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Clinical Laboratories and Pathology Groups

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FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Prescription, Bypassing Doctors and Clinical Laboratories

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.”


Tim Stenzel, MD, PhD (above), Director, Office of In Vitro Diagnostics and Radiological Health at the FDA, told FierceBiotech, “This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice, and does not diagnose any health conditions. Consumers should not use this test to make treatment decisions on their own.” (Photo copyright: LinkedIn.)

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:

  • CYP2C19 *2, *3, *17;
  • CYP2C9 *2, *3, *5, *6, rs7089580;
  • CYP3A5 *3;
  • UGT1A1 *6, *28;
  • DPYD *2A, rs67376798;
  • TPMT *2, *3C;
  • SLCO1B1 *5; and,
  • CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41.

Hospitals Bring PGx Testing to Primary Care

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.

—JP Schlingman

Related Information:

FDA Clears 23andMe’s DTC Drug Metabolism Test

FDA Clears the First Consumer Genetic Test for How Well Your Medications May Work—with Caveats

23andMe Granted the First and Only FDA Authorization for Direct-to-Consumer Pharmacogenetic Reports

Your Genes Can Show Us How Your Body Reacts to Drugs

Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data should be Handled, Secured, and Kept Private

Balance Billing Under Increased Scrutiny at Both State and Federal Levels; Clinical Laboratory Tests Top List of Surprise Bills Received by Patients

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 August 2018, the National Opinion Research Center (NORC) at the University of Chicago interviewed 1,002 respondents age 18 and over about surprise medical 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.

The Centers for Medicare and Medicaid Services (CMS) even included a Request for Information related to surprise billing and price transparency in their “Fiscal Year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System Proposed Rule.”

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.

R-Bruce-Williams-MD-CAP-Geraldine-McGinty-MD
“Many news stories on ‘surprise’ billing blame physicians, because the bill is sent from the doctor’s office or billing company. But the insurance industry is the real culprit, in concert with insurance regulators who have not acted to require network adequacy,” R. Bruce Williams, MD (left), President, College of American Pathologists (CAP), and Geraldine B. McGinty, MD (right), Chair of the American College of Radiology Board of Chancellors, wrote in STAT. (Photos copyrights: College of American Pathologists/Geraldine McGinty.)

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.”

—Jon Stone

Related Information:

Surprise Out-of-Network Bills Are the Fault of Insurance Regulators

Hospitals’ Solution to Surprise Out-of-Network Bills: Make Physicians Go In-Network

Letter from AHA and FAH to Congress

NORC AmeriSpeak Omnibus Survey: Surprise Medical Bills

Arizona Department of Insurance: Arbitration for Surprise Healthcare Bills Will Be Available Soon

New Payment Model Tackles “Surprise Medical Bill” Issue

AB 72 Implementation: What You Need to Know

The $109K Heart Attack Bill Is Down to $332. What about Other Surprise Bills?

Taking Surprise Medical Bills to Court

Surprise Medical Bills Loom for Millions of Americans in 2019

Fiscal Year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System Proposed Rule, and Request for Information

AB 72: What the New “Out-of-Network” Law Means

Double-Digit Increase in Medicare Advantage Plan Growth May Be Good News for Seniors but Bad News for Local Clinical Laboratories and Pathology Groups in 2019

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.

Medicare-Advantage-Enrollment-2010-2019-CMS-KFF

Since 2010, enrollment in Medicare Advantage has doubled to more than 22.6 million enrollees, growing from a quarter of Medicare enrollees to more than one-third. This trend is not favorable to many clinical laboratories, as the private health insurers who operate Medicare Advantage plans often contract with the billion-dollar lab companies and exclude regional and independent medical laboratories as network providers. (Photo copyright: Kaiser Family Foundation, Centers for Medicare and Medicaid Services.)

“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.

SEEMA VERMA

“The steps that the Trump Administration has taken to improve and drive competition in Medicare Advantage means more savings, more benefits and lower costs for seniors, CMS Administrator Seema Verma said in the press release. “[With the] popularity of programs, such as Medicare Advantage, and with the various new supplemental benefits and policy changes that have been adopted, we expect plan choices to be even more robust moving forward.” [Photo copyright: Centers for Medicare and Medicaid Services.)

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.

—Andrea Downing Peck

Related Information:

A Dozen Facts About Medicare Advantage

Medicare Advantage Riding High as New Insurers Flock to Sell to Seniors

Medicare Advantage Growth Drives United Health’s Strong Earnings

Medicare Advantage 2019: First LookMedicare Advantage Premiums Continue to Decline while Plan Choice and Benefits Increase in 2019

With Experienced Baby Boomers Retiring in Ever-Larger Numbers, Clinical Laboratories and Pathology Groups Use New Methods to Improve Productivity, Reduce Costs

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.”

Preparing Your Lab for Continuous Improvement

To help labs prepare for these significant trends, D’Angelo and Stone will co-present a 90-minute webinar on Jan. 16th titled, “Performance Coaching and Management Observations to Improve Productivity and Efficiency: Strengthening the Skills of Management to Execute a Lean Lab Transformation.”

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/.)

