Health Update (July 13)
On Thursday (Jul. 9), the House Appropriations Committee approved a funding increase for the Food and Drug Administration (FDA) in fiscal year 2021. The Agriculture, Rural Development, Food and Drug Administration bill would allocate $3.2 billion in discretionary funds to the FDA.
In addition, the FDA would also acquire authority to recall prescription and over-the-counter drugs. The measure would potentially increase FDA oversight of tobacco products, e-cigarettes, and harmful ingredients in cosmetics. The bill will be scheduled for a full House vote later this month.
The committee will continue the appropriations process next week and is scheduled to markup the Labor-HHS-Education-Related Agencies fiscal year 2021 spending bill on Monday (Jul. 13).
HHS Announces Additional PRF Disbursement
HHS announced the distribution of more than $4 billion in Provider Relief Funds (PRF) on Friday (Jul. 10). This round of funding will be distributed through the Health Resources and Services Administration (HRSA) and includes $3 billion to 215 acute care facilities and $1 billion to specialty rural providers and providers in small metro areas. Additionally, HHS will open the provider portal to allow dentists who have been excluded from previous rounds of relief to apply for funding.
To view the HHS announcement, click here.
To view the Enhance Provider Relief Portal, click here.
Meadows Hints at Drug Pricing EOs to Come
On Thursday (Jul. 9), White House Chief of Staff Mark Meadows announced President Trump will sign a number of executive orders lowering prescription drug prices in the coming weeks.
“This president is going to do three different executive orders that will substantially make sure that the average American gets to pay less for their prescription drugs,” Meadows said in an interview on Fox Business Network.
FDA Prepares to Resume Domestic Inspections
The FDA announced Friday (Jul. 10) that it is preparing new risk assessment systems to ensure a safe resumption of domestic inspection of FDA-regulated facilities, which have been delayed since March. The COVID-19 Advisory Rating System will assess the number of COVID-19 infections near a facility to determine whether on-site inspections can safely proceed, and will be available to state and local partners. The agency aims to resume domestic inspections the week of July 20. FDA inspections will be pre-announced for the foreseeable future.
To view the FDA announcement, click here.
To view the White House reopening guidelines, click here.
DOL, HHS, Treasury Issue Proposed Rule for Grandfathered Group Health Plans
The U.S. Departments of Labor, Health and Human Services, and the Treasury today (Jul. 10) issued a proposed rule to amend the requirements for grandfathered group health plans and grandfathered group health insurance coverage to preserve their grandfather status.
The proposed rule is a result of an executive order issued in January 2017 that directed the departments to minimize the unwarranted economic and regulatory burdens of the Patient Protection and Affordable Care Act (ACA), and subsequent request for information.
The proposed rule would clarify that grandfathered group health coverage that is a high-deductible health plan (HDHP) may increase fixed-amount cost-sharing requirements, such as deductibles, to the extent necessary to maintain their status as an HDHP without losing grandfather status. Additionally, the rule provides an alternative method of measuring permitted increases in fixed-amount cost sharing that would allow plans and issuers to better account for changes in the costs of health coverage over time.
To view the proposed rule, click here.
To view the DOL announcement, click here.
Ways and Means GOP Releases Agenda to Spur Vaccine and Treatment Innovation
On Thursday (Jul. 9), House Ways and Means Republicans unveiled a number of legislative priorities aimed at strengthening the U.S. medical supply chain and encouraging vaccine and therapy development. The agenda includes four bills:
Start-up for Cures Act (Rep. Devin Nunes (R-CA)): removes the obstacles that prevent innovators from starting new companies and beginning work to cure diseases and creates a research and development (R&D) incentive for small biotech companies who are engaged in infectious disease drug development.
The More Cures Act (Rep. Nunes): creates bonus R&D incentives for companies engaged in infectious disease research.
Infectious Disease Therapies Research and Innovation Act (Rep. Mike Kelly (R-PA)): amends the passive loss rules currently in the tax code to help these smaller firms raise private funds from more investors at an earlier stage.
