Staffing specialists advise medical laboratories to expect shortages to continue
Clinical laboratory and pathology group managers are keenly aware of the Great Resignation and how it has affected lab industry staffing and recruiting. Medical technologists (MTs) and clinical laboratory scientists (CLSs) are in particularly short supply and some experts do not see this critical shortage waning anytime soon.
In an exclusive interview with Dark Daily, Maggie Morrissey, Director of Recruiting and Staffing Services at Lighthouse Lab Services, explains the multi-faceted problem labs are facing meeting recruitment goals, and how understaffing can lead to bigger matters regarding morale and job satisfaction.
Based in Charlotte, N.C., Lighthouse Lab Services is a medical laboratory consulting and recruiting firm that employs 150 people and services more than 1,500 medical laboratory clients.
In July, Lighthouse released the results of its 2022 Survey on Wage and Morale Issues among Medical Laboratory Professionals. The collected data from 1,112 respondents found that only 27% indicated their clinical laboratories were adequately or well-staffed. Forty percent of respondents believe their labs were moderately understaffed while an additional 33% felt their labs were significantly understaffed.
The primary reasons, according to Lighthouse, for staffing shortages can be attributed to:
The number of schools offering medical technology programs has decreased.
People have been retiring at a higher rate than most industries.
It is difficult to become a medical technologist/clinical laboratory scientist.
There are hurdles to jump through to become a medical technologist.
Medical technology is not a well-known field.
“[Eastern Carolina University] told us they don’t have anyone graduating from the [medical technology] program this year because of COVID. There are all these issues exacerbating the problem,” said Maggie Morrissey (above), Director of Recruiting and Staffing Services at Lighthouse Lab Services, in an exclusive interview with Dark Daily. “Making it more attractive starts at the school level. People need to be introduced to the science of medical technology. It’s not something that many students know exists as a career.” This lack of interest in training programs is a major reason for the severe shortage of medical technologists on staff at clinical laboratories around the US. (Photo copyright: Lighthouse Lab Services.)
Stagnant Pay, Low Morale, Lack of Appreciation in Clinical Labs
“The major issue that we see with medical labs across the country is that they are understaffed,” Morrissey stated. “That tracks to low morale. It’s a major issue for laboratories because when a lab is understaffed and everyone is working very hard, lab staff may not feel appreciated and their morale starts to wane, which snowballs into larger issues.”
Morrissey pointed out that individuals who work for different sized clinical laboratories have dissimilar grievances about their jobs.
“Pay continues to be a concern for all, but benefits are also important,” she said. “Pay and lack of benefits, like not being able to get time off, not having a 401K, and not having health insurance are hurdles for people working in smaller labs.”
Professionals working in medium-sized and larger labs are also concerned about pay, but they have other complaints as well.
“They feel like they are a cog in the machine and feel underappreciated,” Morrissey said. “What we hear a lot from people who work in the clinical labs of large hospitals is that they feel unappreciated by those working in other departments.”
Too Few MT/MS Training Programs to Meet Demand
According to Forbes, the US currently has a shortage of approximately 20,000-25,000 medical technologists. The approximately 338,000 technologists working in the country equate to about one technologist per 1,000 people, which translates to a vacancy rate of 7% to 11% in almost every region.
Forbes also reported that medical technologists in the US had performed approximately 13 billion laboratory tests annually before the COVID-19 pandemic. However, the pandemic added 997 million SARS-CoV-2 diagnostic tests to the existing workload.
Intensifying the problem is that currently there are only 240 medical technologist and medical scientist training programs in the US, which represents a 7% decrease since 2000. Forbes notes there are some states that have no such training programs at all.
“Having the opportunity to train to be a medical technologist is an important thing,” Morrissey said. “More universities and community colleges need to offer associate’s and bachelor’s degrees in medical technology.”
However, even with an increase in available degrees, few students are enrolling in those programs.
Morrissey suggests that clinical lab professionals contact local educational institutions to inform them of the need for medical technology degrees and determine if they can do anything to help start such training programs.
“If you are a medical laboratory in an area that doesn’t have a school that offers a degree in medical technology, I would recommend banging down the doors of community colleges to see how you can get that type of program into place,” she proposed. “It really benefits you. It is really about getting those schools to realize there is a need for medical technologists.”
