The researchers also found unnecessarily confusing policies and procedures for requesting medical records, such as clinical laboratory test results
Clinical laboratories and anatomic pathology groups looking for ways to improve their customers’ experience should give high priority to ensuring patients have easy, accurate access to their own health records. This would, apparently, set them apart from many hospital health networks if a recent study conducted by Yale University School of Medicine is any indication.
Conducting their research from August 1 through December 7, 2017, Yale researchers evaluated the medical records processing policies of 83 top-ranked hospitals located across 29 states. They found that patients attempting to obtain copies of their own medical records from various hospitals often faced unnecessary and confusing hurdles. They also found serious noncompliance issues with regards to the HealthInsurance Portability and Accountability Act of 1996 (HIPAA).
Overwhelming Inconsistencies in Policies
and Procedures
“There were overwhelming inconsistencies in information relayed to patients regarding the personal health information [PHI] they are allowed to request, as well as the formats and costs of release, both within institutions and across institutions,” said Carolyn Lye, a medical student at the Yale School of Medicine and first author of the study, in a Yale News article. “We also found considerable noncompliance with state and federal regulations and recommendations with respect to the costs and processing times associated with providing access to medical records.”
The researchers collected release authorization forms from
the hospitals by calling each hospital’s medical records department. During the
simulated patient experience, they questioned the hospital policies regarding:
Requestable information (including entire
medical records, medical laboratory test results, medical history, discharge
summaries, physician orders, consultation reports);
Available release formats (pick up in person,
mail, fax, e-mail, CD, online patient portal);
Costs associated with obtaining the records;
and,
Processing times.
The team found inconsistencies between information provided
on written authorization forms and the simulated patient telephone calls, as
well as a lack of transparency.
On the paper forms, only 44 hospitals (53%) had an option
for patients to acquire their entire medical record. However, on the telephone
calls, all 83 of the surveyed hospitals provided that option.
The researchers also discovered discrepancies in the
information regarding the formats available for patient records. For example,
69 (83%) of the hospitals stated during the phone calls that patients could
pick up their records in person, while only 40 (48%) of the hospitals said patients
could do so on the written release forms. Fifty-five (66%) of the hospitals
told callers that medical records were available on CD and only 35 (42%) of the
hospitals provided that option on the written forms.
Similar discrepancies between information provided in phone
calls versus paper authorization forms were found relating to other formats
included in the study as well.
Excessive Fees Exceed
Federal Recommendations
Hospitals are allowed to charge a modest fee for the release
of medical records. But the researchers found quoted costs varied widely among
surveyed hospitals.
On the written authorization forms, only 29 (35%) of the
hospitals disclosed the exact costs associated with obtaining medical records.
The costs for a hypothetical 200-page record from these hospitals ranged from
$0.00 to $281.54. During the phone calls, 82 of the hospitals disclosed their
fees, with quotes for obtaining a 200-page record ranging from $0.00 to
$541.50.
The federal government, however, recommends charging
patients a flat fee of $6.50 to obtain electronically maintained medical
records. Forty-eight (59%) of the hospitals surveyed exceeded that charge.
Access Times Also Vary
The time hospitals needed to release patients’ medical
records also varied, ranging from same-day to 60 days—with electronic data
tending to be delivered fastest. Federal regulations require medical records to
be released within 30 days of the initial request, though HIPAA provides for an
additional 30-day extension. However, six of the 81 hospitals that provided
turn-around times to medical records requests were noncompliant with federal processing
time requirements.
Congress
passed HIPAA primarily to modernize the flow of healthcare information. An
important part of the Act was to make it easier for patients to receive their
medical records and clinical data from hospitals, medical offices, clinical
laboratories, etc. The Yale study, however, indicates that obtaining medical
records can still be a cumbersome and perplexing process for patients.
The United States Government has spent upwards of $30 billion since 2010 in incentives to encourage hospitals and physicians to implement and use electronic health record (EHR) systems. One goal of issuing these incentives was to make it easy and inexpensive to move patient data between providers to support improved clinical care, as reported by the Commonwealth Fund.
