New guidelines also advise people to limit their vitamin D supplementation to recommended daily doses
Clinical laboratories may eventually receive fewer doctors’ orders for vitamin D testing thanks to new guidelines released by the Endocrine Society. The new Clinical Practice Guideline advises against “unnecessary testing for vitamin D levels.” It also urges healthy people, and those 75-years of age or younger, to avoid taking the vitamin at levels above the daily recommended amounts, according to a news release.
Even though the Endocrine Society does recommend vitamin D supplements for certain groups, it advises individuals to hold off on routine testing. That’s because there appears to be uncertainty among ordering clinicians about what to do for patients based on their vitamin D test results.
“When clinicians measure vitamin D, they’re forced to decide what to do about it. That’s where questions about the levels come in. And that’s a big problem. So, what this panel is saying is ‘Don’t screen,’” Clifford Rosen, MD, Director of Clinical and Translational Research and Senior Scientist, Maine Medical Center Research Institute at the University of Maine, told Medscape Medical News.
“We have no data that there’s anything about screening that allows us to improve quality of life. Screening is probably not worthwhile in any age group,” he added.
“This guideline refers to people who are otherwise healthy, and there’s no clear indication for vitamin D, such as people with already established osteoporosis. This guideline is not relevant to them,” the author of the Endocrine Society guideline, Anastassios G. Pittas, MD (above), Professor of Medicine at Tufts University School of Medicine in Boston, told Medscape Medical News. This new guideline could result in doctors ordering fewer vitamin D tests from clinical laboratories. (Photo copyright: Tufts University.)
Vitamin D Screening Not Recommended for Certain Groups
The Endocrine Society’s new clinical guidelines advise healthy adults under 75 years of age to refrain from taking vitamin D supplements that exceed US Institute of Medicine—now the National Academy of Medicine (NAM)—recommendations.
Additionally, these updated guidelines:
Recommend vitamin D supplements at levels above NAM recommendations to help lower risks faced by children 18 years and younger, adults 75 and older, pregnant women, and people with prediabetes.
Suggest daily, lower-dose vitamin D (instead of non-daily, higher-dose of the vitamin) for people 50 years and older who have “indications for vitamin D supplementation or treatment.”
Advise “against routine testing for 25-hydroxyvitamin D [aka, calcifediol] levels” in all the above groups “since outcome-specific benefits based on these levels have not been identified. This includes 25-hyrdoxyvitamin D screening in people with dark complexion or obesity.”
One exception to the guideline applies to people with already established osteoporosis, according to the guideline’s author endocrinologist Anastassios G. Pittas, MD, Chief of Endocrinology, Diabetes and Metabolism; Co-Director, Tuft’s Diabetes and Lipid Center; and Professor of Medicine at Tufts University School of Medicine in Boston.
Vitamin D’s Link to Disease Studied
During a panel discussion at the Endocrine Society’s annual meeting, members acknowledged that many studies have shown relationships between serum concentrations of 25-hydroxy vitamin D (25(OH)D) and physical disorders including those of musculoskeletal, metabolic, and cardiovascular systems. Still, they questioned the link of vitamin D supplementation and testing with disease prevention.
“There is paucity of data regarding definition of optimal levels and optimal intake of vitamin D for preventing specific diseases. … What we really need are large-scale clinical trials and biomarkers so we can predict disease outcome before it happens,” said Panel Chair Marie Demay, MD, Endocrinologist, Massachusetts General Hospital, and Professor of Medicine, Harvard Medical School, Boston, Medscape Medical News reported.
Meanwhile, in their Journal of Clinical Endocrinology and Metabolism paper, the researchers note that use of supplements (1,000 IU or more per day) increased from 0.3% to 18.2%, according to the National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics (NCHS), CDC, for the years 1999-2000 and 2013-2014.
“The use of 25(OH)D testing in clinical practice has also been increasing; however, the cost effectiveness of widespread testing has been questioned, especially given the uncertainty surrounding the optimal level of 25(OH)D required to prevent disease,” the authors wrote.
“Thus, the panel suggests against routine 25(OH)D testing in all populations considered,” the researchers stated at the Endocrine Society annual meeting.