Morrissey added that schools are beginning to re-add medical technology programs to their curriculum. This may translate into more available MTs and CLSs to work in clinical laboratories and relieve some of the staffing shortages.
Laboratory Automation, More Federal Lobbying Could Help
Automating some medical laboratory operations could present another solution to staffing dilemmas.
“Automation will help a little bit,” she said. “A significant number of labs are adding automation—either at the technology or collection level—so they don’t need as many technologists to run the lab.”
Additionally, regionalization of clinical labs could help with staffing issues because high volumes of samples can allow for the streamlining of staff.
“Some integrated delivery networks (IDNs) that have multiple hospitals within a city or metro area are regionalizing their clinical laboratories and using couriers to transport the samples being collected, resulting in better efficiency and productivity,” she said.
Morrissey also believes there is room for lobbying for the occupation of medical technology at both the state and federal levels. She compared the clinical laboratory profession to how the nursing profession dealt with shortages in the past.
“Nursing is in all hospital and doctor groups,” she explained. “They have very large organizations that are advocating for them at the federal and state level and labs need more of that.”
Clinical Lab Recruiting Reverting to Pre-COVID Qualifications
Though more people are testing themselves for COVID at home, Morrissey says the need for more clinical laboratory professionals will not subside any time soon.
“Before COVID, there was a huge increase in requests for toxicology reports due to drug testing and screening,” she explained. “COVID caused those needs to go away, not because people didn’t need those things, but because everyone was focusing on COVID. If an individual is not going into work, does he or she really need a monthly drug screen? The needs shifted during COVID and now they are shifting back.”
During the COVID-19 pandemic, medical labs were more willing to train individuals who had some lab experience or a background that would indicate they could perform the job duties. It is probable that recruiters will start to have more stringent requirements for potential lab employees, reverting back to pre-COVID qualifications.
Nevertheless, Morrissey believes staffing shortages for medical laboratories will continue.
“In the short term, in the next one to three years, I think it is going to get worse before it gets better,” she said. “In the medium term, automation in clinical laboratories will probably ease the staffing shortage quite a bit. Potentially, we will see more medical technology training programs pop up as the staffing shortages become a better-known issue.”
Epidemiologists warn that elderly and other individuals may be at high-risk for co-infection by strains of both SAR-CoV-2 and influenza
As of October, the influenza (flu) season has begun in North America. With the COVID-19 pandemic still prevalent, clinical laboratories must be prepared not only for increased demand for SARS-CoV-2 tests, but also for an increased number of orders for flu tests as well. In fact, virologists are sounding the alarm that some patients may present with an uncommon double infection of both viruses.
The potential for contracting the co-infection was dubbed “flurona” by the Israeli Outbreak Management Advisory Team in 2020. The Israeli Team coined the term flurona to describe the potential of contracting both COVID-19 and influenza after two young Israeli pregnant women were diagnosed with influenza and COVID-19. Since then, cases of co-infections have been confirmed in multiple countries around the world, according to The Washington Post.
The symptoms of influenza and COVID-19 are extremely similar. According to the Centers for Disease Control and Prevention (CDC), symptoms for both influenza and COVID-19 include fever, cough, chills, sore throat, and body aches. However, without a clinical laboratory test it is nearly impossible to distinguish one virus from the other.
Therefore, during this cold and flu season, clinical laboratory testing will be extremely important. And though co-infection with COVID-19 and the flu is rare, lab leaders should be on the lookout for spikes in testing.
“Co-infection is rare with COVID-19 and the flu, or COVID-19 and other types of infections that you might get as far as upper respiratory infections, because COVID-19 tends to take over,” Stephen McMullan, MD, a Mayo Clinic family medicine physician, told Mayo Clinic News. “Once COVID-19 is in your body, it’s going to be the predominant virus, but there are some rare cases where we have seen people getting both COVID-19 and the flu. So, it is possible, but it’s certainly not common.” Clinical laboratories should prepare for a spike in viral infections this winter that could indicate flurona. (Photo copyright: Mayo Clinic.)
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What Exactly Is a Flurona?
