Senate Health, Education, Labor and Pensions (HELP) Committee: “Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use”
Wednesday, Nov. 13, 2019: The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to examine the Food and Drug Administration’s (FDA) and Centers for Disease Control and Prevention’s (CDC) response to lung illnesses and rising youth electronic cigarette use.

Why this is important: Senators of both parties questioned Mitch Zeller, the head of the Food and Drug Administration’s (FDA) Center for Tobacco Products, holding him responsible for a lack of information on upcoming e-cigarette policy and flavor bans from the FDA. Zeller referred the members of the committee to the White House for more comment.

The Office of Management and Budget (OMG) completed regulatory review of a proposed rule about electronic nicotine delivery systems on Nov. 4, and canceled meetings with stakeholders. Department of Health and Human Services (HHS) Secretary Alex Azar commented that the rule is not finished yet, and said President Trump is still interested in hearing from all stakeholders.

Find more details on the hearing here.

House Committee on Energy and Commerce: Markup of H.R. 2339, H.R. 4995, H.R. 4996 and H.R. 2387
Wednesday, Nov. 13, 2019: The House Committee on Energy and Commerce, Subcommittee on Health met in an open markup session of four health-related bills.

H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019, was favorably forwarded to the full committee, amended, by a voice vote.

H.R. 4995, the Maternal Health Quality Improvement Act of 2019, was favorably forwarded to the full committee, without amendment, by a voice vote.

H.R. 4996, the Helping Medicaid Offer Maternity Services (MOMS) Act of 2019, was favorably forwarded to the full committee, amended, by a voice vote.

H.R. 2387, the Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019, was favorably forwarded to the full committee, without amendment, by a voice vote.

Find more details on the markup and amendments here.

House Ways and Means Committee: “Caring for Aging Americans”
Thursday, Nov. 14, 2019: The House Ways and Means Committee held a hearing to discuss long-term care issues, which included discussion of care in the home, hospice and nursing homes and antipsychotic drug use in nursing homes.

Why this is important: The witness panel provided personal anecdotes and noted key concerns, including the abuse and neglect in care residences, the impending lack of money for those that need care in the near future, malnutrition of the elderly and support for caregivers, who need leave from work or even recognition on electronic health records. There was also discussion of expanding funds to community groups who help as caregivers, and inspiration from states like Washington that have created long-term care insurance plans that will distribute $36,500 per person in lifetime benefits, starting in 2025.

Find more details on the hearing here.

Read more on healthcare policy on the McGuireWoods Consulting website.

congressContinuing Resolution

The House will vote next week on a continuing resolution to extend government funding likely through mid-December, with the Senate expected to follow suit as the current CR is set to expire on November 21.

Hearing on Autonomous Vehicles

The Senate Commerce, Science, and Transportation Committee will hold a hearing next Wednesday on autonomous vehicles.

FDA Commissioner Confirmation

Dr. Stephen Hahn will testify next Wednesday before the Senate Health, Education, Labor, and Pensions Committee on his nomination to be Food and Drug Administration (FDA) Commissioner.

Bulgarian Prime Minister to Visit White House

The President will host Bulgarian Prime Minister Boyko Borissov at the White House on November 25.

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

Discussions to Avert a Government Shutdown Ongoing

The House and Senate returned to Washington on Tuesday after the Veterans’ Day holiday. Senator Richard Shelby (R-AL) and Rep. Nita Lowey (D-NY), who chair the Appropriations Committees, met on Tuesday to discuss a deal to avert a government shutdown when the current continuing resolution (CR) expires on November 21. Congress is expected to pass, and the President is expected to sign, a new CR extending funding a current levels through December 20, though negotiations are ongoing.

Administrative Appointments Confirmed

The Senate confirmed Chad Wolf this week to serve as Undersecretary of Homeland Security. Once confirmed, he was sworn in and named Acting Secretary and announced that USCIS Acting Director Ken Cuccinelli would become Acting Deputy Secretary. The Senate Energy and Natural Resources Committee also held a confirmation hearing today for Dan Brouillette, the President’s nominee to succeed Rick Perry as Secretary of Energy, while the Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for Federal Emergency Management Agency (FEMA) Administrator nominee Peter Gaynor.

