Recent attacks illustrate how costly a security breach can be and why clinical laboratories and pathology groups must work to protect their information systems from ransomware attacks
Therefore, it is crucial clinical laboratories and pathology groups have a cybersecurity strategy in place for dealing with ransomware attacks. Running security drills may need to be part of that strategy. Managers and employees should undergo specific training and vendors must be vetted carefully. Without such a strategy, the question is not if an attack will happen, but rather when an attack will succeed.
Ransomware Attackers are Getting Better
“Ransomware is increasing in sophistication; it’s increasing in prevalence. The purveyors of ransomware are generally reinvesting the fees that they collect from the entities they extort to acquire more capabilities,” Beau Woods, Senior Advisor at the federal Cybersecurity and Infrastructure Security Agency (CISA), told The San Diego Tribune.
“They’re getting better, they’re getting more frequent, particularly during the pandemic where we’ve opened up more connectivity to allow more remote work,” he added.
The Scripps Health attack is notable for several reasons, with one being the length of the outage it caused. The attack was first detected on May 1 of this year. It took four weeks before Scripps could restore most of its network and get its Epic EHR back online, Health IT Security reported.
However, the ransomware attack on Universal Health Services (NYSE:UHS) may be the biggest attack so far. It took place on September 27, 2020, and caused a three-week outage. The company told The San Diego Tribune the incident had a $67 million impact on operations.
According to HIPAA Journal, “The phone system was taken out of action, and without access to computers and electronic health records, employees had to resort to pen and paper to record patient information. In the early hours after the attack occurred, the health system diverted ambulances to alternative facilities and some elective procedures were either postponed or diverted to competitors. Patients reported delays receiving test results while UHS recovered from the attack.”
At Utah Pathology Services, an employee e-mail hack resulted in the potential exposure of patient data. The malicious actors attempted to divert funds intended for a physician but failed to do so. However, the information of 112,000 patients was accessible to the hacker during the attempt.
“The compromised data varied by patient but could include names, contact information, insurance details such as ID and group numbers, medical and health information like internal records numbers and clinical and diagnostic information, and some Social Security numbers,” Health IT Security reported.
“We are seeing adversaries that are targeting our pharmaceutical companies, pharmaceutical research, laboratory companies, testing and really even out into the future manufacturing of the vaccine systems,” Bryan S. Ware (above left) Assistant Director for Cybersecurity for the Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) told CyberScoop. CISA Director Christopher Krebs (above right) added, “At the onset of the COVID-19 pandemic, we recognized just how vital the healthcare sector was to the response and we established Project Taken to bring to bear the government’s particular set of skills to protect those organizations.” (Photo copyrights: CyberScoop/Business Insider.)
Value of Patient Data on the Dark Web is Increasing
In the case of the Utah Pathology Services attack, the hackers were specifically after money. However, according to cybersecurity company SecureLink, patient records are “the new prize” for hackers. Healthcare data carries a value of its own on the digital black market. In fact, healthcare data is more valuable than credit card or banking data.
“Healthcare data is valuable on the black market because it often contains all of an individual’s personally identifiable information, as opposed to a single marker that may be found in a financial breach,” SecureLink wrote in a blog post.
A 2018 Trustwave Global Security Report estimated that a healthcare record is worth about $250. Trustwave, however, estimated the value of a banking record at less than $5. That strongly suggests health records are increasing in value.
And even after a healthcare entity has regained control of its IT infrastructure, the hacker still has possession of the stolen patient information. It may take weeks or years for the hacker to sell that information, meaning the breach represents a continuing threat to the healthcare organization and its patients.
Clinical Laboratories Must Prepare for an Attack
Simply understanding the threat is not enough. Clinical laboratory and pathology group managers must have robust plans in place for both protecting patient information and for dealing with a security breach should one occur.
According to a Health IT Security report, “The ransomware attack that struck all 400 UHS care sites and caused three weeks of EHR downtime in September, cost the health system $67 million in recovery costs and lost revenue.”
