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Uncategorized

CMS Approves Medicare Coverage of ‘Breakthrough’ Medical Devices

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.

"COVID-19
Uncategorized

EEOC Issues New COVID-19 Vaccination Guidelines for Employers

The Equal Employment Opportunity Commission has affirmed that employers can mandate COVID-19 vaccines for employees, subject to some limitations.

The EEOC’s updated guidance offers direction regarding employer-mandated vaccinations, accommodations for employees who cannot be vaccinated due to a disability or sincerely held religious belief, and certain implications of pre-vaccination medical screening questions under the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act.

Asking a patient pre-screening questions is a routine part of a vaccination. These questions may constitute a “medical examination” as defined by the ADA. An employer must be able to show that the inquiries are “job-related and consistent with business necessity” and that an unvaccinated employee could pose a direct threat to the health of others in the workplace.

The guidance does make clear that administration of a COVID-19 vaccination to an employee itself does not constitute a medical examination for the purposes of the ADA.

Urging employees to get the vaccine voluntarily or requiring them to submit proof that a non-contracted third party (physician, pharmacist or public health center) administered it may be a better alternative with fewer legal complications.

Reasonable accommodations

Some employees may be unable to get the vaccine for health or disability reasons. Other employees may have sincere religious objections to getting inoculated. In both cases, employers must make reasonable accommodations for the employees. The law permits them to exclude these employees from the workplace only if no reasonable accommodation is possible.

Employers and employees might not agree on what “reasonable accommodation” means. For this reason, employers should consult with human resources experts and carry employment practices liability insurance. Expert advice will help avoid these kinds of conflicts, and the insurance will pay for legal defense and settlement of resulting employee lawsuits.

Requiring employees to get vaccinated will also have implications for the employer’s obligations under state workers’ compensation laws. On the positive side, a vaccinated workforce should reduce the employer’s exposure to claims that an employee got the virus on the job.

On the negative side, some employees may experience adverse side effects. Since the vaccine would be a job requirement, the employee could make a claim for workers’ comp benefits due to the adverse reaction. In addition, the employer may have to pay the worker for the time spent getting vaccinated and for the cost of the injection.

What you can do

Employers can protect themselves by following these guidelines:

  • Follow federal and local health guidelines for the vaccine.
  • Vary the requirements depending on work conditions and locations, such as requiring vaccines for those who regularly interact with the public but making them optional for remote workers.
  • Accommodate employees unable to get the vaccine or resistant to it, to the extent you reasonably can without endangering other employees or the public.
  • Apply the requirements consistently to all employees.

No one wants to catch or spread this virus. Employers can help halt the spread by thoughtfully addressing the issue of vaccinating employees.

"Affordable
Uncategorized

Trimming Hours to Avoid Employer Mandate Can Land You in Hot Water

Ever since the Affordable Care Act was enacted, critics of the law have said that employers would cut staff or reduce workers’ hours to avoid coming under the employer mandate requiring them to provide coverage for their staff.

But employers that decided to go that route could find themselves in a costly legal trap thanks to precedent-setting case that has been cited often by judges when confronted with challenges. 

Workers at Dave & Buster’s, a restaurant chain, in July 2015 filed a lawsuit in the Southern District of New York alleging that the national restaurant chain reduced their hours to keep them from attaining full-time status for the purpose of avoiding the requirement to offer them health coverage under the ACA’s employer mandate.

In February 2016, the federal judge in the case, in declining the employer’s motion to dismiss the case, cited its likely breach of the Employee Retirement Income Security Act (ERISA), which prohibits employers from interfering with a worker’s right to benefits.

This case is significant because many other employers have implemented similar strategies striving to limit work hours for certain groups of employees for the purpose of avoiding penalties under the ACA.

Some background

The ACA’s employer mandate generally requires large employers (those with 50 or more full-time workers or full-time equivalent employees) to offer affordable and minimum value health coverage to their full-time employees (employees who regularly work an average at least 30 hours per week).

Employers are not generally required to offer coverage to employees working less than 30 hours per week on average.

Since the employer mandate took effect, many employers have been moving employees to part-time status to avoid triggering penalties under the employer mandate. 

Why the case is important

The Dave & Buster’s employees alleged that the company violated ERISA by cutting their hours. They cited Section 510 of ERISA, which prohibits employers from discriminating against any participant or beneficiary for exercising a right under ERISA or an ERISA benefit plan. 

