Labor-HHS-Education (LHHS-E) Section

The LHHS-E includes $197 billion for FY21, an increase of $2.8 billion over the FY20 enacted level and $19.2 billion over the President’s 2021 budget request.

Department of Labor (DOL)

The bill provides $12.5 billion in discretionary appropriations for DOL, an increase of $122 million above the FY20 enacted level. This includes:

• $9.4 billion for the Employment and Training Administration
• $2.8 billion for Workforce Innovation and Opportunity Act Grants
• $45 million for Strengthening Community College Training Grants
• $1.7 billion for Job Corps
• $316 million for Veterans’ Employment and Training Service (VETS)
• $58 million for the Homeless Veterans Reintegration Program
• $31 million for the Transition Assistance Program

Department of Health and Human Services (HHS)

The bill includes a total of $97 billion for HHS, an increase of $2.1 billion above the FY20 enacted level. The National Institutes of Health (NIH) received $42.9 billion, an increase of $1.25 billion above the FY20 level, far less than the House sought in its bill but in the end this figure was required by the Budget Control Act and related caps. These caps will not apply next year. The total includes funding for:

• Alzheimer’s Disease and Related Dementias Research - $3.118 billion
• BRAIN Initiative - $560 million
• Universal Flu Vaccine Research - $220 million
• AIDS/HIV Research - $3.90 billion
• Office of Research on Women’s Health - $44 million
• Research on Premature Births - $10 million

Centers for Disease Control and Prevention (CDC)

The bill includes a total of $7.9 billion for CDC, an increase of $125 million above the FY20 enacted level. It increases investments in our public health infrastructure to include:

• Influenza planning and response - $201 million
• Public health emergency preparedness cooperative agreements - $695 million
• Public health workforce and career development - $56 million
• Suicide Prevention - $12 million
• Safe motherhood - $63 million

Within the CDC, the Public Health and Social Services Emergency Fund (PHSSEF) receives $2.8 billion, an increase of $110 million above last year. The total funding level includes:

• $597 million for the Biomedical Advanced Research and Development Authority (BARDA)
• $770 million for Project BioShield
• $705 million for the Strategic National Stockpile
• $287 million for Pandemic Influenza Preparedness, an increase of $27 million

Department of Education

The bill provides a total of $73.5 billion, which is an increase of $785 million above the FY20 enacted level and $7 billion above the President’s budget request. This funds Elementary and Secondary Education (ESEA) programming and some STEM education. It also tackles key higher education issues, including:

• Expanding the Pell Grant program and making it easier for students to predict their eligibility, which will make hundreds of thousands of students newly eligible for Pell and increase award amounts for millions of current Pell recipients.
• Making it easier for students to apply – and qualify – for federal student aid by streamlining the Free Application for Federal Student Aid (FAFSA) and expanding outreach and awareness activities to encourage FAFSA completion, with a focus on low-income students and families.
• Expanding opportunities for justice-involved individuals to get an education and successfully reenter their communities by providing incarcerated students access to Pell Grants.
• Discharging loans made to Historically Black Colleges and Universities (HBCUs) under the HBCU Capital Financing Loan program, providing $1.34 billion in relief.
• Eliminating a confusing and punitive restriction that limits eligibility for subsidized federal loans among low-income students.
• Restoring Pell Grant eligibility for defrauded students, including those who attended shuttered for-profit colleges like ITT Technical Institutes and Corinthian Colleges.

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Agriculture-Rural Development-FDA Section

U.S. Department of Agriculture

The FY21 bill provides $23.395 billion in discretionary funding which is $217 million above the FY20 level. Some highlights include:

• $730 million in the expansion of broadband service
• $6 billion in funding for Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
• $25.1 billion for child nutrition programs. This is $1.5 billion above the FY20 enacted level and covers free or reduced-price school lunches and snacks for qualifying children, $552 million for the Summer Food Service Program, $42 million for the Summer EBT program, $30 million for school kitchen equipment grants, and $21 million for the WIC farmers market nutrition program.
• $114 billion for Supplemental Nutrition Assistance Program (SNAP). This fully funds participation as well as the SNAP enhanced allotments authorized by the Families First Act.

Food and Drug Administration (FDA)

The FDA receives a total of $3.2 billion in funding, $43 million above the FY20 enacted level. Within this total, Congress provides increases for medical product and food safety activities, including new initiatives to advance new influenza vaccine manufacturing technologies and leverage emerging technologies to monitor food and medical product safety. It also increases funding for the safety and cybersecurity of medical devices and appropriates $70 million to accelerate medical product development as authorized in the 21st Century Cures Act.