Other Groups Weigh-in on Vitamin D Testing
Pathologists and medical laboratory leaders may recall the explosion in vitamin D testing starting about 20 years ago. Vitamin D testing reimbursed by Medicare Part B “increased 83-fold” during the years 2000 to 2010, according to data cited in an analysis by the American Academy of Family Physicians (AAFP).
Also, the US Preventive Services Task Force (USPSTF) said in a statement that there is not enough information to “recommend for or against” testing for vitamin D deficiency.
“No organization recommends population-based screening for vitamin D deficiency, and the American Society for Clinical Pathology recommends against it,” the USPSTF noted.
Clinical Laboratories Can Get the Word Out
The vitamin D debate has been going on for a while. And the latest guidance from the Endocrine Society may cause physicians and patients to stop ordering vitamin D tests as part of annual physicals or in routine screenings.
Medical laboratories can provide value by ensuring physicians and patients have the latest information about vitamin D test orders, reports, and interpretation.
Survey shows more than 50% of hospitals and health systems plan to increase virtual care services within two years, a development that can change how patients access clinical laboratory testing services
If anything positive came out of the COVID-19 pandemic, it’s the growing acceptance by physicians and health payers of telehealth—including telepathology, teleradiology, and other types of virtual doctor visits—as a way for patients to meet with their physicians in place of in-office healthcare.
In earlier coverage about the rapid adoption of telehealth and virtual doctor visits, Dark Daily has observed that this trend creates a unique challenge for clinical laboratories. If the patient has a virtual consultation with his or her physician, how would a clinical laboratory get access to this patient to do a venipuncture and collect the samples necessary to perform the medical laboratory tests ordered by the physician?
Nevertheless, according to multiple reports, healthcare providers are planning to increase investment in telehealth technologies.
Disparate Technologies Led to Technical Difficulties for Virtual Healthcare Providers
The terms telemedicine and telehealth are often used interchangeably. However, according to the American Academy of Family Physicians (AAFP), there are subtle differences worth noting.
Telehealth is a broad term which refers to “electronic and telecommunications technologies and services used to provide care and services at-a-distance [while] telemedicine is the practice of medicine using technology to deliver care at a distance.
“Telehealth is different from telemedicine in that it refers to a broader scope of remote health care services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services,” the AAFP notes.
Kelly Lewis, former Vice President of Revenue Strategy and Enablement at telehealth provider Amwell, told Healthcare IT News (HIT News) that “the COVID-19 pandemic caused telehealth adoption to skyrocket.
However, “Because much of this adoption was driven out of an abundance of necessity, there was little time for organizations to think strategically about their technology investments,” she added.
“With urgency at a high, payers, provider organizations and clinicians all turned to the quickest options available so patients could continue to get care. The result, however, was what we are calling platform ‘sprawl’—the use of a number of disparate solutions that are leading to a confusing and frustrating care delivery system and experience.”
Nevertheless, according to a survey conducted by HIT News and HIMSS Analytics, “More than half (56%) of hospital and health system leaders say they are planning to increase their investment in telemedicine during the next two years.” This, “shows that the huge surge in and mainstreaming of telehealth during the ongoing pandemic has caused the C-suite and other healthcare leaders to embrace the technology that has for so long existed on the periphery of medicine,” HIT News noted.
“The clear message is that telehealth is here to stay and will continue to expand,” Lewis told HIT News, adding, “The majority of payers without virtual care offerings also reported planning to add them in the next 24 months.”
“Clinicians agree that moving toward a fully integrated telehealth platform would be beneficial. More than 80% believe investing in a fully integrated virtual or hybrid care system would have a positive impact on clinical outcomes and patient experiences,” Kelly Lewis (above), former VP at telehealth provider Amwell, told Healthcare IT News. Considering the growing demand for telehealth, pathologists and clinical laboratories will need a strategy for supporting virtual healthcare providers. (Photo copyright: Healthcare IT News.)
The HIT News/HIMSS Analytics survey findings suggest telehealth will transition as providers aim for “smart-growth” instead of “pandemic-fueled expediency,” Becker’s Hospital Review reported.
