Though not a replacement for clinical laboratory testing, the CDC says the surveillance system will help slow spread of COVID-19 in vulnerable communities
Clinical laboratory testing for COVID-19 is receiving an ally. In mid-August, the Centers for Disease Control and Prevention (CDC) and the US Department of Health and Human Services (HHS) announced they were initiating a National Wastewater Surveillance System (NWSS) in response to the COVID-19 pandemic.
In collaboration with other federal agencies, the NWSS will work with state, local, territorial, and tribal health departments to collect data on wastewater (aka, sewage) samples throughout the United States.
The goal of the NWSS is to detect SARS-CoV-2, the coronavirus that causes COVID-19, before it spreads by detecting traces of it in local sewer systems. The level of the virus detected in wastewater can be a leading indicator of a worsening outbreak in a community, according to a CDC statement.
“Quantitative SARS-CoV-2 measurements in untreated sewage can provide information on changes in total COVID-19 infection in the community contributing to that wastewater treatment plant,” noted the CDC.
People infected with the coronavirus discard traces of it—whether they are symptomatic or asymptomatic—and levels of the virus in untreated sewage can provide scientists with information about the degree of outbreak in specific areas.
The NWSS will not include or monitor homes that use septic tanks or entities with decentralized systems that treat their own waste, such as hospitals, universities, and prisons.
Not a Replacement for Clinical Laboratory Testing
The CDC stressed that sewage testing is not meant to replace clinical laboratory testing, but it can be a valuable tool in communities where COVID-19 tests are underutilized or unavailable. Wastewater testing, CDC noted in its statement, could have an enormous reach as 80% of households in the US are connected to a municipal sewage system.
The CDC is not actively taking samples from wastewater, but relying on local partners to take samples, test them, and enter data into the NWSS portal for the purpose of summarizing and interpreting for public health action.
The agency predicts that participation in a national database will ensure data comparability across separate jurisdictions.
Could Testing Raw Sewage Be More Effective than Contact Tracing for Tracking COVID-19 Outbreaks?
A Yale University study published in Nature Biotechnology, titled, “Measurement of SARS-CoV-2 RNA in Wastewater Tracks Community Infection Dynamics,” detected SARS-CoV-2 concentrations in sewage sludge in New Haven, Conn., over a 10-week period earlier this year. The results of the study “show the utility of viral RNA monitoring in municipal wastewater for SARS-CoV-2 infection surveillance at a population-wide level,” the study authors noted.
The published study states that “SARS-CoV-2 RNA was detected throughout the more than 10-week study and, when adjusted for time lags, tracked the rise and fall of cases seen in SARS-CoV-2 clinical test results and local COVID-19 hospital admissions. Relative to these indicators, SARS-CoV-2 RNA concentrations in sludge were 0–2 [days] ahead of SARS-CoV-2 positive test results by date of specimen collection, 0–2 [days] ahead of the percentage of positive tests by date of specimen collection, 1–4 [days] ahead of local hospital admissions and 6–8 [days] ahead of SARS-CoV-2 positive test results by reporting date.”
The Yale researchers concluded, “Our results demonstrate that measurement of SARS-CoV-2 RNA concentrations in primary sludge provides an approach to estimate changes in COVID-19 prevalence on a population level. Sludge results were not a leading indicator compared to positive test results or percentage of positive tests by date of specimen collection. However, they led hospitalizations by 1–4 [days] and test results by report date by ~1 week. Thus, in communities where test reporting is delayed, sludge results, if analyzed and reported on the same day as sampling, can provide substantial advance notice of infection dynamics.”
Jordan Peccia, Jr., PhD (above), Professor of Chemical and Environmental Engineering at the Yale School of Engineering and Applied Science, and study author, told NBC News, “There’s still a lot more to do. We’re one of the earlier groups to have developed a robust relationship between wastewater and coronavirus cases, but this is just a first step.” He added, “It doesn’t replace contact tracing. [But] if we know a little bit ahead of time, we can raise the alarm.” (Photo copyright: Yale University.)
Sewage Testing for COVID-19 Around the World
Sewage testing can provide data to complement other collected information about COVID-19 and steer public health decision-making. However, the CDC notes that “it is not possible to reliably and accurately predict the number of infected individuals in a community based on sewage testing” and that “more data on fecal shedding by infected individuals over the course of disease are needed to better understand the limits of detection.”
