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Apple, Fitbit to join FDA program to speed health tech

Wondering how technology can speed the process of developing health tech? In this article from BenefitsPro written by Anna Edney, gain a close insight on how Apple and Fitbit are working together with the FDA to make your health of vital importance.

You can read the original article here.


A federal agency that regulates apples wants to make regulations on Apple Inc. a little easier.

The Food and Drug Administration, which oversees new drugs, medical devices and much of the U.S. food supply, said Tuesday that it had selected nine major tech companies for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Scott Gottlieb said in a statement.

The program is meant to let the companies get products pre-cleared rather than going through the agency’s standard application and approval process that can take months. Along with Apple, Fitbit Inc., Samsung Electronics Co., Verily Life Sciences, Johnson & Johnson and Roche Holding AG will participate.

 

A new report and video from the Health Enhancement Research Organization (HERO) identifies six promising practices for effectively integrating wearables...
The FDA program is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that may be used by patients or their doctors to prevent, diagnose and treat conditions.

Apple is studying whether its watch can detect heart abnormalities. The process it will go through to make sure it’s using sound quality metrics and other measures won’t be as costly and time-consuming as when the government clears a new pacemaker, for example. Verily, the life sciences arm of Google parent Alphabet Inc., is working with Novartis AG to develop a contact lens that could continuously monitor the body’s blood sugar.

Faster Pace

“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” Gottlieb said in July when he announced that digital health manufacturers could apply for the pilot program.

Officially dubbed the Pre-Cert for Software Pilot, Gottlieb at the time called it “a new and pragmatic approach to digital health technology.”

The other companies included in the pilot are Pear Therapeutics Inc., Phosphorus Inc. and Tidepool.

The program is part of a broader move at the FDA, particularly since Gottlieb took over in May, to streamline regulation and get medical products to patients faster. The commissioner said last week the agency will clarify how drugmakers might use data from treatments already approved in some disease to gain approvals for more conditions. In July, he delayed oversight of electronic cigarettes while the agency decides what information it will need from makers of the products.

Rules Uncertainty

As Silicon Valley developers have pushed into health care, the industry has been at times uncertain about when it needed the FDA’s approval. In 2013, the consumer gene-testing company 23andMe Inc. was ordered by the agency to temporarily stop selling its health analysis product until it was cleared by regulators, for example.

Under the pilot, the FDA will scrutinize digital health companies’ software and will inspect their facilities to ensure they meet quality standards and can adequately track their products once they’re on the market. If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all.

More than 100 companies were interested in the pilot, according to the FDA. The agency plans to hold a public workshop on the program in January to help developers not in the pilot understand the process and four months of initial findings.

You can read the original article here.

Source:

Edeny A. (27 September 2017). "Apple, Fitbit to join FDA program to speed health tech" [Web Blog Post]. Retrieved from address http://www.benefitspro.com/2017/09/27/apple-fitbit-to-join-fda-program-to-speed-health-t

 


Absent federal action, states take the lead on curbing drug costs

What's your state's stance on the cost of prescription drugs? See how Maryland has moved forward in their decision making for drug prices, giving themselves the ability to say "no" in this article from Benefits Pro written by Shefali Luthra.

You can read the original article here.


Lawmakers in Maryland are daring to legislate where their federal counterparts have not: As of Oct. 1, the state will be able to say “no” to some pharmaceutical price spikes.

A new law, which focuses on generic and off-patent drugs, empowers the state’s attorney general to step in if a drug’s price climbs 50 percent or more in a single year. The company must justify the hike. If the attorney general still finds the increase unwarranted, he or she can file suit in state court. Manufacturers face a fine of up to $10,000 for price gouging.

As Congress stalls on what voters say is a top health concern — high pharmaceutical costs — states increasingly are tackling the issue. Despite often-fierce industry opposition, a variety of bills are working their way through state governments. California, Nevada and New York are among those joining Maryland in passing legislation meant to undercut skyrocketing drug prices.

Maryland, though, is the first to penalize drugmakers for price hikes. Its law passed May 26 without the governor’s signature.

The state-level momentum raises the possibility that — as happened with hot-button issues such as gay marriage and smoke-free buildings — a patchwork of bills across the country could pave the way for more comprehensive national action. States feel the squeeze of these steep price tags in Medicaid and state employee benefit programs, and that applies pressure to find solutions.

