The bad news is obvious: COVID-19-related deaths have surpassed 200,000 and infection is still spreading rapidly, and a second wave this fall is all but certain. But there is important good news obscured by these grim facts: We have the tools to manage new outbreaks and more quickly develop treatments than at any other time in human history. 

Why? Because governments around the world, in concert with private philanthropies, universities and biotech industries, have invested over the past decades in science: epidemiological models of pandemics, molecular studies of viruses, and strategies to develop and deploy new technologies to treat emerging threats. It is also because there are protocols for well-scripted, meticulously-controlled clinical trials to yield safe and effective treatments and vaccines. 

To best position us for a second wave this fall and winter, we need to stay the course and stick with the scientific process. In the case of COVID-19, the catch is that we still lack ample and reliable data. And it is precise data — carefully, rigorously, scientifically attained — that is the key to minimizing further loss of life and damage to the economy. If we proceed without the right data, in a mad dash to complete this process quickly, we’re likely to fail. 

Read Entire Article - https://thehill.com/opinion/healthcare/496421-data-driven-science-is-the-only-way-to-beat-covid-19?fbclid=IwAR0pBt3RHwED7BgBQZ5jTEPMauwXh0-j3v5ROh8P82hQBcUlD1E-c-OJMWw#.XrnGld5uJSc.facebook

Legislation recently proposed by the House of Representatives risks sending the wrong message to pharmaceutical drug developers. Intended to curb the growing costs of drugs, the process proposed in the legislation isn’t really a negotiation.

It amounts to price control and all its consequences. As it is written currently, the law will most likely curtail investment in personalized medicines (when medical treatments are tailored to each person’s unique molecular and genetic profile), cutting edge cell therapies, gene therapies and many other treatments that improve the lives of Americans.


The new law would give the federal government the power to negotiate the price of several hundred drugs for Medicare. Participating companies would be required to also provide the federally “negotiated” price to private customers outside of Medicare.

The drugs selected for the price “negotiation” would meet two criteria: They would have fewer than two generic competitors, and they would be among the most expensive ones in the Medicare program. This includes new cures, most personalized medicines, cancer therapies, the treatment of rare diseases and cell-based therapies.

The maximum price for specific medicines would be based on prices paid by selected other governments. Should the pharmaceutical company walk away during negotiations, it would be assessed a fine equal to 75 percent of its entire U.S. sales.

This legislation may well make today’s medicines less expensive and more accessible but at a huge cost. Large pharmaceutical corporations would likely take the “negotiated” prices on the drugs they already have developed. Smaller biotech firms, which often depend on larger drug companies to co-market and commercialize their drugs, would struggle to remain viable.

Research and development investment would flow to companies working on medicines in therapeutic areas where there are already established generic treatments, as these would be outside of the scope of “negotiation.” There are thousands of diseases with no medicines at all to treat them, and this legislation would direct drug companies to not pursue treatment for those patients. This bill should be called the “The Me-too Drugs Investment Act.”

There are numerous examples of drug companies making price concessions today for medicines without generic alternatives — including those for hepatitis C, vaccines, HIV, insulins and cancer therapies — both in the United States and globally. While these private price negotiations may not lead to the low prices that could be established by federally enforced price control, they also have less of a deleterious effect on the supply of treatments.

You can’t force companies to invest in making life-changing medicines when they don’t see a market for them — they just won’t do it. Once companies exit a therapeutic area, it is very difficult to get the research started again.

Today, this is the case with antibiotics. There are more and more medicine resistant infections and fewer drugs being developed to treat them. You can’t haggle over the price of a medicine that was never made.

When in our history have we seen price controls stimulate growth, creativity and improved products? Federal programs set prices for physician and hospital services, and we see upcoding (when a bill is inflated by charging for a more expensive procedure than was performed), consolidation and other similar behavior. It just isn’t possible to force people to do exactly what we want them to do for the price we want.

It is a fallacy that only government price setting can lower the cost of drugs that have no generic competition. Insurance health plans have the power to limit the use of new drugs or, conversely, remove barriers when drug companies offer price concessions.