The report added, “Security researchers have long-recommended the need for providers to shift into a proactive security model, like zero trust. Recent reports show successful cyberattacks on healthcare providers doubled in the last year, with at least 560 providers falling victim to ransomware.”
To deal with the ransomware attacks, we wrote, “CISA, FBI, and HHS advise against paying ransoms. ‘Payment does not guarantee files will be recovered,’ the advisory states. ‘It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.’ The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.
“The advisory suggests:
Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should ‘ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.’
Regular backups of data and software. These should be ‘maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.’ Personnel should also test the backups.
Continuity plans in case information systems are not accessible. For example, organizations should maintain ‘hard copies of digital information that would be required for critical patient healthcare.’”
Given the enormous amounts of money hackers can earn from selling protected health information on the Dark Web, it is a near certainty these attacks will continue. Clinical laboratory and anatomic pathology group managers would be well advised to plan for the inevitability that their health system will be targeted.
Four International Pandemics That Occurred Prior to COVID-19 and Contributed to Increased Clinical Laboratory Testing to Aid in Managing the Outbreaks
Since 1900, millions have died worldwide from previous viruses that were as deadly as SARS-CoV-2. But how much do pathologists and clinical laboratory scientists know about them?
SARS-CoV-2 continues to infect populations worldwide. As of May 28, 2021, the World Health Organization (WHO) reported that 168,599,045 people have been diagnosed with COVID-19 infections globally, and 3,507,377 individuals have perished from the coronavirus.
At the same time, federal Centers for Disease Control and Prevention (CDC) statistics show there have been 33,018,965 cases of COVID-19 in the United States, 589,547 of which resulted in death.
But COVID-19 is just the latest in a string of pandemics that spread across the planet in the past century. Since 1900, there have been four major international pandemics resulting in millions of deaths. But how many people even remember them? And how many pathologists, microbiologists, and clinical laboratory scientists working today experienced even the most recent of these four global pandemics?
Here is a summary/review of these major pandemics to give clinical laboratory professionals context for comparing the COVID-19 pandemic to past pandemics.
Spanish Flu of 1918
The 1918 influenza pandemic, commonly referred to as the Spanish Flu, was the most severe and deadliest pandemic of the 20th century. This pandemic was caused by a novel strand of the H1N1 virus that had avian origins. It is estimated that approximately one third of the world’s population (at that time) became infected with the virus.
According to a CDC article, the flu pandemic of 1918 was responsible for at least 50 million deaths worldwide, with about 675,000 of those deaths occurring in the United States. This pandemic had an unusually high death rate among healthy individuals between the ages of 15 and 34 and actually lowered the average life expectancy in the United States by more than 12 years, according to a CDC report, titled, “The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus.”
Interestingly, experts feel the 1918 flu strain never fully left us, but simply weakened and became less lethal as it mutated and passed through humans and other animals.
“All those pandemics that have happened since—1957, 1968, 2009—all those pandemics are derivatives of the 1918 flu,” he told The Washington Post. “The flu viruses that people get this year, or last year, are all still directly related to the 1918 ancestor.”
1957 Asian Flu
The H2N2 virus, which caused the Asian Flu, first emerged in East Asia in February 1957 and quickly spread to other countries throughout Asia. The virus reached the shores of the US by the summer of 1957, where the number of infections continued to rise, especially among the elderly, children, and pregnant women.
Between 1957-1958, the Asian Flu spread across the planet causing between one to two million deaths, including 116,000 deaths in the US alone. However, this pandemic could have been much worse were it not for the efforts of microbiologist and vaccinologist Maurice Hilleman, PhD, who in 1958 was Chief of the Department of Virus Diseases at Walter Reed Army Medical Center.
Concerned that the Asian flu would wreak havoc on the US, Hilleman—who today is considered the father of modern vaccines—researched and created a vaccine for it in four months. Public health experts estimated the number of US deaths could have reached over one million without the fast arrival of the vaccine, noted Scientific American, adding that though Hilleman “is little remembered today, he also helped develop nine of the 14 children’s vaccines that are now recommended.”
