Researchers at UC Berkley developed new ways to use CRISPR as a genetic “search engine” in addition to a cut and paste tool
Clinical pathology laboratory professionals have long been aware of the potential diagnostic properties related to CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology. Now, new tests using the gene-editing tool show that potential is being realized.
One example involves using CRISPR to detect diseases in Nigeria, where a Lassa fever epidemic has already led to the death of 69 people this year alone. According the journal Nature, this diagnostic test “relies on CRISPR’s ability to hunt down genetic snippets—in this case, RNA from the Lassa virus—that it has been programmed to find. If the approach is successful, it could help to catch a wide range of viral infections early, so that treatments can be more effective and health workers can curb the spread of infection.”
Researchers in Honduras and California are working on similar projects to develop diagnostic tests for dengue fever, Zika, and the strains of human papillomavirus (HPV) that lead to cancer. There’s also a CRISPR-based Ebola test pending in the Democratic Republic of Congo.
These new genetic tests, which may be as simple as at-home
pregnancy tests to use, could save many lives throughout the world. They will
give medical laboratories new tools for diagnosing disease and guiding
therapeutic decisions.
Shift in How
Researchers View CRISPR
“We really think of CRISPR fundamentally as a kind of search engine for biology—like Google for biology—rather than [a kind of] word processing tool, although it’s really good at that too,” Trevor Martin, PhD, co-founder and CEO of Mammoth Biosciences, told CRISPR Cuts, a Synthego CRISPR podcast.
Professor of Biochemistry and Molecular Biology, and Li Ka
Shing Chancellor’s Professor in Biomedical and Health.
Martin’s statement represents a shift in how researchers are thinking about CRISPR. At first, CRISPR was seen as a tool for cutting and pasting genetic material. Scientists could tell it to find a target DNA sequence, make a cut, and paste in something different. However, by thinking of the tool as a search engine, CRISPR’s tremendous diagnostic potential becomes apparent.
“This is a very exciting direction for the CRISPR field to
go in,” Doudna told Nature.
Martin told CRISPR
Cuts that diagnostics is “fundamentally a search problem,” adding, “Now you
can program [CRISPR] to find something, and then tell you that result.”
Doudna notes in Technology Networks that, “Mammoth’s technology exemplifies some of the most urgent, impactful, and untapped potential in the CRISPR space.”
Fehintola Ajogbasile (above), a graduate student at the African Centre of Excellence for Genomics of Infectious Diseases in Nigeria, uses a CRISPR diagnostic test to look for Lassa virus in a blood sample. Similar clinical pathology laboratory tests are becoming available in the US as well. (Photo and caption copyright: Nature/Amy Maxmen.)
Investors See
Economic Benefits of CRISPR
The potential financial and economic impact of simple-to-use CRISPR-based diagnostic tools is considerable. Technology Networks notes that the diagnostics market is estimated at $45 billion, and that venture capital firms Mayfield, First Trust Mid Cap Core AlphaDEX Fund (NASDAQ:FNX), and 8VC have all invested in Mammoth Biosciences.
Although the diagnostics market is huge, a critical aspect
of the Lassa fever diagnostic test the Nigerian researchers are developing is
that it will be as accurate as conventional clinical laboratory testing
methods, but much simpler and less expensive.
Dhamari Naidoo, a technical officer at the World Health Organization (WHO) told Nature that researchers often fail to think about the fact that new technology must be affordable for use in low-income countries.
About a dozen diagnostic tests for Ebola have been
developed, according to Naidoo, but only two have been used recently in the
Democratic Republic of Congo, where the virus is resurging, due to economic
concerns. To be useful, medical laboratory tests in low-income countries must
be affordable to license and distribute, and critically, the manufacturers must
identify a market large enough to motivate them to make and distribute such
diagnostic tests.
