Another push for price transparency steps up pressure on medical laboratories and anatomic pathology groups to develop compliance strategies

Clinical laboratories and anatomic pathology groups are under increasing pressure to develop strategies for making their test prices more accessible to patients. Those pressures are likely to grow due to newly proposed federal regulations that aim to allow patients to compare prices for healthcare services on their smartphones.

This new proposed rule comes less than a year after a rule involving hospital prices was implemented. As of January 1, 2019, the federal Centers for Medicare and Medicaid Services (CMS) required US hospitals to post their prices online. Dark Daily reported last year about the risks and opportunities posed by that move.

Now, new proposed rules published separately in March by CMS and also by the Office of the National Coordinator for Health Information Technology (ONC) focus on larger issues involving patient access to electronic health information (EHI). That includes empowering patients who want to compare healthcare costs, said Donald Rucker, MD, National Coordinator for Health Information Technology in a statement to the US Senate Committee on Health, Education, Labor and Pensions (HELP).

“In our current health system, there is an asymmetry of information for patients. They have few ways if any to anticipate or plan for costs, lower or compare costs, and, importantly, measure their quality of care or coverage relative to the price they pay. Transparency in the price and cost of healthcare could help address some of those concerns by empowering patients with information they need to make informed decisions,” said Donald Rucker, MD (above), National Coordinator for Health Information Technology (ONC), in remarks delivered to the US Senate. (Photo copyright: ONC.)

Giving Patients Access to Their Health Information

In May, officials with those agencies discussed the regulations in prepared remarks for a hearing of the HELP committee.

“A central purpose of the proposed [ONC] rule is to facilitate patient access to their EHI on their smartphone, growing a nascent patient- and provider-facing app economy,” he said, noting that this access is impeded by a lack of interoperability between health information systems, as well as restrictions on information exchange imposed by health IT developers.

The proposed rule will mandate use of common software standards so that app developers can access health information systems from different vendors. As a result, patients could choose their own apps to view their data regardless of which electronic health records (EHR) system their provider uses. The rule also includes provisions for dealing with so-called “information blocking” by vendors, Rucker noted.

If the proposed rule is implemented as currently written, there would be a need for clinical laboratories and pathology groups to ensure that their laboratory information systems (LIS) meet the specifications of the new rule. This may mean that, along with enabling two-way digital interfaces with physicians’ EHRs, labs also would need to be able to pass data to the apps and mobile devices used by patients that are covered by the proposed new rule.

“ONC’s proposed rule primarily focuses on clinical data,” he said. “However, advances in computer science and the maturity of data standards are accelerating the convergence of medical data with billing and price data. As such, the rule proposes to include such information as part of a patient’s EHI that should be available for access, exchange, and use.”

Enabling cost comparisons will allow patients to make more-informed decisions about their healthcare, Rucker added. But he acknowledged that implementing this vision won’t be easy.

“Unfortunately, the complex and decentralized nature of how payment information for healthcare services is currently created, structured, and stored presents many challenges to achieving price transparency,” he said. “This entire information chain is geared to retrospective payments rather than prices.”

Rucker told the HELP committee that the [ONC] will be seeking public input about how to capture price information and enable price transparency. Once the rule is finalized and published, providers will have two years to comply.

Medical Laboratories Need a Strategy for Providing Access to Patient Records

The proposed CMS rule imposes requirements on payers to provide electronic access to health claims and other information for their enrollees.

In her prepared remarks for the Senate HELP hearing, Kate Goodrich, MD, Director of the Center for Clinical Standards and Quality (CCSQ) and CMS Chief Medical Officer, said, “A core policy principle underlying our proposals is that every American should be able, without special effort or advanced technical skills, to see, obtain, and use all electronically available information that is relevant to their health, care, and choices—of plans, providers, and specific treatment options.”

That’s all well and good, however, as Fred Schulte, a senior correspondent for Kaiser Health News, wrote in his coverage of the two proposed rules, “Meeting these goals could prove to be a tall order.”

He continued, “For well over a decade, federal officials have struggled to set up a digital records network capable of widespread sharing of medical data and patient records.” Not to mention the billions of dollars already spent by the CMS and ONC incentivizing providers to implement truly interoperable health information exchange (HIE) systems nationwide.

Nevertheless, pressure for greater consumer data access and price transparency will likely continue to build across the healthcare industry, including on medical laboratories. Price transparency as a trend is making steady forward progress, despite resistance by hospitals, physicians, medical associations, and others.

All clinical laboratories should have a strategy to make lab test prices readily available to patients. It is something that will become common at some future point.

—Stephen Beale

Related Information:

Going Above and Beyond the CMS Hospital Price Transparency Rule

Proposed Rule by the Centers for Medicare and Medicaid Services on 03/04/2019

Proposed Rule by the Health and Human Services Department on 03/04/2019

Feds Want to Show Health Care Costs on Your Phone, But That Could Take Years

Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups