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ASCLS to CMS: High Standards Equal Better Care

The laboratory community is being presented a once-in-a-generation opportunity to guide the updating of CLIA regulations to reflect the current and future practices in clinical laboratories that support clinical decision-making in an ever-evolving healthcare system. In advance of a March 12, 2018 deadline, CMS is requesting information, comments, information, evidence, research, and trends related to CLIA personnel regulations that the Agency intends to use to update the existing CLIA personnel regulations in the future.  This will be the first time since 1992 that there has been a comprehensive review of the regulations.

ASCLS is preparing detailed comments for CMS on all of the issues raised, with a central focus on strengthening laboratory personnel standards and ensuring the ongoing, invaluable contributions of laboratory professionals in the healthcare system.

More Information: ASCLS In Depth Analysis and Issue Brief (PDF)

 
High Standards Better Care
 

Nursing Degrees Are Not Equivalent to Biological Sciences Degrees

In April 2016, CMS released a memo updating its interpretation of the personnel regulations allowing surveyors to consider a bachelor’s degree in nursing as equivalent to a bachelor’s degree in a biological science for high complexity testing personnel. After CMS published the previously “unwritten rule” in April 2016, ASCLS, working through the Board of Certification, raised deep concerns with the agency. The societies presented more than 30,000 signatures from laboratorians, physicians, nurses and other healthcare professionals demanding that CMS reverse its decision, expressing their deep concern about patient health and welfare in those institutions that placed unqualified people in key positions in the laboratory. 
 
The ASCLS position has not changed. Nursing and biological sciences degrees are not equivalent and creating a regulatory framework where they are, puts the lives of patients at risk. CMS claimed that this previous unwritten rule was necessary for areas where there were not enough qualified laboratory personnel to perform the necessary work. Equating a bachelor’s degree in nursing with a degree in biological sciences would allow nurses to:
  • Perform high complexity testing without any additional training. 
  • Serve as a technical consultant for high complexity laboratories or as lab director or technical consultant for a moderate complexity laboratory with defined laboratory experience.
Nurses seem to have no interest in taking on these roles, understanding their training best prepares them to contribute to patient health in other ways. The fear is that nurses will be forced into roles for which they do not have adequate training by short-sighted administrators.
 
In both scope and depth, the natural science coursework required for a biological sciences degree vastly outweighs the natural science coursework required as part of a nursing degree. Typical coursework requirements for a bachelor of sciences degree in biological sciences includes a total of at least 63 hours of natural sciences, including at least 39 hours of major requirements in the biological sciences and 32 hours of prerequisites. In contrast, nursing degrees include only a quarter of the course hours in the natural sciences. 
Comparisons from some leading universities with both nursing and medical laboratory science programs illustrate the entirely different degree programs.
 
Louisiana State University Health Science Health Science Center
University of North Carolina at Chapel Hill
University of Mississippi Medical Center
University of Wisconsin Milwaukee

More Information: Detailed analyses comparing nursing, biological science, and medical laboratory science degrees (pdf)

While ASCLS and laboratory professionals have great respect for our nursing colleagues and believe that existing educational programs in nursing provide outstanding training for professionals in the nursing field, the nursing degree is not intended to be, nor should it be viewed as adequate to direct moderate complexity or perform high complexity diagnostic testing. 

Review Comments

More than 8,600 comments were submitted to CMS in response to their request for action. All comments to CMS are public and can be reviewed online.

Sign a Petition

Use the ASCLS Action Center to sign onto a petition supporting key issues on CLIA personnel regulations.

Personnel Qualifications-Alternate Pathways

CMS seeks comment on whether it should add nursing degrees as a separate qualifying degree (as opposed to the equivalent of a biological science degree) to the current list of qualifying degrees for moderate and high complexity testing personnel requirements. The Agency also is seeking to define what is considered a “physical science degree” for regulatory purposes, and whether any physical science degree(s) should meet the CLIA educational requirements.
In all cases, the Board of Certification has clear alternate pathways for those not trained as laboratorians. Nurses holding a BSN or those holding degrees in physical sciences should be able to undergo a standard evaluation of their degree programs to determine if they are prepared to perform these tests.
 
Rather than focus on specific degrees, which may not be entirely descriptive of the coursework, CMS should define the educational requirements for non-laboratory science bachelor degree holders instead of relying on the label of their degree. 

Lowering Standards Is Risky, Ineffective, and Not Patient-Centric

The motivation for CMS to expand qualifying criteria is unclear. If this action is to address concerns about adequately staffing clinical laboratories, there are more effective approaches. Lowering standards is risky and is not supported by data. Expanding a regulatory role for nursing and non-biological science degree holders is unlikely to overcome difficulty finding personnel to properly perform testing. The average salary for a nurse is substantially higher than a credentialed MLS or MLT professional. 
 
If institutions are unable to fill necessary positions with qualified personnel, lowering standards is not an efficacious solution. These institutions should consider increasing compensation and benefits to attract appropriately trained and credentialed personnel or choose to forgo providing those services in ways that clearly put patients’ lives at risk
 
In its 2015 report on diagnostic errors in health care, the Institute of Medicine focused on the causes of harm in our healthcare system, placing sufficient and accurate diagnostic testing at the center of a healthy diagnostic process. Forcing or allowing unqualified personnel to perform laboratory tests weakens the entire diagnostic process and harms patients. 
 