Future Directions for
CRISPR and Clinical Pathology
Researchers first discovered what would come to be known as CRISPR in the early 1990s. However, it wasn’t until 2012 – 2013 that scientists used CRISPR and Cas9 for genome editing, a Broad Institute CRISPR timeline notes.
Now, researchers around the world are finding innovative
ways to employ the technology of CRISPR to detect disease in some of the most
remote, challenging areas where diseases such as Lassa fever, Zika, and dengue
fever among others, have devastated the populations, as Dark Daily has previously reported.
What’s next for clinical and pathology laboratories and
CRISPR? We’ll let you know.
When negotiating an effective Part A contract for professional pathology services, the best approach is to structure an agreement that is fair and reasonable to both the hospital and the pathologist. That’s the advice given by Robert Tessier, Senior Reimbursement Consultant, HBP Services, Inc. in an interview with Dark Daily.
In his position with the Woodbridge, Conn.-based management consulting firm, Tessier advises hospitals on their contracts with pathology groups (HBP stands for Hospital-Based Physician). However, he also helps pathology groups manage negotiations with healthcare providers for their Part A service agreements.
“Your pathology group can ultimately come up with the best
package of options for all parties involved. It’s a strategy of win-win,” he said.
“It’s not strictly what you get on behalf of the pathology group, but also what
is negotiated that is fair and reasonable to the hospital, along with contract terms
that everyone feels are mutually acceptable.”
HBP has compiled detailed data on pathology and fair market
value, as well as new at-risk incentives. It’s the type of information pathologists
should gather at least six months in advance of contract negotiations with
hospitals and health networks.
“Pathologists want to keep what they have been able to
achieve over the years, and the hospital wants more for the bottom line. They generally
spend little time evaluating what is fair and reasonable for both parties,”
Tessier said.
So, what is considered a “fair and reasonable” pathologist’s
hourly rate? Under Medicare’s 2014 Final
Rule CMS-1607-F, the reasonable
compensation equivalent (RCE) limit
for physician services is currently set at $125/hour or $260,300 a year.
“So, while hospitals are enamored with using that number as
a ceiling, we have to let pathologists know it is simply guidance. And, it has
to be brought forward to the cost of living in 2019,” Tessier noted. He added
that $150/hour currently mirrors fair-market-value studies and reflects the
“sweet spot” for a pathologist’s hourly pay for Part A services.
Additionally, to prepare for time studies that providers may
request, Tessier advises pathologists to compile two two-week time studies per
year that offer a reliability factor of about 95%. Based on current market data,
for example, pathologists can reasonably expect to receive $1,500 to $1,800 for
an autopsy.
Brush Up on New
Contract Terms for Pathology Part A Agreements
In addition to fair market value, hospital attorneys also
aim for “commercial reasonableness.” For example, they assess a pathology practice’s
Part A support and ability to bill professional component clinical pathology,
according to Tessier.
“If a practice bills 10% to 15% of payers for overseeing
clinical laboratory operations, it can’t expect at the same time to be paid for
Part A provided to the same payers,” he explained.
Taking Risk
Incentives
Another trend in pathology Part A professional service agreements
is the inclusion of at-risk incentives. Tessier suggests adding “at-risk” metrics
that are supplementary to payments made to pathologists at the hourly rate.
“Hospitals now say, ‘Let’s come up with an incentive plan providing
opportunities for pathologists to demonstrate additional value.’ This is the
newest element in pathology contracting,” Tessier noted.
He suggests each pathologist may obtain a value-based
payment in addition to the annual Part A support. This incentive pay rewards
services such as reducing unnecessary lab tests, participating in outreach and
marketing activities, and ensuring effective blood bank utilization, among
others.
Experts also advise pathologists to remind healthcare
administrators about their medical laboratory’s value throughout the year—not wait
until contract negotiation time. Annual reports from the pathology group can inform
hospital C-suite executives on financial indicators and changes in the
operations.
