Advocacy Update

July 27, 2021

In this Issue:

FDA Authorizes Imported ‘Blue-Top’ Tubes to Address National Shortage

On July 22, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to import and increase the supply of “blue-top” test tubes. The FDA action came after the CAP raised the shortage to the Department of Health and Human Services (HHS) in June. The CAP also issued initial guidance to pathologists and laboratory professionals on the blue-top tubes shortage and reviewed them with the FDA.

The FDA issued the EUA to Becton, Dickinson, and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes manufactured at a facility in the United Kingdom. The device authorized under this EUA is for use in coagulation testing performed by authorized laboratories to identify and treat coagulopathy in patients with known or suspected COVID-19. Pathologists nationwide reported critical blue top shortages in their laboratories. The FDA released guidance on the blue tops shortage and conservation strategies for pathologists and laboratory professionals in the interim.

Acting FDA Commissioner Thanks CAP for Efforts to Address Pandemic

In June, the CAP reviewed with the officials from the FDA the recommendations developed by the CAP to address the shortage of blue-top tubes, which is expected to last throughout 2021. The CAP also had written the Department of Health and Human Services, the parent agency of the FDA, about the shortages.

In a follow-up letter to the CAP, FDA Acting Commissioner Janet Woodcock, MD, wrote to CAP President Patrick Godbey, MD, FCAP regarding its steps to solve the shortage.

“The Biden-Harris Administration is committed to addressing supply chain shortages caused by the COVID-19 pandemic,” Dr. Woodcock said. “Thank you again for your letter, your partnership, and the actions you and your colleagues at the College of American Pathologists are taking to help respond to the COVID-19 pandemic.”

The FDA has posted frequently asked questions (FAQs) about sodium citrate blood specimen collection tubes.

Price Transparency, Laboratory Fee Changes Proposed in 2022 Medicare Payment Regulation

In the proposed regulations from the Centers for Medicare & Medicaid Services (CMS), the CMS plans to update its price transparency policy, authorize physician assistants to receive direct payments for Medicare services, and reevaluate specimen collection fees in the Medicare clinical laboratory fee schedule. The CAP is reviewing the impacts of the proposed regulation on pathologists, including protecting the specialty’s scope of practice.

On July 13, the CMS released the proposed 2022 Medicare payment regulations, which included the Medicare Physician Fee Schedule and Quality Payment Program requirements. The CAP provided its initial analysis of the regulations, including updates on new pathology consultation codes and our impact table showing how fees for pathology services would change in 2022.

Price Transparency

CMS proposes to increase the penalty for some hospitals that do not comply with its Hospital Price Transparency final rule. Specifically, CMS is proposing to set a minimum civil monetary penalty of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500. The CAP has urged the CMS to consider the complexity of pathology practice when drafting a regulation that would require most group health plans and health insurance issuers to disclose the price and cost-sharing information to participants, beneficiaries, and enrollees. While the CAP supports patient access to appropriate price information before receiving physician services and other medical care, the CAP has urged the agency to consider unintended consequences that delay services for patients due to difficulties in determining the cost of pathology services in advance.

Scope of Practice

The CMS proposed to make direct Medicare payments to physician assistants for professional services they furnish under Part B beginning January 1, 2022. Medicare currently can only make payments to the employer or independent contractor of a physician assistant. Consequently, physician assistants could not bill and be paid by the Medicare program directly for their professional services; they also did not have the option to reassign payment for their services or to incorporate with other physician assistants to bill the program for their services. The change does not change the statutory benefit category or the requirement that physician assistant services are performed under physician supervision. The CAP and the AMA have worked with the CMS to ensure that physician assistants work under the direction of a medically trained physician.

Beginning January 1, 2022, physician assistants would bill Medicare directly for their services and reassign payment for their services.

Clinical Laboratory Fee Schedule Updates

To be as expansive as possible within the current authorities to have diagnostic testing available to Medicare beneficiaries during the COVID-19 public health emergency, the CMS changed the Medicare payment rules to provide payment to independent laboratories for specimen collection from beneficiaries who are homebound or inpatients not in a hospital for COVID-19 testing under certain circumstances and increased payments from $3-5 to $23-25.

The CAP has sought clarification on specimen collection fee policies and the travel allowance and calculates costs for transportation and personnel expenses for trained personnel to collect specimens after the COVID-19 public health emergency ends. In the proposed regulation, the CMS proposes to make permanent the option for laboratories to maintain electronic logs of miles traveled to cover the transportation and personnel expenses for trained personnel to travel to collect a specimen sample.

The CAP is reviewing the proposed payment regulations and will review them on August 5 at 1 PM ET/ 12 PM CT during an exclusive members-only webinar.

Webinar on August 5 – Proposed 2022 Medicare Payment Regulations Impact on Pathology Services

The Centers for Medicare & Medicaid Services (CMS) will soon release the proposed 2022 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS). On Thursday, August 5 at 1 PM ET/12 PM CT, the CAP will offer this complimentary live webinar where CAP experts will review the proposed regulation that will impact payment for services and pathologists’ participation in the Quality Payment Program.

Webinar presenters will be the Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Economic Affairs Committee Chair Stephen Black-Schaffer MD, FCAP; Economic Affairs Committee Vice-Chair Ronald McLawhon, MD, FCAP, and Quality and Clinical Data Registry Affairs Committee Chair Diana Cardona, MD, FCAP.

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Breaking Advocacy News? Check out the Advocacy Twitter Channel

Want up to the minute CAP Advocacy news? Then follow us on twitter at CAPDCAdvocacy, where you will be the first to know about CAP Advocacy wins, see your fellow members engage with congressional leaders on key policies affecting the practice of pathology and, of course, breaking Advocacy news.

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75th Anniversary Featured in July Advocacy News Quiz

This month we are featuring the CAP’s 75th anniversary, with a special prize for the first 50 CAP members to take the quiz. Last month, over 70 pathologists took the quiz. See how you compare against your fellow CAP members’ in the July News Quiz and brag about your top scores on social!

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