Washington Watch for the Week of February 7, 2021

Carter L. Alleman, J.D.

Biden Signs More Executive Orders in Second Week
President Joe Biden signed several executive orders (E.O.s). One major E.O. contained the President’s plan for ‘Buy American.’ The order directs U.S. agencies to strengthen purchase requirements for acquiring goods and services from U.S. companies and workers, making it more difficult for the federal government to obtain waivers for the purchase of products overseas. It also establishes a new post in the Office of Management and Budget (OMB) to oversee the changes and provide transparency around agencies that do seek a waiver and revises the standards for American-made products with an aim of ensuring they are manufactured with a higher percentage of U.S. components and labor. The E.O. directs the provisions to be implemented within six months.

Another E.O. issued on January 21 directs the U.S. Department of Health and Human Services (HHS) to review the interoperability of public health data systems across the nation with the goal of better enabling COVID data sharing throughout the federal government, improving vaccine distribution, and increasing the understanding of the scope of the pandemic in communities throughout the country. OMB is directed to issue additional guidance on how to de-identify COVID-related data and make it available to the public.

President Biden also moved to reopen HealthCare.gov for a special enrollment period aimed at those individuals needing coverage during the ongoing pandemic. The administration plans to spend $50 million in advertising and outreach for the additional open enrollment period. The federal marketplace will be opened for three-months starting on February 15 under the E.O., which also directs a broad review of policies “that limit Americans’ access to health care.”

White House Delays, Withdraws Additional Health Rules
The Biden administration has acted to delay the effective date of several Trump-era regulations. The Organ Procurement Organizations Conditions for Coverage final rule, which altered the requirements related to organ procurement organizations (OPOs), was scheduled to take effect on February 1 but is now delayed until March 30 to provide the new administration time to review “issues of fact, law, and policy.” The White House also paused the Trump administration’s drug rebate rule, which would replace current rebates with fixed-fee arrangement, delaying the policy until March 22 from an original effective date of January 29. The Government Accountability Office (GAO) had flagged the rule for violating the Congressional Review Act, which requires major rules to take effect no sooner than 60 days after publication in the Federal Register. The HHS is also delaying the Secure Electronic Prior Authorization for Medicare Part D rule, originally slated to go into effect January 30, until March 30. The rule aims to streamline the prior authorization process for certain products in Part D.

COVID Relief Negotiations Remain Underway
The White House continues to stand by its nearly $2 trillion proposal for coronavirus relief while also expressing hope that a stimulus package can be passed on a bipartisan basis. Republicans have largely rejected the proposal citing concerns about the overall size of the measure. While there is a consensus that more funding is needed for the vaccine distribution campaign, there are lawmakers on both sides of the aisle who are hesitant to approve $1,400 stimulus checks to most individual Americans without any additional means testing. Republicans are also resisting proposals to raise the federal minimum wage and provide additional funding for state and local governments.

A group of 10 Senate Republicans led by Susan Collins (R-Maine) sent a letter to President Joe Biden over the weekend requesting a meeting on COVID relief. The letter outlines framework for their counterproposal, which includes a total of $160 billion for vaccines, testing, treatment, and personal protective equipment (PPE), in line with the President’s plan. The group is expected to release more details on their proposal today. The letter was signed by GOP Sens. Lisa Murkowski (Alaska), Bill Cassidy (La.), Mitt Romney (Utah), Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Todd Young (Ind.), Jerry Moran (Kansas), Thom Tillis (N.C.), and Mike Rounds (S.D.).

Democrats to Start Reconciliation Process
While a bipartisan alternative remains under discussion, Democratic leadership are also preparing to pursue the option of reconciliation, a budget procedure that would allow certain provisions to pass both chambers with simple majorities. Budget Committee Chair John Yarmuth (D-Ky.) has said that the House of Representatives intends to hold a vote this week on a budget resolution, the first step to starting the reconciliation process for COVID stimulus legislation.

The resolution will not be considered by the committee but will instead be brought directly to the floor. Majority Leader Steny Hoyer (D-Md.) released a revised schedule for the House to accommodate this process and provide committees two weeks in February to focus on the legislative work. Senate Majority Leader Chuck Schumer (D-N.Y.) also informed his caucus that a vote on a budget resolution could come as early as this week. Lawmakers are working to pass additional COVID-19 legislation ahead of March 14, when expanded unemployment insurance benefits are set to expire.

Biden Sworn In as 46th President of the United States
Joe Biden and Kamala Harris were sworn in as the nation’s President and Vice President during a scaled-back inauguration ceremony. The 46th President’s inaugural remarks focused on the need for unity to confront the pandemic and the nation’s current social and economic challenges.

Biden’s First Days in Office Include Health-Related Executive Actions, Regulatory Freeze
President Joe Biden took more than a dozen executive actions during his first days in office, many aimed at supporting the economy and containing the coronavirus pandemic. The President also unveiled a national strategy to curtail the coronavirus pandemic. The National Strategy for the COVID-19 Response and Pandemic Preparedness includes a series of executive actions to overhaul the federal government’s response to the coronavirus. The strategy is based on seven goals, including restoring trust with the American people; mounting a safe and effective vaccination campaign; expanding masking, testing, data and treatments; building the health care workforce; safely reopening schools, businesses and travel while protecting workers; protecting those most at risk for serious illness, including people of color; and restoring U.S. leadership globally.

