July Advocacy Recap

Alec Bose:

Hello and welcome to the CAP Advocacy recap, a monthly podcast dedicated to catching you up on the top news for pathologists. I'm Alec Bose from the CAP's Advocacy Communications Team here with your July recap. This month we'll review the proposed 2023 Medicare payment regulations released by the CMS. The technical reporting changes made to CLIA proficiency testing regulations, as well as a declaration of monkeypox as a global health emergency, and the public health emergency in the United States. Later, we will be joined by Dr. Theresa Emery to talk about Good Faith Estimate requirements as they relate to surprise medical bills. But first we go to regulatory news. The CMS released its proposed 2023 Medicare payment Regulations on July 7th, signaling an advocacy win for payment of the technical component of pathology services. The CAP'S Advocacy on this front, will lead to more accurate payments for the technical component of pathology services in 2023, if proposals are finalized later this year.

At the same time, the proposed regulation indicates the overall impact to pathology payments would decrease by about 3.4% next year, according to an analysis by the CAP. The decrease accounts for the expiration of the 3% increased fee schedule payments for 2022 as required by the protecting Medicare and American farmers from sequester acts, and required budget neutrality adjustments to account for changes in relative value units. The CAP continues to aggressively lobby Congress to mitigate these cuts to pathologists for 2023. We continue with more news from the CMS as the agency released a final 2023 CLIA proficiency testing regulation. The final regulation updates proficiency testing rules under the CLIA to amend the current list of regulated analytes to address newer technologies. This final regulation also clarifies that waive testing is exempt from participating in PT, regardless of if non-waived laboratories provide tests.

However, if laboratories elect to participate in PT for waive testing, they are subject to PT referral and other requirements. The CAP advocated to ensure regulations balance patient safety without overburdening pathologists and laboratories and will continue to do so in the future. Earlier in July, the World Health Organization announced the multi-country outbreak of monkeypox is a public health emergency of international concern. The declaration should compel countries to implement strategies aimed at stopping the outbreak, which has increased rapidly over recent weeks, including in the US, which the Biden administration also declared a public health emergency. The Food and Drug Administration has advised laboratories testing for monkeypox to use swab specimens taken directly from a lesion when testing for the virus. The FDA is unaware of clinical data supporting the use of other specimens such as blood or saliva. So testing with these specimens could produce false results.

You can find more FDA guidance on our website. And we round out our podcast with updates on regulation implementing the No Surprises Act. In addition to requirements related to balance billing, the No Surprises Act included provisions intended to protect uninsured or self-pay patients from unexpectedly high medical bills in the form of a Good Faith Estimate. We spoke with Dr. Teresa Emory about the requirements for Good Faith Estimates, and what pathologists can do to best adhere to them. So Dr. Emory, thank you so much for joining us. We really appreciate you being on the podcast with us.

Dr. Teresa Emory:

Thank you so much. I really appreciate being here and bringing you up to date what the CAP is doing on behalf of the membership.

Alec Bose:

In regards to the Good Faith Estimate requirements, when do these start?

Dr. Teresa Emory:

So the requirements went into effect on January 1st of 2022. However, HHS has been using its enforcement authority to provide flexibility in most situations involving pathology. What this means is really over this course of this year, they are allowing pathology groups, laboratories to be able to establish how they're going to provide that Good Faith Estimate. It will go into full effect on January 1st of 2023, and the pathologists and the laboratories will be required to give uninsured or self-pay patients a Good Faith Estimate for the cost of their healthcare before a patient receives an item, or service under specific requirements.

Alec Bose:

And do these Good Faith Estimates apply to all patients, or just some?

Dr. Teresa Emory:

They are not applying to all patients. The healthcare providers and facilities are only required to give uninsured or self-pay patients a Good Faith Estimate. And what that means is a self-pay patient is one who's not seeking to file a claim with their insurance or through an insurance beneficiary program.

Alec Bose:

And what information must pathologists provide when providing a Good Faith Estimate?

Dr. Teresa Emory:

So a GFE, or a Good Faith Estimate must include all expected charges for the items or services provided in conjunction with a primary item or service. So what that means is the initial reason that a patient is coming in to be seen. So the important thing to recognize in this is that unless you are the provider or facility that receives the initial request from the patient, or is responsible for scheduling the service, you are not the one that provides it to the patient. In other words, a pathologist is usually considered a co-provider and will receive the request for the Good Faith Estimate from, what's called the convening provider, or the convening facility. This is the facility that is scheduling the service or providing the service. So co-providers are then required to provide the Good Faith Estimate information to the convening provider or facility within one business day of the request. And then the convening provider or facility will provide the entire Good Faith Estimate to the patient.

