menu
menu
April 05, 2018
Thousands of laboratory professionals responded to an ASCP eAdvocacy campaign and flooded the Centers for Medicare & Medicaid (CMS) with comments opposed to a proposal allowing individuals with a nursing degree to perform high complexity testing (HCT) or serve as a technical consultant in a moderate complexity laboratory. These efforts were in response to a CMS Request for Information (RFI) soliciting comments on possible policy changes to the regulations governing the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In total, CMS received 8,700 comments, almost all of which were the result of an e-advocacy campaign initiated by ASCP and participated in by other organizations representing laboratory professionals affiliated with the ASCP Board of Certification (BOC) as contributing members of the Board of Governors (BOG).
The RFI outlined two nursing degree proposals, one essentially maintaining the Agency’s current policy that nursing degrees are equivalent to biological sciences degrees as well as an alternative proposal that would recognize a bachelor’s degree in nursing as a separate qualifying degree. CMS did not indicate nursing degree holders would have to meet any specific clinical training needs. ASCP and the ASCP BOC urged CMS in a letter to abandon both of these proposals.
In our comments, ASCP and the ASCP BOC acknowledged the existence of a shortage of laboratory personnel but argued that the nursing degree was not an appropriate way to address this problem. Instead, we urged CMS to modify the degree requirements to allow individuals who have a bachelor’s degree and have completed significant coursework (30 or more semester hours) in the biological or chemical sciences to be allowed to perform HCT. In addition, to ensure that all laboratory personnel receive appropriate training, the ASCP and ASCP BOC urged CMS to clarify that individuals with a bachelor’s degree must receive appropriate clinical training to perform HCT. The ASCP and ASCP BOC also urged that CMS require certification of all HCT personnel and supervisors.
Another important component of the ASCP/ASCP BOC comments was to urge CMS to classify the histologic processing of tissues as highly complex. This, we urged, should require that such services be performed in laboratories that are appropriately CLIA certified, under the direction of a board-certified anatomic pathologist, adhere to applicable proficiency testing requirements and use appropriate personnel, such as certified histotechnicians and histotechnologists. It is unclear when CMS will release a proposed rule on this issue, but when it does we will alert ePolicy readers.
On March 16, ASCP scored an important advocacy victory when the Centers for Medicare and Medicaid Services (CMS) reversed course on its final National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. Changes to the NCD will preserve the ability of clinical laboratories to gain Medicare coverage for their Laboratory Developed Tests (LDTs). The immediate purpose of the draft coverage proposal was to provide coverage for Foundation Medicine’s FoundationOne CDx™ (F1CDx) companion diagnostic, but CMS used the proposal to pursue potentially far-reaching policy changes covering what could qualify for Medicare reimbursement.
In the draft coverage proposal, CMS proposed to allow Medicare reimbursement for NGS tests with companion diagnostics that were approved by the Food and Drug Administration (FDA). A second pathway to coverage was included, but it would have made it very difficult, if not impossible, for clinical laboratories to secure coverage for LDTs. ASCP opposed the CMS proposal, in part because the anti-LDT provisions could ultimately be expanded to other areas of laboratory testing, and this could have had a chilling effect on research by clinical laboratories to develop innovative testing methodologies and tests. In the final NCD, the Agency elected to allow its Medicare Administrate Contractors (MACs) to “determine coverage of other Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with cancer.” This will maintain the ability of clinical laboratories to secure coverage for LDTs via the local coverage determination (LCD) process. Interestingly, CMS’s new policy does not state that MACs are limited to approving coverage for NGS services with companion diagnostics, meaning that CMS’s policy does not appear to limit what NGS services are eligible for coverage by the MACs. CMS also clarified that both FDA-approved and –cleared NGS with companion diagnostics will receive Medicare coverage.
Another concern raised by ASCP was that the CMS proposal only provided coverage for undefined advanced stage cancers, meaning that it was unclear whether individuals with stage II or even stage III cancers would be eligible for coverage. CMS has clarified its coverage policy such that NGS services will be covered for patients with recurrent, relapsed, refractory, metastatic, and advanced stages III or IV cancer.