This
research demonstrates that the internal policies of some hospitals and health
systems are contrary to federal and state laws because patients are often
struggling to gain access to their own medical records. The results of the Yale
study present an opportunity for clinical laboratories and pathology groups to
adopt and offer patient-friendly access to obtain lab test data.
Even more compelling was the discovery of DNA from the Staph bacteria on the stethoscopes even after they were cleaned. Though the tests could not differentiate between live and dead bacteria, the researchers found other non-Staph bacteria as well, including Pseudomonas and Acinetobacter.
Similar conditions could no doubt be found in most
healthcare settings in America, highlighting the critical importance for
rigorous cleaning procedures and protocols.
The researchers acknowledged that previous culture-based bacterial
studies looked at stethoscopes, but noted the results fell short of the view
next-generation sequencing technology can offer for identifying bacteria, as
well as determining the effectiveness of cleaning chemicals and regiments.
“Culture-based studies, which focus on individual organisms,
have implicated stethoscopes as potential vectors of nosocomial bacterial
transmission [HAI]. However, the full bacterial communities that contaminate
in-use stethoscopes have not been investigated,” they wrote in Infection Control and Hospital Epidemiology.
• 20 worn by physicians, nurses, and respiratory therapists;
• 20 single patient-use disposable stethoscopes available in ICU patient rooms; and,
• 10 unused single-use disposable stethoscopes to serve as a control.
All stethoscopes worn and/or used in the ICU were found to be contaminated with abundant amounts of Staphylococcus DNA. “Definitive” amounts of Staph was found by researchers on 24 of 40 tested devices, noted MedPage Today.
“Genera relevant to healthcare-associated infections (HAIs)
were common on practitioner stethoscopes, among which Staphylococcus was ubiquitous
and had the highest relative abundance (6.8% to 14% of containment bacterial
sequences),” the researchers noted in their paper.
Cleaning Methods Also
Examined
The researchers also studied the hospital’s cleaning agents
and procedures:
• 10 practitioner stethoscopes were examined before and after a standard 60-second cleaning procedure using hydrogen peroxide wipes;
• 20 additional stethoscopes were assessed before and after cleaning by practitioners using alcohol wipes, hydrogen peroxide wipes, or bleach wipes.
All methods reduced bacteria. But not to the levels of a new
stethoscope, the study showed.
“Stethoscopes used in an ICU carry bacterial DNA reflecting complex microbial communities that include nosocomially important taxa. Commonly used cleaning practices reduce contamination but are only partially successful at modifying or eliminating these communities,” the researchers concluded in their paper.
Prior Studies to Find
and Track Dangerous Bacteria
Studies tracking bacteria where people live, work, and
travel are not new. For years, medical technologists and microbiologists have
roamed the halls of hospitals and other clinical settings to swab and culture
different surfaces and even articles of clothing. These efforts are often
associated with programs to reduce nosocomial infections (HAIs).
This new study by UPenn Perelman School of Medicine researchers—published
in a peer-reviewed medical journal—will hopefully serve as a contemporary
reminder to doctors and other caregivers of how bacteria can be transmitted and
the critical importance of cleanliness, not only of hands, but also
stethoscopes (and neckties).
Hospital-based medical laboratory leaders and microbiology professionals also can help by joining with their infection control colleagues to advocate for CDC-recommended disinfection and sterilization guidelines throughout their healthcare networks.
FDA cautions patients to not use data gained from the DTC test to make healthcare decisions on their own
Clinical laboratories continue to be impacted by the growing direct-to-consumer (DTC) testing market, as more walk-in lab customers order at-home tests. Now, the US Food and Drug Administration (FDA) has authorized a DTC test company to provide results of a pharmacogenetic (PGx) test to customers without needing a doctor’s order. This is the first genetic test of its kind to receive such FDA authorization and is in line with the government’s focus on precision medicine.
