Remote Patient Testing Faces a Cloudy Future under VALID

It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here).  While the potential mitigating impact of the “grandfathering” clause on laboratories currently offering LDTs has been the focus of much attention, many of the numerous other provisions have received little attention.  One example is a short provision that could have a large adverse effect on telehealth-based laboratory testing by sharply restricting grandfathering.

This is not a trivial matter.  Telehealth has become increasing important to the health care system.  It has undergone dramatic recent growth, due in part to COVID-19.  Telehealth can address significant issues with access and convenience.

In response to concerns that VALID would harm health care by blocking currently available tests, the grandfathering provision has been expanded.  However, not all LDTs currently on the market would qualify for grandfathering.  One significant limitation is that VALID would prohibit laboratories from performing LDTs on specimens collected at home unless the specimen collection devices used for such collection are FDA authorized for the specific type of testing performed by the laboratory.  While there are numerous commercial products labeled for sample collection by health care professionals, there are very few collection devices explicitly “authorized” for at-home collection.  Thus, this condition could force laboratories to reduce – or even discontinue — home collection-based testing. (FDA has, in fact, been very resistant to allowing home collection devices on the market, but that’s another story for another day.)  Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

The latest draft of the VALID Act being circulated states (Section 587G) that “in vitro clinical tests” (a term that encompasses tests now offered as LDTs) will be exempt from the new statutory requirements if they were “first offered for clinical use … not later than 45 days after the date of enactment” of the legislation, as long as they meet certain conditions.

Of relevance here, the grandfathering provision applies to an LDT only if:

• The test is not for use with home specimen collection, unless the specimen is collected with a collection container, receptacle, or kit that—
  1. has been approved, cleared, or authorized by the Secretary for home specimen collection and the collection is performed pursuant to the approved, cleared, or authorized labeling, including any indication for use as prescription use or over-the-counter use, or
  2. is exempt from premarket review and its use is consistent with applicable limitations on the exemption. (Emphasis added)

This provision could upend longstanding laboratory practice.  Laboratories routinely test specimens collected in a wide range of specimen types (e.g., blood, urine, saliva) that have been collected using a variety of specimen collection devices.  Laboratories also routinely supply third-party sourced collection devices from IVD manufacturers and distribute them to end users, which may include blood collection stations, physician offices, or – increasingly – individuals at home.  Laboratories are responsible under CLIA to ensure that the specimen collection and transport method adequately maintains sample integrity.

Many of these collection devices are classified as Class I, 510(k)-exempt (e.g., capillary blood collection tube) while some are Class II and require 510(k) clearance (e.g., blood specimen collection device).   The classification regulations typically are worded generically, i.e., they do not specify the type of test that can be performed on the specimen or the setting in which specimen collection must be performed.  Collection device manufacturers routinely sell these devices to laboratories for general specimen collection purposes, without labeling or promoting them for a specific type of test or the setting of collection.  Laboratories take these collection devices, which are lawfully in distribution, and then send them to consumers.

The clause stating that the use of the collection container must be “consistent with applicable limitations on the exemption” could (and we believe in some circumstances likely would) be interpreted by FDA to prohibit home collection unless the collection device was specifically authorized for the type of test being performed by the laboratory.  FDA has in fact asserted this position in the past: CRL v. Sullivan involved an effort by FDA to prohibit a clinical laboratory from offering LDT-based HIV antibody testing on urine and saliva specimens on the basis that the specimen collection devices did not have FDA premarket approval for such testing.  While the appellate court in that case disagreed, based on the “common sense” proposition that the “function of generic . . . specimen containers does not vary with the protocols later executed upon the samples they hold” – the VALID Act’s provision could provide renewed support for FDA’s position.  FDA could also argue that products that are otherwise exempt lose that exemption if they are intended to be used by patients for home collection.The specimen collection provision could therefore limit consumer access to a wide range of laboratory testing via “telehealth.”  Home specimen collection is a linchpin of remote laboratory testing, which has grown in popularity because of the pandemic but is expected to continue to grow significantly even in a post-COVID environment (see here).  The inability to offer existing LDTs via telehealth could create substantial barriers to consumer access to home tests.

In summary, under the VALID Act’s “grandfathering” provision, laboratories may continue performing their LDTs on home-collected specimens only if the specimen collection devices have been specifically authorized for such use or, for devices that are otherwise exempt from FDA review, the device’s use is deemed consistent with the limitations on that exemption.  Since very few specimen collection devices include home use indications and FDA could take the view that an otherwise exempt device forfeits the exemption if intended for home use, the VALID Act may effectively limit the performance of LDTs to specimens collected in a healthcare setting.  Telehealth-based laboratory services providers may well find it much harder to source LDTs, which are critical to caring for their patients.

As far as we can tell, inhibiting telehealth-based laboratory services is not a goal of the legislation, but an inadvertent side effect. Indeed, creating barriers to telehealth-based laboratory testing would appear contrary to bipartisan Congressional efforts to foster telehealth flexibility during the pandemic (see here) which stakeholders have overwhelmingly urged Congressional leaders to extend (see here).  It similarly is out of step with HHS initiatives aimed at expanding telehealth to enable direct to consumer care (see here).

Thus, this seemingly insignificant clause in VALID could have far reaching, unintended consequences.  This makes us wonder what else is lurking in this is nearly 250-page, 43,000-word bill that could have far-reaching – and unintended – consequences. The legislation never received any consideration by a House committee.  And it has never been reviewed as a standalone bill by either chamber.  The seemingly inadvertent limitation on home testing for telehealth stands as a warning sign that the effects of the bill should be better understood by Congress before the bill is enacted.