—Jon Stone

Related Information:

Performance Coaching and Management Observations to Improve Productivity and Efficiency: Strengthening the Skills of Management to Execute a Lean Lab Transformation

Performance Coaching and Management Observations in the Lab: Master this Proven Way to Develop Your Lab’s Managers, Supervisors, and Lab Staff

Secrets of Effective Culture Change in Hospital and Health System Labs: Engaging Staff to Continuously Improve, Sustain Quality, and Regularly Cut Unnecessary Costs

Becker’s Hospital Review Lists Top Challenges Facing Hospitals and Health Networks in 2019

Rising cost of prescription drugs tops Becker’s list of ‘headwinds’ facing healthcare industry, but no clinical laboratory issues make the list

Clinical laboratory managers and anatomic pathologists working in hospitals and health network systems will find their employers facing many familiar challenges in the coming year. And a report by Becker’s Hospital Review (Becker’s) predicts the top challenges it expects hospitals and health systems to encounter in 2019.

Topping the list is the rising price of prescription pharmaceuticals, which is a chronic strain on the wallets of hospitals, health networks, and patients. However, other items on Becker’s list may be equally challenging.

Readers of Dark Daily who are pathologists and clinical laboratory managers working in hospitals and health systems will find the list presented by Becker’s in “11 Headwinds Facing Hospitals and Health Systems” to be useful at bringing together the main challenges confronting their parent organizations today.

Drug Prices Spiraling Upward

The top challenges facing hospitals and health networks include:

  • “Pharmaceutical costs, particularly non-generic;
  • “Payers expanding into providers and combining with providers;
  • “Payer market share;
  • “Health IT and cybersecurity costs;
  • “Labor costs and a labor-intensive business;
  • “High costs of bricks and mortar;
  • “Medicare as a larger percentage of health system revenue and Medicare reimbursement softening now and over time as federal deficits rise;
  • “Slowing overall healthcare inflation as hospitals rise;
  • “Siphoning off of better paying commercial patients;
  • “Siphoning off of profitable ancillaries; and,
  • “Entry of big technology firms into healthcare.”

Since pharmacy operations consume an estimated 10% to 20% of the average U.S. hospital’s overall operating budget, persistent drug-price increases can be damaging to a hospital’s bottom line. According to PipelineRx, a medication management company, average inpatient drug spending increased 38.7% on a per admission basis (from $714 to $990) from fiscal year 2013-2015.

“Drug prices for both commonly and infrequently used drugs are spiraling up faster than bundled reimbursements can keep up with,” explained PipelineRx.

And the Vizient Drug Price Forecast estimates that in 2019 health systems can expect a 4.92% increase in the price of pharmaceutical purchases. The Vizient forecast for 2018 had projected a 7.61% boost in drug costs.

“While the projected increase for 2019 is less than 2018, it is still growing quickly,” said Dan Kistner, Senior Vice President, Pharmacy Solutions for Vizient, in a news release. “Two key themes we saw were the continued growth of specialty pharmacy products as a share of total spending and the critical importance of ongoing, robust generic and biosimilar competition on restraining overall price growth.”

In spite of pressure from the White House to lower drug prices, Pfizer is one of several large pharma companies that recently announced drug-price increases beginning January 1. The Wall Street Journal (WSJ) reported Pfizer is boosting the prices of 41 prescription drugs—10% of its portfolio. Elliot Wilbur (above), Senior Equity Research Analyst with Raymond James Financial, told the WSJ that drug companies have raised list prices on 263 drugs by an average of 7.8%. (Photo copyright: CNBC.)

While the 2019 increases are below the double-digit averages seen in 2014 and 2015, the American Hospital Association’s “Trends in Hospital Inpatient Drug Costs: Issues and Challenges” report explains the impact of rapidly rising hospital pharmacy costs.

“Hospitals bear a heavy financial burden when the cost of drugs increases and must make tough choices about how to allocate scarce resources. One hospital put the challenge starkly: last year, the price increases for just four common drugs, which ranged between 479% and 1,261%, cost the same amount as the salaries of 55 full-time nurses,” the report noted.

Meanwhile, many of the other items on Becker’s 2019 “headwinds” list will not surprise healthcare administrators, such as:

  • High cost of stand-alone hospitals;
  • Impact of softening Medicare reimbursements;
  • Health insurers’ changing business model; and,
  • The entry of Apple, Google, and other giant technology companies into the healthcare space.

Becker’s list could be a harbinger of tough times ahead. It should make pathologists and clinical laboratory mangers who work within health networks and hospitals mindful of the importance of adding value to their parent organizations while providing their patients with excellent service.

—Andrea Downing Peck

Related Information:

11 Headwinds Facing Hospitals and Health Systems

Vizient Drug Price Forecast Projects Lower Inflation in 2019 than 2018

Trends in Hospital Inpatient Drug Costs: Issues and Challenges

Vizient Forecasts Nearly 5 Percent Hike in Pharmaceutical Prices for 2019, But Also Potential Downward Trend in Spending

Pfizer to Rise Prices on 41 Drugs in January

 

 

Independent Clinical Laboratories in Maryland May Need to Step-up Outreach with Hospitals as New CMS Program Launches Jan. 1

Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.

The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.

Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”

Value of Precision Medicine and Coordination of Care to Clinical Labs

“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.

The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.

CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.

“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)

The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.

How Does it Work?

The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.

It includes three programs, including the:

  • Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
  • Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
  • Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.

CMS and Maryland officials also identified these six high-priority areas for population health improvement:

  • Substance-use disorder;
  • Diabetes;
  • Hypertension;
  • Obesity;
  • Smoking; and
  • Asthma.

“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.

OneCare in Vermont, Different Approach to One Payer

Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.

Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.

Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.

—Donna Marie Pocius

 

Related Information:

Maryland’s Total Cost of Care Model

Maryland All-Payer Model Expands to Include Outpatient Services

Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare

The Maryland Model

Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract

CMS Expands Maryland’s All-Payer Program to Outpatient Services

Vermont’s Bold Experiment in Community Driven Healthcare Reform

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