Aim for Balance with
a Pathology Part A Hospital Agreement
Ultimately, successful pathology contracts are achievements
in balance, Tessier notes. Each party should be wary of getting too good a deal,
as well as unreasonable terms.
“Some say, ‘Let’s not bother to challenge something because we have a really good deal here.’ But good deals eventually disappear,” Robert H. Tessier (above) of HBP Services, Inc. cautioned. “Sometimes your pathology group may have to give up on today’s contract benefits if the agreement terms are not beneficial to both parties.” (Photo copyright: The Dark Intelligence Group.)
Additional studies will be needed, but if the apparent causality proves out, it could lead to new clinical laboratory biomarkers to help determine women’s risk for developing cervical cancer.
New Cervical Cancer
Screening Biomarker for Clinical Labs, Pathology Labs?
Human gut bacteria (aka, gastrointestinal microbiota, a component of human microbiome) has been at the center of many revolutionary studies in past years, and has been the subject of many Dark Daily e-briefings. But this may be the first instance of the cervical microbiome being thought of as a potential biomarker in cancer screening.
To perform the research, the scientists obtained tissue samples taken from cervical lesions of 144 women who had undergone cervical cancer screenings in various locations throughout Tanzania between March 2015 and February 2016. The researchers then used a technique known as “deep sequencing” to sequence 16 Ribonucleic acid (RNA) genes from the samples.
One hundred and twenty-six of the women tested positive for HPV
and 41 tested positive for HIV. In addition, 50 of the women were diagnosed
with high-grade lesions that were likely to become cancerous.
And here is where the researchers made their discovery. They found that the “women with the high-grade lesions had a more abundant and diverse microbial mix in their cervical microbiomes than women who had no lesions or less serious lesions,” noted a UNL news release.
“There are certain families of bacteria that appear to be associated with the higher grades of precancerous lesions,” Lead Author Peter Angeletti, PhD, Associate Professor, Biological Sciences, University of Nebraska-Lincoln, noted in the news release. “What we know so far is that there is a relationship between the virus commonly associated with cervical cancer and the microbiome.”
Peter Angeletti, Associate Professor, School of Biological Sciences, and Cameron Klein, graduate student in virology, have discovered a link between the HPV (Human papillomavirus) virus and how various bacteria effect it’s growth. February 18, 2019. Photo by Craig Chandler / University Communication
The researchers found that a certain group of bacteria known as Mycoplasma may play a role in the growth of HPV-related cervical lesions. According to UNL, this type of bacteria is known to cause illnesses such as:
The World Cancer Research Fund (WCRF) lists cervical cancer as the fourth most common cancer occurring in women worldwide and the eighth most common cancer overall.
Cervical Cancer Rates in Sub-Saharan Africa
Nineteen of the top 20 countries for cervical cancer are located in Sub-Saharan Africa. The Centers for Disease Control and Prevention (CDC) reports that about one in four individuals in the US—nearly 80-million individuals—are currently infected with HPV.
At
one time, cervical cancer was the leading cause of cancer deaths for women in
the US. According to the CDC, there were 12,845 new cases of cervical cancer
reported in the US in 2015, and 4,175 women died of the disease that year.
Those numbers correlate to eight new cervical cancers reported per 100,000
women and two cancer deaths per 100,000 women in the US.
By contrast, in 2018, for every 100,000 women there were 75.3 new cervical cancer cases reported in Swaziland, the country with the highest rates of the disease, according to WCRF statistics.
There
were more than 500,000 new cases of cervical cancer reported worldwide in 2018.
However,
new cases of the disease and deaths from cervical cancer have decreased
significantly since regular Pap smears became a standard test for women in the
US.
The findings of this study indicate additional examination
of cervical microbiome could result in useful clinical laboratory data for
developing diagnostic tests and possible new treatments for cervical cancer.
