Health Update (August 17)
Congress Adjourns Without Coronavirus Relief Deal
On Thursday (Aug. 13), House and Senate leaders sent their members home for the August recess without coming to a consensus on the next round of COVID-19 relief. The House and Senate are scheduled to return September 14 and 8 respectively, however, Senate Majority Leader Mitch McConnell (R-KY) and House Speaker Nancy Pelosi (D-CA) have both indicated they will call members back to Washington should a deal be reached during the break.
Negotiations are currently at a standstill.
McConnell has scheduled a number of pro forma sessions throughout August. As of now, no business has been slated for these dates.
Biden Taps Kamala Harris for VP
Democratic Presidential Candidate Joe Biden announced Sen. Kamala Harris (D-CA) as his running mate on Tuesday (Aug. 11). Harris is the first Black woman and first Asian American woman on a major party’s presidential ticket.
Sen. Harris previously signed onto Sen. Bernie Sanders’ (D-VT) Medicare for All bill in the Senate, however, during the Democratic Primary Harris attempted to straddle the line between a single-payer system and the current one. She offered up a government-managed health care system that would give private plans a more limited role.[1] Biden has expressed his opposition to Medicare for All, instead supporting a stronger public option built off the Affordable Care Act.
On drug pricing, Harris released a plan during the primary outlining how she would give HHS the authority to set a “fair price” on any prescription drug whose cost increases were greater than the cost of inflation or that was sold for a lower price outside the U.S. The plan included a proposed regulation to tax profits on drugs priced above said fair price at 100 percent. Harris also said she would make use of the government’s march-in rights if other price-lowering efforts had failed, licensing drug patents to other companies to be produced and sold for less.[2]
To view Biden’s healthcare platform, click here.
Provider Relief Fund Updates
Phase II General Distribution Applications: On Monday (Aug. 10), HHS began accepting additional applications for the Provider Relief Fund (PRF) phase II general distribution from eligible Medicare, Medicaid, CHIP, and dental providers to receive funding equal to two percent of total patient care revenue.
Eligible providers include: providers that were ineligible for phase I due to a change of ownership in calendar year 2019 or 2020 under Medicare Part A or did not have Medicare fee-for-service in 2019; providers that received funding from phase I but missed the June 3 deadline to submit revenue information or did not receive funding equaling two percent of total patient care revenue; and providers who received phase I payments but returned the funding.
Applications should be submitted through the PRF attestation portal by August 28. All applicants must accept the terms and conditions and may be subject to auditing to ensure the data provided to HHS for payment calculation is accurate.
Additional rounds of relief that will take providers over the two percent threshold are expecting in the coming months, however, HHS has yet to make this announcement.
To view the PRF portal, click here.
To view the HHS announcement, click here.
PRF Allocation for Nursing Homes: On August 7, HHS announced it will allocate a $5 billion PRF distribution to nursing homes and long-term care facilities. Approximately $2.5 billion of the distribution will be used to support increased testing, staffing, and PPE needs. Additional funding will be available to set up COVID-19 isolation facilities. Unlike prior distributions, the remainder of the $5 billion will be linked to nursing home performance.
“We anticipate that linking payment to performance will be an effective means of holding nursing homes accountable, stimulating innovation, and encouraging them to reach beyond their own walls for infection control expertise and support,” HSRA Administrator Thomas Engels said.
HRSA anticipates the initial $2.5 billion will be distributed in mid-August and performance-based distributions will occur throughout the fall.
To view the HHS announcement, click here.
HHS Releases Fact Sheet on Operation Warp Speed
HHS released a fact sheet outlining the progress of the administration’s coordinated vaccine effort, Operation Warp Speed (OWS).
OWS aims to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 2021. The program is a partnership between HHS, CDC, FDA, NIH, BARDA, and DoD, and engages with existing HHS efforts including NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, and NIH’s Rapid Acceleration of Diagnostics (RADx) initiative.
