Persistence Pays Off

By Susan Montgomery - February 06, 2024

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ASCP and ASCP Board of Certification achieve one of their greatest advocacy wins 

Advocacy can be a long-term process. Done well, it combines strong leadership, clear and effective communication, perseverance, and, often, a strong grassroots operation. 

In late December, ASCP and the ASCP Board of Certification (ASCP BOC) achieved a significant advocacy victory when the Centers for Medicare and Medicaid Services (CMS) withdrew its proposal to allow individuals with a bachelor’s degree in nursing to perform high complexity testing. In addition, ASCP and the BOC succeeded in getting CMS to reverse its longstanding policy of considering nursing degrees as equivalent to biology degrees.  

ASCP has maintained that nursing degrees lack the scientific coursework and laboratory training necessary to perform quality high-complexity laboratory testing and this could compromise the delivery of high-quality patient care. 

“The nursing degree policy has been a significant concern to ASCP and the ASCP BOC for years,” says Matt Schulze, Senior Director of ASCP’s Center for Public Policy. “Given the proposed policy’s potential impact on quality testing and patient care, its repeal is one of our most important recent accomplishments.” 

This monumental effort would not have been possible without the strong support of other collaborating organizations that make up the ASCP Board of Certification. A key player in that effort was the American Society for Clinical Laboratory Science (ASCLS). In addition, a grassroots effort involving tens of thousands of ASCP members, ASCP BOC certificants, and others who responded to numerous ASCP and ASCP BOC Action Alerts urging them to sign petitions and send letters of opposition to CMS over the past several years contributed to this victory.  

“It is a win for patient care,” says Sue Graham, MS, MLS(ASCP)SHCM, immediate past chair of the ASCP Board of Certification Board of Governors who was integrally involved in the issue. “It speaks volumes about the commitment of ASCP members to remain focused on the mission of providing quality patient care. It also speaks to the dedication of ASCP and BOC leadership to ensure that we do all that we can to advocate on behalf of our members’ and BOC certificants’ professional needs and goals.”  

In late December, CMS stated in its 2023 Final Rule that it concurred with ASCP, the BOC and others that nursing degrees do not provide sufficient instruction in the applicable sciences to perform high complexity laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.  

“Sometimes, when a policy issue captures public attention, an advocacy campaign can be wildly successful in a short period of time,” Mr. Schulze says. “When issues don’t resonate with the public, it can take longer to be successful. Such is the case with the CLIA nursing issue. This is a campaign with clear implications for quality patient care, but issues related to laboratory personnel qualifications aren’t likely to capture the public’s attention. As a result, it took a long time to be successful. That is the nature of advocacy.” 

ASCP and the ASCP BOC began beating the drum back in 2016, when CMS first outlined a policy of considering nursing degrees to be equivalent to biological sciences degrees, which meant these degree holders could perform high complexity testing. Soon thereafter, ASCP and the BOC rallied their members to sign a petition urging CMS to reverse the policy and quickly got 35,000 signatures. However, CMS seemed intent on releasing a proposed rule to make the nursing degree policy a part of the CLIA regulations.  

“We weighed in, repeatedly, as CMS pushed its proposal via the regulatory. In each case, ASCP garnered notable grassroots support,” Mr. Schulze says. The Agency received nearly 9,000 letters of support from its members in response to CMS’ Request for Information from the laboratory medicine community on the proposal. In addition, the Proposed Rule to recognize a bachelor’s degrees in nursing for high-complexity testing garnered another 20,000 letters of protest from ASCP members, BOC credential holders, and others in the laboratory community, in response to an ASCP Action Alert. ASCP members, BOC certificants, and others turned out. 

“That level of response from our members is a big deal,” Mr. Schulze emphasizes. “ASCP worked to keep the matter top of mind with our members, and they showed us that this was a matter of significant concern to them. That is how the issue got traction and longevity, and ultimately, our members made this happen.” 

In addition to the repeal of the nursing degree policy, CMS adopted several other ASCP/ASCP BOC recommendations, including: (1) establishing a degree equivalency requirement, (2) eliminating physical science as a recognized degree for high complexity testing, (3) clarifying training and experience requirements, (4) adopting updated degree nomenclature for medical laboratory science, and (5) updating the CLIA high-complexity personnel requirements for individuals completing a military laboratory training program. 