There are other possible changes to the Medicare drug program that would foster greater savings for expensive medicines. Requiring drug and health insurance companies to subsidize higher drug costs for Medicare beneficiaries is a better approach, for example (as described by MedPAC).

Passing laws is a long process, so while this legislative proposal is unlikely to be enacted exactly as currently written, it sends a negative signal to those willing to invest in new pharmaceutical drugs. It warns them not to invest in companies developing drugs with no generic equivalent, and it encourages them to invest in drugs for diseases where there are already treatments.

The current system is flawed, but it can be fixed. It should not be completely thrown away and replaced with something worse.

Kirsten Axelsen is a visiting fellow at the American Enterprise Institute, where she focuses on domestic and international pharmaceutical policy, and she is also a health innovator fellow at the Aspen Institute and previously worked for Pfizer.

https://morningconsult.com/opinions/you-cant-haggle-over-price-of-medicine-that-was-never-made/

A new analysis from Avalere looked at how access to medicines in Part B may be impacted if the government only covered a certain list of medicines, an approach known as applying a national formulary. Unlike Medicare, the U.S. Department of Veterans Affairs (VA) uses a national formulary, and Avalere compared coverage for physician-administered medicines available to veterans through the VA with the 50 medicines with the most spending in Medicare Part B, excluding vaccines. The analysis revealed that only 26 of the Part B medicines – only half of them – are available to veterans through the VA’s national formulary.

For seniors with complex diseases like cancer, rheumatoid arthritis and autoimmune conditions, disruptions in care that would result from a shift to a national formulary could be life threatening. In fact, in 2017, about 1.3 million Medicare Part B beneficiaries took medicines not covered by the VA. These beneficiaries would likely be forced to switch treatments under a government-imposed formulary in order to have their treatment covered. Rather than being forced to switch treatments, many veterans have chosen to pay for supplemental insurance coverage when their medicines are not covered by the VA’s national formulary.

To set its national formulary, the VA is permitted to rely on cost effectiveness analysis. In conducting these assessments, the VA relies on data from internal analyses, as well as outside sources such as the Institute for Clinical and Economic Review (ICER), which often ignore important patient differences and have been widely criticized as discriminating against vulnerable groups, such as the elderly and disabled. These types of assessments are also relied on in the countries referenced in the International Pricing Index (IPI) model to determine government-mandated prices for medicines. ICER has also been mentioned as a potential reference point for a government arbitrator who would set medicine prices.

As some in Washington explore options for government intervention in Medicare Part B – from government arbitration as proposed by the Medicare Payment Advisory Commission to international reference pricing as proposed in the Administration’s IPI Model to creating a national formulary – it’s important to recognize the dangers and implications for seniors’ access to medicines. Given the wide range of treatment options covered today under Part B, any national formulary would cut back on the number of physician-administered medicines made available to seniors through the program.

There are right and wrong ways to change Medicare, and the right prescription for Medicare is one that helps patients. Proposals that could put patients at risk by allowing the government to restrict access to lifesaving medicines are the wrong prescriptions for Medicare.

To learn more about Medicare Part B, visit PhRMA.org/PartB and to learn more about proposals to change Medicare, visit PrescriptionforMedicare.org.

https://catalyst.phrma.org/new-analysis-government-intervention-in-part-b-threatens-patient-access-to-medicines

Join us for the We Work for Delaware Partner Briefing. This is a great opportunity to learn about impending threats to Medicare and beneficial proposals that would reduce out-of-pocket costs for patients at the pharmacy counter.

Elected officials gathered Monday to celebrate Delaware Changing Lives — an initiative to spread mindfulness training in the First State.

Mindfulness, or moment-to-moment awareness, has been shown to reduce stress and improve focus, according to the American Psychological Association. It’s a tool now used by educators, mental health professionals and even tech companies.

