News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Are Clinical Laboratories Prepared to Cope with Outrage Over Surprise Medical Billing? Patient Access Management May Be an Effective Solution

Consumer demand and federal requirements for price transparency affect how clinical laboratories and anatomic pathology groups meet patients’ expectations while navigating complex payer agreements

Regardless of a clinical laboratory’s payer mix and revenue cycle management (RCM) system, the demand for greater price transparency impacts laboratory services just as it does other healthcare services. Addressing new federal policies that support price transparency may require medical laboratory managers to alter how they approach RCM and patient communications.

Patient access management (PAM) is what some early-adopter medical labs and pathology groups are using to respond to these new federal policies and changing patient expectations. PAM can be an effective tool to fulfill complex payer requirements and implement consumer-friendly healthcare services. Not only does this comply with federal guidelines, it helps independent laboratories increase revenue by lowering denial rates.

How and When Clinical Laboratories Should Implement Patient Access Management

Revenue cycle experts say clinical laboratories are in a position to take an active role in the pricing transparency debate.

“If labs don’t control the pricing narrative, someone else will,” stated Walt Williams, Director of Revenue Cycle Optimization and Strategy for Quadax, a firm that has studied revenue trends in healthcare for more than 40 years, in an exclusive interview with Dark Daily.

He says, given these new demands on clinical laboratories and pathology groups, implementing patient access management practices ensures a satisfactory patient and physician experience and reduces the financial risk related to trends in uncollected revenue.

“In this age of increasing consumerism—along with the complex challenges of navigating the payer landscape and pre-empting administrative denials—it’s no wonder independent labs are turning to new patient access technology solutions to avoid leaving money on the table,” Williams said.

Patient access management solutions allow clinical laboratories to:

  • obtain accurate patient demographic information,
  • verify insurance coverage and eligibility, and
  • gain clarity on payer rules regarding prior authorization and medical necessity.

These capabilities enable medical laboratories to secure appropriate reimbursement closer to the date of service. PAM also can provide the ordering-physician with financial counseling and guidelines on a patient’s financial obligation. This would be shared with the patient to help prevent surprise billing.

New Fact of Life for Labs: Patients Are the New Payers

Medical laboratory patient-access representatives must employ proper patient-liability collection techniques before, during, and after each date of service. This has become increasingly challenging as more patients join high-deductible health plans (HDHPs) and take on more financial responsibility. The problem for labs is that meeting the expectations of consumers requires a different toolset than meeting the needs of complex payer requirements.

Additionally, evolving policies in prior authorization, medical necessity, and coding (see, “Labs Get High Denial Rates Under New NCCI Rules,” The Dark Report) are resulting in potential payment traps for patients and known revenue traps for providers and suppliers.

In its research into trends in healthcare access and affordability, the Peterson Center on Healthcare and the Kaiser Family Foundation (KFF) created the Health System Tracker to monitor consumer spending and surprise medical billing, among other points of interest.

The graphic above, taken from a KFF Health Tracking Poll conducted in 2018, lists “unexpected medical bills” as the top financial fear among Americans. “Four in 10 (39%) insured adults ages 18-64 say there has been a time in the past 12 months when they received care from a doctor, hospital, or lab that they thought was covered and their health plan either didn’t cover the bill at all or covered less than they expected,” the KFF poll notes. This illustrates the critical importance for clinical laboratories to implement patient access management protocols. (Graphic copyright: Kaiser Family Foundation.)

While the current high cost of healthcare will likely continue for some time, publishing information about the lab’s policies can help consumers view choices when it comes to selecting laboratory tests and anticipating potential payment obligations.

Henry Ford Health System, for example, posted information about prior authorization as it relates to its pathology and laboratory services.

Consumer-Facing Price Transparency and CMS Requirements

Rooted in price transparency regulations issued in July 2018, the federal Centers for Medicare and Medicaid Services (CMS) encouraged “all providers and suppliers of healthcare services to undertake efforts to engage in consumer-friendly communication of their charges to help patients understand what their potential financial liability might be for services they obtain, and to enable patients to compare charges for similar services. We encourage providers and suppliers to update this information at least annually, or more often as appropriate, to reflect current charges.”

