House

House Passes USMCA Trade Deal
On Dec. 19, the House passed H.R. 5430, the U.S., Mexico and Canada trade deal. Senate Majority Leader Mitch McConnell announced a Senate vote on the new North American trade deal would happen in 2020, after the impeachment trial for President Trump in January. The deal removes 10-year patent exclusivity for biologics that was in the original agreement and removes patent evergreening.

House Votes to Impeach President Trump
On Dec. 18, the House voted 230-197 to charge President Trump with abuse of power, and 229-198 with obstruction of Congress. Democratic Reps. Collin Peterson and Jeff Van Drew, who is expected to switch to the Republican Party, voted against impeachment. President Trump is officially impeached, and a trail in the Senate is expected in January 2020.

Senate

Senate Passes Spending Bills to Avoid Government Shutdown
On Dec. 19, the Senate passed two spending bills, to fund the government until October 2020. Both bills have already passed the House. The president is expected to sign them. In the first bill considered, several Medicare and Medicaid extenders would be funded through May 22. The bill also delays the Medicaid Disproportionate Share Hospital (DSH) pay cuts through May of next year. The proposal did not include surprise billing legislation. The extensions of some provisions until May provides an opportunity for a Medicare bill in May which may have other legislation attached to it.

The bill includes provisions that would delay commercial pay data reporting until 2021 and require Congress’s Medicare payment advisors to study how the Centers for Medicare and Medicaid Services (CMS) has implemented the Protecting Access to Medicare Act, aimed at basing Medicare pay rates for lab tests on commercial rates. The spending deal includes the delay in data reporting and would give the Medicare Payment Advisory Commission (MedPAC) 18 months to look at how CMS has implemented the private-payer–based lab fee schedule for Medicare.

It also included repeal of several taxes from the Affordable Care Act: the Medicare device tax, the “Cadillac tax” and the Health Insurance tax.

Read more on healthcare policy on the McGuireWoods Consulting website.

FY20 Spending Bills

Appropriations Committee leaders reached a deal early this week to fund the government through FY20 and unveiled two packages of spending bills. One combines the Defense, Homeland Security, Commerce-Justice-Science, and Financial Services measures; the second including the Agriculture-FDA, Labor-HHS-Education, Energy-Water, Interior-Environment, State-Foreign Operations, Transportation-HUD, Military Construction-VA, and Legislative Branch measures. The House passed the packages on Tuesday 280-138 and 297-120, respectively. The Senate is expected to follow suit on Thursday and send the bills to the President to sign, which he is expected to do.

Impeachment

On Wednesday night, the House of Representatives voted to impeach President Trump for abuse of power (230-197) and obstruction of Congress (229-198). The vote split almost entirely down party lines–with only two Democrats, Reps. Collin Peterson (D-MN) and Jeff Van Drew (D-NJ), voting against the articles and Rep. Tulsi Gabbard (D-HI), who is running for president, voting present. Rep. Jared Golden (D-ME) split his votes on the articles, which will now be sent to the Senate for a trial and final vote. Speaker Pelosi has left open the idea of withholding the articles, thus delaying the process.

SALT Cap

On Thursday, the House voted (227-197) to raise the cap from $10,000 to $20,000 on the state and local (SALT) deduction that was set by President Trump’s 2017 tax bill. The deduction is for individuals living in high-tax states and has become a sticking point for Democrats and Republicans debating tax policy. The bill is not expected to get a vote in the Senate, and President Trump has threatened to veto it.

USMCA

The House passed the United States Mexico Canada Agreement (USMCA) (385-41) with strong bipartisan support on Thursday. Now, the Senate must vote to ratify it, and then Canada and Mexico will both need to vote as well. Leader McConnell has said he will conduct and finish President Trump’s Senate impeachment trial before addressing USMCA, so its approval may not come until well into the new year.

National Defense Authorization Act

The Senate voted 86-8 Tuesday to approve the FY2020 National Defense Authorization Act (NDAA). The bill increases defense spending to $738 billion from $716 billion in 2019, but is still below the $750 billion the White House requested. Most notably, the NDAA provides $72 million dollars for the creation of the new sixth division of the military, the Space Force. The House has already approved the bill, and President Trump is expected to sign it into law.