NASA Reauthorization

The Senate Commerce, Science, and Transportation committee advanced a number of bills during an executive session yesterday, including one to reauthorize NASA. A bill to reauthorize a satellite television law set to expire at the end of the year was pulled at the last minute, however.

Section 230

During a House Veterans Affairs Committee hearing yesterday, Chairman Mark Takano (D-CA) suggested that reforms to Section 230 of the Communications Decency Act may be necessary if social media platforms do not do more to combat scammers who impersonate military personnel and veterans. Elsewhere, Rep. Peter King (R-NY), former chairman of the House Homeland Security Committee, announced this week that he will not seek reelection in 2020.

National Apprenticeship Week

President Trump issued a proclamation declaring this week National Apprenticeship Week. He hosted Turkish President Recep Tayyip Erdoğan at the White House yesterday before welcoming NATO Secretary General Jens Stoltenberg today for a discussion that is to include protecting 5G networks and cybersecurity.

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


Senate Special Committee on Aging: “Veteran Scams: Protecting Those Who Protected Us”
Wednesday, Nov. 6, 2019: The Senate Special Committee on Aging held a hearing on protecting veterans from a variety of scams, including fake charities. As a result of the witness testimonies, a letter was sent to Secretary of the Department of Veterans Affairs Robert Wilkie by 13 of the committee’s 15 members asking for more protection of veterans from elder abuse scams. Find more details on the hearing here.


Durbin to Call for Vote on Drug Advertisement Price Disclosure Bill
On Nov. 6, Sen. Dick Durbin (D-IL) said he will soon request a floor vote on the Drug-Price Transparency in Communications Act (S. 1437) that requires that direct-to-consumer advertisement for drugs disclose their list prices. The bill is cosponsored by Sen. Chuck Grassley (R-IA). Sen. Patrick Toomey (R-PA) has objected to the bill because he said other direct-to-consumer advertising for other products is not required to list prices.

Grassley Expected to File Drug Pricing Bill This Week
On Nov. 5, Senate Finance Committee Chair Chuck Grassley(R-IA) suggested that he would file an updated drug-pricing bill this week. The Senate Finance Committee has already passed the Prescription Drug Pricing Reduction Act (S. 2543), by Sen. Grassley, and Senate Finance ranking member Ron Wyden (D-OR). The new version can be filed and bypass the committee process because an earlier version was already passed by the committee. Last week, Sen. Grassley defended the bill’s inflationary rebates on the Senate floor, a measure of the bill that Republicans do not approve. The Trump administration would prefer a version of the Senate Finance Committee bill over Speaker Pelosi’s plan, H.R. 3.

Peters Announces Investigation into Drug Shortages, High Drug Prices
On Nov. 5, Senate Homeland Security and Governmental Affairs Committee ranking member Gary Peters (D-MI) announced an investigation of high drug prices and drug shortages, after a Food and Drug Administration (FDA) report that showed drug manufacturers need financial incentives to produce older, less profitable drugs. The report also concluded that the drug manufacturers need to be rewarded for implementing mature quality management systems in their manufacturing processes. Find the press release here.

Read more on healthcare policy on the McGuireWoods Consulting website.

FY20 Spending Measures

With government spending authorities scheduled to expire on November 21, bipartisan, bicameral Appropriations Committee leadership will meet next week to chart a path for FY20 spending measures, including another likely continuing resolution through mid to late December. The White House said this week that the President would support such an extension.

Fourth Hearing on Online Platforms and Market Power

The House Antitrust Subcommittee will hold the fourth in its series of hearings on online platforms and market power next Wednesday, this one focused on “Perspectives of the Antitrust Agencies.” Federal Trade Commission Chairman Joe Simons and Assistant Attorney General Makan Delrahim will testify.

H.R. 3

House Democratic leadership had planned a vote on H.R. 3, the prescription drug pricing legislation spearheaded by Speaker Nancy Pelosi (D-CA), this month, but now do not expect to bring it to the floor until December as lawmakers continue to wait for a full Congressional Budget Office (CBO) score. There also remain differences to reconcile as a result of markups in three committees of jurisdiction.