“When errors occur, the “deficiencies” of health care providers (e.g., insufficient training and inadequate experience) and opportunities to circumvent “rules” are manifested as mistakes, violations, and incompetence. Violations are deviations from safe operating procedures, standards, and rules, which can be routine and necessary or involve risk of harm.” 
- Patient Safety and Quality: An Evidence-Based Handbook for Nurses.” Agency for Healthcare Research and Quality 2008 
 
As testing has moved closer to the patient and utilization of point of care testing (POCT) has increased, it is common for preanalytical errors to occur and inaccurate results reported. In most of those cases, these tests are performed by non-laboratory professionals, giving a glimpse into what lowering qualifications for performing high complexity testing may hold. Both the scientific literature and the experiences of most laboratorians are filled with examples of mistakes impacting testing. Reviews by CMS and other laboratory accrediting authorities document the frequency of these kinds of errors in moderate complexity and physician office laboratories. If performance in those environments can already be considered unsatisfactory, it is inappropriate to expand similar qualifications to high complexity laboratories.

Addressing Workforce Shortages

While there are clearly shortages of qualified laboratory personnel, current CLIA regulations fail to recognize improvements in technology that allow for the more efficient deployment of qualified laboratory professionals. Updates to the CLIA regulations should anticipate changes in practice, management of clinical knowledge, advancing technology, and expansion of testing capabilities. 
 
In some cases, CLIA regulations already provide for a single person to serve in roles for multiple laboratories simultaneously. Improved technology and its utilization in clinical laboratories should allow the Agency to expand that allowance to a wider range of positions, effectively expanding the workforce and providing typically hard to reach institutions with access to qualified personnel. For technical consultants, supervisors, and clinical consultants, CLIAC has been interpreted to only allow individuals in those positions to work in one laboratory, since wording of the responsibilities suggest they need to be physically present. 
 
Considering what is possible with current technology, that interpretation is no longer necessary.  ASCLS encourages CMS to reconsider the interpretation of those position responsibilities and allow individuals to appropriately serve in those roles for multiple laboratories. 

Important Links

 

Support Fellow Laboratorians on "Giving Tuesday"

This #GivingTuesday, you can support your fellow laboratorians with a donation to the ASCLS Education & Research Fund.

Each year, the E & R Fund provides more than $10,000 in scholarships and research grants to deserving clinical laboratory students and professionals.

Grants have allowed researchers to:

  • Secure sickle cell test kits to improve testing in Haiti.
  • Advance research on Methicillin Resistant, Staphylococcus aureus (MRSA).
  • Support researcher needs for statistical software to complete their work.
  • Expand genomic analysis on a pathogen attacking immunocompromised patients.

Scholarships support the development of future colleagues as they learn and work to join the clinical laboratory profession. Some of the profession's most recognizable leaders have been recipients of this critical support.

Please consider a gift to the E & R Fund for #GivingTuesday and help current (and future) colleagues advance our profession.

The ASCLS Education & Research Fund is a 501(c)3 charitable organization. Donations to the E & R Fund are tax deductible to the extent allowed by law. 

ASCLS Provides Formal Comments to CMS on Preliminary CLFS 2018

Earlier today, in its formal comments sent in response to the release of preliminary pricing for the 2018 Clinical Laboratory Fee Schedule (CLFS), ASCLS urged the Department of Health and Human Services to postpone implementation of the new CLFS until it can work with stakeholders to properly collect data that accurately reflects the market and demonstrated its ability to appropriately analyze that data.

In the letter from ASCLS President Debra Rodahl, the Society objected to the "careless implementation of these proposed rates. If implemented, the loss of access to services will cause increased morbidity and mortality across the healthcare system, felt most acutely in elderly populations and those who live in rural areas."

Specific objections were raised around:

  • Reductions to HCPCS codes without National Limitation Amounts (NLA)
  • Data collection that was skewed and resulted in artificially low weighted medians
  • Data that lacks validation and contains significant numbers of errors
  • A deeply-flawed process that will reduce access to care

Laboratorians who object to these cuts should continue to contact their members of Congress and share their concerns. ASCLS has setup an Action Center that makes it easy to talk to representatives and senators.

Protecting Access to Laboratory Services

 

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The Centers for Medicare and Medicaid Services (CMS) is proposing more than $600 million in cuts to laboratory reimbursements beginning January 1, 2018, with total cuts rising to as much as $1.5 billion annually compared to current reimbursement levels by 2020. These cuts are part of a flawed implementation of the Preserving Access to Medicare Act (PAMA) passed in 2014.

Over ten years, the cuts may total as much as $13 billion, which is more than three times the estimate of $3.9 billion Congress originally anticipated.
 
The impact of cuts to the Clinical Laboratory Fee Schedule (CLFS) will fall disproportionately on nursing homes served by local hospitals, small independent laboratories, and laboratories in physician offices, as well as Medicare-dependent hospitals and community hospitals in rural areas. 
 