Nevertheless, some experts have leaned heavily on sewage sample testing for their conclusions about the origination of the coronavirus. In August, Dark Daily reported on a theory based on finding remnants of SARS-CoV-2 in sewage systems that suggested the virus may not have originated in Wuhan, China. Analysis of sewage samples in Italy, Spain, and Brazil indicated the virus was present in those countries before the disease was known to exist outside of China. The controversy over these findings has motivated virologists to expand wastewater testing.
The creation of the NWSS by the CDC validates growing interest in new methods of testing for infectious disease. Lower cost, faster response time, more automation of genetic sequencing, and improved analytical software has enabled this type of testing to become a useful tool. It would be wise for clinical laboratory managers to monitor the expanded use of new testing technologies for infectious diseases.
Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus
In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and had the necessary resources, to develop their own coronavirus molecular diagnostic tests to help meet the nationwide demand for clinical laboratory testing. However, the response from the US Food and Drug Administration (FDA) was, in essence, “not so fast.”
In this second part of Dark Daily’s two-part e-briefing, we continue our coverage of the Washington Post (WP) investigation that detailed the regulatory hurdles which blocked private laboratories from deploying their own laboratory-developed tests (LDTs) for COVID-19. The report is based on previously unreported email messages and other documents reviewed by the WP, as well as the newspaper’s exclusive interviews with scientists and officials involved.
The CDC’s COVID-19 test kits began arriving at public health laboratories on February 8, just 18 days after the first case of the novel coronavirus was confirmed in the US. As the WP noted in an earlier analysis, titled, “What Went Wrong with Coronavirus Testing in the US,” the CDC’s decision to develop its own test was not surprising. “The CDC will develop [its] own test that is suited to an American healthcare context and the regulations that exist here,” explained Jeremy Konyndyk, Senior Policy Fellow at the Center for Global Development. “That’s how we normally would do things.”
But state and local public health laboratories quickly discovered that the CDC test kits were flawed due to problems with one of the reagents. While numerous academic, research, and commercial labs had the capability to produce their own COVID-19 PCR tests, FDA rules initially prevented them from doing so without a federal Emergency Use Authorization (EUA).
The bureaucratic hurdles arose due to Health and Human Services Secretary Alex Azar’s January 31 declaration that COVID-19 was a “health emergency” in the US. By doing so, HHS triggered a mandate that requires CLIA-certified labs at universities, research centers, and hospitals to seek an EUA from the FDA before deploying any laboratory-developed tests.
Scientists, Clinical Laboratories Frustrated by Bureaucratic Delays and Red Tape
To make matters worse, the EUA process was neither simple nor fast, which exasperated lab scientists and clinical laboratory administrators. “In their private communications, scientists at academic, hospital, and public health labs—one layer removed from federal agency operations—expressed dismay at the failure to move more quickly, and frustration at bureaucratic demands that delayed their attempts to develop alternatives to the CDC test,” wrote the WP investigators.
In a Feb. 27 email to other microbiologists, Marc Couturier, PhD, Medical Director at ARUP Laboratories, a national reference laboratory network located in Utah, voiced his irritation with the red tape that stymied private laboratory development of COVID-19 tests. He wrote, “We have the skills and resources as a community, but we are collectively paralyzed by a bloated bureaucratic/administrative process,” reported the WP.
Keith Jerome, MD, PhD (above), Head of the Virology Division at the Fred Hutchinson Cancer Research Center in Seattle, maintains federal regulations muted one of the nation’s greatest assets in the fight against COVID-19. “The great strength the US has always had, not just in virology, is that we’ve always had a wide variety of people and groups working on any given problem,” he told MIT Technology Review. “When we decided all coronavirus testing had to be done by a single entity, even one as outstanding as CDC, we basically gave away our greatest strength.” (Photo copyright: Jonathan Hamilton/NPR.)
‘FDA Should Not Treat Labs Like They Are Creating Commercial Products’
According to Kaiser Health News (KHN), Greninger was able to identify one of the nation’s first cases of community-acquired COVID-19 by taking “advantage of a regulatory loophole that allowed the lab to test samples obtained for research purposes from UW’s hospitals.”
But navigating the EUA process was a different story, Greninger told the WP. He spent more than 100 hours filling out forms and collecting information needed for the EUA application. After emailing the application to the FDA, Greninger received a reply containing eCopy Guidance telling him he needed to resubmit the information to the Document Control Center (DCC) at the Center for Devices and Radiological Health (CDRH), a federal agency Greninger knew nothing about. Another FDA rule required that the submission be copied to a hard disk and mailed to the DCC.