“There is a noticeable uptick among state legislatures and state governments in terms of what kind of role states can play in addressing the cost of prescription drugs and access,” said Richard Cauchi, health program director at the National Conference of State Legislatures.

Many experts frame Maryland’s law as a test case that could help define what powers states have and what limits they face in doing battle with the pharmaceutical industry.

The generic-drug industry has already filed a lawsuit to block the law, arguing it’s unconstitutionally vague and an overreach of state powers. A district court is expected to rule soon.

The state-level actions focus on a variety of tactics:

“Transparency bills” would require pharmaceutical companies to detail a drug’s production and advertising costs when they raise prices over certain thresholds. Cost-limit measures would cap drug prices charged by drugmakers to Medicaid or other state-run programs, or limit what the state will pay for drugs. Supply-chain restrictions include regulating the roles of pharmacy benefit managers or limiting a consumer’s out-of-pocket costs.

A New York law on the books since spring allows officials to cap what its Medicaid program will pay for medications. If companies don’t sufficiently discount a drug, a state review will assess whether the price is out of step with medical value.

Maryland’s measure goes further — treating price gouging as a civil offense and taking alleged violators to court.

“It’s a really innovative approach. States are looking at how to replicate it, and how to expand on it,” said Ellen Albritton, a senior policy analyst at the left-leaning Families USA, which has consulted with states including Maryland on such policies.

Lawmakers have introduced similar legislation in states such as Massachusetts, Rhode Island, Tennessee and Montana. And in Ohio voters are weighing a ballot initiative in November that would limit what the state pays for prescription drugs in its Medicaid program and other state health plans.

Meanwhile, the California legislature passed a bill earlier in September that would require drugmakers to disclose when they are about to raise a price more than 16 percent over two years and justify the hike. It awaits Democratic Gov. Jerry Brown’s signature.

In June, Nevada lawmakers approved a law similar to California’s but limited to insulin prices. Vermont passed a transparency law in 2016 that would scrutinize up to 15 drugs for which the state spends “significant health care dollars” and prices had climbed by set amounts in recent years.

But states face a steep uphill climb in passing pricing legislation given the deep-pocketed pharmaceutical industry, which can finance strong opposition, whether through lobbying, legal action or advertising campaigns.

Last fall, voters rejected a California initiative that would have capped what the state pays for drugs — much like the Ohio measure under consideration. Industry groups spent more than $100 million to defeat it, putting it among California’s all-time most expensive ballot fights. Ohio’s measure is attracting similar heat, with drug companies outspending opponents about 5-to-1.

States also face policy challenges and limits to their statutory authority, which is why several have focused their efforts on specific parts of the drug-pricing pipeline.

Critics see these tailored initiatives as falling short or opening other loopholes. Requiring companies to report prices past a certain threshold, for example, might encourage them to consistently set prices just below that level.

Maryland’s law is noteworthy because it includes a fine for drugmakers if price increases are deemed excessive — though in the industry that $10,000 fine is likely nominal, suggested Rachel Sachs, an associate law professor at Washington University in St. Louis who researches drug regulations.

This law also doesn’t address the trickier policy question: a drug’s initial price tag, noted Rena Conti, an assistant professor in the University of Chicago who studies pharmaceutical economics.

And its focus on generics means that branded drugs, such as Mylan’s Epi-Pen or Kaleo’s overdose-reversing Evzio, wouldn’t be affected.

Yet there’s a good reason for this, noted Jeremy Greene, a professor of medicine and the history of medicine at Johns Hopkins University who is in favor of Maryland’s law.

Current interpretation of federal patent law suggests that the issues related to the development and affordability of on-patent drugs are under federal jurisdiction, outside the purview of states, he explained.

In Maryland, “the law was drafted narrowly to address specifically a problem we’ve only become aware of in recent years,” he said. That’s the high cost of older, off-patent drugs that face little market competition. “Here’s where the state of Maryland is trying to do something,” he said.

Still, a ruling against the state in the pending court case could have a chilling effect for other states, Sachs said, although it would be unlikely to quash their efforts.

“This is continuing to be a topic of discussion, and a problem for consumers,” said Sachs.

“At some point, some of these laws are going to go into effect — or the federal government is going to do something,” she added.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Source:

Luther S. (29 September 2017). "Absent federal action, states take the lead on curbing drug costs" [Web Blog Post]. Retrieved from address http://www.benefitspro.com/2017/09/29/absent-federal-action-states-take-the-lead-on-curb?page=2


Employers Broadening Health Programs

Employers are starting to change their approach on how they look at their employee benefits program. Take a look at this great article by Nick Otto from Employee Benefit Adviser and find out how employers are reclassifying their employee benefits program in order to expand their employees' well-being.

