Advocacy Update

May 2, 2023

In this Issue:

As Public Health Emergency Ends, Remote Sign-Out for Pathologists Will Continue

Enforcement discretion to allow pathologists to review slides remotely without the need of a separate CLIA certificate for their remote locations will continue once the public health emergency for COVID-19 ends later in May. However, reporting of COVID-19 laboratory results to the federal government will no longer have the authority to require this data to be reported from laboratories. The Centers for Medicare & Medicaid Services (CMS) has released guidance detailing how the agency will manage the various flexibilities and temporary measures instituted during the emergency.

With regards to remote sign-out, the CMS states in the document Laboratories: CMS Flexibilities to Fight COVID-19 that it “has exercised enforcement discretion to facilitate pathologists’ ability to review pathology slides remotely without the need for a separate CLIA certificate for the remote location. Enforcement discretion is not contingent on [public health emergency] authority; the CMS will continue to exercise enforcement discretion that allows pathologists to examine digital images and laboratory data at remote locations.” This reference is located on page 7 under the header Clinical Laboratory Improvement Act (CLIA) Guidance. In addition, remote sign-out only applies to pathologists and not non-pathologists or other clinical laboratorians.

On January 30, President Biden announced that the COVID-19 public health emergency will end on May 11. By extending the emergency, states and Medicaid services would continue with affiliated waivers for various sectors of the US health care system until the public health emergency has officially ended. Since the announcement, various federal agencies have been publishing guidance on whether specific waivers would end or continue beyond the public health emergency’s conclusion.

Reporting Will No Longer Be Required

SARS-CoV-2 reporting will no longer be required by the Department of Health and Human Services (HHS) beginning May 12. However, some states or jurisdictions may still require reporting, and hospitals will still have to report weekly, not daily as is currently the case.

Instead of SARS-CoV-2 results, COVID-19 surveillance will still take place but along the same lines that the HHS uses for surveillance of endemic diseases such as influenza (ie, via sampling and wastewater analysis). The CDC has been working to sign voluntary Data Use Agreements, encouraging states and jurisdictions to continue sharing vaccine administration data beyond the public health emergency. Additionally, hospital data reporting will continue as required by the CMS’ conditions of participation through April 30, 2024, but reporting may be reduced from the current daily reporting to a lesser frequency.

New Podcast: How the Economic Affairs Committee Protects the Value of Pathology Services 

Listen to our new podcast on the CAP’s Economic Affairs Committee (EAC). The EAC is largely responsible for health care policy that affects the coverage, payment, and overall value of pathology services. In this podcast, Jonathan Myles, MD, FCAP, chair of the Council on Government and Professional Affairs spoke with three leaders of the EAC: Ronald McLawhon, MD, PhD, FCAP, who chairs the EAC; Theresa Emory, MD, FCAP, vice chair of the EAC, and Jan Nowak, MD, FCAP. They each discussed a wide range of issues and different policies that allow pathologists to be paid, as well as the payment challenges pathologists face in the future.

Listen now

CMS Responds to CAP’s Request for Changes to Surprise Bill Rules

Regulators implementing the No Surprises Act replied to the CAP’s requests for changes to rules for the law’s independent dispute resolution process where physicians and insurers can settle claims for out-of-network services. The CAP has urged the government to issue strong rules to prevent health insurance plans from manipulating payments to pathologists and laboratories.

The CAP has advocated for changes to regulations by the Centers for Medicare & Medicaid Services (CMS) that have implemented the law. There have been several iterations of rulemaking as physicians have won court challenges to how the CMS has implemented the law and the independent dispute resolution process. On April 10, the CAP sent a letter to CMS calling for specific changes to the open negotiation process, batching, and administrative fees.

In response to the CAP’s comments on batching claims during independent dispute resolutions, the CMS said the government is considering potential improvements to its batching policy and the CAP’s insight on the issue will be helpful during ongoing conversations. The CAP has also raised concerns regarding fee increases.

In 2023, the administrative fee was raised to $350 from $50 per party per dispute. A pathology claim is often less than $350 and the current batching requirements make packaging multiple claims into a single dispute difficult, which compounds the cost effectiveness of participating in the dispute process. The CAP has recommended that the administration rescind the fee increase and allow more flexibility for batching claims. The CMS said the fee increase has been necessary to administer the federal independent dispute resolution process and meet the needs of disputing parties. Without the fee increase, the process would yield slower payment determinations.

Read the full response letter from the CMS.

Survey Deadline Extended to May 5: Check Your Email Inbox

The deadline to complete the CAP’s Practice Leader Survey is now May 5. The biennial survey quantifies changes in the practice of pathology and further assists the CAP in setting its advocacy priorities.

If you did not receive an invitation to take the survey, please check your spam or junk folder, or contact us at practicesurvey@cap.org. Survey invitations arrive from the “College of American Pathologists,” and each email contains a unique link to complete the survey. The survey should take about 20 minutes to complete.

The CAP is seeking one response per practice and recommends that the person who has the most knowledge about the business aspects of your practice should complete the survey. It includes a function that allows you to resume the survey if there is a need to stop and restart. And, if some questions should be answered by another individual in your practice, you can have them use your access code to complete the survey.

In appreciation for your efforts, upon completion of the survey, all participants can receive a $20 gift card of your choice to either Amazon, Starbucks, or Mastercard.

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