In an interview with ProPublica, Greninger stated that after he submitted his COVID-19 test—which copies the CDC protocol—an FDA reviewer told him he would need to prove the test would not show a positive result for someone infected with either a SARS or MERS coronavirus. The first SARS coronavirus disappeared in mid-2003 and the only two cases of MERS in the US were diagnosed in 2014. Greninger told ProPublica it took him two days to locate a clinical laboratory that could provide the materials he needed.
Greninger maintains the FDA should not treat all clinical laboratories as though they are making a commercial product. “I think it makes sense to have this regulation when you’re going to sell 100,000 widgets across the US. That’s not who we are,” he told ProPublica.
FDA Changes Course
Under pressure from clinical laboratory scientists and medical doctors, by the end of February the FDA had issued new policy that enabled CLIA-certified laboratories to immediately use their validated COVID-19 diagnostics while awaiting an EUA. “This policy change was an unprecedented action to expand access to testing,” said the FDA in a statement.
Since then, the FDA has continued to respond—albeit slowly—to scientists’ complaints about regulations that hampered the nation’s COVID-19 testing capacity.
Clinical laboratory leaders and pathologists involved in testing for the SARS-CoV-2 coronavirus should monitor the FDA’s actions and be aware of when and if certain temporary changes the agency implemented during the early days of the COVID-19 pandemic become permanent.
To read part one of our two-part coverage of the Washington Post’s investigation, click here.
Clinical laboratories need to understand how their patients’ protected health information is being used and secured by vendors to avert data breaches and HHS penalties
Most readers of The Dark Report, the sister publication to the Dark Daily, are aware that more than 24-million clinical laboratory patients had their protected health information (PHI) stolen during several recent data breaches involving multiple medical laboratory companies.
The first public statements made by clinical lab companies
about breaches of protected health information were issued in June.
Collectively, the following three lab companies announced that the data of more
than 20 million patients was compromised:
What all these clinical lab companies had in common was that they had contracted with American Medical Collection Agency (AMCA) to process lab test claims. AMCA is where the data breaches originated.
Under the rules established by the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, responsibility for the security of patient PHI falls to covered entities and business associates. This includes healthcare providers, health plans, and healthcare clearinghouses, such as AMCA. For clinical laboratories, this also includes vendors who receive patients’ PHI to complete their service contracts.
Until recently, any violation of HIPAA could draw down enormous fines—called Civil Money Penalties (CMPs)—by the US Department of Health and Human Services (HHS). Fines could reach $1.5 million annually across four categories, or tiers, of violations, depending on HHS’ determination as to the “level of culpability” of the violator. Those categories and min/max fines include:
No Knowledge, $100-$50,000 fine, $1.5 mil annual
limit.
Reasonable Cause, $1,000-$50,000 fine, $1.5 mil
annual limit.
In the notice, HHS stated, “the Department recognized that
section 13410(d) contained apparently inconsistent language (i.e., its
reference to two penalty tiers ‘for each violation,’ each of which provided a
penalty amount ‘for all such violations’ of an identical requirement or
prohibition in a calendar year). To resolve this inconsistency, with the
exception of violations due to willful neglect that are not timely corrected,
the [interim final rule] adopted a range of penalty amounts between the minimum
given in one tier and the maximum given in the second tier for each violation
and adopted the amount of $1.5 million as the limit for all violations of an
identical provision of the HIPAA rules in a calendar year.”
Modern Healthcare reports that “organizations that have taken measures to meet HIPAA’s requirements will face a much smaller maximum penalty than those who are found neglectful.”
Thus, the new HHS guidelines will be of interest to clinical
laboratories, which must ensure the privacy of patients’ PHI, including being
keenly aware of how vendor business associates are handling their patients’
data.
In an exclusive interview with The Dark Report, James Giszczak (above), Data Privacy and Cybersecurity Attorney and Chair of the Litigation Department at McDonald Hopkins, said two important steps clinical laboratories must take include, “ensuring that your vendor has appropriate insurance policies in place that cover PHI breaches, and confirming that vendors comply with laws governing the protection of patients’ information.” To do that, he says, every lab needs to ensure that all critical provisions are covered in each contract it has with each vendor. (Photo copyright: Institute of Continuing Legal Education.)
Did HHS Go Too Far?
Some experts, however, wonder if HHS went too far in
reducing annual penalties providers may owe. Could lower annual CMP caps cause
organizations to relax strict PHI policies? Some privacy authorities urge
caution and raise concern about how incentives may be perceived by providers
and others.