COVID-19 Health Disparities

Black, Asian, Native American and Hispanic patients die far more often than White patients, even as death rates have plummeted for all races and age groups, according to a Washington Post analysis of 5.8 million coronavirus patients’ records from early March through mid-October. Death rates overall have fallen more than 80% from the pandemic’s peak in the spring, according to the CDC, but losses among racial and ethnic minorities remain disproportionately large. Black Americans were 37% more likely to die than Whites, after controlling for age, sex and mortality rates over time. Asians were 53% more likely to die; Native Americans and Alaskan Natives, 26% more likely to die; and Hispanics, 16% more likely to die. The shortage of testing in communities of color still persists to this day. However, concerted efforts have resulted in progress. For example, Michigan’s Lt. Governor Garlin Gilchrist formed one of the nation’s first state racial disparities coronavirus task forces in April, consisting of 23 community organizers, doctors and other experts. Five months later, Black residents who in April accounted for 29.4% of cases and 40.7% of deaths dropped to 8% of cases and 10% of deaths in September.

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NIH’s RADx

NIH expanded research to improve COVID-19 testing among underserved and vulnerable populations by awarding nearly $45 million to expand the research network of the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) program, adding 20 institutions and seven states and territories. RADx-UP aims to support effective approaches to improve COVID-19 testing of populations disproportionately affected by the disease, including African Americans, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated. This second round of awards brings the total investment in the RADx-UP program to more than $283 million at 55 institutions across 33 states and territories and the Cherokee Nation. RADx-UP is part of NIH’s Rapid Acceleration of Diagnostics (RADx) initiative which aims to speed innovation in the development, commercialization and implementation of technologies for COVID-19 testing.

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Hospitals Stretched Thin

In one week alone mid-November, 20% of American hospitals anticipated a critical staff shortage within seven days, according to the Health and Human Services Department. This record high ratio reflects the surge in cases as patients flood facilities for the third time since the pandemic began. North Dakota, Missouri and Wisconsin reported the highest share, each with nearly half of its hospitals needing medical staff as of November 18. Resources face additional strain by the resumption of elective procedures and an influx of patients who had delayed care earlier in the year. Finally, the anxiety, isolation and disruption of routines and support has exacerbated mental health conditions, increasing demand on health care professionals as well.

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BARDA

BARDA recently announced a new type of public-private partnership, BARDA Ventures that will realize authorities granted in the 21st Century Cures Act to utilize venture capital (VC) methods and practices. This will be the first time HHS has utilized VC practices to make investments. As part of the new program, BARDA is soliciting proposals for an existing nonprofit partner to manage an investment fund that will support breakthrough technologies and create entirely new approaches to enhance U.S. preparedness and response to threats, including COVID-19 and future pandemics. Over the past 14 years, BARDA has created many public-private partnerships with companies of all sizes and now is extending this approach to include partnerships with the private investment community.

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Biden Coronavirus Task Force

Biden’s Coronavirus Task Force is led by two veterans of fierce political fights in the past, former FDA Commissioner Dr. David Kessler and former Surgeon General Dr. Vivek Murthy, and a national leader in addressing health disparities who is Associate Dean at Yale, Dr. Marcella Nunez-Smith. Other members include Rick Bright, the former head of BARDA ousted by the Trump administration in April; Atul Gawande, the surgeon, writer, and recently departed CEO of Haven, the joint JP Morgan Chase-Berkshire Hathaway-Amazon health care venture; Zeke Emanuel, former Obama administration health policy adviser and Luciana Borio, a former FDA official and former Director of Medical and Biodefense Preparedness policy for the White House who worked for In-Q-tel. Murthy has said regardless of the lack of cooperation with the Trump administration they are doing everything they can to ensure that there are implementable plans on January 20, the day Biden is sworn in. The task force has also studied the rising incidence rates and found those regions that use mask mandates do better in terms of lower rates of infection spread, suggesting the likelihood of putting federal mandates are in place next year.

