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Uncategorized

Vision Coverage Can Reduce Overall Health Care Costs

by Inoventive Solutions
May 11, 2021

Research has found that employers who offered their workers stand-alone vision benefits experienced $5.8 billion in cost savings in the aggregate over four years due to reduced health care costs, avoided productivity losses, and lower turnover rates.

That’s because individuals who receive an annual comprehensive eye exam are more likely to enter the health care system earlier for treatment of serious health conditions, thereby significantly reducing their long-term cost of care.

Additionally, people are more likely to get an annual comprehensive eye test than a routine physical, according to the study by HCMS Group, a human capital risk management firm that analyzes data to help employers reduce waste in health benefits.

While not mandatory under the Affordable Care Act for adults, you may consider vision coverage for your employees as it may help decrease your overall health insurance outlays in the future.

The ACA requires that pediatric vision care coverage be embedded in medical benefits for children up to age 19 in group health plans purchased by employers with 100 or fewer employees.

The ACA’s vision care requirement for kids has exposed a gap in coverage for adults that is prompting an uptick in interest in voluntary vision benefits.

According to the “2020-2021 WorkForces Report” by the life insurer Aflac, 67% of U.S. employers surveyed offered voluntary vision benefits in 2020.

And nearly eight out of 10 employees said they would enroll in vision benefits if they were offered by their employer.

Early detection

The main reason vision benefits can help with early detection of illnesses is that comprehensive eye exams provide the only possible non-invasive view of blood vessels and the optic nerve.

As a result, eye doctors can detect early signs of chronic diseases before any other health care provider.

Eye doctors were the first to identify in patients signs of:

  • Diabetes (34% of the time) — The HCMS study estimates savings of $3,120 per employee due to early identification of diabetes.
  • High blood pressure (39% of the time) — The study estimates savings of $2,223 per employee due to early identification of high blood pressure.
  • High cholesterol (62% of the time) — The study estimates savings of $1,360 per employee due to early identification of high cholesterol.

The case for vision insurance

Vision insurance policies typically cover routine eye tests and other procedures, and provide specified dollar amounts or discounts for the purchase of eyeglasses and contact lenses. Some vision insurance policies also offer discounts on refractive surgery, such as LASIK and PRK.

Vision insurance only supplements regular health insurance. Regular health insurance plans pay for eye injuries or ocular disease.

Vision insurance, on the other hand, is a wellness benefit designed to reduce your costs for routine, preventative eye care such as eye exams, eyewear and other services.

With the prospect of reduced health care costs among your employees, which in turn would reflect well in your health insurance premiums, if you have not considered vision benefits before, it may be time to take a second look.

Contact us for more information on how a vision plan can be incorporated into your employee benefits offerings.

"health
Uncategorized

Put Money into an HSA instead of a 401(k) After Employer Matching: Report

by Inoventive Solutions
April 27, 2021

One of the main recommendations for employees with 401(k) plans is that they should contribute at least enough to their plan every paycheck to ensure they receive the maximum they can in their employer’s matching contributions.

But a new study by Willis Towers Watson recommends that younger, healthier workers should divert savings to their health savings account from their 401(k) after capping out employer matching instead of continuing to put money into their retirement plan.

The report reasons that if they do this, they can get more bang for their buck when they use their HSAs to pay for future medical expenses.

That’s because HSAs can be kept for life and the money they’ve accumulated in them can be used to pay for medical expenses whenever they need them, including in retirement. And the moneys used in HSAs to pay for those expenses are not taxed when they are withdrawn, unlike 401(k)s, the funds of which are subject to federal income tax when withdrawn

The benefits of HSAs

With HSAs:

  • Pretax contributions, gains from investment, and withdrawals used for qualified medical expenses are exempt from federal and most state taxes.
  • Any unused balance is carried over to the next year.
  • Funds never expire.
  • Unused funds can be passed on to a beneficiary after death.
  • After turning 65, account holders can withdraw money for any purpose. However, if those funds are not use for a bona fide medical expense, they are taxed as income.

