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Clinical Laboratories and Pathology Groups

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Demographic Shift Means Lower Birthrates and Aging Populations around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories

Demographic shifts are most acute in Europe and East Asia but could be a harbinger of things to come for US healthcare as well

Across the globe, major shifts in many countries’ demographics are starting to drive notable changes in how healthcare is delivered in these nations. Having fewer pediatric patients and more senior citizens is fundamentally altering what types of tests are in greatest demand from the medical laboratories in these countries. It is the population trend writ large on a global scale.

For example, in countries as diverse as Sweden, Hungary, Japan, and South Korea, birthrates are declining as fewer young people decide to have kids, or they choose to have smaller families. Thus, demand for pediatric care is declining in those countries.

Meanwhile, populations around the world continue to age as greater numbers of people reach their retirement years. Not only does this create the need to expand medical services designed to serve the elderly, but there are important economic consequences. That’s because each wave of retirees leaves fewer people in the workforce to support the healthcare of ever-growing numbers of senior citizens.

According to The New York Times (NYT), this trend is likely to accelerate. In “Long Slide Looms for World Population, with Sweeping Ramifications,” the paper reported that “All over the world, countries are confronting population stagnation and a fertility bust, a dizzying reversal unmatched in recorded history that will make first-birthday parties a rarer sight than funerals, and empty homes a common eyesore.”

The NYT added that, “With fewer births, fewer girls grow up to have children, and if they have smaller families than their parents did—which is happening in dozens of countries—the drop starts to look like a rock thrown off a cliff.”

In countries such as the US, Canada, and Australia, this is partially mitigated by immigration, the NYT reports. However, some nations, such as Germany and South Korea, have instituted programs aimed at boosting birthrates, though with varying degrees of success.

According to demographer Frank Swiaczny, Dr. rer. nat., Senior Research Fellow at the Federal Institute for Population Research in Germany, countries around the world—especially in Europe and East Asia—“need to learn to live with and adapt to decline.”

“A paradigm shift is necessary,” he told the NYT.

An Aging Nation

The graphic above, taken from the US Census Bureau’s 2018 report, “The Graying of America: More Older Adults than Kids by 2035,” illustrates the rate at which America’s elder population is catching up with the rest of the world. It will soon exceed younger portions of the population, thus shifting demand for healthcare from pediatrics to geriatrics. Anatomic pathology groups and clinical laboratories will be impacted by this trend. (Graphic copyright: US Census Bureau.)

Elder Population Growth: Academics Take Notice

Healthcare scholars also have been looking at the topic of demographic shift. A recent commentary in Health Affairs, titled “Actualizing Better Health and Health Care for Older Adults,” focused on the policy implications for senior care.

The authors, which included Terry Fulmer PhD, RN, FAAN, and John Auerbach, Director of Intergovernmental and Strategic Affairs at the CDC, noted that in 2018, adults 65 or older were 15.6% of the population. This will rise to 20% by 2030, when, according to the authors, seniors will outnumber the portion of the population that is younger than age five.

Fulmer is President of the John A. Hartford Foundation, which is dedicated to improving care for older adults, and until May, Auerbach was President and CEO of Trust for America’s Health (TFAH).

They recommended six broad policy goals:

  • Foster an “expanded and better-trained workforce” to care for older adults, through enhanced training as well as “scholarships, loan forgiveness, and clinical internships.”
  • Adapt the public health system to account more for the needs of an aging population, such as by “improved coordination and collaboration with Area Agencies on Aging and key healthcare providers.”
  • Address disparities and inequities in healthcare access, such as social isolation “caused or exacerbated by social, economic, and environmental conditions.”
  • Facilitate advances in telehealth and other technologies to improve care delivery. “The lack of access to technology, low digital health literacy, and design barriers in patient portals and apps have disproportionately affected older adults, especially those in underserved communities,” the authors wrote.
  • Improve palliative and end-of-life care. “Many older adults are living with serious illness,” the authors wrote, and “most will live for years with their illnesses, resulting in a high burden of physical and psychological distress, functional dependence, poor quality of life, high acute care use, loss of savings, and caregiver distress.”
  • Reform long-term care, by improving conditions in long-term care facilities and making it easier for older adults to stay at home.