Tamara DeFer of GIFT Global, the nonprofit that spearheaded the initiative, says Delaware Changing Lives coordinates providing mindfulness training to staff in places like local schools, businesses and social service programs. She says Delaware Changing Lives is currently  involved in approximately 18 projects — including with veterans affairs, the Delaware National Guard, West End Neighborhood house, Baylor Women’s Correctional Institution and Limen House.

According to officials, over the past 18 months more than 3,000 Delawareans have already received training under the initiative.

DeFer says there are only a handful of mindfulness-based stress reduction trainers in the state. She says Delaware Changing Lives recently brought them together, and the group will begin meeting monthly.

“A lot of people who do this work recognize that it’s trauma resilience training as well as mindfulness training,” said DeFer. “We need to be together in this so that everyone understands why both are important and not just one or the other.”

Logan Herring leads the Kingswood Community Center in Riverside — where staff participate regularly in mindfulness training through Delaware Changing Lives. He says the training helps staff serve clients better.

“Think about our early learning center, or our senior center, or just our clients that come in every day that need help— a lot of times the help that we’re providing we’ve needed at some time, or maybe we didn’t get it,” he said. “[Mindfulness training means] being able to substantiate ourselves and make sure that we’re providing professional services no matter what’s going on in our lives or what we’ve been through.”

Herring is also CEO of REACH Riverside and its planned Teen Warehouse. He sees mindfulness training potentially benefiting the entire Riverside neighborhood.

“We’re dealing with a lot of people [who] for generations have dealt with a lot of trauma, a lot of baggage,” said Herring. “So when we think about everything that they’ve endured and gone through, we have to think about mindful ways that we can uplift them and empower them, and just interact with them on a daily basis. So this is a neighborhood that really takes this mindfulness training very seriously.”

The Delaware Changing Lives initiative has found support from elected officials including Gov. John Carney, Delaware’s congressional delegation, Attorney General Kathy Jennings, and Lt. Gov. Bethany Hall-Long, who chairs the state’s Behavioral Health Consortium.

Trauma, stress and anxiety can all affect quality of life — and that’s especially true in neighborhoods with a history of social marginalization.

Delaware Changing Lives, an offshoot of GIFT Global, is a mindfulness initiative aimed at underserved communities, launched in 2016 with a goal to increase access to self-care skills, trauma recovery and stress reduction in Delaware. Since then, it has trained over 3,000 people in schools, nonprofits and healthcare to teach the benefits of mindfulness, including breathing exercises, meditation and other stress reduction techniques.

On April 29, in partnership with Tapp Network, Delaware Changing Lives will hold a celebration at the Kingswood Community Center in Riverside to celebrate Delaware success stories and bring awareness to the organization, projects in Delaware and the launch of its website.

Speakers will include Gov. John Carney, U.S. Sen. Chris Coons and Lt. Gov.Bethany Hall-Long.
 
We're excited to have Delaware Leaders speaking at the Delaware Changing Lives Celebration on Monday, April 29th at the Kingswood Community Center. Get your tickets today! #ChangingLivesDE #Mindfulness #MentalHealth


Riverside, located in northeast Wilmington, is undergoing a 10-year community-focused revitalization plan that will include a new education pipeline, new mixed-income housing, a new community center and a community health and wellness initiative. It is part of the Purpose Built Community model, an Atlanta-based approach to urban revitalization that focuses on improving the lives of the people who live in communities with concentrated poverty.

In its latest move to help stem the opioid crisis, Delaware’s Division of Public Health is trying to reduce opioid prescriptions in First State dentist offices.

The state is partnering with the Delaware State Dental Society to distribute pamphlets and posters to dentist offices across Delaware to raise awareness of the addictive nature of opioid pain medication.

“By no means would we ever try to tell the prescriber how to treat pain, because certainly, that is always going to be a decision best managed by the provider and the patient on their own,” said Dr. Nick Conte, Dental Director for DPH’s Bureau of Oral Health and Dental Services. “What we’re really trying to do is make sure everyone has the best and most current information available.”