The questions below, which CMS posed for comment in “Hospital Outpatient Prospective Payment-Notice of Proposed Rulemaking” (CMS-1695-P), may help lab managers tasked with making price transparency program decisions. They include:

  • How should we define “standard charges” in provider and supplier settings? Is the best measure of a provider’s or supplier’s standard charges its chargemaster, price list, or charge list?
  • What types of information would be most beneficial to patients … enable patients to use charge and cost information in their decision-making?
  • How can information on out-of-pocket costs be provided to better support patient choice and decision-making? What can be done to better inform patients of their financial obligations?
  • What changes would need to be made by providers and suppliers to provide patients with information on what Medicare pays for a particular service performed by that provider or supplier?

These considerations and more can help the development of patient access management and consumer-friendly communication initiatives that are tailored to clinical laboratory services.

Patient Access Management for Clinical Laboratories

Patient access management facilitates critical components of the revenue cycle. However, it must be fine-tuned to fit each healthcare provider’s unique revenue cycle process. This includes clinical laboratory and anatomic pathology services.

“Having business rules and workflows based on best practices to verify patient demographics, support insurance discovery, and navigate prior authorizations are now a minimum requirement for any healthcare provider to maintain financial viability,” Williams notes.

To help clinical laboratories fulfill CMS’ patient access guidelines—including best practices for reversing the trend of uncollected revenue—a free white paper titled, “Patient Access Antidote: Retaining More Revenue with Front-End Solutions,” has been published by Dark Daily in partnership with Quadax.

The white paper will provide useful insights regarding front-end patient access management. And it will equip clinical laboratories and pathology groups with the expert tools and solutions they need to optimize their cash flow and successfully meet key revenue cycle objectives.

Download it here.

—Liz Carey

Related Information:

WHITE PAPER: Patient Access Antidote: Retaining More Revenue with Front-End Solutions

Undertaking CMS Efforts to Engage in Consumer-Friendly Communication

An Examination of Surprise Medical Bills and Proposals to Protect Consumers from Them

Kaiser Health Tracking Poll – Late Summer 2018: The Election, Pre-Existing Conditions, and Surprises on Medical Bills

Labs Get High Denial Rates Under New NCCI Rules

KFF Study Finds HDHPs and Increased Cost-Sharing Requirements for Medical Services are Making Healthcare Increasingly Inaccessible to Consumers

Though ACA reforms may have slowed healthcare spending, rapidly increasing deductibles and cost sharing requirements have many experts questioning if patients can afford care at all, despite the increased availability of insurance coverage

Much of the debate surrounding efforts to replace and repeal the Affordable Care Act (ACA) has centered on premiums as a central facet of out-of-pocket spending. However, new data from a Kaiser Family Foundation (KFF) survey reveals that premiums are only one factor affecting consumers’ ability to pay healthcare bills. High-deductible health plans (HDHPs) are another culprit. This directly impacts clinical laboratories and anatomic pathology groups that find revenues down as more American’s avoid costs by delaying or opting out of testing and treatments.

The KFF report highlights both the complexity of managing healthcare costs and how the current focus on premium prices might miss other important considerations that make healthcare inaccessible to many Americans.

High Deductibles and Consumers’ Lack of Savings

An increasing number of insurance plans now include high deductibles—particularly in the individual markets, though employer-based insurance plans are experiencing steady increases as well.

This leaves consumers facing larger bills and making tough decisions about whether their healthcare is affordable—even with insurance.

When healthcare consumers cannot afford the out-of-pocket costs of healthcare, they are less likely to schedule wellness visits, adhere to treatments, or follow through on physician-ordered clinical laboratory tests they don’t consider essential to their well-being or simply cannot afford.

Even when they follow protocols and recommendations, that does not mean patients will be able to pay medical laboratories for tests performed, or anatomic pathology groups for specialized services, when the bill comes due.

