This week: Agencies issue guidance on UAS detection and mitigation technology; White House calls for 30% boost to AI and quantum information science funding; California approves final CCPA regulations; DOE and DOD announce First Five Consortium to leverage AI in disaster response.

Agencies Issue Guidance on UAS Detection and Mitigation Technology

This week, the Departments of Justice (DOJ) and Homeland Security (DHS), the Federal Aviation Administration (FAA), and the Federal Communications Commission (FCC) released interagency advisory guidance on use of unmanned aircraft system (UAS) detection and mitigation technology. The document is intended to advise both non-federal public and private entities and provides an overview of relevant US criminal code enforced by DOJ, as well as laws and regulations enforced by the FAA, DHS, and FCC pertaining to aviation safety, airport security, and spectrum.

In recent years, Congress granted limited UAS countermeasures authorities to the Departments of Defense (DOD) and Energy (DOE), and later to DOJ and DHS, in annual National Defense Authorization Act (NDAA) legislation. These entities do not have authority to approve state and local or private use of UAS detection or mitigation capabilities, or to conduct legal reviews of commercially available products.

Deputy Attorney General Jeff Rosen, who previously served as Deputy Secretary of Transportation, said the guidance is a response to an increase in the availability of UAS countermeasures technologies, which “may be presented for sale without a full discussion of important legal requirements.”

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


Energy and Commerce Democrats Ask Insurers for Details on COVID-19 Coverage, Profits
On Aug. 13, House Energy & Commerce Democrats asked five major health insurers and four dental insurance companies to explain their profits, coverage policies and practices during the COVID-19 pandemic. Chair Frank Pallone (D-NJ), Oversight subcommittee Chair Diana DeGette (D-CO) and Health subcommittee Chair Anna Eshoo (D-CA) sent letters to Anthem, Cigna, CVS Health, Humana and UnitedHealth Group, as well as dental insurance companies. The letters asked for the companies’ net income and earnings for years 2018, 2019 and each of the first two quarters of 2020, broken down by line of business and including stand-alone dental. The letters asked for member premiums and the claims amounts paid out during each of those periods.

House and Senate Democrats Against Proposed Rule Granting Flexibility for Grandfathered Plans
On Aug. 11, House Labor & Education Chair Bobby Scott (D-VA), Energy & Commerce Chair Frank Pallone (D-NJ), Ways & Means Chair Richard Neal (D-MA), Senate Finance ranking Democrat Ron Wyden (D-OR) and Senate Health, Education, Labor and Pensions (HELP) ranking member Patty Murray (D-WA) asked the Trump administration to end its proposal for more flexibility to grandfathered plans not compliant with the Affordable Care Act (ACA). The listed concerns included an increase in cost sharing during the COVID-19 pandemic, as well as an increase of the premium adjustment percentage that could increase out-of-pocket costs.


Baldwin, Murphy Ask CBO to Revisit Assumptions on Short-Term Plans
On Aug. 13, Sens. Tammy Baldwin (D-WI) and Chris Murphy (D-CT) asked the Congressional Budget Office (CBO) to reevaluate the determination that an amount of the short-term limited-duration insurance (STLDI) plans allowed by the Trump administration should be considered as health insurance. CBO earlier projected traditional short-term plans for which those enrolled would be considered uninsured, and new STLDI plans, the enrollees of which would be considered insured. The senators said only plans without protections are being offered.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This week: EU-US privacy shield struck down, but talks continue; White House and Defense Department announce mid-band spectrum auction for 5G; Ninth Circuit decision largely upholds FCC decisions to promote 5G deployment; President Trump signs Executive Order targeting Chinese apps.

President Trump Signs Executive Order Targeting Chinese Apps

After months of threats, on August 6 President Trump issued an Executive Order prohibiting any person or entity under the jurisdiction of the United States from conducting transactions with ByteDance, the parent company of Chinese social media platform TikTok. The order will come into effect on September 20 and follows warnings that the President would move to ban the social media platform if not sold to an American company. Microsoft is currently in discussions to purchase the app; however, the Trump Administration has only given Microsoft until September 15 to close a deal, or the app will be banned from the United States on national security grounds. President Trump issued a similar order targeting WeChat, a Chinese messaging app that is much less popular in the United States, on the same day.

