aggressive than the CREATES Act and pay-for-delay legislation because it addresses issues like patent thickening and product hopping. The Senate Judiciary Committee marked up this legislation on June 27. Garnering widespread bipartisan support, the bill was unanimously reported favorably by the Judiciary Committee. This bill is still awaiting a floor vote.

S. 1227- Prescription Pricing for the People Act Introduced by Senators Grassley (R-IA), Cantwell (D-WA), Tillis (R-NC), Blumenthal (D-CT), Ernst (R-IA), and Blackburn (R-TN), this bill directs the Federal Trade Commission to report to Congress on the effect of certain anticompetitive practices in the pharmaceutical supply chain. The Senate Judiciary Committee marked up this legislation on June 27 (see notes below). Garnering widespread bipartisan support, the bill was unanimously reported favorably by the Committee. The bill has not received a vote on the floor.

-11-

H.R. 2113 - Prescription Drug Sunshine, Transparency, Accountability, and Reporting (STAR) Act

Introduced by Rep. Richard Neal (D-MA) on April 8, 2019, this bill is to provide for drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain health care providers.

H.R. 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act Introduced by Rep. Lisa Blunt-Rochester (D-RI) on February 6, 2019, this bill is a package including three bipartisan drug pricing bills aimed to reduce anticompetitive behavior and increase competition in the market place- H.R. 938 the BLOCKING ACT, H.R. 965 the CREATES Act, and H.R. 1499 the Protecting Consumer Access to Generic Drugs Act.

H.R. 2609 - Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act

Introduced by Rep. Steven Horsford (D-NV) on April 3, 2019, this bill is to provide for drug manufacturer price transparency.

S. 1664 - Prescription Drug Price Reporting Act Introduced by Sen. Rick Scott (R-FL) on May 23, 2019, this bill is to require reporting on prescription drug expenditures under group health plans and on prescription drug price changes.

H.R.2087 - Drug Price Transparency Act Introduced by Rep. Lloyd Doggett (D-TX) on April 4, 2019, this bill is to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes.

H.R.3523 and S.1987 - End Price Gouging for Medications Act Introduced by Rep. Peter Welch (D-VT) and Sen. Jeff Merkley (D-OR) on June 6, 2019, this bill is to require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal Health Programs.

S.1416 - Affordable Prescriptions for Patients Act of 2019 Introduced by Sen. John Cornyn (R-TX) on May 9, 2019, this bill is to amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug product manufacturers.

In The News

Modern Healthcare (11/30/2020): Providers try to address mounting delays in care as pandemic stretches on - Patients are putting off needed care during the pandemic, creating concerns about the long-term implications for patients.

-12-

Modern Healthcare (11/30/2020): 4 healthcare issues to watch as Congress faces a funding deadline next month - Healthcare providers are working to ensure their priorities are included in legislation to avert a government shutdown on Dec. 11.

Politico (11/30/2020): INDUSTRY GROUPS LINE UP FOR FINAL PUSH ON SURPRISE BILLING BAN — Insurers and employers are trying to capitalize on recent congressional talks around an end to “surprise” medical bills and other key reforms, POLITICO's Susannah Luthi and Rachel Roubein report.

Modern Healthcare (11/25/2020): Drugmakers sue to stop Trump administration importation plan - The lawsuit is the first of what will likely be many healthcare industry legal challenges to the Trump administration's last-minute attempts to achieve policy goals before the transition in January.

Politico (11/25/2020): BIDEN CLOSES IN ON HHS SECRETARY PICK — New Mexico Gov. Michelle Lujan Grisham and former Surgeon General Vivek Murthy are top contenders to be Biden’s health secretary, POLITICO’s Adam Cancryn and Alice Miranda Ollstein report.

Modern Healthcare (11/24/2020): Why Biden worries Big Pharma - Any price limits would shake the business model of an industry accustomed to routine hikes that far exceed the rate of inflation.

Axios (11/24/2020): Essential workers likely to get vaccine priority - Essential workers — who are at higher risk of coronavirus infection and are disproportionately people of color — will likely receive a coronavirus vaccine before adults 65 and older and people with pre-existing medical conditions, STAT reports.

Axios (11/23/2020): Trump sends a parting shot at pharma - The Trump administration on Friday released a pair of drug pricing regulations that could significantly shake up the industry — if they survive inevitable lawsuits, and if the Biden administration chooses to keep them in place.

Politico (11/23/2020): What the FEDERATION OF AMERICAN HOSPITALS is urging Biden : The organization for investor-owned hospitals wants the president-elect to extend the public health emergency and its accompanying waivers, in a letter shared first with PULSE.

Politico (11/20/2020): TRUMP PREPS ELEVENTH-HOUR POLICY BLITZ — The Trump administration is likely to finalize a host of major policies today, in a bid to put a final stamp on the health system before President-elect Joe Biden takes office.

Modern Healthcare (11/19/2020): Small doc groups struggle with telehealth, state panel finds - Telehealth has not been an antidote to lagging patient volumes for all providers, with small physician groups in Massachusetts acutely feeling the problem.

