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Departments Issue Guidance Requiring First Annual “Gag” Attestation by December 31, 2023

March 09 - Posted at 1:12 PM Tagged: , , , , , ,

On February 23, 2023, the Departments of Labor, Health and Human Services and the Treasury (Departments) issued FAQs on the prohibition of gag clauses under the transparency provisions of the Consolidated Appropriations Act, 2021 (CAA). These FAQs require health plans and health insurance issuers to submit their first attestation of compliance with the CAA’s prohibition on gag clauses by December 31, 2023.

Effective December 27, 2020, the CAA forbids health plans and issuers from entering into contracts with health care providers, third-party administrators (TPAs)  or other service providers that would restrict the plan or issuer from providing, accessing or sharing certain information about provider price and quality and deidentified claims.

Plans and issuers must annually submit an attestation of compliance with these requirements to the Departments. The first attestation is due by December 31, 2023, covering the period beginning December 27, 2020, through the date of attestation. Subsequent attestations, covering the period since the last attestation, are due by December 31 of each following year.

Action Steps

Employers should ensure any contracts with TPAs or other health plan service providers offering access to a network of providers do not violate the CAA’s prohibition of gag clauses. Additionally, employers with fully insured or self-insured health plans should prepare to provide the compliance attestation by December 31, 2023. If the issuer for a fully insured health plan provides the attestation, the plan does not also need to provide an attestation. Also, employers with self-insured health plans can enter into written agreements with their TPAs to provide the attestation, but the legal responsibility remains with the health plan.

Prohibition on Gag Clauses

A gag clause is a contractual term that directly or indirectly restricts specific data and information that a health plan or issuer can make available to another party. Effective December 27, 2020, the CAA generally prohibits group health plans and issuers offering group health insurance from entering into agreements with health care providers, TPAs or other service providers that include certain gag clause language. Specifically, these contracts cannot restrict a plan or issuer from:

  1. Providing provider-specific cost or quality-of-care information or data to referring providers, the plan sponsor, participants, beneficiaries or enrollees (or individuals eligible to become participants, beneficiaries or enrollees of the plan or coverage);
  2. Electronically accessing de-identified claims and encounter information or data for each participant, beneficiary or enrollee upon request and consistent with privacy rules under the Health Insurance Portability and Accountability Act (HIPAA), the Genetic Information Nondiscrimination Act (GINA), and the Americans with Disabilities Act (ADA); and
  3. Sharing information or data described in (1) and (2) above or directing such information to be shared with a business associate, consistent with applicable privacy rules.

For example, if a contract between a TPA and a health plan provides that the plan sponsor’s access to provider-specific cost and quality-of-care information is only at the discretion of the TPA, that contractual provision would be considered a prohibited gag clause.

Plans and issuers must ensure their agreements with health care providers, networks or associations of providers, TPAs or other service providers offering access to a network of providers do not contain provisions that violate the CAA’s prohibition on gag clauses.

Gag Clause Compliance Attestations

Health plans and issuers must annually submit an attestation of their compliance with the CAA’s prohibition on gag clauses to the Departments. The first attestation must be submitted no later than December 31, 2023, covering the period beginning December 27, 2020, through the date of the attestation. Subsequent attestations are due by December 31 of each following year, covering the period since the last attestation.

According to the Departments’ FAQs, health plans and issuers that do not submit their attestations by the deadline may be subject to enforcement action.

COVERED HEALTH PLANS

The attestation requirement applies to fully insured and self-insured group health plans, including ERISA plans, non-federal governmental plans and church plans. Additionally, this requirement applies regardless of whether a plan is considered “grandfathered” under the ACA. However, plans that only provide excepted benefits and account-based plans, such as health reimbursement arrangements (HRAs), are not required to submit an attestation.

RELYING ON ISSUERS/TPAS TO SUBMIT ATTESTATION

With respect to fully insured group health plans, the health plan and the issuer are each required to submit a gag clause compliance attestation annually. However, when the issuer of a fully insured group health plan submits a gag clause compliance attestation on behalf of the plan, the Departments will consider the plan and issuer to have satisfied the attestation submission requirement.

Employers with self-insured health plans can satisfy the gag clause compliance attestation requirement by entering into a written agreement under which the plan’s service provider, such as a TPA, will provide the attestation on the plan’s behalf. However, even if this type of agreement is in place, the legal requirement to provide a timely attestation remains with the health plan.

ATTESTATION WEBSITE

The Departments launched a website through the Centers for Medicare and Medicaid Services for health plans and issuers to submit their gag clause compliance attestations. The Departments have also provided instructions for submitting the attestation, a system user manual, and a reporting entity Excel template for plans and issuers to submit the required attestation, all of which are available here.

New Tools Aid Consumers in Estimating Health Care Costs in Advance

January 06 - Posted at 11:00 AM Tagged: , , , ,

Need medical treatment this year and want to nail down your out-of-pocket costs before you walk into the doctor’s office? There’s a new tool for that, at least for insured patients.   

As of Jan. 1, 2023, health insurers and employers that offer health plans must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs.

It’s the latest effort in an ongoing movement to make prices and upfront cost comparisons possible in a business known for its opaqueness.

Insurers must make the cost information available for 500 nonemergency services considered “shoppable,” meaning patients generally have time to consider their options. The federal requirement stems from the Transparency in Coverage rule finalized in 2020.

So how will it work?

Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.

Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.

Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.

Starting in 2024, the requirement on insurers expands to include all drugs and services.

These estimator-tool requirements come on top of other price information disclosures that became effective during the past two years, which require hospitals and insurers to publicly post their prices, including those negotiated between them, along with the cost for cash-paying or uninsured patients.

Still, some hospitals have not fully complied with this 2021 disclosure directive and the insurer data released in July is so voluminous that even researchers are finding it cumbersome to download and analyze.

The price estimator tools may help fill that gap.

The new estimates are personalized, computing how much of an annual deductible patients still owe and the out-of-pocket limit that applies to their coverage. The amount the insurer would pay if the service were out of network must also be shown. Patients can request to have the information delivered on paper, if they prefer that to online.

Insurers or employers who fail to provide the tool can face penalty fines of at least $100 a day for each person affected, a significant incentive to comply — if enforced.