Survey respondents expressed positive attitudes about telehealth:
56% of healthcare leaders plan to increase investment in virtual care over the next two years.
80% of respondents noted “very” or “extremely” important telehealth factors are integrating with existing workflows, fast video connections, and reducing administrative burden.
77% called telehealth platform integration with the electronic health record (EHR) “very” or “extremely” important.
80% envision positive clinical outcomes and patient experiences from a fully integrated telemedicine platform.
75% of payers said a single digital platform has potential to streamline member experiences.
“With telehealth visits stabilizing at roughly 10 times pre-pandemic levels, digital transformation initiatives are rising across the field. As a result of the pandemic, 60% of healthcare organizations are adding new digital projects, with telemedicine becoming a higher priority for 75% of executives (vs. 42% in 2019) to improve the patient experience,” the AHA reported.
Medical laboratories and anatomic pathology groups are advised to keep pace with the changing healthcare landscape which increasingly puts a premium on remote and virtual visits. This has become even more critical as healthcare providers and investors infuse more capital into telehealth technology.
As physicians expand telemedicine virtual office visits post-pandemic, a clinical laboratory strategy to reach patients and acquire specimens will be required.
Research conducted by Kalorama suggests the popularity of retail clinics represents a trend towards newer healthcare models that challenge existing models of care, and which could severely impact hospitals, clinical laboratories, and pathology groups
In recent years, pathologists and medical laboratory managers have watched as retail clinics housed in drug and grocery stores became a go-to service for healthcare customers seeking relief from minor illnesses. However, to market research company Kalorama, retail clinics also are a “game-changer” that could pose a threat to healthcare providers if their growth remains unchecked.
At risk are health systems and office-based physicians, along with the clinical laboratories and pathology groups that serve them. This would happen if patients shy away from primary care doctors in favor of cheaper, faster, medical care. However, as retail clinics expand the services they provide, they also could become an important source of orders for certain types of medical laboratory tests.
Kalorama defines retail clinics as, “healthcare centers that provide basic and preventative care in a retail setting; excluded are crisis and acute care centers; urgent care centers; emergency facilities; and wellness centers.” According to Kalorama’s data, “in 2016, total US retail clinic sales are estimated at more than $1.4 billion, an increase of 20.3% per year from $518 million in 2010.”
This increased use of retail clinics is a mixed blessing. On one hand, easy accessibility, low-wait times, and flexibility combined with lower costs for basic care is a boon for certain patients. On the other hand, this emergent healthcare model requires that traditional healthcare facilities address the impact of retail clinics on traditional practices, patient care, and regulatory standards.
Here are five reasons why retail clinics could threaten traditional healthcare models:
Retail Clinics Disrupt the Normal Healthcare Delivery Environment
Retail clinics are designed for immediate treatment of symptoms and vaccinations, not in-depth examination or long-term healthcare relationships between physician and patient. However, because retail clinics are a convenient low-cost option for patients, they become direct competition for full-service. Why visit a primary care physician (PCP) when you can receive off-hour care at lower prices and with faster wait times?
Based on data from peer-reviewed journal Mayo Clinic Proceedings, the graph above illustrates the huge growth of retail clinics over just the past 10 years, which is expected to continue. (Image copyright: Accenture Consulting.)
There is a rising fear among PCPs that the quick fix of retail clinic services will translate into poorer overall health for patients who fail to establish permanent long-term healthcare connections. This fear is validated by an American Medical Association (AMA) report that states, “only 39% of retail clinic users report having an established relationship with a primary care physician, which contrasts to about 80% of the general population reporting such a relationship.”
Retail Clinics Increase Competition for Primary Care Practices
Rather than competing with emergency departments, retail clinics directly compete with primary care clinics, according to Kalorama and the AMA. Staffed primarily by nurse practitioners and physician assistants, retail clinics treat symptoms of acute and easily identifiable health issues. There is growing concern that this limits opportunity for patients to receive more comprehensive healthcare that includes identification and treatment of chronic diseases.
And though competition in the healthcare market is good, physicians worry that retail clinics may push smaller stand-alone clinics out of business. The Kalorama report explains that “ultimately, medical practices are businesses that rely upon a steady flow of [patients] for their success.” When primary care facilities close due to loss of patients, it can create immediate healthcare gaps in communities.
