Health

The latest news and legislative activity affecting healthcare and bioscience

November 24, 2020
Legislative updates

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.

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.

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.

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.

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.

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.

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)

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.

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.

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.

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.

October 13, 2020
Legislative updates

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.

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.

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.

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.

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.

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.

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.

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.

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.

August 18, 2020
Legislative updates

COVID-19

Operation Warp Speed – Vaccines

OWS continues to lead the Covid-19 response in developing vaccines and therapeutics under the leadership of Moncef Slaoui, former GlaxoSmithKline (GSK) vaccine head, former member of the Board for Moderna and current partner at Medicxi, a venture capital firm that invests in biotech companies, several of which are developing treatments or vaccines against the coronavirus. The Department of Health and Human Services (HHS) received two more complaints just last week for not subjecting the Slaoui to financial conflict rules due to the enormous contracts awarded to these companies.

On July 31, GSK and its partner French drug maker Sanofi secured an agreement of up to $2.1 billion to manufacture 100 million doses of its experimental coronavirus vaccine while clinical trials are underway, the largest such deal announced to date and includes an option for the government to buy an additional 500 million doses. In the agreement, Sanofi would be paid $1.7 billion for the vaccine antigen and GSK would be paid $342 million for its adjuvant that boosts the immune response to the vaccine. Also, on July 31, the government awarded Moderna a $1.525 billion contract to manufacture 100 million vaccine doses with the option to increase the contract to cover 400 million doses, which is a follow-up to the previous $955 million BARDA contract – for a total of $2.48 billion. Of this total, $300 million depends on getting the vaccine either approved or authorized for emergency use by the end of January 2021. These announced contracts come less than two weeks after the government said it would pay Pfizer and BioNTech $1.95 billion to produce 100 million doses of their vaccine.

Some controversy surrounds Slaoui because while he is no longer employed by GSK and did sell about 155,000 shares in Moderna, worth an estimated $10-12 million in May, he remains a partner in Medicxi, which is investing in companies developing coronavirus vaccines and therapeutics. Also, he was hired for this role as a government contractor, and therefore, does not have to file ethics disclosures normally required of federal employees. Moreover, he is also allowed to keep his investments in drug makers, although any gain in GSK shares above an unspecified stock index will be donated to NIH research.

In any case, the OWS BAA is working to identify the best available projects focused on plasma and therapeutics. Specifically, for plasma states HHS-OWS is interested in state-of-the-art plasma collection within the US from people who have recently fully recovered from Covid-19 and are symptom free for at least 14 days to develop the rapid implementation of an FDA-approved plasma collection expansion capability IOT plan. Once the plasma is donated, it can be directly transfused into (up to three) patients or used to make potential plasma-derived medicines. NIAID Director Fauci recently touted the potential for monoclonal antibodies to serve as an early intervention to treat patients who are infected with COVID-19 but who have not gone on to have advanced disease where they require hospitalization.

The BAA for therapeutics states HHS-OWS is working on prophylactic/pretreatment and therapeutic pharmaceuticals that can be administered pre- or post-exposure. This will provide health care providers with appropriate pharmaceuticals, tools to diagnose and monitor response of casualties, and appropriate means to protect themselves from Covid-19. Overarching goal is the ability to demonstrate through human clinical trials, efficacy and safety of products that protect against COVID-19, including novel and previously unrecognized products. These tests would enable transition to the advanced developer with a decreased risk profile in taking these products through FDA licensure.

NIH Response to Covid-19 – Therapeutics

NIH launched two randomized controlled clinical trials to test multiple monoclonal antibody treatments for use against Covid-19. NIH’s two trials, both of which are part of the agency’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, test whether monoclonal antibodies can treat people with the virus in the inpatient and outpatient setting. FDA’s CDER Director Janet Woodcock is overseeing the studies. The first treatment tested in both trials, Eli Lilly’s LY-CoV555, is derived from an isolated antibody taken from the blood sample of a patient who recovered from Covid-19. The antibody was copied and then synthesized in a laboratory. The outpatient study, dubbed ACTIV-2, is a phase 2 clinical trial to determine whether monoclonal antibodies can shorten the severity of COVID-19 in patients who haven’t been hospitalized. Participants are randomly assigned to one of two groups; 110 volunteers will be assigned to the treatment group and 110 will be to the placebo group. Both groups will receive intravenous infusions of either the experimental treatment or saline placebo. Over a 28-day period, participants will attend clinic or at-home visits by clinicians to track their Covid-19 symptoms and give blood samples to help researchers understand how the therapy functions in the body. If there are no serious safety concerns and if the therapy meets other criteria, the trial will transition to phase 3 with up to 1,780 patients enrolled for a total of 2,000 trial participants.