During his lifetime, Maurice Hilleman, PhD (above), developed a staggering 40 vaccines to help prevent everything from measles, mumps, rubella, pneumonia, meningitis, hepatitis A and B, and other infectious diseases. (Photo copyright: Scientific American.)
1968 Hong Kong Flu
The 1968 influenza pandemic known as the Hong Kong flu emerged in China and persisted for several years. Within weeks of its emergence in the heavily populated Hong Kong, the flu had infected more than 500,000 people. Within months, the highly contagious virus had gone global.
According to the Encyclopedia Britannica, this pandemic was initiated by the influenza A subtype H3N2 virus and is suspected to have evolved from the viral strain that caused the 1957 flu pandemic through a process called antigenic shift. In this case, the hemagglutinin (H) antigen located on the outer surface of the virus underwent a genetic mutation to manufacture the new H3 antigen. Persons who had been exposed to the 1957 flu virus seemed to retain immune protection against the 1968 virus, which, Britannica noted, could help explain the relative mildness of the 1968 outbreak.
It is estimated that the 1968 Hong Kong Flu killed one to four million people worldwide, with approximately 100,000 of those deaths occurring in the US. A vaccine for the virus was available by the end of 1968 and the outbreaks appeared to be under control the following year. The H3N2 virus continues to circulate worldwide as a seasonal influenza A virus.
2009 H1N1 Swine Flu
In the spring of 2009, the novel H1N1 influenza virus that caused the Swine Flu pandemic was first detected in California. It soon spread across the US and the world. This new H1N1 virus contained a unique combination of influenza genes not previously identified in animals or people. By the time the World Health Organization (WHO) declared this flu to be a pandemic in June of 2009, a total of 74 countries and territories had reported confirmed cases of the disease. The CDC estimated there were 60.8 million cases of Swine Flu infections in the US between April 2009 and April 2010 that resulted in approximately 274,304 hospitalizations and 12,469 deaths.
This pandemic primarily affected children and young and middle-aged adults and was less severe than previous pandemics. Nevertheless, the H1N1 pandemic dramatically increased clinical laboratory test volumes, as Dark Daily’s sister publication, The Dark Report, covered in “Influenza A/H1N1 Outbreak Offers Lessons for Labs,” TDR June 8, 2009.
“Laboratories in the United States experienced a phenomenal surge in specimen volume during the first few weeks of the outbreak of A/H1N1. This event shows that the capacity in our nation’s public health system for large amounts of testing is inadequate,” Steven B. Kleiboeker, DVM, PhD, told The Dark Report. At that time Kleiboeker was Chief Scientific Officer and a Vice-President of ViraCor Laboratories in Lee’s Summit, Mo.
1.7 Million ‘Undiscovered’ Viruses
As people travel more frequently between countries, it is unlikely that COVID-19 will be the last pandemic that we encounter. According to the World Economic Forum (WEF), there are 1.7 million “undiscovered” viruses that exist in mammals and birds and approximately 827,000 of those viruses have the ability to infect humans.
Thus, it remains the job of pathologists and clinical laboratories worldwide to remain ever vigilant and prepared for the next global pandemic.
Though clinical laboratory RT-PCR tests remain the ‘gold standard’ when diagnosing COVID-19, at-home antigen tests offer convenience and quick test results. But are they accurate?
Clinical laboratory and pathologists generally acknowledge that RT-Polymerase Chain Reaction (RT-PCR) tests remain the preferred method for detecting COVID-19 disease. However, according to Popular Science, rapid at-home antigen tests that accurately identify people carrying larger loads of the virus are becoming important tools in the fight against spread of the coronavirus.
DxTerity SARS-CoV-2: This saliva-based collection kit is available on Amazon and at Walmart for $110. Specimens must be sent via FedEx on the same day as collection. Results are available within 24 to 72 hours of the sample being received by the PCR testing lab.