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Congressional Priorities

Given the Democrats taking the reins of the White House and at least one of the two chambers in Congress (maybe three, depending on the results of the January 5 Georgia run-off elections), some key health issues are likely to dominate the next year. These include:

• Coronavirus remains the top issue and Congress will address everything from vaccine distribution to BARDA funding to unemployment relief to online education with one million teachers leaving the field since March.
• Price transparency and an end to surprise billing is a priority as the October rule announced by CMS requires most private health plans, including group health plans and individual health insurance market plans to disclose pricing and cost-sharing information starting in 2021. The rule makes it easier for certain types of health plans to encourage patients to shop for services from lower-cost, higher-value providers by sharing the savings with patients. The rule allows health plans to take credit for “shared savings” payments in their medical loss ratio calculations, which can create incentives for health plans to encourage people to shop around for the best deal. While some legislation started to move in Congress establishing penalties for lack of transparency, nothing got close to passage.
• Drug pricing proposals are expected as the Trump Administration issued two final rules on November 20 for the “most-favored-nations rule” first proposed in October 2018 and the “rebate rule” first proposed in January 2019. Following the House-passed HR 3 that pursues a similar path, the Senate balked. There is significant controversy in tying the U.S. to the lowest foreign drug prices. Biden wants to repeal the law prohibiting Medicare from negotiating lower prices with drugmakers and has expressed support for allowing people to import drugs from other countries and establishing an independent review board to limit launch prices for drugs that don’t have competing versions on the market. Biden favors limiting price hikes for all brand, biotech, and some generic drugs as a condition of participation in the Medicare program and the public option.
• Value-based care redesign is on-going and expected to continue. The Biden administration is likely to keep pushing VBC through voluntary approaches. Meanwhile new care and payment models designed to improve quality and reduce costs are changing the way providers practice medicine and how they are compensated for their services, thanks to state-initiated efforts that are in many cases taking a larger role in transforming the healthcare industry than the feds.
• National stockpile and global supply chain security are bipartisan concerns. Biden is likely to push harder on this issue and find ways to use the Defense Production Act and direct more funding to BARDA, which was stripped down when funds were redirected to Operation Warp Speed, and to domestic manufacturing for public health emergencies.
• User fees agreement for medical devices and therapeutics (MDUFA and PDUFA) expire September 2022 and the final draft for the next one beginning in 2023 is due March 21, 2021. The details are usually negotiated behind the scenes among the leading trade associations and the FDA before presented to Congress to tweak and move through committees. The process will consider legislation on laboratory developed tests (LDTs): the VALID (Verifying Accurate and Leading-edge IVCT Development) Act, which has the most support in Congress and was built on consensus over time to provide such diagnostic testing to relatively flexible FDA review and the VITAL (Innovative Testing in American Laboratories) Act, which would advance a new regulatory regime for the FDA to manage all diagnostics and create a public health emergency standard that has gained support due to the coronavirus crisis and FDA’s failure in making diagnostic testing widespread in early 2020. While policy riders are always promoted and debated during the process, the FDA has tried to rein in control of LDTs for decades and with the pandemic, it is likely legislation will be enacted in some form.
• Telehealth has emerged as a top issue during the coronavirus crisis and some 35 bills are pending in each chamber to advance this health care resource, especially to address the lack of access to care during the pandemic. The Telehealth Caucus expects to push significant legislation and more HHS, CMS and FDA regulations are expected during the next Congress to apply lessons learned the past several months in COVID telehealth practices that can help patients and clinicians longer term. Related, the COVID nursing homes crisis brought to light ways to use telehealth and how to enable better care so more agency oversight and legislative activities are expected here as well.
• Maternal health and health disparities have been brought to the forefront due to vocal members of Congress authoring legislation addressing the much higher infant mortality and maternal health morbidity rates among Black women as well as the glaring statistics and stories on health disparities making headlines throughout the pandemic. In talking with health policy staff for Chair Eshoo (D-CA) of the Health Energy and Commerce Subcommittee, G2G learned legislation is expected in this area next year.
• Cancer research funding and attention will make a big return with the inauguration of Biden, who led the Cancer Moonshot Initiative under President Obama and went onto create his own Biden Cancer Initiative to convene, call attention to and address gaps in the fighting cancer ecosystem. He will have strong support in Congress, as both chambers and parties have worked to increase funding for NIH and specifically NCI over the years.