STELAR Reauthorization

Senate Commerce Committee Chairman Roger Wicker (R-MS) introduced legislation this week; a clean STELAR reauthorization bill to extend for five years the satellite television law that is set to expire at the end of the year. No House companion reauthorization, clean or otherwise, has been offered. The Committee will also consider nearly two dozen bills and a handful of nominations next week.

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

The House was in recess this week. The Senate resumed legislative business on Tuesday and spent the bulk of the week on pending nominations.

Rep. Pete Visclosky (D-IN), who chairs the House Appropriations Subcommittee on Defense, announced this week that he will retire. The Appropriations Chairwoman, Rep. Nita Lowey (D-NY), previously announced that she would not seek reelection.

Section 230 of the Communications Decency Act

Last Friday, Senator Ted Cruz (R-TX) sent a letter to US Trade Representative Robert Lighthizer urging him to remove from any draft trade agreement language incorporating Section 230 of the Communications Decency Act. “With members of both the Senate and House of Representatives seriously considering whether to amend or eliminate Section 230’s grant of immunity because big tech is not living up to its end of the legislative bargain, I believe that enshrining it in our trade agreements would be a mistake,” Cruz wrote.

NASA Reauthorization Legislation

Cruz, in his capacity as Senate Aviation and Space Subcommittee Chairman, also introduced NASA reauthorization legislation this week alongside Senate Commerce Committee Chairman Roger Wicker (R-MS), Ranking Member Maria Cantwell (D-WA), and Subcommittee Ranking Member Kyrsten Sinema (D-AZ). The Committee will mark up the bill, along with a slew of others, during an executive session next Wednesday.

Pending Nominations

President Trump announced last Friday that Acting Undersecretary for Strategy, Policy, and Plans Chad Wolf would become Acting Secretary of Homeland Security, succeeding Kevin McAleenan. Senate Majority Leader Mitch McConnell (R-KY) plans to hold a vote next week to confirm Wolf to his undersecretary position, to which he was nominated in February, to weaken any legal challenges to Wolf assuming the role of Acting Secretary.

Trump also announced last Friday that he will nominate Dr. Stephen Hahn to lead the Food and Drug Administration (FDA). The White House sent Hahn’s nomination to the Senate on Tuesday and in announcing his support for the nomination, Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) said he will hold a confirmation hearing on November 20.

Voice Cloning Technologies

The Federal Trade Commission (FTC) announced this week that it will hold a workshop on January 28, 2020 to examine the status of – and potential consequences of – voice cloning technologies. The FTC also released a new guide this week for social media influencers as it pertains to endorsements and sponsorships that summarizes the agency’s existing guidance, including its Endorsement Guides and a 2017 Q&A document.

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


Senate Committee on Finance: “Medicaid: Compliance with Eligibility Requirements”
Wednesday, Oct. 30, 2019: The Senate Committee on Finance, Subcommittee on Health held a hearing on eligibility requirements under the Medicaid program. This hearing foreshadows action that is expected to be taken by the administration soon related to states’ ensuring Medicaid recipients are eligible for Medicaid.

Why this is important: The OIG recommended that states have better oversight over eligibility of enrollees, while the GAO identified the need for CMS to publicly share more data and take part in greater oversight of the state auditors. The Louisiana Legislative Auditor argued that states have too much latitude, and should be required to use federal tax data, with additional verification using federal databases.

The Center on Budget and Policy Priorities added that low-income Americans are having an unnecessary churn of going on and off coverage because it is difficult to reach them, or to report changes of status, and recommended better use of technology to do so.

In addition, the Centers for Medicare and Medicaid (CMS) is planning a rule focused on how states determine who is eligible for Medicaid. The effort follows concern from Trump officials that states are improperly classifying certain Medicaid beneficiaries as ACA expansion enrollees and getting more federal funds than allowed.

The administration is also considering a separate regulation to make more transparent how states finance their Medicaid programs and their use of supplemental payments. Concern has been raised that oversight of these arrangements has been lax and may lead to overspending. CMS could issue rules this fall.

Find more details on the hearing here.

Senate Health, Education, Labor and Pensions (HELP) Committee: Health Legislation Markup, including Over-the-Counter (OTC) Drug Safety, Innovation, and Reform Act of 2019
Thursday, Oct. 31, 2019: The Senate Health, Education, Labor and Pensions (HELP) Committee held a markup of eight bipartisan, public health bills, all of which were favorably reported to the Senate floor, by voice vote.

