This week in Washington: CMS develops additional code for coronavirus lab tests, announces actions to address spread of coronavirus; House passes bill to ban e-cigarette flavors; Grassley says updated Senate Finance drug pricing bill saves $80 billion.


House Passes Bill to Ban E-Cigarette Flavors, Expand Tobacco User Fees
On Feb. 28, the House passed H.R. 2339, the Reversing the Youth Tobacco Epidemic Act, 213 to 195. The legislation was sponsored by the chairman of the House Energy and Commerce Committee, Rep. Frank Pallone (D-NJ). The bill would ban all products categorized as e-cigarette flavors, allow the Food and Drug Administration (FDA) to collect user fees from all classes of tobacco products and increase the total amount of user fees collected by $100 million.


Grassley Says Updated Senate Finance Drug Pricing Bill Saves $80 Billion
On March 5, Senate Finance Committee Chair Chuck Grassley (R-IA) said that the updated version of the committee’s drug pricing bill, S. 2543, the Prescription Drug Pricing Reduction Act of 2019, would save $80 billion over 10 years, reduce patient out-of-pocket spending in Part D by about $50 billion and reduce premiums by about $1 billion. The Congressional Budget Office (CBO) estimated that the previous version of the bill would save $105 billion, and CBO lowered that score to account for the cost of a new provision to lower beneficiary coinsurance by 5 percent. Majority Leader Mitch McConnell (R-KY) still has not scheduled floor time for consideration of this bill.

House and Senate Pass Emergency Supplemental Appropriations Package to Address Coronavirus – President Signs Legislation
On March 6, President Trump signed the $8.3 billion emergency funding package Congress passed in the same week, sending funds to federal agencies and states working to combat a rising number of coronavirus cases in the U.S. The bill, H.R. 6074, provides a total of $7.7 billion in new discretionary spending and authorizes an additional $490 million in mandatory spending through a Medicare change. More than $400 million will be disbursed to states within the first 30 days of the bill’s enactment, with each state receiving no less than $4 million.

Read more in McGuireWoods Consulting’s Washington Healthcare Update.

FY21 Budget

Senior administration officials will continue to make the rounds on Capitol Hill next week to answer questions from lawmakers on the FY21 budget. The FY21 National Defense Authorization Act (NDAA) process is also moving forward, with the House Armed Services Committee looking towards a late April markup. The Senate will also continue consideration of its comprehensive energy bill.

Pence Scheduled to Meet with Cruise Line Executive on Coronavirus

Vice President Pence is scheduled to meet with cruise line executives Saturday in Florida on the coronavirus outbreak. On Monday, President Trump was scheduled to speak at the Healthcare Information and Management Systems Society (HIMSS) conference in Orlando while the White House Office of Management and Budget continues to review two Health and Human Services health data sharing rules. HIMSS announced today that the event will be cancelled due to coronavirus, however.

Read more in McGuireWoods Consulting’s Emerging Technologies Washington Update.

American Energy Innovation Act

The House and Senate were both in session this week. The Senate took up S.2657, the American Energy Innovation Act (AEIA), a package of more than 50 energy-related bills reported by the Senate Energy and Natural Resources Committee in 2019. On Wednesday, the Senate Judiciary Subcommittee on Crime and Terrorism held a hearing on Dangerous Partners: Big Tech and Beijing. Yesterday, the Senate passed legislation calling on the administration to develop a 5G security strategy. The House passed a similar measure earlier this year.

Coronavirus Response

The House on Wednesday passed an $8.3 billion emergency coronavirus package with a 415-2 vote. The two nays were from Reps. Andy Biggs (R-AZ) and Ken Buck (R-CO). Today, the Senate approved the package in a 96-1 vote. Sen. Rand Paul (R-KY) voted against it.

The President added several Cabinet and other officials to the coronavirus task force this week and attended a meeting on Monday with pharmaceutical executives to discuss the outbreak. The President and Vice President Mike Pence, who is leading the task force, met with airline CEOs on Wednesday to discuss the implications for travel.

Earl Comstock Resigns

Earl Comstock, who served as director of policy and strategic planning at the Commerce Department for three years, resigned Friday. Comstock was at the center of debates concerning how to repurpose airwaves for commercial 5G services and also helped lead the Trump administration’s efforts to impose export restrictions on Huawei Technologies. In addition, he was a key point person on trade, especially with respect to the Commerce Department’s Section 232 investigations into the national security impacts of automotive, steel, and aluminum imports.

50,000 Comments Submitted to FAA’s Notice of Proposed Rulemaking for Remote ID of Drones

The FAA received over 50,000 comments in response to its notice of proposed rulemaking for remote identification of drones ahead of Monday’s deadline. The FAA also closed out a comment period this Wednesday on a Notice of Policy for type certification of drones.

