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.