And there are caveats: Consumers using the tools must be enrolled in the respective health plan, and there’s no guarantee the final cost will be exactly as shown.

That’s because “unforeseen factors during the course of treatment, which may involve additional services or providers, can result in higher actual cost sharing liability,” federal regulators wrote in outlining the rules.

Insurers will not be held liable for incorrect estimates.

Because the cost estimates may well vary from the final price, either because the procedure was more complex than initially expected, or was handled by a different provider at the last minute, one risk is that a consumer might get a bill for $4,000 and they will be upset because the estimator told them $3,000.

Many insurers have offered versions of cost-estimator tools before, but small percentages of enrollees actually use them, studies have shown.

Federal regulators defended the requirement for estimator tools, writing that even though many insurers had provided them, the new rule sets specific parameters, which may be more detailed than earlier versions.

In outlining the final rule, the Centers for Medicare & Medicaid Services pointed out that some previous calculators “on the market only offer wide-range estimates or average estimates of pricing that use historical claims data” and did not always include information about how much the patient had accumulated toward an annual deductible or out-of-pocket limit.

The agency says such price disclosure will help people comparison-shop and may ultimately help slow rising medical costs.

But that isn’t a given.

“CMS has a lot of people who believe this will make a significant impact, but they also have a long time frame,” said David Brueggeman, director of commercial health at the consulting firm Guidehouse.

In the short term, results may be harder to see.

“Most patients are not moving en masse to use these tools,” said Dr. Ateev Mehrotra, a professor of health care policy at Harvard Medical School.

There are many reasons, he said, including little financial incentive if they face the same dollar copayment whether they go to a very expensive facility or a less expensive one. A better way to get patients to switch to lower-cost providers, he said, is to create pricing tiers, rewarding patients who seek the most cost-effective providers with lower copayments.

Mehrotra is skeptical that the cost estimator tools alone will do much to dent rising medical prices. He’s more hopeful that, in time, the requirement that hospitals and insurers post all their negotiated prices will go further to slow costs by showcasing which are the most expensive providers, along with which insurers negotiate the best rates.

Still, the cost-estimator tools could be useful for the increasing number of people with high-deductible health plans who pay directly out-of-pocket for much of their health care before they hit that deductible. During that period, some may save substantially by shopping around.

Those deductibles add “pressure on consumers to shop on price,” said Brueggeman, at Guidehouse. “Whether they are actually doing that is up for debate.”

December 27, 2022, Deadline for Mandatory Rx Data Collection Reporting

December 27 - Posted at 10:32 AM Tagged: , , , , , , ,

As group health plan sponsors, employers are responsible for ensuring compliance with the prescription drug data collection (RxDC) reporting requirements added to ERISA by the Consolidated Appropriations Act of 2021 (CAA).  Under ERISA section 725, enforced by the US Department of Labor (DOL), group health plans (not account-based plans, e.g., health reimbursement arrangements and health savings accounts, or excepted benefit arrangements) must report details regarding the plan’s prescription drug benefit utilization, including the drugs most frequently dispensed, the most expensive drugs, and the drugs with the highest cost increase for a given calendar year.  Reporting is to be made annually to the US Department of Health and Human Services’ (HHS) CMS enterprise portal’s Health Insurance Oversight System (HIOS) module, starting with the report due by December 27, 2022, for the 2020 and 2021 calendar years.  After that, annual reporting is due by June 1st following the calendar year (so, the 2022 calendar year report is due by June 1, 2023).  The DOL must thereafter post aggregated information on its website so that the public can see trends in prescription drug utilization and pricing.        

What’s required.  Under regulations issued jointly by HHS, DOL, and the US Treasury Department, plans must submit RxDC reports which include –

  • General information about the plan like the plan sponsor, plan year, number of participants, market segment (small or large group and fully-insured or self-insured), insurer and other vendors, and the states in which coverage is offered, etc. (“plan list” information – see the template document for reporting, using code P2 for group health plans, at this link);
  • Eight data files:
    • Premium/cost and life-year (average number of covered members) data (D1),
    • spending by six categories – hospital, primary care, specialty care, other medical costs and services, known medical benefit drugs, and estimated medical benefit drugs (D2),
    • top 50 most frequently dispensed brand name drugs by state and market segment (D3),
    • top 50 most costly drugs by state and market segment (D4),
    • top 50 drugs by spending increase by state and market segment, excluding drugs issued an Emergency Use Authorization or not FDA-approved (D5),
    • prescription drug spending totals (D6),
    • prescription drug rebates by therapeutic class (D7),
    • and prescription drug rebates for the top 25 drugs by state and market segment (D8); and
  • A narrative that describes the impact of prescription drug rebates on premium and cost-sharing, how the employer size was estimated (for self-insured plan sponsors), how bundled or alternative payment arrangements attributable to drugs covered under a medical benefit were estimated, and how net payments from government reinsurance and cost-sharing reduction programs were considered (if applicable).  The narrative also is used to identify any drugs prescribed for which a National Drug Code (NDC) was not on the CMS RxDC code crosswalk, and the types of rebates and other remuneration included in or excluded from the D8 data file.     

How to comply.  HIOS issued specific reporting instructions which explain the reporting requirements in detail and assure plan sponsors that submission for a plan “is considered complete if CMS receives all required files, regardless of who submits the files.”  Many group health plan vendors (insurers, third-party administrators, pharmacy benefit managers, etc.) have proactively contacted plan sponsors to assure them that the vendor will report at least some of the information on the plan’s behalf.  However, not all vendors are willing to accept responsibility for the RxDC reporting requirements.  Employers need to know which reporting obligations will be fulfilled by the group health insurer or other vendor and which reporting obligations must be satisfied by the plan sponsor.  Most plan sponsors are wise to be prepared to upload at least some of the data to the HIOS module themselves, which means first setting up a HIOS account on the CMS portal HIOS accounts can take a couple of weeks to set up, so it’s important for plan sponsors to act on this now if they’ve not already done so.  CMS has provided detailed instructions for setting up the HIOS account. 

