VA Office of Inspector General recommends changes in management processes after doctor is sentenced to long federal prison term
In a compelling report, the US Department of Veterans Affairs (VA) Office of Inspector General (OIG) found that a host of management failures and “deficiencies in the facility’s quality management processes” at an Arkansas VA hospital contributed to “thousands of diagnostic errors” throughout the tenure of the facility’s Chief of Pathology and Laboratory Medical Services Robert Morris Levy, MD.
“Any one of these breakdowns could cause harmful results,” the report states. “Occurring together and over an extended period of time, the consequences were devastating, tragic, and deadly.”
The OIG report’s findings on how hospital and laboratory administrators dealt with Levy over the years of his employment at the Fayetteville VA Medical Center demonstrate why clinical and pathology lab leaders need to be constantly vigilant in how various quality and compliance procedures are administered in their laboratories. When people and processes are not meeting acceptable standards, it is patients who are at risk of being harmed.
In January, the federal court in Arkansas sentenced Levy to “240 months in federal prison, followed by three years of supervised release and ordered [him] to pay $497,745.70 in restitution for one count each of mail fraud and involuntary manslaughter,” according to court documents.
VA Pathologist ReceivedMultiple Suspensions, then Termination
Following his removal in April 2018, the OIG assembled a team of pathologists to review nearly 34,000 cases interpreted by Levy since he began working at the VA hospital. They identified more than 3,000 errors, of which 589 were classified as “major diagnostic discrepancies” potentially having a negative impact on patient care.
Of the 589, 34 were deemed serious enough to require institutional disclosures, defined as a discussion with the patient or the patient’s representative revealing “that an adverse event has occurred during the patient’s care that resulted in or is reasonably expected to result in death or serious injury.”
The OIG report cited at least two deaths likely resulting from misdiagnoses.
Levy’s hospital privileges were initially suspended in March 2016 following a blood alcohol test indicating he was legally intoxicated while at work. He was reinstated about six months later after completing a treatment program and agreeing to submit to random drug testing.
His privileges were suspended again in October 2017 after he showed signs of impairment during a hospital committee meeting. He was terminated in April 2018 after he was arrested for allegedly driving while intoxicated (DWI) during work hours.
Federal Court Indicts Levy on Multiple Counts
Shortly after the OIG team began reviewing Levy’s cases, a separate OIG group launched a criminal investigation. Levy admitted to investigators that he had been an alcoholic for 30 years, the report stated, and that he had “purchased a substance, 2-methyl-2-butanol (2M2B), online that could be ingested, was similar to alcohol but more potent, and was not detectable using routine drug and alcohol testing methods.”
Citing the federal indictment, the OIG report noted that Levy passed 42 drug and alcohol tests following his reinstatement at the hospital in 2016.
In August 2019, federal authorities charged Levy with three counts of involuntary manslaughter along with multiple counts of wire fraud, mail fraud, and making false statements. The wire and mail fraud charges were related to his 2M2B purchases.
Levy pleaded guilty in June 2020 and was sentenced on January 22, 2021. In addition to the 20-year prison term, he was ordered to pay approximately $498,000 in restitution to VA. The OIG report noted that Levy has appealed the sentence.
And in “Arkansas Pathologist Faces Three Manslaughter Charges,” Dark Daily’s sister publication, The Dark Report, noted that “The outcome of [the Levy] case could be a precedent that gives other prosecutors the confidence that they can file criminal charges in cases where evidence shows that a pathologist’s actions contributed to diagnostic errors that directly contributed to the death of one or more patients.”
OIG Finds Numerous ‘Deficiencies in Quality Management’
In its report, OIG found deficiencies in quality management going back to Levy’s original appointment as Pathology and Laboratory Medical Services Chief.
He was initially hired in September 2005 as a locum tenens (temporary) provider and appointed as full-time service chief a month later. This was despite a DWI conviction from 1996 and a stay of only eight months with his previous employer.
Neither would have barred the doctor as a potential candidate; however, the OIG report states, “the OIG is concerned that a rigorous process was not in place to better evaluate his clinical competency at the time he was hired.”
And that was just the beginning.
In his role as service chief, Levy was responsible for the Path and Lab quality management program with assistance from a subordinate staff pathologist, “which made the process susceptible to subversion,” the report states.
