By a voice vote, the House Energy and Commerce health subcommittee on Thursday approved the latest draft of its 21st Century Cures Act and forwarded it to the full committee for consideration. While the subcommittee says the proposed bipartisan legislation is the product of more than a year of listening to healthcare stakeholders across the country, the bill has detractors who feel that members of Congress have not been paying attention to their concerns.

“Every policy has been scrutinized, every voice considered,” according to Rep. Fred Upton (R-Mich.), chairman of the full committee, which will consider the legislation next week. Although the subcommittee asserts that patient and industry groups have “lined up” to support the provisions of the 21st Century Cures Act, critics of the updated discussion draft claim that the legislation falls short in several key technology areas.

Also See: 21st Century Cures Draft Bill Gets Stakeholder OK

One of those areas is telehealth. Section 3021 of the bill, “Telehealth services under the Medicare program,” calls on 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.

However, the American Telemedicine Association (ATA) expressed its disappointment at the lack of substantive telehealth provisions in the current version of the 21st Century Cures bill.

“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 ATA. “These studies are ‘snooze buttons’ that allow CMS to delay any action for years.  Unfortunately, this is not the first time this has occurred.  Fifteen years ago CMS also convinced Congress to ask for a study instead of taking action—but the agency has yet to deliver that report.  We suspect the same will occur this time around as well.”

“The new version of the bill leaves the Medicare program in the slow lanes while states, private payers and every other developed nation are quickly adopting the use of technology to transform the delivery of healthcare,” added Linkous. “It is ironic that a bill titled the 21st Century Cures will leave Medicare and Medicaid patients firmly in the 20th Century when it comes to delivering healthcare.”

HIMSS also expressed its disappointment by what it called the “narrow scope of the language” concerning telehealth. “HIMSS and its members want to work with Congress and our coalition partners to develop and enact policies that encourage use of broader types of technologies that will expand access to high quality, cost-effective healthcare,” according to a written statement. “HIMSS looks forward to continuing this dialogue with both the House and the Senate to address these concerns.”

At the subcommittee’s May 14 markup of the 21st Century Cures Act, Rep. Doris Matsui (D-Calif.) countered such criticism and made the case that “if fixing this problem were simple, it would have been done years ago.” Acknowledging stakeholder disappointment in the limited nature of the legislative language, Matsui said the telehealth section of the bill is “designed to be an on-ramp to the ongoing effort” of the Energy and Commerce Bipartisan Telemedicine Member Working Group.

“This is not the last that you will hear from us and the provision that was included [in the draft legislation] is not a replacement for our larger effort that will get to ways to expand Medicare reimbursement for telehealth,” she promised.     

Another technology area lacking in the proposed legislation, say stakeholders, is how lawmakers deal with the regulation of health software. 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 by the committee’s vice chair Rep. Marsha Blackburn (R-Tenn.) in October 2013.

The latest language of the SOFTWARE Act would curb the U.S. Food and Drug Administration’s authority to regulate health information technology by establishing a risk-based regulatory framework for health IT. And, though HIMSS said it “encouraged a risk-based oversight framework that includes factors, such as risk relative to intended use and cost/benefit of any proposed oversight, with the intent of ensuring patient safety,” the organization added it is “concerned that the definition of clinical decision support may be impacted by the current legislation.”

Instead, HIMSS argues that Congress should support the risk-based oversight framework for health IT software and devices specified in the FDASIA Health IT Report issued in April 2014 by FDA, FTC and ONC.

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