MEDTECH Act Vital to Healthcare Innovation

A new bill, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, has been introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), with the aim to exempt low-risk medical software and mobile medical apps from regulation by the U.S. Food and Drug Administration. It was officially was introduced to Congress Dec. 4, 2014.

According to FierceHealthIT, the bill has been introduced as the “the beginning of a conversation” on the issue of health IT regulation. The bill will be re-introduced in January if it doesn’t move throughout the remainder of the 2014 lame duck session.

“Our bill attempts to create specific legal definitions around types of software to exempt them from FDA regulation,” Hatch told FierceHealthIT. “Specifically, the bill limits and clarifies the FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records and software that aids healthcare providers in developing treatment recommendations for their patients.”
Hatch also said his bill, in conjunction with a repeal of the medical device tax, is important to protecting and enabling innovation in healthcare. “Since the tax took effect last year, it has been a drain on American innovation, job growth and our ability to provide groundbreaking medical technologies to patients in need,” he told FierceHealthIT.

According to HIMSS, the MEDTECH Act would allow the FDA to continue regulating EHR software that serves as an accessory to medical devices of medium or high risk, but would exclude EHR software considered lower risk from regulation in five specific areas:

• Software intended for administrative or operational support of a healthcare facility
• Products unrelated to clinical treatment of a disease or disorder,
• EHRs that “functionally represent a medical chart, including patient history records, but excluding diagnostic image data,” as long as the EHR system is “validated prior to marketing”,
• Software intended to format, organize or otherwise present clinical laboratory test report data prior to analysis;
• Software for analyzing and supporting the display or printing of patient or other medical information for supporting or providing prevention, diagnostic or treatment recommendations to clinicians.

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is regulatory legislation that that provides the FDA with the authority to:

• Collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics,
• Promote innovation to speed patient access to safe and effective products,
• Increase stakeholder involvement in FDA processes;
• Enhance the safety of the drug supply chain.

FDASIA included the Medical Device User Fee Amendments of 2012, or MDUFA III.
The intent of MDUFA III was to encourage greater collaboration and efficiency of regulatory processes between the medical device industry and the FDA to reduce the time it takes to bring safe and effective medical devices to the U.S. market. EHRs were not clearly distinguished and may have led to over-regulation of medical software at the “expense of continued innovation.”
MEDTECH Act is a response to that.

Patients are becoming more familiar with and are now accessing information in their electronic health records now more than at any other time. In fact, access to this point has nearly doubled, surging from 26 percent in 2011 to 50 percent in 2014, according to results of a study released recently by the National Partnership for Women & Families.

According the research, in the last year, more than four in five patients with online access to their health records (86 percent) used their online records at least once, and more than half (55 percent) used them three or more times a year. The reasons for this might be many, but it’s very likely that familiarity with patient portals and encouragement from their physicians, who are vying for meaningful use dollars, is at play here.

The report, “Engaging Patients and Families: How Consumers Value and Use Health IT,” offers an in-depth look at how patients value and use health IT, such as EHRs, and which functions are important to them. The National Partnership report provides seven strategies to engage patients and families more effectively in their care and was released five years after the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 was enacted and the Medicare and Medicaid EHR “Meaningful Use” Incentive Program began.

The survey was collected by asking participants some of the same questions as those that were asked in 2011. According to the National Partnership for Women & Families’ report, the updated data collected identifies trends in patient attitudes, “reflecting progress from the launch of the meaningful use and other federal and state programs to substantial adoption and use of EHRs today.”

Key findings include:

• 80 percent of adults in the United States who have doctors and know what kind of record systems—electronic or paper—their doctors use said that their doctors use EHR systems, up from 64 percent in 2011;
• 85 percent to 96 percent of all patients found EHRs useful in various aspects of care delivery, while only 57 percent to 68 percent saw paper records as useful;
• Consumers want even more robust functionality and features of online access than are available today, including the ability to email providers (56 percent); review treatment plans (56 percent), doctors’ notes (58 percent) and test results (75 percent); schedule appointments (64 percent); and submit medication refill requests (59 percent);
• Patients’ trust in the privacy and security of EHRs has increased since 2011, and patients with online access to their health information have a much higher level of trust in their doctor and medical staff (77 percent) than those with EHRs that don’t include online access (67 percent); and

Different populations prefer and use different health IT functionalities, the study found. For instance, Hispanic adults were significantly more likely than non-Hispanic whites (78 percent vs. 55 percent) to say that having online access to their EHRs increases their desire to do something about their health; and African American adults were among the most likely to say that EHRs are helpful in finding and correcting medical errors and keeping up with medications. So specialized strategies may be necessary to improve health outcomes and reduce disparities in underserved populations.