Lucira Check It COVID-19 Test Kit: Billed as offering “PCR quality molecular accuracy,” this nasal swab test costs $55 and provides results in 30 minutes or less.
Abbott BinaxNOW Antigen Self-Test. Results within 15 minutes and available for $23.99 at major pharmacies. Each box includes two nasal swab tests, with the second test taken within 36 hours of the first.
Pixel COVID-19 At-Home Collection Kit: This nasal-swab-based mail-in collection kit is available online for $119. Results delivered within 24 to 48 hours of the sample being received by Labcorp.
Many of the newest at-home tests not only have users collect their own swab or saliva samples, but some also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home-based collection kits that are returned to clinical laboratories for testing can take 48 hours or longer for shipping and processing.
The FDA’s emergency use authorization announcement (EUA) for Ellume’s $38.99 COVID-19 At Home Test (above) states the test “is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.” Ellume’s self-collection test was the first such test to receive an FDA EUA for use without a physician’s order. (Photo copyright: Ellume).
Among the issues cited were the potential for inadequate samples and improper handling to cause inaccurate results, as well as uncertainty whether at-home antigen tests will pick up on COVID-19 variants.
At-home tests also are less likely to be covered by insurance, MedPage Today reported.
During the CAP virtual media briefing, pathologist Kalisha Hill, MD (above), Chief Medical Officer and Chair, Department of Pathology and Medical Director, Laboratory Services, at AMITA Health St. Mary’s Kankakee (Ill.), said, “The gold standard is still a laboratory-performed real-time PCR test and that is the most sensitive and most accurate that we do that is very specific for COVID-19.” Hill called at-home tests a “good screening tool,” but she noted, “You’re testing that moment, that day, and as soon as you leave your home or come in contact with someone else, you could potentially be COVID positive. It’s also important to recognize that when you’re collecting a sample yourself, you may not be able to obtain enough sample for an accurate result … It’s very important how it is collected and also the sensitivity and specificity of the test,” she added. (Photo copyright: AMITA Health/LinkedIn.)
How Do the Tests’ Accuracy Compare?
The Quest Direct and LabCorp Pixel tests—both of which are sent to company labs for PCR testing—scored highest on the two main statistical measures of performance sensitivity (positive percent agreement) and specificity (negative percent agreement). According to Popular Science, each of these tests’ sensitivities and specificities are close to 100%.
According to the websites of the other tests reviewed by Popular Science:
DxTerity test, which uses a saliva sample—97.2% sensitivity and a 92.5% specificity.
BinaxNOW test—84.6% sensitivity and 98.5% specificity.
Cue COVID-19 test—98.7% sensitivity and 97.6% specificity.
Lucira Check Its test—98% accuracy.
Ellume test—95% sensitivity and 97% specificity.
Rapid Antigen Tests Accurate and Easy to Use, says Popular Science
Popular Science found the tests generally easy to use and concluded they are a beneficial—if imperfect—tool in the fight against COVID-19.
“If you’re unvaccinated and symptomatic, they’re a great way to confirm a COVID-19 infection without risking a trip out of the house,” Popular Science stated in its article. “If you’re unvaccinated and have no symptoms, and just want to know whether you can safely attend a family dinner or soccer game, an at-home test remains an imperfect way of self-screening. Remember: If the test comes back negative, there’s still the chance the result is false, and you could accidentally expose others by being within six feet of them without a mask on.”
As the popularity of at-home COVID-19 tests increases, clinical laboratories that perform RT-PCR tests may want to keep a watchful eye on the demand for at-home rapid antigen testing, especially now that some tests are available without prescription.
New USPSTF guidelines suggest reducing the volume of Vitamin D deficiency testing in the general population, which could reduce revenue for clinical laboratories
From 2005 to 2011, the volume of clinical laboratory tests for Vitamin D soared nationally as more doctors tested more patients for Vitamin D deficiency. This became a major source of revenue growth for many clinical laboratories performing those tests. But at least a portion of lab revenue associated with Vitamin D testing may be in jeopardy.