Concerns surrounding TikTok are not new. Many privacy stakeholders have suggested that user data owned by the company may be compromised, as current Chinese law provides Chinese regulators with near universal access to user data stored in the country. In prefacing the orders, Trump highlighted that many federal entities, including the Department of Homeland Security and United States Armed Forces, have already prohibited downloading TikTok on government phones. Similarly, the Senate, by a unanimous vote, passed a bill last week banning TikTok on all government-issued devices. The House passed a similar measure as an amendment to its National Defense Authorization Act (NDAA) last month. TikTok is expected to file a lawsuit against the Administration soon.

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


House Energy and Commerce Committee to Investigate Health, Dental Insurers Over Record Profits
On Aug. 6, the House Energy and Commerce Committee announced an investigation into health and dental insurers’ business practices as companies reported record-setting second quarter profits. Chairman Frank Pallone (D-NJ) is concerned that companies are profiting from patients’ forgoing care. In addition he questions why insurers are denying coverage for COVID-19 testing, while accumulating large cash reserves. He will ask companies whether they are covering tests cost-free as required by law and how they intend to use their profits to help Americans during the crisis. The committee has yet to say which companies will be investigated. Find more information here.

House Ways & Means Committee: COVID-19 Nursing Home Data Missing, Unreliable
On Aug. 5, House Ways and Means Committee Chair Richard Neal (D-MA) wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma that his committee has found large gaps in the COVID-19 data nursing homes report to CMS. Rep. Neal announced that the incomplete data is making it difficult to accurately assess death rates and staffing needs and to allocate provider relief funds. The committee wants to know by Aug. 21 how CMS will fix the data collection problems. Find more information here.


Wyden Introduces Legislation to Prevent Vaccine Manufacturers From Hiking Prices Post-Pandemic
On Aug. 7, Senate Finance Committee Ranking Member Ron Wyden (D-OR) introduced legislation to maintain lower prices for a COVID-19 vaccine for all vaccines developed with government funds. The Vaccine and Coverage Certainty Act caps increases on prices the drug manufacturers offer the federal government during the pandemic. The inflation rebates proposed in the bill apply to Medicare and Medicaid. The legislation would also provide more federal Medicaid funding to states that expanded Medicaid coverage after 2014, ensure migrants have access to Medicaid, and protect people who are experiencing job and health insurance instability during the pandemic and associated economic concerns. Find the bill here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This week: FCC requests comment on social media order as White House withdraws O’Rielly nomination; U.S. Justice Department asks court to block California net neutrality law; FTC Commissioners testify before Senate Commerce on Section 230, antitrust; Congress voices support for Open Technology Fund; National Institutes of Health announces new COVID-19 testing technologies.

FCC Requests Comment on Social Media Order as White House Withdraws O’Rielly Nomination

On July 27, the Department of Commerce’s National Telecommunications and Information Administration (NTIA) filed a Petition for Rulemaking with the Federal Communications Commission (FCC) related to President Trump’s May Executive Order on Section 230 of the Communications Decency Act. FCC Chairman Ajit Pai announced on Monday the agency would collect public comment on the petition; initial comments are due by September 2 and reply comments are due by September 17. The Petition would have the FCC create regulations to clarify the scope of the liability protections afforded under Section 230 for third party users.

Also on Monday, President Trump withdrew Republican Commissioner Mike O’Rielly’s renomination to another five year term. O’Rielly has been a member of the FCC since 2013 and was confirmed for a second term in January 2015. His reappointment would have been retroactive to June 30, 2019 and would conclude in 2024, but now he must step down at year’s end.

Although President Trump has not commented on rescinding O’Rielly’s renomination, reports indicate the decision might have to do with the Commissioner’s reservations regarding the President’s Executive Order to clarify the scope of Section 230, and in particular whether the FCC has proper authority to limit social media companies’ legal protections. He expressed his concern in remarks last week before The Media Institute, whose primary mission is to promote freedom of speech. The decision could also relate to O’Rielly’s support for Ligado Network’s plan to use L-Band spectrum to support 5G and other Internet of Things services. Just last week, Senate Armed Services Committee Chairman Jim Inhofe (R-OK) placed a hold on O’Rielly’s renomination over the FCC’s Ligado order.

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


Senate Committee on Finance: Part 1: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic
Tuesday, July 28, 2020: The Senate Committee on Finance held a hearing on the COVID-19 pandemic’s effects on the U.S. medical supply chain in a two-part series. Find more details on the hearing here.

