“The Food and Drug Administration is investigating dozens of reports of people who experienced seizures after using e-cigarettes.
“The agency announced Wednesday that it has received 35 reports of people suffering seizures after vaping between 2010 and 2019. Most of those cases were in adolescents and young adults. And while it isn’t clear whether there is a direct link between e-cigarettes and the seizures, health officials said they found the reports troubling.
“’While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases,’ FDA Commissioner Scott Gottlieb and Principal Deputy Commissioner Amy Abernethy said in a statement.
“Convulsions and seizures are known to be a potential side effect of nicotine poisoning, according to the FDA. The agency said it’s possible that some e-cigarette products make it possible for people to inhale a significant amount of nicotine quickly. E-cigarette users also might be inadvertently or deliberately inhaling more nicotine than normal. But the FDA said it’s also possible that other factors were behind the seizures.
“”We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure. We can’t yet say for certain that e-cigarettes are causing these seizures,’ Gottlieb and Abernethy said.
“A few of the cases also occurred in people who had a history of seizures or who were also using marijuana or amphetamines.
“Health officials are urging people who experience any health issues after using an e-cigarette to report the problem to a federal safety reporting portal. The FDA said more data might help the agency determine whether there is a link between seizures and vaping and if so, whether there are any common risk factors or e-cigarette designs that might be involved.” Source: Megan Thielking, “STAT”
“Centene Corp. has said it will buy fellow Medicaid insurer WellCare Health Plans in an estimated $17.3 billion deal.
“All in all, the two insurers would cover nearly 22 million people in Medicare, Medicaid and the ACA exchanges. Centene CEO Michael Neidorff will serve as chairman and CEO of the merged company.
“‘With the addition of WellCare, we expect to bolster and diversify our product offerings, increase our scale and have access to new markets, which will in turn, enable us to continue investing in technology and better serve members with innovative programs designed to meet their needs,’ Neidorff said in a statement.
“…It would include more than 12 million Medicaid beneficiaries and almost 1 million Medicare members, along with a Medicare prescription drug plan WellCare is acquiring from Aetna…
“Centene saw its ACA exchange membership swell to almost 2 million during the latest open enrollment, giving it about a 20% market share across the country. WellCare’s recent growth focused on Medicaid, where it has million members, thanks in large part to its $2.5 billion acquisition of Meridian Health Plan that closed in September.” Source: ModernHealthcare.
It has been announced that Ned Sharpless, the director of the National Cancer Institute, will be named the acting commissioner of the Food and Drug Administration next month.
“Health secretary Alex Azar confirmed the announcement at a hearing before the House Energy and Commerce health subcommittee.
“Sharpless, a physician-scientist, ran the Lineberger Comprehensive Cancer Center at the University of North Carolina before taking over the NCI in October 2017.
“’Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,’ Azar said in a statement. ‘There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.’”
“Sharpless was an enthusiastic supporter of Gottlieb’s aggressive push to increase tobacco and e-cigarette regulations.
It is uncertain “if Sharpless will lead the FDA in a long-term capacity, he was seen as a likely pick to replace Gottlieb. Sharpless is already well acquainted with the agency, Gottlieb said in a staff memo the FDA provided to STAT.
“One of the things that made me appealing to the White House was that in addition to working in research and as a cancer center director, I’d had some work in the commercialization of ideas, from a basic science lab into a Phase 2 trial asset,” Sharpless told STAT in a 2018 interview, shortly after taking over NCI.”
“Scott Gottlieb, MD, announced his resignation as chief of the FDA on March 5. He plans to leave his post sometime next month.
“Dr. Gottlieb has served in his post since May 2017, and has been a staunch advocate for developing new drugs and regulation. His resignation may especially affect biotech and pharmaceutical companies, as well as tech companies looking to move into the healthcare space.
“Before appointing Dr. Gottlieb, President Donald Trump considered a variety of candidates for the position, including individuals who sought to dismantle FDA drug oversight and review process — a move that worried many pharma executives and health sector investors, STAT News reports.
“‘I think Scott was pretty much a best-case scenario for the sector that one could see under a Trump administration, so any replacement is probably going to be worse. Hopefully not much, much worse,’ a Baird biotech analyst told STAT.
“During his time at the FDA, the physician and former venture capitalist also gained a reputation as a supporter of healthcare innovation, establishing programs like Pre-Cert, software that allowed tech giants like Apple to get approval for low-risk health products faster, CNBC reports.
“‘Scott did a lot culturally to make the agency easier to work with,’ Bob Kocher, a partner at venture capital firm Venrock, told CNBC. ‘I think he’ll be missed by many in the tech industry, including the startups.'” Source: “Becker’s Hospital Review”
3/4/2019. “Eli Lilly and Co., which has come under fire for the high cost of its insulin, announced Monday that it will introduce a version of one of its medicines to treat diabetes that will have a 50 percent lower list price
“Insulin Lispro, the same molecule as the Lilly insulin drug Humalog, will cost $137.35 for a single vial. The drug also will be available in a pen option and run $265.20 for a five pack of KwikPens.
“A Lilly subsidiary, ImClone Systems, will make the drug available as an authorized generic, the company said.
“David Ricks, Lilly chairman and chief executive officer, said in a statement that this price reduction alone would not solve the problem of the high price of prescription drugs.
“‘While this change is a step in the right direction, all of us in the health care community must do more to fix the problem of high out-of-pocket costs for Americans living with chronic conditions,’ Ricks said. ‘We hope our announcement is a catalyst for positive change across the U.S. health system.’
