Advocacy Update

• CAP Urges HHS to Address Critical ‘Blue-Top’ Tube Shortage; FDA Recommends Conservation Tactics
• Special AMA Report: CAP Advocates to Address Rural Health Care Challenges, Information Blocking Regulations
• CAP, AMA Ask for APM Changes to Benefit Physicians
• HHS Details New Provider Relief Fund Reporting Requirements for Physicians, Providers
• Surviving Future Payment cuts—Hear Advice from Dr. Diana Cardona
• Reminder- Your Valuable Input Needed for 2021 Practice Leadership Survey
• Test your Advocacy Knowledge

The CAP urged the Department of Health and Human Services (HHS) and other key federal agencies to take immediate actions to increase the supply of sodium citrate light blue-top tubes used for coagulation testing. Pathologists across the country have reported shortages in their laboratories and are seeking guidance for providing these important tests until blue-top tube supply levels are adequate.

The pandemic has disrupted various industries and supply chains across the globe. Pathologists have worked to overcome challenges with obtaining supplies related to COVID-19 testing, but in recent weeks critical shortages of blue-top tubes have drawn concern over continued patient access to coagulation tests from pathologists across the United States. In the June 7 letter to HHS Secretary Xavier Becerra, the CAP asked for immediate actions from the Biden Administration to resolve the supply shortage of blue-top tubes.

Blue-top tubes are used for specimen collection for coagulation testing. Coagulation tests measure the blood’s ability to clot, and how long it takes to clot. This testing determines the risk of excessive bleeding or developing clots (thrombosis) in blood vessels. Clotting disorders can cause dangerous levels of bleeding, which can be life threatening. The CAP insisted that the HHS address this critical shortage by also providing “guidance so clinical laboratories can identify and/or create alternative collection methods, including validation processes for development of sodium nitrate tubes within clinical laboratories.”

FDA Takes Initial Actions

The CAP has also discussed the issue with the Food and Drug Administration (FDA) and on June 11 the agency added the sodium citrate blood specimen tubes to its list of medical device shortages during the COVID-19 public health emergency. The FDA released guidance on the blue tops shortage and conservation strategies for pathologists and laboratory professionals. They include:

• Do not include sodium citrate (light blue top) tubes in routine collections of a variety of specimens at the time of other blood sampling or IV insertion.
• Do not use sodium citrate (light blue top) tubes unless medically necessary.
• Do not use sodium citrate (light blue top) tubes as discard tubes; consider clear top or red stopper (no additive) tubes as an alternative.
• Limit allocation of 1.8mL sodium citrate (light blue top) tubes for difficult blood collections.

The FDA also recommended health care and laboratory facilities develop and implement the above strategies to minimize the use of these tubes and maintain the quality and safety of care for patients for whom such testing is medically necessary.

The FDA encouraged pathologists and other providers to report any adverse events or suspected adverse events experienced with the tubes. If you or your laboratory is experiencing shortages, you may contact the FDA at deviceshortages@fda.hhs.gov.

The CAP is scheduled to discuss the shortage further with the agency. The CAP will update pathologists and the laboratories they direct when further developments are announced.

The CAP led a delegation of pathologists at the virtual 2021 American Medical Association (AMA) Special House of Delegates (HOD) Meeting to set policy affecting the practice of medicine from June 11-16. The AMA special HOD meeting focused on the COVID-19 pandemic and the role physicians played like heroes, rising to the challenge to guide the nation’s health care during this unprecedented pandemic. Additionally, the AMA House of Delegates virtually welcomed the new AMA President Gerald E. Harmon, MD, a family medicine physician from Pawleys Island, SC, and President-elect Jack Resnick, MD from northern California. During the meeting, the CAP’s advocacy included addressing the sustainability of the rural health care system, voicing concerns about information blocking requirements for pathologists, relaxing Centers for Medicare & Medicaid Innovation Center (CMMI) regulations, and fighting for scope of practice protections.

Addressing Rural Health Care’s Challenges

The CAP has engaged in addressing rural populations' health needs and support efforts to further this work with the AMA. In response to the challenges facing the rural health system, the HOD adopted policy advocating for public and private payers to take the following actions “to ensure payment to rural hospitals is adequate and appropriate.”

In the new policy, delegates said payers should:

• Create a capacity payment to support the minimum fixed costs of essential services, including surge capacity, regardless of volume.
• Provide adequate service-based payments to cover the costs of services delivered in small communities.
• Adequately compensate physicians for standby and on-call time to enable very small rural hospitals to deliver quality services in a timely manner.
• Use only relevant quality measures for rural hospitals and set minimum volume thresholds for measures to ensure statistical reliability.
• Hold rural hospitals harmless from financial penalties for quality metrics that cannot be assessed due to low statistical reliability.
• Create voluntary monthly payments for primary care that would give physicians the flexibility to deliver services in the most effective manner, expecting that some services will be provided via telehealth or telephone.

ONC and Information Blocking

The CAP and the Pathology Section Council asked AMA to urge the Office of the National Coordinator for Health Information Technology (ONC) to consult with relevant stakeholders about unintended or unforeseen consequences from the 21st Century Cures Act information blocking regulations. The CAP has been engaged on this issue and believes providing patients with direct and immediate access to laboratory and pathology reports has advantages. Still, there are genuine barriers, challenges, and potential safety issues with the current ONC regulations. Additionally, the group directed the AMA to urge the ONC to broaden and relax its Patient Harm Exception through regulatory revisions that would include patients’ emotional and mental distress to the current and narrow definition of this exception. The CAP urged the ONC to consider a broader ability for pathologists and ordering physicians to make exceptions to the immediate release requirement. The CAP will continue to work on this important issue to get the additional time and compliance flexibility needed for pathology. The CAP will continue to work on this important issue to get the additional time and compliance flexibility needed for pathology.