Having committed the agency to a deeply-flawed data collection process, CMS has now drafted a distorted fee schedule built on questionable data collected from just five percent of the laboratories in the United States. CMS admits that just 1.85 percent of data was collected from laboratories serving rural areas.
 
take action now
 
Large, national laboratories efficiently deliver an important component of laboratory services, but function using entirely different models of care and reimbursement than laboratories serving local communities. Smaller, local, independent, physician office and hospital laboratories, functioning closest to the patient and clinician, provide services for nursing home residents, patients requiring frequent testing for management of chronic conditions like diabetes and hypothyroidism, same day information for oncologists to treat their patients undergoing chemotherapy or those suffering from infections that require rapid detection and identification for proper monitoring and treatment. 
 
To serve the needs of their patients, local laboratories provide more rapid results drawn from more specialized test menus without economies of scale. The methods used by CMS to collect and interpret an incomplete dataset without validation excluded the possibility of measuring those differences.
 
Cuts to the CLFS will have a ripple effect through private insurers and other government payors like Medicaid, which use the CLFS to set their own rates. The outpatient laboratory service system in the United States could see a reduction in total annual reimbursements by as much as 25 percent over the next three years. 
 
The result will be a dramatic reduction in available testing and access to laboratory services for patients and clinicians. The cuts will also result in a near elimination of capital investment in the latest technologies needed to improve care.
While these cuts directly impact outpatient services, because some of these laboratories share resources within hospitals, there will be a spillover effect to inpatient care because laboratories will no longer be able to afford the breadth of testing offered now, especially in rural areas. 
 
Last year, the 21st Century Cures Act passed Congress with broad, bipartisan support, to usher in the advent of precision medicine. Implementation of PAMA, as it is currently structured, will cut off access to the vital laboratory data that underpins this emerging approach to delivering healthcare.
 
Congress must act to prevent their constituents from losing access to these critical, life-saving medical services.
 

Deeply Flawed Approach by CMS

Based on the implementation by CMS, Congress could have called this law the Preventing Access to Medicare Act.  Choices made by the agency throughout this process were designed to lock out entire service sites and limit patient access to appropriate laboratory services. CMS chose to:
  • Define which laboratories would report data in the narrowest possible terms, resulting in 90% of reported data coming from independent laboratories. Hospitals and physician office laboratories provide 44% of Medicare services but represent just 8.5% of the reporting entities. Less than 1 percent of hospitals and physician office laboratories reported data. In 2016, HHS Office of Inspector General predicted 3,500 laboratories would report data, but 55% of that number actually did.
  • Change reporting requirements and deadlines multiple times and then ignore concerns that reported data lacked any verification process, resulting in a data set that includes erroneous data points, dramatic outliers and magnitudes of difference between the calculated mean and median. 
  • Ignore the intent of Congress and publish rates for some highly used codes that will cut actual reimbursement by as much as 40% next year. For those HCPCS codes without a National Limitation Amount (e.g. 80061 Lipid Panel), CMS failed to set a reasonable benchmark for what laboratories are currently being reimbursed, and instead, proposes implementing the full cut in a single year.
The laboratory community has warned CMS and Congress during this entire process that the implementation was improperly managed. The agency’s own analysis shows significant numbers of reporting entities don’t appear to meet the definition of applicable laboratories. The analysis also show entities that submitted inaccurate data. CMS exhibited a pattern of excluding data that would have increased the weighted median, but included questionable data that lowered the weighted median.
 
In September 2016, The Department of Health and Human Services Office of Inspector General shared its concern about a lack of data validation. "Absent processes to verify whether applicable labs report their data or to verify the quality of data that labs report, CMS may set inaccurate Medicare payment rates for lab tests. PAMA required CMS to set Medicare payments rates for lab tests by using a market-based approach… If CMS does not have appropriate safeguards to ensure that all applicable labs report complete and accurate data, it may result in new Medicare payment rates that are inaccurate.” (OEI-09-16-00100)
 
It is worth noting that CMS, trying to blunt criticism, performed “simulations” of broader reporting of data and claims that additional reporting would have not made a “significant impact.” However, the simulations ignore the fact that unreported data would likely be at higher payment rates, making the simulations entirely useless as a predictor of the actual market. The reported “simulations” are designed to distract Congress and the public from the mistakes the agency made during implementation.
 
Congress may have anticipated these issues. Within the law, Congress directs the General Accounting Office (GAO) to perform a study of the PAMA implementation that examines payment rates across laboratory settings (including laboratories that furnish low volume services), the response from private payors, the impact on beneficiaries, and whether the data “accurately reflects market prices.” Congress should accelerate the timeline for this report.
The wide-ranging impact these cuts will have on the entire healthcare system are too grave to base them on incomplete and unverified data. Congress must seek a delay and direct GAO to study the implementation immediately.

Solution

Through the chairs of the Senate Finance, House Ways and Means and House Energy and Commerce committees, Congress must communicate to the Administration that these misguided cuts must not be implemented. Delay is critical until CMS can work with stakeholders to demonstrate the agency can properly collect and validate data that accurately reflects the market.
 

Additional Resources