Health Update (June 22)
House to Vote on the ‘Affordable Care Enhancement Act’
In a press conference held Thursday (Jun. 18), House Speaker Nancy Pelosi (D-CA) signaled the House will take up their Affordable Care Act (ACA) improvement bill on June 29. H.R. 3, the drug pricing bill voted on earlier this year, may act as a ‘pay for’ for ACA expansion.
The House will also be working on a policing reform package, infrastructure package, NDAA, DC Statehood, and the Senate lands package through the end of this month and July. The policing reform package will go to conference should the Senate proceed with Sen. Tim Scott’s (R-SC) legislation.
Operation Warp Speed
On Tuesday (Jun. 16), HHS released a fact sheet outlining Operation Warp Speed (OWS), a program that aims to deliver 300 million doses of a safe and effective coronavirus vaccine by January 2021. OWS is working through collaboration with HHS, CDC, FDA, NIH, BARDA, and DoD. Additionally, OWS coordinates with existing HHS efforts, including NIH’s industry partnership, ACTIV, and diagnostic program, RADx.
OWS has selected 14 vaccine candidates from over 100 submissions. These 14 candidates will be reduced to seven, and will undergo large-scale randomized trials for safety and efficacy. Manufacturing and distribution potential are considerations throughout the selection process.
To view the fact sheet, click here.
CMS Releases Proposed Rule on Drug Pricing Requirements
On Wednesday (Jun. 17), CMS proposed to “modify and relax” certain requirements on drug manufacturers pricing in Medicaid. The rule change is intended to move towards more value-based pricing agreements between states and manufacturers in order to manage costs and increase access. Additionally, the proposal includes minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related abuse and fraud. The proposed rule also includes changes to regulations on average manufacturer price and third-party liability.
The proposal is open for comments for the next month.
To view the proposed rule, click here.
To view the CMS announcement, click here.
FDA Revokes EUA
The FDA revoked a number of Emergency Use Authorizations (EUA) related to the coronavirus this week. Most recently, the Chembio antibody test lost its EUA. One of the first antibody tests to receive EUA, the Chembio test has now been proven to generate a higher than expected rate of false results.
“Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health.
“By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public,” he added.
EUAs for hydroxychloroquine and chloroquine were revoked earlier this week.
Senate HELP Examines Telehealth
The Senate HELP Committee met on June 17 to discuss the expansion of telehealth during the pandemic. Committee members heard from various healthcare professionals on the benefits and challenges presented by telehealth, as well as their opinions on which federal policy changes enacted in response to the COVID-19 crisis should be extended beyond the pandemic. In his opening statement, Chairman Lamar Alexander (R-TN) claimed the three most impactful policy changes have been the originating site rule, expansion of the types of telehealth providers eligible for Medicaid/Medicare reimbursement, and relaxation of certain HIPPA provisions. Of these, he noted the first two are the ones he would like to see made permanent. Ranking Member Patty Murray (D-WA) was not present.
Witnesses described efforts their organizations have taken to expand telehealth access. They agreed with the Chairman on the extension of the aforementioned provisions, but pushed for extending most or all of the federal telehealth policy changes that have taken place in past months. Committee members were all supportive of continuing telehealth services beyond the pandemic, but asked questions surrounding reimbursement rates, privacy concerns, and the bridging the digital divide.
To view an executive summary, click here.
E&C Holds Hearing on Health Disparities
On Wednesday, June 17 the House Energy & Commerce Committee Subcommittee on Health held a virtual hearing about racial and ethnic disparities in the health care system. Subcommittee Chairwoman Ann Eshoo (D-CA) opened the hearing by reporting the most recent numbers on coronavirus cases and deaths and the disproportionate share of those numbers that minorities account for. Subcommittee Ranking Member Michael Burgess (R-TX) emphasized the need for Congress to take heed of any information gained from the hearing and use it to draft passable legislation. He also pointed out that he was the one who requested the hearing take place. Full Committee Chairman Frank Pallone (D-NJ) outlined his frustrations with trying to get data from the administration, especially CMS. Lastly, Full Committee Ranking Member Greg Walden (R-OR) expressed his appreciation to the Trump administration for requiring reports from nursing facilities.
The question and answer portion included numerous inquiries on the differences in health care in terms of race and also age. Witnesses advocated for Medicaid and Medicare expansion to allow minorities and lower-income communities to gain access to primary care for chronic illness. They also expressed support for universal healthcare and spoke about the consequences of residential segregation.
To view an executive summary, click here.
Press Release, U.S. Food and Drug Administration “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test” 16 Jun. 2020