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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.
 
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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

ASCLS Reacts to Travel Ban Executive Order

"In light of the recent Executive Order on travel into the United States, I would like to assure the members of the American Society for Clinical Laboratory Science that the organization will continue to support, encourage and applaud the diversity of our members," said ASCLS President Suzanne Campbell. "We recognize the knowledge, talent and expertise of our colleagues world-wide. We support and encourage professional collaboration as we seek to provide leading edge laboratory services for our diverse patient population."

At its Fall 2016 meeting, the ASCLS Board of Directors adopted a policy in diversity and inclusion at the state and local level (included below), but the sentiments inform President Campbell's statement today.

ASCLS Policy on Discriminatory Laws and Statutes

The American Society for Clinical Laboratory Science (ASCLS) is an inclusive, culturally diverse organization of laboratory professionals that acknowledges the differences and unique characteristics of each member. ASCLS is committed to an inclusive environment where all individuals are treated with dignity and respect.

Laws enacted by states and municipalities that are contrary to embracing diversity and inclusion are unacceptable. ASCLS joins with other organizations, groups, and businesses that condemn discriminatory laws as anathema to our fundamental belief of equality.

Where it has a choice, ASCLS will refrain from scheduling conferences and events, or making other investments in states and municipalities with discriminatory laws and statutes.

New, Updated Entry Level Curriculum

The updated versions of the Entry Level Curriculum for Medical Laboratory Science (MLS) and Entry Level Curriculum for Medical Laboratory Technician (MLT) are available for purchase in the ASCLS Online Store.  We have a variety of formats available to meet your needs:

  • Institutional Licensed Versions
  • Single User Licensed Versions
  • Curricula for Individual Disciplines
  • Complete Set of MLS and MLT Curricula 

The MLS and MLT entry-level curricula (ELC) are defined as the knowledge and skills expected of a new graduate upon successful completion of a formal educational program.  The curriculum format is delineated by discipline area within the MLS and MLT levels.  

The ELC is designed to

  • Help develop the curriculum for a new program
  • Assist the new instructor/professor with course development
  • Update a current program or course

Some highlights of the updated versions include cross referencing within each publication, a new section on Molecular Diagnostics, and a combined section on Body Fluids and Urinalysis. 

Volunteer Opportunity Deadline is February 6th

Even though we are just half way through the society year, we are already looking forward to our next year that begins at the Annual Meeting in San Diego this summer.

Applications are now open for a number of volunteer opportunities that begin this spring as well as the national committee appointments for terms beginning in August.

The lifeblood of ASCLS is its volunteers whose talent, passion, insight, experience, effort and wisdom of is what powers the Society’s good work, amplifying the single voice of the laboratory science profession.

National volunteers on committees are critical to the achievement of the ASCLS mission, and grass roots members like you, who serve on them, are the people that GET THINGS DONE and help keep our organization moving forward.

ASCLS Representatives serve as the face of the Society to other organizations, such as the Board of Certification, the American Hospital Association and NAACLS. Serving ASCLS in one of these capacities allows you to have an influence within your professional organization which, in turn, sets the direction for the medical laboratory profession.

Diversity within the volunteer ranks makes ASCLS stronger. A mix of new and experienced professionals on all of the committees rejuvenate the organization with fresh ideas while those who have served ASCLS in various capacities over the years bring a wealth of institutional knowledge.

ASCLS utilizes an online system that matches volunteers with positions. Adding yourself to the volunteer pool is as easy as 1-2-3.

  1. Login to the ASCLS Connect Community and fill out your regular member profile.
  2. Review all of the open volunteer opportunities.
  3. Apply for the opportunities where you think you can make the biggest contribution.

Deadline for application on the current volunteer opportunities is Monday February 6th, but your profile will be used throughout the association year to fill other volunteer opportunities as they arise.

Speaking with One Voice, Laboratorians Convince VA to Change Rule

It is our great pleasure to inform you that the efforts you made to alert the VA to problems with the agency's proposed rule expanding the authority for APRNs to "perform and supervise" laboratory testing has met with success.

Tomorrow, the VA will publish the final personnel regulations in the Federal Register with changes ASCLS and its members pursued.

We have successfully convinced the VA to adjust the language to better protect patients while expanding access to care for our nation’s veterans. Further, the VA calls out the "crucial role" laboratorians play in the care of VA patients. The key language explaining this change is below (with our emphasis added).

“Several commenters stated that they were concerned with proposed § 17.415(d)(1)(i)(B), where we stated that a Certified Nurse Practitioner (CNP) may order, perform, or supervise laboratory studies. The commenters stated that the proposed language does not “adequately appreciate the levels of complexity involved in laboratory testing” and that there are rigid standards for laboratory tests that require rigorous academic and practical training, which are not part of the training for APRNs. Another commenter stated, “While the VHA uses the word ‘interpret’ in reference to laboratory and imaging studies,” the commenter “…infers that the VA’s intent is to grant the ability for CNPs to interpret laboratory and imaging results, not to interpret or report raw images or data.” The commenter suggested that VA amend the term “‘interpret’ and recommends instead to use ‘integrate results into clinical decision making,’ or some other phrase” in order to avoid confusion between the duties of an APRN and those of a laboratory specialist. We agree with the commenter in that the proposed language might be construed as allowing CNPs the ability to perform laboratory studies. It is not VA’s intent to have APRNs take over the role of laboratory specialists. These specialists perform a crucial role at VA medical facilities and are skillfully trained in performing the various testing techniques that allow health care professionals to properly treat a veteran’s medical condition. We are amending proposed § 17.415(d)(1)(i)(B) to now state that a CNP may be granted full practice authority to ‘Order laboratory and imaging studies and integrate the results into clinical decision making.’”

Congratulations to everyone who worked so hard and with so much passion to address this issue!