The evolution of the nursing issue

Years ago, word got out in the medical laboratory community that CMS had a so-called “secret” (or little known) policy, allowing individuals with a Bachelor of Nursing to perform high-complexity testing. “The requirements under CLIA were that you had to have a bachelor’s or higher degree in a chemical, biological, physical, or clinical laboratory science or medical technology to do that testing,” Mr. Schulze says. “You could also do high-complexity testing with an associate’s degree with credit hours and at least 24 semester hours of specific science courses.” 

On April 1, 2016, CMS sent to its various state and local branch managers a memo on a few topics, one of which was that CMS had adopted a policy where it considered a Bachelor of Nursing to be equivalent to a degree in biology.  

“A Bachelor of Science in Nursing requires far fewer hours of coursework in the sciences applicable to laboratory testing than the degrees that are recognized by CLIA,” Mr. Schulze says.  

ASCP policy staff in the Society’s Washington, DC, office drafted a letter to comment on the CMS memo, raising significant concern about the policy. ASCP and the ASCP BOC held two meetings, one in 2016 and another in 2017, with CMS leaders to discuss the issue. 

“At one point, CMS staff said this had been their longstanding policy,” recalls Mr. Schulze, adding, “Yet their policy didn’t seem consistent with the CLIA regulations.” 

ASCP submitted a petition with 35,000 signatures from members and others in the medical laboratory community, voicing their opposition to the policy recognizing a nursing degree for high-complexity testing. During one of those meetings, CMS said the only way they could reverse the rule was through a regulation to put the policy out for public comment. 

That process started when CMS released a Request for Information (ROI) in 2018 seeking public comments on their proposal to consider a Bachelor of Nursing to be the equivalent of a biology degree. When CMS’ ROI was issued, the ASCP BOC and its contributing societies submitted a letter and ASCP issued several Action Alerts to its members, generating nearly 9,000 responses to CMS, objecting to the proposal. ASCP worked with other laboratory medicine organizations, such as ASCLS, which also sent out an Action Alert.  

“Ninety-five percent of the comments CMS received from its request for information came from our collective efforts,” recalls Mr. Schulze.  

Shortly after the comment period closed, ASCP learned that the Agency was planning to move forward and release a proposed rule supporting its nursing degree proposal. 

It took four years, but in 2022, CMS released that proposed rule. The proposed rule required ASCP and the ASCP BOC to undertake several actions as part of an all-out defense against the proposal. First, CMS announced a 30-day comment period for the proposed rule on the nursing degree. CMS’ standard comment period is 60 days. This didn’t leave much time to mount an effective grassroots advocacy campaign. 

“It felt like CMS wanted to prevent us from doing a grassroots campaign,” Mr. Schulze says. “So ASCP and the ASCP BOC advocated for an extension of the comment period from 30 to 60 days, circulating a ‘sign-on’ letter that received the support of more than 20 pathology, laboratory, and medical organizations. The day before the 30-day comment period ended, CMS granted us more time for public comment. The ASCP/ ASCP BOC sign-on letter appears to be the only one requesting an extension for public comment.” 

ASCP and the ASCP BOC submitted two letters on the proposed rule. In a detailed letter responding to a number of policies in the proposed rule, they were joined by many of the ASCP BOC participating societies. ASCP also submitted a shorter letter focused on the nursing degree issue that was signed by 14 pathology and laboratory medicine organizations. In addition to those formal comments, ASCP mounted a grassroots effort, urging members to call on CMS to withdraw its nursing degree proposal. In response, more than 20,000 comments were submitted to CMS through the ASCP portal. 

“Clearly, CMS saw that the laboratory community is really invested in this issue and concerned about it, and that our focus was entirely on patient care,” Mr. Schulze says. “We recognize that nurses provide important and high-quality care to their patients. However, a nursing degree is not intended to train someone to perform high-complexity testing services and it should not be recognized as such.”  

After that big push for public comment, ASCP did not hear back from CMS until 2023. CMS submitted its Final Rule to the federal Office of Budget Management for review, and it remained there for months.   

Just days before the end of 2023, ASCP learned that CMS’ final rule had been published. Given that CMS kept repeating its proposal to recognize the nursing degree for high complexity testing, ASCP was anticipating the same in the final rule. But the results were a clear victory for patient care as CMS withdrew its plans to add nursing degrees to the list of degrees that qualify individuals to perform high complexity test and CMS tabled its policy that nursing is a biological science.  

After more than eight years of advocacy on the issue, ASCP and the ASCP BOC had finally succeeded. 

Susan Montgomery

ASCP communications writer