CMS Approves Medicare Coverage of ‘Breakthrough’ Medical Devices

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.

Uncategorized

EEOC Issues New COVID-19 Vaccination Guidelines for Employers

by Inoventive Solutions

February 16, 2021

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.

Uncategorized

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

by Inoventive Solutions

February 9, 2021

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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How a New Law Affects Group Health Plans

by Inoventive Solutions

February 3, 2021

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.