Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."

The CMS said in the draft Medicare physician fee schedule (MPFS) that it is proposing to add four codes for the use of telehealth, although much of the telehealth focus in the draft was on treatment of opioid use disorders. There were also provisions in the draft dealing with rates for various scopes used in surgical procedures, as well as a nod toward more engagement on the agency's advisory opinion process despite some concerns that requests for such opinions could prove unmanageable. (See BioWorld MedTech, Aug. 1, 2019.)

Don May, executive vice president for payment policy at Advamed, said the association was supportive of the changes proposed for telehealth services found in the MPFS draft, but said the agency should rethink its policies across "many benefit categories" if telehealth is to live up to its billing. May said that in addition to posting notices of proposed rulemaking, the CMS should convene an advisory committee consisting in part of digital technology vendors, in addition to patients and providers, who can shed some light on the effect of existing payment policies on access to digital health. He said such a committee should meet on a regular basis and that those meetings should be open to the public to allow for input from those not serving on the committee.

'Fear of audits' sustains overdocumentation

The American Medical Informatics Association (AMIA) of Bethesda, Md., said it supports CMS's proposal to adjust the documentation requirements related to evaluation and management (E&M) services. AMIA's president and CEO, Douglas Fridsma, and board chairman, Peter Embi, said the elimination of the patient history and physical examination requirements – along with the option to document the encounter using time or medical decision-making – "represents the greatest opportunity medicine has had to rethink how the patient's story is captured and conveyed for continuity of care."

Nonetheless, Fridsma and Embi said fears of audit and incentives created by reimbursement will sustain the practice of overdocumentation. They noted that the inertia still seen in fee-for-service care may be the largest source of drag on the effectiveness of the Medicare Merit-based Incentive Payment System, adding that the agency could work with the medical specialty societies to establish benchmarks for clinicians and Medicare auditors regarding time-based billing and medical decision making.

Advamed's May said CMS should not read too much into the lack of feedback on whether additional telehealth services are needed, noting that the addition of category 2 services requires data from clinical studies. He suggested the agency consider allowing the use of observational studies and other sources of evidence beyond prospective studies to provide the needed data, adding that the legislatively mandated study of utilization of telehealth by accountable care organizations could provide much of the data needed to establish the impact of telehealth services.

While the Center for Medicare and Medicaid Innovation is not required to file a report on such uses of telehealth, May said CMMI could rely on its experience in this area to produce such studies.

MDMA says 'flawed methodology'

Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), took aim at some of the relative value units for several services and procedures, including those for minimally invasive spine procedures. Leahey said the American Medical Association's relative value update committee was blasted for using a "flawed methodology" in its survey of physicians in 2014 for CPT code 27279 (imaging for arthrodesis of the sacroiliac joint), which yielded a work relative value of 9.03. The same value was proposed four years later, but Leahey said a more appropriate value would be 20.0, which would bring this code more in line with CPT 27280, adding that experienced surgeons had criticized this feature of the draft MPFS.

Another pair of CPT codes proposal that drew criticism from MDMA were 52441 (cystourethroscopy/single permanent adjustable prostatic implant) and 52442 (multiple implants). Leahey said the CMS should leave the relative values for these codes at the levels recommended by the relative value update committee of 4.50 (52441) and 1.20 (52442) instead of the lower levels CMS had floated in the physician fee draft.

Intensity vs. time for TAVR

The American College of Cardiology (ACC) said the CMS has focused "disproportionately" on the difference in in practice time for implant of transcatheter aortic valve replacement (TAVR) devices between the introduction of this technology and subsequent years. ACC President Richard Kovacs said the updated version of the national coverage determination (NCD)for TAVR, posted in March 2019, had modified institutional and operator experience, but that the NCD update did not "fundamentally change" the approach to coverage.

The ACC's preference, he said, is that the CMS to routinely account for intensity, magnitude estimation and survey data to "avoid payment disparities in the relative valuation payment system" rather than rely on "arbitrary calculations based on time" to arrive at relative values that are nearly uniformly lower than those developed via the update committee process.

Among the other issues cited by the ACC is the CPT code for myocardial PET imaging (CPT 78492), the volume of which Kovacs said had at least doubled between 2009 and 2014. Kovacs said the proposed rate would constitute a cut of 72%, similar to the rate cuts that would be seen for at least two other codes related to myocardial perfusion studies. He said a more appropriate course of action would be to sustain current rates while additional data are collected in order to avoid under-valuation of the technical component of these services. Any drastic cuts should be phased in so as to avoid significant financial damage to the affected health care professionals, he said.

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