In a recommendation statement published in JAMA Network, titled, “Screening for Vitamin D Deficiency in Adults,” the United States Preventive Services Task Force (USPSTF)—following up on its 2014 recommendations—stated “that the current evidence is insufficient to assess the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults.”
The USPSTF’s new recommendations concerning Vitamin D testing came after the federal task force performed an extensive review of the benefits and potential harm of screening for Vitamin D deficiencies in non-pregnant adults who displayed no symptoms of a deficiency. Symptoms of a Vitamin D deficiency include fatigue and tiredness, bone and back pain, depression, impaired would healing, bone loss, hair loss, and muscle pain.
After completing its research, the USPSTF concluded “the overall evidence on the benefits of screening for Vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults cannot be determined.”
Are USPSTF Conclusions Contrary to Current Deficiency Testing Practices?
“Among asymptomatic, community-dwelling populations with low Vitamin D levels, the evidence suggests that treatment with Vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the JAMA Network article states.
Other studies have linked low Vitamin D levels with some health conditions and risks, however, the USPSTF review found no studies that directly evaluated any perks associated with Vitamin D screening in otherwise healthy individuals.
Everyday Health listed 10 illnesses linked to low Vitamin D deficiency. They include:
“We see a lot of associations between Vitamin D deficiency and poor health outcomes,” Mary Byrn, PhD, RN, an associate professor at Loyola University in Chicago who studies Vitamin D, told Everyday Health. “Although these are relationships and we are unable to conclude cause and effect, taking Vitamin D supplements or exposing yourself to the sun in a safe manner to increase Vitamin D naturally are easy ways to improve your health and try to reduce your risk of multiple diseases,” she said. (Photo copyright: Midwest Nursing Research Society.)
Can Vitamin D Supplementation Be Harmful?
The USPSTF study also stated that Vitamin D supplementation appears to be safe and that toxicity from too much Vitamin D would be rare. One of the USPSTF’s key concerns of screening for Vitamin D in asymptomatic individuals was the potential for misclassification and inaccurate diagnoses.
The study also revealed that more research is needed to determine what serum levels are optimal when diagnosing a Vitamin D deficiency, and whether those levels vary by subgroups, such as race, ethnicity, or gender.
The JAMA Network article states that “the evidence is inconclusive about the effect of treatment on physical functioning and infection.”
The amount of Vitamin D individuals need each day depends upon their age. The National Institutes of Health (NIH) recommends that adults between the ages of 19 and 70 get 15 micrograms or 600 International Units (IU) of Vitamin D daily.
According to an NIH fact sheet, people can receive Vitamin D through sun exposure, supplements, and some food, such as fatty fish, mushrooms, beef liver, cheese, and egg yolks, plus foods that are fortified with Vitamin D, such as some milk products and breakfast cereals.
Vitamin D and COVID-19
It has been widely reported that approximately 42% of Americans are Vitamin D deficient. And Vitamin D deficiency has been linked to an increased risk of contracting the SARS-CoV-2 coronavirus and how well patients recover after COVID-19 treatment.
A study published in the Journal of Clinical Endocrinology and Metabolism that examined 216 COVID-19 hospitalized patients in Spain found that over 80% of those individuals were deficient in Vitamin D. The study also found that COVID-19 patients who had lower Vitamin D levels also had a higher number of inflammatory markers that have been associated with poorer COVID-19 outcomes. The results of this study were in March.
For several decades, experts have recommended avoiding sun exposure and using sunscreen to avoid skin cancers. This may have caused people to get less Vitamin D from sun exposure. It may also have contributed to an increase in the number of Vitamin D deficiencies and increased COVID-19 infections.
Pathologists and clinical laboratory managers should keep in mind that the USPSTF recommended less testing for Vitamin D deficiencies in asymptomatic individuals. This proposal may affect test volume in clinical laboratories, as Vitamin D testing has been a common and lucrative assay for many years.