The VHA requires a second pathologist to review certain findings, such as diagnosis of a new cancer malignancy. But in some cases, “it was determined that Dr. Levy was entering concurrence statements into some patients’ electronic health records (EHR) when a second pathologist had not agreed with the interpretation or diagnosis,” the OIG report states.
In addition, second reads sometimes “were communicated by sticky notes, which provided Dr. Levy the opportunity to alter or ignore the results,” the OIG reported.
Inherent Conflict of Interest, Fear of Reprisals, and OIG Recommendations
The periodic privileging process, which grants ongoing hospital privileges, was based in part on a “10% peer review” conducted by the staff pathologist. “The involvement of a subordinate in the peer review process of a supervisor creates an inherent conflict of interest,” the OIG report stated. And in some cases, appraisals of the doctor’s competence came from non-pathologists.
The OIG report suggested that the Veteran’s Health Administration (VHA) re-examine its guidance on the peer review, which requires cases to be randomly selected. Instead, the report suggests that targeting specific kinds of cases, such as those with higher risk of interpretation error, could be more effective in analyzing a pathologist’s performance.
The OIG report also noted failures in dealing with the doctor’s impairment and fostering a “culture of accountability.” Hospital staff, apparently, reported signs of impairment as early as 2014, including incidents when the doctor smelled of alcohol and displayed hand tremors. But hospital leadership failed to “vigorously address allegations of impairment,” the OIG report states. And in interviews with the OIG, some staffers expressed fear of reprisal if they reported what they saw.
The OIG report offers 10 recommendations to the VA, including practices related to hiring processes, the 10% peer review, and alcohol and drug testing. It makes two additional recommendations to the director of the Ozarks VA health system: one related to the credentialing processes and the other aimed at ensuring staff and patients can report concerns without fear of reprisal.
Clinical laboratory managers and hospital pathologists may want to review these recommendations and consider the value of applying them in their own practices.
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.
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.
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:
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.
Cozy relationships between hospital chief executives and healthcare companies they do business with may raise ethical questions
If hospital employees, including pathologists, wonder why their hospital uses a certain company’s products and services it may be because their Chief Executive Officer (CEO) sits on the Board of Directors of the same companies from which the hospital buys products and services. That’s the suggestion in a recent Boston Globe investigative report.
In “Boston’s Hospital Chiefs Moonlight on Corporate Boards at Rates Far Beyond the National Level,” The Boston Globe reported that, in Boston, hospital CEOs at the city’s academic medical centers frequently sit on the boards of healthcare companies with which their hospitals do business. However, because the investigative reporters did not list the healthcare companies which had Boston hospital CEOs as board members, clinical laboratory managers and pathologists cannot determine from the article if their medical laboratories are using products from those same companies.
According to The Globe, five of seven CEOs and Presidents of Boston’s major teaching hospitals also receive compensation for serving as directors of publicly traded companies. And in their roles as corporate board members, hospital CEOs often receive stock in these companies, making the value of their remuneration potentially worth millions of dollars, The Globe reported.
Not Illegal, But Is It Ethical?
The Boston Globe’s investigation noted that such moonlighting, while not unheard of elsewhere in the country, is commonplace in Boston, raising ethical concerns despite conflict-of-interest policies aimed at limiting outside relationships.
“Hospitals in Boston and elsewhere that allow this outside corporate work do so under the terms of conflict-of-interest policies,” The Globe reported. “A Globe review of more than a dozen hospital conflict-of-interest policies across the country found more similarities than differences. Almost all require hospital trustees to approve a hospital chief’s outside board work and consider certain factors, such as the amount of business a company does with the hospital and time required.
“But the policies offer limited evidence about actual practices,” The Globe added. “Trustees typically retain significant discretion over what is permitted or barred, and their deliberations are generally hidden from the public. It is hard to tell if the relative rarity of hospital chiefs in other cities holding outside directorships is because of a lack of interest or opportunity, or is the result of trustees saying no.”
One of the hospital chief executives The Globe’s investigation highlighted was former-Boston Children’s Hospital CEO Sandra Fenwick. While there, The Globe noted, she also held a seat on the board of for-profit telehealth company Teledoc Health, and during her tenure as Children’s CEO, she lobbied Massachusetts legislators for telehealth funding at the start of the COVID-19 pandemic.