The workers alleged that by reducing employees’ hours to keep them below the 30-hour weekly average to qualify as a full-time employee, Dave & Buster’s interfered with the attainment of the affected employees’ right to be eligible for company health benefits.

Dave & Buster’s in October 2015 filed a motion to dismiss the case, but the Southern District of New York federal judge denied the motion in February 2016.

The law firm of McDermott Will & Emery in its blog highlighted the importance of the decision, stating, “The opinion focuses on ERISA Section 510 and holds that the plaintiff has a viable claim that reducing her work hours was done for the purpose of interfering with her right to benefits under the company health plan.

“Second, the opinion finds that the complaint successfully alleged the employer’s ‘unlawful purpose’ and intention to interfere with benefits, pointing to allegations that company representatives publicly stated that they were reducing the number of full-time employees to avoid ACA costs.” 

The law firm noted that the decision has given plaintiff’s attorneys a model for filing similar complaints when employers reduce hours to avoid their obligations under the ACA.

It also noted that if judges in other cases deny employers’ motions to dismiss cases, it will put the employer in a more difficult position because the employees’ attorneys will be able to take discovery and depositions, and to compel document production.

Any signs or proof of reducing hours to avoid their obligations under the ACA will make defending the case even more difficult, McDermott Will & Emery wrote.

If you have trimmed hours to avoid the employer mandate, or if you are contemplating doing so, it’s best that you first discuss these plans with your company lawyer.

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Uncategorized

How a New Law Affects Group Health Plans

The newly enacted Consolidated Appropriations Act, 2021 contains a number of provisions that will affect group health plans, with most changes aimed at helping insured workers with flexible spending accounts (FSAs), cost transparency and surprise billing.

Some of the provisions are permanent while others are temporary, slated to run through the anticipated end of the COVID-19 pandemic. Here’s a look at the highlights that will affect employer-sponsored health benefits.

FSA carryover rules loosened

The new law authorizes employers to amend their cafeteria plans and FSAs to either:

  • Allow participating staff to carry over unused amounts from the 2020 plan year to the 2021 plan year (and from 2021 to 2022 as well), or
  • Provide a 12-month period at the end of the 2020 and 2021 plan years.

Under existing law, employers can only allow employees to carry over $550 from one plan year to the next.

The law also allows employees who stop participating in their FSA because they were terminated to continue receiving reimbursement from unused funds through the end of the year during which they stopped participating.

Finally, under the CAA, employees can change how much they set aside into their FSA mid-year (usually they can only change their contribution levels ahead of a new plan year).

In all of the above cases, employers must approve these changes and update them in their plan documents.

Health plan transparency

The CAA also bars “gag clauses,” which bar health insurers from entering into contracts that restrict a plan from accessing and sharing certain information. This is effective as of Dec. 27, 2020.

The goal of these new rules is to increase transparency in pricing and quality information for health care consumers and plan sponsors. 

In addition, there are new requirements for health plan ID cards for enrollees, and they will be required to include the following information starting with the 2022 plan year:

  • Deductibles that are applicable to their coverage
  • Out-of-pocket maximum limits
  • Phone number and website address that enrollees can access for assistance.

Surprise billing

The CAA also created the No Surprises Act, which will, starting with the 2022 plan year, cap a plan enrollee’s cost-sharing obligations for out-of-network services to the plan’s applicable in-network cost-sharing level for the following three categories of services:

  • Emergency services performed by an out-of-network provider or facility, and post-stabilization care if the patient cannot be moved to an in-network facility;
  • Non-emergency services performed by out-of-network providers at in-network facilities, including hospitals, ambulatory surgical centers, labs, radiology facilities and imaging centers; and
  • Air ambulance services provided by out-of-network providers.

The takeaway

With so many changes, employers who sponsor group health plans for their workers need to have a plan to make sure they and their health plans comply.

 What to do now: If you offer FSAs to your staff and want them to be able to carry over funds from 2020 to 2021, and next year as well, you will need to make those changes to your plan documents.

Employers that sponsor group health plans should review their agreements with their health insurers and ensure that their plan contractors include language indicating that the contract complies with the prohibition on gag clauses.

What to prepare for: Starting with the 2022 plan year, employers should check with us or their insurer to make sure that the transparency changes are reflected in their plan documents and that their employees’ health plan cards also include the changes required by the new law. 

Plans should also reflect the new rules created by the No Surprises Act.

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Uncategorized

Changes for 2021 Summary of Benefits and Coverage

There are new Summary of Benefits and Coverage notice requirements for health plans starting with the 2021 coverage year.

