On July 31, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) announced a $2.1 billion contract with Sanofi and GlaxoSmithKline to support vaccine development, including purchase of 100 million doses of the vaccine produced during the demonstration. Doses will be used in future clinical trials or distributed as part of a national vaccination campaign... Read More
NIH: $248.7 Million Awarded to Support New COVID-19 Testing Technologies
The National Institutes of Health (NIH), through its Rapid Acceleration of Diagnostics (RADx) Initiative, announced $248.7 million in awards for seven new COVID-19 diagnostic technologies. The agency estimates that the new technologies could "significantly increase the number, type, and availability of test by millions per week" as early as September 2020. The NIH details that three of the technologies utilize... Read More
Finance: During Two-Part Hearing on COVID-19 Supply Chain, PPE Shortages, Counterfeit Products, and Supply Chain Improvements Discussed
The Senate Finance Committee convened a two-part hearing on protecting the reliability of the medical supply chain during the COVID-19 pandemic. Part I, on July 28, featured witnesses from the Customs and Border Protection, Immigration, Customs, and Enforcement (ICE), and the Department of Homeland Security. The Senators largely focused on the ongoing shortages of personal protective equipment (PPE) and the... Read More
CMS: Payment Available for Self-Isolation Counseling at Testing Sites & New Codes for COVID-19 Treatments
The Centers for Medicare & Medicaid Services (CMS) announced that payment is available for health care providers that offer self-isolation counseling to patients at the point of testing. CMS states providers will be able to bill existing evaluation and management (E/M) payment codes to receive reimbursement for these counseling services. Providers will be able to furnish such services regardless of... Read More
FDA: New Template Posted for At-Home and Over-the-Counter COVID-19 Diagnostic Tests
The Food and Drug Administration (FDA) posted a new template for at-home and over-the-counter COVID-19 diagnostic tests for use in non-lab settings (press release). The template is intended to be used by commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostics tests that can be performed at home or in other settings besides... Read More
HHS: ASPE Releases Report on Medicare Telehealth Utilization During the COVID-19 Pandemic
The Department of Health and Human Services (HHS), through the Assistant Secretary for Planning and Evaluation (ASPE), released a report on Medicare beneficiary telehealth utilization during the COVID-19 pandemic (press release). The report analyzes Medicare fee-for-service (FFS) claims data from January through May 2020 and addresses how the telehealth flexibilities helped maintain access to health services during the public health... Read More
CMS: Monthly Update to COVID-19 Medicare Snapshot Reveals Disproportionate Impact on Native American Populations
The Centers for Medicare & Medicaid Services (CMS) released its first monthly update to its report detailing the impact of COVID-19 on Medicare beneficiaries. The report draws from COVID-19 cases and hospitalizations of Medicare beneficiaries between Jan. 1 and June 20, 2020, and is based on Medicare claims and encounter data reported to CMS. Most notably, the data reveals that... Read More
CDC: Supplemental Funding Opportunity to Support Public Health Priorities: COVID-19 Response, Racial Justice & Health Equity, HIV Epidemic; Due Aug. 10
The Centers for Disease Control and Prevention (CDC) announced a supplemental funding opportunity (CDC-RFA-OT18-18020302SUPP20) titled, “Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nation’s Health.” The purpose of this program is to strengthen the nation’s public health infrastructure through partners that will deliver capacity-building assistance, such as technical assistance, training, information sharing, technology transfer,... Read More
Senate: Senate Republicans Unveil HEALS Act, Proposed 'Phase 4' Coronavirus Relief Package
Senate Republicans unveiled the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act – a roughly $1 trillion package intended to provide additional coronavirus relief, support the federal government’s coronavirus response, help businesses and schools reopen safely, and stimulate the economy. The package is a compilation of individual bills authored by Republican Committee leaders. The HEALS Act appears to be... Read More
WHG - Weekly, July 27-31
After days of negotiating with the Trump administration, Senate Majority Leader Mitch McConnell (R-KY) is expected to unveil Republicans’ coronavirus relief package later today, finally kicking off negotiations with Democrats. The $600 federal unemployment benefit expiring at the end of the week is putting pressure on the White House and Congress to act fast, with Treasury Secretary Steven Mnuchin and... Read More
NIH: Operation Warp Speed COVID-19 Vaccine Begins Phase 3 Clinical Trial
The National Institutes of Health (NIH) announced that the Operation Warp Speed sponsored COVID-19 vaccine, Moderna's mRNA-1273, has begun Phase 3 clinical trial. The trial is expected to enroll 30,000 adult volunteers. The NIH notes that Moderna is leading the trial as the regulatory sponsor, and National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and... Read More
HHS: $7.6 Million Contract Awarded to Hologic for Expanded COVID-19 Testing Supplies Production
The Department of Health and Human Services (HHS) and the Department of Defense (DOD) awarded Hologic Inc. a $7.6 million contract to expand production of custom sample collection and processing consumables for COVID-19 testing. HHS notes that this investment will increase Hologic's production from 4.8 million COVID-19 tests per month to 6.8 million tests per month by January 2021. Through... Read More
HHS: Secretary Azar Renews COVID-19 Public Health Emergency Declaration through October 23