No other retirement savings vehicle has the same tax advantages as an HSA, so a dollar saved in an HSA can be worth significantly more than an unmatched dollar saved in a 401(k), according to Willis Towers Watson. Some employers will match a portion of workers’ HSA contributions or seed their accounts with money to encourage participation. 

That said, HSAs won’t outperform funds that are matched partly or fully by an employer, according to the report.

Willis Towers Watson said that those tax-free dollars and withdrawals can help pay for health care when we are likely to use it most: in retirement.

Men who retire at 65 with an average life expectancy of 85 would spend about $140,000 out of pocket for medical costs, and woman who retires at the same age and lives to 87 would spend an average of $159,000, according to the research.

The HSA pitch

HSAs can only be used in conjunction with a high-deductible health plan. When HSAs were first introduced, they did not have investment options for the money in the accounts, but as they have grown in popularity over the years, many HSAs now have evolved to essentially have the same investment choices as a 401(k).

HSAs have rules about how much of the balance can be invested. They will typically require that the first $1,000 in the account to be held in cash, and anything above that can be invested to help the funds grow over time.

In 2021, workers can contribute a maximum of $3,600 to their individual HSA account and $7,200 to a family coverage account.

If you are offering your workers high-deductible health plans with matching HSAs, and if you also provide a 401(k) and match part of the contributions, you may want to consider sharing this information with them to help them make informed choices on where to park their money for future use.

"pandemic
Uncategorized

Addressing Pandemic Fatigue Among Your Staff

by Inoventive Solutions
April 21, 2021

As the country and our businesses continue trudging along and hope that vaccines will pave the way out of the COVID-19 crisis, employers are increasingly seeing the effects of pandemic fatigue among their workers.

The same issues people are grappling with in their personal lives — exhaustion with social distancing and masking, a sense of loss of community and camaraderie, sadness over lost loved ones — are also spilling over into workplaces and affecting job performance. 

Pandemic fatigue can manifest itself in noticeable changes in employees’ mood or demeanor and result in an inability to concentrate due to anxiety and sleeplessness.

And now that vaccines are being administered at a quickening pace and word is that we may be able to soon resume normal activities, people have a sense of unbridled excitement. It’s like how kids feel when they’ve had a year of school and summer vacation is right around the corner.

It’s important for all employers to stay the course on their safety protocols, while at the same time acknowledging what their employees are going through. Keep requiring mask-wearing and social distancing.

The effects

Pandemic fatigue is real and can result in:

Employee disengagement — This can lead to poor productivity and mistakes in their work.  

Employee conflicts — Many people are stressed and exhausted, which can lead to arguments and irritation with co-workers. It can also happen if one employee doesn’t take COVID-19 precautions seriously, wearing a mask below their nose or chin (or not at all) and angering a co-worker who is serious about safety.

Failing to observe social distancing rules of being 6 feet apart can also result in arguments between co-workers.

Lost concentration — Pandemic fatigue can also lead to employees not focusing well on their jobs and safety regimens. This can result in workplace accidents.

What you can do

There are steps you can take to combat pandemic fatigue in the workplace, but the first and foremost thing you should do is consistently enforce safety rules and make sure that COVID-19 protocols should be part and parcel of the rest of your safety procedures.

You should do this by incentivizing good safety behavior, and rewarding that good behavior.

But you must also be cognizant of the emotional toll the pandemic has had on your workers. You can do this by boosting morale through:

Giving compliments — Provide positive feedback when merited, even for smaller achievements. Compliments go a long way these days due to the stress people have been through.

Showing compassion — Be consistent in your treatment of staff and consider checking in with employees to ensure that they are doing well. Ask how they’ve been faring and show empathy and sympathy for the issues they may be wrestling with.