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Committee Leadership

Other factors shaping 2021 are changing leadership positions. The new chairs include:

• Senate Finance Committee that oversees CMS and tax policy is likely Senator Mike Crapo (R-ND)
• Senate HELP (Health Education Labor Pensions) Committee that oversees health and education policy, including the Early and Secondary Education Act and Higher Education Act is likely Senator Richard Burr (R-NC)
• House Energy and Commerce Health Subcommittee Ranking that will write ACA reforms, telehealth and other health policies is likely Rep. Brett Guthrie (R-KY)
• House Appropriations Chair will be Rep. Kaptur (D-OH), DeLauro (D-CT) or Wasserman Shultz (D-FL) – all women
• House Appropriations Defense Subcommittee Chair is likely be Rep. Betty McCollum (D-MN) or Rep. Tim Ryan (D-OH)
• House Armed Services Committee Ranking Member will be either Rep. Mike Turner (R-OH) or Mike Rogers (R-AL)

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Biden’s Health Priorities

ACA – Regarding policy, Biden wants to strengthen Obamacare by expanding premium subsidies for ACA coverage to include people who earn more than 400% of the federal poverty level. He has also called for lowering how much a family can spend on individual market coverage to no more than 8.5% of its annual income. The current limit is 9.8%. Both of those proposals would require Congress to act and would likely see pushback from Republicans. While this could save people hundreds of dollars a month, it could also hurt the employer-sponsored health insurance market. Biden also wants a public option for those who can’t afford private coverage and lower the age for Medicare eligibility to 60 from 65. With Biden’s determination on this issue, the Supreme Court pending decision on ACA, and the many cracks in our health care system surfacing during the coronavirus pandemic, we can expect significant health legislative activity in the 117th Congress.

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FUNDING – Biden is committed to medical research not only due to his past leadership of the Cancer Moonshot, but due to the devastating impact of the coronavirus and many years in the Senate supporting NIH. The NIH estimates it has lost about $10 billion in research due to COVID-19 — nearly a quarter of its budget — and the CDC said it needs about $6 billion to distribute the vaccine. In response, the House included a new emergency funding line but the Senate has yet to agree to this line. In any case, funding for NIH is likely to keep rising over the next four years.

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LAWSUITS – The Biden administration will likely withdraw from several lawsuits the Trump administration is appealing, including state work requirements for Medicaid and regulations that allow health care providers to decline to treat LGBT people. The Health and Human Services Department under Biden also will likely halt the expanding availability of short-term health plans that don’t meet Obamacare requirements for minimum care for patients. In addition, there are 14 states that haven’t expanded eligibility for the low-income health program Medicaid, even though they’re allowed under the ACA to offer coverage to people at or below 138% of the federal poverty level. The Biden team will likely work to expand Medicaid, especially given the coronavirus crisis demonstrating the need to provide care to the most vulnerable.

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SCIENCE –Biden has vowed to listen to scientists, embracing public health measures such as a push to encourage wearing masking nationally. Career scientists at the CDC, such as Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases, who held weekly press calls and was informing the public on the crisis to come when suddenly forced to adopt a low profile during the Trump administration, would likely re-emerge as the leading voices on responding to COVID-19. NIAID Director Fauci and former BARDA Director Rick Bright will all play key roles. Also, the Operation Warp Speed effort will continue as the Biden administration will work to distribute millions of vaccines. It is unclear if Biden will replace FDA Commissioner Stephen Hahn and Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research during this critical juncture in the coronavirus response.

Covid-19

About 331,000 new coronavirus cases were recorded last week — an eight-week high — underscoring the economy’s inability to fully return to its pre-pandemic strength without a vaccine. The proportion of Americans dying from coronavirus infections is the highest in the developed world, according to a study of global mortality rates. Covid-19’s sweep across the Midwest and West is largely responsible. The hardest-hit states, based on trailing one-week new cases per capita, are now North Dakota, South Dakota, Montana, Wisconsin and Utah, according to the most recent data from Johns Hopkins University and hospitalizations are on the rise in all five states.

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Covid-19 Vaccines and the FDA

Last week, the president criticized FDA Commissioner Stephen Hahn, after the agency pushed through new guidance that will raise the bar for a vaccine authorization and likely delay vaccines approval before election day. The FDA appeared to end a standoff with the White House over the enhanced standards, publishing them as part of a set of instructions to vaccine makers. The White House, which had held up the guidance for two weeks, approved it hours later for official release. That marked a victory for the FDA’s career scientists, who had pushed for releasing the stricter guidelines in hopes of reassuring the public that authorization of a Covid-19 shot would be guided by science, not politics.