23andMe gained the authorization through the FDA’s de novo classification process, which the FDA uses to classify new devices that have no existing classification or comparabledevice on the market.
“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” said Anne Wojcicki, co-founder and CEO of 23andMe, in a news release. “Pharmacogenetic reports are an important category of information for consumers to get access to, and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”
However, some experts caution that informing patients
directly on how they metabolize medications based on genetic testing could
encourage them to bypass physicians and medical laboratories in the decision-making
process.
In a safety communication, the FDA alerted patients and
healthcare providers that “claims for many genetic tests to predict a patient’s
response to specific medications have not been reviewed by the FDA and may not
have the scientific or clinical evidence to support this use for most
medications. Changing drug treatment based on the results from such a genetic
test could lead to inappropriate treatment decisions and potentially serious
health consequences for the patient.”
PGx Supports
Precision Medicine
Pharmacogenetics (PGx) is the study of how genetic differences among individuals cause
varied responses to certain drugs. Demand for PGx testing has increased
exponentially as it becomes more valuable to consumers. It could provide a path
to precision medicine treatment plans based on each patient’s genetic traits. And
help determine which drug therapies and dosages may be optimal and which
medicines should be avoided.
“This test is a step forward in
making information about genetic variants available directly to consumers and
better inform their discussions with their healthcare providers,” Stenzel told FierceBiotech. “We know that consumers
are increasingly interested in genetic information to help make decisions about
their healthcare.”
The genes and their variants examined in the 23andMe PGx
test are:
Innovative hospital and health networks also are starting to
make PGx tests available in primary care settings.
Sanford Imagenetics, part of the Sanford Health system, has produced a $49 laboratory-developed test (LDT) for genetic screening known as the Sanford Chip to help physicians select the most advantageous therapies for their patients. It uses a small amount of blood to identify patients’ risk for certain genetic diseases and determine which medications would be best for them.
Sanford Health, headquartered in Sioux Falls, SD, is one of
the largest health systems in the US with 44 hospitals, 1,400 physicians, and
more than 200 senior care locations in 26 states and nine countries.
Geisinger Health, headquartered in Danville, PA, has initiated a pilot project based on PGx testing. The genetic sequencing data from 2,500 patients will be reviewed to determine if they are taking the best medication for their health conditions. Patients in need of changes to their prescriptions will be contacted by Geisinger pharmacists for recommendations.
As consumer demand for PGx testing increases, DTC customers will
likely continue seeking new information about their genome. Clinical
laboratories could play a role in interpreting that data and assisting
pathologists and other healthcare providers determine the best drug therapies
for optimal health outcomes.
Experts blame insurance regulators for not ensuring the adequacy of healthcare networks that include hospital-based physicians, such as pathologists and radiologists
According to a recent study, clinical laboratories, anatomic pathologists, radiologists, and anesthesiologists top the list of providers who bill patients for the difference between what they charge for their services and a hospital’s contracted reimbursement rates.
This so-called “balance-billing” not only causes hardship for patients and consumers already shouldering a larger portion of their healthcare costs, but poses a public relations concern for service providers across the US healthcare industry as well.
Following public outcry from patients who received care at
what they believed to be in-network medical facilities, only then to be surprised
by bills from their care providers for the remaining balance not covered by
their insurance, the practice of balance billing has drawn increased scrutiny from
state and federal officials.
Medical Laboratory
Charges Top Reason for Surprise Bills
In their report, NORC notes that of those surveyed, 57% (567 individuals) acknowledged receiving a surprise medical bill they thought would be covered by their health insurance.
When asked about the network status of the doctor who
provided care during the episode related to the surprise bill, 79% responded
that charges were not for doctors being out-of-network for their insurance
plan. Medical laboratory-related charges were near the top of reasons patients
received surprise bills, with 51% of individuals receiving bills related to “a
laboratory test, like a blood test.”