Compliance issues.  The statute and regulations impose the RxDC reporting requirements on group health plans, which, by default, usually means that requirements and liability for noncompliance are imposed on plan sponsors (generally, employers).  Thus, each group health plan sponsor should ensure that all of the RxDC reporting requirements are satisfied for each group health plan subject to the reporting requirements.  Employers should obtain written agreements from plan vendors identifying what data each vendor will upload.  Note that the employer remains liable for noncompliance (and subject to excise tax and potential civil penalties), even if it has an enforceable agreement with its vendor to ensure compliance unless the plan is fully-insured and the agreement is with the insurer.  Unfortunately, only the reporting entity can view the files it uploads to HIOS, so there is no way for an employer to confirm on the HIOS module that a vendor uploaded the file(s) it agreed to upload on behalf of the employer’s group health plan.  Instead, the employer should obtain written assurance from the plan’s vendor(s) and rely on contractual provisions for recourse if a vendor fails to fulfill its RxDC reporting service as agreed.

Supreme Court Set to Resolve Vaccine ETS and Healthcare Mandate: What Employers Should Do Until Decision is Reached

December 27 - Posted at 11:41 AM Tagged: , , , , , , ,

The nation’s highest Court has announced it will step in and rule whether the Biden administration’s aggressive workplace vaccine strategy – including a mandate-or-test rule for larger employers and a strict mandate for certain healthcare organizations – should be temporarily blocked or are permitted to move forward as planned. In a pair of brief orders issued on Dec 22nd, the Supreme Court accepted review of the challenges to both OSHA’s ETS and CMS’s healthcare mandate and announced that oral argument will be held for both cases on January 7th. So what should you be doing in the meantime? Here is a review of what has happened, along with a five-step survival guides for employers subject to either the OSHA ETS or the CMS mandate.

Brief Overview and Recap

There are two rules at play here: a general ETS issued by OSHA that covers employers with over 100 workers and the CMS’s Healthcare Mandate which is specific to the healthcare industry. Whereas OSHA’s general ETS provides an option for employers to test employees for COVID-19 at least weekly in lieu of mandating the vaccine, the CMS mandate does not allow for a testing option and requires a vaccination policy.

General OSHA ETS

After workplace safety officials at the Occupational Safety and Health Administration (OSHA) unveiled the mandate-or-test ETS on November 4, many groups opposing the rule filed actions in several federal courts to block the rule. The conservative Fifth Circuit Court of Appeals was the first to act by issuing a temporary “stay” that preliminarily blocked the ETS. This was followed by a November 12 extension of that stay which ordered OSHA to take no steps to implement or enforce the ETS.

But the Judicial Panel of Multidistrict Litigation announced on November 16 that it would consolidate all of the legal challenges and send them to the conservative Sixth Circuit Court of Appeals to decide the outcome of the rule. Then, on December 17, a surprise decision from a three-judge panel of the Sixth Circuit once again jolted employers back into scramble mode, as the court dissolved the stay and cleared OSHA to enforce the ETS across the country.

CMS Healthcare Mandate

The history and procedural status of the healthcare vaccine mandate are a bit messier. In early November, the Centers for Medicare & Medicaid Services (CMS) published a vaccine mandate, requiring all employees of healthcare facilities participating in Medicare and Medicaid – more than 17 million workers – to be fully vaccinated by January 4. Then, a pair of federal court decisions issued in late November blocked the mandate. First, on November 29, a federal judge in Missouri temporarily blocked the agency from enforcing the mandate in 10 states. And then, on November 30, a Louisiana federal court took one giant step further and blocked the rule from taking effect in any healthcare facility across the country that was not already covered by the Missouri decision.

Serving up yet another curveball for healthcare employers, the Fifth Circuit Court of Appeals effectively reactivated the CMS vaccination mandate with a surprise decision on December 15 – but only for employers operating in nearly half of the country. And that’s where things stand now. You can review this most recent Insight for a list of states where the CMS mandate has been kept alive and a list of states where the CMS mandate is currently blocked.

What Happened Yesterday?

While the orders from SCOTUS were brief and to the point, three significant takeaways can be gleaned from the announcements:

  1. First and foremost, the Supreme Court agreed to entertain challenges to both rules. That in and of itself is significant. While many might believe that the nation’s highest Court must render a definitive ruling in this matter, its decision to accept review of the challenges was far from certain. In fact, many observers thought the Court might even duck the cases and avoid wading into what is sure to be perceived as a political dispute. At the very least, employers can take some solace in knowing that we will soon have a decisive answer about the immediate enforceability of both vaccine rules.
  2. Second, the Court rejected the chance to block the rules pending the outcome of their final rulings. The slew of challenges filed with SCOTUS not only asked the justices to fast-track the matter but also to pause the rules while the appeal was being decided. The Court declined to do so, keeping the rules alive for the time being.
  3. Third, by setting the oral argument for January 7, the Court has essentially forced employers to invest time and resources in preparing their compliance efforts. In the case of the general OSHA ETS, the first compliance deadline is January 10 – and employers not preparing in “good faith” could actually feel an enforcement sting before that date according to recent guidance from OSHA. Of course, there’s no telling when the Court will rule on the ETS, but even if it issued a decision immediately after oral argument, that would leave precious little time for employers to comply and demonstrate good faith before January 10 – meaning you need to prepare now. And for those healthcare employers subject to the CMS mandate in about half the country, the deadline for full compliance still appears to be the January 4 date to aim for (because the agency has still not provided any further clarification about deadlines despite the appeals court rulings described above). This means that you need to keep that deadline in mind and operate under the presumption that the Court will uphold the mandate.