Why this is important: Chairman Chuck Grassley (R-IA) argued that the main concerns around PPE and medical equipment are the fault of the U.S.’s major supplier, China. Ranking Member Ron Wyden (D-OR) believes that the concerns revolve around a lack of organization and oversight by the Trump administration and its agencies. Members agreed that increased domestic production was a first step toward solving the supply chain concerns.

House Committee on Energy and Commerce: Improving Access to Care: Legislation to Reauthorize Key Public Health Programs
Wednesday, July 29, 2020: The Subcommittee of Health on the Committee on Energy and Commerce held a hearing to discuss the following legislation:

  • H.R. 2075, the “School-Based Health Centers Reauthorization Act of 2019”
  • H.R. 4078, the “EARLY Act Reauthorization of 2019”
  • H.R. 4439, the “Creating Hope Reauthorization Act”
  • H.R. 4764, the “Timely Reauthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2019” or the “TRANSPLANT Act of 2019”
  • H.R. 5373, the “United States Anti-Doping Agency Reauthorization Act of 2019”

Find more details on the hearing here.

Senate Committee on Finance: Part 2: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic
Thursday, July 30, 2020: The Senate Committee on Finance held a second hearing on the COVID-19 pandemic’s effects on the U.S. medical supply chain, in a two-part series. Find more details on the hearing here.

Why this is important: The witnesses across the supply chain agreed that more oversight by the agencies of the Trump administration, and more transparent allocation and bidding could help lessen the counterfeit personal protective equipment (PPE) and price gouging.


House Approves $1.3 Trillion Spending Package for 2021
On July 31, the House approved a $1.3 trillion appropriations package for the 2021 fiscal year, 217-197. The package included the spending bills for Defense; Labor, Health and Human Services, and Education; Commerce, Justice and Science; Energy and Water; Financial Services and general government; and Transportation and Housing and Urban Development.

House Republicans Accuse States of Not Using CARES Act Funds
On July 30, the House Ways & Means Republicans said a recently released Treasury Inspector General (IG) report proves states do not need extra COVID-19 funds, as several states have not even spent half of their CARES Act allocations. House Ways & Means Ranking Member Kevin Brady (R-TX) pointed out that the IG report shows while Michigan and New Jersey’s governors have specifically asked for more relief, they have spent 3 percent and 2.1 percent respectively of their CARES Act funds from March 1 through June 30. The Senate GOP proposal gives states greater flexibility in spending their CARES Act funds instead of sending them more money.


Senate GOP Proposal Includes Liability Limits, Telehealth Waiver Extensions

On July 27, Senate Republicans unveiled their proposal for the next COVID-19 response bill. The draft includes a provision that would keep Medicare Part B premiums in place for next year instead of increasing the premium. The idea is to protect Medicare’s 62.5 million beneficiaries from a spike in the Part B premium which is anticipated because of less money flowing into the program in the midst of the pandemic. However, beneficiaries would pay an average of $3 a month extra until the shortfall caused by freezing the premiums is recouped. In addition, the proposal would delay providers’ repayment of Medicare funds they received as part of the initial COVID-19 response. Repayment would be delayed until Jan. 1, 2021. Find the proposal here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This week: A tech-focused week in review, big tech testifies at House Antitrust hearing, Senate Commerce holds a hearing on the PACT Act as calls for Section 230 reform grow.

A Technology-Focused Week in Review

Amidst frenzied efforts to enact a COVID-19 relief bill to extend unemployment benefits during global pandemic and address issues such as state and local funding needs, PPE and testing needs nationwide and liability protections for employers, Congress briefly turned its attention to the technology sector.  In two hearings in particular, Congress set its sights on scrutinizing whether this critical sector of our economy has sufficient competition or is dominated by a few key companies and whether statutory protections that have allowed the sector to offer consumers a diverse array of content should remain intact or if they are in need of updating.

The Antitrust Subcommittee of the House Judiciary Committee held its sixth hearing in its series “Online Platforms and Market Power,” but it was the first time it heard directly from the CEOs of the four largest technology companies: Apple, Google, Amazon and Facebook. For more than five hours, the Antitrust Subcommittee members probed questions on the role of these companies in today’s economy and whether they have used their position in the market to further extend their market power. The areas of concern range from online search and advertising, app store policies for developers, and e-commerce. Content moderation focused on political speech and alleged bias against conservative voices was also an issue of debate at the hearing.  The law under which these and other online companies moderate their content, Section 230, was the subject of a Senate Commerce subcommittee hearing earlier in the week, in which Chairman Thune (R-SD) and Ranking Member Schatz (D-HI) heard from expert witnesses on whether Section 230 should be updated to reflect current market conditions.