Although it is possible—albeit rare—to contract the flu and COVID-19 at the same time, flurona does not appear to be a “twindemic,” nor is it a distinct disease or a mutation of the two viruses, The Washington Post reported.
“The name seems to suggest that the viruses have somehow combined—and that’s not the case. It’s just that a person may get infected with two respiratory viruses at the same time or in short succession,” epidemiologist Judith O’Donnell, MD, Director, Department of Infection Prevention and Control, and Section Chief, Division of Infectious Diseases at Penn Presbyterian Medical Center, told an NPR affiliate in Pittsburg.
“It’s rare, but it’s not surprising that during a typical influenza season—which here in the northern hemisphere is right now during the winter months—that you will see multiple respiratory viruses circulating at the same time, and that people can get infected with more than one respiratory virus at the same time,” she added.
Though flurona may not be a hybrid virus, that does not mean it is of no concern.
“Although a low proportion of COVID-19 patients have influenza co-infection, the importance of such co-infection, especially in high-risk individuals and the elderly, cannot be ignored,” wrote the authors of a study published in Frontiers of Medicine titled, “COVID-19 and Influenza Co-infection: A Systematic Review and Meta-Analysis.”
Did COVID-19 Lockdowns, Social Distancing Cause Flurona?
According to the Washington Post, the US had record lows of influenza during the 2020-2021 flu season, however this was likely due to lockdown measures. With lockdown measures and social distancing even less prevalent this flu season, there is a risk of individuals being at risk for multiple respiratory viruses.
“We’re all a little bit more back together than we were a year ago,” McMullan told Mayo Clinic News. “The kids are back in school, and we have more events that people are attending, which could explain why we’re seeing flu cases rise.”
Thus, clinical laboratories should prepare for not only a higher number of flu tests, but also COVID-19 tests as well. That is because patients will not be able to distinguish which virus they are sick with based on symptoms alone. Further, because COVID-19 and the flu have similar symptoms, individuals may seek out multiple tests, or test for one virus and not the other.
McMullan asserts that a co-infection of the flu and COVID-19—though rare—is not impossible. For the best chance to avoid both diseases he suggests high-risk individuals “Get vaccinated against COVID-19, including your booster if eligible, and make sure to get your flu vaccine, continue to do the same strategies to protect yourself and others, such as wearing a mask in high-risk situations, washing your hands, and staying home if you feel ill.”
Meanwhile, clinical laboratory managers will want to track developments during this flu season. For example, flurona may be uncommon at this time, but emerging variants of SARS-CoV-2 and different strains of influenza might increase the number of patients diagnosed as infected with both COVID-19 and influenza.
As the number of Hospital at Home programs increase, clinical laboratories will want to develop programs for collecting samples from patients where they live
Shortages of nurses and hospital staff, combined with pressure to lower the cost of care, are encouraging more institutions to implement hospital-in-the-home programs. One such project involves Oregon Health and Science University (OHSU), which last November began a Hospital at Home (HaH) program that enables certain patients to receive hospital-level care in the comfort of their own homes. Clinical laboratories servicing these programs will need to develop specimen collection and testing services in support of these patients.
The OHSU program can provide healthcare for eight patients simultaneously, and it has treated more than 100 patients at home since its inception. Although this number is only a small segment of OHSU’s 576 bed capacity, it does affect the overall healthcare provided by the hospital.
Under the program, basic services, such as the monitoring of vital signs—as well as some clinical laboratory work and routine imaging studies—are performed in the patient’s home. Individuals are transported to OHSU for more complex imaging or other procedures.
“Every patient we have in Hospital at Home is one who is not waiting in the emergency room or a hallway for a bed to become available in the hospital,” said Matthias Merkel, MD, PhD (above), Senior Associate Chief Medical Officer, Capacity Management and Patient Flow at OHSU, in a press release. In the same way clinical laboratories support telehealth programs, medical laboratories will need procedures for collecting specimens and testing patients participating in Hospital at Home programs as well. (Photo copyright: Oregon Health and Science University.)
OHSU’s HaH program utilizes advances in technology to connect at-home patients with physicians and nurses around the clock via a smart tablet. In addition, participating patients receive real-time monitoring and at least two daily in-person visits from nurses and paramedics that have been contracted by OHSU.