The Ever-Growing Deductible Dilemma

In its 2017 study, “Do Health Plan Enrollees have Enough Money to Pay Cost Sharing?,” the KFF compares median data on liquid assets from 6,254 single and multi-person households—spanning a range of incomes and age brackets—to the average cost of both standard employer-based insurance and individual market insurance deductibles.

They further note that their data modeling and estimates present a “conservative estimate,” because chronic conditions might cause an extended period of out-of-pocket spending, and that median assets might not be available at a single time or throughout the year.

Concerning a previous 2016 KFF study on high-deductible insurance plans, the authors noted in a press release, “In 2016, 83% of covered workers face a deductible for single coverage, which averages $1,478. That’s up $159 or 12% from 2015, and $486 or 49% since 2011. The average deductible for workers who face one is higher for workers in small firms (three to 199 employers) than in large firms ($2,069 vs. $1,238).”

In the press release following KFF’s 2016 survey, Drew Altman, CEO (above), Kaiser Family Foundation, noted, “We’re seeing premiums rising at historically slow rates, which helps workers and employers alike, but it’s made possible in part by the more rapid rise in the deductibles workers must pay.” (Image copyright: Kaiser Family Foundation.)

In their latest look at deductibles and out-of-pocket spending, the KFF study authors note, “About half (53%) of single-person non-elderly households could pay the $2,000 from their liquid assets towards cost sharing, and only 37% could pay $6,000, which … was less than the maximum out-of-pocket limit for single coverage in 2016. For multi-person families, 47% could pay $4,000 from their liquid assets for cost sharing, while only 35% could pay $12,000.”

This sets the stage for the grim picture now facing many Americans. Despite increased access to medical insurance, being able to use the insurance to obtain care can be a struggle for a sizeable part of the lower to middle class population.

Creating a More Affordable Future for Healthcare

Data from the Q1 National Health Interview Survey (NHIS) conducted by the Centers for Disease Control and Prevention (CDC) show that growth in high-deductible plans might skew these numbers further still. They found that the number of persons under the age of 65 enrolled in HDHPs increased from 25.3% in 2010 to 40.0% in the first quarter of 2016 despite uninsured rates dropping from 22.3% to 11.9% over the same period.

In the 2017 study, KFF outlines the complexity of the issue: “There are significant differences across the income spectrum … For example, 63% of multi-person households with incomes of 400% of poverty or more could pay $12,000 from liquid assets for cost sharing, compared with only 18% of households with incomes between 150% and 400% of poverty, and 4% of households with incomes below 150% of poverty.”

While there are no simple answers to address today’s increasing deductibles, KFF emphasizes the importance of looking at the bigger picture.

“Much of the discussion around affordability has centered on premium costs. A broader notion of affordability will have to focus on the ability of families,” they note. “To adequately address the issue of affordability of health insurance, reform proposals should be evaluated on the affordability of out-of-pocket costs, especially for low and moderate-income families, and be sensitive to the financial impacts that high cost sharing will have on financial wellbeing.”

In the meantime, lack of access to preventative care and regular checkups can increase long-term healthcare costs and health risks, creating a spiral of financial concerns for patients as well as the healthcare professionals and the clinical laboratories serving them.

—Jon Stone

Related Information:

The Biggest Health Issue We Aren’t Debating

Do Health Plan Enrollees Have Enough Money to Pay Cost Sharing?

Average Annual Workplace Family Health Premiums Rise Modest 3% to $18,142 in 2016; More Workers Enroll in High-Deductible Plans with Savings Option Over Past Two Years

Americans Are Facing Rising Out-of-Pocket Healthcare Costs—Here’s Why

Americans’ Out-of-Pocket Healthcare Costs Are Skyrocketing

Americans Are Shouldering More and More of Their Healthcare Costs

Medicare Out-of-Pocket Costs Seen Rising to Half of Senior Income

Consumer Reaction to High-Deductible Health Plans and Rising Out-of-Pocket Costs Continues to Impact Physicians and Clinical Laboratories

Because of Sizeable Deductibles, More Patients Owe More Money to Clinical Pathology Laboratories, Spurring Labs to Get Smarter about Collecting from Patients

Growth in High Deductible Health Plans Cause Savvy Clinical Labs and Pathology Groups to Collect Full Payment at Time of Service

 

Because of Expanded Numbers of Patients with High-deductible Health Plans, Patients Are Now Responsible for 30% of Hospital Revenues

Medical laboratories and pathology groups should expect point-of-service collection strategies to become increasingly important to their overall success

Not only is patient bad debt a growing problem for the nation’s hospitals, but it is now getting national attention within the hospital industry. This is bad news for clinical laboratories and anatomic pathology groups, because the same trends causing increased patient bad debt at hospitals are doing the same thing within the lab industry.