Though no laws were broken, some questioned the ethics of such actions. Nevertheless, The Boston Globe wrote that “Debra O’Malley, a spokesperson for Secretary of State William Galvin’s office, said Fenwick’s actions did not appear to violate the law: She is required to disclose in writing to the state that she is a lobbyist for the hospital and the bills she lobbied on, which she did, O’Malley said. That information is publicly available.”
And though The Globe reported that Boston Children’s Hospital had “declined to answer detailed questions about [Fenwick’s] lobbying efforts,” the paper wrote that a hospital spokesperson said, “[Fenwick’s] directorships are publicly disclosed in filings with the Securities and Exchange Commission.”
Fenwick retired from Boston Children’s Hospital in March 2021. The Globe noted that at that time her Teledoc Health stock, which was compensation for her board work, was worth $8.8 million. Additionally, she had been paid $2.7 million annually as CEO of Boston Children’s Hospital.
Avoiding Conflicts of Interest
Bad optics created by a Boston hospital CEO receiving seven-figure compensation for serving on the board of directors of a publicly traded company is not new. In July 2020, former Brigham and Women’s Hospital President Elizabeth Nabel, MD, resigned from the board of biotech company Moderna (NASDAQ:MRNA) “to alleviate any potential concern about the conduct or the outcome of the COVID-19 vaccine trial when Brigham and Women’s Hospital was identified by NIH as one of the clinical sites for the Phase 3 trial,” a Moderna press release states.
On March 1, 2021, Nabel also stepped down as Brigham and Women’s Hospital president. She then rejoined the Moderna board of directors on March 10, 2021, the press release noted.
In a STAT editorial, titled, “Hospital CEOs, Med School Leaders Shouldn’t Sit on For-Profit Health Care Company Boards,” endocrinologist and former Dean of Harvard Medical School Jeffrey Flier, MD, wrote, “As dean, I vigorously supported the value of robust interactions between faculty and industry to advance innovation and human health, and still do. In my current status as a professor of medicine at Harvard, I serve on several for-profit and not-for-profit boards. I learn from this work, and I believe I am making useful contributions as a board member. But I also believe that the considerations governing such relationships should be judged differently for institutional leaders.”
Flier maintains there are multiple reasons why hospital and medical school leaders should not sit on for-profit boards despite the expertise they bring to the table, including:
The time commitment required,
The “extraordinary compensation packages” they receive in their full-time jobs,
The potential for complicated “business intersections,” and
The risks to an “institution’s reputation for integrity.”
“I recommend that hospital CEOs and academic leaders at the level of Deans and Presidents devote their full attention to their well-compensated day jobs and defer positions on the boards of for-profit companies—and the unavoidable conflicts they raise—to the post-leadership phase of their careers,” Flier wrote.
While cozy relationships between hospital and academic medical center leaders and for-profit healthcare companies may not directly impact hospital pathologists and staff, it is worth staying aware of potential conflicts of interest.
Acceptance of digital pathology and whole-slide imaging is now almost universal among academic health center pathology departments and the nation’s largest pathology companies
Across the United States, many private practice anatomic pathology groups now recognize that digital pathology is the path forward for the entire profession. During the past decade, most academic pathology departments and large pathology lab companies have incorporated digital pathology (DP) and whole-slide imaging (WSI) into many of their labs’ daily activities.
However, in community hospital-based anatomic pathology groups, there have been barriers to even the partial adoption of digital pathology. The two biggest barriers are well-known and discussed frequently at conferences and in the literature.
Some Pathologists Reluctant to Give Up Light Microscopes
One recognized barrier to wider adoption of DP is the reluctance of many long-serving pathologists to give up their familiar light microscopes and glass slides so they can make the transition to reading pathology images on a computer screen. These pathologists remain loyal to the tools and workflows that have served them well throughout their careers.
They generally oppose their group’s move to digital pathology when the subject is discussed in partner meetings and strategic retreats. Since many pathology groups require 100% of partners or shareholders to approve major business decisions, even one recalcitrant and stubborn pathologist-partner can block the motion to adopt digital pathology that is supported by most partners.
The second barrier is the fully-loaded cost to acquire, validate, implement, and use a digital pathology system with whole-slide imaging. A full-featured scanner can cost $250,000 or more and acquiring all the software, systems, and tools needed by a group to fully incorporate digital pathology into daily workflow can easily total $500,000 to $1,000,000.