Such surprise medical bills received frequent coverage in
2018. This has led many states to enact or discuss legislation to address the
practice and offer cost protections for patients.
Thus far, however, little change to existing regulations and
contract systems has been enacted to protect patients or help laboratories and
other service providers offer alternative payment solutions for patients.
There also are few requirements for insurance providers to verify
that plans include sufficient numbers of in-network service providers when
offering plans to consumers.
States Move to Change
Trends While Patients Continue to Experience Bill Shock
States are beginning to address surprise billing concerns ahead of action by insurance regulators and the federal government. In December, the Arizona Department of Insurance issued a news release outlining the agency’s plan to allow for arbitration questions for surprise out-of-network bills.
And, California effectively banned out-of-network billing from groups within in-network facilities in 2017 with Assembly Bill 72. However, the state only finalized reimbursement rates for service providers and patients affected by surprise bills in January of this year according to Capital Public Radio.
Many of these state-level regulations do not account for the complexity of creating rules based on emergency or non-emergency care or the insurance providers in question. For example, Assembly Bill 72 does not apply to “Medicare, Medi-Cal, out-of-state plans, self-insured employer plans, or other products regulated by federal law,” according to a news release from the California Society of Anesthesiologists.
Finding Fair
Solutions for Both Patients and Care Providers
Speaking with Kaiser Health News about a report of a man in Texas receiving a $109,000 surprise bill related to treatment after a heart attack, Rep. Lloyd Doggett of Texas said, “This is a nationwide problem, and we need a nationwide solution. We have a system where the patient, the most vulnerable person of all those involved, is caught between the insurer and the healthcare provider … these problems are solvable.”
Modern Healthcarerecently covered how some hospitals are now requiring physicians to go in-network as a provision of their contracts. However, they also note this approach disadvantages physicians and shifts reimbursement negotiation power to insurers. Should hospitals take a similar approach with medical laboratory specialists, it could create similar concerns.
While surprise medical bills create added hardship for
patients and pose reputational and reimbursement concerns for clinical laboratories
and healthcare providers, creating regulations that establish effective
protections while also protecting the financials of service providers continues
to prove difficult.
Speaking with Modern Healthcare, Dan Sacco, Vice President for Strategic Affairs and Payer Relations at Boca Raton Regional Hospital, summarized concerns concisely, saying, “We’re trying to protect [consumers], but we’re also trying to be reasonable business partners as well.”
Popularity of Medicare Advantage Plans fuels influx of new companies into the marketplace with anticipated enrollment of more than 22.6 million beneficiaries, or more than one-third of Medicare-eligible consumers
Continuing enrollment growth in Medicare Advantage plans is expected in 2019 and beyond. The projections are for double-digit percentage increases in Medicare Advantage enrollees. This is not auspicious for clinical laboratories and anatomic pathology groups because it means a shrinking proportion of Medicare beneficiaries remain in the Part B program.
Whereas any medical laboratory can provide services for any Medicare Part B beneficiary, that is not true for beneficiaries enrolled in Medicare Advantage plans. That’s because private health insurers operating Medicare Advantage plans typically contract with national lab companies while narrowing their lab networks, thereby limiting access to these patients by independent community laboratories, hospital lab outreach programs, and pathology groups.
Enrollment in Medicare Advantage is expected to reach record totals in 2019. More than 22.6 million new Medicare beneficiaries are anticipated, with 14 new private companies offering plans, Kaiser Health News (KHN) reports. As enrollment shifts from traditional Medicare to Medicare Advantage the health of regional clinical laboratories can suffer, as smaller labs lose access to beneficiaries.
Enrollment in
Medicare Advantage Plans Increases, Despite Cut in Funding
Because Medicare Advantage penetration varies across counties and states, some local laboratories may experience less of an impact from the growing popularity of Medicare Advantage plans than others. According to the Kaiser Family Foundation (KFF), Medicare Advantage plans attract less than 11% of eligible beneficiaries in Arkansas, Vermont and Wyoming. However, more than 41% of Medicare participants in Florida, Hawaii, Minnesota, and Oregon choose Medicare private health plans over Medicare Part B.