The siloed approach to retirement, healthcare and wellness is a thing of the past as employers are increasingly taking a holistic approach to addressing their employees’ health and wealth.

Employers are expanding their view of employee overall well-being, according to a new report from Optum, a technology-enabled health services company. That means that, while employers are still offering traditional wellness programs, there has been a significant shift in the last three years to those programs addressing workers’ financial, behavioral and social health.

“For example, we see increased interest among companies in developing new programs around mindfulness, positivity and creativity, which can reduce stress, improve eating and sleeping habits, and stimulate innovative thinking,” says Seth Serxner, Optum’s chief health officer.

While physical health still remains a significant focus for employee wellness programs, other dimensions are tracking with higher importance among large employers:

· 51% of such programs now address financial health, up from 38% in 2015;
· 47% address employees’ social health by using strategies like team-based activities to increase feelings of connectedness and a sense of belonging, compared to 37% in 2015; and
· 68% address behavioral health, up from 65% in 2015

And technology is helping employers to better engage these programs to workers. Since 2014, there has been a significant increase in the use of a variety of innovations, including online competitions, activity tracking devices, social networks, mobile apps and mobile messaging to help engage employees, the study notes.

Additionally, incentive strategies are helping to get workers in the wellness game.

Use of incentives is at an all-time high, Optum notes, with 95% of employer respondents offering incentives to their employees. Recognizing that workers can be highly influenced by their family members, 74% of employers also are offering incentives to family members. According to Optum, average incentives per participant per year equate to $532.

See the original article Here.

Source:

Otto N. (2017 August 15). Employers broadening health programs [Web blog post]. Retrieved from address https://www.employeebenefitadviser.com/news/employers-broadening-health-programs


doctor and patient

How Health Coaching can Revitalize a Workforce

Do you need help revitalizing your workforce? Check out this great column by Paul Turner from Employee Benefit Advisor and see how health coaching can be a great way to increase engagement and productivity among your employees.

Nearly 50% of Americans live with at least one chronic illness, and millions more have lifestyle habits that increase their risk of health problems in the future, according to the Centers for Disease Control and Prevention. Type 2 diabetes, cardiovascular disease, cancer, pulmonary disease and other conditions account for more than 75% of the $2 trillion spent annually on medical care in the U.S.

Employers have a stake in improving on these discouraging statistics. People spend a good portion of their lives at work, where good health habits can be cultivated and then integrated into their personal lives. While chronic diseases often can’t be cured, many risk factors can be mitigated with good health behaviors, positive and consistent lifestyle habits and adherence to medication and treatment plans. Moreover, healthy behaviors — like smoking cessation, weight management, and exercise — can help prevent people from developing a chronic disease in the first place.

Companies that sponsor well-being programs realize the benefits of a healthier and more vital employee population, with lower rates of absenteeism and improved productivity. Investing in such programs can yield a significant return — particularly from condition management programs for costly chronic diseases.

Digitally-based well-being programs in particular are powerful motivators to adopt healthy behaviors. Yet for many employees, dealing with difficult health challenges can be daunting and digital wellness tools may not offer them sufficient support. Combining these health technologies with the skill and support of a health coach, however, can be a winning approach for greater workplace well-being. The benefits of coaching can also extend to employees that are currently healthy. People without a known condition may still struggle with stress, sleep issues, and lack of exercise, and the guidance of a coach can address risk factors and help prevent future health problems.

Choosing a health coach

Coaching is an investment, and the more rigor that employers put into the selection of a coaching team, the better the results. Coaches should be a credentialed Certified Health Education Specialist or a healthcare professional, such as a registered nurse or dietician, who is extensively trained in motivational interviewing. It also helps when a coach has a specialty accreditation in an area such as nutrition, exercise physiology, mental health or diabetes management. Such training allows the coach to respond effectively to highly individualized needs.

This sort of personalization is essential. A good coach will recognize that each wellness program participant is motivated by a different set of desires and rewards and is undermined by their own unique combination of doubts, fears and temptations. They build trust and confidence by helping employees identify the emotional triggers that may lead them to overeat, smoke or fail to stick with their treatment plans and healthy lifestyle behaviors.

What works for one employee, does not work for another. A 50-year-old trying to quit smoking may need the personal touch of a meeting or phone conversation to connect with her coach; a 30-year-old focused on stress management might prefer email or texting. It’s important for the coaching team to accommodate these preferences.

Working with our employer clients, WebMD has seen what rigorous coaching can achieve:
· A 54% quit rate for participants in a 12-week smoking-cessation program
· Successful weight loss for 68% of those who joined a weight-management program
· A nearly 33% reduction in known health risks for relatively healthy employees in a lifestyle coaching program
· A corresponding 28% health risk reduction for employees with a known condition who received condition management coaching.

Coaching is more likely to succeed when it is part of a comprehensive wellness program carried out in an environment where employee well-being is clearly emphasized by the employer and its managers. WebMD popularizes the saying that ‘When the coach is in, everybody wins.’ Qualified health coaching may be the missing ingredient that helps an employer achieve its well-being goals and energize its workforce.

See the original article Here.

Source:

Turner P. (2017 July 27). How health coaching can revitalize a workforce [Web blog post]. Retrieved from address https://www.employeebenefitadviser.com/opinion/how-health-coaching-can-revitalize-a-workforce?feed=00000152-1387-d1cc-a5fa-7fffaf8f0000


Employee financial health connects to physical health

Did you know that there is a direct corelation between financial and physical health? This article from Benefits Pro is a great read explaining the link between an employee's financial and physical health by Caroline Marwitz

LAS VEGAS -- Are poor physical health and poor financial health connected? The benefits industry is making the link, if you consider how many deals between health-related benefits companies and retirement providers have occurred lately.

Obviously, the poor, at least in America, have a more fragile state of health than the more affluent. And as we age, the potential for unplanned health events to hurt us financially increases -- and that's important for retirement advisors and plan sponsors to remember. But what about your typical employees who are neither poor nor elderly?

A study in the journal Psychological Science looked at worker attitudes and actions to find out whether poor physical health and poor financial health might be linked, and how.

The researchers studied employees who were given an employer-sponsored health exam and were told they needed to change certain behaviors to improve their health. Which employees made the changes and who blew them off?

The researchers accounted for external factors such as different levels of income and physical health, and differences in demographics. Yet the results were still startling:

“Employees who saved for the future by contributing to a 401(k) showed improvements in their abnormal blood-test results and health behaviors approximately 27% more often than noncontributors did,” the researchers concluded in Healthy, Wealthy, and Wise: Retirement Planning Predicts Employee Health Improvements.

The employees who made the behavior changes to better their physical health were also the ones who were taking action to better their financial health.

Employee attitudes about the future and how much control they have over it affect whether they take care of their physical health and their financial health. That sense of control, or conversely, that feeling of no control, and thus, no investment in long-term results, is one reason why some employees might not participate in retirement plans, and, maybe, wellness and well-being programs.

What if, along with the retirement health-care cost calculators many retirement plan providers offer, there was a fatalism calculator too? That way you could see right away each person’s sense of control or feelings of inevitability about their future and help them more efficiently.

Because if someone is more fatalistic, telling them about their 401(k) match or pension options isn’t going to make them enroll in a retirement plan. Scaring them with statistics about the high costs of health care in retirement isn’t going to do the trick either. Instead, consider the following points for such employees:

  • They can be helped to see that the future is a lot more unpredictable (and complex) than they realize, both negatively and positively.
  • They can be helped to realize that even the smallest actions they undertake can have a big impact in the long term.
  • They can be helped to understand that seemingly unobtainable goals can be broken down into steps and tackled bit by bit.

Look behind employee behavior for the unexamined biases and long-held assumptions that are causing it. If they can see that it’s not who they are that determines their future but what they do, it's a start.

See the original article Here.

Source:

Marwitz C. (2017 March 19). Employee financial health connects to physical health [Web blog post]. Retrieved from address http://www.benefitspro.com/2017/03/19/employee-financial-health-connects-to-physical-hea?ref=hp-top-stories


Get The Best of Both Worlds

OSMA's Health Benefits Plan: Frequently Asked Questions & Answers

In response to the changes brought about by the Affordable Care Act (ACA), the Ohio State Medical Association (OSMA) plans to offer a Health Benefits Plan (HBP). The OSMA HBP will be a self-funded multiple employer welfare arrangement developed for Ohio physician practices. The HBP is currently pending approval by the Ohio Department of Insurance. If approved, it would be an innovative alternative to the ACA.