The other NIH trial, known as ACTIV-3, is a master protocol designed to test multiple kinds of monoclonal antibody treatments in the inpatient setting. The primary endpoint is participants’ sustained recovery for 14 days after release from the hospital. The initial stage of ACTIV-3 will enroll approximately 300 volunteers who have been hospitalized with mild to moderate COVID-19 and have had fewer than 13 days of symptoms. Participants will be randomly assigned to receive an IV infusion of the treatment or a saline placebo. They also will receive standard care for COVID-19, including remdesivir. After five days, participants’ symptoms will be assessed along with their need for supplemental oxygen, mechanical ventilation or other supportive care. If the therapy appears to be safe and effective, the trial will enroll an additional 700 participants. It also will begin enrolling more severely ill participants, such as those with organ failure requiring mechanical support or COVID-19-associated dysfunction of organs other than the lungs.

NIH will also soon announce a third trial to assess monoclonal antibodies for prevention of COVID-19 in nursing homes. Eli Lilly issued a press release detailing the study for LY-CoV555, which will enroll residents and staff who live or work at facilities that have had recently diagnosed cases of COVID-19 and who are at high risk of exposure. The study will test whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through four weeks, as well as complications of COVID-19 through eight weeks. It is expected to enroll up to 2,400 participants.

Monoclonal antibodies are one type of passive immunotherapy that could be used against COVID-19. Convalescent plasma is another. Both are derived from the blood or plasma of recovered COVID-19 patients. However, monoclonal antibodies focus precisely on the neutralizing sites on the SARS-CoV-2 spike protein, whereas convalescent plasma contains a wide range of antibodies, according to a July 9 editorial in the journal BMJ. Some plasma antibodies are neutralizing, but many have off-target effects that can potentially contribute to tissue damage, the BMJ article says. During a JAMA interview NIAID Director Fauci said it’s still unclear whether convalescent plasma will work against the disease and still needs to be studied in clinical trials. Interestingly, four former FDA commissioners, Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb together wrote a recent Washington Post op-ed stating that convalescent plasma, if it works, could help millions of patients with Covid-19, but there needs to be a concerted effort to collect plasma and study it in clinical trials. They also said there needs to be new pathways for quickly advancing promising therapies while clearly determining whether they’re safe and effective to avoid wasting time on therapies that do not work or miss opportunities to collect and use data that informs on when treatment is beneficial. Thousands of COVID-19 patients have already been treated with plasma and ACTIV is standing up trials of promising treatments, but only a small number of Covid-19 patients are able to participate in plasma trials thus far.

In other therapeutic news, an NIH-funded study found 21 existing drugs have potential in treating Covid-19 patients and four of them, coupled with remdesivir (for which FDA granted Gilead Sciences emergency use authorization (EUA) on May 1 for Covid-19 treatment), can be repurposed to help block coronavirus infections. Researchers first did a high-throughput screening of 11,987 drug compounds for their potential to block SARS-CoV-2 in cells grown in the lab, which narrowed the list to about 300. Next, they narrowed the list to 100 compounds that could reliably limit the virus growth by at least 40% by using lower concentrations of the drugs in cells exposed to a second strain of SARS-CoV-2 since an effective anti-viral drug shows greater activity as its concentration is increased. Finally, they narrowed the field to 21 therapies, 13 of which, including remdesivir, were found to be potentially effective at doses that can be safely given to patients. The findings prompted researchers to identify four medications that could be administered with remdesivir to fight SARS-CoV-2 infections, with some reducing the number of infected cells by 65% to 85%, including apilimod, an autoimmune therapy, and clofazimine, used to treat leprosy.

Covid-19 Testing

The FDA just approved its first emergency use authorization (EUA) for a saliva-based Covid-19 diagnostic test called SalivaDirect that was created by the Yale School of Public Health (and partly funded by the NBA) and does not require any special swab or collection device on August 15 in the hopes of increasing testing capacity and reducing the current strain on testing equipment. The new test, unlike other saliva diagnostic tests, does not utilize a separate step for nucleic acid extraction. This means performing a test without specialized materials, such as swabs and collection kits, removes the reliance on nasopharyngeal swabs and nucleic acid extraction kits that are facing shortages. Plus, it makes the test much more pleasant than the nasal swab. The test is also self-collected, potentially lowering the risk of infection to health care workers collecting samples. The new test can be used with different combinations of common reagents and instruments, which allows the test to be provided broadly to any high complexity lab nationwide if they follow the EUA protocol.