Although the Patient Protection and Affordable Care Act (ACA) cut federal funding to Medicare Advantage plans, the 2010 law ultimately did not cause insurers to exit states or leave the business altogether, as was predicted. Instead, enrollment in Medicare Advantage doubled to more than 22.6 million enrollees, growing from a quarter of Medicare beneficiaries to more than a third, between 2010 and 2019, KHN reported.
Bonus payments from the federal government to Medicare
Advantage plans that have quality ratings of four or more stars (on a one to five
scale) helped fuel the growth. Plans without ratings also are eligible for
bonus payments, which must be used to reduce cost-sharing or premiums or to
provide extra benefits.
“The Affordable Care Act did not kill Medicare Advantage, and the program looks poised to continue to grow quite rapidly,” Bill Frack, Managing Director with healthcare advisor L.E.K. Consulting, told KHN.
In total, 2,734 Medicare Advantage plans will be available nationwide to consumers in 2019, an 18% increase from 2018 (417 more plans). That’s the largest number available since 2009, KFF announced late last year in a report on the program’s growth. These numbers exclude employer or union-sponsored group plans and Special Needs Plans, which are only available to select populations.
The average Medicare beneficiary has access to 24 Medicare
Advantage plans in 2019, an increase from 21 last year and 19 from 2016-2017.
Profits Increase
While Premiums Decline
Medicare Advantage plans are attractive to seniors because
premiums, deductibles, and cost sharing typically are lower than government-run
Medicare Part B and because many plans include additional benefits such as vision,
dental, and prescription drug coverage and fitness programs.
In a press release, the Centers for Medicare and Medicaid Services (CMS) noted that the Medicare Advantage average monthly premium has continued to steadily decline, recording an estimated 6% drop in 2019 to $28, from an average of $29.81 in 2018. Nearly 83% of Medicare Advantage enrollees remaining in their current plan will have the same or lower premium in 2019. Approximately 46% of enrollees in their current plan will have a zero premium.
Declining premiums, however, have not meant reduced profits
for Medicare Advantage plan administrators. Healthcare Finance recently reported
that UnitedHealth Group’s third-quarter earnings from operations grew $502
million, or 12.3%, year-over-year to $4.6 billion, with growth in the insurer’s
Medicare Advantage business claiming most of the credit for the higher numbers.
UnitedHealthcare’s Medicare Advantage plans served 525,000
more consumers year-over-year, with the purchase of a physician-owned Medicare
Advantage organization in Louisiana accounting for 65,000 of the total.
“These results reflect our businesses delivering increased value at an accelerating pace to society and the millions of people we serve—one person at a time,” David S. Wichmann, CEO of UnitedHealth Group, told Healthcare Finance.
While Medicare Advantage plan growth may be good news for insurers,
the outlook for anatomic pathology groups and medical laboratories is less
rosy. The proportion of Medicare beneficiaries enrolled in the Part B program
shrinks steadily. Meanwhile, payers’ increased reliance on narrow networks as a
way to rein in rising costs excludes many regional laboratories. Ultimately,
these developments threaten many in the clinical laboratory industry, not just
smaller laboratories, and underline the need for pathologists and clinical
laboratory managers to add recognized value to the medical testing services
they provide in their communities.
All labs face the challenge of coping with shrinking budgets and staffing shortages, which is why coaching, management observation, and continuous improvement initiatives are proving helpful to medical laboratories
It’s the biggest generational shift since baby boomers began working in clinical laboratories and anatomic pathology groups. Across the nation, labs are watching their most experienced and knowledgeable medical technologists and other lab scientists retire. The need to train their replacements while maintaining peak productivity and controlling costs is motivating lab leaders to adopt powerful new management methods.
Innovative lab administrators and pathologists recognize that automation and the ability to leverage the increasing amounts of data produced by today’s innovative diagnostic technologies and assays can only go so far in helping to compensate for declining revenues.