“HHS is adopting a much lower annual cap for all violations except those due to willful neglect, which means significantly lower penalties for large breaches and for ongoing persistent violations of the rules,” Deven McGraw, Chief Regulatory Officer at Citizen Corporation and former Deputy Director Health Information Privacy for HHS’ Office for Civil Rights, told FierceHealthcare.
“Arguably,” she continued, “the incentive to fix these
persistent failures is much less because the potential fines for failing to do
so will not be very large. Same is true for large breaches—if you breach 10
records, at a minimum penalty of $1,000 for a breach due to reasonable cause,
your fine would be $100,000, which is the annual cap.”
New Annual Limits Recognize ‘Unintentional’ Violations
But not all experts agree. Prior to HHS’ announcement,
minimum to maximum penalty violations were the same as noted in the tiers
above. The annual limits ($1.5 million), however, were the same for each of the
four tiers.
Matthew Fisher, Partner at Mirick O’Connell and Chair of the Worcester, Mass. firm’s health law group, says the new penalty structure “is arguably good in terms of aligning potential penalties with the level of culpability.”
“If a violation was clearly unintentional and without
knowledge, why should a potentially massive fine follow? While the discretion
existed, the interpretation will now be binding and remove the potential
uncertainty,” he told FierceHealthcare.
Advice for Clinical Laboratories
Labs are advised to develop appropriate procedures to
safeguard their patients’ PHI under federal and state laws. And this includes
knowing how vendors handle PHI.
“Every lab should be proactive and do a review to understand
each vendor’s policies, procedures, training, and response in the event of a
breach,” James
Giszczak, Data Privacy and Cybersecurity Attorney and Chair of the
Litigation Department at McDonald
Hopkins in Bloomfield Hills, Mich., told The
Dark Report (TDR).
“By being prepared, clinical laboratories can save
themselves many headaches,” he said. “Ultimately, these proactive steps may
help laboratories save time, money, and costly bad publicity.”
Following that advice, along with understanding the new HHS notice,
will help medical laboratory managers ensure the privacy and security of their
client’s PHI.
Another big question is whether the lobbying of medical laboratory and pathology societies can educate and convince members of Congress to delay and reform the PAMA Final Rule that uses the market price study of what private payers pay for lab tests
The bad news doesn’t stop there. Lab industry observers say that significant numbers of hospital laboratories and independent lab companies are unprepared for the drop in revenue they will experience once the Medicare price cuts take effect. And, with only 157 days remaining before Jan. 1, 2018, medical laboratory executives and pathologists have precious little time to prepare their labs to operate on significantly less Medicare revenue.
PAMA Market Study of What Private Payers Pay for Clinical Laboratory Tests
Blame it on the Protecting Access to Medicare Act (PAMA) of 2014! PAMA directed CMS to conduct a market study of the lab test prices paid by private health insurers, and then use this data to set the prices of the CLFS. As many lab professionals know, CMS spent the last 24 months publishing a final price reporting rule that defined which medical laboratories must report the prices they are paid by private payers, and then collecting that data.
The data reporting period ended on May 31. In coming months, CMS will publish the new CLFS test prices and allow time for public comment.
First Opportunity to See What Private Payers Pay for Medical Laboratory Tests
The first expert to speak is Lâle White, Executive Chairman and CEO of XIFIN, Inc., a health information technology (HIT) company headquartered in San Diego. Annually, White and her colleagues handle as many as 300 million lab test claims for hundreds of their clinical laboratory clients. Also, XIFIN is electronically interfaced with every health insurance plan in the US. These two facts mean that White has essentially the same data their lab clients reported to CMS.
During her presentation, White will show you how her company analyzed the real information from hundreds of millions of medical lab test claims that were reimbursed by thousands of private payers. You are in for a big surprise!
Learn Why Medicare Lab Test Fee Cuts Will Be Deep and Painful
XIFIN’s conclusions are based on real-world data. They demonstrate how the CMS final rule was written to direct the way federal officials calculate and set the 2018 Part B clinical laboratory test prices, and reveal why the fee cuts will be deep and painful for the lab industry’s highest-volume tests. You’ll hear facts about XIFIN’s analysis and learn to use that knowledge to model and predict precisely how deep Medicare’s revenue cuts to your lab will be when the new price schedule becomes effective on Jan. 1.
Lâle White (above left), CEO of XIFIN, Inc., spoke at the Executive War College on Laboratory and Pathology Management last May, where she shared insights about the coming price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Julie Scott Allen (above right) is Senior Vice President of the District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. White and Allen will be speaking at a special Dark Daily webinar later this week on the current status of the Medicare fee cuts and how lab executives should respond to protect the financial integrity of their labs. (White photo copyright: The Dark Report. White photo by Linda Reineke. Allen photo copyright: Drinker Biddle.)
