Comply With Us

Regulatory Flurry as the Clock Tick Down for the Trump Administration

December 22, 2020

Over the past few weeks, the Trump Administration has been doing what every previous presidential Administration has done its way out—dumping out new pieces of regulatory guidance at an astonishing pace. Of course, we cannot stop talking about the never-ending flow of new requirements. We are both pleased about the normalcy and aggrieved to be reading regulations when we should be wrapping presents, watching Love Actually, and eating latkes. (Not to mention the fact that Congress finally decided to pass a 5,500+ page law addressing among many other things, substantial COVID-19  economic relief, major updates to employee benefit plan requirements, surprise billing protections, broker compensation disclosure and more plan transparency requirements—more on that in likely several future posts!)

Because we love you, friends, we are here to cut down your government-sponsored reading list. Here are summaries of the most significant regulations released over the past few weeks that could affect private health insurance coverage. As a holiday bonus for you, we listed them in order of importance (to us) and offered some color commentary too!

Final Transparency Rules:

As we've said before, the regulatory action dominating our minds this Fall is the new healthcare price transparency rules. They came out on October 29, 2020, and the first big deadline is January 1, 2022. Plans will need to be collecting and preparing to publish data looking back to August of 2021 to meet it. In a nutshell, this is what the new rules require:

  1. Beginning with plan or policy years starting on or after January 1, 2022, almost all group health plans and employer plan sponsors must publicly disclose in-network provider negotiated rates, historical out-of-network allowed amounts, and drug pricing information. The disclosure must be through three machine-readable files posted on their internet website. These data files, which must be kept current, will allow the public to access broad medical care price information.
  2. Beginning with plan or policy years starting on or after January 1, 2023, almost all non-grandfathered health plan issuers and employer plan sponsors will have to make sure that plan participants can access personalized and detailed cost estimates for 500 designated shoppable services before they incur a claim. All information must be made available via an Internet-based search tool or, if requested, in paper form.
  3. By the start of plan or policy years beginning on or after January 1, 2024, the disclosure requirements listed above must be available to all plan participants via an Internet-based search tool and on paper if requested for ALL covered items and services.

Our Take:

Many people are still burying their heads in the sand about the plan transparency requirements, and many more still don't know about them yet. In case you've slept on these, they will:

  • Up-end almost every type of contract out there in the health insurance industry.
  • Release a treasure trove of data into the marketplace, and
  • Take an enormous amount of effort and money to implement.

We are convinced we will be working on and around these rules, or a variation thereof, for years to come. They affect every single non-grandfathered group major medical plan out there. While cool, they will be a BEAR to implement correctly, and the non-compliance penalties are steep ($100 per day per affected beneficiary).

Already, we are helping clients wrap their minds around disclosing all this data and preparing for implementation every day. If you are not, then we would love to talk to you about why you should be!

Interim Final Rule on COVID-19 Testing and Vaccination Coverage Mandate:

A new COVID-19 coverage interim final regulation clarifies that almost all group health insurance plans will have to provide employees with free access to all authorized COVID-19 vaccines while the national public health emergency is in effect. Coverage must be before any deductible and without cost-sharing, regardless of where a person gets the vaccine. (Meaning that a health plan cannot impose any network restrictions on vaccine coverage.) Plans must consider an approved COVID-19 vaccine as part of their preventive care coverage within 15 business days of a formal federal approval recommendation. So, claims processing updates need to happen FAST! The rule also clarifies some issues regarding the COVID-19 testing coverage mandate.

Our Take:

We see COVID-19 issues continuing to dominate the health care scene for the next six months at least. This regulation provides much-needed clarity to health plans and employers about how to cover both vaccines and tests. We cannot wait for a day when we can get through an hour without thinking about the coronavirus, but since we are not there yet, we're going to be relying on the provisions of this rule a lot.

New COVID-19 Vaccine Guidance for Employers:

The federal Equal Employee Opportunity Commission (EEOC) recently issued guidance about how businesses can legally address the COVID-19 vaccine with employees. Employers may make vaccination a job requirement, if they provide reasonable notice and allow exemptions and accommodations for people with sincerely held religious objections. If a private company has 15 or more employees and is subject to the Americans with Disabilities Act, the business will also need to accommodate demonstrable disabilities.

Suppose an employee cannot get vaccinated for COVID-19 because of a disability or sincerely held religious belief, and there truly is no reasonable accommodation possible. In that case, the guidance does permit employers to exclude the employee from the workplace. However, this "right to exclude" does not mean the employer may automatically terminate the worker. Employers will need to determine if any other rights apply under federal, state, or local laws before taking that step. The guidance also spells out privacy requirements for employers regarding health and genetic information that may result from giving access to vaccines in the workplace.

Our Take:

With several COVID-19 vaccines either approved for emergency use and distribution or awaiting imminent approval, we are answering questions from employers who wonder if they will be able to ask their workforce to get the vaccine as a condition of employment. So it is wonderful have definitive guidance specific to COVID-19 so that we can tell people the quick answer is yes, but several caveats and exceptions apply.