Coronavirus Negatively Impacting Tech Industry

Coronavirus continues to negatively impact the technology industry. Domestically, tech giants like Facebook and Google have canceled their annual conferences, and abroad, international events such as the Mobile World Congress and the World ATM Congress have been called off. Now, the virus may be threatening South by Southwest. The event, which takes place annually in Austin, is scheduled to start on March 13th, but Facebook, Apple, Twitter, and others have pulled out, throwing the event’s fate into question.

Read more in McGuireWoods Consulting’s Emerging Technologies Washington Update.


Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: “Review of the FY2021 Budget Request for HHS”

Tuesday, February 25, 2020: The Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Senate Committee on Appropriations held a hearing to discuss HHS’s budget request for fiscal year 2021. Alex Azar, secretary of HHS, served as witness. Find more details on the hearing here.

Why this is important: HHS Secretary Azar fielded a bipartisan concern regarding the spread of coronavirus in every hearing he attended this week in Congress. In all separate budget hearings, Azar told members of Congress that the spread of coronavirus is contained at the moment, comments that seem to contradict the Centers for Disease Control and Prevention’s (CDC) warnings to prepare for a possible pandemic. Azar told members, however, that more cases of the coronavirus are likely, requesting $2.5 billion in funding to address the outbreak. Azar said the funding would help the U.S. expand surveillance systems for the fast-spreading virus, support state and local governments, help development of vaccines and therapies and expand stockpiles of protective equipment, such as masks.

House Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: “Department of Health and Human Services (HHS) Budget Request for FY 2021”

Wednesday, February 26, 2020: The Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the House Committee on Appropriations held a hearing to discuss HHS’s budget request for fiscal year 2021. Alex Azar, secretary of HHS, served as witness. Find more details on the hearing here.

Why this is important: Facing criticism on the HHS response to the coronavirus outbreak thus far, HHS Secretary Azar said that the risk right now is very low to Americans, and that from a public health perspective, there is technically a state of containment in the U.S. Members also expressed concern over the president’s budget cutting the Medicaid program by $1.5 trillion.

House Committee on Energy and Commerce, Subcommittee on Health: “The Fiscal Year 2021 HHS Budget and Oversight of the Coronavirus Outbreak”

Wednesday, February 26, 2020: The Subcommittee on Health of the Committee on Energy and Commerce held a hearing to address the recent concerns surrounding the international spread of coronavirus and cover the HHS budget request for FY 2021. HHS Secretary Alex Azar gave a witness testimony. Find more details on the hearing here.

Why this is important: Health subcommittee Chairwoman Anna Eshoo (D-CA) told the committee and HHS Secretary Azar that the Trump administration’s lack of coordination for the coronavirus (COVID-19) outbreak response is on full display. Eshoo reiterated that contradicting statements are being released from the administration and that as such, financial markets are reacting to this lack of trusted information.


House Democrats Warn Trump Administration of Potential COVID-19 Drug Price Gouging

On Feb. 26, 46 House Democrats cautioned the Trump administration against awarding companies exclusive licenses for coronavirus drugs (COVID-19) invented with taxpayer money, adding that the administration must ensure a coronavirus vaccine is affordable and accessible. During a House Energy and Commerce health subcommittee hearing the same day, the Department of Health and Human Services (HHS) Secretary Alex Azar refused to promise that a coronavirus vaccine would for sure be affordable for everyone. Azar said prices of COVID vaccines and treatments are not up to the government to set because the government cannot quickly develop those products without the help of private drug manufacturers.


Senate Democrats Make a Request for $8.5B in Emergency Coronavirus Funds

On Feb. 26, Senate Minority Leader Chuck Schumer (D-NY) released an appropriations request to provide $8.5 billion in emergency money for fighting the coronavirus. The plan provides $1.5 billion for the Centers for Disease Control and Prevention (CDC), $3 billion for the Public Health and Social Services Emergency Fund, $2 billion to reimburse state and local governments, $1 billion for a U.S. Agency for International Development (USAID) emergency reserve fund and $1 billion for vaccine development at the National Institutes of Health (NIH). Find the request here.

Read more on healthcare policy on the McGuireWoods Consulting website.

FY21 Appropriations

With the FY21 appropriations process officially underway, Cabinet secretaries and other senior administration officials will continue to make the rounds before congressional committees of jurisdiction over the coming weeks to testify in support of the President’s budget request. The House Appropriations Committee is planning to begin subcommittee markups on April 21, followed by full committee markups the week of April 28. The Committee plans to complete all markups by May 19 with the goal of passing all of its bills before July. The House and Senate Armed Services Committees are also in the early stages of hearings for the FY21 National Defense Authorization Act (NDAA).