Governors’ Initiative on Regulatory Innovation

On Monday, the President hosted a roundtable discussion with governors as part of the Governors’ Initiative on Regulatory Innovation. The President and Vice President delivered remarks on the Administration’s efforts related to deregulation, taxes, and trade agreements. On Tuesday, President Trump hosted Guatemalan President Jimmy Morales at the White House for a bilateral meeting.

NTIA Head to Step Down, Changes at FTC

Acting head of the National Telecommunications and Information Administration (NTIA) Diane Rinaldo is stepping down from her post, which she assumed in May. Rinaldo took over for David Redl, who lead the entity from 2017 to 2019 and for whom a permanent replacement has not yet been found. Elsewhere, Federal Trade Commission (FTC) Chairman Joseph Simons announced this week that Deputy Director of the Bureau of Competition Marian Bruno will retire at the end of the year. Subject to FTC approval, Ian Connor will become the Bureau’s director and Daniel Francis will serve alongside Gail Levine as Deputy Director.

Public Comment Period Extended on Quality and Effectiveness of the American Research Environment

On December 17, the White House Office of Science and Technology Policy (OSTP) updated a November request for public comment on how federal agencies can work together with academic, philanthropic, and non-profit organizations to improve the quality and effectiveness of the American research environment. The comment period, which was scheduled to close on December 23, has been extended and will now end on January 28, 2020. Specific emphasis has been placed on making the community more inclusive, efficient, safe, and ethical.

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

Hearings/Markups

House Committee on Energy and Commerce: “Proposals to Achieve Universal Health Care Coverage”
Tuesday, Dec. 10, 2019: The Subcommittee on Health of the Committee on Energy and Commerce held a hearing on a variety of plans offered to achieve universal health care.

Why this is important: The committee examined nine legislative proposals that could expand health insurance coverage universally, including Medicare buy-in bills.

The legislation discussed:

  • H.R. 1277, the “State Public Option Act”
  • H.R. 1346, the “Medicare Buy-In and Health Care Stabilization Act of 2019”
  • H.R. 1384, the “Medicare for All Act of 2019”
  • H.R. 2000, the “Medicare-X Choice Act of 2019”
  • H.R. 2452, the “Medicare for America Act of 2019”
  • H.R. 2463, the “Choose Medicare Act”
  • H.R. 4527, the “Expanding Health Care Options for Early Retirees Act”
  • H.R. 584, the “Incentivizing Medicaid Expansion Act of 2019”
  • H.R. 2085, the “Consumer Health Options and Insurance Competition Enhancement Act” or the “CHOICE Act”

Find more details on the hearing here.

House Committee on Energy and Commerce: “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program”
Tuesday, Dec. 10, 2019: The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce held a hearing on the methods, facilities and controls used in manufacturing, processing and packing of a drug product, through the FDA.

Why this is important: The committee discussed the FDA’s regulation of cosmetics, general public health preparedness and response to the flu season. There was further discussion of Chairman Frank Pallone’s (D-NJ) legislation, the Cosmetic Safety Enhancement Act of 2019.

Find more details on the hearing here.

House Committee on Rules: “H.R. 3 – Elijah E. Cummings Lower Drug Costs Now Act”
Tuesday, Dec. 10, 2019: The Rules Committee considered H.R. 3, the Lower Drug Costs Now Act of 2019 [Elijah E. Cummings Lower Drug Costs Now Act of 2019]. Find more details here.

Senate Committee on Health, Education, Labor and Pensions (HELP): “Executive Session: S. 2971, Title VII Reauthorization, S. 2080, S. 2683, S. 2927, and Nominations”
Thursday, Dec. 12, 2019: The Senate HELP committee held an executive session on the following legislation and nominees:

  • S. 2971, “CAPTA Reauthorization Act of 2019”
  • S. ___, “Title VII Reauthorization”
  • S. 2080, “Palliative Care and Hospice Education and Training Act”
  • S. 2683, “Child Care Improvement Act of 2019”
  • S. 2927, “NIMHD Research Endowment Revitalization Act of 2019”
  • Nomination of Crosby Kemper III to be director, Institute of Museum and Library Services

Find more details on the hearing here.

