On The Hill

Relief Talks Continue, Little Progress is Made

This week, Senate Majority Leader Mitch McConnell (R-KY) announced that the Senate will vote on a standalone relief bill Monday (Oct. 19). This bill would cost around $500 billion and extend the Paycheck Protection Program (PPP). In a Dear Colleague letter issued by the House Speaker Nancy Pelosi’s (D-CA) office Thursday (Oct. 15), the Speaker criticized McConnell for refusing to work with Democrats on a larger relief bill. The Democrat’s current proposal includes approximately $2.2 trillion in relief dollars.

Pelosi and Treasury Secretary Steven Mnuchin continue to negotiate, however, it is unlikely a package will be agreed upon prior to the election.

On Friday (Oct. 16), the Congressional Budget Office (CBO) and Joint Committee on Taxation (JCT) completed an estimate of the budgetary costs of the HEROES Act, as passed by the House Oct. 1, 2020. CBO estimates the legislation would add $2.4 trillion to the deficit over the 2021-2030 period. The HEROES Act is unlikely to be taken up by the Senate.

To view the CBO report, click here.

 

Senate Panel to Hold Vote on SCOTUS Nominee

The Senate Judiciary Committee will vote on Judge Amy Coney Barrett’s nomination to the Supreme Court on Oct. 22. It is likely she will be confirmed before the election. The court will hear a case on the Affordable Care Act this November, and has a number of other high-profile cases on the docket.

 

Trump Announces Pharmacy Partnership at ‘Protecting America’s Seniors’ Event

At an official event Friday (Oct. 16), President Trump appealed to seniors by announcing a new public-private partnership between DoD, HHS, CVS, and Walgreens to deliver free COVID-19 vaccinations to residents and staff in long-term care facilities (LTCF). The announcement in the administration’s latest move to address senior’s medical costs; earlier this month, Trump announced a plan to send $200 drug discount cards to seniors to assist with copays at the pharmaceutical counter.

Throughout the address, Trump also touted his administration’s effort to address drug prices through the executive orders signed late this summer on most favored nations, pharmacy rebates, and drug importation.

CVS, Walgreen Tapped for LTCF Vaccine Partnerships: The DoD, in collaboration with HHS, will partner with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of LTCF with no out-of-pocket costs. The initiative, dubbed the Pharmacy Partnership for Long-Term Care Program, will manage vaccinations for LTCF residents and staff once a vaccine becomes available.

As a part of the agreement, CVS and Walgreens will coordinate with LTCFs to schedule on-site visits to administer vaccine doses. The pharmacies will also manage: vaccine doses and necessary supplies, cold chain management, and fulfilling reporting requirements for state, local, and federal public health authorities.

The program aims to protect this vulnerable population and minimize administrative, and vaccine handling burdens on LTCFs and jurisdictional health departments. The program will be free of charge and available in most rural areas that do not have easily accessible pharmacies.

“CVS Health has been on the frontlines of the fight against COVID-19, working across the health care spectrum in all the communities we serve and that will continue to be the case when we have a vaccine to dispense,” said Troy Brennan, Chief Medical Officer, CVS Health.

LTCFs will be able to opt-in and indicate which pharmacy their facility would like to partner with beginning Oct. 19, 2020. LTCFs are not required to participate in the program.

“Today’s historic pharmacy partnership will truly help jurisdictions solve a logistical hurdle and decrease the burden of distributing, administering, and reporting COVID-19 vaccination for both states and long-term care facilities,” said CDC Director Dr. Robert Redfield.

“CDC is proud to be a part of this public-private partnership that is advancing care for the Nation’s most vulnerable,” he added.

To view the DoD announcement, click here.

 

PRF Phase 3 Funding

This week, HHS provided additional tools to assist providers in navigating the Provider Relief Fund (PRF) application process during the Phase 3 General Distribution, including: an updated fact sheet, a step-by-step application guide, and a stakeholder toolkit.

As of Oct. 5, HHS has made $105,247,761,304 in payments to 531,548 provider TINs under the General and Targeted Distributions of the PRF program. Of these payments, 352,235 providers (unique TINs) have attested to the Terms and Conditions for $89,037,036,146 in payments.

The application for Phase 3 General Distribution is now open. Applications are due Nov. 6.

To view the PRF application portal, click here.

To view the updated fact sheet, click here.

To view the application guide, click here.

To view the stakeholder toolkit, click here.

 

CEO Indicates Pfizer Could Apply for Vaccine EUA By Late November

In an open letter released Friday (Oct. 16), Pfizer Chairman and CEO Albert Bourla suggested the company could be ready to apply for an emergency use authorization (EUA) for its COVID-19 vaccine candidate as soon as the third week of November, assuming trials continue to deliver positive results.

Pfizer is currently in the process of collecting data to ensure the vaccine meets FDA safety and efficacy requirements. The company may have sufficient data to make a determination on efficacy by the end of October. Bourla has indicated Pfizer will share this information with the public “as soon as practical” and expects sufficient data on safety to be available in late November.

Should Pfizer be granted an EUA, the company is on track to have 100 millions doses manufactured by the end of the year – enough to vaccinate 50 million people.

To view the letter, click here.

 

BARDA, DoD Partner with AstraZeneca, Cytiva

On Monday (Oct. 12), AstraZeneca announced they had reached an agreement with the HHS and DoD to conduct “late-stage” trials and develop “large-scale” manufacturing of their potential COVID-19 antibody medication. The company is testing over 12,000 participants to determine the effectiveness of their preventative monoclonal antibody, AZD7442.

BARDA, in collaboration with DoD, provided approximately $486 million to AstraZeneca for two “Phase 3” clinical trials and related development activities, including a large-scale manufacturing project to supply 100,000 doses of AZD7442 by the end of the year.

The treatment is expected to be used on high-risk patients who are unable to take a potential COVID-19 vaccine.

To view the HHS announcement, click here.

On Tuesday (Oct. 13), HHS and DoD reached an agreement with Cytiva to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines. BARDA, in collaboration with DoD, awarded Cytiva $31 million for vaccine-related products, including liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors.

To view the HHS announcement, click here.