Much of the blame can be attributed to the increase number of patients with high-deductible health plans (HDHPs). The latest statistics reveal that patients’ out-of-pocket payments now make up 30% of hospital revenues. That is why hospitals desperately need strategies for successfully collecting payments from patients. And they’re not alone.

Kaiser Family Foundation (KFF) reported that more than half of all workers have deductibles and out-of-pocket liability of greater than $1,000. That is the reason why clinical laboratories and anatomic pathology groups also need a formula for collecting the total bill from their patients.

Jase DuRard, Chief Revenue Officer for revenue-cycle technology company AccuReg, told Modern Healthcare the increase in patient self-pay represents a seismic shift from roughly five years ago. At that time, patients paid only 10% of their hospital bills out-of-pocket and insurers paid about 90% of hospital claims.

Patient Responsibility to Blame for Revenue Loss at Nation’s Hospitals

A November 2016 study of 660 hospitals conducted by Crowe Horwath—an  international public accounting, consulting, and technology firm—stated that “patient responsibility” was to blame for an overall managed care net revenue decline of 2.5% for outpatient care and 1.4% for inpatient care. Self-pay-after-insurance (SPAI) collection rates have improved slightly during the past 12 months—with the inpatient median rising 0.2% and outpatient median increasing 0.7%.

However, according to the Horwath report, “While seemingly a good sign for providers in the face of rising patient copays and deductibles, slight increases in patient collection rates are not enough to counter the larger increase in self-pay-after-insurance patient responsibilities.”

High-deductible health plans (HDHPs) are becoming the coverage of choice for healthcare consumers struggling to pay medical bills in full. The net effect is that revenues are declining at hospitals, clinical laboratories, and pathology groups, as well as other providers. (Graphic copyright: Consumer Reports.)

In a Modern Healthcare article, Crowe Horwath’s Managing Partner of Healthcare Services, Brian Sanderson, noted, “It’s imperative that healthcare organizations establish effective point-of-service collection programs by training and educating front-line staff.”

Complicating matters is that many patients faced with self-pay are unable to pay their medical bills at time of service.

“Higher deductibles and the increase in patient responsibility are causing a decrease in patient payments to providers for patient care services rendered,” John Yount, TransUnion Vice President for Healthcare Products, told RevCycle Intelligence. “While uncompensated care has declined, it appears to be primarily due to the increased number of individuals with Medicaid and commercial insurance coverage.”

Hospitals Offer Patients Financial Options for Paying Bills

Some hospitals are responding to this trend by rolling out programs that offer patients financing options for their out-of-pocket costs. A recent article in Modern Healthcare outlined the steps taken by Missouri hospital system Mosaic Life Care, as it realized the full impact that $23 million worth of self-pay patient care had on its bottom line. Though the hospital posted record census and gross revenue during the first four months of 2017, net revenue was flat because patient self-pay didn’t keep pace.

“We win all kinds of awards for patient quality, but our revenue cycle didn’t match that performance,” Deborah Vancleave,  Mosaic’s Vice President of Revenue Cycle, told Modern Healthcare.

Since then, Mosaic has taken steps to improve the accuracy of information it gets at registration and how it makes determinations on patients’ ability to pay. In addition, it has joined forces with ClearBalance— a provider of patient loan programs to US hospitals and health systems—to offer zero-interest or low-interest revolving lines of credit to patients for their out-of-pocket medical costs.