The requirements, released by the Department of Labor, have new model templates, new instructions and new information that affects the coverage examples that are required to be in SBC documents that employers with group health plans must distribute to their employees.

Under the Affordable Care Act, all non-grandfathered health plans are required to provide enrollees and prospective applicants an SBC, which is essentially a synopsis of the plan’s coverage and benefits. It must be produced in a specific format, contain specific information, and be written in a way that is easily understood.

Here are the changes that were made to the SBC template for plans that started on or after Jan. 1:

Coverage example

The coverage examples that appear on the last page of the document have been modified to reflect changes in the cost of medical services that occur over time due to inflation and other factors:

  • “Managing Joe’s Type 2 diabetes” (diabetes example): The total amount of expenses incurred for “Joe” has decreased.
  • “Mia’s simple fracture” (fracture example): The total amount of expenses incurred by “Mia,” who visited the emergency room for a simple fracture, has increased.
  • “Peg is having a baby” (maternity example): The costs incurred during “Peg’s” hospital stay have been changed to remove separate newborn charges. The deductible line of the example should now match “your deductible amount” (if applicable).

Minimum essential coverage

Under the entry for minimum essential coverage, the template has been revised to reflect the elimination of the individual mandate penalty, which was repealed effective Jan. 1, 2019.

The entry now indicates that individuals eligible for certain types of minimum essential coverage may not be eligible for a premium tax credit under the ACA marketplace.

Uniform glossary

The uniform glossary has been updated to remove references to the individual mandate penalty.

What to do

If you offer group health plans to your employees, you are a plan sponsor and thus required to distribute SBCs to staff who are eligible for coverage during open enrollment. The SBC must also be given to new hires within 90 days of hiring for mid-year enrollment. 

If you don’t have your latest SBC, you can contact us or your health insurer. The insurer is obligated to provide all covered employers with updated SBCs after the Department of Labor and the Department of Health and Human Services release changes to templates.

"COVID-19
Uncategorized

Demand for Voluntary Group Benefits Grows During Pandemic

As the COVID-19 pandemic drags on and many Americans see unmet needs outside of their health insurance, more and more workers are increasingly signing up for the voluntary benefits their employers offer.

While many workers in the past had skipped on voluntary benefits, they have grown concerned that a good group health insurance plan may not be enough to provide all the coverage they need.

It’s important for employers to react to this trend as the pandemic has put many people on edge about how they can continue to pay the bills if they are laid up with COVID-19, and especially if they have long-haul symptoms that have plagued some people for months after first getting sick. 

Employers who fail to upgrade offerings could see higher turnover and more difficulty in retaining and attracting talent.

More employers have added these insurance products to their voluntary benefit offerings. According to a recent Aflac survey, more than 80% of employers are looking at offering insurance plans that cover costs associated with coronavirus or a future pandemic. 

Also, many insurers are actively developing new plans and enhancing existing plans that pay benefits for prevention, diagnosis and treatment of a variety of virus strains.

Extra peace of mind

Voluntary benefits offer both employers and employees added peace of mind in uncertain times. These plans serve a dual role: In addition to helping pay expenses health insurance doesn’t cover, they also serve as a financial safety net if covered illnesses arise as complications of the coronavirus. 

There are a number of plans that can provide coverage that would be outside the scope of health insurance, including:

  • Hospital indemnity insurance – This is a supplemental plan designed to pay for the costs of a hospital admission that may not be covered by other insurance. It will cover out-of-pocket expenses like medical copays, deductibles and regular expenses, such as food, rent and utilities.
  • Critical illness insurance – These plans pay out in the event of covered critical illnesses. This insurance can help alleviate financial worries during a serious illness by providing a lump-sum cash payment to the insured person when they’re diagnosed with a specific critical illness. The benefit provides cash at a time when it may be needed most.
  • Life insurance – In case the unthinkable happens.
  • Disability insurance – These plans pay benefits when insureds are unable to work due to covered illnesses or injuries. If you have disability insurance and become injured or sick and lose your ability to work, you’ll get paid monthly disability insurance benefits to cover your lost income.
    Disability insurance can be bought individually, but many employers offer long-term and short-term disability insurance as part of an employee benefits package, like health insurance.

The pandemic has highlighted the need for these and other employee benefits that take care of the whole individual, rather than focusing on just health insurance. 

Executives at insurers that offer these products say that as Americans struggle to balance their work and home lives, particularly if they work from home as a result of the pandemic, they are looking to their employers for more support to help cover holes in their benefits.