What Should You Do? 5-Step Survival Guides

To demonstrate reasonable good faith efforts to comply between now and January 10, 2022, employers subject to the OSHA ETS should follow this five-step game plan:

  1. Are You Covered? Determine if you are covered by the ETS. Work with your workplace safety counsel to answer the following questions: Is your workplace covered by OSHA normally? If so, do you have more than 100 employees nationwide? Or are you exempt because you are covered by either the Healthcare COVID-19 ETS or Federal Contractor mandate? (More on this below).
  2. Check Vaccine Status. If you are covered, gather vaccine status information on your workforce and develop the required vaccination roster for employees, noting whether or not they are fully vaccinated as defined under the ETS. This information (the percentage of vaccinated workers) will allow you to determine if you will mandate vaccines or conduct testing under the ETS.  
  3. Choose: Vaccine Mandate or Test? Depending on your decision, develop the required mandatory vaccine and/or testing/masking policies required under the ETS – and make sure they are adapted to your own unique workplace. While you don’t necessarily need to implement these policies before January 10, you should be ready to implement them as soon as possible and be prepared to demonstrate good faith efforts to put them into place. Of course, if your organization has low risk tolerance, you could proceed with implementing the policies before January 10. Employers in OSHA “state plan” states face the further complication of needing to wait for states to adopt the ETS – OSHA told state plans yesterday that they will need to act by January 24 to adopt the ETS or otherwise ensure that their state plans are “as effective” as the federal rule. The ETS will generally not be effective in state plan states until they do so.  
  4. Compliance Training. Develop programs that would allow you to conduct compliance training for your managers and deliver information about your policies to your employees as required under the ETS. You may want to conduct this training and start your informational campaign before the January 10 deadline to further demonstrate your good faith efforts.
  5. Testing Proof. If you decide to provide the COVID-19 testing option, then in addition to implementing the above requirements by January 10 you should be prepared to have unvaccinated employees demonstrate proof of a negative test as of February 9.

If you are subject to the CMS healthcare mandate, the following five steps, described in further detail here, are critical parts of a successful plan:

  1. Safeguard Information. Adopt systems and procedures to determine and safeguard all information regarding employees’ vaccination status;
  2. Communicate Policies. Communicate applicable policies and procedures to everyone who may work on-site, including but not limited to the particulars of your vaccine requirement and the process for requesting exemptions;
  3. Accommodation Requests. Develop a non-discriminatory, streamlined process to handle vaccine accommodation requests;
  4. Accommodation Precautions. Review and confirm additional COVID-19 precautions that apply to individuals who are granted accommodations; and
  5. Prepare for Pushback. Prepare to respond to some inevitable pushback and complaints, as well as likely on-site CMS inspections, by communicating clearly and maintaining detailed records of your processes.

Conclusion

We will continue to monitor this litigation and provide updates as warranted. 

Florida Passes Legislation Banning Vaccine Mandates: What Employers Need to Know

November 19 - Posted at 8:24 AM Tagged: , , , , , , , ,

During a special legislative session, Florida just passed a new law banning private employers from mandating COVID-19 vaccines unless several exemptions are offered to employees. The law, signed by the governor on 11/18/21, comes as OSHA’s national emergency temporary standard mandating vaccines is embroiled in legal challenges. What do Florida employers need to know about this new law, which takes effect immediately?

Who is Covered and What Does It Do?

The law applies to all private employers in Florida, regardless of size. It prohibits those employers from requiring employees to get vaccinated against COVID-19 unless various exemptions are offered.

What are the Exemptions?

Some of the exemptions in the new law will sound familiar to employers. Others are unique. If an employer receives a statement from an employee (as described below), they must allow the employee to opt-out of the vaccine mandate. The Department of Health will be creating template forms for each of these exemptions.

  1. Medical Reasons

    This includes for reasons of pregnancy or anticipated pregnancy. To receive a medical exemption, an employee must submit a signed statement by a physician or physician assistant that vaccination is not in the best interest of the employee. While not addressed in the legislation, we suspect that this exemption will function similarly to those provided for disabilities under the Americans with Disabilities Act (ADA).

  2. Religious Reasons

    An employee must present a statement that they decline the vaccine because of a “sincerely held religious belief.” Although that term is undefined, it likely refers to sincerely held religious beliefs as understood under federal lawA.

  3. COVID-19 “Immunity”

    An employee must show “competent medical evidence” that they have immunity to COVID-19, which is documented by the results of laboratory testing on the employee. The law does not state what “immunity” is but directs the Department of Health to establish a standard for determining that immunity.

  4. Periodic Testing

    An employee must provide a statement indicating that they will comply with the employer’s requirement to submit to regular testing. Although “regular testing” is not defined, the law directs the Department of Health to adopt emergency rules specifying requirements for frequency of testing. Importantly, any testing must be at no-cost to the employee.

    Because this exemption has no ties to existing federal law such as Title VII and the ADA, and the law does not address any “undue hardship” defense, it is likely that an employer cannot decline to pay for the testing if there is a charge the employee would otherwise incur.

  5. Agreement to Use PPE

    An employee must present a statement that they agree to comply with the employer’s reasonable written requirement to use employer-provided personal protective equipment when around others. “Personal protective equipment” is not defined. It is unclear whether the use of the term would implicate OSHA regulations or CDC guidance on “personal protective equipment.”

But What About Federal Law?

The CMS Rule and Federal Contractor vaccine mandate requirements, which both require that covered staff be vaccinated and only allow for exemptions for medical conditions (ADA) and sincerely held religious beliefs (Title VII), should preempt this Florida law to the extent the laws directly conflict. The CMS Rule explicitly provides that it preempts state and local laws.

If OSHA’s ETS survives in the courts, it is likely that Florida’s new law will conflict with the OSHA ETS at least in so far as an employer (with 100 or more employees) might want to implement a mandatory vaccination policy instead of allowing employees to choose to be vaccinated or undergo weekly testing. However, the scope of that conflict is unknown and will depend on the final terms of the ETS if it survives.

How is the Law Going to be Enforced?

Florida’s vaccine mandate law will be enforced by the Department of Legal Affairs, in the Attorney General’s office. Employees can file complaints that an exemption was not offered or was improperly applied or denied, which will then be investigated. If the Department finds a violation, it must notify the employer of its determination and allow the employer the opportunity to cure the noncompliance. If the Department finds that an employee was improperly terminated and the employer does not restore the employee to their position with back pay, then the Department may fine the employer up to $50,000, depending on employer size and other factors. Employees who are wrongfully terminated may also be entitled to unemployment benefits. The Department of Legal Affairs will be issuing rules to further flesh out the complaint and investigation process.