Walmart, T-Mobile, and Philips have partnered with the VA and will be providing key resources that could offer opportunities for local clinical laboratories
In what may prove to be a useful innovation, the U.S. Department of Veterans Affairs (VA) is preparing a major expansion of its telehealth (aka, telemedicine) offerings. What adds interest to this effort is that veterans will be able to access telehealth services in such settings as selected posts run by the Veterans of Foreign Wars (VFW) and American Legion, as well as in some Walmart stores.
Many in healthcare view telehealth as key to bringing
healthcare services to outlying, rural, and remote areas that lack critical
medical services. And, a new telehealth initiative proposed by the VA could
further advance that effort by helping bring the advanced technology into the
mainstream healthcare arena.
Dubbed the “Advancing Telehealth through Local Access Stations” (ATLAS) initiative, the goal is to provide veterans living in rural or remote areas with the best possible care. And, of course, many types of healthcare services require clinical laboratory testing. Thus, labs with access to VA patients in remote areas of the country should be looking for opportunities to collaborate with the VA.
Medical laboratory leaders will find it useful to follow the progress of this initiative, because when the VA completes a major project such as this proposed telehealth program, the results often serve as a proof-of-concept that can lead to wider acceptance among Medicare and private insurers of similar projects in the civilian community.
Philips will equip 10 VFW and American Legion posts with its telehealth technology;
Walmart will dedicate store space and technical support to host VA-led telehealth appointments in select stores across the country; and,
T-Mobile will provide 70,000 wireless service lines that will enable veterans to use the VA’s encrypted, secure Video Connect telehealth app without incurring charges regardless of their data plan.
VA Already Largest
Telehealth Provider in America
With the 2017 launch of its “Anywhere to Anywhere, Together” program, the VA quickly became the nation’s largest telehealth provider. In fiscal year 2018, the VA held more than one million video telehealth encounters—a 19% increase over the prior year—the VA stated in a news release. Of the one-million plus video encounters, 105,300 were conducted using the VA Video Connect application on mobile devices or home computers.
“VA’s telehealth capabilities are bridging the care gap for many veterans,” stated VA Secretary Robert Wilkie (above) in a VA press release. “This technology gives veterans access to the timely, quality care they deserve, without having to travel great distances to a VA facility. Time spent traveling is time away from veterans’ jobs and families.” (Photo copyright: Veterans Administration.)
At the time of the 2011-2015 United States Census, five million of the nation’s roughly 20 million veterans lived in rural areas.
“[The VA’s telehealth program] totally changes the VA’s footprint for delivering care,” Deborah Lafer Scher, Executive Advisor to the Secretary, Secretary’s Center for Strategic Partnerships, US Department of Veterans Affairs, told the Federal News Network. “We mapped out where our veterans are in greatest concentration against VA facilities, and then we put the Walmart map on top of that. Ninety percent of veterans live within 10 miles of a Walmart. Ninety percent of veterans don’t live within 10 miles of a VA medical center. This totally changes their ability to access care in a way that works for their lives.”
Another appealing aspect of the VA’s telehealth service is
its simplicity. According to Becker’s Hospital Review, users can access
the service automatically from their personal computers, mobile phones, or
tablets by clicking a link sent to them prior to a telehealth encounter.
“Connectivity is that simple: the veteran need not install
an app, change their behavior, worry about passwords or administrative rights,”
Becker’s notes. “They just connect.
Simply. Easily. Moving forward, these efforts will be extended further. Imagine
a veteran that is hard of hearing joining a video encounter and getting the
settings on [his or her] hearing aid device tweaked on the fly.”
Such advances led VA Secretary Wilkie to declare in his opening remarks at the Anywhere to Anywhere, Together summit, “We are on the cusp of the most transformative period in the history of the Department of Veterans Affairs. Virtual care is the future of medicine. It is our most powerful emerging tool,” the VA’s blog reported.