Alec Bose:

And in what situations must a pathologist provide this information?

Dr. Teresa Emory:

So an uninsured or self-pay patient is entitled to the GFE basically in two circumstances. One, if they schedule an item or service like a doctor's visit or surgical procedure, endoscopy, for example, with a provider or facility at least three business days in advance. Or when a patient requests a GFE, when they request to know what it would cost for whatever they're coming in for, regardless if they've scheduled the item or service. But it's important to note that the requirement to provide the GFE to an uninsured patient is not triggered upon scheduling an item or service. If that procedure or service is being scheduled in less than three business days before the date of the service is expected to be furnished. So for example, if an uninsured or self-pay patient arrives to a schedule a same day laboratory testing service, the laboratory testing provider or facility is not required to provide the patient with a GFE.

Another important piece about this providing the information is that the Good Faith Estimate requirements are broader than what we see in the rest of the surprise billing legislation, with regard to balanced billing requirements. In the case of the GFE, any state or locally licensed healthcare institution will need to comply, including items and services from a physician's office. So when we look back at the surprise billing legislation, talking about surprise medical bills for the insured patients, typically in a facility where the facility, the patient's insurance is covered by that facility and that there are services that are outside of that insured patient's coverage. So the GFE is much broader, so it's all uninsured or self-pay patients, if they ask for a GFE for a service or an item that they're going to have, regardless of whether it's in a hospital or not, even a doctor's office, the GFE must be provided.

Alec Bose:

Thank you. And finally, can you talk a little bit about what the CAP is doing to help with this, and preparing pathologists for this?

Dr. Teresa Emory:

Sure. And the CAP has really tried to be on the forefront of this even before the legislation went into effect in January. But following the January enactment in anticipation of the full requirement in January of 2023, CAP reached out to CMS, the Centers for Medicare and Medicaid Services, in March, and the C A P met with CMS to try to obtain some clarification and further guidance around these requirements. We also sent a letter in April of this year asking for further clarification. And we did hear back from CMS, and what they have done is tell us some basic information that now we're trying to relay to the CAP members, including what they made clear to us, which was that they recognized that there may be instances where providers or facilities, such as laboratories or pathology professionals, might not know the full extent of the tests and interpretations that will be needed in advance of receiving an order for laboratory or pathology services from another provider or facility.

And while the interim final rules do not require the GFE to include charges for items or services that could not have been reasonably expected, we would expect that providers or facilities such as pathologists or laboratories would develop and submit GFE information based on the initial anticipated order, and clinical circumstances known at the time of scheduling the primary item or service. This response came when we met with them and indicated to them that we could not see a clear way to proceed in providing prospective reliable estimates for pathology services, as pathologists are not the initiator of tissue or fluids submitted for diagnosis. And we will not, as pathologists, we would not know what would be submitted nor what would be needed to be done until the pathologist has reviewed the original specimen from each patient. So they further clarified to us that of course they understood that we may not know all the testing we need to do and it may actually trigger the independent or the dispute resolution with the patient.

However, they said that there would be an arbiter and it would be at that point that we could clarify why it was medically necessary, the extra charges that the patient incurred. Also, CAP regularly updates its surprise billing webpage and there are additional resources there, including frequently asked questions, related to the entire New Balance billing, as well as the Good Faith Estimate requirements. If members do go onto the CAP website, there are additional resources, not only CAP resources, but there are links to CMS resources, as well as resources to the American Medical Association's toolkit for physicians that should help also if there are other questions. CAP will continue to monitor, and any information that we can, or any information that we receive, we will pass along. We also always encourage members to reach out to the CAP Advocacy to let us know any sorts of questions or issues that are arising with regard to the GFE, so that we can explore and look for solutions and answers for our members.

Alec Bose:

Thank you, Dr. Emory, I think that's a great note to leave it on. Thank you so much for being here with us. This was very informative.

Dr. Teresa Emory:

Thank you.

Alec Bose:

That's all for this edition of the CAP Advocacy recap. Thank you so much for listening. For more information, be sure to read our weekly advocacy newsletter, and follow us on Twitter @CAPDCAdvocacy. Once again for CAP Advocacy, I'm Alec Bose and we'll see you next month.

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