House

Senate

Read more on healthcare policy on the McGuireWoods Consulting website.

Continuing Negotiations on FY20 Appropriations

Bicameral Appropriations Committee leadership and the Administration continue to negotiate a deal on FY20 appropriations as the current continuing resolution prepares to lapse at the end of next week.

Robocall Legislation

The Senate may also bring up compromise robocalls legislation that passed the House last week 417-3, though Senator Rand Paul (R-KY) has indicated he will object to an effort to move it by unanimous consent.

Pending Nominations

On Tuesday, Paul Ray, the President’s nominee to serve as Administrator of the Office of Information and Regulatory Affairs, will testify before the Senate Homeland Security and Governmental Affairs Committee.

Online Privacy Legislation

House Energy and Commerce Consumer Protection Subcommittee Chairwoman Jan Schakowsky (D-IL) is expected to release draft online privacy legislation next week. Bipartisan negotiations have not yet yielded agreement on controversial issues like preemption and a private right of action. Ranking Member Cathy McMorris Rodgers (R-WA) said that while she will not endorse the draft, it will help solicit feedback to inform ongoing discussions.

USMCA

Looking to next year, the Senate is expected to take up the USMCA trade agreement in January, likely following an impeachment trial.

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

FY20 Appropriations

With just a handful of legislative days remaining before government spending authority expires on December 20, House and Senate Appropriations Committee leaders met this morning to continue to discuss a path forward for FY20 appropriations.

Pending Nominations

The Senate spent most of the week on pending nominations, including Stephen Hahn’s nomination to serve as FDA commissioner and John Sullivan’s nomination to be the next US Ambassador to Russia. Today, Senate Republicans met with US Trade Representative Robert Lighthizer to discuss the recently agreed upon US-Mexico-Canada trade agreement (USMCA).

National Defense Authorization Act Agreement

Bicameral Armed Services Committee leadership announced on Monday night that they reached an agreement on the FY20 National Defense Authorization Act (NDAA) conference report. The House passed the compromise package on Wednesday, 377-48. The Senate is expected to follow suit.

TV View Protection Act

The House adopted the TV View Protection Act by voice vote Tuesday, legislation that would reauthorize the STELAR satellite television law set to expire at the end of the year. There is no Senate companion yet; bicameral committee leaders are discussing a short-term extension into next year while the Senate committees of jurisdiction continue to work on legislation. Today, the House votes on H.R. 3, the drug pricing legislation championed by Speaker Nancy Pelosi (D-CA).

Reps. Yoho, Heck, and Graves Not Seeking Reelection

Reps. Ted Yoho (R-FL), Denny Heck (D-WA), and Tom Graves (R-GA) announced in recent days that they will not seek reelection in 2020. Rep. Duncan Hunter (R-CA) also confirmed he will resign after the holidays after pleading guilty to campaign finance violations.

Section 230

On Tuesday, Attorney General Bill Barr told state attorneys general that the Department of Justice has “started thinking critically” about Section 230 of the Communications Decency Act and plans to hold a public workshop on the subject. Barr’s comments coincided with Speaker Pelosi’s renewed criticism of the provision as similar protections were included in USMCA, as well as the recently approved US-Japan trade deal. That agreement did not require congressional approval and Tokyo formally approved it last week.

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

House

House to Vote on Pelosi Drug Pricing Bill This Week
On Dec. 5, it was announced that Speaker Nancy Pelosi’s (D-CA) drug pricing bill, H.R. 3, will be voted on next week in the full House. As of now, there is no complete score of projected savings from the Congressional Budget Office (CBO) before the vote occurs. CBO has only evaluated the part of H.R. 3 that allows for direct government negotiation of some Medicare drug prices.

