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

Hosted by Robert Michel

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

Hosted by Robert Michel
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CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

CMS Says Obamacare Premiums to Increase by an Average of 7.5% in 2016, But Squeeze on Consumers’ Wallets Will Vary Depending on Where They Live

UnitedHealthcare announces it may exit the federal marketplace because of slow growth and higher-than-expected claims; clinical laboratories may see less reimbursement

Health insurance premiums in 2016 for plans offered through federal Obamacare exchanges (more formally known as the Health Insurance Marketplace) will see an average rate hike on midrange plans of 7.5%. This amount may vary widely depending on which state a consumer lives. In 2016, 38 states will have healthcare consumers apply for and enroll in coverage through the HealthCare.gov platform.

Big increases in healthcare premiums from one year to the next have a direct link to the amount of money health insurers will pay clinical laboratories for lab test claims. That’s because, when health insurers are in a financial squeeze, they tend to reduce reimbursement to providers, including clinical laboratories.

This news about premium increases for 2016 comes from a report issued by the Centers for Medicare and Medicaid Services (CMS). The rate analysis is part of the federal agency’s 2016 Marketplace Affordability Snapshot. CMS said that nearly eight in 10 returning marketplace consumers will be able to find a plan with premiums for less than $100 per month after tax credits and seven out of 10 will pay less than $75, once taxpayer subsidies are factored in.

“For most consumers, premium increases for 2016 are in the single digits and they will be able to find plans for less than $100 a month,” stated Kevin Counihan, CEO of the Health Insurance Marketplace, in the CMS statement. (more…)

ONC Releases Final Rule for Stage 3 Meaningful Use: What Most Affects Clinical Laboratories and Anatomic Pathology Groups

Meaningful Use Stage 3 focuses on interoperability, which is good news for medical laboratories that must spend time and money to develop effective LIS-EHR interfaces

On December 15, 2015, the final rule for Stage 3 meaningful use (MU) went into effect. By now, pathologists and clinical laboratory managers and personnel are well-acquainted with the MU incentive program and the myriad of challenges it presents for almost everyone working in the healthcare sector.

Although the implementation of electronic health records (EHRs) has caused labs some headaches, the Stage 3 MU requirements could reduce some of that pressure. One of the biggest changes in Stage 3, according to the Office of the Federal Register (OFR), is that the ONC is “finalizing changes to remove the menu and core structure of Stage 1 and Stage 2 and reduce the number of objectives to which a provider must attest.” There will be fewer objectives to prove an EHR system is being used in a meaningful way.

That’s good news for providers struggling with EHR attestation. However, the struggle for clinical laboratories isn’t with attestation per se, it’s with interoperability between lab information systems (LIS) and physicians’ EHRs. (more…)

‘10 Disruptive Forces in Healthcare’ Provide Challenges for Clinical Laboratories and Pathology Groups Forced to Respond to a Changing Marketplace

Transition to value-based reimbursement tops Insigniam’s list of factors altering healthcare landscape

Management consulting firm Insigniam recently identified “10 Disruptive Forces in Healthcare”. Several of these development create significant implications for clinical laboratories and anatomic pathology groups that are navigating today’s rapidly-changing healthcare landscape.

ACA and Aging Population Reshaping Healthcare

“I have been doing healthcare for 33 years at this point. And there has been more change in the last three [years] than at any time, and it’s by a long shot,” declared Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Cardinal Health in Ohio. He was quoted by Insigniam Quarterly.

donald casey

Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Ohio-based Cardinal Health, has firsthand experience responding to the fundamental changes taking place in healthcare today. Casey points to the Affordable Care Act (ACA) and an aging population as the two drivers behind what is a fundamental reshaping of American healthcare. (Photo copyright: Cardinal Health.)

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Digital-Era Millennials Using New Tools to Select Doctors, Stay Informed, and Shop for Care, Including Selecting Clinical Pathology Laboratories

Medical laboratories can get ahead of the trend by developing processes for serving younger healthcare consumers in different ways

Experts say that Millennials are rewriting the rules of healthcare. Rather than following in baby boomers’ footsteps, this new generation of young adults shops for healthcare in ways that may change the provider-patient relationship for all providers, including pathologists and medical laboratories.

Also known as Gen Y, this generation interacts with healthcare providers differently than earlier generations in at least three basic ways:

  1. When seeking medical advice, they first turn to websites;
  2. They prefer to ask friends for physician referrals; and,
  3. They are not shy about requesting discounts from providers to cut their medical costs.

Different Approaches to Choosing Doctors and Communicating Concerns

A recent survey by Nuance Communications showed how baby boomers and millennials are taking different approaches to their healthcare. It starts with how they choose their primary care physician. (more…)

Walmart Health Plan Praised as Affordable, Superior Option to Obamacare Exchange Coverage While Offering Expanded Provider Networks

Yet financial pressures on insurers continue to increase premiums and potentially squeeze reimbursement rates for clinical laboratories and pathology groups

Walmart shoppers expect to find low prices on the retailer’s shelves, but the discounter’s full-time employees may be surprised to learn their company healthcare plan is also a low-cost leader. This is a significant finding and is significant for pathologists and clinical lab managers because the Walmart health benefit plan includes an expanded provider network, at a premium that is about half of the subsidized rate for a comparable health plan at Healthcare.gov.

A Washington Examiner analysis comparing Walmart’s employee health insurance program with Obamacare—more formerly referred to as the Patient Protection and Affordable Care Act (PPACA) or simply the Affordable Care Act (ACA)—found that “Walmart’s plan is more affordable and provides significantly better access to high-quality medical care than Obamacare.”

The report also noted that Walmart’s participation in a national healthcare network means employees typically choose from a list of participating providers and high-profile hospitals that dwarfs the number of options on Obamacare exchanges. (more…)

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