Health Care Checkup
January 22, 2021
THE BIG PICTURE
What Happened This Week
 
On January 20, Joe Biden was sworn in as the 46th President of the United States, and Kamala Harris was sworn in as the Vice President. President Biden gave a speech aimed at uniting the country and overcoming hardships caused by the coronavirus pandemic, racial injustice, climate change, and extremist groups. After being sworn in, President Biden signed a slew of executive actions to initiate his administration’s highest-priority policy changes, including rejoining the Paris Climate Agreement, reversing the ban on immigration from certain Muslim-majority countries, extending the pause on student loan payments, implementing the “100 Day Masking Challenge,” advancing civil rights, and extending eviction moratoriums.
 
Biden’s Chief of Staff, Ron Klain, released a memo on Wednesday, stating that the Biden administration will be freezing last-minute Trump administration regulations. This 60-day freeze will apply to all regulations and guidance that have not yet been published into the Federal Register or enacted. A full list of the health-related provisions affected by this freeze can be found here.
 
On Thursday morning, President Biden released the National Strategy for the COVID-19 Response and Pandemic Preparedness plan, which includes action items for overcoming the pandemic. The new plan emphasizes the need to restore trust in the American people by tackling the pandemic based on scientific evidence and equity. The plan lays out goals, including mounting a national COVID-19 vaccine campaign; accelerating vaccine distribution; expanding emergency relief; exercising the Defense Production Act; increasing emergency funding to states; bolstering the Federal Emergency Management Agency (FEMA) response; and safely reopening schools, businesses, and travel.
 
Also on Thursday, President Biden signed additional COVID-related Executive Orders and presidential memorandums. These Orders included the creation of a Pandemic Testing Board, Orders to promote research into new treatments for the virus, and Orders to ensure a sustainable public health workforce for COVID-19 and other biological threats. More information on the President’s Orders can be found here.
 
Both Moderna and Pfizer have begun their vaccination trials in adolescent populations. Pfizer has completed its enrollment and has 2,000 volunteers ages 12 to 15 participating. In December, Moderna gave its first doses to 12-to-18-year-olds. The company hopes to have initial data from its trial and potential approval before the 2021-2022 school year begins. 
What to Expect Next Week: The Biden Administration will continue to assemble its team and define key policy initiatives for the new administration. Over on the Hill, Congress will continue holding full committee nomination hearings for the 117th session. Additionally, Senate Majority Leader Chuck Schumer announced on Friday that the House's article of impeachment will be delivered to the Senate on Monday, which will ignite the Senate’s process for the impeachment trial of former President Donald Trump.
DEEP DIVE
President Joe Biden and Vice President Kamala Harris Sworn into Office, and Biden Signs Range of New Executive Orders
On January 20, Joe Biden was sworn in as the 46th President of the United States, and Kamala Harris was sworn in as the Vice President. President Biden gave a speech aimed at uniting the country and overcoming hardships caused by the coronavirus pandemic, racial injustice, climate change, and extremist groups. He immediately signed a slew of executive actions to initiate his administration’s highest-priority policy changes, including rejoining the Paris Climate Agreement, reversing the ban on immigration from certain Muslim-majority countries, extending the pause on student loan payments, implementing the “100 Day Masking Challenge,” advancing civil rights, and extending eviction moratoriums. On Saturday, Biden’s Chief of Staff, Ron Klain, sent a memo to the incoming White House staff. This memo outlined Biden’s key goals for his first 10 days in office. Some of the initiatives from Klain’s memo include actions on criminal justice reform, the raging pandemic, climate change, expanded access to health care, and steps to reunite families separated at the border. Klain released an additional memo on Wednesday, stating that the Biden administration will be freezing last-minute Trump administration regulations. This 60-day freeze will apply to all regulations and guidance that have not yet been published into the Federal Register or enacted. A full list of the health-related provisions affected by this freeze can be found here.
 
Administration Releases New COVID Response Plan
On Thursday morning, President Biden released the National Strategy for the COVID-19 Response and Pandemic Preparedness plan, which includes action items for overcoming the pandemic. The new plan emphasizes the need to restore trust in the American people by tackling the pandemic based on scientific evidence and equity. The plan lays out goals, including mounting a national COVID-19 vaccine campaign; accelerating vaccine distribution; expanding emergency relief; exercising the Defense Production Act; increasing emergency funding to states; bolstering the Federal Emergency Management Agency (FEMA) response; and safely reopening schools, businesses, and travel. Also included in the plan is the $1.9 trillion COVID relief package that the Biden-Harris transition team released prior to Biden’s inauguration. President Biden also signed additional COVID-related Executive Orders and presidential memorandums on Thursday. These Orders will include the creation of a Pandemic Testing Board, as well as Orders that will promote research into new treatments for the virus. We will continue to monitor the new administration’s actions as they unfold.

