AOA’s patient safeguards reflected in final ‘Cures’ Bill

Bipartisan medical innovation legislation that includes key telehealth policy safeguards backed by the AOA over the past two years has become law in the closing days of the 114th Congress.

The  21st Century Cures Act, signed into law by President Barack Obama on Dec. 13, pumps significant funding into disease research and addiction response, while also overhauling regulatory processes aimed at bringing new drugs and proven medical devices to market sooner.

Negotiated and re-negotiated by U.S. House and Senate leaders for the better part of two years, the $6.3 billion legislation was the focus of intense scrutiny by the AOA and others from the start, especially as some parties pushed for sweeping telehealth policy changes, including changes that would have radically altered how eye care is delivered under the Medicare program.

The ultimate outcome of the legislation underscores the work the AOA continues doing on behalf of patients and doctors of optometry, winning key concessions that further advance optometry's priorities and prevent an irresponsible expansion of telehealth.

Reigning back telehealth

Early in committee deliberations, the AOA came out strongly against proposals to capriciously expand uses of telehealth products and programs, including into Medicare. This included some proposals that sought new authority and reimbursement to replace face-to-face care, including eye care, regardless of a patient's health needs.  

While backing new technology to help doctors advance patient care, the AOA stood firmly for safeguards that ensure patient health and safety won't be compromised by false claims that in-person care is unimportant or unnecessary. This section of the bill, which the AOA fought back from a sweeping expansion of telehealth under Medicare, now instead directs the Department of Health and Human Services (HHS) to study how telehealth's expansion may or may not work.

A major win, the section includes AOA-backed language making clear that "any expansion of telemedicine under Medicare...must meet or exceed the conditions of coverage and payment with respect to the Medicare program if the service was furnished in person, including standards of care..."

"It is because of the tireless work of hundreds of AOA volunteer leaders and staff that we were able to fight back and win against those seeking to downplay and discount the essential, in-person care provided by America's doctors of optometry," says Andrea P. Thau, O.D., AOA president. "From the very start, we made clear that, while we fully embrace appropriate uses of new and evolving technologies, we will do everything in our power to beat back those seeking to undermine the standard of care that our patients need and deserve."

Clarifying device requirements

"Breakthrough" medical device prioritization is a major tenet of the Cures Act, providing the HHS Secretary with authority to expedite the development and Food and Drug Administration (FDA) review of devices that provide for more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.

Even with improved patient safety language included in the measure, AOA leaders recognize there will continue to be a need for public health vigilance and aggressive federal advocacy by optometry as next-generation devices and technologies emerge.

The bill is not expected to slow the FDA's investigation of false claims by tech profiteers trying to convince the public that they're offering "online eye exams." The inquiry is based on an AOA complaint filed with the agency in April and supplemented in a meeting last month led by Christopher J. Quinn, O.D., AOA president-elect.

Other noteworthy changes

Additionally, two other specific sections would further impact aspects of doctors' patient care and professional business, including:

• Leveraging EHRs. Sec. 4005 encourages the exchange of health information between registries and EHR systems. The section would add a new requirement that to be certified, EHRs must be capable of transmitting to a clinical data registry, such as AOA MORE (Measures and Outcomes Registry for Eyecare).
• Medicare Local Coverage Determinations (LCDs).Sec. 4009 requires Medicare Administrative Contractors (MACs) that develop aLocal Coverage Determination (LCD) to publicly post that information at least 45 days before the LCD effective date. The MAC also must post responses to comments received on the LCD, list evidence for the decision, and a rationale for the LCD.  "We made clear gains for optometry and our patients, but the fight is just getting started," says Clarke Newman, O.D., AOA Federal Relations Committee (FRC) chair. "Today there is a growing movement aimed at replacing in-person care from eye doctors with technology administered by technicians or even patients themselves.Our patients, now more than ever, need the involvement and advocacy of every AOA-member optometrist and student to prevail in this vital public health policy debate."

Help AOA take action

The AOA continues to fight for what's best for patients and the profession, and members can get involved by joining the AOA Federal Keyperson Network (member login required) to serve as a conduit for the profession. Also, consider donating to AOA-PAC, one of the most effective ways to get involved in the advocacy process.

Read how AOA's early advocacy efforts help shaped the Cures Act.