Regulation a Barrier
to Telehealth Adoption
Yet, the road to wide spread use of Medicare/Medicaid telehealth may not be smooth. Law firm Epstein Becker Green in their 2018 Telemental Health Laws Survey found reimbursement and regulatory barriers continue to block widespread adoption of telehealth services.
“Despite Medicaid’s fewer restrictions on telehealth coverage as compared to its Medicare counterpart, there is limited federal guidance or information regarding the implementation of telehealth services in state Medicaid programs or coverage parameters for states choosing to offer such services,” the attorneys stated in a press release.
Becker’s Hospital Review cited other issues slowing telehealth adoption as well, including reliability and accuracy, access, and security. However, Becker’s also highlighted a 2018 Deloitte survey that showed 67% of physicians polled stated that making virtual care technologies more interoperable would lead to greater adoption rates of telehealth services.
As an ever-growing number of veterans receive their healthcare
through telehealth services, clinical laboratories and anatomic pathology groups
should look for opportunities to collaborate with the VA to provide diagnostic
testing services to our great former service men and women.
Different clinical labs use different names for the same medical laboratory test, causing confusion among doctors who order and interpret tests and adding risk to patient care
Is there a common name for every unique medical
laboratory test? Patients and consumers generally assume that to be so. But
clinical
pathologists, medical
technologists, and other lab scientists know that different labs use
different names for the same medical lab test and methodology.
The lack of uniformity in how medical laboratory tests are
named by different labs is a problem—not just for physicians and patients, but
also when lab test results are shared across the electronic
health record (EHR) systems of hospitals and doctors’ offices. The
multiplicity of names for the same medical laboratory test can confuse
physicians when they are ordering lab test or interpreting the results of those
tests. All of this adds risk to patient care.
Now, a new national coalition of pathologists, clinicians,
professional organizations, accreditation agencies, large reference labs, and
terminology groups called TRUU-Lab (Test
Renaming for Understanding and Utilization in the Laboratory), is working “to
create a consensus guideline for giving laboratory tests more rational and
consistent names.”
TRUU-Lab aims to create a set of guidelines for the
development of clear and consistent medical laboratory test names, as well as
the launching of easy-to-understand names in online lab test menus.
“It is a bit shocking that it is 2019 and there is no standardization in the US on how to name the lab tests,” Ila Singh, MD, PhD, founder of TRUU-Lab, told Dark Daily. “Sometimes we name the medical laboratory tests based on the analyte—or the patient for which it was first discovered—or we call it after the physician who discovered it. And vendors give names to lab tests that meet their goals. So, it’s kind of a free-for-all,” she admitted.
Singh is Chief of Laboratory Medicine in the Department of
Pathology at Texas Children’s
Hospital and a tenured Professor of Pathology and Immunology at Baylor College of Medicine in Houston. She will
be speaking at the upcoming Executive
War College in New Orleans on TRUU-Lab’s national initiative to “create a
consensus guideline for giving laboratory test more rational and consistent
names.”
Lack of Standard Clinical
Lab Test Names Confuses Ordering Physicians
Some medical
laboratory scientists and pathology leaders say the lack of standardization
in naming medical lab tests not only confuses ordering clinicians, it confuses patients
and insurers as well. It also leads to inappropriate test utilization, high
costs, and safety and quality issues.
“Vitamin D
is a big one,” Singh said. “There are two main tests, but you can find up to a dozen
names for the same test.”
One such blood test is 25-hydroxy vitamin D (Calcifediol)
and another is 1,25-dihydrozy
vitamin D (Calcitriol). Both tests involve vitamin D, however the latter
test is ordered “when kidney disease or abnormalities of the enzyme that
converts 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D is suspected,”
according to Lab Tests Online, a guide to lab
tests coordinated by the American Association
for Clinical Chemistry (AACC), a TRUU-Lab coalition member.
“If physicians cannot distinguish between the two different
vitamin D names, they decide to just order both tests and deal with the issue
later when the results come back. And if results are fine, they know they don’t
have to deal with it at all. So, there is a lot of excessive test ordering and
wrong ordering,” Singh explained.