The fact sheet provides a timeline of HHS agreements with pharmaceutical manufacturers for vaccine development, manufacturing, and development. Existing manufacturing contracts include:
- Johnson & Johnson*: investment in manufacturing capabilities (Mar. 30)
- Moderna*: investment in manufacturing capabilities (Apr. 16)
- AstraZeneca*: $1.2 billion for at least 300 million doses (May 21)
- Emergent BioSolutions: $628 million “Task Order” Advance domestic manufacturing capabilities for vaccine &/or therapeutics (Jun. 1)
- Novavax: $1.6 billion for 100 million doses of their vaccine candidate (Jul. 7)
- Pfizer: $1.95 billion for 100 million doses & nationwide distribution of their vaccine candidate (Jul. 22)
- Texas A&M University & FUJIFILM Diosynth Biotechnologies: $265 million “Task Order” to advance domestic manufacturing
- Sanofi/GlaxoSmithKline*: $2 billion for 100 million doses expected to result from demo project (Jul. 31)
- Grand River Aseptic Manufacturing: $160 million for aseptic fill & finish manufacturing capacity
- Johnson & Johnson/Janssen: $1 billion for 100 million doses of vaccine candidate, with option to acquire more (Aug. 5)
- Moderna: Up to $1.5 billion for 100 million doses of vaccine candidate, option to acquire 400 million more (Aug. 11)
*Contract includes funding for vaccine development and manufacturing.
To view the fact sheet, click here.
Ways and Means, Finance Committee Leaders Request Info from USITC
On Thursday (Aug. 13), House Ways and Means Chairman Richard Neal (D-MA), Ranking Member Kevin Brady (R-TX), and Senate Finance Chairman Chuck Grassley (R-IA) sent a letter to U.S. International Trade Commission Chairman Jason Kearns and requested that the Commission conduct a follow-on investigation to provide more detailed information on industry sectors producing COVID-19-related goods and key products within those sectors.
According to the letter, the request reflects the active interest of Members of Congress to address U.S. supply chain resilience, especially for medical products.
“In light of the Commission’s recent investigation and report, the ongoing pandemic, and the persistent challenges in meeting supply for these critical products, we are writing today to request that the Commission conduct a follow-on investigation and prepare a report under section 332(g) of the Tariff Act of 1930,” wrote Brady, Neal, and Grassley.
The lawmakers requested the Commission deliver its report no later than December 15, 2020.
Administration Releases Fact Sheet on COVID-19 Response
On Monday (Aug. 10), the White House released a fact sheet outlining the administrative actions taken to curb the spread of the coronavirus, including: cutting off travel from China, building a testing system, enacting mitigation measures, mobilizing public and private sectors to secure supplies, protecting vulnerable populations, launching efforts to deliver a vaccine and therapeutics, supporting workers and businesses, reopening America, and allocating resources to hot spots.
To view the fact sheet, click here.
Trump Signs EOs on Payroll Tax, Eviction Moratorium, and More
On Saturday (Aug. 8), President Trump signed four COVID-19 related Executive Orders (EO). The orders intend to: defer payroll taxes for those who earn less than $104,000, defer student loan payments, provide assistance to renters and homeowners, extend unemployment insurance. The orders are facing potential legal challenges and it is unclear to what extent they will be able to be enacted.[3]
References
[1] Collins, Eliza. “Kamala Harris, Biden Differed on Trade, Medicare for All. Here’s a Guide to Their Positions.” The Wall Street Journal, 12 Aug. 2020.
[2] Siders, David. “How Kamala Harris would address rising drug prices.” Politico, 16 Jul. 2019. https://link.edgepilot.com/s/0454f38a/ZIqDezqIJUKrrKMfFEllww?u=https://www.politico.com/story/2019/07/16/kamala-harris-2020-drug-costs-aarp-1416130
[3] McGraw, Meredith “With latest executive orders, Trump gets approval from his golf club crowd,” Politico, 9 Aug. 2020.
HOUSE.GOV
The Week Ahead
For the main events of the next week and more, go straight to the key events on the house.gov website.
SENATE.GOV
The Week Ahead
For the main events of the next week and more, go straight to the key events on the senate.gov website.