The precipitous drop in COVID-19 testing leaves clinical lab leaders wondering, “What comes next?” So it’s time to pivot—again.
When the pandemic hit in March 2020, clinical labs faced a sudden halt in routine testing, and many were able to shift quickly to COVID-19 test offerings. Fast forward one year: with the COVID-19 vaccine rollout, SARS-CoV-2 testing in clinical laboratories has rapidly declined. In the United States, COVID-19 testing dropped from two million per day in January 2021 to only about one million by March.
Now labs are having to adapt again, leading forward-looking lab managers and directors to ask:
What will be the new balance between testing for SARS-CoV-2 and routine diagnostics?
Should my clinical laboratory even continue testing for coronavirus?
Where is the best opportunity to generate revenue now?
How do I transition my lab effectively—and efficiently—to best serve patients and the healthcare industry as a whole?
This white paper, Repurposing Your Lab’s Leftover COVID-19 Samples: Building New Revenue and Better Patient Outcomes Through Collaboration with Life Science, answers these questions and more. It explores how the rapid decline in SARS-CoV-2 testing affects molecular laboratories and the life sciences industry as a whole and offers opportunities for drug developers and labs to work together in new and beneficial ways.
Biospecimens present a win-win proposition for both the clinical lab and life sciences industries
As researchers on the life-science side study coronavirus and other diseases, the value of accumulated biosamples is being reevaluated. UCSF Professor Scott VandenBerg, MD, PhD, draws the connection: “Biospecimens are important because they allow researchers to better understand the causes of diseases and evaluate potential therapies.” Labs have always retained biospecimens, but COVID-19 has spotlighted their value.
Drugmakers are expected to prioritize the development of therapeutics for new patient cohorts, such as long-haul COVID-19 patients while verifying the fidelity of biomarkers used to identify and treat comorbidities. Data generated from analysis of leftover COVID-19 samples that labs can provide could dramatically accelerate this process.
This white paper examines how molecular laboratories can generate new revenue while also contributing to the greater good of society. One primary way to achieve both is to harvest more value from samples through new relationships with life science companies and biobanks. In these new business arrangements, labs would also benefit because instead of paying to dispose of their leftover COVID-19 specimens as regulated medical waste, they could biobank them at little to no cost.
Table of Contents—Chapters at a glance
This 24-page white paper, Repurposing Your Lab’s Leftover COVID-19 Samples: Building New Revenue and Better Patient Outcomes Through Collaboration with Life Sciences, includes the following main chapters:
Chapter 1: COVID-19 Testing: What’s Next After the Rapid Ramp Up and Sudden Decline?
While many labs initially lost revenue when routine testing crashed with the pandemic shutdown, the seemingly unending demand for SARS-CoV-2 testing helped labs rally as they pivoted from traditional diagnostics to COVID-19 testing. Some labs reported exceptional year-over-year revenue growth. At least 48% of clinical labs adopted new testing methodologies or automation to meet the demands of COVID volumes, and many startup and pop-up labs were launched, pointing to a significant investment in COVID testing alone. This chapter examines where we are now and what might be ahead now that COVID-19 testing is winding down.
Chapter 2: Looking Beyond COVID-19 Testing to Find Residual Value and Revenue in Collected Specimens
To stay profitable and relevant, every clinical and molecular laboratory’s short-term and long-term strategic planning must consider the evolving nature of the pandemic. This chapter covers what labs should consider as they evaluate how to repurpose their COVID-related assets, including equipment, molecular testing platforms, and COVID-19 specimens themselves.
Chapter 3: Key Points of Molecular Laboratory Diversification into Biobanking
Biobanking can be a positive thing for labs—for example, to supplement revenue, advance research, and lead to other business development in the lab services space. But it also has its challenges. This chapter discusses both the potential benefits of biobanking and the hurdles labs can face, including regulations, logistical difficulties, consent, collecting and managing samples, and building relationships with industry and research partners.