Department of Health and Human Services (HHS) Secretary Alex Azar signed a renewal of his determination that the novel coronavirus (COVID-19) pandemic constitutes a nationwide public health emergency (PHE). Secretary Azar first declared COVID-19 a nationwide PHE on January 31, 2020, utilizing his authority under Sec. 319 of the Public Health Service Act (PHS law; PHE FAQs). He issued a previous renewal... Read More
HHS: OCR Releases Guidance for Recipients of Federal Funds About Civil Rights Protections Related to Race, Color, and National Origin
On July 20, the Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) issued (press release) guidance for recipients of federal financial assistance about civil rights protections prohibiting discrimination on the basis of race, color, and national origin during the COVID-19 pandemic. The bulletin focused on recipients' compliance with Title VI of the Civil Rights... Read More
CMS: Agency to Provide Additional Funding and Training to Nursing Homes; Require Staff Testing; Send Weekly Reports on Facilities with Case Increases
The Centers for Medicare & Medicaid Services (CMS) announced a new set of actions to support nursing homes and prevent further outbreaks during the COVID-19 pandemic. Details on the components of this latest initiative follow. Funding – CMS states that the U.S. Department of Health and Human Services (HHS) will dedicate an additional allotment of $5 billion from the provider... Read More
HHS: Administration Partners with Pfizer to Secure Future Vaccine Doses for Americans
On July 22, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) announced an agreement with Pfizer for large-scale production and delivery of 100 million doses of a COVID-19 vaccine after the vaccine’s successful manufacture and approval. The agreement also permits the federal government to obtain an additional 500 million doses. The Biomedical Advanced Research... Read More
NIH: Framework Outlined to Achieve 6 Million Daily COVID-19 Diagnostic Tests
The National Institutes of Health (NIH) announced that the Rapid Acceleration of Diagnostics (RADx) program has outlined a framework to manufacture 6 million diagnostic tests per day by the end of 2020 with support from the Office of the Assistant Secretary for Health, the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense. The program consists of... Read More
Senate: Special Committee on Aging Explores Disproportionate Impact of COVID-19 on Senior Citizens of Color
The Senate Special Committee on Aging convened a hearing yesterday to discuss the COVID-19 pandemic and its effect on seniors. In particular, the hearing focused on the prevalent racial health disparities that are affecting seniors in minority communities. Witnesses representing multiple health institutions spoke about the social determinants of health and the steps needed to address racial health disparities. Many... Read More
House: Lawmakers Urge Greater Investment by BARDA, HHS in Clinical Trials for Preventative COVID-19 Immune Globulin (COVID-IG) Injections
Reps. Katie Porter (D-CA) and Raja Krishnamoorthi (D-IL) recently sent a letter to the Department of Health and Human Services (HHS) and the Biomedical Advanced Research Development Authority (BARDA) regarding “the lack of investment” in clinical trials and research on preventive COVID-19 immune globulin (COVID-IG) injections. The lawmakers wrote that HHS and BARDA “must take the lead on the allocation... Read More
FDA: Real-World Data Reveals Higher Hospitalization and Death Rates Among Cancer Patients with COVID-19
The Food and Drug Administration (FDA) published findings that reveal people with cancer who contracted COVID-19 face an increased rate of hospitalization and a 16-fold increased mortality risk. Using real-world data analysis, the FDA's Oncology Center of Excellence examined the clinical experience of patients with cancer who contracted COVID-19 to better under the impact of the disease in this patient... Read More
HHS: OCR Announces Two Religious Rights Resolutions Related to COVID-19
On July 21, the Office for Civil Rights (OCR) in the Department of Health and Human Services (HHS) announced two resolutions to protect religious rights within health care settings during the COVID-19 pandemic. The first is related to religious visitation, and the second involves religious accommodation related to the use of personal protective equipment (PPE). In the first case, a... Read More
E&C: COVID-19 Vaccine Developers Testify Before Subcommittee on Oversight and Investigations; Safety and Efficacy, Pricing, Vaccine Confidence, and Supply Chains Discussed
The House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing to examine the COVID-19 vaccine development process. Representatives from five developers of potential COVID-19 vaccines testified about their efforts to develop a safe and effective vaccine, including details on clinical trials, vaccine availability timelines, and increased manufacturing capabilities. Many members of the Subcommittee focused on how to... Read More
HELP: Chairman Alexander Introduces Preparing for the Next Pandemic Act
On July 20, 2020, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) introduced the Preparing for the Next Pandemic Act – a bill aimed at bolstering the nation’s capacity to respond to the COVID-19 pandemic and future public health crises (press release; white paper). At a high-level, the bill would: Provide $5 billion over 10 years... Read More
HHS: Administration Restores Public Access to COVID-19 Data
The Department of Health and Human Services (HHS) restored public access to COVID-19 data that hospitals report to the federal government. The data is now available on HHS Protect, a data and analytics platform that “integrates data across federal, state, and local governments and the healthcare industry” and which supports the HHS Coronavirus Data Hub. Previously, the Centers for Disease... Read More
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