This week the U.S. House Energy and Commerce committee voted unanimously in favor of the 21st Century Cures Act, formally known as H.R. 6. Some critics have voiced concern that the health bill doesn’t do enough for patient data oversight or telemedicine, however.
How the bill deals with the regulation of health software is one of the areas that has come under fire. Sections 2221-2223 of the 21st Century Cures Act are based on a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, first introduced in 2013. The act curbs the U.S. Food and Drug Administration’s authority to regulate health information technology by establishing a risk-based regulatory framework for health IT.
Some have argued that Congress should have supported an alternate risk-based oversight framework for health IT software and devices specified in the FDASIA Health IT Report instead.
Telemedicine also has gotten short shift in the bill, according to some.
Section 3021 of the bill, “Telehealth services under the Medicare program,” asks the Centers for Medicare and Medicaid Services to provide Congress with a report on the populations of Medicare beneficiaries whose care may be improved most by the expansion of telehealth services, the types of high volume procedures codes or diagnoses which might be suitable for telehealth, as well as the barriers that might prevent expansion of such services.
The critics say this is just kicking the can down the road, however.
“It appears that the staff and members of the committee have once again been led by CMS and the Congressional Budget Office into asking for a study instead of taking real action,” said Jonathan Linkous, CEO of the American Telemedicine Association (News - Alert). “These studies are ‘snooze buttons’ that allow CMS to delay any action for years.”
If the issues of telemedicine were simple, however, they already would have been fixed. That’s the stance of Rep. Doris Matsui (D-Calif.).
Noting the disappointment of some stakeholders at the outcome of the legislation, Matsui added: “This is not the last that you will hear from us and the provision that was included is not a replacement for our larger effort that will get to ways to expand Medicare reimbursement for telehealth,” she said.
Edited by Rory J. Thompson