According to Modern Healthcare, ClearBalance pays hospitals “upfront for the outstanding bills of patients who sign up for their financing program, but the hospital guarantees the money and repays lenders if patients default on their credit lines. The companies make their profit by getting a 10% to 15% fee for the outstanding amount of the loan.”

Medical Laboratories Slow to Respond to Consumer Demand for Price Transparency

As consumers shoulder more of the burden for their healthcare, they also will be demanding more price transparency from medical laboratories and anatomic pathology groups, which so far have been slow to respond to the trend.

“Patients expect cost estimates in every other retail industry, and are starting to demand them in healthcare as well. According to one recent study, for example, more than 90% of patients felt it was important to know their payment responsibility upfront,” TransUnion, a global risk information provider, stated in a white paper outlining the importance of precare cost estimates.

As hospitals struggle to collect from patients saddled with HDHPs, laboratory executives and other healthcare providers should take note. The change in payment mix means the ability to collect payments from patients at the point of service is becoming a critical success factor.

—Andrea Downing Peck

Related Information:

Hospitals Struggle with the Dilemma of Patients Hit by High Deductibles

Kaiser Family Foundation 2016 Employer Health Benefits Survey

The Impact of Consumerism on Provider Revenues

Patient Financial Responsibility On the Rise

Improve Revenue Cycles and Patient Engagement by Delivering Pre-Care Cost Estimates

68% of Consumers Did Not Pay Patient Financial Responsibility

Kaiser Family Foundation Estimates Approximately 16% of US Population Uninsurable under Pre-ACA Underwriting Standards

As the latest attempts to replace the Affordable Care Act (ACA) generate increased debate over protections for pre-existing conditions, Kaiser Family Foundation highlights that using pre-ACA underwriting guidelines would result in an estimated 52-million Americans unable to obtain coverage

With the American Health Care Act (AHCA) clearing the House on the way to the Senate, the public and media are scrutinizing key points. One highly-contested topic is insurance availability for people with pre-existing conditions.

Unfortunately, as most pathologists and medical laboratory managers know, media coverage—whether from the left or the right—tends to play up points that are sensational and resonate with their core audiences, but often fail to provide a full and accurate picture of the subject being covered. Thus, it is refreshing when useful information and insights about aspects of healthcare in America are presented in a fair and measured way.

Biased media coverage is certainly true on the issue of health insurance coverage for individuals who are considered to have pre-existing conditions. However, as a December 2016 Kaiser Family Foundation (KFF) study highlights, protections for pre-existing conditions were not always guaranteed. In fact, if insurers currently used the medical underwriting practices in place prior to implementation of the Patient Protection and Affordable Care Act or ACA (also known as Obamacare), the study estimates that 52-million adults under the age of 65 would likely be denied coverage on the individual market.

According to US Census Bureau figures, at the start of 2017 there were 324-million Americans. Using KFF’s figures, this means that 16% of the population are considered to have pre-existing conditions.

Who is Impacted by the Individual Market?

KFF was quick to point out that many of the 52-million people with pre-existing conditions have always qualified for insurance through their employer or a public program such as Medicaid. The foundation’s estimates show that in 2015, only 8% of the non-elderly population relied on individual market insurance plans, such as those plans offered on the ACA healthcare exchange.

 graph above shows the percentage of American’s with pre-existing conditions who “most likely” would have been denied insurance in the Individual Marketplace

The graph above shows the percentage of American’s with pre-existing conditions who “most likely” would have been denied insurance in the Individual Marketplace prior to the Affordable Care Act (ACA). According to the Kaiser Family Foundation (KFF), while the proposed American Health Care Act (AHCA) does not enable insurance companies to deny coverage for these conditions, coverage premiums could increase if a state seeks a community rating waiver. (Image copyright: Kaiser Family Foundation.)

For many patients, obtaining health insurance through individual plans is often temporary and driven by a life event, such as job loss, divorce, marriage, or reaching the threshold of an age bracket for coverage through other programs. However, for some individuals—such as the self-employed, low wage earners, or early retirees—the individual market is the only option for obtaining health insurance. For this population, pre-ACA underwriting made coverage difficult to obtain and more expensive for patients with pre-existing conditions.