The poll was conducted online with responses from 2,045 adults who indicated that they have a primary doctor and their doctor keeps medical and health information in electronic or paper format. The survey was conducted between April 22 and May 7, 2014.

The results indicate that healthcare organizations must take their jobs of providing access to patient information to patients seriously, not only because of meaningful use requirements, but because patients want their data. Long thought to be a one of the solutions to engaging patients, it now seems as though portals are bringing patients closer to their doctors and possibly their care.

As the population continues to change and patients become more connected, there’s now little doubt that patients will come to expect access, if not control, portions or all of their data. Those organizations that don’t take advantage of these solutions are going to find themselves left in a lurch, and soon.

Hospital CFOs are again reporting that their budgets are thin and that they are facing such a financial drain that they are unable to afford much needed new IT solutions like revenue cycle management software, and that their organization’s financial problems likely will last until at least 2016.

According to a new study published by Black Book Rankings, expenses from investments in electronic health records, health information exchanges and patient portals are currently occupying the majority of hospital’s budgets. In fact, 94 percent of the 2,300 hospital CFOs, CIOs and business office managers surveyed said that implementations of IT systems, particularly EHRs, are impacting their organization’s financial positions and are keeping them from making new, much-needed IT investments.

Strapped hospitals are in need of new solutions to help improve their revenue streams and to dig themselves from near financial ruin because other IT priorities, like meaningful use, continue to take precedence. CFOs at fiscally healthy hospitals, though, say that they are moving ahead with new solutions, like implementing RCM, as they are preparing for the switch to new payment risk models. Ninety-one percent of these individuals said their organizations are fully committed to next generation revenue cycle management solutions and that they are currently in the middle of implementations or plan to outsource or purchase the new software sometime in 2015.

The Black Book study was conducted between June and October 2014 and 590 hospital and inpatient organizations from 45 states responded to the survey. According to the research firm, the hospital RCM software and services industry grew 13 percent in the last year mostly because of business shifts, reimbursement and payment reforms, accountable care participation, physician practice acquisitions, self-pay collection issues and declining margins for hospitals.

“Most hospitals have no choice but to look for next generation solutions to keep their organizations solvent,” said Doug Brown, managing partner of Black Book, in a statement. “Increased self-pay volumes, lack of pricing transparency, no patient financial responsibility/estimation technology and other reimbursement challenges are driving many marginally performing healthcare organizations to the brink.

“Hospital viability has never been more thoroughly secured to a single organizational venture as revenue cycle management transformation,” he added. “And chief financial officers in struggling hospitals are in a very perilous position as the risk models are still being charted while limited funds remain for next generation RCM tools.”

The Black Book report says that hospital CFOs face pressure from approaching payment reforms, poor reimbursements and other financial burdens, and, therefore, lack the resources to move their revenue cycle management plans forward. Shockingly, though, things may be so bad for some of the under-performing hospitals in the U.S. that more than 60 percent of the CFOs in struggling organizations actually expect to be fired within the next year because their organization are focused too heavily on fee-for-service models.

Regarding their financial burdens, more than 55 percent of those surveyed said their hospital’s bad debt comes from outstanding patient balances and can be traced to the proliferation of high-deductible patient health plans; larger plan co-pays; and consistently high numbers of uninsured patients.

Perhaps most eye-opening is that most of the problems reported here could likely have been avoided had these organizations taken a more thorough or active approach to previous IT implementations. Respondents said many of their previous IT implementations were hindered while attempting to bring in solutions that did not fit their organizations or were poorly budgeted.

Health systems small and large should set a clear plan – even borrowing or copying others’ best practices — when undertaking a system implementation or integration. However, even with a plan in place, evolution of the plan should continue.

Despite best practices and proven workflows, leaders must steer clear of cookie-cutter and easy-out approaches. Examine and review their processes, and identify ways that they can reach their goals without setting themselves up for the overwhelming disappointment, and hurdles faced by many. With a plan, and possibly a partner in place, organizations can reach their goals without fear of failure.

For more on managing successful implementations or for guidance on creating a plan for moving a difficult IT task forward, the following resource may provide some insight: Engineering Effective Implementation Plans: Best practices approaches.

Health system leaders continue to face many difficult and ongoing challenges, including managing financials, technology and systems across their networks. According to the American College of Healthcare Executives (ACHE), healthcare reform is near the top list of challenges, as are government mandates and patient safety and quality. However, these are not their only concerns.

