The “21st Century Cures Act” (Cures) cleared its first major hurdle last month when the House Energy and Commerce Committee voted unanimously in favor of the legislation.  Among other things, Cures helps to modernize Medicare by including mandatory interoperability for electronic health records (EHR), study of and support for telehealth, and the creation of a pharmaceutical and technology ombudsman.

EHR Interoperability

Cures includes language on EHR interoperability that attempts to eliminate barriers to the sharing of clinical data. Beginning in 2018, EHR vendors would be required to certify compliance with interoperability standards and would be subject to decertification from the government’s EHR incentive program for non-compliance.  Cures lists some broad criteria for EHR interoperability:

1. The EHR technology must allow for the “secure transfer” of all patient data from all other qualified EHR programs.

2. The EHR technology must allow “complete access to health data” without “special effort” by the requestor.

3. The EHR technology must not engage in “information blocking,” which is the knowing and unreasonable interference with the ability of authorized persons to access, exchange, or use EHR. For more information on data blocking, see this recent article.

Cures tasks the Department of Health and Human Services (HHS) with adopting “appropriate” methods by which to measure the satisfaction of the EHR criteria.  For the study of these methods, Cures provides for the establishment of a “Charter Organization,” made up of representatives from the health care standards development organizations that are accredited by the American National Standards Institute.  This group would provide recommendations for measuring compliance with Cure’s interoperability provisions.

These recommendations would be subject to public comment and ultimately to the approval of the Secretary of HHS.  The Secretary would be tasked with the adoption of interim and further methods of measurement for interoperability by negotiated rulemaking.  This process would be carried out in consultation with “appropriate” organizations and stakeholders.

A provider using an uncertified EHR vendor would be subject to a Medicare payment penalty.  Both payment of the penalty or, in the alternative, switching to a certified vendor, could prove extremely expensive.  Thus the interoperability provisions have caused considerable consternation among providers.  These provisions have been called “blunt instruments” that will hurt innocent providers along with the bad actors.

However, providers may be able to seek shelter in hardship exemptions.  At the discretion of HHS, these exemptions can be made available to providers who use decertified software and can be authorized for periods of one to five years.  Unfortunately, providers cannot now know, with any degree of certainty, how readily and for how long HHS would issue the exemptions.

Telehealth     

Cures also calls for intensive study of telehealth.  The Medicare Payment Advisory Commission (MedPAC) would be obligated to collect data on services where payments are made for telehealth and areas where payments are not provided.  Further, MedPAC would need to identify barriers to “furnishing telehealth” in areas where payment can be made.

Cures also obligates the Centers for Medicare and Medicaid Services (CMS) to report information in four areas:

1. CMS must identify populations of Medicare beneficiaries whose care “may be improved most” by the expansion of telehealth services.

2. CMS must describe its current activities related to the actual adoption and use of telehealth services.

3. CMS must identify the types of “high volume procedures codes or diagnostics” which might be most “suitable” to adaption to telehealth.

4. CMS must identify barriers to the expansion of telehealth services.

Although Cures calls for study, and expresses the “Sense of Congress” in favor of telehealth generally and the implementation of interstate telehealth services in particular, it does not mandate any changes to the limited telehealth services currently provided under the Medicare program.  One advocate for telehealth referred to the studies as “snooze buttons” that allow CMS to delay action for years.

Pharmaceutical and Technology Ombudsman

Finally, Cures would create a pharmaceutical and technology ombudsman within CMS.  This ombudsman would receive and respond to complaints from manufacturers of pharmaceuticals, biotechnology, medical devices, and diagnostic products about the coverage, coding, or payment for those products.  The exact scope of the ombudsman’s role is not clear but, given the breadth of the duties outlined in Cures, creation of the ombudsman position could be a significant development.

The 51-0 vote in favor of this legislation in the Energy & Commerce Committee might be a harbinger of bipartisanship on at least some health issues, but Cures still faces a full vote of the House, which may happen as early as this month.  This would be followed by a possible battle in the Senate, where members like Lamar Alexander (R-Tenn.) and Richard Burr (R-N.C.) have their own ideas about modernizing research and innovation within the health space.

Jack Lund, co-author of this article, is a summer associate and student at the University of Virginia School of Law