What We Don’t Know Yet

There are many unanswered questions. For example, the new law does not address workers’ compensation claims and remains an open question whether an employee’s side effects to a mandated vaccine is covered by workers’ compensation.

What About Public Employers or Schools?

The legislature also passed statutes banning vaccine mandates for public employees and prohibiting any public educational institution or elected or appointed local official from imposing a COVID-19 vaccination mandate for any student. Unlike private sector employers, public sector employers are prohibited from mandating the vaccine — even if they offer the enumerated exemptions.

There are also provisions prohibiting public schools from requiring a student to wear a face mask, a face shield, or any other facial covering. Instead, such issues are left to the parent’s sole discretion. Further, the law prohibits public schools from barring any student or employee from school or school-sponsored activities or subjecting them to other disparate treatment based on an exposure to COVID-19, so long as the student or employee remains asymptomatic and has not received a positive test for COVID-19.

What Employers Can Do

Importantly, the law is not an outright prohibition on vaccine mandates. Private employers can still have a vaccine mandate, so long as you offer the various exemptions discussed above.

Neither does the law prohibit employers from “stacking” their COVID-19 prevention and mitigation efforts. Meaning, for example, you likely can still require both use of PPE and regular testing in order to protect its workforce. In other words, the statute is a ban on vaccine mandates without certain opt-out accommodations, but it is not a ban on your organization opting to require testing and/or continued use of PPE.

It is worth noting that this new law does not address employers’ immunity against COVID-19 claims. In March 2020, Florida passed a law granting businesses immunity from COVID-19 claims. Absent any more specific legislation, if an employer meets the standards of the immunity law (specifically, demonstrating good faith effort to comply with government-issued health guidance), the language of the immunity law is clear that the employer is immune from civil liability. This new law does not affect that.

You should also keep an eye out for the implementing rules to be issued by the various state agencies. According to the statute, such rulemaking must occur initially by filing emergency rules within 15 days after the effective date of the statute, followed by regular rulemaking thereafter. For the next 15 days (unless the Department of Health files its emergency rules earlier), employer COVID-19 vaccination mandates are deemed invalid under this statute.

What’s Next?

This new law is yet another issue facing employers, who are increasingly confronting a myriad of conflicting orders at the state and federal levels. Unfortunately, the issue of COVID-19 vaccines in the workplace remains incredibly fluid and will surely continue to evolve through the holiday season. As always, we will continue to monitor the situation regarding employers’ vaccine mandates and provide updates as warranted. 

Oct. 15th Deadline Nears for Medicare Part D Coverage Notices

September 15 - Posted at 9:00 AM Tagged: , , ,

Prior to each year’s Medicare Part D annual enrollment period, plan sponsors that offer prescription drug coverage must provide notices of creditable or noncreditable coverage to Medicare-eligible individuals.

The required notices may be provided in annual enrollment materials, separate mailings or electronically. Whether plan sponsors use the federal Centers for Medicare & Medicaid Services (CMS) model notices or other notices that meet prescribed standards, they must provide the required disclosures no later than Oct. 15, 2021.

Group health plan sponsors that provide prescription drug coverage to Medicare Part D-eligible individuals must also disclose annually to the CMS—generally, by March 1—whether the coverage is creditable or noncreditable. The disclosure obligation applies to all plan sponsors that provide prescription drug coverage, even those that do not offer prescription drug coverage to retirees.

Background

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires group health plan sponsors that provide prescription drug coverage to disclose annually to individuals eligible for Medicare Part D whether the plan’s coverage is “creditable” or “noncreditable.” Prescription drug coverage is creditable when it is at least actuarially equivalent to Medicare’s standard Part D coverage and noncreditable when it does not provide, on average, as much coverage as Medicare’s standard Part D plan. The CMS has provided a Creditable Coverage Simplified Determination method that plan sponsors can use to determine if a plan provides creditable coverage.

Disclosure of whether their prescription drug coverage is creditable allows individuals to make informed decisions about whether to remain in their current prescription drug plan or enroll in Medicare Part D during the Part D annual enrollment period. Individuals who do not enroll in Medicare Part D during their initial enrollment period (IEP), and who subsequently go at least 63 consecutive days without creditable coverage (e.g., they dropped their creditable coverage or have non-creditable coverage) generally will pay higher premiums if they enroll in a Medicare drug plan at a later date.

Who Gets the Notices?

Notices must be provided to all Part D eligible individuals who are covered under, or eligible for, the employer’s prescription drug plan—regardless of whether the coverage is primary or secondary to Medicare Part D. “Part D eligible individuals” are generally age 65 and older or under age 65 and disabled, and include active employees and their dependents, COBRA participants and their dependents, and retirees and their dependents.

Because the notices advise plan participants whether their prescription drug coverage is creditable or noncreditable, no notice is required when prescription drug coverage is not offered.

Also, employers that provide prescription drug coverage through a Medicare Part D Employer Group Waiver Plan (EGWP) are not required to provide the creditable coverage notice to individuals who are eligible for the EGWP.

Notice Requirements

The Medicare Part D annual enrollment period runs from Oct. 15 to Dec. 7. Each year, before the enrollment period begins (i.e., by Oct. 14), plan sponsors must notify Part D eligible individuals whether their prescription drug coverage is creditable or non-creditable. The Oct. 14 deadline applies to insured and self-funded plans, regardless of plan size, employer size or grandfathered status

Part D eligible individuals must be given notices of the creditable or non-creditable status of their prescription drug coverage:

  • Before an individual’s IEP for Part D.
  • Before the effective date of coverage for any Medicare-eligible individual who joins an employer plan.
  • Whenever prescription drug coverage ends or creditable coverage status changes.
  • Upon the individual’s request.

According to CMS, the requirement to provide the notice prior to an individual’s IEP will also be satisfied as long as the notice is provided to all plan participants each year before the beginning of the Medicare Part D annual enrollment period.

Model notices that can be used to satisfy creditable/non-creditable coverage disclosure requirements are available in both English and Spanish on the CMS website. Plan sponsors that choose not to use the model disclosure notices must provide notices that meet prescribed content standards.