This substantial commitment of a pathology group’s capital can trigger the same intense debates as the original question of whether the pathologists in the group should adopt DP and WSI. And, not surprisingly, in most pathology groups the same dynamics come into play when votes are tallied on the motion for the pathology group to commit the funds necessary to acquire a digital pathology system, the scanners, and associated tools.
Just one or two partner holdouts can block the decision to spend the money, despite that most of the pathologist partners are ready to make the commitment.
More Community Pathology Groups Considering Digital Pathology
Yet, the momentum in favor of adopting DP and WSI continues to build. “Those pathology labs that are early adopters report multiple clinical and financial benefits. These can include generating positive financial outcomes—including the ability to attract new clients, increasing case referrals, and generating new sources of revenue to the group. In turn, the increased revenue can allow the group to increase pathologist compensation,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“We are in a time when health insurers are hammering away at the reimbursement paid to anatomic pathologists,” Michel continued. “Year after year, payers cut reimbursement for technical component and professional component services. They exclude many pathology groups from payer networks. That is why more community pathology groups are recognizing several important benefits with the use of DP and WSI that can increase a pathology group’s revenue and boost its pathologist compensation.
Community Pathology Groups Can Use Digital Pathology to Add Value
Equally important, there are specific ways that digital pathology and whole-slide imaging increase the value of the clinical services pathologists deliver to their client physicians. These dual benefits of DP are often overlooked—or not discussed—when community pathology groups conduct their annual retreats and debate the key points of when to adopt—and how to fund—a digital pathology system for their group. These benefits range from giving physicians a faster diagnostic answer on their cancer cases to helping the group’s subspecialist pathologists get more case referrals from physicians in other states.
“It’s important for all surgical pathologists to recognize several realities in today’s pathology marketplace,” Michel noted. “First, almost every sector in healthcare is digitizing itself. Reinforcing this trend is the federal government’s mandates for interoperability across EHRs, HISs, and LISs. Any private pathology group practice that lags in its adoption of digital capabilities and digital images will find itself falling farther and farther behind as physicians switch their case referrals to other pathology labs that have converted to digital pathology and whole-slide images.
“Second, pathology groups that adopt DP and WSI put themselves in a position to build market share in their service region, while at the same time increasing case referrals for their in-house subspecialist pathologists from throughout the United States,” Michel continued. “Also, when the histology is done locally, the local pathology group can deliver faster diagnostic answers and provide digital images as appropriate to referring physicians and hospitals in that region without the need to transport glass slides by couriers.
“Third—and this is an often-overlooked benefit of digital pathology—the local pathology group with DP and WSI can recruit today’s graduating pathology residents and fellows who have trained on DP and WSI. These new pathologists typically limit their job search to pathology groups that have gone digital,” Michel noted. “Millennial pathologists trained with digital images in their residency program. They are eager to work with the automated image analysis algorithms now coming to market.”
Recognizing the significant capital investment needed to acquire and deploy digital pathology and WSI, one goal of the webinar’s panel of experts is to identify ways that pathology groups can go digital on a budget. “We will do our best to identify different ways that pathology groups with limited financial resources can get into digital pathology,” said Keith Kaplan, MD, Chief Medical Officer at Corista in Concord, Mass., who will chair the upcoming webinar. “This may be the first public presentation where there is candid information about different financial strategies that your pathology group can utilize to acquire the scanners, the DP systems, and the associated tools needed for a full conversion to daily digital pathology.”
Don’t overlook how your participation in this webinar can be the foundation for helping your pathology group practice develop a timely, cost-effective path forward to introduce digital pathology and whole-slide imaging. Use of DP and WSI can become an important factor in helping your group offset payer prices cuts, develop new clients and sources of revenue, and increase pathologist compensation.
Click HERE to register today (or copy and paste this URL into your browser: https://www.darkdaily.com/webinar/adopting-digital-pathology-on-a-budget/). Make sure to have your pathology practice administrator and your histology manager join you for this important webinar.
In a letter, Congress urged the HHS Secretary to conduct “vigorous oversight and enforces full compliance with the final rule”
Analysis of more than 3,100 hospital websites by The Wall Street Journal (WSJ) has found “hundreds” containing embedded code that prevents search engines from displaying the hospitals’ prices. This is contrary to the Hospital Price Transparency Final Rule (84 FR 65524), passed in November 2019, which requires 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.