Meanwhile, the Department of Commerce’s National Telecommunications and Information Administration (NTIA) sent a petition for rulemaking to the Federal Communications Commission (FCC) asking the FCC to seek public comment on rules to constrain the applicability of Section 230. The NTIA petition was prepared pursuant to President Trump’s Executive Order issued on May 28, 2020 and seeks the adoption of regulations by the FCC to define certain statutory terms and clarify what practices are outside the scope of Section 230’s liability protections.

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


Senate Committee on Aging: The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities
Tuesday, July 21, 2020: The Senate Committee on Aging held a hearing on how the COVID-19 pandemic and racial health disparities are affecting the country’s seniors. Find more details on the hearing here.

Why this is important: Ranking Member Sen. Bob Casey (D-PA) highlighted how challenges to the Affordable Care Act (ACA) have erected barriers between communities of color and accessible health care, and how this has exacerbated the deadly impact of the virus for older Americans of color.

House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine
Tuesday, July 21, 2020: The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce held a hearing to cover ongoing efforts to develop a COVID-19 vaccine. Operation Warp Speed finalists testified on whether the rapid pace of vaccine development could lead to approvals of vaccines that are not up to the Food and Drug Administration’s (FDA) historical standards. AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer testified at the hearing. Find more details on the hearing here.

Why this is important: Leaders of the companies working on COVID-19 vaccines predict they should have shots available by early 2021, but said they will rely on the federal government to determine how to distribute them.


House Passes First Set of Appropriations Bills
On July 24, the House approved a $259.5 billion spending package in a 224-189 vote. The four-bill minibus adds to the budgets at the departments of State, Interior, Agriculture, Veterans Affairs and other agencies. The package is the first of two fiscal 2021 funding bundles that House Democrats plan to pass by the end of the month. The House will take up a seven-bill, $1.4 trillion package this week that would fund the Pentagon and the Departments of Labor, Health and Human Services, Education, Homeland Security, Justice, Transportation, Energy and more.

Appropriations Committee Urges Domestic Production of Drugs, Domestic Production of Influenza Vaccine
On July 23, the House Appropriations Committee urged the Department of Health and Human Services (HHS) to boost domestic production of drugs and drug ingredients and to make more influenza vaccine than usual to gear up for a second wave of coronavirus infections colliding with flu season. The committee added that Medicare can hopefully improve vaccination rates among seniors by figuring out how to make vaccines free in Part D, similar to coverage in Part B. The proposals were included in the HHS spending bill passed by the House Appropriations Committee last week, with a 30-22 vote.


Senate GOP to Unveil COVID-19 Aid Bill, After Delay
On July 23, Senate Majority Leader Mitch McConnell (R-KY) announced a delay in the Senate Republicans’ counteroffer to the Democratic $3.4 trillion coronavirus bill. The bill is expected to be released today. The delay put in jeopardy a bipartisan goal of getting a bill done by July 31 in jeopardy. The Republican $1 trillion bill will include $105 billion in support for school reopening, a liability shield for businesses that reopen, a reduced boost in federal unemployment insurance down to 70 percent of pre-pandemic pay and a possible second round of Paycheck Protection Program loans for businesses. A side-package will propose more direct payments to individuals, according to Treasury Secretary Steve Mnuchin.

Republican Senators Call for Grassley Drug Pricing Bill to be put in COVID-19 Relief Plan
On July 22, Sens. Mike Braun (R-IN), Bill Cassidy (R-LA), Susan Collins (R-ME), Cindy Hyde-Smith (R-MS) and Martha McSally (R-AZ) gave floor speeches in support of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543), Senate Finance Chair Chuck Grassley’s (R-IA) drug pricing bill. Sen. Grassley wrote a bipartisan bill with Ranking Member Ron Wyden (D-OR), which was reported out of the Senate Finance Committee. Sen. Grassley, in seeking support for the bill, made changes to the bipartisan bill with no Democrats supporting. Find the bill here.