5G Summit

The White House is planning to host a 5G summit in April, according to National Economic Council Director Larry Kudlow. The Federal Communications Commission (FCC) will also hold a forum on March 26 focused on 5G virtualized radio access networks.

Read more in McGuireWoods Consulting’s Emerging Technologies Washington Update.

Republican and Democratic Retreats

Congress was in session this week, though the Senate recessed for Republican and Democratic retreats on Wednesday and Thursday.

Section 230

House Judiciary Antitrust Subcommittee Chairman David Cicilline (D-RI) is planning to introduce legislation to reform Section 230 of the Communications Decency Act to make platforms liable for running “demonstrably false” political ads. The bill will be the latest in a series of legislative proposals to reform the landmark law and comes on the heels of last week’s Department of Justice public workshop.

President Trump Concludes India Trip

On Tuesday, President Trump concluded a 36-hour trip to India. He was accompanied by a high-level delegation that included Commerce Secretary Wilbur Ross, Energy Secretary Dan Brouillette, FCC Chairman Ajit Pai, and about a dozen others. Although the visit did not secure a “mini” trade deal as was originally intended, it did showcase the strength of the US-India relationship and the friendship between President Trump and Prime Minister Modi. As a participant in the delegation, it was reported that Chairman Pai spoke to Indian counterparts about spectrum issues including 5G.

Coronavirus Appropriations

Stateside, the President requested $2.5 billion in supplementary appropriations to protect the United States from the spread of the coronavirus as multiple congressional committees of jurisdiction have been convening hearings on various aspects of the crisis. Negotiations continue as Senate Democrats have put forth their own proposal for $8.5 billion in spending. In the meantime, President Trump announced during a Wednesday evening press conference that Vice President Mike Pence would lead the U.S. effort to manage the response to the virus. The administration Thursday announced that State Department Ambassador-At-Large Debbie Birx will serve as the administration’s coronavirus “czar.”

CCPA Implementation

Meanwhile, California Attorney General Xavier Becerra sent a letter on Tuesday to the bipartisan leadership of the Senate Commerce and House Energy and Commerce Committees providing an update on California Consumer Privacy Act (CCPA) implementation. He also urged Congress to adopt federal privacy legislation that, at a minimum, provides the rights to access, correct, and delete personal data that has been collected; to minimize data collection, processing, and retention; to data portability among services; and; to know what data is collected and processed and for what reasons. He also urged Congress to make clear that state attorneys general have parallel enforcement authority and to adopt a private right of action, while warning against preemption.

Read more in McGuireWoods Consulting’s Emerging Technologies Washington Update.


Twelve Republican Senators Support Grassley-Wyden Drug Pricing Bill
As of Feb. 18, Senate Finance Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden’s (D-OR) bipartisan drug pricing legislation now has 12 Republican senators in support of the plan. Sen. Grassley said he needs support from at least 25 Republican senators to convince Senate Majority Leader Mitch McConnell (R-KY) to bring S. 2543 to the Senate floor for a vote. The senators who have said they support the legislation, however, have not officially cosponsored the legislation.


FDA, FTC Collaborate to End Biosimilars Misinformation and Increase Competition
On Feb. 3, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced a collaboration to advance biosimilars adoption, discourage false or misleading communications about biosimilars and deter anticompetitive behaviors.

To begin, a public meeting will be held on March 9, 2020, for input on how to increase competition for biological products.

Find the statement here.

Read more on healthcare policy on the McGuireWoods Consulting website.

The State of Education in Washington

President Trump released his $4.8 trillion budget proposal for FY 2021 spending last week. The president’s budget aims to cut non-defense spending, including funding for the U.S. Department of Education. President Trump requested $66.6 billion for the Department of Education for FY 2021, which represents a $5.6 billion, or nearly 8 percent, cut from enacted levels. While the president’s budget is dead on arrival in Congress, it provides insight on the president’s education priorities.

Expanding School Choice

School choice has always been a top priority for the Trump administration. As such, the president’s budget included up to $5 billion for the Education Freedom Scholarships (EFS) program, a federal tax credit program for donations to organizations that grant scholarships to students to attend private school or other educational opportunities.

Reducing the Federal Role in Education

The president’s budget creates the Elementary and Secondary Education for the Disadvantaged (ESED) block grant program by consolidating funding for 29 education programs (and $24 billion in spending) into one $19 billion block grant. The programs that will be consolidated include Title 1 programs, arts programs, and charter and magnet school programs among others. States will be able to determine how this funding is used as long it is used for authorized purposes, reducing the federal role in education, which is a long-time goal of the Trump administration.