Officials cite data from the Centers for Disease Control and Prevention that shows dentists are the third most common prescriber of opioids behind Internal Medicine and Family Medicine practices.

Conte adds that while those practices prescribe more opioids, dentists often prescribe to younger patients.

“We’re frequently prescribing to teenagers, young adults as they’re having wisdom tooth extraction. This can often represent their first exposure to opioids,” said Conte. “So it’s important for us to really pay attention to who really needs opioids and where pain can be managed by other means.”

CDC data also shows about 80% of the people who use heroin, first used prescription opioids.

Conte says hydrocodone and oxycodone are the most common opioids prescribed after dental procedures, but he adds there are many instances where over-the-counter medication like Motrin or Aleve can work better to treat acute pain.

He says the educational campaign is funded by a Health Resources and Services Administration grant.

There were 419 suspected drug overdose deaths in Delaware in 2018. That number has gone up in the First State for the past six years. The CDC ranks Delaware with the sixth highest overdose rate in the country.

For most of the 20th Century, many Americans could sustain a career — one that could help them buy a house, buy a car, and raise a family — at a single company. With a high school diploma and a foot in the door, most American workers could get on-the-job training as they continued to work at the company that first hired them, and with that, they could often count on good benefits and enough help to retire after a lifetime of hard work. Here in Delaware, many of those jobs came at companies like GM or Chrysler.

Today, things are different.

It’s now increasingly common that Americans’ careers consist of multiple jobs in multiple industries, and the reality is that new technologies are increasingly able to complete tasks that real people were previously responsible for. As the Aspen Institute has written, up to one-third of the U.S. workforce will need to learn new skills or find work in new occupations by 2030 because of automation.

It’s a daunting challenge that raises a difficult question: How can we ensure that American workers can change, grow, and succeed in a rapidly changing, digitizing economy?

There’s no silver-bullet solution, but one thing is certain: education and training for Americans can no longer stop after high school or even college.

At the end of the day, businesses and employees will have to modernize and change, but the federal government can help lead the way to ensure that lifelong learning and training opportunities are available, affordable, and meaningful for Americans of all ages and backgrounds. That’s no easy task — it requires real policy changes and real investment — but to continue to be the strongest economy in the world, it’s worth it.

In that spirit, I joined my colleague, Sen. Mark Warner of Virginia, in introducing legislation early this year to provide every American with a portable, government-matched savings vehicle for lifelong learning. The bill creates a tax-preferred savings account, called a Lifelong Learning and Training Account (LLTA). The federal government will match every dollar — up to $1,000 a year — that any hard-working American and his or her employer contributes to an account.

Since small businesses often struggle to dedicate sufficient funds for employee education, this tax-preferred savings account would be a huge boost to small businesses by offering them another way to invest in the development of their staff.

The best part? Individuals have the freedom to choose how to use their LLTA funds, which can be applied towards a variety of training programs that lead to a meaningful credential recognized anywhere you go. In short: you get to decide what learning and training is best for you, your family, and your career.

Here in Delaware, there is no shortage of quality training programs with a record of preparing folks who have been at their jobs for years or even decades for new careers in better-paying, growing industries.

For example, a person whose job was lost to automation could tap his or her LLTA to start a better-paying career as a registered nurse, through DelTech’s Associate Degree Nursing program.

Someone who’s previously worked in a service industry could use his or her LLTA savings to enroll in an ESL and welding programs through Sussex Tech’s Adult Division.

Or, a parent who took time off to care for young kids could get ahead by reentering the workforce with a certificate in Electrical Trades from Polytech Adult Education in Woodside.

Lifelong Learning and Training Accounts should be one piece of a revamped workforce system in the United States. I have also introduced bipartisan legislation, with Indiana Senator Todd Young, that invests in registered apprenticeship programs like those being offered by unions and employers around our state that are partnering with schools to provide quality instruction and on-the-job training to workers in a variety of skilled trades.

We know that the talent and drive of American workers is second to none, but we can do more to ensure that every American has the tools they need to keep up and succeed in our ever-changing economy.