Senate Refuses to Vote on Bill That Would Require Trump to Invoke DPA
On July 22, the Senate rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Trump to invoke the Defense Production Act (DPA) to provide states with medical equipment, such as tests, respirators, gowns and gloves. During a Senate floor debate, Sen. Ron Johnson (R-WI) objected to Murphy and Baldwin’s bill, the Medical Supply Transparency and Delivery Act (S. 3627), arguing that the two senators were trying to bypass the committee of jurisdiction. The House included its version of the Medical Supply Transparency and Delivery Act as part of its COVID-19 relief package, the Health and Economic Recovery Omnibus Emergency Solutions Act, which passed the House on May 15.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

The Latest

With the Senate back in session this week, Republican leaders were expected to unveil their Phase 4 coronavirus relief proposal, but Senate Majority Leader McConnell (R-KY) announced this evening that while Republicans have reached “an agreement in principle with the Administration,” he will not bring legislation to the floor until next week. Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows met with Speaker Pelosi (D-CA) and Senate Minority Leader Schumer (D-NY) yesterday, marking the beginning of what are expected to be contentious negotiations. However, the White House and congressional Republicans and Democrats are united in their goal to pass a Phase 4 bill before Congress leaves for the August recess.

Today, the House began consideration of H.R. 7608, a “minibus” FY21 appropriations package consisting of the State and Foreign Operations, Military Construction and Veterans Affairs, Agriculture and Interior and Environment spending bills. Floor action for the second minibus is scheduled for next week, though leaders are under pressure to pull the Homeland Security bill from the package. This week, the House also passed the $750.5 billion National Defense Authorization Act (H.R. 6395) in a veto-proof 295-125 vote. Today, the Senate approved its version of the National Defense Authorization Act for Fiscal Year 2021 in an 86-14 vote. The President has threatened to veto it if it includes directives to rename military installations named after people associated with the Confederacy, among other provisions.

Both chambers continue to hold hearings examining various COVID-19-related issues, including its impact on certain sectors and communities and the federal government response. This week, committees looked at issues ranging from protecting Americans from COVID-19 scamsefforts to develop a COVID-19 vaccinea look at racial health disparities, seniors and COVID-19getting veterans back to work after COVID-19the State Department’s COVID-19 responseexamining the national response to the worsening pandemic:capital access for small minority businessesproviding for economic recovery from COVID-19how to safely reopen public schools, and FEMA’s preparedness and response efforts during the pandemic.

Also this week, the Treasury Department published Paycheck Protection Program (PPP) lender application forms for 1) federally insured depository institutions, federally insured credit unions, and farm credit system institutions and 2) non-bank and non-insured depository institution lenders and the Small Business Administration (SBA) updated its summary of Paycheck Protection Program (PPP) Round 2 data.

What’s Next

With text now not expected until Monday at the earliest, there will be a race to find consensus on a Phase 4 COVID relief package that can pass both chambers – and that the President will sign – before Congress aims to leave Washington the first week of August for recess.

In the meantime, Senate and House committees have scheduled a number of COVID-19-related hearings next week on topics including oversight of COVID-19 financial relief packages, a review of private sector telework policiesprotecting the reliability of the US medical supply chainreducing uncertainty and restoring confidence, and kick starting entrepreneurship and main street economic recovery.

Elsewhere, while the House is moving forward with FY21 appropriations, the Senate has not yet begun the process, all but guaranteeing Congress will have just a handful of legislative days in September to avert a government shutdown at the end of the fiscal year.

Relevant Resources

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


House to Consider Four-Bill Appropriations Minibus this Week
On July 16, in advance of House floor consideration, the House Appropriations Committee released the first minibus of fiscal year 2021 appropriations bills. The House is expected to consider the legislation, H.R. 7608, this week. The package includes four FY 2021 spending bills: State-Foreign Operations, Agriculture-Rural Development-FDA, Interior-Environment, and Military Construction and Veterans Affairs. The Agriculture, Rural Development, Food and Drug Administration and Related Agencies bill funds THE Food and Drug Administration (FDA). For FY 2021, total discretionary funding in the legislation is $23.98 billion, an increase of $487 million above the FY 2020 enacted level. In total, the bill allows for $153 billion in both discretionary and mandatory funding, an increase of $331 million above the FY 2020 enacted level. The bill prioritizes important agricultural and food programs and services, including food and medical product safety, animal and plant health programs, rural development, farm services, agricultural trade, financial marketplace oversight and nutrition programs, both domestic and international. Find more details here.