  • S. 1657, Ticks: Identify, Control, and Knockout Act
    Sens. Susan Collins (R-ME), Angus King (I-ME) and Tina Smith (D-MN) introduced this bill that will authorize centers of excellence and grants to states to improve treatment of diseases transmitted by vectors like mosquitos, ticks and fleas. The legislation will also require a national strategy to ensure federal agencies coordinate to combat these diseases.
  • S. 2619, Healthy Start Reauthorization Act of 2019
    Sens. Richard Burr (R-NC) and Sherrod Brown (D-OH) introduced this bill to help prevent low birth weights to give babies the best opportunity at living long, healthy lives.
  • S. 1399, Title VIII Nursing Workforce Reauthorization Act of 2019
    Sens. Jeff Merkley (D-OR), Richard Burr (R-NN), Marsha Blackburn (R-TN) and Tammy Baldwin (D-WI) introduced a bill to update and reauthorize programs that help ensure we have the trained nurses that are needed. Sen. Lisa Murkowski (R-AK) added an amendment, adopted by voice vote, which added community health aides to the bill as well.
  • S. 995, Lifespan Respite Care Reauthorization Act of 2019
    Sens. Susan Collins (R-ME) and Tammy Baldwin (D-WI) introduced a bill to continue the support of state programs that give breaks to the 45 million Americans who provide care for a seriously ill or disabled family member with special needs.
  • S. 1130, Scarlett’s Sunshine on Sudden Unexpected Death Act
    Sens. Bob Casey (D-PA) and Johnny Isakson (R-GA) introduced a bill that provides grants to help states prevent sudden unexpected infant and child deaths and to better understand the causes of these deaths.
  • S. 1608, Promoting Physical Activity for Americans Act
    Sens. Roger Wicker (R-MS) and Sherrod Brown (D-OH) introduced a bill that requires the Department of Health and Human Services to routinely update its recommendations on exercise.
  • S. 2629, United States Public Health Service Modernization Act of 2019
    Sens. Mike Rounds (R-SD) and Doug Jones (D-AL) introduced a bill that allows the Secretary of HHS to create a ready reserve of public health professionals to ensure preparation in response to a national or public health emergency.
  • S. 2740, Over-the-Counter Drug Safety, Innovation, and Reform Act of 2019
    Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) introduced this bill to modernize how over-the-counter medications are regulated and brought to market. The bill includes a provision that provides 18 months of market exclusivity for new or improved OTC products to promote innovation and streamlines the FDA’s OTC rule-making process. The bill also authorizes a five-year user fee program at the Food and Drug Administration (FDA), allowing the FDA to make more hires in overseeing the industry.

Find markup details here.



Read more on healthcare policy on the McGuireWoods Consulting website.

Negotiations Continue on Government Spending Authority

The House is in recess next week. The Senate will be in session with just a few legislative days remaining before government spending authority is set to expire on November 21. Aside from continuing to negotiate a deal to avert a shutdown, lawmakers will likely soon take up a pared down version of the National Defense Authorization Act (NDAA) that does not address controversial issues like PFAS chemicals. USMCA trade deal negotiations are also ongoing.

Hearing Scheduled on Privacy Legislation

Elsewhere, Senate Commerce, Science, and Transportation Committee Chairman Roger Wicker (R-MS) is planning a hearing next month on privacy legislation, though the legislation to be considered remains to be determined. Senator Josh Hawley’s (R-MO) Senate Judiciary subcommittee will also hold a hearing next Tuesday on data security.

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

FY20 Spending Levels

As the House and Senate continue to negotiate FY20 spending levels, the Senate spent most of the week on the first appropriations bills to reach the floor in a package that includes the Commerce-Justice-Science, Agriculture, Interior, and Transportation-Housing and Urban Development bills. After dispensing with several amendments, the Senate voted 84-9 this afternoon to adopt the package before turning to a second package that includes the Labor-HHS-Education, Defense, State-Foreign Operations, and Energy-Water bills. A procedural vote to take up that second package failed 51-41.