Biden Administration Announces Additional Key Health Leaders
The Biden administration has continued to announce its health leaders. President Biden has tapped the Pennsylvania Health Secretary, Dr. Rachel Levine, to be his Assistant Secretary of Health. Wisconsin health advisor Andrea Palm has been nominated to be Deputy Secretary of the U.S. Department of Health and Human Services (HHS). At the Centers for Medicare and Medicaid Services (CMS), Liz Richter will serve as the Acting Administrator, and Jeff Wu will serve the Acting Principal Deputy Administrator and the Deputy Director of Policy in the Center for Consumer Information and Insurance Oversight. Richter is a veteran of CMS, having served for over 30 years, and Wu has been at the agency since 2011. Additionally, Sean McCluskie, who was previously the Chief Deputy Attorney General in California, will become the HHS Chief of Staff. Topher Spiro, Health Policy Researcher at the Center for American Progress, will reportedly lead the health programs at the Office of Management and Budget, and Sarah Despres, the Director of Government Relations at the Pew Charitable Trusts, is expected to be a counselor to the Health Secretary. Surgeon General Jerome Adams announced on Wednesday that the Biden administration had asked him to step down ahead of Biden’s inauguration. He will, however, stay on as an Adviser during the early days of the new administration. Biden has tapped former Surgeon General Vivek Murthy to return to the role. Murthy still must undergo Senate confirmation hearings, so an Acting Surgeon General is expected to be chosen to fill the role in the meantime. At the U.S. Food and Drug Administration (FDA), Erika Anderson will serve as the Acting Deputy Commissioner for Policy, Legislation, and International Affairs; and Mark Raza will serve as the Acting Chief Counsel. 
Lawmakers and Advocacy Group Urge Rescinding Medicaid Guidance
In the waning days of the Trump presidency, HHS created guidance that purports to bind states to continue implementing CMS demonstration waivers for at least the next nine months. In pursuit of this endeavor, CMS Administrator Seema Verma had asked states to sign agreements “as soon as possible” claiming to lock in the states to a new nine-month process for killing Medicaid waivers. These moves have been highly criticized, as critics claim the rules were implemented to hamper the Biden administration’s likely efforts to change Trump-era CMS demonstration waiver policies. These announcements came after CMS approved various Medicaid waivers for controversial new experiments, such as Tennessee’s block-grant financing waiver. Critics of such waivers are concerned that Medicaid recipients will lose critical coverage for care because they fear states will make cuts to their Medicaid programs. In response, the National Health Law Program, a legal advocacy group, sent a letter to HHS and CMS on January 20, urging the agencies to “withdraw each of the letters of agreement and enclosures that [CMS] sent to states on or about January 4, 2021.” House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) also wrote a letter to CMS Administrator Seema Verma, urging her to rescind the Medicaid guidance. The Congressmen wrote that, “While the letters claim to establish the procedures the Trump Administration will follow to withdraw approval of section 1115 demonstrations, they are nothing more than a hastily-drafted, transparent attempt to tie the hands of the Biden Administration for at least nine months, and entrench your shameful Medicaid legacy after your time as CMS Administrator has ended.”
COVID-19 Vaccination Trials Begin in Adolescents
Both Moderna and Pfizer have begun their vaccination trials in adolescent populations. Pfizer has completed its enrollment and has 2,000 volunteers ages 12 to 15 participating. In December, Moderna gave its first doses to 12-to-18-year-olds. The company hopes to have initial data from its trial and potential approval before the 2021-2022 school year begins. However, both companies have struggled with recruiting volunteers. Moderna needs 3,000 children participants to obtain FDA approval, but currently only 800 kids have enrolled in its trial. A spokesperson for Moderna said that, although enrollment was low during the holidays, numbers are expected to pick up during the new year. While children have been relatively unaffected by COVID-19, experts assert that it is important for children to eventually receive the vaccine, as it will help to reduce the spread to other populations that are more severely affected by the virus. 
SENATE HEARINGS AND EXECUTIVE SESSIONS
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HOUSE HEARINGS AND EXECUTIVE SESSIONS
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ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

National Institutes of Health
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