The key: Education

If employers have too many voluntary benefit offerings and don’t do a good job of explaining how they complement each other, it can only lead to confusion among their employees. And if they are confused, the chance that they will opt for any of the plans is greatly diminished.

That’s why education about the products, and how if set up properly they can provide a powerful level of protection for a variety of events, is crucial. If you’re interested in expanding the voluntary benefits you offer your employees, now is the time. We can help you get the ball rolling and help educate your staff on their choices and why they are important.

"COVID-19"/
Uncategorized

COVID-19 Relief Bill Extends Unemployment Benefits, PPP and More

The $900 billion COVID-19 relief bill, passed by Congress and signed into law on Dec. 27, includes a number of provisions that affect employers and their workers in terms of paid sick leave and Emergency Family and Medical Leave Act provisions.

The legislation also boosts unemployment benefits to out-of-work Americans, as well as reopening and expanding the Paycheck Protection Program that was introduced in March as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Paid sick leave and family medical leave

The new law has not extended the obligation for employers to provide emergency paid sick leave and expanded family and medical leave beyond Dec. 31, 2020, instead making it voluntary after that date.

From Jan. 1, employers can continue receiving tax credits if they provide emergency paid sick leave (EPSL) and emergency family medical leave (EFML) to employees for COVID-19-related purposes through March 31. Here are the caveats:

  • Tax credits will be available for leave granted to employees who did not already exhaust 80 hours of EPSL and 12 weeks of EFML. For example, if a worker who was entitled to 80 hours of EPSL last year used 50 of those hours, they’d have 30 hours left to use between Jan. 1 and March 31 this year.
  • Employers must protect the jobs of any employee that is granted EPSL and EFML.

Other provisions

The legislation extends some CARES Act unemployment programs:

Unemployment benefits ― The new law extends the Federal Pandemic Unemployment Compensation (FPUC) program supplement from December 26, 2020 to March 14. However, instead of receiving $600 a week under the original program, benefits will be $300 per week.

Gig worker unemployment benefits ― The law also extends the Pandemic Unemployment Assistance (PUA) program, which covers independent contractors and gig workers who would usually not be eligible for unemployment insurance payments.

This program (originally created by the CARES Act) is also extended to March 14, and then a three-week phase-out period begins and will run until April 5. The law increases the number of weeks independent contractors are eligible for these benefits to 50 from the original 39. 

Extra weeks for those whose benefits ran out ― The Pandemic Emergency Unemployment Compensation (PEUC) program, which provides additional weeks of unemployment insurance benefits to individuals who use up all of their state unemployment benefits, will be extended until March 14.

The law also increases the number of benefit weeks to 24, from 13 under the original version of the program. After March 14, this program will be phased out over three weeks until April 5.

More money ― Taxpayers with annual incomes below $75,000 will receive a $600 check, plus another $600 per dependent child. Payments are phased out for people with incomes in excess of $75,000.

Paycheck Protection Program (PPP) part II ― The law also sets aside $284 billion for forgivable loans to struggling businesses as part of a second PPP. Companies that receive funds will have to use the money on payroll and other specific expenses if they want the loan to be forgiven.

Depending on the loan, employers will have either eight or 24 weeks after receiving the loan to spend it on approved expenses.

But PPP part 2 does have some additional prerequisites that differ from the original. It lowers the employee threshold for businesses to 300 employees or fewer (down from 500). Additionally, the maximum loan is now $2 million, compared to $10 million under the original PPP.

Qualifying expenses are also different in this version, which means any business thinking about applying needs to read all the fine print.

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Uncategorized

New Law Bans Surprise Billing

Part of the COVID-19 relief package that Congress passed in late December includes a notable provision that bans surprise medical bills when out-of-network doctors work on insureds at in-network hospitals.

This so-called “balance billing” occurs when an out-of-network provider is involved in a patient’s care at a hospital that accepts their insurance, often without the patient knowing about it. Patients can end up facing unexpected bills in the tens of thousands of dollars.

Specifically, the law bars out-of-network providers and air ambulance firms from billing patients for more than they would be charged by in-network providers (ground ambulance services are not covered under the law).

Additionally, health plans are barred from requiring patients to pay more for care they unknowingly receive from out-of-network providers at in-network facilities.

According to the Kaiser Foundation, 18% of emergency visits lead to at least one out-of-network charge for people covered by large group plans, as do 16% of in-network inpatient admissions.