The CDC plans to combine some of the Coronavirus Aid, Relief, and Economic Security (CARES) Act funding allocated by Congress with funds from the Paycheck Protection Program to send $12.1 billion to states to enable modernization of their systems and improve their integration with national systems. The agency plans to invest in contact tracing with software that will help contact tracers manage their cases or opt-in proximity tracing and exposure notifications with people’s phones. CDC Director Robert Redfield claims these tools can reduce the burden of data collection on public health staff by automating workflow, allowing electronic self-reporting by cases and contacts, and facilitating daily symptom monitoring. CDC still has not provided more explanation as to why the administration took the unprecedented move to send coronavirus information directly to HHS as opposed to the CDC.

Covid-19 Supplies

Despite reassurance of "excess" Covid-19 testing supplies from the White House, FDA revealed in its first medical device shortage list posted late on August 14 three shortage categories of Personal Protective Equipment, Testing Supplies and Equipment, and Ventilation-Related Products. Specifically, ventilators, surgical masks, testing swabs, gloves, gowns, and key testing chemicals called reagents are all on the list. The list is aimed at providing transparency to healthcare providers as the agency continues to monitor for disruptions to the US supply chain. The government is drawing up plans to distribute personal protective gear from its stockpile. The CARES Act added the requirement that the FDA provide an up-to-date, publicly available list of devices that are in shortage.

The DoD’s Joint Acquisition Task Force just awarded $104 million in contracts to procure syringes and safety needles for FDA-approved Covid-19 vaccine once one becomes available. Funded by CARES Act, in support of the HHS Strategic National Stockpile, the six companies awarded contracts include:

  • Duopross Meditech Corp.
  • Cardinal Health Inc.
  • Gold Coast Medical Supply, LP
  • HTL STREFA Inc.
  • Quality Impact, Inc.
  • Medline Industries, Inc.

Covid-19 Reimbursement

Medicare just announced it will boost reimbursements by 20% next month for beneficiaries with Covid-19. The payment bump takes effect on September 1 and will apply to all Medicare patients with Covid-19 who needed to be hospitalized, according to new guidance issued by CMS on August 17.

Covid-19 White House Science Adviser with National Impact

Scott Atlas is the new go-to adviser for President Trump on Covid-19. He is a conservative policy wonk and radiologist who was a fellow at Stanford’s Hoover Institution who did some eye-catching interviews on Fox before being plucked to join the administration in early July. He quickly established himself as a voice pushing for the resumption of daily activity. He advised, “Here’s the science … the risk to children from this disease for fatality, is nearly zero,” during a July 13 Fox News appearance, adding that kids don’t appear to significantly spread the virus. This contradicts several public health scientists. He also said, “Teaching is a young profession,” citing data that 90% of public school teachers are under age 60. Atlas has argued against expanded Covid-19 testing, including a proposal championed by White House coronavirus coordinator Deborah Birx to scale up home testing through methods such as saliva tests, and disagreed publicly with NIAID Director Fauci on universal wearing of face masks. As clashes and competition continue among Trump’s advisers and between Secretary Azar and CMS Administrator Verma, criticism from the Biden campaign, past Obama officials and their supporters is gaining momentum, attention and broader support. National polling is showing 9-10 point spread between Biden and Trump for the upcoming election. But the White House keeps working to regain control of the management and message regarding Covid-19 and the economy.

Nursing Homes Get Pandemic Relief

CMS announced it will resume all regular inspections of nursing homes, after postponing them earlier this year as nursing homes grappled with COVID-19 outbreaks and will give nursing homes an additional $5 billion for testing, staffing and protective gear as well as establishment of Covid-19 isolation wards with some of the new funding beiing performance-based, unlike previous distributions from the Congress-approved provider relief fund. Facilities will be evaluated based on the local Covid-19 infection rate and the nursing home’s ability to minimize infections and fatalities among residents. As of July 30, nursing homes and other long-term care facilities in 43 states reported 62,925 Covid-19 deaths, according to the Kaiser Family Foundation. That’s 44% of all Covid-19 deaths in those states. The first $2.5 billion will be distributed in mid-August, followed by additional performance-based payments throughout the fall. Linking payment to performance will be an effective means of holding nursing homes accountable, stimulating innovation, and encouraging them to reach beyond their own walls for infection control expertise and support is the thinking, according to Thomas Engels, administrator of the HHS’s Health Resources and Services Administration (HRSA).