This year, thousands of researchers in more than 30 countries have been collaborating and competing on more than 600 projects to develop a vaccine against the novel coronavirus. Authorities in China and Russia claim to be near the finish line, but researchers elsewhere are skeptical. Decisions by AstraZeneca Plc and Johnson & Johnson to pause testing on their promising candidates, both after one person got sick, highlighted the risks. Normally, the process of bringing a conventional vaccine from inception to the finish line takes on average nearly 11 years with just 6% of experimental vaccines crossing the finish line. For Covid-19, the shortcuts being used include:

1. Using innovative vaccine designs – About a fifth of the Covid-19 vaccine projects rely on gene-based technology that use the body’s own cells to produce proteins that trick the immune system into reacting as if it’s been invaded by a pathogen, training it for the real thing. These experimental vaccines can be made more quickly than conventional ones, which contain an inactivated or weakened version of a pathogen, or a piece of it. Moderna Inc. and the U.S. National Institute of Allergy and Infectious Diseases began the first human test of this version of a vaccine a record-short 66 days after Chinese researchers made public the coronavirus’s genetic sequence. However, no gene-based vaccine has yet been licensed for humans, although a few are in use in veterinary medicine.
2. Compressing steps – Moderna was able to move so quickly because it tested its vaccine in animals and humans simultaneously. For Covid-19 vaccines, U.S. and European regulators in March waived the requirement for proving efficacy in animals first.
3. Building on past work – Oxford researchers got a jump by betting on a method they’ve used in their ongoing work on a vaccine against Middle East respiratory syndrome (MERS), which is caused by a related coronavirus. That vaccine appeared to be safe in animal and early human testing. The technique uses a modified cold virus as a harmless carrier to expose the immune system to the spiked protein that projects from the surface of a coronavirus rather like a crown, hence the name.
4. Skipping Placebo Results – For the final stage, researchers typically give a vaccine to one group of volunteers and a placebo to another, then see if significantly fewer in the first group develop the targeted infection. A quicker but riskier alternative is to inject volunteers with the vaccine, then deliberately expose them to the pathogen. Such trial designs have been used in human tests of cholera, malaria and typhoid shots as well. Some prominent scientists argue that the urgency of a Covid-19 vaccine justifies their use now, but others disagree.

As for manufacturing, Johnson & Johnson, Sanofi and Moderna are scaling up production facilities already and philanthropist Bill Gates, is committing funds to the worldwide manufacturing effort. As for distribution, a collaboration called COVAX – led by the Oslo-based Coalition for Epidemic Preparedness Innovations, the World Health Organization and Gavi, a global non-profit group focused on vaccine delivery – aims to raise $18 billion from high- and middle-income countries to invest in developing and manufacturing the five to ten most promising vaccine candidates and ensure access for those at greatest risk across the globe, not just because it is ethical but also vital to ending the crisis.

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Covid-19 Testing and Emergency Use Authorization

On October 2nd, LabCorp received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new molecular COVID-19 testing method that uses heat and technology to extract RNA from COVID-19 samples. It is the first corporate laboratory to receive an EUA for this technology. The innovative heat extraction technology aims to improve the speed and efficiency of RT-PCR tests. The extraction process traps viral particles, thereby eliminating the need for RNA extraction reagents, and streamlines resources and reduces the time to complete and report results.

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Drug Pricing Hearings

The Government Reform and Oversight Committee held a two-part hearing on unsustainable drug pricing. The first of a two-day hearing on September 30 at which executives from Celgene, Bristol Myers Squibb and Teva Pharmaceuticals testified; Bristol Myers Squibb recently bought Celgene, and former Celgene CEO Mark Alles testified. The investigation and hearing covered the drug pricing issues we have heard in the press numerous times as well as revelations from internal company emails about the role of price hikes in executive compensation and thwarting competing drug development, which runs counter to industry arguments that high prices fund new drug research. Internal Celgene emails show executives hiked prices of Revlimid primarily to meet company revenue and shareholder earnings goals. In 2014, then-CEO Mark Alles called for an emergency price increase for Revlimid to meet quarterly revenue targets. That email feeds into another point that House Democrats drove home: prices are far higher in the United States than in other countries and it’s easy to raise prices here when companies need the extra cash. Documents obtained by the committee also show executives would not have received bonuses had they not raised Revlimid’s price. More than half of the bonus formula was based on meeting yearly revenue and earnings targets, according to the report. For decades, the drug industry has said curbing drug prices will impede future inventions. However, when Celgene executives outlined a plan in 2016 to increase Revlimid’s price by 40% over six price hikes between 2017 and 2019, the executives cited clinical trials involving Revlimid to justify those price hikes, but more than half of those were funded by an entity other than Celgene. Rep. Carolyn Maloney (D-NY), the Chairwoman of the Committee on Oversight and Reform, and many of her colleagues remain determined to continue to publicly press pharmaceutical companies, but no legislation is expected until next year.