American Innovation Act (Rep. Vern Buchanan (R-FL)): provides special tax treatment for start-up costs and by preserving valuable tax attributes like R&D credits to make it easier for America’s innovators to start new drug companies that can research and develop new cures and treatments.
Biden Releases Supply Chain Plan
Former Vice President and Democratic Nominee Joseph Biden unveiled a plan to “rebuild U.S. supply chains and ensure the U.S. does not face future shortages of critical equipment” on Tuesday (Jul. 7). The plan indicates, should Biden be elected, he will: use the full power of the Federal Government to rebuild domestic manufacturing capacity in our critical supply chains; implement a comprehensive approach to ensuring that the U.S. has the critical supplies it needs; and, work with allies to protect their supply chains and to open new markets to U.S. exports.
To view an overview of the plan, click here.
Supreme Court Upholds Trump ACA Rollback on Birth Control
On Wednesday (Jul. 8), the Supreme Court ruled 7-2 to uphold the Trump Administration’s rollback of ACA regulations requiring employers to supply free birth control to female employees.
“It is clear from the face of the statute that the contraceptive mandate is capable of violating (the religious freedom laws),” Justice Clarence Thomas wrote in the opinion.
Justices Elena Kagan and Stephen Breyer concurred that the Trump administration had the authority to grant religious exemptions to the birth control mandate. However, Kagan and Breyer suggested the case be sent back to lower courts for further review.
House Panels Hears from State, Local Officials on COVID Response
The House Committee on Homeland Security held a virtual hearing on Wednesday (Jul. 8) to hear from state and local officials about their response to the Coronavirus pandemic. Illinois’ Governor J.B. Pritzker criticized the Trump administration for not utilizing the Defense Production Act, and called for more funding to states and local governments in order to prevent a massive wave of layoffs. Mayor Jason Shelton, of Tupelo, MS, also asked for direct payments to cities and municipalities. Dr. Umair Shah of Harris County Public Health explained how the U.S.’ public healthcare system has been underfunded, undervalued, and unacknowledged for far too long. Retired Colonel Brian Hastings, Director of Alabama’s Emergency Management Agency, provided suggestions for where the government can improve, including analyzing supply chain vulnerabilities and clarifying CARES Act funding.
To view an executive summary, click here.
E&C Holds Hearing on Tribal Needs
On Tuesday (Jul. 8), the House Energy and Commerce Committee held a hearing on the current needs of tribal communities. Lawmakers were in agreement that the expansion of telehealth has provided a great opportunity for tribal communities. However, members also said limited broadband capabilities has made telemedicine access for various tribes and communities difficult. Dr. Grim noted broadband access, reimbursements, and funding as barriers to telehealth use. Additionally, committee members discussed Medicaid expansion in Indian Country, and Rep. Diana DeGette (D-CO) asked questions about the Special Diabetes Program for Indians. Witnesses described this program as successful but underfunded.
To view an executive summary, click here.
Beech, Eric, “Trump will sign three executive orders on lowering drug prices: chief of staff”, Reuters, 9 Jul 2020. https://link.edgepilot.com/s/e1f2f32a/etaxkF2Uf0OUrll5VZmfzw?u=https://www.reuters.com/article/us-usa-healthcare-trump/trump-will-sign-three-executive-orders-on-lowering-drug-prices-chief-of-staff-idUSKBN24A3CO
 US House of Representatives Committee on Ways and Means Minority “Ways & Means GOP Unveils Faster Cures through Innovation Agenda,” (Press Release), 9 Jul 2020. https://link.edgepilot.com/s/9b4e7d54/AZQ9GZNvjECSTcxSwb5syA?u=https://gop-waysandmeans.house.gov/ways-means-gop-unveils-faster-cures-through-innovation-agenda/
 Luthi, Susannah, “Supreme Court upholds Trump’s rollback of birth control coverage mandate,” Politico Pro, 8 Jul 2020. https://link.edgepilot.com/s/a2b35701/3sovm9V2xECZEpYIi8gwSg?u=https://subscriber.politicopro.com/article/2020/07/supreme-court-upholds-trumps-rollback-of-birth-control-coverage-mandate-1939521