Remember, some of your employees may have family that has succumbed to the virus or may be currently battling it.

Being calm and patient — It’s important that management shows calm and measured leadership, which can reassure the ranks that things aren’t so bad. Also, if management and supervisors can be patient when workers are dealing with stress, it can in turn tamp down any stress building among staff.

Exuding confidence — Part of being a steady and calming force includes expressing confidence that better times are ahead. This too can help your employees feel more relaxed about the future. Supervisors and managers should also express confidence in and appreciation for the employee’s individual commitment to stay the course.

The final word

These are tough times for most everyone, and for many people their work and personal lives have been upended and replaced with little to no social activity and feelings of isolation and frustration.

By providing steady leadership, continuing to enforce safety protocols and paying attention to the struggles your staff are facing, you can help any workers dealing with pandemic fatigue to better weather the storm that we may soon be exiting.

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Uncategorized

HDHPs Do Not Slow Down Health Care Spending: Study

by Inoventive Solutions
April 13, 2021

A new study has found that high-deductible health plans have only a limited effect on the growth of health care spending for people who sign on for these plans.

The National Bureau of Economic Research researched HDHPs over a period of four years and found they failed to control health spending any more than traditional preferred provider organization plans (PPOs) and health maintenance organizations (HMOs). The only statistically significant impact on lower growth by HDHPs was on more expensive pharmaceuticals.

The news comes as HDHPs continue growing in use and popularity among employers and some of their workers. They are often paired with a health savings account that allows participants to set aside a portion of their wages before taxes in special accounts used to pay for health-related expenses, including deductibles.

When HDHPs first came on the scene they were touted as a potential cost-saver. The logic went that when the worker has more skin in the game and has to pay more for their medical care and medications, they will shop around for the lowest-cost service or drug.

Here are the main findings of the report:

  • Covered workers who switched from low-deductible plans to high-deductible plans saw lower growth rates of spending, but for no more than a year.
  • HDHPs seem to discourage the use of less cost-effective drugs. The report surmised that’s because people with these plans will be more motivated to shop around for better prices, like from an online pharmacy.

Considerations

PPOs continue to be the most popular choice among employees and HDHPs continue growing as employers look to cut their and their employees’ premium expenditures, according to a recent report by Benefitfocus, a benefits technology company. HDHPs currently account for about 30% of group health plans in play.

Also, some employees prefer having an HDHP as they can save money up front on the premium.

Over the past few years, employers have noticed that younger and healthier workers will gravitate towards HDHPs when offered them, as they will usually not need much health care and they are willing to trade a lower up-front premium for the small likelihood that they will need a significant amount of medical care, which they would have to pay for out of pocket.

However, workers in their 40s and older are more apt to stick to their PPO or HMO plans, which have higher premiums but lower out-of-pocket maximums.

But the authors of the National Bureau of Economic Research report said that for some people with health problems, HDHPs “may have high adverse health consequences when patients delay, reduce, or forgo care to curb costs, even when costs are moderate compared to health benefits.”

The takeaway

There is no doubt that HDHPs will continue growing in use, but they are not for everyone. Employers that give their workers an option of choosing an HDHP or a traditional PPO plan will be able to better cater to the different needs of their workers.

This is important as the U.S. workforce becomes more diversified, and for employers with multi-generational employee pools.

"unemployed"/
Uncategorized

100% COBRA Subsidy in Effect Through Sept. 30

by Inoventive Solutions
April 7, 2021

The recently enacted American Rescue Plan Act of 2021 includes a 100% COBRA subsidy for up to six months for employees laid off during the COVID-19 pandemic. The subsidy is in effect through September 30.

Due to the short ramping up period, it’s imperative that employers who have laid off workers, or who plan to do so, start preparing to notify them.

The Consolidated Omnibus Budget Reconciliation Act requires group health plans sponsored by employers with 20 or more employees to offer staff and their families the opportunity for a temporary extension of health coverage (called continuation coverage) after they have quit or been laid off for 18 months. The employees will usually be responsible for the entire premium.