Bipartisan House Members Introduce the “Protecting Access to Post COVID-19 Telehealth Act”
On July 16, Rep. David Schweikert (AZ-06), co-chair of the Congressional Telehealth Caucus, along with caucus co-chairs Rep. Mike Thompson (D-CA), Rep. Peter Welch (D-VT), Rep. Bill Johnson (R-OH), and caucus member Rep. Doris Matsui (D-CA), announced the introduction of the Protecting Access to Post-COVID-19 Telehealth Act. This bipartisan bill will continue the expanded use of telehealth beyond the coronavirus pandemic by eliminating restrictions on the use in Medicare, providing a bridge for patients currently using the practices because of the crisis and requiring a study on the use of telehealth during COVID-19. Find more details here.

Ways and Means Committee Chair Neal Releases Report Examining Inequities in American Health System
On July 14, the House Ways and Means Chairman Richard Neal (D-MA) released a staff report, titled “Left Out: Barriers to Health Equity for Rural and Underserved Communities,” that analyzes the barriers to health care in underserved communities and discusses the challenges associated with scalable and sustainable solutions. From massive geographic coverage deficiencies to structural environmental factors, the report examines the realities millions of Americans face that adversely affect their health. The report also takes a close look at how these challenges are biproducts of systemic racism and economic inequality. Disparities and inequalities have only been exacerbated by the COVID-19 pandemic, the report says. For example, telehealth and other technology have been helpful during the pandemic for some, but it will not help if individuals do not have access to smartphones or broadband. Find the report here.

Energy and Commerce Committee Sends 4 FDA Drug, Device and Labeling Policy Bills to House Floor
On July 15, the House Energy and Commerce Committee passed four bipartisan Food and Drug Administration (FDA) policy bills that would increase the FDA’s authority over imported counterfeit medical devices, stop gaming of certain orphan drug exclusivity provisions, boost use of continuous manufacturing and empower the FDA to require labeling updates for generic drugs. All bills cleared the committee by voice vote.

  • The Fairness in Orphan Drug Exclusivity Act (H.R. 4712), by Reps. Madeleine Dean (D-PA), Marc Veasey (D-TX), Buddy Carter (R-GA) and David McKinley (R-WV), would amend the cost recovery prong pathway under the Orphan Drug Act to require drug makers seeking orphan drug designations to demonstrate they do not expect to recoup development costs.
  • The National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866), by Energy and Commerce Chair Frank Pallone (D-NJ) and Rep. Brett Guthrie (R-KY), would direct FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs) with the aim of increasing use of continuous manufacturing in drug development. NCEs would work with FDA and industry to craft a national framework for continuous manufacturing. The bill would authorize $80 million to be appropriated for NCEs each year from fiscals 2021 through 2025.
  • The Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (H.R. 5668), by Reps. Guthrie (R-KY) and Doris Matsui (D-CA), would give FDA authority to make drug companies update generic drug labeling.
  • The Safeguarding Therapeutics Act (H.R. 5663), by Reps. Guthrie (R-KY) and Eliot Engel (D-NY), would allow FDA to seize and destroy counterfeit medical devices that are refused admission at the border, if the devices are valued at an amount less than $2,500 or any higher amount set by the Department of the Treasury.

Find more details here.


Sen. Casey Says Republican Senators Should Increase Medicaid in Next COVID-19 Bill
On July 16, Sen. Bob Casey (D-PA) asked for provisions in the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act that would bump the federal Medicaid match rate for states a second time to be included in the next coronavirus stimulus package. He said Senate Majority Leader Mitch McConnell (R-KY) does not include enough state aid in his proposal for the upcoming package. H.R. 6800, already passed in the House, would bump the Medicaid match to 14 percent starting July 1 through June 2021. The Families First Coronavirus Response Act initially bumped the match up by 6 percent.

Sen. Grassley Introduces the Updated Prescription Drug Pricing Reduction Act of 2020
On July 2, Senate Finance Committee Chairman Chuck Grassley (R-IA) reintroduced bipartisan legislation co-authored by Ranking Member Ron Wyden (D-OR), the Prescription Drug Pricing Reduction Act of 2020, which originally passed out of the committee on a bipartisan 19-9 vote. All provisions of this updated legislation have bipartisan support. Joining Grassley in introducing the bipartisan legislation as original co-sponsors are Sens. Rob Portman (R-OH), Bill Cassidy (R-LA), Steve Daines (R-MT), Joni Ernst (R-IA), Susan Collins (R-ME), Martha McSally (R-AZ), Mike Braun (R-ID), Cindy Hyde-Smith (R-MS) and Lisa Murkowski (R-AK). Find the legislation here.

Read more in McGuireWoods Consulting’s Washington Healthcare Update.