Senate to HHS: More Time, Flexibility Needed for MU
After months of behind-the-scenes-activity, last week saw the release of a letter from seventeen senators to HHS Secretary Sebelius requesting a one-year extension to the reporting window for Meaningful Use in 2014. CHIME has been a prominent and early advocate for a year-long extension, as many CIOs have yet to receive 2014 Edition EHRs from their vendor. In previous statements to officials from CMS, ONC and members of Congress, CHIME has said an extension would give providers sufficient time to meet new program requirements, while maintaining software development and deployment deadlines, and it will better enable patients to receive the benefits of an e-enabled U.S. healthcare system.
A group of senators took up the call coming from CHIME, AHA, AMA, AAFP, ACP, HIMSS, MGMA and others, saying by the end of 2014, over 500,000 hospitals and physicians will be required to upgrade their existing technology to demonstrate new standards of Meaningful Use in order to be eligible for the corresponding incentive payments. Hospitals have exactly 9 months and one day to implement, test and develop workflows to meet these new requirements and the senators believe “This time pressure has raised questions about whether such a short period for Stage 2 is in the best long-term interest of the program," they told HHS in their letter. Led by Sens. John Thune (R-S.D.) and Lamar Alexander (R-Tenn.) the senators formally requested a one-year extension, citing this timing crunch, a danger of widening the digital divide between more advanced and less advanced facilities and patient safety concerns as a basis for their rationale. The senators were explicit in their belief that Stage 2 should begin on time (tomorrow) and those providers who are ready to move forward should be encouraged to do so. “If the goal is to improve care by achieving broad and meaningful utilization of EHRs, providing sufficient time to ensure a safe, orderly transition through Stage 2 is critical to having stakeholder buy-in,” they said.
“We strongly believe that EHR incentive payments under the policy of Meaningful Use have been essential in moving the nation’s healthcare system into the 21st Century,” CHIME President and CEO Russell P. Branzell said in a statement. “Since we began this conversation last May, our belief was the industry would best be served by maximizing the opportunity of program success, which means maximizing participation in Meaningful Use. This letter is an important step towards seeing that opportunity seized.”
For CHIME members who wish to engage their Senator or Representative on this issue, CHIME has developed a template that can be sent from a personal or organizational perspective. Please click here or contact Jeff Smith for more information.
Leadership Shuffle at ONC Leaves Reider as Acting National Coordinator
ONC’s Chief Medical Officer, Jacob Reider, will become the acting National Coordinator this Friday, when Farzad Mostashari steps down. Also leaving at the end of this week is ONC Principle Deputy National Coordinator David Muntz. “CHIME applauds Mr. Muntz for his tireless efforts to guide providers, policymakers and patients through this exciting journey to modernize the nation’s healthcare system as Principle Deputy National Coordinator,” said a statement from the organization of healthcare CIOs. “In over 20 years of experience as a healthcare CIO, Mr. Muntz has gained respect from all quadrants of the healthcare community. In these last few years as a policymaker, Mr. Muntz served as a vital bridge between the provider community, policymakers and patient advocates. His experience and leadership will be sorely missed at ONC.”
“As ONC widens its focus beyond Meaningful Use and EHR certification criteria, there remains a vast array of challenges, including patient safety, interoperability, and continued alignment with Affordable Care Act programs,” organization continued.
“We pledge to work with ONC and Dr. Jacob Reider as he assumes Acting duties.”
FDA Issues Long-Awaited Guidance on Mobile Medical Apps
The Food & Drug Administration unveiled final guidance on how it intends to regulate mobile medical applications last week. For CIOs who have developed or plan to develop mobile apps to help clinicians monitor, diagnose or treat patients, this is a document you’ll need to understand.
The final guidance has been more than two years in the making, though it does not shift from the "core policy" established in the FDA's 2011 draft guidance on mobile medical applications. Instead, it provides more examples and explanations to clarify how FDA plans to regulate mobile medical apps, says device center Director Jeffrey Shuren. "The gist of that guidance is the following: Although many mobile apps pertain to health, of which many may be medical devices, we are only continuing our oversight for a small subset of those mobile apps that are medical devices," he told a Beltway publication, InsideHealthPolicy.com. According to an agency announcement, the FDA intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended. Examples include mobile medical apps that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
The FDA has cleared about 100 mobile medical applications over the past decade, and nearly half of those were cleared in the past two years.
Legislation & Politics
House, Senate Leadership Still at Odds over ACA Funding; Government Shutdown Nears
For anyone who has been stuck in their server room for the lasts few weeks, the US Federal government is roughly 14 hours away from shutting down for the first time since Roseanne went off the air. While there are a number of factors keeping the House of Representatives and the Senate from passing a budget for the coming fiscal year, the Affordable Care Act sits at the very center of the stalemate. House Republicans are deadlocked with Senate Democrats over funding the ACA; the latest House-passed budget would delay its implementation for a year. However, the Democratic majority in the Senate and the Democratic White House has repeatedly stated that such provisions would not be considered as part of any budget deal. In what is, perhaps, an ironic twist, White House officials have said that most of the Affordable Care Act will continue as planned, government shutdown or not. This is because President Obama has designated many functions of the ACA as essential government service or is funded through mandatory spending, not subject to the annual appropriations process.
With any luck, Washington will emerge from this game of chicken by midnight tonight, avoid a government shutdown on October 1 and live to fight until mid-October – when the federal debt ceiling must be raised (the next political lever House Republicans hope to use in defunding or repealing the ACA).
If you’ve just come up from the server room, perhaps now is a good time to refill your coffee, grab some Snickers bars and go back down for a while.