Who is eligible?

Eligible individuals include:

  • Workers who were previously laid off or lost their benefits and became eligible for COBRA continuation coverage but chose not to purchase it, as long as they would still be eligible now. Example: A worker who was laid off in November 2020 but rejected the offer of COBRA coverage then.
  • Individuals who previously elected COBRA continuation coverage, but later dropped it, as long as they would still be eligible now. Example: A worker was laid off in August 2020, elected and purchased COBRA coverage, but dropped the coverage in January.
  • Individuals who were involuntarily terminated or experienced a reduction in hours, and who timely elect COBRA continuation coverage after April 1.

Individuals are not eligible for a subsidy:

  • If they voluntarily resigned from their job.
  • They become eligible for other employer coverage or Medicare.
  • They are beyond their maximum COBRA coverage period (which under federal law is 18 months, and under California law may be up to 36 months).

What’s covered

The subsidy applies to all health coverage that COBRA usually covers: health insurance, and dental and vision coverage too. Generally, the coverage that employers offer Assistance Eligible Individuals (AEIs) should be the same coverage in effect prior to their COBRA-qualifying events. 

Individuals who qualify for the COBRA subsidy are not required to pay a premium.

The group health plan will cover the cost of the coverage, which will be reimbursed (including any administrative fee) by the U.S. government via a payroll tax credit.

Notice requirements

When notifying newly eligible individuals, the information can be included with the COBRA election notice or a separate notice that would come along with the election packet.

The notices must include:

  • Notification of the availability of subsidies.
  • A prominently displayed description of the AEI’s right to the subsidy and conditions.
  • The forms necessary to establish eligibility.
  • A description of the special election period.
  • A description of the qualified beneficiary’s obligation to notify the plan when they are no longer eligible for coverage.
  • Contact information of the plan administrator and any other person maintaining relevant information in connection with the subsidy.

Important: The Department of Labor is expected to provide model language for these notices by April 10.

What you should do

There are a number of steps employers need to take as the ramping up period is quite short:

The recently enacted American Rescue Plan Act of 2021 includes a 100% COBRA subsidy for up to six months for employees laid off during the COVID-19 pandemic. The subsidy is in effect through September 30.

Due to the short ramping up period, it’s imperative that employers who have laid off workers, or who plan to do so, start preparing to notify them.

The Consolidated Omnibus Budget Reconciliation Act requires group health plans sponsored by employers with 20 or more employees to offer staff and their families the opportunity for a temporary extension of health coverage (called continuation coverage) after they have quit or been laid off for 18 months. The employees will usually be responsible for the entire premium.

Who is eligible?

Eligible individuals include:

  • Workers who were previously laid off or lost their benefits and became eligible for COBRA continuation coverage but chose not to purchase it, as long as they would still be eligible now. Example: A worker who was laid off in November 2020 but rejected the offer of COBRA coverage then.
  • Individuals who previously elected COBRA continuation coverage, but later dropped it, as long as they would still be eligible now. Example: A worker was laid off in August 2020, elected and purchased COBRA coverage, but dropped the coverage in January.
  • Individuals who were involuntarily terminated or experienced a reduction in hours, and who timely elect COBRA continuation coverage after April 1.

Individuals are not eligible for a subsidy:

  • If they voluntarily resigned from their job.
  • They become eligible for other employer coverage or Medicare.
  • They are beyond their maximum COBRA coverage period (which under federal law is 18 months, and under California law may be up to 36 months).

What’s covered

The subsidy applies to all health coverage that COBRA usually covers: health insurance, and dental and vision coverage too. Generally, the coverage that employers offer Assistance Eligible Individuals (AEIs) should be the same coverage in effect prior to their COBRA-qualifying events. 

Individuals who qualify for the COBRA subsidy are not required to pay a premium.