Modern Healthcare (11/19/2020): White House reviews rule for 340B dispute resolution - The move comes amid heated conflict in recent months between providers and drugmakers.

Modern Healthcare (11/19/2020): 4 policy priorities for the American Medical Association - The American Medical Association's House of Delegates indicated its top advocacy goals for the year, including expanding access and affordability of health insurance coverage.

-13-

Politico (11/19/2020): WHAT LIBERALS WANT FROM BIDEN — Leading House progressives on Wednesday night laid out their health care demands for the incoming Biden administration, in a sign they’re going to continue pushing the party toward “Medicare for All,” POLITICO’s Susannah Luthi reports.

Politico (11/18/2020): MOST FAVORED NATION' IS IMMINENT — The Trump administration could announce a long-delayed plan to tie U.S. drug prices to an international index as soon as today, POLITICO's Sarah Owermohle and Dan Diamond report.

Politico (11/17/2020): And most-favored nations? The other once-stalled rule, which would link Medicare payments to much lower costs abroad, has also found new momentum in recent weeks, sources familiar with the talks tell Prescription PULSE. But the administration never issued a real draft of the plan — so attempts to leapfrog standard rule-making steps like public comment are likely to meet legal challenges.

Politico (11/17/2020): IT’S BAAACK — The rebate rule — yes, really — landed at the White House Office of Management and Budget on Friday. Trump revived the once-scrapped plan to eliminate rebates that drugmakers pay to pharmacy benefit managers with an executive order this summer.

Modern Healthcare (11/17/ 2020): Trump's executive order on drug rebate rule may not be binding - An executive order the president signed in July may not have legal force if the HHS secretary moves forward with rulemaking.

Politico (11/12/2020): PROVIDERS TRY TO STAVE OFF MEDICARE PAY CUT — More than two dozen health care groups are asking Congress to extend a moratorium on Medicare reimbursement cuts for as long as the Covid-19 public health emergency continues, warning that the pandemic is already straining providers’ finances.

Politico (11/11/2020): Telehealth - Trump and his Centers for Medicare and Medicaid Services have boosted virtual care by expanding the number of types and telehealth services that Medicare pays for, at least during the pandemic. Telehealth advocates don’t expect that trend to change under Biden, especially given broad bipartisan support. Biden has touted telehealth in his rural health care plan, including a pledge to expand federal grants for virtual care. “There’ll be lots of regulations and things they’ll be trying to undo that folks did, but telehealth is not one of them,” said the American Telemedicine Association’s Kyle Zebley.

Modern Healthcare (11/11/2020): Supreme Court justices seem unlikely to strike down full ACA - The justices focused on issues including whether challengers had legal standing and whether the entire law would have to fall if the individual mandate were unconstitutional.

Modern Healthcare (11/10/2020): 6 healthcare moves Trump could make before he leaves office - The Trump administration will likely sign off on Medicare payment rules before inauguration day, but it could also wrap up its deregulatory agenda to ease provider burden and encourage value-based care.

Modern Healthcare (11/10/2020): 4 issues to listen for in the Supreme Court's ACA oral arguments - The arguments have high stakes because the justices' decision could destabilize the framework the healthcare industry has operated under for a decade.

-14-

Politico (11/10/2020): ROSA DeLAURO BIDS FOR HOUSE APPROPS CHAIR — The Connecticut Democrat, who currently chairs the House subcommittee panel that oversees HHS's pursestrings, on Monday shared an endorsement from the AFL-CIO for the top job. The House appropriations committee is currently led by Rep. Nita Lowey, who's retiring.

Politico (11/10/2020): SENATE SPENDING BILLS — The upper chamber is slated to roll out its spending proposals for fiscal year 2021, offering the first look at the Senate GOP’s response to the Democratic-led House, Susannah and POLITICO's Brianna Ehley write.

Modern Healthcare (11/9/2020): COVID-19 and the ACA will dominate Biden's early regulatory agenda - The decisions that the Biden transition team makes in the coming weeks will set the course for his healthcare agenda.

Axios (11/9/2020): The 3 questions that will determine the ACA's fate - The Supreme Court will hear oral arguments Tuesday over the future of the Affordable Care Act — the third time in eight years the ACA has been on the brink of life or death at the high court, Axios' Sam Baker reports.

Politico (11/9/2020): HHS WILL BE GROUND ZERO FOR THE BIDEN-HARRIS AGENDA — As a new president in February 2017, Trump infamously said that "nobody knew that health care could be so complicated." And while many of his key policies ran through the Humphrey building, Trump was always more interested in priorities like trade and finance that drew on his experience as a businessman.

bracewell.com policyresolutiongroup.com

Bracewell LLP makes this information available for educational purposes. This information does not offer specific

legal advice or create an attorney-client relationship with the firm. Do not use this information as a substitute for

specific legal advice. Attorney advertising.

Bracewell is a leading law and government relations firm primarily serving the energy, infrastructure, finance and

technology sectors throughout the world.

Our industry focus results in comprehensive state-of-the-art knowledge of the commercial, legal and governmental

challenges faced by our clients and enables us to provide innovative solutions to facilitate transactions and resolve

disputes.

If you are an EU citizen and would like to be forgotten, please click here.