Advocacy Update

• Biden Administration Declares Monkeypox a Public Health Emergency
• CAP Releases Good Faith Estimate Toolkit for Pathologists
• CAP, Laboratory Groups Demand 60-Day Feedback Period on Proposed CLIA Regulations
• Medicare In-Patient Regulation Includes CAP-Advocated Health Diversity for Quality Measures
• CAP’s Advocacy Newsletter Wins 8th APEX Award of Excellence
• Upcoming Webinar - CAP Leaders Discuss LDT Oversight Updates
• Missed Our Medicare Proposed Payment Regulations Webinar? Watch the Recording
• Test Your Advocacy News Chops

On August 4, the Biden administration declared the monkeypox outbreak a public health emergency, allowing for increased flexibility to dedicate the necessary resources to stop the virus’ spread. The declaration allows federal agencies to direct funding toward developing and evaluating vaccines and drugs, access emergency funding, and hire additional workers to help manage the outbreak. National public health emergencies last 90 days but can be extended by the Secretary of the Department of Health and Human Services (HHS).

After the declaration, government officials said 800,000 monkeypox vaccine doses would be available for distribution. According to the HHS, the US will receive another 150,000 monkeypox vaccine doses in the strategic national stockpile in September. The focus of the administration's response to the outbreak has been to vaccinate those at high risk of contracting the disease.

Monkeypox, a virus like smallpox but with less severe symptoms, has primarily been found in parts of Central and West Africa. But in the current outbreak, the United States has the world’s largest monkeypox cases, and the virus is spreading fast. Less than a month ago, there were about 700 cases; now, there are nearly 10 times that many. In the current outbreak, most people appear to be catching the virus from sexual contact.

The World Health Organization has already declared monkeypox a global emergency. Monkeypox has spread to more than 70 countries in the recent outbreak. In addition, New York, California, and Illinois declared public health emergencies related to monkeypox in the last two weeks.

In April, the Centers for Medicare & Medicaid Services (CMS) released good faith estimate requirements. To help members understand the good faith estimates and price transparency for diagnostic medicine, the CAP created a toolkit to download and use in their practices. Specifically for pathologists, the good faith estimate must include expected charges for the items or services provided in conjunction with the primary item or service. The CAP had urged Congress to hold patients harmless from bills for out-of-network services provided at in-network hospitals or facilities and now engages with the administration on implementing the No Surprises Act.

The No Surprises Act included provisions intended to protect uninsured (or self-pay) individuals from unexpectedly high medical bills. When a physician/facility schedules an item or service (such as a medical device, a doctor’s visit, or a surgical procedure), it must determine the individual’s health insurance status. Suppose the patient has no coverage (uninsured) or does not intend to submit a claim to the plan/coverage (self-pay). In that case, the physician/facility must notify the patient of the good faith estimate of expected charges.

Specifically, a good faith estimate provided to uninsured (or self-pay) individuals must include an itemized list of all items or services that are reasonably expected to be furnished for that period of care, grouped by each provider or facility.

Check out the toolkit and look for additional resources.

The CAP and 22 other laboratory health and medical groups urged the Biden Administration to extend the comment period for the recently proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. The Centers for Medicare & Medicaid Services (CMS) released the proposed 2023 CLIA Fees; Histocompatibility alternative Waived Testing Sanctions regulation, signaling a change in the CLIA fee schedule, including histocompatibility requirements, personnel requirements, and allowing for alternative sanctions for waived testing. The original regulation was slated for only a 30-day comment period from stakeholders like the CAP, unlike the usual 60-day comment period. The group asked the Biden Administration to provide a 60-day comment period to ensure that interested organizations and individuals have a meaningful opportunity to comment as required by law.

In the August 3 letter, the group asked the Biden Administration to provide a 60-day comment period to ensure that all stakeholders have the time to provide comprehensive and quality comments that will impact laboratory regulations. In the letter, the group “recognizes and appreciates the goal of swift rulemaking. However, to ensure that these rules can meet the goals of quality patient care without causing unintended consequences, it is imperative that stakeholders be given sufficient time to provide comprehensive, thoughtful, and well-reasoned comments.”

This proposed rule:

• Outlines numerous increases in funding for the CLIA program, including significant fee increases (20%) for clinical laboratories, follow-up surveys, substantiated complaint surveys, and revised certificates;
• Clarifies the methodology used to determine program compliance fees.
• Amends laboratory personnel and histocompatibility regulations under CLIA; and
• Changes the CLIA requirements pertaining to alternative sanctions (including the imposition of civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring) for Certificate of Waiver laboratories.

On August 1, the Centers for Medicare & Medicaid Services (CMS) released the 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) final regulation. In the final regulation, the CMS agreed with provisions that the CAP advocated for, including improving the formula to establish residence slots, and is considering the CAP’s concern regarding increasing stratification of quality measures in hospital reporting programs. The CAP advocates fair payment for the value pathologists provides and reduced regulatory burdens on pathologists.

In the proposed 2023 Medicare Hospital Inpatient regulation, the CMS sought input when advancing the use of measurement and stratification as tools to address health care disparities and advance health care equity. The CMS will utilize the CAP’s comments when advancing its initiative going forward. The CAP also urged the CMS change its calculations for the adjusted weighted direct graduate medical education methodology and stressed the importance of increasing pathology slots in residency programs. The CMS responded by adjusting the weight for direct graduate medical education full-time employee count in their methodology.

The final regulation updated Medicare fee-for-service payment rates and policies for inpatient hospitals for 2023.

For the eighth consecutive year, the CAP's Advocacy newsletter earned an Award of Excellence for 2022 in APEX’s newsletters category. This was the 34th annual APEX Awards for Publication Excellence.

APEX awards are based on excellence in graphic design, editorial content, and the ability to achieve overall communications excellence. Moreover, APEX's Award of Excellence recognizes exceptional entries submitted in dozens of individual categories covering print and digital media. The CAP’s advocacy newsletter also received APEX awards from 2015-2021.

For the 2022 APEX contest, staff submitted special breaking coverage of the 2022 final Medicare Payment Regulations. View the entire list of 2022 winners from the APEX contest.

The CAP’s Advocacy newsletter provides pathologists with news articles on topics ranging from federal regulation to legislation and local grassroots action. CAP members receive Advocacy Update, the official source for advocacy and policy news from Washington, DC, and electronic newsletter issues weekly.

CAP President Emily E. Volk and Council on Government and Professional Affairs Chair Jonathan Myles will provide an update on the latest laboratory-developed testing oversight legislation during a member webinar.

On August 17 at 1PM ET/12 PM CT, CAP leaders will provide an update on the latest on congressional efforts to enact legislation for a new comprehensive regulatory framework for clinical laboratory tests, including laboratory-developed tests (LDTs) and the Verifying Accurate Leading-edge IVCT Development (VALID) Act.

Register for the webinar.

The CMS released proposed the 2023 Medicare Proposed Payment Regulations. The CAP hosted a webinar where experts reviewed the proposed regulation changes that will impact your pay, practice, and reporting in 2023.

Missed the webinar? Check out the recording and download the slides.

Think you know CAP Advocacy facts - then test your knowledge with the August Advocacy News Quiz. Last month over 70 members took the quiz. See how you compare against your fellow CAP members and brag about your top scores on social! 

Take the quiz.