“It’s a better experience for patients, plus it increases our system’s capacity to provide care for all the people who need it,” said Darren Malinoski, MD, Chief Clinical Transformation Officer and Professor of Surgery at OHSU in the press release. “It allows us to make good on our promise to take care of the state as best we can.”
The current eligibility criteria to participate in OHSU’s Hospital at Home program include:
Patient must be over the age of 18.
Patient’s primary residence must be within a 25-mile radius of the OHSU hospital.
Inpatient hospitalization is initially required.
Patient must have a diagnosis that can be managed remotely, such as COVID-19, pneumonia, cellulitis, congestive heart failure, urinary tract infections, or pyelonephritis.
Malinoski feels that OHSU’s HaH program is ready to expand. In fact, he is so confident in it he enrolled his own 83-year-old mother as one of its first patients. While undergoing treatment for lung cancer, a routine clinical checkup exposed evidence of toxicity in her blood. Typically, she would have been directly admitted to the hospital for monitoring, but instead she was entered into the HaH program.
“It was unbelievable,” stated Lesley Malinoski in the press release. “I had the feeling of being well taken care of. I was in my own home. I could cook, I could rest—anything I wanted and still have all this care.”
“They didn’t just come in and run out,” she continued. “I felt like a celebrity.”
HaH programs around the country were made possible through a federal waiver granted by the federal Centers for Medicare and Medicaid Services (CMS) in November 2020 in response to the COVID-19 pandemic.
According to the American Hospital Association (AHA), “this care delivery model has been shown to reduce costs, improve outcomes, and enhance the patient experience.”
Prior to the waiver, there were only about two dozen hospitals across the US that had HaH programs. However, as of May 20, 2022, 227 hospitals in 35 states had received a HaH waiver from CMS. This number represents nearly 4% of all hospitals in the country, according to Health Affairs.
In “Two US Studies Show Home-based Hospital Care Lowers Costs while Improving Outcomes and Patient Satisfaction,” we reported on a hospital-based home care program that involved 323 patients at Presbyterian Healthcare Services in Albuquerque, N.M. We surmised that significant growth in the number of patients treated in home-based hospital care programs would directly affect hospital-based clinical laboratories and pathology groups. Among other things, it would reduce the volume of inpatient testing while increasing the number of outpatient/outreach specimens.
And in “Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes,” Dark Daily saw that wider adoption of that country’s Hospital in the Home (HITH) model of patient care would directly affect pathologists and clinical laboratory managers who worked in Australia’s hospital laboratories. We reported that more HITH patients would increase the need to collect specimens in patient’s homes and transport them to a local clinical laboratory for testing, and that because they are central to the communities they serve, hospital-based medical laboratories would be well-positioned to provide this diagnostic testing.
OHSU’s overall experience with their Hospital at Home program demonstrates that such a model can be a highly successful and cost-effective method of providing patient care. It is probable that in the future, more medical institutions will create similar programs in an effort to effectively serve as many patients as possible while ensuring shorter hospital stays and rendering better healthcare outcomes. As this happens, it will give hospital-based medical laboratories an opportunity to deliver value in home-based patient care.
Organizations representing clinical laboratories and other critical healthcare providers urged Congress to pass the Saving Access to Laboratory Services Act by January 1, 2023, to prevent deep cuts in reimbursements
Lessons about the essential role of clinical laboratories during a pandemic was the central theme in a significant publication released recently. The authors were the presidents of two of the nation’s largest healthcare companies and their goal was to connect the value clinical labs delivered during the COVID-19 pandemic to the financial threat labs face should the Protecting Access to Medicare Act of 2014 (PAMA) fee cuts coming to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) be implemented.
In an article for RealClearPolicy, healthcare executives William G. Morice II, MD, PhD (left), CEO/President, Mayo Clinic Laboratories, and Matt Sause (right), President of Roche Diagnostics North America wrote, “Without PAMA reform, labs could face drastically reduced reimbursement for commonly performed lab tests for a host of diseases.” (Photo copyrights: Mayo Clinic Laboratories/Roche Diagnostics.)
