Advocacy Update

April 6, 2021

In this Issue:

CAP Obtains CMS Reapproval as Accreditation Organization

The CAP earned the CMS reapproval as an accreditation organization for clinical laboratories. As reported in the Federal Register, the CMS determined the CAP, in its application for reapproval, met or exceeded the applicable Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements.

The CMS regulates all laboratory testing, except research, performed on humans in the US through CLIA. It began granting deeming authority to accrediting organizations in 1994, with the CAP consistently winning renewals for six years, the maximum allowable period under federal regulation.

Laboratories participating in CAP accreditation are based in a variety of settings including large university medical centers, physician offices, and COVID-19 testing sites. The accreditation program enables laboratories to:

  • Meet CLIA regulatory requirements (specific to laboratories subject to U.S. regulations);
  • Ensure compliance through the guidance of the most comprehensive scientifically endorsed laboratory standards; and
  • Maintain accuracy of test results and ensure accurate patient diagnosis.

The CAP currently accredits nearly 8,000 laboratories worldwide.

Tennessee Pathologists, CAP Successful in Opposition to Test Reporting Bill

In a win for the Tennessee Society of Pathologists (TSP) and the CAP, a measure that would have placed additional burdens on clinical laboratories when reporting test results failed to advance out of the subcommittee on March 30. The TSP and CAP worked collaboratively to raise awareness about the negative effects of the measure on laboratories in the state.

House Bill 579, introduced by State Rep. John Ragan, would require clinical laboratories to report test results to ordering providers in an electronic format dictated by the Medical Laboratory Board and transmit a laboratory control report electronically to the board and Department of Health. In addition, the bill also required all laboratory test results to be transmitted to the state and stored in what would be a future, contemplated state database containing all patient information generated by clinical laboratories. Additionally, the measure would have given the board authority to impose fees, if necessary, to accomplish the provisions of the legislation.

In a memorandum of opposition sent to lawmakers, the TSP said it opposed the legislation for several reasons:

  • The legislation would impose a new, substantial regulatory burden on clinical laboratories at a time when laboratory personnel and resources are strained under the unprecedented weight of pandemic-related testing;
  • The legislation is vague and without definition in citing key terms that are not amenable to electronic data field reporting (ie, “concurrent calibration standards and control charts recording”);
  • The reporting frequency for this requested information is not prescribed in the bill.
  • The legislation grants an extraordinary authority to the Laboratory Board to collect individual patient health and clinical data, which exceeds the predicate statutory authority of the board and transcends the historical role of the board in focusing on laboratory quality oversight; and
  • The legislation expressly allows the board to rely upon “internationally recognized standards” for state regulation of clinical laboratory reporting. Reliance upon international standards that are not used, endorsed, or promulgated in the United States is of questionable merit, says the TSP, noting “there would likely be a strong reason for such standards to have been rejected in the United States.”

The CAP considers this a win for Tennessee pathologists and clinical laboratories, which already face tremendous regulatory burdens and financial pressures.

Take Action to Further Your State Pathology Society’s Influence

Our member-exclusive 2021 Pathologists Leadership Summit offers state pathology leaders a focused educational track Sunday, May 2, with sessions on organizing, improving, and elevating their state pathology society. Join state pathology leaders from across the country in courses including Fundamentals for a Strong State Pathology Society, Advanced Essentials for State Pathology Societies and How to Establish and Maintain an Effective State Advocacy Program.

Further your society’s influence by learning to communicate in a way that is relevant to lawmakers Monday, May 3, and meet virtually with congressional officials during our annual day on Capitol Hill, Tuesday, May 4.

Learn more

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Medicare Temporarily Holding Claims to Give Congress More Time to Stop Cut

In anticipation of pending congressional action to extend the 2% sequester reduction suspension for Medicare claims, the Centers for Medicare & Medicaid Services (CMS) instructed the Medicare Administrative Contractors (MACs) to hold all claims with dates of service on or after April 1, 2021, for a short period without affecting providers’ cash flow. This will minimize the volume of claims the MACs must reprocess if Congress extends the suspension; the MACs will automatically reprocess any claims paid with the reduction applied if necessary.