Notices of creditable/non-creditable coverage may be included in annual enrollment materials, sent in separate mailings or delivered electronically. Plan sponsors may provide electronic notice to plan participants who have regular work-related computer access to the sponsor’s electronic information system. However, plan sponsors that use this disclosure method must inform participants that they are responsible for providing notices to any Medicare-eligible dependents covered under the group health plan.

Electronic notice may also be provided to employees who do not have regular work-related computer access to the plan sponsor’s electronic information system and to retirees or COBRA qualified beneficiaries, but only with a valid email address and their prior consent. Before individuals can effectively consent, they must be informed of the right to receive a paper copy, how to withdraw consent, how to update address information, and any hardware/software requirements to access and save the disclosure. In addition to emailing the notice to the individual, the sponsor must also post the notice (if not personalized) on its website.

In Closing

Plan sponsors that offer prescription drug coverage will have to determine whether their drug plan’s coverage satisfies CMS’s creditable coverage standard and provide appropriate creditable/noncreditable coverage disclosures to Medicare-eligible individuals no later than Oct. 15, 2021.

President’s Path Out of the Pandemic Adds Hurdles for Employers

September 10 - Posted at 8:10 AM Tagged: , , , , , , , ,

On September 9, 2021, the White House issued Path Out of the Pandemic: President Biden’s COVID-19 Action Plan (the Plan). The Plan outlines a six-pronged approach, portions of which will impose new obligations on employers across the country.

Most notably for employers, the first prong of the Plan, “Vaccinating the Unvaccinated,” includes:

  • Direction to the Department of Labor’s Occupational Safety and Health Administration (OSHA) to issue an Emergency Temporary Standard (ETS) requiring all employers with 100 or more employees to ensure that all employees are fully vaccinated or able to produce a negative COVID-19 test result on at least a weekly basis;
  • A new Executive Order that requires certain government contractors to comply with guidance, to be published later this month by the Safer Federal Workforce Task Force (Task Force Guidance or Guidance), which presumably will require that employees who work on or in connection with certain government contracts be vaccinated, regardless of whether they work on a federal site;
  • A statement that the Centers for Medicare & Medicaid Services (CMS) will be taking action to require COVID-19 vaccination for workers in most health care settings that receive Medicare or Medicaid reimbursement as a condition of Medicare/Medicaid reimbursement (similar to what was previously announced by the President in August 2021 for nursing homes); and
  • Direction to OSHA to require covered employers to provide paid time off for employees to get vaccinated or recover from vaccination.

The Plan also calls on states to adopt vaccination requirements for all school employees as part of the effort to “keep schools safely open.”

The Plan indicates that the administration will increase the amount of COVID-19 testing by ramping up production of testing products, offering at-home rapid COVID-19 tests at cost through certain retailers, and expanding free testing at retail pharmacy sites, among other things.

While the Plan is far-reaching, there are still many unknowns. Employer obligations arising from OSHA’s ETS will be dictated by the timing and the specific ETS provisions and corresponding requirements. The only thing we know for certain about the forthcoming ETS is that employers will need to continue to adapt and be prepared to pivot if necessary.   It is also unclear how the new ETS will fit in with OSHA’s current COVID-19 Healthcare ETS, in 29 C.F.R. 1910 Subpart U, or impact OSHA’s current guidance for non-healthcare employers. Further, the 27 states with OSHA-approved State Plans, such as California, Washington, Oregon, and Virginia, will need to determine how to respond to the ETS, once it is issued, and if certain provisions require implementation alongside the state’s standards and regulations.

CMS also issued a press release urging Medicare and Medicaid-certified facilities to “make efforts now to get health care staff vaccinated.” However, the agency noted that it is still developing an Interim Final Rule with Comment Period that will be issued in October.

Employers who are impacted by the Plan, and who may be impacted by an ETS once issued, are advised to start thinking through how they will navigate many legal issues and operational challenges related to required vaccination and testing. These issues include policy requirements, workplace testing strategies, vaccination tracking and management, medical record collection and retention, and accommodations for religion, disability and pregnancy, as well as wage and hour implications, bargaining obligations for unionized workplaces, employee confidentiality and privacy issues. Further, employers should consider the logistical impact on federal contracts and how these obligations will interplay with other state or local mandates or restrictions on vaccinations.

Stay tuned as we dive into the Plan and corresponding guidance documents, as well as await further information from federal agencies responsible for complying with the Plan and its directives. 

Oct. 15th Deadline Nears for Medicare Part D Coverage Notices

September 28 - Posted at 9:30 AM Tagged: , , ,

Prior to each year’s Medicare Part D annual enrollment period, plan sponsors that offer prescription drug coverage must provide notices of creditable or noncreditable coverage to Medicare-eligible individuals.

The required notices may be provided in annual enrollment materials, separate mailings or electronically. Whether plan sponsors use the federal Centers for Medicare & Medicaid Services (CMS) model notices or other notices that meet prescribed standards, they must provide the required disclosures no later than Oct. 15, 2019.

Group health plan sponsors that provide prescription drug coverage to Medicare Part D-eligible individuals must also disclose annually to the CMS—generally, by March 1—whether the coverage is creditable or noncreditable. The disclosure obligation applies to all plan sponsors that provide prescription drug coverage, even those that do not offer prescription drug coverage to retirees.

Background

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires group health plan sponsors that provide prescription drug coverage to disclose annually to individuals eligible for Medicare Part D whether the plan’s coverage is “creditable” or “noncreditable.” Prescription drug coverage is creditable when it is at least actuarially equivalent to Medicare’s standard Part D coverage and noncreditable when it does not provide, on average, as much coverage as Medicare’s standard Part D plan. The CMS has provided a Creditable Coverage Simplified Determination method that plan sponsors can use to determine if a plan provides creditable coverage.

Disclosure of whether their prescription drug coverage is creditable allows individuals to make informed decisions about whether to remain in their current prescription drug plan or enroll in Medicare Part D during the Part D annual enrollment period. Individuals who do not enroll in Medicare Part D during their initial enrollment period (IEP), and who subsequently go at least 63 consecutive days without creditable coverage (e.g., they dropped their creditable coverage or have non-creditable coverage) generally will pay higher premiums if they enroll in a Medicare drug plan at a later date.