Progressive House Democrats are concerned that a provision by Rep. Pramila Jayapal (D-WA) added to the bill will dropped before the final bill goes to the House floor. The provision directs the federal government to examine how to require drug manufacturers to refund money to employer-sponsored health plans when the companies raised prices above the rate of inflation. Then regulations would have to be issued based on the study.

Pallone Works With FDA to Modify Cosmetics Bill, Eyes Preemption
On Dec. 4, House Energy & Commerce Chair Frank Pallone (D-NJ) said he has been working with the Food and Drug Administration (FDA) and Republican members, as well as stakeholders, to modify his bill, the Cosmetic Safety Enhancement Act of 2019. The changes would increase the FDA’s power to regulate cosmetics and shift the ingredient review and user fee language. Pallone added that he is open to adding some type of preemption clause. Ranking Member Greg Walden (R-OR) asked Pallone to add language preempting states’ cosmetics laws, and said whatever bill is voted on also should avoid burdening small businesses.

Senate

Senate Finance Releases Updated Drug Pricing Bill
On Dec. 6, the Senate Finance Committee’s Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) released an updated version of the Prescription Drug Pricing Reduction Act of 2019. The bill now reduces senior’s Part D coinsurance, allows seniors to pay capped catastrophic costs over the year and moves part of the drug manufacturers’ share of seniors’ retail drug costs from the catastrophic phase of the program to the initial coverage phase. The changes resulted from an agreement after working with the Trump administration on updating the bill. The changes build off of the $25 billion reduction in beneficiary Part D cost-sharing (over a 10-year period) generated by the committee-reported bill by further reducing beneficiary costs on out-of-pocket spending. Find the new text here.

Wyden, Booker Ask CMS, FTC and Health Care Companies to Evaluate Bias in AI Tools
On Dec. 3, Sens. Ron Wyden (D-OR) and Cory Booker (D-NJ) sent letters to the Centers for Medicare and Medicaid Services (CMS), the Federal Trade Commission (FTC) and the executives of UnitedHealth Group, Blue Cross Blue Shield, Cigna Corporation, Humana and Aetna asking them to ensure artificial intelligence tools used in health care are not biased. The letters warn that biased artificial intelligence algorithms can pose threats to marginalized communities by denying them care. In the letter to the health plans, the senators asked what artificial intelligence tools they use, what algorithms they use and why, and what efforts they make to combat biases. The senators asked for responses by Dec. 31 of this year. Find the letter to CMS here. Find the letter to the FTC here. Find the letter to the chosen executives here.

Senate HELP Sends Nomination for FDA Commissioner to Senate Floor
On Dec. 3, the Senate Health, Education, Labor and Pensions Committee voted 18-5 in favor of Stephen Hahn’s nomination as FDA commissioner. The nomination will now go to the Senate floor for a final vote.

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

Hearings/Markups

House Committee on the Judiciary: “The Patent Trial and Appeal Board and the Appointments Clause: Implications of Recent Court Decisions”
Tuesday, Nov. 19, 2019: The House Committee on the Judiciary held a hearing on the patent system and implications of recent court decisions on the system.

Why this is important: On Nov. 20, the full committee unanimously approved two bills that aim to stop drug manufacturers from misusing patents. H.R. 5133, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2019, targets product hopping and allows the Federal Trade Commission (FTC) to prosecute manufacturers who encourage customers to shift from one drug that is losing market exclusivity to another, similar drug that will have market exclusivity for a longer time. The legislation also allows the FTC to prosecute drug manufacturers for engaging in patent gaming.

H.R. 3991, the Affordable Prescriptions for Patients through Improvements to Patent Litigation Act of 2019, targets patent dancing, which is when a drug manufacturer files many patent claims that do not represent significant changes to fend off biosimilars attempting to enter the market. The two patent bills are not included in the House Democrats’ drug pricing package.

Find more details on the hearing here.

Senate Committee on Health, Education, Labor and Pensions: “Nomination of Stephen M. Hahn, MD, to serve as Commissioner of Food and Drugs”
Wednesday, Nov. 20, 2019: The Senate Committee on Health, Education, Labor and Pensions held a confirmation hearing for Dr. Stephen Hahn, President Trump’s nominee to be the new Food and Drug Administration (FDA) commissioner. On Nov. 6, Chairman Lamar Alexander (R-TN) released a statement of support for Dr. Stephen Hahn ahead of the hearing. Find more details on the hearing here.