Here are the main points of the legislation:

  • The law requires that patients be billed on their plan’s in-network rate for emergency medical care at an out-of-network facility, or if they are treated by an out-of-network clinician at an in-network hospital.
  • It protects patients admitted to an in-network hospital for a planned procedure when an out-of-network doctor works on the patient. Most often this happens when a doctor is called to provide assistance in the operating room, or if the anesthesiologist on duty is out of network.
  • Doctors and health plans are allowed to bill for out-of-network treatment in the above situations if the patient is informed of the estimated costs at least 72 before they receive care.
  • Whatever the patient pays for the above out-of-network services must be counted toward their in-network annual deductibles.

Billing disputes

For the health insurers and providers to agree on the cost of care, the new law sets up an arbitration process to settle payment disputes for out-of-network claims. The plan sponsor and the covered employee are not part of this dispute resolution process.

The law gives the insurer and provider 30 days to settle a dispute and if they can’t come to an agreement during that time, they can go to a binding arbitration process that the law creates. This “Independent Dispute Resolution” (IDR) will be administered by independent entities.

During IDR, both the insurance company and the provider submit what they want to pay to the dispute resolution arbiter, who will decide a fair amount based on what other providers charge for similar services.

The arbiter will not be allowed to consider rates paid by Medicare and Medicaid, which tend to be lower than what commercial insurers pay for services and what hospitals normally charge. 

The decisions are binding. after which the insurer has 90 days to pay the bill.

The new law takes effect in January 2021.

One more thing…

Besides banning surprise billing, the law also bars gag clauses. Many contracts between health insurers and providers include provisions that bar enrollees, plan sponsors or referring providers from seeing cost and quality data on providers. These provisions will now be prohibited.

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Uncategorized

New Rules Require Health Plans to Cover COVID-19 Vaccines, More

The Trump administration has issued new interim final rules that set out accelerated coverage requirements for COVID-19 preventative services and covering out-of-network testing for the coronavirus.

There are two parts to the interim final rules:  

  • One requires that COVID-19 preventative services – including vaccines – be covered without any cost-sharing on the part of plan enrollees.
  • The second creates a reimbursement formula for insurers to pay for COVID-19 testing conducted on their enrollees by out-of-network providers.

The new rules, which implement important parts of the CARES Act, were rolled out by the Treasury, Labor, and Health and Human Services departments.

If you are a plan sponsor, you need to know how this affects your group health plan so you can help your staff understand how testing and preventative COVID-19 services are covered.

COVID-19 preventative services

The CARES Act requires that COVID-19-related preventative services be covered within 15 business days after a doctor recommends that a patient needs them.

COVID-19 preventative services must be covered without any out-of-pocket costs on behalf of health plan enrollees, whether they receive those services inside or outside their plan’s provider network. The reason for this is that as vaccines start rolling out, not all providers may have access in the beginning.

The rules are required to ensure that people who need vaccines can access them without any hardship to help put an end to the pandemic.

Under the rules, insurers must pay out-of-network providers a “reasonable amount,” which would be determined by the prevailing market rates that providers are charging health plans for the service. That may be the Medicare rate, the regulations note.

The rules cover more preventative services than just vaccines. They must also cover services that are “integral” to delivering preventative services, such as administrative costs.

Finally, if a preventative service, including a COVID-19 vaccine, is not billed separately from an office visit, and the primary purpose of the office visit is to deliver the recommended service or vaccine, the plan or insurer may not charge cost-sharing for the office visit.

COVID-19 tests by out-of-network providers

The new rules also set out the parameters for how health plans will pay out-of-network providers for COVID-19 diagnostic tests they perform on the latter’s enrollees.

On testing, the CARES Act requires that:

  • Health care providers post on their websites the cash price or any lower negotiated price for COVID-19 diagnostic testing. The “cash price” is the charge that applies to a walk-in patient who pays cash for the service.
  • Health insurers pay out-of-network providers of COVID-19 diagnostic tests the price posted on the provider’s website during the public health emergency.

The takeaway

If you sponsor a group health plan, you should communicate the new rules to your participating employees so that they are aware of the no out-of-pocket rules for COVID-19 preventative services. 

You should also keep up with the news about when vaccines will be rolled out in your area, so you can encourage your staff to get vaccinated.

The new rules will sunset at the end of the public health emergency. Currently, that’s slated for Jan. 21, 2021, but will likely be extended as it is unlikely a vaccine can be rolled out en masse by that time.

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