Who Gets the Notices?

Notices must be provided to all Part D eligible individuals who are covered under, or eligible for, the employer’s prescription drug plan—regardless of whether the coverage is primary or secondary to Medicare Part D. “Part D eligible individuals” are generally age 65 and older or under age 65 and disabled, and include active employees and their dependents, COBRA participants and their dependents, and retirees and their dependents.

Because the notices advise plan participants whether their prescription drug coverage is creditable or noncreditable, no notice is required when prescription drug coverage is not offered.

Also, employers that provide prescription drug coverage through a Medicare Part D Employer Group Waiver Plan (EGWP) are not required to provide the creditable coverage notice to individuals who are eligible for the EGWP.

Notice Requirements

The Medicare Part D annual enrollment period runs from Oct. 15 to Dec. 7. Each year, before the enrollment period begins (i.e., by Oct. 14), plan sponsors must notify Part D eligible individuals whether their prescription drug coverage is creditable or non-creditable. The Oct. 14 deadline applies to insured and self-funded plans, regardless of plan size, employer size or grandfathered status

Part D eligible individuals must be given notices of the creditable or non-creditable status of their prescription drug coverage:

  • Before an individual’s IEP for Part D.
  • Before the effective date of coverage for any Medicare-eligible individual who joins an employer plan.
  • Whenever prescription drug coverage ends or creditable coverage status changes.
  • Upon the individual’s request.

According to CMS, the requirement to provide the notice prior to an individual’s IEP will also be satisfied as long as the notice is provided to all plan participants each year before the beginning of the Medicare Part D annual enrollment period.

Model notices that can be used to satisfy creditable/non-creditable coverage disclosure requirements are available in both English and Spanish on the CMS website. Plan sponsors that choose not to use the model disclosure notices must provide notices that meet prescribed content standards.

Notices of creditable/non-creditable coverage may be included in annual enrollment materials, sent in separate mailings or delivered electronically. Plan sponsors may provide electronic notice to plan participants who have regular work-related computer access to the sponsor’s electronic information system. However, plan sponsors that use this disclosure method must inform participants that they are responsible for providing notices to any Medicare-eligible dependents covered under the group health plan.

Electronic notice may also be provided to employees who do not have regular work-related computer access to the plan sponsor’s electronic information system and to retirees or COBRA qualified beneficiaries, but only with a valid email address and their prior consent. Before individuals can effectively consent, they must be informed of the right to receive a paper copy, how to withdraw consent, how to update address information, and any hardware/software requirements to access and save the disclosure. In addition to emailing the notice to the individual, the sponsor must also post the notice (if not personalized) on its website.

In Closing

Plan sponsors that offer prescription drug coverage will have to determine whether their drug plan’s coverage satisfies CMS’s creditable coverage standard and provide appropriate creditable/noncreditable coverage disclosures to Medicare-eligible individuals no later than Oct. 15, 2020.

Oct. 15th Deadline Nears for Medicare Part D Coverage Notices

September 29 - Posted at 10:16 PM Tagged: , , ,

Prior to each year’s Medicare Part D annual enrollment period, plan sponsors that offer prescription drug coverage must provide notices of creditable or noncreditable coverage to Medicare-eligible individuals.

The required notices may be provided in annual enrollment materials, separate mailings or electronically. Whether plan sponsors use the federal Centers for Medicare & Medicaid Services (CMS) model notices or other notices that meet prescribed standards, they must provide the required disclosures no later than Oct. 15, 2019.

Group health plan sponsors that provide prescription drug coverage to Medicare Part D-eligible individuals must also disclose annually to the CMS—generally, by March 1—whether the coverage is creditable or noncreditable. The disclosure obligation applies to all plan sponsors that provide prescription drug coverage, even those that do not offer prescription drug coverage to retirees.

Background

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires group health plan sponsors that provide prescription drug coverage to disclose annually to individuals eligible for Medicare Part D whether the plan’s coverage is “creditable” or “noncreditable.” Prescription drug coverage is creditable when it is at least actuarially equivalent to Medicare’s standard Part D coverage and noncreditable when it does not provide, on average, as much coverage as Medicare’s standard Part D plan. The CMS has provided a Creditable Coverage Simplified Determination method that plan sponsors can use to determine if a plan provides creditable coverage.

Disclosure of whether their prescription drug coverage is creditable allows individuals to make informed decisions about whether to remain in their current prescription drug plan or enroll in Medicare Part D during the Part D annual enrollment period. Individuals who do not enroll in Medicare Part D during their initial enrollment period (IEP), and who subsequently go at least 63 consecutive days without creditable coverage (e.g., they dropped their creditable coverage or have non-creditable coverage) generally will pay higher premiums if they enroll in a Medicare drug plan at a later date.

Who Gets the Notices?

Notices must be provided to all Part D eligible individuals who are covered under, or eligible for, the employer’s prescription drug plan—regardless of whether the coverage is primary or secondary to Medicare Part D. “Part D eligible individuals” are generally age 65 and older or under age 65 and disabled, and include active employees and their dependents, COBRA participants and their dependents, and retirees and their dependents.

Because the notices advise plan participants whether their prescription drug coverage is creditable or noncreditable, no notice is required when prescription drug coverage is not offered.

Also, employers that provide prescription drug coverage through a Medicare Part D Employer Group Waiver Plan (EGWP) are not required to provide the creditable coverage notice to individuals who are eligible for the EGWP.

Notice Requirements

The Medicare Part D annual enrollment period runs from Oct. 15 to Dec. 7. Each year, before the enrollment period begins (i.e., by Oct. 14), plan sponsors must notify Part D eligible individuals whether their prescription drug coverage is creditable or non-creditable. The Oct. 14 deadline applies to insured and self-funded plans, regardless of plan size, employer size or grandfathered status

Part D eligible individuals must be given notices of the creditable or non-creditable status of their prescription drug coverage:

  • Before an individual’s IEP for Part D.
  • Before the effective date of coverage for any Medicare-eligible individual who joins an employer plan.
  • Whenever prescription drug coverage ends or creditable coverage status changes.
  • Upon the individual’s request.