Pre-Existing Conditions Cover More than Just Conditions

Study authors also note that the estimate of 52-million individuals considered to have pre-existing conditions is conservative due to other factors considered in the underwriting process. Insurance companies also based denial and uprating on a range of other factors—such as:

  • Prescription medication;
  • Doctor visits or procedures;
  • Mental health conditions; and
  • Family history.

They list a table of 30 conditions, including pregnancy and eating disorders, that might qualify as a pre-existing condition along with a list of 40 medications that might also result in a denial of coverage.

Despite the already growing list of reasons for insurance denials, there’s yet another list with job occupations that might result in ineligibility. This means that even healthy individuals could find themselves without coverage due to how they earn their income.

Neither medications nor professions were considered in KFF’s estimates due to a lack of data.

Uncertainty and Instability in Individual Market Pricing

A 2001 KFF report showed yet another hurdle faced by enrollees in the individual market.

In this KFF study, researchers created seven hypothetical applicants and compared their conditions to the underwriting practices at major insurance companies. Even if applicants cleared the underwriting process, the premiums offered by the various insurance companies differed greatly. Prices for each applicant fluctuated between hundreds and thousands of dollars per month when coverage was available. Benefits changed between plans as well, with many plans exempting coverage for pre-existing conditions.

Even with insurance, coverage for maternity care, prescriptions, or mental health fell behind the options available through most group plans. Yet, these conditions are some that might facilitate the events mentioned in the 2016 study for entering the individual market.

In the study’s conclusion, the authors found, “Insurance carriers seek to avoid covering people who have pre-existing medical conditions, and when they offer coverage, often impose limitations on the coverage they sell. This can price insurance out of the reach of many consumers in poor health or create significant gaps in coverage that could result in being underinsured.”

Decreased Demand for Clinical Laboratory Tests

Both studies show similarities to many of the concerns cited for the new AHCA. Time Magazine recently published a list of pre-existing conditions under the new proposal. The list bears striking similarity to the list offered in the 2016 KFF study. Speaking with Time, Cynthia Cox, Associate Director at KFF said, “There are plenty of other conditions, even acne or high blood pressure, that could have gotten people denied from some insurers, but accepted and charged a higher premium by other insurers.”

If fewer people can access affordable preventative care, prescriptions, and medical laboratory services, disease diagnosis is delayed. In a 2013 KFF study into the impact a lack of insurance has on healthcare, study authors noted, “Consequently, uninsured patients have increased risk being diagnosed in later stages of diseases, including cancer, and have higher mortality rates than those with insurance.”

Supporters of the proposed AHCA legislation are quick to point out that it does not eliminate protections for people with pre-existing conditions. It simply provides a process for state governments to provide an alternative solution to the federal framework and regulations.

Regardless of the outcome, KFF’s studies make it clear that a decrease in access to insurance means patients skip medical procedures they do not see as essential or cannot afford. This could result in decreased demand for screening and prevention diagnostics, such as those offered by pathology groups and clinical laboratories.

—Jon Stone

Related Information:

An Estimated 52 Million Adults Have Pre-existing Conditions That Would Make Them Uninsurable Pre-Obamacare

50 Health Issues That Count as a Pre-existing Condition

The Uninsured a Primer 2013 – 4: How Does Lack of Insurance Affect Access to Health Care? 

How Accessible Is Individual Health Insurance for Consumers in Less-Than-Perfect Health?

GOP Health Bill Leaves Many ‘Pre-existing Condition’ Protections Up to States

Key Facts About the Uninsured Population

Gaps in Coverage Among People with Pre-Existing Conditions

 

Ongoing Growth in Volume of Clinical Laboratory Tests That Support Precision Medicine Due to Physician Acceptance; Payers Still Have Concerns

Every medical laboratory ready to begin the move away from fee-for-service payment and towards value-based reimbursement needs to start offering lab tests that support the practice of precision medicine

Nearly every clinical laboratory and pathology group in America today is aware of the opportunity to provide medical laboratory tests that enable physicians to successfully practice precision medicine. The goal of precision medicine is to enable a patient to get a more accurate diagnosis, receive the most appropriate therapy, and have his/her condition monitored with unprecedented insight during the course of treatment.