Senate Committee on Finance: “Alzheimer’s Awareness: Barriers to Diagnosis, Treatment and Care Coordination”
Wednesday, Nov. 20, 2019: The Senate Committee on Finance, Subcommittee on Health Care held hearing to shed light on the obstacles surrounding Alzheimer’s diagnosis and care.

Why this is important: Witnesses highlighted concerns that include gaps in coverage for patients with Alzheimer’s, burdening costs of long-term care and representation for caregivers. The members of the subcommittee asked for feedback on further federal action that can be taken to address these concerns.

Find more details on the hearing here.

House

Senate

Read more on healthcare policy on the McGuireWoods Consulting website.

Continuing Resolution

With government spending authority set to expire on Thursday, the House unveiled a continuing resolution (CR) on Monday to extend funding through December 20. It went on to pass the chamber Tuesday, 231-192 and the Senate followed suit today, 74-20. The President is expected to sign it into law, averting a government shutdown.

Confirmation Hearing for FDA Commissioner

On Wednesday, the Senate Health, Education, Labor, and Pensions Committee held a confirmation hearing for Dr. Stephen Hahn, the President’s nominee to serve as the next Food and Drug Administration (FDA) Commissioner. The Committee pressed Hahn on his opinions on issues related to vaping, opioids, and prescription drug pricing.

STELAR Reauthorization

House Energy and Commerce Committee leaders struck a deal on legislation to reauthorize an expiring satellite television law (STELAR) just hours before marking up the compromise on Wednesday. The Television Viewer Protection Act does not include a license renewal provision that falls under the jurisdiction of the House Judiciary Committee, which marks up the Satellite Television Community Protection and Promotion Act today. The Senate Commerce Committee has yet to consider a STELAR reauthorization ahead of its December 31 expiration.

Antitrust Forum Comments

On Monday, Deputy Attorney General Jeffrey Rosen gave a speech at the American Bar Association Antitrust Forum during which he said: “we do not view antitrust law as a panacea for every problem in the digital world. Indeed, we will not ignore any harms caused by online platforms that partially or completely fall outside the antitrust laws.” This raises questions about whether the Department of Justice is willing to pursue tech companies for issues that do not implicate the Sherman Antitrust Act.

Autonomous Vehicles Oversight

During a National Transportation Safety Board (NTSB) meeting on Tuesday, federal accident investigators criticized the National Highway Traffic Safety Administration (NHTSA) for a lack of oversight over autonomous vehicles (AVs), including producing guidance that does not outline metrics by which developers can determine if they’ve met certain safety goals. The NTSB recommended that NHTSA require developers seeking to test on public roads to provide safety self-assessment plans before testing begins. During the hearing, the NTSB noted that there are 62 developers undergoing testing in California, but only 16 have submitted safety self-assessments to NHTSA.  (Current NHTSA policy recommends but does not require companies to provide self-assessments.) The Senate Commerce, Science, and Transportation Committee also held a hearing yesterday on AVs; see below for more details.

Advanced Driver Assistance Systems

NHTSA announced today in a Federal Register notice that it is requesting public comment on nine draft research test procedures to assess the performance of Advanced Driver Assistance Systems (ADAS) available to consumers. Comments are due by January 21, 2020.

FCC’s Precision Agriculture Task Force

On Tuesday, the FCC announced the members of its Precision Agriculture Task Force and the first meeting of the group. The Task Force will be chaired by Teddy Bekele, Senior Vice President and Chief Technology Officer, Land O’Lakes, and Catherine Moyer, Chief Executive Officer and General Manager, Pioneer Communications. Members of the Task Force include John Deere, SpaceX, and a host of other entities that represent a range of stakeholders in the agriculture sector. The Task Force’s first meeting it set for December 9 at 9:30 am.

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

Hearings/Markups

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.