Raphael Stevens

Mina De La O | Digital Vision | Getty ImagesDr. Anand Shah is an oncologist and the former deputy commissioner at the FDA and the former chief medical officer at the Center for Medicare & Medicaid Innovation. He’s also an advisor to Morgan Stanley.Navigating public and commercial health insurance to get innovative medical products covered can be a never-ending cycle of bureaucracy. Medical technologies deemed “safe and effective” by the Food and Drug Administration – the global gold standard for drug and device regulation – aren’t always covered by the Centers for Medicare & Medicaid Services, which requires companies to meet the additional hurdle of proving their product is “reasonable and necessary.” Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can’t access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years — requiring additional data and a lengthy regulatory process to determine coverage criteria — and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime.A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a short period of guaranteed Medicare coverage — granted as early as the day of FDA authorization.The proposed policy would be a crucial step forward for Medicare beneficiaries to make informed choices about their care.As it stands, the FDA has approved, authorized or cleared at least 26 breakthrough diagnostics and devices. These medical products include in vitro diagnostics and imaging platforms to implants and portable devices, covering a range of ailments, including Ebola, traumatic brain injury, severe emphysema, and heart disease. As an oncologist who helped develop this medical device policy while at CMS, I have cared for many patients who have been unable to access cutting-edge testing, such as next-generation DNA sequencing as part of a cancer workup because Medicare does not allow it. The same product can often be obtained by the patient through commercial insurance, which many forgo after aging into the Medicare program. As a last resort, the patient has no choice but to pay out of pocket.Seniors deserve access to FDA-designated breakthrough medical devices – narrowly defined by Congress to include the most promising new technologies, like those that can treat life-threatening or irreversibly debilitating conditions – as soon as the FDA deems them safe and effective. Importantly, the proposed rule maintains the same high standards required by both the FDA and CMS. It also maintains existing FDA post-market surveillance requirements. This policy closes the gap for patients who otherwise can’t get access the latest FDA-authorized technologies while waiting for CMS coverage. Yet it still encourages researchers to continue to collect real-world evidence on health outcomes specific to Medicare beneficiaries. Protections for patients are maintained as MCIT uses existing procedures to restrict access to new technologies if safety or efficacy concerns arise.There is no downside to approving this policy change. Seniors will have more treatment options available to them, and medical technology innovators can work with CMS to carefully study these patients over four years, generate meaningful real-world evidence to prove a new device is “reasonable and necessary” and potentially secure a more permanent Medicare coverage decision. This policy also encourages early investors to support innovation for the most pressing medical conditions as it creates a clear and predictable path — from investment to medical product development to regulatory review and then patient access.If the federal government wants to incentivize investment for the development of transformative medical innovations, and expand choices for our seniors while encouraging rigorous evidence generation, MCIT provides a clear path forward. Too many lives depend on it.Correction: This editorial was updated to correct the name of the agency that needs to approve the rule in the headline. It’s CMS. More

In this articleKSnacking habits consumers picked up during the pandemic aren’t going away.Kellogg, the owner of Pringles and Cheez-its, is actually seeing snacking accelerate.Shares of Kellogg jumped more than 7% in midday trading Thursday after the company topped Wall Street’s earnings estimates and raised its full-year outlook. Despite last year’s pantry stockpiling, the company’s net sales rose 5.1% year over year to $3.58 billion.Strong demand for its snacks helped drive the quarter’s sales growth. In North America, Kellogg saw organic revenue of its snacking division rise 3.5%.”Snacking has not slowed down. In fact, snacking has sped up, so we believe in choice at Kellogg,” CEO Steve Cahillane said on CNBC’s “Squawk on the Street.”Other companies, such as PepsiCo and Mondelez, have also reported that consumers are maintaining their pandemic snacking habits, even as states reopen their economies.Cahillane said the company is seeing bifurcated eating trends from consumers. While some are trying to eat healthier by buying plant-based products from Kellogg’s MorningStar Farms, others are turning to more indulgent options. More