“Hundreds of hospitals embed code in their websites that prevented Alphabet Inc.’s Google and other search engines from displaying pages with the price lists,” the WSJ reported. “Among websites where [the WSJ] found the blocking code were those for some of the biggest US healthcare systems and some of the largest hospitals in cities including New York and Philadelphia.”
Additionally, the WSJ found hospitals were finding ways to “hide” the price lists they did display deep within their websites. The prices can be found, but the effort involves “clicking through multiple layers of pages,” on the providers’ websites, the WSJ added.
Lawmakers Put Pressure on CMS
The WSJ report drew the attention of federal lawmakers who weighed in on the current state of hospital price transparency and on the WSJ’s findings in a letter to Xavier Becerra, Secretary of the federal Department Health and Human Services (HHS).
In their letter, members of the Congressional Committee on Energy and Commerce called for HHS “to revisit its enforcement tools, including the amount of civil penalty, and to conduct regular audits of hospitals for compliance.”
Committee members wrote, “The Hospital Price Transparency Final Rule requires hospitals to make public a machine-readable file containing a list of all standard charges for all items and services and to display charges for the hospital’s 300 most ‘shoppable’ services in a consumer-friendly format. We are concerned about troubling reports of some hospitals either acting slowly to comply with the requirements of the final rule or not taking any action to date to comply.”
The letter, which was signed by the committee’s Chairman Frank Pallone (D, New Jersey) and Committee Ranking Member Cathy McMorris Rodgers (R, Washington State), cited the WSJ investigation as well as other analyses of price transparency at US hospitals.
Additional Studies Show Major Hospitals “Non-Compliant”
One such study cited by the Congressional committee in its letter to HHS was conducted by Health Affairs, which looked into transparency compliance at 100 hospitals. In a blog post, titled, “Low Compliance from Big Hospitals on CMS’s Hospital Price Transparency Rule,” the study authors wrote “our findings were not encouraging: Of the 100 hospitals in our sample, 65 were unambiguously noncompliant.
“Of these 65,” they added:
“12/65 (18%) did not post any files or provided links to searchable databases that were not downloadable.
“53/65 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges (n = 46) or were in some other way noncompliant (n = 7).
“We are troubled by the finding that 65 of the nation’s 100 largest hospitals are clearly noncompliant with this regulation. These hospitals are industry leaders and may be setting the industrywide standard for (non)compliance; moreover, our assessment strategy was purposefully conservative, and our estimate of 65% noncompliance is almost certainly an underestimate,” Health Affairs concluded.
A previous similar investigation by The Washington Post called compliance by hospitals with the pricing disclosure rules “spotty.”
So, why is complying with the federal price transparency rule so challenging for the nation’s largest hospitals? In its reporting on the Wall Street Journal analysis, Gizmodo wrote, “we’ve seen healthcare providers struggle to implement the new law due, in part, to how damn ambiguous it is. Past reports have pointed out that the vague requirements hoisted onto hospitals as part of these new rules often result in these pricing lists being difficult—if not downright—impossible to find, even if the lists are technically ‘machine-readable’ and ‘on the internet.’”
“Meanwhile,” Gizmodo continued, “as [the WSJ] points out, the order doesn’t specify exactly how much detail these hospitals are even supposed to offer on their pricing sheets—meaning that it’s up to the hospitals whether they want to include rates pertaining to specific health insurance plans, or whether they want to simply include different plan’s rates in aggregate.”
And in their letter to HHS, the Congressional committee wrote, “… some hospitals are providing consumers a price estimator tool instead of providing the full list of charges and payer-negotiated rates in one file, and some are making consumers fill out lengthy forms for estimates. Some hospitals also are providing the data in a non-useable format or failing to provide the codes for items and services.”
Clinical Laboratories Must Comply with Price Transparency Rules
Clearly, transparency in healthcare has a long way to go. Nevertheless, hospital medical laboratory leaders should expect reinforcing guidance from CMS on making price information on commonly used clinical laboratory tests fully accessible, understandable, and downloadable.
As Dark Daily noted in previous coverage, consumer demand for price transparency is only expected to increase. Clinical laboratories need to have a strategy and process for helping consumers and patients see test prices in advance of service.