With baby boomers retiring in droves, the medical laboratory profession needs to intensify efforts to recruit the next generation of professionals, according to the newly-released ASCP 2016-2017 Vacancy Survey. A focus on qualifications and certification status is crucial to addressing the needs of the laboratory workforce of the future, according to the Vacancy Survey, which was published in the March 2018 issue of the journal, AJCP.
Retirement rates of laboratory professionals (for those retiring in the next 5 years) are at their highest across the majority of departments since 2012. Moreover, the rate of supervisory retirements is higher compared with staff, especially in the anatomic pathology, chemistry toxicology, cytogenetics, cytology, flow cytometry, hematology coagulation, immunology, microbiology, phlebotomy, point-of-care, send-outs, and specimen departments. Data suggest that these fields will soon be experiencing a drain in personnel who have been working for a long period of time and have a vast amount of experience.
Overall, 24 percent of survey respondents said their primary concern is finding qualified laboratory professionals to staff the labs. They also indicated that the number of applicants is extremely low compared with the number of personnel retiring. To fill the vacancies, some laboratories are hiring non-certified staff.
Conducted every two years, the ASCP Vacancy Survey serves as the primary source for industry labor, government, and academic analysts. Overall, this year’s 1,340 respondents (who hold management level or human resource positions) represent 51,586 medical laboratory employees across the United States.
ASCP joined with the American Clinical Laboratory Association (ACLA) and eleven other laboratory and medical organizations in urging Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma to discourage states from imposing huge cuts on payment rates state Medicaid programs pay for clinical laboratory services. On Jan. 1, CMS proceeded with its flawed implementation of the Protecting Access to Medicare Act (PAMA) by establishing a new Medicare Clinical Laboratory Fee Schedule based on incomplete payment rate data.
ASCP’s concern is that some states have established policies of imposing percentage discounts on Medicare rates, sometimes paying 80 or less percent of the Medicare rates. Due to the problems with how CMS established new laboratory payment rates, this state discounting practice could result in payment rates below cost. This threatens patient access to quality laboratory services, which as the letter states “will pose hardships for patients and for clinical laboratories providing this key healthcare service. Medicaid cuts on top of Medicare cuts target the most vulnerable patient populations in the U.S. This is not sound policy.”
The ACLA-lead sign-on letter urges CMS to remind state Medicaid directors of their obligation “to provide Medicaid reimbursement for laboratory services that is sufficient to ensure access to those services.” To read the letter in its entirety, click here.
Last month, ASCP attended a panel hosted by Health Affairs on Advancing Health Equity. Health policy experts convened to discuss implications of research in the approaches to achieving equity, examining effects of income and health, and identifying and reducing health disparities. The panel strongly emphasized the benefits of patient-centered care and a focus on both primary and preventive health care measures to deliver positive patient outcomes. The panel’s research provided several potential solutions to health equity issues across gaps in various minority populations. The panelists presented their research on topics in health inequity, including gender and racial or ethnic disparities. Panelists developed policy recommendations from their findings to support immediate action from policymakers. Policies suggested include providing low-income mothers with supplemental income, dispersing conditional cash transfers for low-income families who are achieving educational and family health goals, and utilizing Coordinated-Care Organizations (CCO) in Medicaid expansion states to supplement preventive and primary care. Also recommended were community-based interventions that better integrate health resources and education to foster mentorships and community networks particularly in mixed immigration status populations. Experts agreed that incorporating an emphasis on the social determinants of health will give policy officials a framework to advance health equity. This is a strong forward step in prioritizing patient-centered care and promoting achievable health equity across all genders and racial or ethnic minority groups. At ASCP, our work with the Choosing Wisely initiative aims to ensure patient-centered care is promoted by reducing waste in testing and diagnostics and other procedures. Recommendations such as these can have an important role in improving the use of effective testing. ASCP will continue to monitor these policy recommendations and others related to preventative healthcare measures.
For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).
ASCP
ePolicy News is supported by
an unrestricted grant from Hologic.
ADVERTISEMENT