Relaxing Pathology CMMI Reporting Regulations

The CAP and the Pathology Section Council supported efforts to oppose mandatory Center for Medicare & Medicaid Innovation (CMMI) payment model demonstration projects. Instead, the pathology delegation directed the AMA to ask the Office of the National Coordinator for Health Information Technology (ONC) to relax their current regulatory requirements and seek innovative payment delivery model ideas from physicians and medical specialty societies to guide the Physician-Focused Payment Model Technical Advisory recommendation Committee (PTAC). Additionally, the group asked that the CMMI propose demonstration projects that are voluntary and appropriately tested.

Lessons Learned from COVID-19 and Global Vaccine Distribution

The HOD discussed at length the lessons learned by the medical community from the COVID-19 pandemic and continuing needs, including personal protective equipment (PPE) supplies, pandemic treatment procedures, and vaccine distribution. The CAP and the AMA support efforts to distribute COVID-19 vaccines to health care agencies globally that are scientifically tested and approved by the US Food and Drug Administration. The HOD discussed sending and administering vaccines to other countries where the pandemic is at its height, like India and Vietnam. Additionally, the AMA and the CAP advocated for improvements to PPE and supply chain issues and increased distributions for future health emergencies.

The CAP is an active member of the AMA House of Delegates and encourages pathologists to join the AMA or renew their AMA membership. A robust CAP delegation at the AMA can shape a health care system that best utilizes pathologists to deliver high-quality care and meet the evolving demands of patient care. The CAP and AMA work together on many of the health and medical policies that affect the way you practice and your reimbursements. Join or renew your AMA membership today.

The CAP, the AMA, and a group of physician organizations urged the new director of the CMMI, Elizabeth Fowler, to make improvements in the development of alternative payment models (APMs). In the May 25 letter, the group made several recommendations to improve the process for designing and implementing APMs and engaging the physician community in their development.

The CAP, the AMA, along with 45 physician organizations, outlined the limitations of APMs, and how most physicians did “not have the opportunity to participate in an APM designed for the kinds of patients they treat or the level of risk they are equipped to take on. Existing models are also often geographically limited, excluding physicians in other areas who are interested and well-equipped to participate.” The group provided recommendations to the CMMI on improving APMs by:

• Increasing transparency and stability of APMs;
• Enabling APMs to reduce health inequities;
• Extending incentive payments for APM participation; and
• Investing in care transformation by medical practices.

The group also urged the CMMI to increase physician engagement in the development of future APMs by:

• Jointly setting joint goals and process;
• Dedicating funds to support development and testing of physician-developed APMs; and
• Providing feedback and data.

The group will follow-up with the CMMI on the future development of APMs.

The HHS released on June 11 details on reporting requirements for recipients of Provider Relief Fund (PRF) payments. This HHS announcement included improvements to the requirements, such as expanding the amount of time providers will have to report information, reducing burdens on smaller providers, and extending key deadlines for expending PRF payments for recipients.

The revised reporting requirements will be applicable to physicians and other providers who received one or more payments exceeding, in the aggregate, $10,000 during a single Payment Received Period from Provider Relief Fund General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.

HHS published the full updated requirements on its website. Updates highlighted by the department include:

• The period of availability of funds is based on the date the payment is received (rather than requiring all payments be used by June 30, 2021, regardless of when they were received).
• Recipients are required to report for each Payment Received Period in which they received one or more payments exceeding, in the aggregate, $10,000 (rather than $10,000 cumulatively across all Provider Relief Fund payments).
• Recipients will have a 90-day period to complete reporting (rather than a 30-day reporting period).
• The Provider Relief Fund Reporting Portal will open for providers to start submitting information on July 1, 2021.

Pathologists are likely to continue facing risks of professional fee payment cuts and value-based payment programs like the CMS’ Quality Payment Program are here to stay. By now you are likely wondering “Is there something I can be doing to lessen the impact of these cuts?”

The answer is yes—develop a longer-term strategy. It may be tempting to request a MIPS hardship exemption in 2021 to avoid reporting, but for those looking for a more sustainable solution, using the Merit-based Incentive Payment System (MIPS) as part of your strategy may, in reality, help offset other payment cuts in the future.

Listen as Diana Cardona, MD, FCAP, Vice Chair, Economic Affairs Committee and Chair of the Measures and Performance Assessment Subcommittee explains while hardship exceptions may seem welcome, accepting an exemption this year, results in a neutral payment adjustment in 2023, and that may not be in your practice’s best interest.

The CAP 2021 Practice Leadership Survey is underway, and you can help by providing data from your pathology practice regarding your economic, demographic, and market trend information in the evolving business environment. Reminder invitations were sent via email on June 14 and the survey will remain open until this Friday, June 18.

Data from the survey will help CAP leaders determine which advocacy issues are most important to pathology practices and to provide support to CAP advocacy efforts on behalf of the pathology specialty. The survey is targeted to practice leaders who can answer the questions for the whole practice.

Survey participants will have early access to survey results and will receive a $20 gift card. The survey should not take more than 20 minutes to complete.

The survey invitation was sent to all board-certified pathologists with five or more years in practice. If you have not received your invitation, please contact practicesurvey@cap.org.

Think you know CAP advocacy, well let’s put that to the test! Last month, over 90 pathologists took the quiz. See how you compare against your fellow CAP members in the June News Quiz and brag about your top scores on social!

Take the news quiz.