The authors also urged a move away from “traditional fee-for-service Medicare” through “policy changes such as bundled, capitated, and other value-based payments.”

A perspective in the journal NPJ Urban Sustainability, titled “Ageing and Population Shrinking: Implications for Sustainability in the Urban Century,” notes that these trends have led some cities or countries to adopt technological innovations in healthcare, such as “socially assistive robots and virtual entertainment for mental health, roadside AI services for healthcare, and a series of innovations for house-based healthcare, digital nursing, and monitoring.”

Aging population of Italy vs. Nigeria

The graphic above, taken from PopulationPyramid.net, illustrates the stark differences in the age of populations in two countries at opposite ends of the progressing demographic shift. Italy’s population pyramid (left) shows how the senior population makes up a substantial proportion of total population, while Nigeria’s 2030 population pyramid (right) shows the classic pyramid of a wide base of younger people trailing off to a small number of the elderly at the top of the pyramid. Medical laboratories in those nations will continue to be affected by how these demographic shifts taking place worldwide are changing the type of healthcare in highest demand. (Graphic copyright: PopulationPyramid.net.)

Impact on Pediatrics

At the other end of the age spectrum, a recent presentation from the American Academy of Pediatrics noted a 13% decline in the US birthrate between 2007 and 2019. But a white paper from physician search firm Merritt Hawkins suggests this has not necessarily resulted in reduced demand for pediatric services, at least not in the US.

Despite the decline, “there are still about four million births in the US annually, and immigration adds to the number of children in the population,” the white paper notes. Even rural areas with aging populations “have far fewer pediatricians per capita than they require.”

However, according to The New York Times, in South Korea, “expectant mothers in many areas can no longer find obstetricians or postnatal care centers.” And the town of Agnone, Italy, no longer has a maternity ward because the number of births—just six this year—is below the national minimum.

This is important to note. If there are developed countries around the world where demographics point to a steady decline in population, then the type of healthcare provided will be different than what is currently used. Clinical laboratories and pathology groups in those regions can expect changes and should prepare for them.

Stephen Beale

Related Information:

Long Slide Looms for World Population, with Sweeping Ramifications

Aging and Population Shrinking: Implications for Sustainability in the Urban Century

Actualizing Better Health and Health Care for Older Adults

US Birth Rate Falls to Lowest Point in More than a Century

CMS Considers Using Artificial Intelligence to Battle Fraud; Medical Laboratories Must Ensure Billing Practices Comply with New Federal Affiliation Regulations

Physicians and clinical laboratories that do business with other healthcare providers who have been denied enrollment in Medicare or had their enrollment revoked are under increased scrutiny

Efforts by the Centers for Medicare and Medicaid Services (CMS) to crack down on fraud could soon be bolstered by artificial intelligence (AI) tools, placing new pressure on medical laboratories and anatomic pathology groups to ensure that their billing practices are fully compliant with current federal “affiliations” regulations.

This is why, last October, CMS issued a Request for Information (RFI) seeking feedback from vendors, providers, and suppliers about the potential use of AI tools to identify cases of fraud, waste, and abuse in billing for healthcare services. Statements from CMS indicate that the agency plans to deepen its investigation into the affiliations physicians and clinical laboratories have with healthcare providers that been involved in fraudulent behavior within the Medicare program.

At present, CMS uses a variety of approaches to spot improper claims, the RFI notes, including the use of human medical reviewers. However, this is a costly process that allows review of less than 1% of claims. AI tools would increase the speed and accuracy of those investigations exponentially.

The RFI notes that AI technology could “help CMS identify potentially problematic affiliations upon initial screening and through continuous monitoring. One example would be a new tool or technology that would allow easy, seamless access to state and local business ownership and registration information that could improve CMS’ line-of-sight to potentially problematic business relationships.”

In a blog post on the federal agency’s website, CMS Administrator Seema Verma (above) wrote that “Advanced analytics and artificial intelligence can perform rapid analysis and comparison of large-scale claims data and medical records that could allow for more expeditious, seamless and accurate medical review, and ultimately, improved payment accuracy.” [Photo copyright: Centers for Medicare and Medicaid Services.)

CMS’ New Affiliations Rule Affects Clinical Laboratories

One area where CMS sought input relates to the new anti-fraud rule, titled, “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process.” This final rule, which took effect Nov. 4, 2019, requires providers, including medical laboratories, to disclose affiliations with entities that may have engaged in past fraudulent activities.