IVD Companies and Clinical Laboratories Sound Alarm
Morice and Sause warn that—without PAMA reform—the nation’s vital medical laboratories will face “drastically reduced reimbursement” for commonly performed lab tests for diseases, including diabetes, heart disease, and cancer. Reimbursement cuts may cause clinical labs serving “the most vulnerable and homebound” to reduce services or close, they noted.
“To emerge from nearly three years of a pandemic by sending the signal that austerity is our nation’s health policy when it comes to testing and diagnostics would be a significant mistake,” they wrote.
“If the proposed cuts to reimbursements for diagnostic tests are allowed to take effect, disparities caused by challenges with accessing diagnostic tests will likely grow even further,” the authors continued.
However, they added, “The Saving Access to Laboratory Services Act [SALSA] would reform PAMA to require accurate and representative data from all laboratory segments that serve Medicare beneficiaries to be collected to support a commonsense Medicare fee schedule that truly represents the market.”
How PAMA Affects Clinical Laboratory Reimbursements
PAMA, which became law in 2014, was aimed at marrying Medicare Part B Clinical Laboratory Fee Schedule (CLFS) reimbursement rates to rates medical laboratories receive from private payers, the National Independent Laboratory Association (NILA) explained in a news release.
But from the start, in its implementation of the PAMA statute, the methods used by the federal Centers for Medicare and Medicaid Services (CMS) to collect data on lab test prices paid by private payers—which were the basis for calculating new lab test prices for the Medicare program—were criticized by many laboratory professionals and other health experts.
Critics frequently pointed out that several types of clinical laboratories were excluded from reporting their private payer lab test prices. Thus, the data collected and used by CMS did not accurately represent the true range of prices paid for clinical lab tests by private health insurance plans, said lab industry groups.
CMS regulations “exclude most hospital outreach laboratories and physician office laboratories from data collection. This approach depresses median prices and has led to deep cuts to lab reimbursement. Many tests were cut up to 30% in 2018 when the new system went into effect,” the America Association for Clinical Chemistry (AACC) noted in a statement.
On September 8, just weeks after publication of the article authored by Morice and Sause, 26 organizations representing clinical laboratories and diagnostics manufacturers sent a letter to Congressional leaders. In it they described the financial impact on labs due to the current law’s omission of some outreach and physician office lab testing, and they urged the passage of the SALSA legislation.
“The significant under-sampling led to nearly $4 billion in cuts to those labs providing the most commonly ordered test services for Medicare beneficiaries,” the organizations wrote in their letter. “For context, the total CLFS spend for 2020 was only $8 billion.”
Reimbursement Cuts to Lab Tests are Coming if SASLA Not Passed
“Without Congressional action, beginning on Jan. 1, 2023, laboratories will face additional cuts of as much as 15% to some of the most commonly ordered laboratory tests,” the NILA said.
“Enactment of the Saving Access to Laboratory Services Act (SALSA/H.R. 8188/S.4449) is urgently needed this year, to allow laboratories to focus on providing timely, high quality clinical laboratory services for patients, continuing to innovate, and building the infrastructure necessary to protect the public health,” NILA added.
In an editorial she wrote for Clinical Lab Products, titled, “Be a Labvocate: Help Pass SALSA Legislation,” Kristina Martin, Clinical Pathology Operations Director, Department of Pathology, University of Michigan Medicine said, “The SALSA legislation provides a permanent, pragmatic approach to evaluating the CLFS, eliminating huge swings, either positive or negative as it pertains to Medicare reimbursement. It also allows for a more comprehensive evaluation of data to be collected from a broader sampling of laboratory sectors.”
Uses statistical sampling for widely available tests performed by a “representative pool of all clinical laboratory market segments.”
Introduces annual “guardrails” aimed at creating limits for reductions as well as increases in CLFS rates.
Excludes Medicaid managed care rates since they are not true “market rates.”
Gives labs the option to exclude mailed remittances from reporting if less than 10% of claims.
Eases clinical labs’ reporting requirements by changing data collection from three years to four.
Make Your Views Known
Proponents urge Congress to act on SALSA before the end of the year. Clinical laboratory leaders and pathologists who want to express their views on SALSA, test reimbursement, and the importance of access to medical laboratory testing can do so through Stop Lab Cuts.org. The website is sponsored by the ACLA.