She added that a study conducted at Texas Children’s
Hospital found that ordering clinicians chose the wrong vitamin D test 30% of
the time.
Ila Singh, MD, PhD (above), is board-certified in Clinical Pathology and Clinical Informatics and is the founder of TRUU-Lab, which she formed “to bring these consistent and easy-to-understand lab test names into electronic health record (EHR) and laboratory information systems (LIS) everywhere.” (Photo copyright: Texas Children’s Hospital.)
Other popular tests have different names for the same test and the redundancies can lead to inefficiencies in test ordering, the TRUU-Lab website notes. It gives the example of hemoglobin A1c, which is also known as glycosylated hemoglobin or HgbA1C.
Problems also arise when doctors cannot find the right lab tests
to order. Take, for instance, viral tests that are named for the virus. Sounds
simple enough. The test for the human
immunodeficiency virus (HIV) is called the HIV test. However, viral test ordering can
get tricky. For example, the test for measles is named after the rubella virus (Rubella, Latin
for “little red,” was first used to describe measles in 1866). “People forget
it is called rubella. Then, it is hard for physicians to find the name of the
test. They end up ordering tests that lead to delays (in diagnosis and care),”
Singh said.
Another example is the test for Syphilis, which is called Rapid Plasma Reagin or RPR. The name does not immediately suggest a Syphilis test.
“There are lots of problems,” Singh noted, adding that people think a Free Prostate-Specific Antigen test is a lab test that is “free-of-charge,” which would be funny if it weren’t so concerning.
Clinical Laboratory
Leaders Can Help!
Though Singh acknowledges past attempts to rename medical laboratory
tests in the US, as well as the work by lab industries in Canada and Australia,
where standard guidelines for lab test names do exist, she stresses that more
work is needed. “The problem is they have not made ease of understanding the
standardization (among clinicians) a priority,” Singh said.
TRUU-Lab has three goals:
Reach consensus on guidelines for naming lab
tests;
Develop easy-to-use names for tests; and,
Implement and adopt use of lab test names as
widely as possible.
Singh’s presentation will inform clinical lab leaders that:
Understanding the lack of lab test name
guidelines is a huge problem affecting utilization management at hospitals;
TRUU-Lab is a way to address the problem nationally;
and,
Opportunities exist for pathologists and lab
leaders to get involved.
“I want this to be the kind of project people want to get
aligned with,” Singh said.
Register for EWC online by clicking here, or by
calling 707-829-8495. (Or copy and paste this URL into your browser:
https://www.executivewarcollege.com)
Prior (2018) price reporting cycle offers lessons that can help clinical laboratory benefit administrators and personnel take an informed approach to meeting the requirements of the Protecting Access to Medicare Act of 2014 (PAMA)
With the PAMA Private Payor Price Reporting period under way, some clinical laboratories may be grappling with questions about the new requirements.
Under PAMA, applicable labs must report private payer data on
selected Clinical Diagnostic Laboratory Tests (CDLTs) to CMS every three years. For the current
cycle, data must be collected from Jan. 1 through June 30.
A six-month review period follows so that laboratories can
assess whether the applicable lab thresholds are met. Data must be reported to
the Centers for Medicare & Medicaid Services (CMS) during a three-month
window starting Jan. 1, 2020, with data due by March 31, 2020.
To help clinical laboratories
meet PAMA’s new requirements, CMS defines an applicable laboratory as one that answers
yes to the following questions:
1) Does the lab
have CLIA certification?
2) Does the lab
meet the majority of Medicare threshold, which is either greater than 50
percent of Medicare payments received on CLFS and PFS (Physician Fee Schedule)
by National Provider Identifier (NPI) or a hospital lab with a shared NPI bills
any Type of Bill (TOB) 14x to Medicare during the six-month reporting timeframe.