Deepfake Report Act of 2019

Last Thursday, the Senate passed Senator Rob Portman’s (R-OH) Deepfake Report Act of 2019 by unanimous consent. Portman and Senator Martin Heinrich (D-NM) launched the Senate Artificial Intelligence (AI) Caucus earlier this year. The bipartisan legislation requires the Department of Homeland Security (DHS) to study deepfake technology, how it is used both domestically and overseas, and what countermeasures are available. Rep. Derek Kilmer (D-WA) introduced a bipartisan companion bill in the House.

Mobile Workforce State Income Tax Simplification Act of 2019

On the other side of Capitol Hill, House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) announced this week that he will retire at the end of his term. Rep. Greg Steube (R-FL) recently introduced the Mobile Workforce State Income Tax Simplification Act of 2019, which would prevent people who work 30 days or less in a state outside of their home state from being required to file a state income tax return for the state they are visiting. A companion Senate bill introduced earlier this year has 35 bipartisan cosponsors.

Investing in Tomorrow’s Workforce Act

Bicameral lawmakers also recently introduced the Investing in Tomorrow’s Workforce Act to address estimates that nearly 50% of US jobs could be a risk due to automation. Specifically, the legislation would direct GAO to study barriers to and opportunities for training workers in industries in which automation will have an impact, create a Department of Labor grant program to support training programs for workers who are or may be displaced, and increase funding for National Dislocated Worker Grants.

USPTO Seeking Impact of AI on IP Law and Policy

The United States Patent and Trademark Office (USPTO) announced this week that it is seeking information on the impact of artificial intelligence (AI) on intellectual property law and policy. Comments are due by December 16.

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


House Energy and Commerce Committee: “Sabotage: The Trump Administration’s Attack on Health Care”
Wednesday, Oct. 23, 2019: The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce held to seek clarity on the Trump administration’s health care policy choices. The Centers for Medicare and Medicaid (CMS) Administrator Seema Verma testified at the hearing, and was met with hostility from Democratic members who wanted more answers on why the administration is dismantling the Affordable Care Act (ACA).  Find more details on the hearing here.

Senate Committee on Finance: “Treating Substance Misuse in America: Scams, Shortfalls, and Solutions”
Thursday, Oct. 24, 2019: The Senate Committee on Finance held hearing on solutions to the substance misuse concern in the United States. Witnesses included the surgeon general, Dr. Jerome M. Adams; the director of Health Care at the Government Accountability Office (GAO), Dr. Mary Denigan-Macauley; and the deputy inspector general for Investigations at the Department of Health and Human Services (HHS), Gary L. Cantrell. Find more details on the hearing here.


Ways and Means Passes Speaker Pelosi’s Drug Pricing Negotiation Bill, H.R. 3
On Oct. 22, the House Ways and Means Committee passed its amended version of H.R. 3, the Lower Drug Prices Now Act, to the House floor with a 24-17 vote along party lines. Health subcommittee Chairman Lloyd Doggett (D-TX) voted present on passage after unsuccessful attempts to expand the reach of the drug pricing reforms. The committee also endorsed renaming the bill the Elijah E. Cummings Lower Drug Prices Now Act. The Ways and Means bill will now be consolidated with the marked-up bills from the House Energy and Commerce, and Education and Labor Committees for full House vote, expected in November.


Bipartisan Drug Patent Bill Used in Negotiations for Broader Drug Pricing Reform
A bipartisan bill from Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) to stop drug manufacturers from gaming the patent system to eliminate generic competition is now part of negotiations for broader drug pricing reform. S. 1416, the Affordable Prescriptions for Patients Act of 2019, allows the Federal Trade Commission (FTC) to sue drug manufacturers that get duplicative patents or attempt to delay cheaper generics from entering the market as well. While the Senate Judiciary Committee already passed the bill, Senate Democrats are using the bipartisan bill’s full passage as a bargaining chip to have more drug pricing legislation on the Senate floor. This is a result of Senate Majority Leader Mitch McConnell’s (R-SC) not yet committing to bring up either the Senate Finance Committee drug package, S. 2543, the Prescription Drug Pricing Reduction Act of 2019 or the Senate HELP Committee bill, S. 1895, the Lower Health Care Costs Act.

Read more on healthcare policy on the McGuireWoods Consulting website.