There are other issues, such as changing budgets; infrastructure and technology; and staff resources, revenue cycle management and a variety of other problems. Here are some of the most pressing issues hospital leaders face every day:

Balancing time, priorities and tasks

Leaders increasingly must borrow experience, resources and talent from a variety of departments and teams within their organizations. Funds are often limited for staff investment in non-critical roles and many positions often go unfilled or under filled. A problem with this approach is that business operations and technology enhancements often go unaddressed, and problems can fester; IT troubles can become huge problems as can poor management of a hospital’s organizational and administrative operations in the long term.

Managing mandates and regulation

ICD-10 is going live Oct. 1, 2015. Meaningful use continues to be a challenge for many. Becker’s Hospital Review reports that the amount of preparation hospitals have devoted to ICD-10 and other mandates varies greatly from institution to institution. “Some have been working diligently for the past two to three years and have made great progress. Other organizations are incredibly far behind. The latter problem isn’t limited to small practices or 90-bed hospitals.” In many cases, health systems continue to do nothing, or have done next to nothing to comply.

“Most have had a hard time preparing for it simply because their resources and time are devoted to meeting other high-priority demands” Becker’s reports.

Payer problems

The payer/physician relationship tends to be tenuous. Providers and their employers face uncertainty, perhaps more so now because of the Affordable Care Act. Hospitals are left wondering how to properly treat the patients who choose to see them according to payer contracts and plan guidelines.

Additionally, according to Medical Economics, ACA has caused many payers to drop physicians from networks, making the process of finding new providers confusing and tedious for patients. Medical Economics says that dealing with payers is a top issue faced by hospitals; according to the magazine, “Insurance companies dictate which doctor, which medicine, which test, how long in the hospital. Insurance companies have planted themselves between the patient and doctors and on top of the money pile.”

Technology costs

Health information technology will continue to incur expenses for the foreseeable future. ICD-10 remains a culprit, as does the seeming never-ending changes related to EHRs and other tech investments. HIPAA compliance also could continue to be a significant investment for health systems. Technology and processes that hinder a hospital’s workflows also can be a huge challenge for healthcare organizations, as well as an expense; technology upgrades alone can break some organizations’ budgets.

Staffing and training

Hospitals continue to face trouble, or at least difficulties, with staffing levels and training current staff.

As reimbursements are becoming tied to performance and patient outcomes, staff will be central to this success. The challenge of finding qualified staff is exacerbated by keeping the talent that can be found, plus turnover rates for physicians are at an all-time high, according to American Medical Group Association. AMGA also speculates that retaining care staff will only intensify as shortages continue to persist and more aging physicians begin to retire from the workforce.

There are other challenges that remain, such as patient engagement and improving health outcomes, but these are some of the most pressing issues that nearly every hospital in the United States faces. The challenges can be overcome, of course, but new approaches and solutions are likely needed in the queue for those tasked with tackling the problems.

Cleveland, OH-based ALEGO HEALTH named top company in 2014 Inaugural Crain’s Cleveland Business FAST 50 Award list of fastest growing companies in Northeast Ohio Healthcare IT services company ALEGO HEALTH selected as the number one company for the 2014 award to identify the fastest 50 revenue growth companies in Northeast Ohio.

WESTLAKE, OH, November 10th , 2014- Alego Health’s Jonathan Levoy, VP of Business Development & Technology, announced today that Alego Health was named as the top company on the 2014 Inaugural FAST 50 Awards list presented by Crain’s Cleveland Business Magazine. “We are extremely honored to be part of this decorated group of companies, especially to be the top company of Inaugural Class members for this award. It is an incredible honor, and a true testament to our employees, clients and partners that we have sustained this success while continuing to grow as we have,” said Mr. Levoy. Crain’s FAST 50 recognizes the entrepreneurial spirit, innovative business tactics and skyrocketing revenue growth of the 50 fastest-growing privately-held companies in Northeast Ohio. The FAST 50 have been selected based on a combination of revenue growth and total revenue. The rankings will be published in the November 10 issue of Crain’s Cleveland Business. The award comes on the heels of being named to the 2014 Inc. 500|5000 award for two straight years and being named to the 2014 Weatherhead 100 Award for the fourth straight year. “We have really had a mind-blowing few years with all of these awards and recognition. But our focus is even sharper now that the expectation level has risen for our organization,” stated Levoy. “Our commitment to our clients and our employees is what drives our success. We can never lose sight of what got us here, and what it will take to make our company sustain this success while continuing to service our clients at the highest levels possible.” Mr. Levoy explained that Alego Health is continuing its growth through sales initiatives that will expand Alego Health’s national reach and product offerings. “Our goal has always been to build a strong local and regional foundation, then to expand our services throughout the US. We have seen some great traction nationally and are moving into new markets every month. We are very proud of our track record, services, and client satisfaction ratings. This has undoubtedly led to the awards that we have received.”