Final Updated Grandfathered Plan Regulation

The federal Departments of Health and Human Services, Labor, and Treasury issued a final rule for group health insurance plans with "grandfathered" status under the Affordable Care Act (ACA). It makes two changes to existing rules to help make it easier for grandfathered plans to maintain their status. The first prevents groups from needing to choose between keeping a qualified high-deductible plan and grandfathered status due to cost-sharing limitation requirements. The second creates an alternative path for groups to calculate their "maximum percentage increase" for fixed-amount cost-sharing requirements.

Our Take:

We like this rule. We would have liked it better if it got rid of the requirement that fixed cost-sharing can only increase by 15 percent over the plan's whole life and replaced it with an annual fixed amount limit, but you can't have everything. The thing is, the reach of this regulation is small. Not too many employers still have a grandfathered plan in place. For those that do, it provides critical relief. For the rest of the market, this measure has no impact whatsoever.

Proposed Privacy Requirements

HHS also issued a proposed regulation to modify the health information privacy rule initially authorized by the federal Health Insurance Portability and Accountability Act (HIPAA). The comprehensive proposal intends to help people access information digitally, improve information sharing for value-based care and case management, and help relatives manage family health crises. This proposal is still in draft form, and the Biden Administration will be the one to make finalization decisions.

Our Take:

If finalized, this regulation is going to have a massive impact on individual people and all covered entities, which include providers, health insurers, and self-funded plans. It will also affect business associates of covered entities, like health insurance agents and brokers. Many changes are good and reflect real-life needs revealed over the past two decades of experience with the HIPAA privacy rules. However, the devil is in the details. We do not know which, if any, the Biden Administration will finalize. We also cannot say when the new regime at HHS will get to this rule. When they do, we will be all over the final version, and the anticipated compliance changes it will bring. Until then, it is on a back burner.

Proposed Notice of Benefits and Payment Parameters

The Notice of Benefits and Payment Parameters (NBPP) is an annual catch-all measure. It contains all of HHS's requirements for private health insurance arrangements for the following year. Usually, it comes out in the spring. The Trump Administration did an early release of the draft rule, presumably to finalize it before leaving office. It would change special enrollment requirements and addresses COVID-19 related premium credits from health insurance carriers. Another change would be to allow states to move away from a traditional health insurance exchange model to more direct enrollment through carriers and web-brokers without filing for a waiver, among many other things.

Our Take:

When final, the NBPP is one of the most critical regulations of the year for health policy nerds like us. However, today it is just a proposal. We know the Trump Administration will probably finalize it in close to its current form. Still, we would bet our houses that the Biden Administration will issue a new rule sometime this spring to undo or revise many of the concepts in this measure and insert their ideas. For example, we do not think the state-level exchange flexibility without a Section 1332 waiver is long for this world. Bottom line—we are not spending too much time on this regulation right now, but we are waiting eagerly for both a final Trump version and a Biden update!

Regulatory Review Proposal

Another HHS notice of proposed rulemaking would require the Department to assess its regulations every ten years to see if each is still needed and whether it has appropriate impacts. If they do not review an existing rule on-time, it will expire.

Our Take:

We appreciate the concept behind this rule. There is very little in life that does not need an update every few years, let alone every decade. However, this is just a proposal—nothing final yet, and the draft review timeframe proposed concerns us a bit. The way this is written, a ton of rules will need review over the next two years. For example, almost every ACA rule is about ten years old. There is a global pandemic going on. Shouldn't HHS focus on THAT right now? Hopefully, in the final version, they will spread the reviews out a bit.

Prescription Drug Cost Rules

The Administration finalized two regulations to lower prescription drug prices, mainly for the Medicare population. One will create point-of-sale pharmaceutical rebates for Medicare Part D beneficiaries. The other would tie Medicare Part B payment rates for prescription drugs patients receive during inpatient care settings to international drug prices.

Our Take:

Of all the measures released recently, these two rules interest us the least. While we want lower drug prices, and we know Medicare rates ultimately have a critical impact on the private market, neither of these rules will impact most Americans any time soon. Plus, due to legal and process issues with each, there is a good chance that neither one will ever affect anyone. The Trump Administration withdrew the rebate rule and then brought it back from the dead in final form—a big legal no, no. Plus, they got rid of it in the first place because it will make Medicare premium rates go up. The most favored nation drug payment regulation also has legal issues since they issued it as an interim final rule without adequate need. The measure also takes effect on January 1, 2021, but there is no guidance available about the data needed to implement it!

Well, folks, that's a wrap on Friends with Health Benefits for 2020—a year that will live in infamy for decades (okay, centuries) to come. We want to take this moment to thank you for your loyal readership. It has been a trying year, but we are so fortunate to have friends like you!!

We wish you all a very healthy, prosperous, and less bizarre New Year. May it be filled with new hope, time with family (and friends), and yes, Employee Benefits conferences!!! Until 2021—be well.