This bill is one way we can empower every American to take charge of their future by actively planning, saving for, and completing the training programs they need to thrive.

Chris Coons is Delaware’s junior senator in the United States Congress.

(CNN)The Trump administration unveiled a proposal Thursday that could radically change the way many drugs are priced and paid for in Medicare and Medicaid.

The plan calls for effectively banning drug makers from providing rebates to pharmacy benefit managers and insurers in Medicare Part D- and Medicaid-managed care plans. Instead, drug companies would be encouraged to pass the discounts directly to patients at the pharmacy counter and would pay pharmacy benefit managers a fixed fee.

The move, which was immediately praised by pharmaceutical companies but panned by insurers and pharmacy benefit managers, would be one of the most substantial steps in the Trump administration's quest to lower drug prices.

"If this rule goes into effect in its current form, it would be the largest change the administration has yet announced on drug pricing," said Rachel Sachs, an associate law professor at Washington University.

However, the actual impact of the proposal remains unclear. It's likely that Medicare and Medicaid patients with high drug costs would save money, but the shift could result in larger premiums for all beneficiaries.

The administration estimates that 30% of Medicare Part D enrollees spend enough that their savings would likely exceed any premium hikes. It also projects that federal spending could rise between $35 billion and $196 billion over 10 years since the government provides various subsidies in the Part D program.

Also, the effect on drug costs for the more than 150 million Americans who get their insurance on the job remains to be seen. While the proposed rule changes could touch aspects of the commercial insurance market, the Health and Human Services Department acknowledged that Congress has more power to ban rebates in that area.
Drug makers resist pressure from Washington on prices

Rebates have long been a controversial part of the US drug industry and are blamed for incentivizing many players to keep list prices high. Manufacturers dole out billions of dollars in discounts every year, but these savings don't usually trickle down directly to consumers.

Under the proposal, rebates that amount to 26% to 30% of a drug's list price may be passed on to patients, the department estimates.

Drug companies, however, may not actually provide discounts at the pharmacy counter. Instead, they could eliminate the rebates and lower the list prices of the medicines, among other options.

Here's how rebates work: Pharmacy benefit managers negotiate rebates from drug manufacturers to insurers in exchange for better coverage terms -- often in the form of lower copays for brand-name drugs. This makes it more likely that the insurers' enrollees will choose that cheaper brand-name medication over a competitor's version. The pharmacy benefit managers, however, also keep a portion of the rebate for themselves.

The rebate figures are eye-popping. Insurers received $89 billion in rebates, reducing their spending on prescription drugs to $279 billion in 2016, according to estimates from Altarum, a research and consulting firm. This doesn't include the portion of the rebate that pharmacy benefit managers keep, which isn't disclosed. To save his parents money, this diabetic teen cut back on his insulin

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, and America's Health Insurance Plans, an industry group for insurers, said Thursday that the proposal could increase consumers' expenses. Both pointed the finger at drug makers for high costs.

"PBMs keep coverage affordable by negotiating rebates with drug-makers, which are used to enhance benefits and reduce beneficiary cost-sharing and premiums," said JC Scott, the association's president.

Drug manufacturers, meanwhile, laid the blame for high prices on others in the industry.

"This proposal would also fix the misaligned incentives in the system that currently result in insurers and pharmacy benefit managers favoring medicines with high list prices," said Stephen J. Ubl, the chief executive of PhRMA, a trade group for drug makers.
Democrats ramp up battle to lower drug prices

Lowering drug prices is also a top priority for Congress, with two committees holding hearings on the matter this week. Some Democrats, however, do not agree with HHS's latest move.

"The Trump administration's rebate proposal will increase government spending by nearly $200 billion and the majority of Medicare beneficiaries will see their premiums and total out-of-pocket costs increase if this proposal is finalized," Reps. Richard Neal of Massachusetts and Frank Pallone of New Jersey said in a statement. "While we agree that the cost of prescription drugs must be addressed, we are concerned that this is not the right approach."