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Acting FDA Commissioner

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.”

Source: Sharon Begley, “STAT”

 

 

 

Lower Cost Insulin Coming

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.

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.

Doing More Harm Than Good

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.”

Source: Morgan Haefner, Becker’s Hospital Review.

Innovation by Ambulance

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.

New to Medicare: Some DNA Tests

“The CMS announced Friday that it will cover diagnostic laboratory tests using gene sequencing technology for Medicare cancer patients.

“The CMS said the tests — called next generation sequencing — can help patients and their oncologists make better treatment decisions as well as help more patients enroll in clinical trials. Patients with recurrent, metastatic, relapsed, refractory or stages III or IV cancers will be eligible to get the tests covered under Medicare, according to the agency.

“‘We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,’ said CMS Administrator Seema Verma in a statement. ‘That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.’

“The CMS’ decision to cover such tests comes shortly after the FDA’s recent approval of Foundation Medicine’s genomic profiling test called FoundationOne CDx. The CMS worked with the FDA to review the effectiveness of the test.” Source: Maria Castellucci, Modern Healthcare.

Changes in Cardiac Device Coverage

CMS, the Centers for Medicare and Medicaid, has finalized its changes to its Medicare coverage of implantable cardiac devices, which should reduce the wait-times required to get the implantation procedure done and cut the regulatory burden for providers that use the devices for their patients.

This “is the first major change to Medicare’s implantable cardioverter defibrillator, or ICD, coverage in more than a decade. The CMS wants to reduce some of the barriers to care outlined in its most recent coverage determination, issued in 2005.

“The CMS is eliminating waiting periods for device implantation and dropping a policy that requires patients to be tracked in a registry.”

“It is also requiring shared decision-making, which the agency said would empower patients…

“The agency is also looking to hasten access to ICDs by allowing patients with an existing ICD who suffer a heart attack or undergo a coronary revascularization procedure to obtain a replacement device without waiting. Previously, the devices could not be implanted within 40 days of a heart attack or 90 days of bypass surgery or angioplasty…

“ICDs have been used since the 1980s, and the CMS began covering them in 1986. Initially, they were mostly used in patients with recurrent cardiac arrest who were not responsive to drug treatments. In 2005, the agency finalized coverage for primary prevention of arrhythmia.

“The devices are wired to the heart and deliver an electric shock if they detect an abnormal rhythm. They are a significant revenue driver for hospitals. It’s estimated that 10,000 ICDs are implanted every month, and the average hospital stay after placement is eight days. That generates an average of $12,423 in hospitalization costs per patient.”
Source: Virgil Dickson, Modern Healthcare.

CMS: “Patients Over Paperwork”

CMS Administrator, Seema Verma,  has announced the initiative to ease the burden of records and reporting management in medical pracctices.  Nationally, medical providers and staff typically spend a disproportionate amount of time on maintaining medical records in comparison to actual patient care.

“On a typical day, primary care doctors spent about 27% of their time on “meaningful patient care” and about 49% on administrative activities, he said, according to a 2016 study published in Annals of Internal Medicine.”

The new initiative, “Patients Over Paperwork,”  seems to be set to review current regulations and eliminate those that may not be adding to quality of care, or possibly unnecessary altogether.  The coming steps to be taken have the potential, in the long run, to lower today’s healthcare costs, increase efficiency and benefit both the healthcare industry and the people in America directly.  Source:  Medpage.

Approved! Glucose Monitor: No Sticks

In what could be the a huge relief for millions in America with Type 1 or Type 2 diabetes- the FDA has approved the first glucose monitor that doesn’t require a person to stick themselves with a needle daily, or regularly, to keep an eye on their blood sugar levels.  This is a major advancement in the healthcare industry because of the potential ease of use, the lack of additional durable medical equipment like testing strips and needles.   Not to mention that this has the potential to monitor glucose over time more accurately than just taking a one-moment-in-time kind of measurement.  For more details click here.

1ST EVER: Less Than Half of Docs Own Their Practices

According to a study by the American Medical Association only 47.1% of practicing physicians had an ownership stake in their practice last year. This is the first time in American history that less than half of physicians owned their practices. Many factors were cited as reasons for the change, and among them were the market effects of payment models, information technology requirements, compliance costs, etc. Source: Modern Healthcare.

Update: Non-Profit Hospitals

A study using 2016 data has shown that charity care provided by non-profit hospitals in America equals anywhere from 0.46% to 16.69% of a hospital’s expenses.   These figures reflect uncompensated care and losses from care given to Medicaid-covered patients.  These figures do not include bad debt, or write-offs from patients who do not pay.

Among the Top 20 hospitals, by revenue, the average amount of charity care provided is 5.21% of expenses.   Source:  Modern Healthcare.