Experts cite high vaccination rates and behavioral changes among at-risk groups, but warn about complacency; clinical laboratories should remain vigilant
In July, Scott Gottlieb, MD, Commissioner of the US Food and Drug Administration (FDA) from May 2017 to April 2019, wrote an op-ed in The New York Times titled, “Monkeypox Is About to Become the Next Public Health Failure.” In it, he wrote, “Our country’s response to monkeypox has been plagued by the same shortcomings we had with COVID-19.” But has it improved? Clinical laboratory leaders and pathology group managers will find it informative to find out what has taken place since Gottlieb made his stark prediction.
The global monkeypox outbreak that emerged last spring appears to have subsided in the US and Europe, though it remains to be seen if the disease can be completely eradicated, according to multiple media reports. As of Oct. 26, 2022, the Centers for Disease Control and Prevention (CDC) reported a 7-day rolling average of 30 cases per day in the US, down from a peak of nearly 440/day in early August.
Cases are also down in cities that earlier reported heavy outbreaks. For example, the New York City Health Department reported a 7-day average of just two cases per day on Oct. 25, compared with 73/day on July 30.
And the San Francisco Department of Public Health announced on Oct. 20 that it would end the city’s public health emergency on monkeypox (MPX) effective on Oct. 31. “MPX cases have slowed to less than one case per day and more than 27,000 San Franciscans are now vaccinated against the virus,” the agency stated in a press release.
“Once again, we caution that a declining outbreak can be the most dangerous outbreak, because it can tempt us to think that the crisis is over and to let down our guard,” said World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, PhD, in an Oct. 12 global press briefing. “That’s not what WHO is doing. We are continuing to work with countries around the world to increase their testing capacity, and to monitor trends in the outbreak.” Clinical laboratories should not assume the outbreak has passed but continue to be vigilant and prepared for increased demand in monkeypox testing. (Photo copyright: ITU Pictures.)
Changing Behavior Lowers Infection Rates
In addition to high vaccination rates, public health experts have attributed the decline to behavioral changes among at-risk groups. “There were really substantial changes among men who have sex [with] men,” infectious disease physician Shira Doron, MD, of Tufts Medical Center in Boston, told ABC News.
On September 2, the CDC published the results of a survey indicating that about half of men who have sex with men “reported reducing their number of sex partners, one-time sexual encounters, and use of dating apps because of the monkeypox outbreak.”
Another likely factor is the disease’s limited transmissibility. “Initially, there was a lot of concern that monkeypox could spread widely at daycares or in schools, but, overall, there has been very little spread among children,” NPR reported.
But citing multiple studies, the NPR story noted “that often there isn’t very much virus in the upper respiratory tract,” where it might spread through talking or coughing. “Instead, the highest levels of virus occur on sores found on the skin and inside the anus.”
These studies, along with earlier research, “explain why monkeypox is spreading almost exclusively through contact during sex, especially anal and oral sex, during the current outbreak,” NPR reported.
Monkeypox Could Mutate, experts say
Despite the promising numbers, public health experts are warning that monkeypox could remain as a long-term threat to public health. According to an article in Nature, “At best, the outbreak might fizzle out over the next few months or years. At worst, the virus could become endemic outside Africa by reaching new animal reservoirs, making it nearly impossible to eradicate.”
In addition to the limited transmissibility of the virus, Nature noted that the outbreak stems from a relatively mild form of the pathogen and is rarely fatal. As of Oct. 28, the CDC reported a total of just six confirmed deaths in the US out of a total of 28,302 confirmed cases since the first infections were reported in May.
It is possible that the virus could mutate into a more contagious form, but Nature noted that monkeypox is a DNA virus, and that they tend to mutate more slowly than RNA viruses such as SARS-CoV-2 and HIV. Nevertheless, University of Alabama at Birmingham School of Medicine bioinformatician Elliot Lefkowitz, PhD, warned that a “worrisome mutation” could arise if the outbreak continues for much longer.
“I have no confidence that all the people who need to be tested are being tested,” she told Nature. She expressed concerns that people could resume risky behavior if they think the danger has passed.