CMS Spending on Genetic Testing

This month, the Health and Human Services Office of Inspector General issued a report finding that total Medicare spending for clinical diagnostic laboratory tests increased in 2018, despite lower payment rates for most tests. Medicare spent $7.6 billion for lab tests in 2018, a $459 million increase from $7.1 billion in 2017. The increase was mainly driven by higher spending for genetic tests, which more than doubled from $473 million in 2017 to $969 million in 2018. Although payment rates for 75% of tests decreased in 2018 under the new payment system, savings that resulted from lower rates were overtaken by increased spending on other tests, including genetic tests and certain chemistry tests. Spending on genetic tests doubled because of new and expensive tests entering the Clinical Laboratory Fee Schedule (CLFS), as well as an increase in the volume of existing genetic tests. Spending on certain automated chemistry tests, such as cholesterol, glucose or potassium also increased by $82 million in 2018 following the end of the Protecting Access to Medicare Act of 2014 (PAMA) discount on these tests. Finally, a one-time spending increase on some tests occurred in cases in which the national rate was higher than the local payment rates that it replaced.

While the OIG report concluded genetic tests can provide valuable information to providers and help to identify appropriate treatments for Medicare beneficiaries, it also warned that even a small number of inappropriate tests could expose Medicare to extremely high spending. The report said that as the spending on genetic tests and the volume of these tests continue to grow, oversight of these tests becomes more important. To address the ongoing risk to cost savings, OIG recommended that CMS seek legislative authority to establish a mechanism to control costs for these tests. CMS has not responded on this recommendation but said the $82 million in higher spending for automated chemistry tests represents about 1% of Medicare’s overall spending for lab tests in 2018.

Telehealth Expansion

On August 6, the House Ways and Means Committee rural health task force led by Reps. Terri Sewell (D-AL), Brad Wenstrup, MD (R-OH) and Jodey Arrington (R-TX) called for extending telehealth flexibilities beyond the pandemic, and some members stressed a need to add guardrails against waste, fraud and abuse. Meanwhile, some stakeholders warned the task force that telehealth is not the solution to long-standing structural challenges in health care. The members are trying to tackle the lack of certainty in reimbursement for telemedicine in a post-COVID-19 world that is stopping many from investing in related innovations. Prior to the pandemic, Medicare telehealth coverage was very limited. Many stakeholders have pushed lawmakers to make permanent the Medicare telehealth flexibilities instituted during the current public health emergency. CMS recently took some steps in that direction following President Trump’s August 3 executive order calling on CMS to make permanent some telehealth provisions allowed during the Covid-19 pandemic as well as authorize the Center for Medicare and Medicaid Innovation to create a rural health payment model, emphasizing telehealth flexibility for beneficiaries and providers in rural areas.

In early August, CMS Administrator Seema Verma met with rural healthcare providers and said CMS is examining the audio-only telehealth policy and the proposed rule would not continue Medicare codes for audio-only telehealth services. However, she wants public input on developing coding and payment for these services and is very interested in addressing rural healthcare needs. Some key areas to clarify are prioritizing value in telehealth, easing restrictions on site of service and geography, expanding providers and services, expanding care across state lines, protecting health data, and closing the digital divide to address health disparities and not exacerbate them, leaving behind underserved communities. At a minimum, many agree that Congress must remove the geographic restrictions on telehealth as well as the originating site restrictions and avoid adding more barriers, such as requiring an existing relationship between providers and patients. A significant number of people, especially among low-income and transient populations do not have a primary care doctor.

Antimicrobial Resistance

On July 9, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund that aims to bring 2-4 new antibiotics to patients by 2030 due to the rapid rise of antibiotic-resistant infections or antimicrobial resistance (AMR). The companies have raised $1 billion to support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. The AMR Action Fund includes pharmaceutical companies, philanthropies, development banks, and multilateral organizations. While the focus on the high death toll from the coronavirus pandemic dominates global attention, AMR has plagued patients for several years as it claims 700,000 lives per year with experts projecting that by 2050, AMR could claim as many as 10 million lives per year.

Many in the AMR Action Fund as well as PhRMA and BIO were disappointed with FDA’s new guidance on antimicrobial drugs released on August 5 due to the lack of detail in laying out a pathway to expedite antimicrobial drugs that treat serious or life-threatening diseases in limited patient populations. The Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) guide is very similar to the draft published in 2018 and is required by the 21st Century Cures Act despite industry calls for additional clarity and flexibility on eligibility criteria and clinical trials. Some clarity was provided regarding broad population and rare disease. In its 2018 draft guide, FDA said it would not consider a population to be limited solely based on the fact the infectious disease rarely occurs, but in its final guide, FDA says an antibacterial drug that would help prevent disease in a select patient population with no other options, such as mechanically ventilated patients, may be considered for the LPAD path. In contrast, a drug intended for broad population-level prevention of a rarely occurring serious or life-threatening disease generally wouldn’t be appropriate for the LPAD path. The purpose of the LPAD pathway, established by Cures Act, is to speed development of certain antimicrobial drugs by easing clinical trial requirements and imposing new labeling requirements while offering incentives to encourage companies to develop therapies for antimicrobial diseases. Many are skeptical these aims can be maximized under this guidance.