Growing Career and Technical Education Programs

President Trump’s budget includes a $900 million increase for Career and Technical Education (CTE) programs. The president has focused on the importance of CTE in recent weeks. On January 31, President Trump issued a presidential proclamation declaring February as CTE month. Additionally, the president mentioned CTE in his State of the Union address, asking Congress to support his goal of ensuring every high school student in America has access to CTE programs.

Changing the Student Loan Program

The president’s budget proposes to make cuts to the student loan program of almost $5 billion. The proposal would eliminate the public servant student loan forgives program, cap the amount of money graduate students and parents can borrow, and end supplemental grants for low income students. The plan would instead allow for undergraduate borrowers to qualify for loan forgiveness after 15 years, down from the current 25 years. It also would expand Pell Grants to people in prison pursuing higher education degrees.

Read more on education policy in McGuireWoods Consulting’s Education Policy Update.


House Education and Labor Committee: “Markup: H.R. 5800, Ban Surprise Billing Act”
Tuesday, February 11, 2020: The House Education and Labor Committee held a markup for:

Find more details on the hearing here.

Why this is important: The committee approved H.R. 5800, 32-13, to end surprise medical billing. The plan uses a federal benchmark payment to settle differences while allowing providers and payers to appeal to an independent arbiter in disputes over bills above $750. The Congressional Budget Office (CBO) estimates the bill would save the federal government about $24 billion over a decade.

House Ways and Means Committee: “Markup of Health Legislation”
Wednesday, February 12, 2020: The House Ways and Means Committee held a markup for the follow three bills:

  • H.R. 5821, the “HOSPICE” Act
  • H.R. 5825, The “Transparency in Health Care Investments Act of 2020”
  • H.R. 5826, the “Consumer Protections Against Surprise Medical Bills Act”

Find more details on the markup here.

Why this is important: The bill, H.R. 5826, passed by voice vote and addresses surprise medical billing by requiring negotiations between health plans and providers who could submit disputes to an independent mediator if there is an impasse. The Congressional Budget Office (CBO) estimated that the bill would save the federal government $17.77 billion over a decade. The committee also passed H.R. 5821 by voice vote.

House Committee on Energy and Commerce, Subcommittee on Health: “Protecting Women’s Access to Reproductive Health Care”
Wednesday, February 12, 2020:The Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to discuss H.R. 2975, the Women’s Health Protection Act of 2019Find more details on the hearing here.

Senate Committee on Aging: “There’s No Place Like Home: Home Health Care in Rural America”
Wednesday, February 12, 2020: The Senate Committee on Aging held a hearing on rural health care concerns, featuring a panel of witnesses to discuss home care and hospice care. Find more details on the hearing here.


HHS Secretary Azar Testifies to Senate Finance on President Trump’s 2021 Budget
On Feb. 13, the Department of Health and Human Services (HHS) Secretary, Alex Azar, testified to the Senate Finance Committee during a hearing on President Trump’s fiscal 2021 budget proposal. Senate Finance Democrats asked Azar to describe the administration’s Affordable Care Act (ACA) replacement plan, but Azar said the high-profile litigation over the constitutionality of the health law is a long way from being finished and at this point, an ACA replacement is a hypothetical situation.

Bipartisan Senate Bill Introduced to Close Orphan Drug Act Cost Recovery “Loophole”
On Feb. 11, Senate Health, Education, Labor and Pension (HELP) members Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) along with Sen. Jeanne Shaheen (D-NH) introduced the Fairness in Orphan Drug Exclusivity Act, a companion to the House’s bipartisan bill of the same name. The bill aims to close an Orphan Drug Act loophole that is believed to allow drug manufacturers to obtain orphan drug designation, and the corresponding seven years of exclusivity, if they claim they are unable to recover development costs on the drug.

Read more on healthcare policy on McGuireWoods Consulting’s website.

House and Senate in Recess

The House and Senate will be in recess next week coinciding with Presidents’ Day.

DOJ Workshop on Section 230

On February 19, the Department of Justice will hold a workshop on Section 230 of the Communications Decency Act titled “Section 230 – Nurturing Innovation or Fostering Unaccountability?.”

US-India Trade Agreement

The President and First Lady will travel to India on February 24 and 25. President Trump and Prime Minister Modi are expected to celebrate a new US-India trade agreement during the visit. On April 21, the President and First Lady will host King Felipe VI and Queen Letizia of Spain at the White House for a state visit.

Read more in McGuireWoods Consulting’s Emerging Technologies Washington Update.