The group health plan will cover the cost of the coverage, which will be reimbursed (including any administrative fee) by the U.S. government via a payroll tax credit.

Notice requirements

When notifying newly eligible individuals, the information can be included with the COBRA election notice or a separate notice that would come along with the election packet.

The notices must include:

  • Notification of the availability of subsidies.
  • A prominently displayed description of the AEI’s right to the subsidy and conditions.
  • The forms necessary to establish eligibility.
  • A description of the special election period.
  • A description of the qualified beneficiary’s obligation to notify the plan when they are no longer eligible for coverage.
  • Contact information of the plan administrator and any other person maintaining relevant information in connection with the subsidy.

Important: The Department of Labor is expected to provide model language for these notices by April 10.

What you should do

There are a number of steps employers need to take as the ramping up period is quite short:

  • Coordinate with your COBRA administrator to ensure that you agree about who should identify eligible individuals and who will be sending out notifications.
  • If that is you, identify those individuals who may be eligible for the COBRA subsidy and who may be eligible to make a new election.
  • Prepare notification documents.
  • Notify all eligible individuals.
"COVID-19
Uncategorized

Group Health Plans Must Cover COVID-19 Testing for Asymptomatic People

by Inoventive Solutions
March 30, 2021

The Centers for Medicare and Medicaid Services announced in late February that private group health plans cannot deny coverage or impose cost-sharing for COVID-19 diagnostic testing, regardless of whether or not the patient is experiencing symptoms or has been exposed to someone with the disease.

The CMS said it had issued the new guidance to make it easier for people to get tested with no out-of-pocket costs if they are planning to visit family members or take a flight, for example. Up until now, some health plans have not covered testing if a person is not experiencing symptoms or has not come into contact with someone who is later confirmed as being infected with COVID-19.

The guidance covers the part of the Families First Coronavirus Response Act of 2020 that required that plans and issuers must cover COVID-19 diagnostic testing without any cost-sharing requirements, prior authorization or other medical management requirements. Still, many people were denied getting tests because they had no symptoms or hadn’t been exposed to someone infected with the virus. 

According to the guidance:

“Plans and issuers must provide coverage without imposing any cost-sharing requirements (including deductibles, copayments, and coinsurance), prior authorization, or other medical management requirements for COVID-19 diagnostic testing of asymptomatic individuals when the purpose of the testing is for individualized diagnosis or treatment of COVID-19.

“However, plans and issuers are not required to provide coverage of testing such as for public health surveillance or employment purposes. But there is also no prohibition or limitation on plans and issuers providing coverage for such tests.”

"ACA"/
Uncategorized

HHS Proposes Higher Cost-Sharing Limits for 2022

by Inoventive Solutions
March 23, 2021

The Department of Health and Human Services has proposed cost-sharing limits that would apply to all Affordable Care Act-compliant health insurance policies for the 2022 policy year.

The ACA imposes annual out-of-pocket maximums on the amount that an enrollee in a non-grandfathered health plan, including self-insured and group health plans, must pay for essential health benefits through cost-sharing.

This means that health plans are not allowed to require their enrollees to pay more than the maximum in a given year for health services. 

The proposed 2022 out-of-pocket maximums are $9,100 for self-only coverage and $18,200 for family coverage. This represents an approximate 6.4% increase over 2021 limits. For 2021, the out-of-pocket maximums are $8,550 and $17,100, respectively.

Penalties to rise

Applicable large employers (ALEs) — employers with 50 or more full-time or full-time-equivalent workers who are required to offer their employees health insurance under the ACA — can face large penalties known as “shared responsibility” assessments if they have at least one full-time employee who enrolls in public marketplace coverage and receives a premium tax credit. There are two types of infractions with different penalty amounts:

The “play or pay” penalty — This can be levied when an ALE fails to offer minimum essential coverage to at least 95% of its full-time employees and their dependent children during a month, and at least one of its full-time employees receives a premium tax credit through a public marketplace.