Retail Clinics Could Increase Strain on Medical Laboratories and Pathology Groups
Kalorama’s data shows that retail clinics could place strain on medical laboratories and pathology practices. The study notes, “retail clinics are becoming relatively large users of point-of-care (POC) tests, clinical chemistry, and immunoassay laboratory tests and vaccines.” Kalorama’s report states, “the combined sales of these three types of products to retail clinics reached $240 million” in 2015, reflecting a 26% per year growth in testing since 2010. Projections from Kalorama suggest further increases in retail clinic test ordering in years to come.
The COLA newsletter also warns that pathologists and clinical laboratory managers “should expect to see, over time, a steady increase in the menu of diagnostic testing offered by retail clinics.” COLA suggests that pathologists and laboratory scientists will experience increased demand from retail clinics for their services and expertise, but that because retail clinics often require high-volume, fast-paced testing without the benefit of full clinical laboratories (both in terms of staff and equipment) there is potential for retail clinic testing to fall short of industry standards.
Retail Clinics Fragment Health Records
According to an article in AMA Wire, the AMA House of Delegates (HOD) established guidelines for retail clinics that focus on continuity of medical records and the safeguarding of patient care. The guidelines state that retail clinics “must produce patient visit summaries that are transferred to the appropriate physicians and other healthcare providers in a meaningful format that prominently highlights salient patient information.” The fear, according to the AMA, is that the fragmenting of medical records may bring harm to patients via miscommunication that undermines patient-physician relationships and complicates oversight in treatment plans.
The Kalorama report echoes this sentiment. It states that physicians often take a negative view of retail clinics because of the lack of communication between retail clinics and primary care practices, citing a lack of cooperation or “unwillingness or inability on the part of convenience clinics to share medical information about patients with primary care providers.”
Retail Clinics Are Expanding Their Reach
Despite the fact that the AMA Council on Medical Services 2017 report on delivery reform recommends that retail clinics limit the scope of their care, expansion of retail clinic services has gone unchecked in many areas according to the Kalorama report. AMA policy states that retail clinics must have a “well-defined and limited scope of clinical services,” and the AMA’s 2017 guidelines state that “retail health clinics should neither expand their scope of services beyond minor acute illnesses … nor expand their scope of services to include infusions or injections.”
As retail clinics open around the country and expand their offerings there is a call for increased regulation of retail clinics to check that growth. COLA states that retail clinics are positioning themselves to play a major role in the delivery of primary care services. And the Kalorama report suggests that the trend towards retail clinic use will continue to rise, creating both challenges and opportunities for providers, clinical laboratories, pathologists, and healthcare policy makers who will be required to address the disruption to their businesses.
Growth in the number of medical homes could make winners of those pathology groups and medical laboratories that learn how to best meet the needs of these providers
Physician executives at TransforMED, a wholly-owned subsidiary of the American Academy of Family Physicians, are blogging with their opinions about which providers will be winners and losers in healthcare. Although most pathologists may not agree with these opinions, there are useful insights to be gleaned from the reasoning behind these opinions.
According to TransforMed’s physician-leaders, healthcare is not about to transform—it already has! The healthcare world is no longer changing, it has changed, and “there will be winners and losers,” stated Terry McGeeney, M.D., MBA, FAAFP, in a blog published on the TransforMed Website. (more…)
Clinical laboratory managers and pathologists have an opportunity to expand the presence of laboratory medicine
IBM (NYSE: IBM) recently issued a press release announcing its new Watson Healthcare Advisory Board (WHAB). The board is comprised of healthcare leaders with a broad range of research, medical and business expertise. Unfortunately, that expertise does not include pathology or specialists in laboratory medicine.
“Watson represents a technology breakthrough that can help physicians improve patient outcomes,” said Herbert Chase, M.D., Professor of Clinical Medicine (in Biomedical Informatics) at Columbia University, in a recent IBM press release. “As IBM focuses its efforts on key areas including oncology, cardiology and other chronic diseases, the advisory board will be integral to helping align the business strategy to the specific needs of the industry.” (more…)