The Senate passed legislation to delay a mandated 2% Medicare cut through the end of the year. Action is expected in the House when it returns from a scheduled recess next week. If Congress fails to act, the 2% cut would be effective on April 1.

The CAP has urged Congress to stop the Medicare cut from hitting pathology services.

CMS Begins Recovery of COVID-19 Accelerated and Advance Payments on March 30

On March 30, the Centers for Medicare & Medicaid Services (CMS) began to recover any outstanding balance from Medicare providers who requested and received COVID-19 accelerated and advance payments, depending on the one year anniversary of when the provider received their first payment. The CMS will show the recoupment on the remittance advices issued for Medicare Part A and B claims the agency processes after the one-year anniversary of issuing the first payment. The recoupment will appear as an adjustment in the Provider-Level Balance (PLB) section of the remittance advice.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the CMS expanded the accelerated and advance payment program for Medicare participating physicians and other providers to ensure they have resources needed to combat COVID-19. On April 26, 2020, the CMS announced that it suspended its advance payment program. According to the CMS, this decision was reached in part because Congress appropriated $175 billion for health care provider relief payments.

For more information, view the CMS’ Fact Sheet: Repayment Terms for Accelerated and Advance Payments Issued to Providers and Suppliers During COVID-19 Emergency. See “Accelerated and Advance Payment Repayment & Recovery Frequently Asked Questions” for more information, especially if the repayment timeframe presents a hardship for you. The CMS expects to alert providers and suppliers as any additional information becomes available. If you have questions, your Medicare Administrative Contractor may have more information. Find their website at For more:

CAP Urges Clarification in Cures Act Regulations with Medicare Technology Office

On April 1, the CAP met with the Office of the National Coordinator for Health Information Technology (ONC) chief clinical and chief medical officers to discuss implementation challenges regarding the new Cures Act information blocking and interoperability regulations. CAP Council of Government and Professional Affairs (CGPA) Chair Jonathan Myles, MD, FCAP; and CGPA Vice-Chair Joe Saad, MD, FCAP; and Pathology Electronic Reporting (PERT) Committee Chair Mary Elizabeth Edgerton, MD, PhD, FCAP; Informatics Committee Chair James Harrison, MD, FCAP, and Vice-Chair Alexis Carter, MD, FCAP asked for further clarification regarding the new regulations and outlined the potential harms to patients, burdens on pathologists, and laboratories.

During the meeting, the CAP acknowledged that providing patients with direct access to their pathology reports may have some advantages. However, challenges and potential safety issues exist for patients with the current regulation requiring immediate release to a patient portal of finalized pathologist and laboratory results. Only case-by-case exceptions are allowed; no blanket exceptions are allowed. When implementing this particular regulation, the CAP advocated that the ONC should consider a broader ability for pathologists and ordering physicians to make exceptions to the immediate release requirement.

The CAP does not think that ONC intends for patients to receive uncoordinated or confusing information. The CAP urged ONC to consider allowing a delay for the opportunity for involved clinicians to create an integrated response before patient communication. The CAP did clarify that this may not be the case for all diagnostic test results, but rather, for more complex diagnostic tests, which could be misconstrued without proper context. Those tests that require patient counseling should be allowed to have a blanket delay of release.

The CAP updated its fact sheet summarizing key provisions and answering pathologists’ questions on regulation regarding sharing test results with patients that is set to take effect on April 5.

Download the CAP’s fact sheet on the regulations

In November 2020, the Department of Health and Human Services (HHS) pushed back the deadline for the regulations, which include information blocking, citing implementation concerns during the coronavirus pandemic. The rules will change how many physicians, including pathologists, pass along and receive electronic health information.

New Month, New Advocacy News Quiz

It's April and that means a new Advocacy News Quiz. Last month, over 90 pathologists took the quiz. See how you compare against your fellow CAP members’ in the April News Quiz and brag about your top scores on social!

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