In this articleFLWS1-800-Flowers CEO Chris McCann said Thursday the company can ride out global shortages in flowers and berries.”Farms not knowing how to plan for this year, cut back and it is causing a bit of contention,” McCann told CNBC’s “Squawk Box.” “That, coupled with some weather conditions, has caused the challenge that we see in the floral industry today.”After low demand for flowers and berries this time last year, farmers cut back on planting those crops leading to global shortages this year. Despite shortages, 1-800-Flowers is confident its local florists have enough supply to meet this year’s Mother’s Day demand.”Fortunately because of the size and the scale that we have and the size of the relationships we have in the growing community, we are able to manage through this and, in fact, help many of our local florists to get the supplies they need to give us the anticipation of a very successful Mother’s Day holiday this year, McCann said.It’s the same for its berry supply. “We’re ahead of the curve there and we don’t see that impacting our Mother’s Day holiday either,” McCann said.At the beginning of the pandemic, demand for fresh berries fell largely due to restaurant closures, so suppliers cut back on berry production in anticipation of low demand this year. Then, demand for berries surged when Americans were stuck at home, creating a shortage.Soren Bjorn, president of the Americas division of Driscoll, the world’s largest berry company, told suppliers to increase their strawberry acres this fall, but those berries will not be available till next spring, according to the Wall Street Journal.But shares of 1-800-Flowers were down about 6% on Thursday. Its stock has gained nearly 23% this year, putting its market value at more than $2 billion.The flower giant said it was able to expand its customer base during the pandemic as more people shopped for gifts online and it anticipates continued growth for next year. 1-800-Flowers reported an unexpected profit last week, and raised its fourth-quarter forecast.”We’ve had this great growth momentum going into the pandemic, accelerated by the pandemic, it’s put us at a new level,” McCann said. “Our ability to manage this gave us the confidence to guide for Q4, which we are in now, a double-digit growth rate of 10-15%, on top of the 61% we grew last year.”The company also anticipates large growth for the next fiscal year, beginning at the end of this quarter.”We even guided double-digit growth last week for the next fiscal year,” McCann said. “Based on what we see this quarter, based on what we see the supply-chain challenge we have and based on what we see consumer confidence going forward. We think we’re just taking the business to a new level to grow from here.”One factor in its improved performance has been a turnaround at its Sheri’s Berries business since it was acquired in 2019.”We bought Sheri’s Berries about 18 months or so ago and it’s been a roaring success for us,” said McCann. “We took a company that was stagnant in growth, not making any money, we have it now growing nicely double digits.” More

Flames from a flaring pit near a well in the Bakken Oil Field. The primary component of natural gas is methane, which is odorless when it comes directly out of the gas well. In addition to methane, natural gas typically contains other hydrocarbons such as ethane, propane, butane, and pentanes.Orjan F. Ellingvag | Corbis News | Getty ImagesA landmark United Nations report has declared that drastically cutting emissions of methane, a key component of natural gas, is necessary to avoid the worst impacts of global climate change.The report, published Thursday by the Climate and Clear Coalition and the U.N. Environment Programme, represents a shift in the worldwide conversation on how to best address the climate crisis, which has focused on longer-term carbon dioxide reduction.Methane is 84 times more potent than carbon and doesn’t last as long in the atmosphere before it breaks down. This makes it a critical target for reducing global warming more quickly while simultaneously working to reduce other greenhouse gases.More than half of global methane emissions come from oil and gas extraction in the fossil fuel industry, landfills and wastewater from the waste sector, and livestock emissions from manure and enteric fermentation in the agricultural sector.The world could slash methane emissions by up to 45% this decade, or 180 million tons a year, according to the U.N.’s Global Methane Assessment. Such a target will avoid nearly 0.3 degrees Celsius of warming by 2045 and help limit the rise in global temperatures to 1.5 degrees Celsius, a goal of the Paris climate accord.The report comes after methane emissions surged to record highs last year despite worldwide lockdowns during the coronavirus pandemic, according to research from the National Oceanic and Atmospheric Administration. Methane emissions are also rising faster than ever since record-keeping began in the 1980s.”Cutting methane is the strongest lever we have to slow climate change over the next 25 years and complements necessary efforts to reduce carbon dioxide,” Inger Andersen, executive director of the U.N. Environment Programme, said in a statement.”The benefits to society, economies, and the environment are numerous and far outweigh the cost,” Andersen said. “We need international cooperation to urgently reduce methane emissions as much as possible this decade.”The fossil fuel industry has the greatest potential for reducing global emissions at little or negative cost by repairing leaks from oil and gas infrastructure, the report said. It added that companies that prevent leaks and capture methane could profit while curbing methane release.CNBC PoliticsRead more of CNBC’s politics coverage:Biden says the corporate tax rate should be between 25% and 28%Battle over tax hikes muddies GOP push to become the working class partyU.S. sends more firepower to the Middle East as troops leave AfghanistanRepublicans ramp up threats against Big Tech after Facebook ruling on TrumpThe report also pointed to the public health benefits of reducing methane, which is responsible for creating ground-level ozone, a dangerous air pollutant.The 45% methane emissions reduction would prevent 255,000 premature deaths, 775,000 asthma-related hospital visits and 73 billion hours of lost labor from extreme heat and 26 million tons of crop losses each year, according to the report.”We must tackle emissions not only from the energy sector, but also from landfills, agriculture, and abandoned coal mines,” Jutta Paulus, a Green Party member of the European Parliament, said in a statement.”Setting aside dedicated funds for these super-emitters will be well-invested money on the path to reach our climate targets in 2030,” Paulus said.A new study published in the journal Environmental Research Letters also said that cutting methane emissions from the oil and gas sector, agriculture and other human sources could slow global warming by as much as 30%.Oil and gas extraction, processing and distribution account for 23% of emissions, while coal mining comprises roughly 12% of emissions, the report said. Agriculture and livestock emissions from manure and enteric fermentation account for about 32% of methane emissions.CNBC has reached out to the American Petroleum Institute, the oil and gas industry’s largest trade group, and the American Farm Bureau Federation, a lobbying group for the U.S. agricultural sector, for comment on the U.N. report.Countries such as Russia, France and Argentina called for curbing methane emissions at the global leaders’ climate summit hosted by President Joe Biden last month.In the U.S., the Senate recently restored an Obama-era regulation designed to reduce methane emissions from oil and gas fields by requiring companies to monitor and repair methane leaks from pipelines, storage facilities and wells. More