This is why one trend is quietly gaining momentum. There are many medical laboratories, pathology groups, and other diagnostics providers working to help their lab staffs create a culture of continuous, meaningful improvement. The stakes are great. Not only is this essential for financial sustainability, it can be the source of competitive advantage with physicians, patients, and payers in today’s increasingly competitive diagnostic market.
This is why many medical laboratories are turning to continuous improvement systems such as Lean to increase personnel skills, reduce waste, and make the most out of shrinking budgets and margins. Yet, without a solid foundation of staff trained in these methods and a framework of processes to encourage improvement, lean laboratory managers often struggle to see consistent, significant improvements.
Optimizing Staff Performance and Developing Improvement Processes with Coaching and Management Observation
Performance Coaching and Management Observation offer powerful tools for laboratory managers to reinforce improvement efforts. They encourage the success of personnel, leverage existing personnel to meet growing demands while maintaining service levels, and establish an effective foundation for Lean execution.
Benefits of effective coaching and management observation sessions for laboratories include:
Enhancement of laboratory manager performance and skills;
Improved retention of skilled labor and consistent improvement of personnel skills through individualized assessment and improved communication;
Establishing a method of creating and maintaining a culture of continuous improvement, while empowering staff across all levels of lab operations; and,
Creating a competitive edge on laboratories struggling to implement Lean processes and other optimizations in response to increased workloads, reduced staff, and tighter budgets.
Stephen Stone (left), Managing Director, Argent Global Services, and, Rita D’Angelo, PhD (right), President and CEO, D’Angelo Advantage, spoke at Lab Quality Confab in 2018 on the benefits of coaching and management observation sessions for clinical laboratories and implementing continuous improvement systems using Lean Production Methods. (Photo copyright: Dark Daily.)
“While many laboratories are familiar with management observation because of competency testing, few laboratories use coaching and management observation as part of their Lean efforts.” Stephen Stone, Managing Director at Argent Global Services told Dark Daily. “Coaching and management observation offers laboratories an effective means to not only increase throughput using existing staffing and encourage sustainable growth, but also increase retention of existing skilled personnel and reduce hiring costs.”
Speaking at Lab Quality Confab in Oct. 2018, Stone highlighted why these later benefits are increasingly important to laboratories. Citing data from LabTestingMatters and the American Society for Clinical Pathology (ASCP), he reported that while the job market for medical technologist and laboratory technician openings should increase by roughly 11,300 openings in 2018, fewer than 5,000 individuals are graduating each year from accredited training programs.
Lab Supervisor Retirements Projected to Exceed Staff Retirements
Of possibly greater concern, he goes on to point out, is that projected retirement rates for supervisors are higher than those of staff. This means laboratories which fail to focus on staff development and retention could face further issues in both leadership and staffing shortages should trends continue.
“Investing in and empowering your staff will improve productivity, improve quality, improve safety, and help laboratories to work toward goals as a cohesive team,” Rita D’Angelo, PhD, President and CEO at D’Angelo Advantage, LLC, told Dark Daily. “As a result, costs and waste drop significantly. Coaching and management observation alongside a culture of continuous improvement can help labs to overcome many of the staffing and budget obstacles faced today.”
The webinar will include essential coaching skills to help laboratory managers pass on the skills to serve as Lean champions to personnel and establish the foundation and structure for a lasting culture of improvement within the laboratory.
C-Level laboratory leadership, laboratory directors, managers and supervisors, and key members of continuous improvement teams also can use the interactive Q/A session following the webinar to gain answers to questions and concerns directly facing their laboratories’ efforts to develop continuous improvement processes or implement Lean methodologies.
(To register for this critical Jan. 16th webinar, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/performance-coaching-and-management-observations-to-improve-productivity-and-efficiency-strengthening-the-skills-of-management-to-execute-a-lean-lab-transformation-2-2/.)