Two bipartisan-backed bills could affect mobile health

By Jonah Comstock
11:14 am
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Gregg Harper Rep. Gregg Harper (R- Mississippi)

Calling Obamacare a contentious topic between Republicans and Democrats in the US House of Representatives would be something of an understatement. But that doesn't mean there's no bipartisan momentum in healthcare legislation. One bill currently in the House would expand Medicare and Medicaid coverage for telehealth, while another would restrict the FDA's regulatory purview over mobile health apps.

Last week US Representatives Gregg Harper (R-Miss.), Mike Thompson (D-Calif.), Devin Nunes (R-Calif.), and Peter Welch (D-Vt.) introduced to Congress the "Telehealth Enhancement Act of 2013," a bill that seeks to modify Medicare and Medicaid to more fully cover telemedicine, including remote patient monitoring.

The bill is similar to one proposed by Thompson at the very end of the last Congressional session, but considerably less comprehensive.

"We expect it to be passed piecemeal," American Telemedicine Association CEO Jonathan Linkous told MobiHealthNews about the Thompson bill at the time. "With a comprehensive bill like this you have to expect to get things passed however you can pass them."

As such, this year's bill includes a few of the provisions from the Thompson bill most likely to be passed by Congress.

"What we're focused on right now is having a realistic package that could get bipartisan support and withstand the scrutiny of the budget office," Gary Capistrant, Senior Director of Public Policy at ATA told MobiHealthNews. "It's not a big or expansive bill, but we had to be very smart about what was doable for us this year."

Primarily, the bill would eliminate restrictions on reimbursement for telehealth that are currently built in to Medicare. Despite that new payment models like bundled payments and accountable care organizations are meant to afford physicians and hospitals more freedom in how they treat patients, Capistrant said they're still subject to restrictions. These include only covering telehealth in urban areas and failing to cover remote patient monitoring or store and forward diagnostics. The bill removes these and similar restrictions related to home-based video services for hospice care, home dialysis, and homebound beneficiaries.

The bill also gives states the option of setting up telehealth consultation networks for high-risk pregnancies in their Medicaid programs, something that has been successfully piloted in Arkansas. Capistrant said that ATA commissioned Evolent Health to calculate savings from such a plan, and the conclusion was that it would save $186 million over 10 years.

Finally, as Linkous alluded to in a recent conversation with MobiHealthNews, the bill would introduce a shared savings component to Medicare's incentive plan for hospitals reducing readmissions. Currently, hospitals can have their Medicare funding cut for failing to reduce readmissions a certain amount. While the bill stipulates the addition of a positive incentive, it's not specific about the exact amount, leaving that up to the discretion of CMS.

"With respect to payment for discharges occurring during a fiscal year beginning on or after October 1, 2014," the bill says, "in order to provide a positive incentive for hospitals [...] to lower their excess readmission ratios, the Secretary shall make an additional payment to a hospital in such proportion as provides for a sharing of the savings from such better-than-expected performance between the hospital and the program under this title."

Another bipartisan-sponsored piece of legislation was recently proposed by Representative Marsha Blackburn (R-Tenn.) and Representatives Gene Green (D-Texas), Dr. Phil Gingrey (R-Georgia), Diana DeGette (D-Colorado), Greg Walden (R-Oregon), and G. K. Butterfield (D-N.C.). Called the SOFTWARE Act, the bill is the latest move in an ongoing struggle about the FDA's role in mobile health regulation.

As well as participating in the Congressional Hearings on mobile medical apps and signing a letter to the FDA asking for faster, clearer regulations, Blackburn has said in the past that she would rather the ONC, not FDA, regulate medical apps.

While Blackburn's bill would not put medical apps under the ONC's jurisdiction, it would limit the number and kinds of apps FDA would be responsible for regulating, exempting the categories of "clinical software" and "health software," defined as software that "captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals."

While the bill appears to take regulation of those apps away from the FDA, it does not establish what, if any, government body should be responsible for overseeing those applications.

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