Q. How is the OSMA's HPB different from the ACA?

A. Unlike the current ACAstructure, the OSMA HBP
• Will be a self funded plan for small physician practices.
• Will offer a variety of plan designs that meet the minimum essential coverage requirement, including:
• Eight different options with deductibles ranging from $ 500 to $6,350 for single coverage (2x for family
coverage)
• Several plans with copays and prescription drug cards
• Will allow for the continued use of Health Reimbursement Accounts (HRA) and Health Saving Accounts (HSA).
• May be less expensive than many comparable options under the ACA.
• Will allow for changes in benefits and contribution roles al renewal without being "locked in" by the grandfathered status, and no monthly administrative billing fee.

Q. Will my current plan rates go up under the ACA?

A. The ACA premium will be dependent on a variety of factors and specific to each group. Our in-house insurance agent will help you understand your options and will be in a position to help you get the most affordable benefit option available.
Q. Do I have to switch doctors?

A. The OSMA HBP utilizes the SuperMed Plus network from Medical Mutual of Ohio, one of the largest networks of providers and facilities in the state. You should, however, always check to make sure your doctor is in network prior to any service. (https://providersearch.medmutual.com/NetworkRealignment.aspx)

Q. Does the OSMA HBP provide the employer with a Summary Plan Description (SPD)?

A. Yes. We provide each employer with an SPDfor the OSMA HBP that meets ERISA compliance regulations. (All employers are responsible for providing SPD's for all of their health and welfare benefits.)
Q. What is the cost to me for joining the OSMA HBP?

A. Each group will have a monthly funding rate based on a variety of factors including but not limited to:

• Number of CoveredEmployees
• Medical History
• Gender
• Tobacco Usage
• Location

Q. Why should I change plans now?

A. Due to the constant policy evolution of the ACA and the uncertainty of future year premiums, many groups will be able to experience a competitive rate that may not be available from Ohio's ACA Marketplace. The OSMA Insurance Agency will provide an easy to understand comparison between the ACA plans and the HBP.

Q. If I leave my current plan (including an ACA plan) will I be subject to preexisting conditions limitations?

A. No. The coverage will be offered on a guarantee issue basis with no preexisting condition exclusion.

Q. What happens if I decide to leave the OSMA HBP in the future?

A. Members may elect to withdraw from participation in the Plan at the end of a calendar month by giving written notice to the Plan at least thirty (30) days prior to the end of such month.
Q.Is there a fee to be part of the OSMA HB Plan?

A. No. There is no fee to join the OSMA Health Benefit Plan but at least one insured must be an active member of the Ohio State Medical Association.

Q. Is the OSMA HBP permitted by the ACA?

A. Yes. The OSMA HBP is a self-fund ed option allowed under the ACA. The OSMA Insurance Agency is authorized to offer health insurance plans as a Federally-facilitated Marketplace Certified agent and Certified Patient Protection and Affordable Care Act (PPACA) Professional.
Q. What is the OSMA Health Benefit Plan's legal structure?

A. The OSMA HBP is technically known as a multiple employer welfare arrangement (MEWA). A MEWA provides health and welfare benefits to employees of two or more employers who pool their contributions, enabling them to offer health insurance rates and benefits typically available only to larger groups.
Q. How secure is the OSMA's HBP?

A. The Ohio Department of Insurance and several federal government agencies coordinate the oversight and regulation of the OSMA HBP. This multi-jurisdiction gives the State of Ohio's Department of Insurance primary responsibility for overseeing the financial soundness the OSMA HBP, while the U.S. Department of Labor provides oversight for employee benefit plans and the Internal Revenue Service ensures the nonprofit tax status of the OSMA HBP.

Q. Is there a situation when my practice should use the ACA's marketplace options?

A. The Ohio Department of Insurance and several federal government agencies coordinate the oversight and regulation of the OSMA HBP. This multi-jurisdiction gives the State of Ohio's Department of Insurance primary responsibility for overseeing the financial soundness the OSMA HBP, while the U.S. Department of Labor provides oversight for employee benefit plans and the Internal Revenue Service ensures the nonprofit tax status of the OSMA HBP.

Q. How do I learn more about the OSMA Health Benefit Plan?

A. Contact Saxon' s Expert at jcharlton@gosaxon.com or visit our website at http://gosaxon.com/get-the-best-of-both-worlds-with-osma/

For the full download click Here.

Learn more about OSMA Here.