Insulin prices have skyrocketed in recent years. (Photo: Michelle Pemberton/IndyStar)
“As the price of insulin has soared in recent years, as many as one in four people who rely on the drug have had to ration their supply, according to a study in JAMA Internal Medicine.
“Both local and federal lawmakers have discussed ways to reform the system to make such drugs more affordable. The Indiana House unanimously passed a bill this session that would create a prescription drug pricing study committee.
“At the federal level, Congress also is exploring ways to tame the rise in prescription drugs. US Department of Health and Human Services Secretary Alex Azar, a former Lilly executive, has proposed ending the elaborate rebate system for drugs, which many experts point to as one of the sources for the price increase.
“‘For people with diabetes, a lower-priced insulin can serve as a bridge that addresses gaps in the system until a more sustainable model is achieved,’ Ricks said. Source: Shari Rudavsky, Indianapolis Star.
Several healthcare groups, including the American Hospital Association and Blue Cross and Blue Shield plans, have joined coalitions that oppose “Medicare for All” plans, according to The New York Times.
Three things to know:
1. While 2020 presidential hopefuls incorporate Medicare for All into their platforms, hospitals, physicians, drugmakers and insurers are lobbying against the idea and proposed legislation.
2. In June 2018, the Federation of American Hospitals, America’s Health Insurance Plans, and the Pharmaceutical Research and Manufacturers of America created a coalition to combat Medicare for All proposals. The lobbying group, the Partnership for America’s Health Care Fund, also includes the American Medical Association, the AHA and Blues plans, according to the NYT.
3. The AHA’s president and CEO, Rick Pollack, recently cautioned against Medicare for All proposals in a Feb. 22 blog post, writing that such legislation “could do more harm than good to patient care.”
Medicare wants to change how it pays for emergency ambulance services to give seniors more options besides going to a hospital emergency department, according to officials at HHS, Health and Humans Services, the federal agency the oversees CMS, the Centers for Medicare and Medicaid.
“Other options could include going to an urgent care center, a doctor’s office, or even treatment at home under supervision of a doctor via telehealth links
“It’s just a pilot project for now, but if adopted nationwide the idea could save Medicare more than $500 million a year and allow local fire departments and ambulance services to focus the time and energy of first responders on the most serious emergencies…
“Unveiling the ambulance proposal at a Washington, D.C., fire station, Adam Boehler, the innovation center director, said he was astounded to learn that under current rules Medicare will only pay for emergency ambulance services if the patient is going to a hospital, in most cases.
“‘I thought that was a joke,’ said Boehler, a former health care entrepreneur who ran a company providing in-home medical care to seriously ill patients. He called Medicare’s current policy a “ridiculous incentive” to funnel patients to the most high-cost setting. Most private insurance plans discourage emergency room use by imposing higher copays, and some state Medicaid plans are trying similar tactics.
“Appearing at the same event, the chief medical officer for the New York City fire department endorsed Medicare’s experiment. Dr. David Prezant said his agency is overwhelmed with non-emergency calls and transporting patients to a hospital is a time-consuming process that keeps ambulance crews needlessly tied up.
“‘If only 20 percent of our calls no longer required transport to an ED (emergency department), we would save lives in cases when every second counts,’ Prezant said. Associated Press.
Improvements in the cost of medications for Medicare-eligible customers may not be too far off. The Centers for Medicare and Medicaid (CMS) has proposed some new ways to lower drug costs for those in the Medicare program, and with drug coverage through a stand-alone prescription drug plan or with a Medicare Advantage plan that includes drug coverage.
One provision in the proposal targets e-prescribing and would require the person’s plan “to adopt a provider Real Time Benefit Tool by the start of 2020.
“‘RTBTs have the capability to inform prescribers when lower-cost alternative therapies are available under the beneficiary’s prescription drug benefit, which can improve medication adherence, lower prescription drug costs, and minimize beneficiary out-of-pocket costs,’ CMS stated.
Another provision of the CMS proposal is that drug coverage Explanations Of Benefits (EOBs) that people receive from their plans will be tasked with including drug pricing information and lower cost therapeutic alternatives as part of these EOBs to give customers the information in hand that can also potentially help them lower their out-of-pocket costs for their particular medications.
This is not a comprehensive list of the provisions of the CMS proposal which could become a set of new rules in the near future. However, we do want to get info about these two particular provisions out there, so everyone can have confidence in any changes to come and know there will be tangible things for American households coming that can help lower their drug costs.
The hospital price transparency rule takes effect on January 1, requiring providers to publicize their rates for all items and services.
“Starting January 1, 2019, hospitals will be required to post their price lists online in an effort to increase price transparency and empower consumers to make informed choices about their care.
“The mandate stems from the 2019 inpatient and long-term care hospital prospective payment system (IPPS/LTCH PPS) final rule, released in August, in which CMS included the requirement for hospitals to update their public price lists at least annually.
“‘The policies in the IPPS/LTCH PPS final rule further advance the agency’s priority of creating a patient-centered healthcare system by achieving greater price transparency, interoperability, and significant burden reduction so that hospitals can operate with better flexibility and patients have what they need to be active healthcare consumers,’ CMS wrote…
“While hospitals can choose the format for presenting the data, as long as it’s machine-readable, the list must include all items and services provided by the facility, CMS stated.
“‘CMS encourages hospitals to undertake efforts to engage in consumer friendly communication of their charges to help patients understand what their potential financial liability might be for services they obtain at the hospital, and to enable patients to compare charges for similar services across hospitals,’ the agency said.”
Source: Jennifer Bresnick, “HealthPayer Intelligence”