The per-employee penalty will rise to $2,880 in 2022 from the current $2,700.

The “play and pay” penalty — An ALE can be hit by this penalty if it offers minimum essential coverage to at least 95% of its full-time employees but a full-time employee receives a premium tax credit because: (1) the employer-offered coverage is unaffordable or fails to provide minimum value, or (2) the employee was not offered employer-sponsored coverage.

For 2022, the maximum annual assessment for each full-time employee receiving a premium tax credit will be an estimated $4,320, up from the current $4,060.

Uncategorized

IRS Lets Employers Give Workers a Break on FSA Contributions, Health Plan Rules

by Inoventive Solutions
March 17, 2021

New guidance from the Internal Revenue Service allows employers to temporarily give their employees extra benefits leeway in making changes to their flexible spending accounts (FSAs) and health savings accounts (HSAs).

The guidance, in response to the COVID-19 pandemic, also allows employees to make changes to their health plans outside of the traditional open enrollment period.

The COVID relief bill signed into law at the end of 2020 changed the tax law. The law ordinarily requires employees to make irrevocable plan choices before the first day of the plan year; later changes are normally permitted only under certain circumstances, such as a change in employee status.

However, 2020 was an abnormal year. For example, stay-at-home orders left employees with unused money in their dependent care FSAs because they unexpectedly did not have to pay for child daycare.

The temporary changes

Recognizing the current extraordinary situation, the new guidance makes several temporary changes:

  • Employers can permit employees to carry over unused funds from their 2020 FSAs to 2021, and from 2021 to 2022. Ordinarily, these accounts have a “use it or lose it” rule under which the employee forfeits unused funds at the end of the year.
    If an employee contributed $5,000 to a dependent care FSA in 2020 but used only $3,000 because he or she worked from home, they can now carry the remaining $2,000 forward for use in 2021.
  • Alternatively, employers can extend the grace period for employees to spend unused FSA funds. Normally, employees have two and a half months from the end of the plan year to spend the money on qualifying expenses. The temporary rules permit employers to give them up to 12 months to do it.
  • Employers can allow certain employees to use dependent care FSA funds for care of children up to age 14. The normal cut-off age is 13.
  • Employers may allow employees to change their future contributions to 2021 FSAs mid-year, something that is ordinarily prohibited.
  • Employers may also permit employees to make mid-year health plan changes. Employees who did not enroll in the employer’s health plan during open enrollment will be able to do so.
    Employees can change available plans, or they can drop coverage entirely if they can show that they have replacement coverage such as through a spouse’s employer.
  • If an employee changes from a high-deductible health plan to one with copayments or lower deductibles (or vice versa), employers can also permit them to switch mid-year between contributing to an HSA or an FSA. By law, an HSA must be coupled with an HDHP.
  • Lastly, they can allow employees who stop contributing to a health care FSA mid-year to receive reimbursements through the end of the plan year.

It is important to know that:

  • The law does not require employers to make these changes.
  • The changes expire for plan years starting in 2022 and later.

The pandemic has been difficult for employers and employees alike. These temporary changes will make it a little easier for both to cope.

"generic
Uncategorized

Generics and Biosimilars the Key to Reducing Drug Spending

by Inoventive Solutions
March 2, 2021

The soaring cost of new prescription drugs is becoming a major driver in overall health insurance price increases, and some of those drugs are so expensive that they are out of reach for the average patient.

When people can’t afford the drugs their doctor prescribes for their ailments, it can result in either severe financial strain (even for those with insurance) or, if they can’t buy the medication at all, serious consequences for their long-term health. 

What’s driving these cost increases? Patients are paying more because of:

  • High launch prices of new brand biologics and specialty drugs. Specialty drugs are often used to treat complex, chronic conditions, and are among the most expensive medicines on the market.
  • Annual price increases of brand-name drugs that have no real competition.