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BARDA Shake-Up

Rick Bright, the ousted BARDA chief stepped down from NIH on October 5, alleging that he'd been deliberately idled in his new role at NIH and complaining that Director Francis Collins' "timidity" had effectively blocked his new plan for a national Covid-19 testing strategy. This follows Bright’s abrupt transfer in April to NIH after HHS officials suspected he was the source of a critical media report about the administration's hydroxychloroquine strategy, which Bright later confirmed. Bright subsequently filed a whistle blower complaint alleging that he was being punished for raising concerns about hydroxychloroquine, the drug favored by President Trump to treat the coronavirus despite scant evidence. Bright then testified to a House panel in May and did several media appearances to speak out against the administration's handling of the pandemic. His criticism continues to bother the administration and alarm scientists and public health professionals.

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BARDA Milestones

Amidst this controversy, BARDA announced BARDA milestones: 55 FDA Approvals, Licensures, and Clearances since 2006; 15 diagnostic Emergency Use Authorizations for SARS-CoV-2 product candidates; over 3,800 market research submissions to the BARDA TechWatch/CoronaWatch program and 510 CoronaWatch meetings this year. These market research efforts enabled BARDA to invest over $15 Billion in COVID-19 funding, either directly or through our interagency partnerships. While COVID-19 may have had the spotlight, important work continued across traditional health security focus areas to prepare for pandemic influenza, CBRN threats, and innovation programs under DRIVe. These programs resulted in over 360 contracting actions and the investment of over $1.95 billion in funding. While BARDA has run out of funding, the Operation Warp Speed continues to advance vaccine and therapeutic work. Also, the annual BARDA Industry Day is coming up on October 27. The G2G team will be attending the virtual event.

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Racial Disparities and NIH

With Covid-19 hospitalizations for minorities five times higher than white Americans, the NIH will pour more work into eliminating health disparities, according to Director Francis Collins. Calling Covid-19’s impact on minorities, especially African Americans, a big wake-up call, Collins committed to going deeper and being more thoughtful than ever before in terms of addressing these health inequities and health disparities. He said this has nothing to do with genomics and everything to do with access to health care and to resources. Covid-19-related hospitalizations for Black, Hispanic, and Native American populations are about five times higher than white Americans, according to Centers for Disease Control and Prevention data. Black Americans account for 13% of the population but more than 20% of Covid-related deaths in the U.S. and are dying at 2.3 times the rate of white Americans, according to the COVID Tracking Project. The agency’s 27 institute directors have met with Collins six times since June to discuss what the NIH should be doing on a deeper level and are working on building on progress made over the last several years to recruit and retain scientists from diverse backgrounds, the National Cancer Institute’s training and career development program to improve diversity in cancer research, and existing community engagement efforts to expand point-of-care testing in communities. Finally, the NIH recently announced $234 million in grants to make testing more accessible in underserved communities.

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Medicare Tops 1 Million Covid-19 Patients

With more than one million Covid-19 patients costing $4 billion in hospital expenditures, the pandemic is making a significant impact on seniors. More than 178,000 Medicare enrollees have been hospitalized for Covid-19 and traditional Medicare spent $4.4 billion in 2020 to do so. As of today, more than one million Medicare beneficiaries have contracted the disease. With nursing homes and long-term care facilities taking the majority of the brunt of the virus since March, the administration has focused on distributing Covid-19 testing capabilities to these locations and included performance incentive dollars to drive reductions in cases and better response systems. This will continue to be a focus in addressing the pandemic.

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Digital Health

On September 30, the FDA announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The center will be an important step in furthering the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device (SaMD), wearables used with medical devices, and technology used to study medical products. The goal is to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S. to provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings, according to FDA Commissioner Stephen M. Hahn, MD. This is part of its effort to modernize policies and regulations, as well as providing efficient access to specialized expertise, knowledge, and tools in accelerated access to digital health technology.