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May 02, 2018
Recently, the U.S. Department of Health and Human Services (HHS) submitted its response to a lawsuit brought by the American Clinical Laboratory Association (ACLA) and supported by ASCP. The lawsuit challenges the Department’s definition of the term “Applicable Laboratory.” HHS believes that its work to craft a new, though highly flawed, clinical laboratory fee schedule (CLFS), is beyond “administrative or judicial review.” ACLA disagrees with the Department’s response.
ACLA says it filed the lawsuit against HHS to “challenge the data reporting requirements of Section 216 of the Protecting Access to Medicare Act (PAMA). Specifically, the lawsuit challenges the unlawful exemption of the vast majority of laboratories from the requirement to report private payor data to CMS to determine Medicare reimbursement for lab tests under the Clinical Laboratory Fee Schedule (CLFS).” ASCP has repeatedly raised similar concerns with the Department and Congress about the intentional exclusion of scores of clinical laboratories, such as hospital and physician office laboratories, which often receive higher payment rates from payers. The exclusion of data from these laboratories ignored a key goal of PAMA, which was to establish a Medicare laboratory fee schedule based on the “market rate” for each laboratory service. Excluding this data has created payment rates below the market rates in violation of PAMA’s purpose.
ASCP will monitor developments in the case and will report on this case as events unfold.
On April 10, the Clinical Laboratory Improvement Advisory Committee (CLIAC) was briefed by ASCP about its wage and vacancy survey data. ASCP member Barbara Caldwell, MS, MASCP, MLS(ASCP)CM, SHCM, Administrative Director of Clinical Laboratory Services at MedStar Montgomery Medical Center, provided the federal advisory committee with an in-depth overview and assessment of the latest vacancy data along with an analysis of the 2015 Wage survey data. She noted that current testing personnel vacancy rates have decreased compared with data from the last few vacancy surveys. That said, data collected from respondents suggest that a large portion of the labor market is expected to retire within the next 5 years. This retirement dilemma is problematic because our nation’s current capacity to train the next generation of laboratory professionals is relatively fixed, meaning that the demand for laboratory personnel is likely to dramatically increase. Because it is not believed that the training capacity exists to meet this demand, vacancy rates are likewise expected to increase.
ASCP also noted that wages are increasing but slowly—which may be attributable in part to the limited reimbursement landscape for laboratory services. Moreover, survey data show that among the issues of greatest concern to survey recipients is that they feel underappreciated and underpaid. Employers may need to address these issues in order to more effectively recruit individuals to fill vacant positions and to incentivize individuals to consider laboratory careers.
In addition to Ms. Caldwell’s remarks, ASCP Chief Medical Officer Dan A. Milner, MD, MSc(Epi), FASCP, addressed CLIAC about the recent Centers for Medicare and Medicaid Services (CMS) Request for Information (RFI) on the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations. He noted ASCP’s opposition to the CMS proposal to allow a baccalaureate degree in nursing to satisfy the CLIA requirements to perform high complexity laboratory testing and to supervise moderate complexity testing. He noted that this nursing degree does not provide sufficient academic preparation to enable its holder to provide these services.
On April 23, the Centers for Medicare & Medicaid Services (CMS) announced its plan to allow Medicare beneficiaries to contract directly with physicians. This is a major departure from the current payment model wherein physicians are paid under the Medicare Physician Fee Schedule and are limited in the amount they can charge patients for services. CMS’s decision to introduce this new payment model stems from comments received in late 2017 in response to a Request for Information on new priorities to be pursued by the CMS Innovation Center.
Patient advocacy groups have expressed concern about this change and fear it will lead to “cherry-picking,” meaning physicians may choose the patients or services they will bill Medicare for, and decide to contract directly with patients for other services. ASCP will continue to track this development and report on its potential impacts as they arise.
ASCP is one of 40 organizations that recently signed on to a letter drafted by the American Medical Association (AMA) urging the Centers for Medicare & Medicaid Services (CMS) to reduce the 2018 Merit-based Incentive Payment System (MIPS) quality measure reporting period from 12 months to a minimum of 90 consecutive days. The concerns shared by AMA are in alignment with a comment letter ASCP submitted to CMS this past December. MIPS is one of two ways to participate in the Quality Payment Program (QPP) and is comprised of four categories: quality, advancing care information, improvement activities, and cost. ASCP is concerned that maintaining the 90-day performance period for Improvement Activities and Advancing Care Information (ACI) while increasing the quality performance period to 12 months will create confusion, and is in opposition to a key goal for the MIPS program which is to streamline reporting and simplify participation for providers.