While generic drugs are affordable for most people, brand-name drugs can cause serious financial pressure on most people. That’s not factoring in the fact that the cost of many popular brand-name drugs doubles every seven to eight years.

Per capita spending on specialty drugs increased by 55 % from 2015-2018 and their average cost hit $4,500 in 2018, according to a study by the American Association of Retired Persons.

According to the association’s report, brand-name medicines account for 77% of all spending on prescription drugs. The numbers are enough to make your head spin.

The answer

One way to tackle these skyrocketing prices is to increase patient access to more affordable generic or biosimilar pharmaceuticals that are approved by the Food and Drug Administration.

Using generics and biosimilars has proven to be the top way to reduce the cost of medicine outlays. For example, generic drugs can often cost 80 to 85% less than brand-name drugs, according to an analysis by the FDA. That’s usually the first option when trying to reduce a patient’s spending.

That gets more difficult when no generics exist, which is often the case for new drugs which still have their patent.

That’s where biosimilars come in. They can be affordable alternatives to expensive brand biologics, and more are coming to the market every year. 

Between 2015 and 2020, the FDA approved 29 biosimilars. If the trend continues, the potential savings could reach $54 billion over the next 10 years, according to a study by the Rand Corporation.

The takeaway

The more biosimilars that come on the market, the less of a burden drug prices will be on those who need them most. Also, as more biosimilars become available, fewer people will opt for abandoning their prescriptions at the pharmacy due to cost.

In addition, when you are being prescribed drugs, you should always talk to your doctor about generic alternatives since 90% of them can be purchased for less than $20 for insured patients.

"advanced
Uncategorized

CMS Approves Medicare Coverage of ‘Breakthrough’ Medical Devices

by Inoventive Solutions
February 23, 2021

The Centers for Medicare and Medicaid Services has issued new rules that require Medicare to cover medical devices that the Food and Drug Administration designates as “breakthrough” technology. 

The rule paves the way for giving Medicare recipients access to the latest technologies four years after they receive market approval by the FDA. The move should greatly speed up the time by which these new devices are covered by Medicare, the approval process of which can be extremely slow.

Under the final rule, the CMS will use the data for these devices during the four years after the FDA approves them, to evaluate them based on clinical and real-world experiences. If the data shows they are effective, the CMS could move to approve them for coverage under Medicare. 

The CMS said the rule was necessary because the current process hinders innovative technologies from getting to Medicare beneficiaries. Companies that make the breakthrough devices currently have to receive approval from the FDA and then receive approval for Medicare coverage, which costs them both time and funds.

Examples of breakthrough devices that were approved in 2020 include:

  • Innovative stents
  • Heart valve replacements
  • Advanced lab tests
  • Automatic defibrillator machines.

To further reduce the time it takes for Medicare to approve a device after FDA approval, the CMS has created a special “breakthrough” approval timeline that the FDA can use to approve innovative devices and potentially life-saving equipment.

Along with the expedited pathway to FDA approval, Medicare may automatically cover FDA-approved products for up to four years. After four years or the given timeframe for coverage, the CMS can reassess whether it will continue covering the device based on patient outcomes.

Qualifying requirements

Covered devices would have to fit Medicare statutory definitions of “reasonable and necessary” for treating patients. To that end, the final rule refines these definitions. Among the requirements, devices would have to be considered:

  • Safe and effective.
  • Not experimental or investigational.
  • Appropriate for Medicare patients, including the duration and frequency that is considered appropriate and whether it is covered by commercial insurers.

The new rule aims to nationalize what some state Medicare systems are already doing and avoid the possibility that a revolutionary new product may receive Medicare coverage in one state, but not another.

Making coverage of breakthrough products national also prevents the product manufacturers from having to approach individual Medicare administrative contractors for local coverage determinations, the CMS said in a press release.

The rule takes effect March 15 and is retroactive for two years before the effective date.

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