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

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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.

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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.

Hearings/Markups

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.

Senate

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.

Hearings/Markups

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.

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Senate

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