Medicare's Clinical Research Policy -- Another Shoe Dropping?

That soft "thud" out of Baltimore last Friday may have been another Medicare clinical research shoe dropping.  For among a small torrent of transmittals that CMS uncorked just before the long holiday weekend were two that speak directly to how providers file claims for Medicare-reimbursed research.

The first transmittal, "New HCPCS Modifiers when Billing for Patient Care in Clinical Research Studies,"  is pretty much self-descriptive.  Effective January 1, with implementation no later than April 7, the transmittal discontinues the current HCPCS modifiers QA (IDE devices), QR (Medicare-specified study), and QV (routine care) and replaces them with two new modifiers . . . QO and Q1, which define, respectively, "investigational clinical service" and "routine clinical service."  Why?  "It has come to our attention," says CMS, referring to QA, QR, and QV, "that these modifiers are not being used as intended as the long descriptions are vague and overlapping."

The tenor of this language rang familiar, and a quick check confirmed it to be an echo of the 2006-2007 debate surrounding the agency's first and second reconsiderations of Medicare's clinical trial policy.  Indeed, Friday's transmittal uses language to define the new QO and Q1 modifiers that's virtually identical to that which CMS proposed -- but never finalized -- in the clinical trial policy's second reconsideration last July.  Aside from whatever substantive implications this language may hold, it's interesting that CMS now achieves via transmittal a result it previously sought through a national coverage decision (and which some might say are legally attainable only though notice-and-comment rulemaking).

The second Friday transmittal, bearing April effective and implementation dates and traveling under the innocuous "Requirements for Including an 8-Digit Clinical Trial Number on Claims," proceeds in a similar if less prescriptive vein.  The punch line for this transmittal is that it allows providers and suppliers to voluntarily add to claims for Medicare-covered research the number assigned by the National Library of Medicine's Clinical Trials Data Bank.  CMS implied that this change would help keep Medicare's records consistent with FDA's clinical trial-registration requirements.  Again, echoes of the recent past:  In its proposed-but-never finalized decision memo on the second clinical trials reconsideration, CMS included as one required standard that a Medicare-reimbursed study be "registered on the ClinicalTrials.gov website by the study sponsor/principal investigator prior to the enrollment of the first study subject." 

Are these two transmittals just so much regulatory flotsam?  Or do they presage something more?

Last October, in the second clinical trials reconsideration -- in the policy that CMS actually did finalize -- the agency cited the recent FDA statutory changes and other factors as reasons for not altering Medicare's research policy "at this time."  And so as we consider the new procedures for claiming reimbursement for clinical research, it's hard not to wonder if we're discarding an old shoe or slipping into a new one.

Comments

[Joel Harder]

While I concur with the assessment, CMS is still adding the proposed NCD Clinical Trial Policy provisions into any new Coverage with Evidence Development decisions.

[Ted Mannen]

Yes, that's certainly the case. The connection with CED was established in CMS' first reconsideration of the clinical research policy.

[christian louboutin]

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