The AMA’s sign-on letter also points out that CMS did not post eligibility information on the Quality Payment Program (QPP) website until April 6, despite clinicians being held accountable for data tracking and collections as of Jan. 1, 2018. The late notification of MIPS eligibility creates an additional barrier in clinicians’ ability to participate in the program. In addition, the CMS QPP website has yet to be updated with 2018 information, despite several changes to MIPS between 2017 and 2018. Clinicians would not receive feedback on their MIPS performance until July, which may reduce flexibility to incorporate the feedback into their 2018 performance.
ASCP will continue to advocate for increased opportunities for pathologists to meaningfully participate in payment and delivery reform through the Medicare. We believe the changes outlined in the sign-on letter will help provide easier reporting and less confusion for participating pathologists.
The ABIM Foundation released its Top 12 list of Choosing Wisely recommendations that drove the largest decrease in unnecessary tests and procedures and this includes ASCP’s recommendations on Vitamin-D testing and preoperative testing for low risk surgeries. The two ASCP recommendations, submitted by the ASCP Effective Test Utilization Steering Committee, are as follows:
Don’t perform population-based screening for 25-OH-Vitamin D deficiency.
Vitamin D deficiency is common in many populations, particularly in patients at higher latitudes, during winter months and in those with limited sun exposure. Over the counter Vitamin D supplements and increased summer sun exposure are sufficient for most otherwise healthy patients. Laboratory testing is appropriate in higher risk patients when results will be used to institute more aggressive therapy (e.g., osteoporosis, chronic kidney disease, malabsorption, some infections, and obese individuals).
Avoid routine preoperative testing for low risk surgeries without a clinical indication.
Most preoperative tests (typically a complete blood count, Prothrombin Time and Partial Prothomboplastin Time, basic metabolic panel and urinalysis) performed on elective surgical patients are normal. Findings influence management in under 3% of patients tested. In almost all cases, no adverse outcomes are observed when clinically stable patients undergo elective surgery, irrespective of whether an abnormal test is identified. Preoperative testing is appropriate in symptomatic patients and those with risks factors for which diagnostic testing can provide clarification of patient surgical risk.
The ASCP Effective Test Utilization Steering Committee has since released subsequent lists in 2015, 2016 and 2017, bringing the total to 20 recommendations of overused or unnecessary tests and treatments in pathology. Along with the newly formed Advisory Board, the team is developing its 5th list of recommendations this year.
ASCPs’ Choosing Wisely recommendations can be found here.
ABIM Foundation Report on the Top 12 Recommendations can be found here.
ASCP is urging the U.S. Department of Health and Human Services (HHS) to reverse course on its plan to end its support for the National Guideline Clearinghouse (NGC) in July 2018. ASCP has joined with a number of other organizations asking HHS to maintain the Clearinghouse. This letter will be delivered to the Office of the Secretary of HHS in May. The goal of the advocacy campaign is to outline the impact of the loss of the NGC and its value to public health, in hopes that the decision to sunset this valuable resource will be reversed, or that the information on the NGC website could be hosted elsewhere.
The value of the NGC to clinical practice guideline development is that it stands currently as the only centralized location that is freely accessible with easy to understand presentation of the National Academies of Sciences, Engineering, and Medicine, formerly the Institute of Medicine standards on clinical practice guideline development.
This year marks the 30th year that ASCP has been conducting its vacancy survey. Conducted every two years, the ASCP Vacancy Survey serves as the primary source for industry, labor, government, and academic analysts. According to the U.S. Department of Bureau and Labor Statistics, the job outlook for Medical and Clinical Laboratory Technologists and Technicians for 2016-2026 will grow 13 percent faster than the average projected growth compared to all occupations, indicating the need for more laboratory professionals to fill upcoming vacancies. The ASCP Vacancy Survey provides department-specific information on vacancies as well as identifies training and qualifications gaps within the laboratory workforce. The ASCP 2016 Vacancy Survey can be accessed here.
For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-408-1110).
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