According to CMS, the requirement to provide the notice prior to an individual’s IEP will also be satisfied as long as the notice is provided to all plan participants each year before the beginning of the Medicare Part D annual enrollment period.

Model notices that can be used to satisfy creditable/non-creditable coverage disclosure requirements are available in both English and Spanish on the CMS website. Plan sponsors that choose not to use the model disclosure notices must provide notices that meet prescribed content standards.

Notices of creditable/non-creditable coverage may be included in annual enrollment materials, sent in separate mailings or delivered electronically. Plan sponsors may provide electronic notice to plan participants who have regular work-related computer access to the sponsor’s electronic information system. However, plan sponsors that use this disclosure method must inform participants that they are responsible for providing notices to any Medicare-eligible dependents covered under the group health plan.

Electronic notice may also be provided to employees who do not have regular work-related computer access to the plan sponsor’s electronic information system and to retirees or COBRA qualified beneficiaries, but only with a valid email address and their prior consent. Before individuals can effectively consent, they must be informed of the right to receive a paper copy, how to withdraw consent, how to update address information, and any hardware/software requirements to access and save the disclosure. In addition to emailing the notice to the individual, the sponsor must also post the notice (if not personalized) on its website.

In Closing

Plan sponsors that offer prescription drug coverage will have to determine whether their drug plan’s coverage satisfies CMS’s creditable coverage standard and provide appropriate creditable/noncreditable coverage disclosures to Medicare-eligible individuals no later than Oct. 15, 2019.

Oct. 15th Deadline Nears for Medicare Part D Coverage Notices

August 30 - Posted at 3:00 PM Tagged: , , , , , , ,

Prior to each year’s Medicare Part D annual enrollment period, plan sponsors that offer prescription drug coverage must provide notices of creditable or noncreditable coverage to Medicare-eligible individuals.

The required notices may be provided in annual enrollment materials, separate mailings or electronically. Whether plan sponsors use the federal Centers for Medicare & Medicaid Services (CMS) model notices or other notices that meet prescribed standards, they must provide the required disclosures no later than Oct. 15, 2018.

Group health plan sponsors that provide prescription drug coverage to Medicare Part D-eligible individuals must also disclose annually to the CMS—generally, by March 1—whether the coverage is creditable or noncreditable. The disclosure obligation applies to all plan sponsors that provide prescription drug coverage, even those that do not offer prescription drug coverage to retirees.

Background

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires group health plan sponsors that provide prescription drug coverage to disclose annually to individuals eligible for Medicare Part D whether the plan’s coverage is “creditable” or “noncreditable.” Prescription drug coverage is creditable when it is at least actuarially equivalent to Medicare’s standard Part D coverage and noncreditable when it does not provide, on average, as much coverage as Medicare’s standard Part D plan. The CMS has provided a Creditable Coverage Simplified Determination method that plan sponsors can use to determine if a plan provides creditable coverage.

Disclosure of whether their prescription drug coverage is creditable allows individuals to make informed decisions about whether to remain in their current prescription drug plan or enroll in Medicare Part D during the Part D annual enrollment period. Individuals who do not enroll in Medicare Part D during their initial enrollment period (IEP), and who subsequently go at least 63 consecutive days without creditable coverage (e.g., they dropped their creditable coverage or have non-creditable coverage) generally will pay higher premiums if they enroll in a Medicare drug plan at a later date.

Who Gets the Notices?

Notices must be provided to all Part D eligible individuals who are covered under, or eligible for, the employer’s prescription drug plan—regardless of whether the coverage is primary or secondary to Medicare Part D. “Part D eligible individuals” are generally age 65 and older or under age 65 and disabled, and include active employees and their dependents, COBRA participants and their dependents, and retirees and their dependents.

Because the notices advise plan participants whether their prescription drug coverage is creditable or noncreditable, no notice is required when prescription drug coverage is not offered.

Also, employers that provide prescription drug coverage through a Medicare Part D Employer Group Waiver Plan (EGWP) are not required to provide the creditable coverage notice to individuals who are eligible for the EGWP.

Notice Requirements

The Medicare Part D annual enrollment period runs from Oct. 15 to Dec. 7. Each year, before the enrollment period begins (i.e., by Oct. 14), plan sponsors must notify Part D eligible individuals whether their prescription drug coverage is creditable or non-creditable. The Oct. 14 deadline applies to insured and self-funded plans, regardless of plan size, employer size or grandfathered status

Part D eligible individuals must be given notices of the creditable or non-creditable status of their prescription drug coverage:

  • Before an individual’s IEP for Part D.
  • Before the effective date of coverage for any Medicare-eligible individual who joins an employer plan.
  • Whenever prescription drug coverage ends or creditable coverage status changes.
  • Upon the individual’s request.

According to CMS, the requirement to provide the notice prior to an individual’s IEP will also be satisfied as long as the notice is provided to all plan participants each year before the beginning of the Medicare Part D annual enrollment period.

Model notices that can be used to satisfy creditable/non-creditable coverage disclosure requirements are available in both English and Spanish on the CMS website. Plan sponsors that choose not to use the model disclosure notices must provide notices that meet prescribed content standards.

Notices of creditable/non-creditable coverage may be included in annual enrollment materials, sent in separate mailings or delivered electronically. Plan sponsors may provide electronic notice to plan participants who have regular work-related computer access to the sponsor’s electronic information system. However, plan sponsors that use this disclosure method must inform participants that they are responsible for providing notices to any Medicare-eligible dependents covered under the group health plan.

Electronic notice may also be provided to employees who do not have regular work-related computer access to the plan sponsor’s electronic information system and to retirees or COBRA qualified beneficiaries, but only with a valid email address and their prior consent. Before individuals can effectively consent, they must be informed of the right to receive a paper copy, how to withdraw consent, how to update address information, and any hardware/software requirements to access and save the disclosure. In addition to emailing the notice to the individual, the sponsor must also post the notice (if not personalized) on its website.

In Closing

Plan sponsors that offer prescription drug coverage will have to determine whether their drug plan’s coverage satisfies CMS’s creditable coverage standard and provide appropriate creditable/noncreditable coverage disclosures to Medicare-eligible individuals no later than Oct. 15, 2018.

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