CLN - Federal Insider

Future of LDT Regulation Hangs in the Balance

Federal Insider: July/August 2022

Even as a Senate committee has voted to include the VALID Act within a larger medical device user fee bill, the FDASLA Act, more than 100 medical and patient organizations have joined AACC in calling out problems with provisions in the bill. AACC has long argued that VALID would burden clinical laboratories with a new, duplicative layer of onerous costs and regulation and limit patient access to laboratory developed tests (LDTs). AACC believes any changes to LDT regulation should be accomplished through the Centers for Medicare and Medicaid Services (CMS), the agency that currently oversees LDTs through CLIA.

In a letter with 94 other healthcare organizations, AACC called on Congress “not to rush this very flawed, problematic legislation through the user fee reauthorization legislative process.”

The American Medical Association and the American Hospital Association (AHA) also have expressed concerns with the VALID Act. “The AHA is concerned that, if enacted in its current form, the VALID Act could lead to a loss of patient access to many critical tests and could dramatically slow down advances in hospital and health system laboratory medicine,” AHA wrote to senators.

With the Senate committee’s vote to keep VALID in the larger FDASLA bill, AACC and other groups remain focused on the next steps in the legislative process. At CLN press time, the bill had yet to arrive on the Senate floor. In addition, the House version of FDASLA does not include VALID, and reconciling the law between the two chambers opens an opportunity to make changes.

AACC members have been meeting virtually with the offices of legislators in both the Senate and the House and have encouraged the laboratory community to participate in the association’s grassroots campaign:

Colorado Launches First State-Based Health Plan Under New ACA Program

The Centers for Medicare and Medicaid Services (CMS) announced approval of Colorado’s request to create the “Colorado Option,” a state-specific health coverage plan that aims to increase health coverage enrollment and lower healthcare costs starting in 2023.

The new state health plan operates under a special section of the Affordable Care Act (ACA) allowing states to apply for state innovation waivers in order to pursue alternative strategies for health insurance.

Colorado’s plan will combine federal support and state subsidies and projects that approximately 32,000 residents will gain health insurance by 2027. The plan will be available to those who purchase insurance on the individual market or to small employers with fewer than 100 employees. The state estimates it can lower premiums by up to 15% by 2025.

New Guidance on HIPAA and Audio-Only Telehealth

The Department of Health and Human Services (HHS) through its Office for Civil Rights (OCR) issued guidance on how healthcare providers and health plans can offer audio-only telehealth services and still meet Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security, and breach notification rules.

In its announcement, HHS noted that telehealth can significantly expand access to healthcare, but certain populations have trouble accessing audio-video telehealth due to financial resources, English proficiency, disability, and availability of broadband internet access.

One critical clarification in the guidance is that the HIPAA Security Rule does not apply to audio-only telehealth services when the healthcare provider is using a standard telephone landline. Under HIPAA rules, landlines are not considered “electronic,” reducing the burden of security measures that would be required for internet-based systems.

The caveat: many providers may be using landlines that hospitals have replaced with Voice over Internet Protocol (VoIP) that use the internet or Wi-Fi. In these cases, audio-only communication is considered electronic transmission of protected health information and the full suite of HIPAA security rules come into play.