On The Hill

Monday (Jun. 29), the House passed the Patient Protection and Affordable Care Enhancement Act. The legislation expands the Affordable Care Act’s (ACA) subsidies for private health insurance, encourages Medicaid expansion, and includes a component of last year’s drug pricing bill, H.R. 3, that requires the government to negotiate drug prices.^[1] Former Democrat Jeff Van Drew (R-NJ) and Republican Brian Fitzpatrick (R-PA) joined Democrats in supporting the legislation. The passage of the bill contrasts with the administration’s move last week to overturn the ACA.

 

On Wednesday (Jul. 1), the House passed H.R. 2, the INVEST in America Act, 233-188. The bill was focused on rebuilding roads and bridges, combating climate change, promoting clean energy, and rebuilding drinking water infrastructure.

 

 

 

The House and Senate are in recess for the next two weeks.

 

The Senate will return the week of July 20, where they will continue their work on NDAA. The hope is that they complete the must-pass legislation by the end of the month. Senate Majority Leader McConnell (R-KY) said they will begin working on the next COVID-19 package after the July Fourth recess, ideally getting it off the Senate floor by Aug. 6, when they begin their August recess.

 

The House will return the week of July 20 for votes, however Committees are expected to hold hearings over the next two weeks while it stands in recess. The House is currently scheduled to adjourn on July 31 for the August break. The House has extended rules allowing for proxy voting and remote House hearings until August 14. This gives the House flexibility to finalize any additional COVID-19 package before the August recess.

 

The Democratic National Convention will be held August 17 – 20.

 

The Republican National Convention will be held August 24 – 27. 

 

 

 

Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) released updated drug pricing legislation Thursday (Jul. 2), after Wyden withdrew his support from the original bill. All provisions of the updated Prescription Drug Pricing Reduction Act of 2020 have bipartisan support.

 

The Congressional Budget Office estimates the bill would save taxpayers $95 billion, reduce out-of-pocket spending by $72 billion, and reduce premiums by $1 billion.^[2]

 

To view the bill text, click here.

 

To view a section-by-section summary, click here.

 

 

 

HHS has announced it will give providers who have not received funds from previous relief tranches the ability to apply for funds. The intended bailout fund will be particularly beneficial to mental health and addiction specialists who missed out on earlier aid due to confusion over funding rules. Like other providers, they will need to submit relevant financial data and will be limited to 2 percent of their total revenue.^[3]

 

 

 

House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released the second pillar of their Second Wave Preparedness Project on Wednesday (Jul. 1). The second pillar includes recommendations on COVID-19 vaccine and therapies development and distribution.

 

“As American innovators continue to race toward new treatments and a vaccine, it’s important the federal government do everything it can to prepare to ramp up production and distribution quickly and efficiently,” Walden and Guthrie stated in their release.^[4]

 

“The Trump administration is already taking steps to ensure we are ready, and we hope they will closely consider the recommendations included in today’s report. We look forward to working alongside the administration to continue the fight against COVID-19, and we are confident this is a fight we will win,” they continued.

 

The recommendations include: incentivizing providers to collect and report key data, FDA exploration of quick approval for vaccines and therapies, considering the impact of seasonal influenza, the creation of a national vaccine plan for manufacturing and distribution, and more.

 

To view a summary of key recommendations, click here.

 

To view the full report, click here.

 

 

 

On Tuesday (Jun. 30), the FDA released guidance on COVID-19 vaccine development. The guidance, entitled “Development and Licensure of Vaccines to Prevent COVID-19,” provides recommendations for vaccine developers on satisfying requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation.

 

The guidance encourages the inclusion of diverse populations, specifically racial and minorities, in all phases of clinical development and the inclusion of elderly individuals and those with comorbidities during late phase trials.

 

Additionally, the guidance indicates the FDA expects a vaccine to prevent disease or decrease severity in at least 50 percent of those vaccinated and will consider the Accelerated Approval pathway for licensure on a case-by-case basis.

 

To view the FDA press release, click here.

 

To view the FDA guidance, click here.

 

The announcement drew immediate comment from House Speaker Nancy Pelosi’s (D-CA) office. The Speaker highlighted the importance of the FDA meeting its safety standards despite pressure to deliver a vaccine quickly, insisting: the vaccine have a trial size of at least 30,000 with diverse populations in all stages; the vaccine be at least 50 percent more effective than a placebo; the approval process is fully transparent and involves a public advisory committee prior to the issuance of an Emergency Use Authorization (EUA); and, the FDA tracks the health of vaccinated individuals for a year following vaccination to understand long-term safety.

 

To view Pelosi’s statement, click here.

 

 

 

On Monday (Jun. 29), Rep. James Comer (R-KY) was selected as the top Republican on the House Oversight and Reform Committee. Comer is expected to fill the seat previously held by Rep. Mark Meadows (R-NC). In an interview, Comer expressed his avidity to assume his new role and focus on implementing reform in the areas of “waste, fraud, and abuse”. Since Comer will be assuming his role halfway through the 116th Congress, he will be eligible to serve for an additional three full terms under the House GOP’s rules.

 

The Steering Committee also decided to reinstate Rep. Gary Palmer (R-AL) as a member of the panel. Palmer previously sat on the committee during the 115th Congress.^[5]

 

 

 

During an eHealth Initiative webinar held Wednesday (Jul. 1), CMS analyst Emily Yoder hinted an upcoming CMS provider fee schedule pay rule may contain provisions to make permanent certain telehealth waivers.^[6] The waivers, issued during the COVID-19 crisis, were intended to make telehealth services more accessible for both patients and providers, and included: eliminating origination site rules to allow practitioners to provide services from their homes, expanding the list of eligible providers and services, and allowing audio-only telehealth platforms to ensure access for those without broadband.

 

Telehealth proponents have called for the removal of state licensure requirements, allowing rural health clinics and community health centers to be reimbursed as distant sites, and allowing face-to-face end-stage renal disease evaluations via telehealth in addition to the changes.

 

CMS has indicated some of the telehealth rules will need congressional action to be made permanent. During a hearing in June, Senate HELP Chairman Lamar Alexander (R-TN) expressed interest in pursuing legislation to eliminate the originating site rule for Medicare and allow Medicare and Medicaid to expand the list of eligible providers (To view an executive summary of this hearing, click here).

 

CMS will be seeking stakeholder comments following the release of the rule in coming weeks.

 

 

 

The House Energy & Commerce Subcommittee on Health met Tuesday (Jun. 30) to hear testimony from healthcare professionals on the importance of bringing awareness to mental health, particularly during a health crisis, and creating legislation that provides for the availability of care for individuals suffering from mental illnesses without discriminatory repercussions.

 

In their opening statements, Subcommittee Chairwoman Anna Eshoo (D-CA), Subcommittee Ranking Member Michael Burgess (R-TX), Chairman Frank Pallone (D-NJ), and Ranking Member Greg Walden (R-OR) spoke about the committee’s bipartisan efforts in introducing bills necessary for improving improve telemental health and mental health services, and increase mental health parity.

 

In their testimony, Former Representative Patrick J. Kennedy, Arthur C. Evans, Jr. Ph.D., Chief Executive Officer of the American Psychological Association, Jeffrey L. Geller, M.D., M.P.H.,President, American Psychiatric Association, and Arriana Gross, National Youth Advisory Board Member, discussed the importance of implementing legislative measures to ensure that students and individuals in vulnerable communities have access to mental healthcare. Additionally, the witnesses encouraged the members to vote in favor of bills that will accomplish these goals. Specifically, the Medicare Mental Health Access Act (H.R. 884) was examined in great detail. Members are working in a bipartisan way and acknowledge this is a critical issue in the United States.

 

To view an executive summary, click here.

 

 

 

On Tuesday (Jun. 30), the Senate Committee on Health, Education, Labor, and Pensions convened a hearing to receive an update on the pandemic as it relates to getting back to work and to school. The committee heard from members of the White House Coronavirus Task Force.

 

Chairman Lamar Alexander (D-TN) began his remarks by saying the goal for everyone should be getting students back in school as many do not have adequate resources to continue their education remotely. He also mentioned that some students are safer in school than they are at home. He closed by emphasizing the need to hire more contract tracers. Ranking Member Patty Murray (D-WA) criticized the Trump administration’s handling of the pandemic, calling it a disaster. She said that a future vaccine will need to be safe, easily accessible, and widely distributed.

 

Witnesses emphasized the importance of maintaining social distancing and wearing a mask. Hahn announced that the FDA is providing guidance for vaccine developers in hopes of expediting the process and said the FDA is clarifying the data it needs in order to streamline the approval process. Witnesses also advocated for a massive update to the nation’s healthcare infrastructure, with Redfield saying it would be “one of the great investments in our time.”

 

To view an executive summary, click here.

 

 

 

The Senate Committee on Foreign Relations convened a hearing Tuesday, June 30, to examine U.S. and global pandemic preparedness. In his opening statement, Chairman James Risch (R-ID) spoke about the effectiveness of the World Health Organization (WHO), claiming its problems cannot be fixed. Risch asked witnesses to speak on what international body is, or could be, the ‘first responder’ in a global health crisis. Ranking Member Bob Menendez (D-NJ) criticized the administration’s decision to withdraw funding from WHO, and explained Democrats’ COVID-19 International Response and Recovery Act.

 

Each witness explained that WHO is central to international coordination on health. They stressed that any agency tasked with global pandemic preparedness should exist within the WHO and that the U.S. must work with the international community. Witnesses noted the lack of U.S. leadership in this pandemic has been unusual, and the continued spread of COVID-19 across the country calls the U.S.’ credibility into question. Additionally, witnesses claimed the State Department needs additional funding and said there must be a clear division of responsibility between State and the CDC.

 

To view an executive summary, click here.

 

 

 

On Thursday, July 2, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to receive an update on Operation Warp Speed’s efforts to research, manufacture, and distribute a safe and effective COVID-19 vaccine. The committee heard from Dr. Francis Collins who discussed the RADx program and the status of remdesivir and dexamethasone as treatments. Dr. Robert Redfield outlined the intricacies of vaccine development and distribution, pointing out that there may be multiple vaccines for different cases and each will behave differently. Dr. Gary Disbrow provided details on the public-private partnerships between the U.S. government and private companies.

 

To view an executive summary, click here.

 

 

 

^[1]Luthi, Susannah & Ollstein, Alice Miranda. “House Democrats approve health bill, seeking contrast with Trump’s Obamacare assault” Politico Pro, 29 Jun. 2020.

 

^[2]U.S. Senate Committee on Finance. “Grassley, Colleagues Introduce Updated Bipartisan Prescription Drug Pricing Bill” (Press Release) 2 Jul. 2020.

 

^[3]Roubein, Rachel & Ehley, Brianna. “Health providers to get another shot at bailout cash” Politico Pro, 2 Jul. 2020.

 

^[4]U.S. House of Representatives Committee on Energy and Commerce Minority. “Walden, Guthrie Release Second Pillar of E&C Republicans’ Second Wave Project” (Press Release) 1 Jul. 2020.

 

^[5]Brufke, Juliegrace. “Comer Tapped to Serve as Top Republican on House Oversight” The Hill, 2 Jul. 2020..

 

^[6]Cirruzzo, Chelsea. “CMS Hints At Permanent Telehealth Proposals In Upcoming Pay Rule” Inside Health Policy, 1 Jul. 2020.