3) Does the lab
have a minimum of $12,500 payments received from Medicare during the six-month
reporting period.
Failure to file, or filing late, incomplete, or
inaccurate data can result in federal fines for laboratories—up to
$10,000 a day.
Sarah Simonson, Director of Laboratory Client Management for Change Healthcare, outlines ways labs can avoid those fines and best prepare for this cycle of private payer reporting.
“Begin with the end in mind,” Simonson said. “Understand what is required and prepare for data extraction.” Simonson is one of several pros who will offer insights during a special post-Executive War College workshop geared to private payer price data reporting under PAMA.
Labs should allow
ample time to review extracted data, Simonson said, as well as evaluate the
data for quality assurance. It’s also important to understand login
requirements and the format required to deliver the data. That
means getting your IT team involved.
Trish Hankila, Chief Financial Officer of South Bend Medical Foundation, will return to the Executive War College on Lab and Pathology Management, for a special post-conference workshop on the PAMA price reporting requirement. (Photo copyright: Dark Daily)
Having learned many lessons from the previous reporting cycle, Trish Hankila, Chief Financial Officer of the South Bend Medical Foundation, recommends talking with your internal IT or vendor to ensure that accounts receivable (A/R) reports capture the required data. Review available data to ensure accuracy and completeness of data, and review the A/R report that will be used to transmit that data, she says.
Hankila, who will also speak at the 24th Annual Executive War College post-conference workshop encourages a visit to the CMS website to obtain documents regarding the data, registration, and submission requirements.
“The Center for
Medicare Management, CLFS User Manual explains in detail how to log in to the
CMS portal, register the data submitter and data certifier, and the process for
submitting and certifying the data,” Hankila said.
CMS will use the
data collected to calculate 2021 fees for each individual laboratory Current
Procedural Terminology (CPT) code.
“CMS is trying to establish fees
that reflect the market value of the tests being performed, using a weighted
average of the various amounts paid per CPT code by third-party payers,”
Hankila said.
How to structure your
data when working with your internal IT team or third-party billing will be one
focus of the PAMA workshop, in addition to how to avoid the pitfalls when
gathering, analyzing, and reporting lab test price data. The post-conference workshop will
benefit administrators and personnel responsible for reporting PAMA data.
“What Hospital and
Health Network Labs Must Know to Comply with PAMA Private Payer Price
Reporting,” will take place from 8 a.m. to 5 p.m., May 2, in New Orleans.
“The takeaways include
understanding PAMA, lessons learned from the prior (2018) cycle, and how to
structure your request to your IT/billing department,” Simonson said.
To help attendees prepare to
participate in the PAMA workshop, Hankila previewed what South Bend Medical
Foundation has learned:
Get
started early with data gathering and the reconciliation process;
Reconcile
the data by using other reports from your A/R system;
Ensure
you have enough time to modify programs; and
Do
not wait until the last minute to transmit the data.
“There may be issues with
registration of the submitter and certifier in the CMS portal, the CMS website,
or with your data file that you have prepared for submission,” Hankila said.
More Upcoming PAMA Workshop
Highlights
Elizabeth Sullivan, JD, will cover “Compliance and Regulatory Issues Associated with the PAMA Statute and the CMS Final Rule for Reporting Private Payer Lab Test Prices: Risks, Consequences, and Often-Overlooked Requirements.”
Diana Voorhees, MA, CLS, MT, SH, CLCP, CPCO, will cover “Understanding the Requirements for Reporting PAMA Private Payer Lab Test Price Data: Who Reports, What Is Reported, How to Report, When Penalties Apply, and More.”
Kyle C. Fetter, MBA, BA, will present “Key Recommendations for Reporting Your Lab’s Private Payer Price Data: Identifying Data Sources, Using Informatics Tools, Understanding Where Data is Missing or Inaccurate, and Transmitting Your Data.”