The good news for the clinical laboratory industry concerning precision medicine is that it is the fastest-growing sector of lab testing and these are the tests that contribute the greatest value in patient care. For example, molecular and genetic tests are revolutionizing the diagnosis and treatment of infectious disease. These are the clinical lab tests that enable a physician to identify the specific subtype of the bacteria or virus, then help him or her select the therapeutic drug that will have maximum benefit for the patient.

Clinical Laboratories Support Cancer Diagnosis with Companion Diagnostic Tests

It is equally true that the diagnosis and treatment of cancer is undergoing a major transformation. Genetic knowledge is being used to develop both diagnostic tests and new therapies that enable physicians to better diagnose cancer, and then treat it with the drugs identified by a companion diagnostic test as having the best potential to cure the patient or slow the progression of the disease.

But if there is an area of precision medicine with immense potential, it is pharmacogenomics and its associated testing.

In 2015, the Kaiser Family Foundation reported that more than four billion prescriptions were filled in the United States. As science understands more about the human genome, proteome, metabolome, and microbiome (to name just a few of the “omes”), it becomes possible to design clinical laboratory tests that:

1. Contribute to a more accurate diagnosis;

2. Identify which prescription drugs will be of the greatest benefit; and

3. Inform the physician as to which drugs will not be effective and may even be harmful to the patient.

More Good News for Medical Laboratories

There is even more good news. Many clinical laboratories, hospital labs, and pathology groups already have lab instruments capable of performing the tests used in precision medicine. For these labs, no major up-front investment is needed to begin offering tests that allow physicians to practice precision medicine.

“Many of our lab clients got started in this way,” stated Don Rule, MBA, Founder and Chief Executive Officer of Translational Software in Bellevue, Wash. “They realized that their existing lab instruments could run some of the lab tests physicians use when practicing precision medicine. This would be a low-cost way to enter the precision medicine field and they could, on a small scale with minimal risk, begin offering these tests to gain experience, learn more about the market, and identify which such tests would have highest value to the physicians in the communities they serve.”

Is Your Pathology Group Interested in Supporting Precision Medicine?

“For a lab that is serious about understanding the current and future clinical demand for precision medicine tests, several careful steps are recommended,” he continued. “One step is to build demand by educating clinicians and their staffs about the best ways to use these tests to improve patient care. Keep in mind that more of a physician’s reimbursement is now keyed to the patient outcomes they deliver. These doctors recognize that labs helping them do a better job with precision medicine are also helping them demonstrate greater value in the patient care they provide.

“There are other steps required to launch an effective, clinically successful precision medicine testing program,” Rule noted. “For example, labs need to understand how to be paid by the health insurers in their region. That includes getting in-network and teaching physicians and lab staff how to follow each payer’s clinical and coding criteria so that clean claims will be paid in a timely manner.

“Another step is to build the market in a careful fashion,” he emphasized. “For example, labs should identify the thought leaders among their clients and work with them to demonstrate the clinical utility of tests performed in support of precision medicine. And above all, it’s important to focus on patients that are most likely to get some insight from testing. When your lab starts with the right population, it’s remarkable how often you will uncover actionable issues.”

Clinical Labs Can Enter Precision Medicine by Initially Referring Tests

“It’s also feasible for a lab to start its precision medicine strategy by referring out testing in the early stages and using third-party experts to do the interpretations,” Rule advised. “Then, as specimen volume increases, and the lab’s clinical team gains more experience with these molecular and genetic tests, it becomes easy to bring that testing in-house to develop the market further with faster turnaround times and in-house expertise that local physicians appreciate.”

Every clinical lab, hospital lab, and pathology group that is considering how to support precision medicine will want to participate in a special webinar, titled, “What Molecular and Genetic Testing Labs Need to Know to Succeed with Commercialization of Their Precision Medicine Products.” It will take place on Wednesday, March 22, 2017 at 1 PM EDT.