Because it is generally agreed that CMS officials will target the top 20 lab tests by volume for the deepest price cuts, the actual revenue drop will depend on your mix of tests and the volume of Medicare patients associated with each test. CMS says it will use the weighted median of the private payer lab test price data to determine its new Part B fees.
However, that is a flawed approach and the source of much criticism.
White will show why the weighted median generates a lower price than the use of a weighted average calculation. You’ll see the direct impact that CMS’ use of the weighted median will have on your lab’s Medicare revenue, beginning on Jan. 1.
Understanding Current Developments at CMS and Within Congress
Julie Scott Allen will be the second speaker on the July 20 webinar. She is Senior Vice President, District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. In this role, Allen works with officials at CMS, the Department of Health and Human Services (HHS), and with members of Congress on issues relevant to the clinical laboratory members of NILA. She regularly participates as part of the Clinical Laboratory Coalition on these matters.
Allen will give you an up-to-the minute perspective on efforts by the clinical laboratory industry to educate officials within Congress, HHS, and CMS about the consequences of allowing the PAMA final rule price cuts to become effective on January 1, 2018. This is important information you can use to craft strategies to protect your lab’s financial stability. You’ll also recognize opportunities to contact your elected officials in Congress at the time when your input can make an important difference.
The message of many in the Clinical Laboratory Coalition to members of Congress is that, if the PAMA Medicare fee cuts happen as planned, many hospital lab outreach programs and community lab companies in the states and districts of the various Senators and Representatives will probably end up going out of business, filing bankruptcy, or selling to a national lab company.
Behind the Scenes on PAMA Fee Cuts, ACA Repeal-and-Replace
Allen will take you behind the scenes of the inside-the-beltway developments that relate to the coming Medicare Part B clinical laboratory fee cuts. Different players from the clinical laboratory community are in discussions with CMS officials about the need to delay and reform the implementation of these price cuts.
Meanwhile, there are several developments unfolding within Congress that affect clinical laboratories. Yes, one of them is the PAMA final rule on lab price cuts. However, congressional efforts to repeal and replace the Affordable Care Act (ACA) are creating opportunities for different medical specialties—including the profession of laboratory medicine—to advocate for needed reforms in their areas of clinical services.
When clinical laboratory and anatomic pathology leaders are informed, they are more effective in two roles:
Protecting the clinical excellence and financial sustainability of their respective laboratories;
Advocating with government officials and lawmakers on the issues that are important to keeping the nation’s laboratories financially viable and key contributors to improving the quality of patient care.
To hasten the day when all Americans have an electronic health record (EHR), last year, on August 8, 2006, the U.S. Department of Health and Human Services (“HHS”) issued regulations that would allow hospitals to provide certain software and technical support services to physicians without violating federal antikickback law. Because many physicians have been slow to invest in electronic health record systems, this new regulation is designed to encourage hospitals and health systems to step into the gap and offer software and services that support EHR systems.
This is a significant development for hospital-based laboratories. It creates new opportunities to build relationships with referring physicians. But it also creates new compliance exposure for laboratories which fail operate within the parameters of the law.
Since the IRS lingo is complicated, to say the least, we asked Jane Pine Wood, attorney for McDonald Hopkins and a specialist in clinical laboratory and anatomic pathology legal matters, how this change would affect hospital laboratories. Wood responded, saying:
“The IRS memorandum offers greater assurance to tax-exempt hospitals that they can provide EHRs to members of their medical staffs, in compliance with the applicable Stark exception and the applicable safe harbor under the Medicare and Medicaid anti-kickback law, without jeopardizing their tax-exempt status. It is important to note that this memorandum provides approval only to those arrangements which comply fully with the numerous criteria of the Stark exception and anti-kickback law safe harbor.”
We also asked Wood if hospital laboratories should take any special steps to react to this memo. “For many laboratory clients, particularly gastroenterology and endoscopy providers, EHRs are increasingly important,” said Wood. “So,this IRS memorandum is of significant benefit to those tax-exempt hospitals who wish to make EHRs more accessible for their clients.”
And there you have it. Hospital laboratories that want to take advantage of the memo should carefully study the Stark exception and the applicable safe harbor under Medicare and Medicaid anti-kickback law to ensure full compliance. Once this due diligence is complete, hospital laboratories can safely make EHRs more accessible to their medical staff.