Another question is whether currently available vaccines offer long-lasting protection. And though reported case numbers are down in the US and Europe, they are rising in parts of Africa and South America, Nature noted.
Gottlieb’s Dire Prediction
The decline in new infections followed dire warnings last summer about the possible consequences of the outbreak. In his New York Times op-ed, former Gottlieb criticized the CDC for being slow to test for the virus. He wrote, “[I]f monkeypox gains a permanent foothold in the United States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable.”
At the time of his writing, Gottlieb was right to be concerned. On July 29, the CDC reported a seven-day moving average of 390 reported cases per day. According to the federal agency, a reported case “Includes either the positive laboratory test report date, CDC call center reporting date, or case data entry date into CDC’s emergency response common operating platform, DCIPHER.”
Quashing the outbreak, Gottlieb estimated, would have required about 15,000 tests per week among people presenting symptoms resembling monkeypox. But between mid-May and the end of June, he noted, the CDC had tested only about 2,000 samples, according to the federal agency’s July 15 Morbidity and Mortality Weekly Report (MMWR).
As a remedy, Gottlieb called on the Biden administration to re-focus the CDC’s efforts more on disease control “by transferring some of its disease prevention work to other agencies,” including the FDA.
Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services
Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year.
Among the initiatives under consideration are the following:
Below are details about these laboratory-related federal bills and regulatory documents that observant laboratory managers will want to track in the coming months.
“Clinical laboratories need to make sure that they have proper requisitions and documentation for genetic testing that involves telemedicine.” Danielle Tangorre, JD (above), a partner at law firm Robinson and Cole LLP in Albany, NY, told Dark Daily. (Photo copyright: Robinson and Cole LLP.)
CLIA Fee Increases and Testing Personnel Changes
The federal Centers for Medicare and Medicaid Services (CMS) is examining fee and personnel changes for CLIA. Officials from CMS are reviewing public comments on the proposal ahead of publishing a final rule.
Among other changes, the proposal would:
Institute a 20% across-the-board increase on existing fees.
Establish a biennial increase of CLIA fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
Add doctoral, master’s, and bachelor’s degrees in nursing to qualify testing personnel for high and moderate complexity testing.
“The Practitioner does not have sufficient contact with or information from the purported patient to meaningfully assess the medical necessity of the items or services ordered or prescribed.
“The Telemedicine Company compensates the Practitioner based on the volume of items or services ordered or prescribed, which may be characterized to the Practitioner as compensation based on the number of purported medical records that the Practitioner reviewed.
“The Telemedicine Company only furnishes items and services to Federal health care program beneficiaries and does not accept insurance from any other payor.
“The Telemedicine Company does not expect Practitioners (or another Practitioner) to follow up with purported patients nor does it provide Practitioners with the information required to follow up with purported patients (e.g., the Telemedicine Company does not require Practitioners to discuss genetic testing results with each purported patient).”
And more.
“In the telehealth space, the issue the OIG has flagged is that genetic tests are being ordered without patient interaction or with only brief telephonic conversations,” Danielle Tangorre, JD, a partner at law firm Robinson & Cole LLP in Albany, N.Y., told Dark Daily.
New Bill May Eliminate 2023 Medical Laboratory Payment Cuts Under PAMA
Medical labs and pathology groups face payment cuts of up to 15% for 800 lab tests on the Medicare Clinical Lab Fee Schedule (CLFS) on Jan. 1, 2023, as part of PAMA.
The bill proposes to move regulatory oversight of LDTs from CLIA to the federal Food and Drug Administration (FDA). Champions of the bill argue that FDA regulation is needed for in vitro clinical tests (IVCTs) because they are similar to medical devices and bring with them patient safety concerns.
The bill seemed ready for a Senate vote over the summer but stalled. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. During negotiation, the VALID Act was removed from the larger spending package, according to Boston law firm Ropes and Gray.
Expect discussion to renew in Congress about the VALID Act after the mid-term elections.
Clinical laboratory leaders and pathology group managers will want to closely monitor the progress of these four federal legislative and regulatory developments. Each of the possible actions described above would significantly change the status quo in the compliance requirements and reimbursement arrangements for both clinical laboratory testing and anatomic pathology services.