Chapter 4: The Role of LIMS in Biobanking
Questions often surround the value of a sample, such as: How was the sample collected from the patient? How was it stored? Is the label still secure? When will the sample expire and no longer be considered valuable for research? For labs trying to organize their samples and have at-a-glance answers to questions about them, a proper laboratory information management system (LIMS) or laboratory information system (LIS) streamlines the process. This chapter covers what lab managers and directors should consider as they look to strengthen their quality systems to validate and verify their samples and tests.
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CMS says it is responding to hospitals’ plea for relief from burdensome reporting requirements, but not altering federal price transparency laws
Despite federal price transparency law that went into effect January 1 after a year-long court battle, some hospitals continue to balk at sharing their payer-negotiated rates for healthcare goods and services—including medical laboratory testing—claiming a variety of challenges due to the COVID-19 pandemic, vaccine distribution, and other difficulties, Modern Healthcare reported.
This requirement was originally part of the Hospital Price Transparency Final Rule (84 FR 65524), passed in 2019 during the Trump administration, which required hospitals to “establish, update, and make public a list of their standard charges for the items and services that they provide,” including clinical laboratory test prices. This reporting requirement did not sit well with the AHA.
In a statement, Ashley Thompson, Senior Vice President for Public Policy Analysis and Development for the American Hospital Association, said, “This policy will require hospitals to divert critically needed resources during this historic pandemic to administrative tasks that will not benefit patients.” She added, “We do not believe CMS has the authority to compel the disclosure of these terms and our legal challenge remains ongoing.”
However, if the new proposed rule goes into effect, CMS would no longer expect hospitals to report the rates they have negotiated with each Medicare Advantage plan, RevCycleIntelligence reported.
“Hospitals are often the backbone of rural communities—but the COVID-19 pandemic has hit rural hospitals hard, and too many are struggling to stay afloat,” HHS Secretary Xavier Becerra (above) said in an announcement, RevCycleIntelligence reported. “This rule will give hospitals more relief and additional tools to care for COVID-19 patients and it will also bolster the healthcare workforce in rural and underserved communities.” (Photo copyright: Modern Healthcare.)
CMS Relieving a Burden, Not Eliminating a Requirement
In the fact sheet, CMS wrote that it “is proposing to repeal the requirement that a hospital report on the Medicare cost report the median payer-specific negotiated charge that the hospital has negotiated with all of its MA organization payers, by MS-DRG (Medicare-severity diagnosis related group), for cost reporting periods ending on or after January 1, 2021. CMS estimates this will reduce administrative burden on hospitals by approximately 64,000 hours.”
Experts noted that CMS is attempting to reduce providers’ administrative burdens, while keeping federal price transparency requirements in effect.
“The repeal of this requirement more falls into the bucket of easing hospitals’ burden as opposed to the agency’s stance on hospital price transparency,” Caitlin Sheetz, Director and Head of Analytics at ADVI Health, LLC, told Fierce Healthcare.
Still, the recent CMS action could be a sign that price transparency requirements for hospitals will not intensify, she added. “I would think it is very unlikely that [CMS] would put out a rule that is easing up hospital administrative burden [and] they would then ramp up audits for the hospital price transparency rule.”
AHA Supports CMS’ Latest Proposed Rule on Hospital Reporting
The AHA said the new proposed rule moves in the right direction.
In a statement, Tom Nickels, Executive Vice President of the AHA, said, “We have long said that privately negotiated rates take into account any number of unique circumstances between a private payer and a hospital and their disclosure will not further CMS’ goal of paying market rates that reflect the cost of delivering care.” He added, “We once again urge the agency to focus on transparency efforts that help patients access their specific financial information based on their coverage and care.”
Though federal price transparency rules are evolving, medical laboratories are encouraged to accept that consumer demand is one powerful force driving this trend. Thus, clinical laboratories that currently make it easy for patients to see the prices for common medical laboratory tests in advance of service should gain competitive advantage from this feature over time.