Two expert speakers will cover the essentials that all labs should know about building a market presence in precision medicine. First to present is Don Rule of Translational Software. Rule currently provides a variety of services to more than 80 lab clients, which includes the annotation and interpretation of gene sequences. In addition, Rule and his team provide consulting expertise to help labs develop their strategies for precision medicine, identify the best tests to offer physicians, and develop the steps needed to obtain network status with payers.

Webinar Will Present the Best Successes of Molecular, Genetic Testing Labs

Rule will share the experiences and best successes of the molecular and genetic testing labs he has worked with since 2009. He will discuss the types of lab tests used in precision medicine in different specialties, identify the fastest-growing sectors, and note which instruments already found in most clinical laboratories can be used to provide lab tests used for precision medicine.

Don Rule (above left), Founder and CEO of Translational Software, and Kyle Fetter (above right), Vice President of Advanced Diagnostics at XIFIN, will share their unique insights, knowledge, and experience at developing a precision medicine lab testing program for clinical laboratories that want to build more market share, make the billing/collections team more effective, and increase revenue. (Photo copyright: Dark Daily.)

Don Rule (above left), Founder and CEO of Translational Software, and Kyle Fetter (above right), Vice President of Advanced Diagnostics at XIFIN, will share their unique insights, knowledge, and experience at developing a precision medicine lab testing program for clinical laboratories that want to build more market share, make the billing/collections team more effective, and increase revenue. (Photo copyright: Dark Daily.)

As one example, a growing number of long-term care facilities are using tests to practice precision medicine—and paying for these tests under value-based arrangements—because so many of their patients are taking from 10 to 15 prescriptions each day. If a lab test indicates that the patient may not be getting therapeutic benefit from a specific drug (or that there are negative side effects from the polypharmacy), then the long-term care facility is money ahead because of less spending on drugs and the decreased care costs from patients who remain healthier. In the extreme case, the care facility might lose a patient to a skilled nursing facility due to mental fog or a fall that is precipitated by adverse drug effects.

Making the Case for a Precision Medicine Lab Testing Program

Additional topics to be discussed are:

• How to make the case to administration and the clinicians;

• How to build demand; and

• How to identify thought leaders and work with them to educate the physicians in the lab’s service region.

The second speaker will address the important topic of how to get paid. Kyle Fetter, MBA, is Vice President of Advanced Diagnostics at XIFIN, Inc., based in San Diego. XIFIN provides revenue cycle management (RCM) services to more than 200 labs and handles as many as 300 million lab test claims annually. What this means is that Fetter sees which labs are most successful with their coding, billing, and collections for molecular and genetic tests. He also sees how different payers are handling these claims.

During his presentation, Fetter will provide you and your lab team with valuable knowledge about the best ways to collect the information needed to submit clean claims and be paid promptly. He will illustrate ways to optimize the process of gathering this data and the different software tools that not only make the job easier, but help ensure that a higher proportion of claims are clean and paid at first submission.

Secrets of Preparing for Payer Challenges, Denials, and Audits

But the single best element of Fetter’s presentation will be how labs performing molecular and genetic testing should prepare, as part of the normal course of business, for the inevitable challenges, denials, and audits. He will describe the elements of a system that helps labs be ready to make the case that claims are properly documented, and that they represent appropriate and necessary tests for the patient.

You can find details for this important webinar at this link. (Or copy this URL and paste it into your browser: https://www.darkdaily.com/webinar/what-molecular-and-genetic-testing-labs-need-to-know-to-succeed-with-commercialization-of-their-precision-medicine-products.)

This webinar is perfect for any lab that is already performing molecular and genetic tests, and which is interested in building more market share, making the billing/collections team more effective, and increasing revenue.

For every lab watching the precision medicine space, this webinar is a “must attend” because it delivers to you and your lab team the collective knowledge and insights from two experts who are working with hundreds of the nation’s most successful labs. It is your guaranteed way to get the accurate, relevant information you need to craft your own lab’s strategy for expanding its molecular and genetic testing opportunities.

—Michael McBride

Related Information:

Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors

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