Our sister publication, The Dark Report (TDR), provided in-depth coverage of this rule, which allows CMS “to revoke or deny enrollment if it finds that a provider’s or supplier’s current or previous affiliations pose an undue risk of fraud.” (See TDR, “Labs Must Respond to New CMS Anti-Fraud Rule,” October 14, 2019.)

“For too many years, we have played an expensive and inefficient game of ‘whack-a-mole’ with criminals—going after them one at a time—as they steal from our programs,” CMS Administrator Seema Verma said in a statement about the new rule. “These fraudsters temporarily disappear into complex, hard-to-track webs of criminal entities, and then re-emerge under different corporate names. These criminals engage in the same behaviors again and again.”

As TDR reported, the rule defines four “disclosable events” that trigger the disclosure requirements:

  • Uncollected debt to Medicare, Medicaid, or CHIP;
  • Payment suspension under a federal healthcare program;
  • Exclusion by the Office of Inspector General from participation in Medicare, Medicaid, or CHIP; and
  • Termination, revocation, or denial of Medicare, Medicaid, or CHIP enrollment.

If disclosure is required, CMS described five definitions of an affiliation, using a five-year look-back:

  • Direct or indirect ownership of 5% or more in another organization;
  • A general or limited partnership interest, regardless of the percentage;
  • An interest in which an individual or entity “exercises operational or managerial control over, or directly conducts” the daily operations of another organization, “either under direct contract or through some other arrangement;”
  • When an individual is acting as an officer or director of a corporation; and
  • Any reassignment relationship.

One interesting consequence of these definitions is that individuals or companies that invest and own an interest in a provider organization that has one or more “disclosable events” would be flagged by the provider at time of enrollment or re-enrollment in the Medicare program. Over the years, some very prominent private equity companies have been investors and owners of medical laboratory companies that owed money to Medicare or entered into civil settlements with the federal government where the full amount of the alleged overpayments was not recovered and the provider neither admitted nor denied guilt. These affiliations would need to be disclosed and could be used by CMS to deny enrollment in the Medicare program.

“Lab companies that engage in fraud and abuse—often paying illegal inducements to physicians to encourage them to order medically-unnecessary tests—distort the lab testing marketplace and capture lab test referrals that would otherwise go to compliant clinical labs and pathology groups,” stated Robert Michel, Editor-In-Chief of The Dark Report. “So, honest labs will recognize how the new rule can help suppress various types of fraud that constantly plague the clinical lab industry.” (See TDR, “Is New Medicare Affiliation Rule Good, Bad, or Ugly?” November 4, 2019.)

Other AI Applications in Healthcare

The CMS RFI also suggests other areas in which artificial intelligence could help identify fraudulent activity, including real-time monitoring of electronic health records (EHR), risk adjustment data validation (RADV) audits, and value-based payment systems.

“These tools hold the promise of more expeditious, seamless and accurate review of chart documentation during medical review to ensure that we are paying for what we get and getting what we pay for,” the RFI states. “However, concerns about potential improper payments and bad actors remain. We need to determine whether innovative new strategies, tools, and technologies presently exist that can increase data accuracy and integrity and consequently reduce improper payments.”

Clinical laboratories should not be surprised by any of this. Artificial intelligence and machine learning are increasingly becoming vital tools in today’s modern healthcare system. Nevertheless, lab leaders should closely monitor CMS’ use of these technologies to root out fraud, as labs are often caught up in their investigations.

—Stephen Beale

Related Information:

CMS Explores Use of AI to Improve Program Integrity Tools

CMS’s Request for Information Provides Additional Signal That AI Will Revolutionize Healthcare

CMS Thinks Artificial Intelligence Could Help Cut Medicare Fraud

AI, Technology Key to Reducing Medicare Fraud and Waste, CMS Says

How AI Can Battle A Beast—Medical Insurance Fraud

Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process

CMS Request for Information on Using Advanced Technology in Program Integrity

CMS Announces New Enforcement Authorities to Reduce Criminal Behavior in Medicare, Medicaid, and CHIP

Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

Is New Medicare Affiliation Rule Good, Bad, or Ugly?

Labs Must Respond to New CMS Anti-Fraud Rule

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