Regulation Freeze and Review in Place
Upon taking office, the new administration also acted to freeze all pending rules and regulations. All rules, guidance, or other agency action that did not take effect prior to noon on January 20 will be subject to review by the new administration before taking effect. If the regulations raise questions of “fact, law, or policy” the current agencies can further delay the effective dates and consult with the Office of Management and Budget (OMB) on further options.

More than 20 actions from the U.S. Department of Health and Human (HHS) are now on hold. Amongst other rules, the regulatory pause includes the Medicare Coverage of Innovative Technology (MCIT) rule, the Implementation of Executive Order on Access to Affordable Life saving Medications rule, the Secure Electronic Prior Authorization For Medicare Part D rule, the Reducing Provider and Patient Burden by Improving Prior Authorization Processes rule, the Promoting Patients’ Electronic Access to Health Information rule, the Organ Procurement Organizations Conditions for Coverage rule, the Most Favored Nations (MFN) Model, changes to the Stark Law and Anti-Kickback Statute, and the Medicare Rebate rule.

President Signs CHIRA Into Law
President Trump has signed into law the Competitive Health Insurance Reform Act (CHIRA), Public Law No: 116-327, which repeals the exemption from U.S. antitrust laws for health insurance companies. The McCarran-Ferguson Act of 1945 exempts the business of insurance from the federal antitrust laws intended to protect and promote fair competition. CHIRA will give the Department of Justice (DOJ) and the Federal Trade Commission (FTC) the authority to apply federal antitrust laws to anticompetitive behavior by health insurance companies, while continuing to allow for data sharing among health insurers within certain limits. The law will not affect or interfere with the authority of each state to regulate the business of insurance.

President Trump Impeached for the Second Time
The House of Representatives acted to impeach President Trump last Wednesday, making him the first U.S. president to be impeached more than once. The four-page impeachment resolution includes a single article accusing the President of high crimes and misdemeanors for “Incitement of Insurrection,” and details the events surrounding the January 6 violence at the Capitol building. After about three hours of debate, the House voted to approve H.Res.24 by a vote of 232-197. It was supported by all Democrats and 10 Republicans, including Liz Cheney (R-Wyo.), the third-ranking GOP leader in the House. The vote marked the most bipartisan group of lawmakers to ever impeach a U.S. president.

PHE Declaration Extended
As a result of the continued COVID-19 pandemic, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar renewed the public health emergency (PHE) declaration effective January 21, 2021. The renewal lasts for the duration of the emergency or 90 days and may be extended again by the Secretary. The nationwide PHE was first declared on January 27, 2020.

Wenstrup, Harris to Lead Doc Caucus
Representatives Brad Wenstrup (R-Ohio) and Andy Harris (R-Md.) have been selected to lead the House GOP Doctors Caucus during the 117th Congress. The two lawmakers will succeed Representative Phil Roe (R-Tenn.), who retired from Congress this year. Dr. Wenstrup is a Doctor of Podiatric Medicine, and Dr. Harris is an anesthesiologist.

Congress Provides More Funds for the Provider Relief Fund
On December 27, the President signed the Consolidated Appropriations Act, 2021, which among other things, included $3 billion for the Provider Relief Fund (PRF), along with additional language: (1) clarifying that a parent organization can transfer funds to a subsidiary (under certain circumstances, even for Targeted Distributions), (2) describing how a provider may calculate lost revenues (i.e., that the provider may use the calculation using the FAQ guidance from June 2020, including the difference between such provider’s budgeted and actual revenue budget if such budget had been established and approved prior to March 27, 2020), and (3) specifying that not less than 85 percent of the unobligated balances available as of December 27, and any funds recovered from health care providers after December 27, shall be for any successor to the Phase 3 General Distribution allocation to make payments to eligible health care providers based on applications that consider financial losses and changes in operating expenses occurring in the third or fourth quarter of calendar year 2020, or the first quarter of calendar year 2021.

U.S. Purchases 100 Million More Doses of Pfizer Vaccine
The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have purchased an additional 100 million doses of Pfizer’s COVID-19 vaccine. Under the agreement, the company will manufacture and deliver up to 100 million doses to government designated locations – with at least 70 million doses provided by June 30, 2021, and the balance delivered no later than July 31, 2021. The government had previously contracted with Pfizer for an initial 100 million doses. This latest agreement includes options for an additional 400 million doses of the vaccine. As a part of the deal, President Trump will invoke the Defense Production Act (DPA) to increase access to nine products that are necessary for the Pfizer vaccine. President-elect Joe Biden has also announced plans to invoke DPA to increase the production of coronavirus vaccines.

VA Releases 2021 Fee Schedule
The U.S. Department of Veterans Affairs (VA) has published its community care fee schedule payment rate calculations for 2021. Instead of rates being calculated based on the location of the referring VA medical center, rates will now be calculated based on the location of where the care is provided starting on January 1, 2021. VA generally reimburses hospital care, medical services, and extended services at the applicable Medicare rate determined by the Centers for Medicare and Medicaid Services (CMS). The recently published rate changes only apply to services being reimbursed under the VA fee schedule, which is mainly used for geriatrics and extended care services, along with a small number of health care services not covered by the CMS schedule.