About Crain’s Cleveland Business

Entering its fourth decade of service to Northeast Ohio, Crain’s Cleveland Business is the preeminent source for news, analysis, commentary and data essential for top executives and business owners. Named Ohio’s best business publication several times.

About Alego Health

Founded in 2004, Alego Health, a woman-owned company (WBENC), is headquartered in Westlake, OH, and  is a solutions provider of Healthcare IT Services and Consulting. Alego specializes in providing clinical resources to fulfill Healthcare IT needs for hospital systems, community hospitals, ambulatory facilities, and extended care facilities.

For information about Alego Health please contact: Rachael Watson, Director of Marketing, pr@alegohealth.com, or (440) 617-6517.

Given the ever-present evolution of the use of mobile devices to connect patients and providers to their care, or the practice of care, it’s no wonder that the concept of mHealth is, and will be, a major driver in healthcare. Patients – the consumers of healthcare, are the driver behind the movement, which is leading another movement in healthcare – the consumerization of healthcare.

Since mobile health is now more than a $1.3 billion industry and it’s expected to grow to more than $20 billion by 2018. For physicians, smartphones are the most prominent device in the care setting, and it’s estimated that more than 62 percent of doctors use tablets while more than 72 percent of nurses and other caregivers use smartphones in the care setting. From a patient perspective, almost every person in the US – 247 million – have downloaded a healthcare app for their personal use. There are more than 40,000 apps available for use by patients.

Physician use of devices will increase alongside consumers. Top uses for smartphones by those in healthcare are using generic search functions (46 percent), accessing professional resources (38 percent) and communicating with colleagues (38 percent). Top uses for tablets among clinicians are editing or viewing electronic health records or e-prescribing (49 percent), using generic search functions (39 percent) and accessing a professional resource (24 percent).

According to Becker’s Hospital Review, by 2016 a majority of consumers expect mHealth to significantly change their healthcare experience. For example:

• 59 percent said mHealth will change how information on health issues is found
• 51 percent said mHealth will change how providers or services send general healthcare information
• 49 percent said mHealth will change their overall health management
• 48 percent said mHealth would change how they manage chronic conditions
• 48 percent said mHealth would change how they communicate with providers
• 52 percent said mHealth would make healthcare more convenient
• 48 percent said mHealth will improve healthcare quality
• 46 percent said mHealth will substantially reduce healthcare costs

It’s safe to say that the technology, for either side – patients and physicians – the mobile devices are becoming indispensable. Even though we’re still in the relatively early days of a more connected system, much more is yet to come, according to Axial Exchange.

For example:

• More than 25 percent of commercially-insured patients use mobile apps to manage their health.
• 30 million wearable health devices were shipped in 2012, a 37 percent increase over 2011.
• 75 million US adults used their mobile devices to access health information in 2012, up from 61 million in 2011.
• 29 percent of US adults own a tablet or an eReader, up from 2 percent in 2009.
• More than half of tablet users 55 or older use tablets for health purposes.
• 13 percent of 2012 global Internet traffic came from mobile devices, up from 1 percent in 2009.
• 64 percent of mobile phone time is spent on apps.
• 13 percent of health systems plan to offer their patients an app in 2014.

Finally, strategy& (formerly Booz & Company), presents some compelling information about the effects of mhealth technology in the actual practice of medicine. If for no reason, the following numbers suggest the power of the technology in the care setting, and explain perhaps, why if practice technology is being slow to be implemented in the care setting, this may not be the case for those providing the care.

According strategy&, the following stats seem to paint a rosy picture for those venturing forward in health It:

Here are six statistics on the ever-growing use of mHealth, compiled and presented by Booz & Company.

1. Physicians are 250 percent more likely to own a tablet than other consumers.

2. Forty percent of physicians said tablets help cut down time spent on administrative tasks.

3. The number of nurses and physicians using smartphones in their everyday practices increased by 10 percent in the last year, from 78 percent in 2012 to 86 percent in 2013.

4. There are more than 10,000 medical apps available for consumers, but only 28 percent of smartphone users and 18 percent of tablet users report being “very satisfied” with the quality of the apps.

5. Eighty-eight percent of physicians want patients to monitor their health at home, including weight, blood sugar and vitals.

6. Approximately half of patients, 52 percent, said they would be comfortable undergoing a video consultation with their physician.