If you have a pacemaker in your chest, the FDA wants to make sure the device works correctly. But if you want to wear a Fitbit, the agency will leave you alone.
In another sign that the FDA intends to assume a markedly hands-off policy when it comes to the wellness devices and programs that are proliferating in the health IT marketplace, the federal regulatory agency’s Center for Devices and Radiological Health (CDRH) has issued
The CDRH considers wellness devices to be products only intended for general health and available from retailers.
In particular, the products in this category involve claims about sustaining or improving a general state of health and refer to specific diseases or conditions.
Areas monitored by these devices include weight management, physical fitness, stress management, sleep management and sexual function.
Many products on the market – ranging from Fitbit and Jawbone UP wellness bands to smart watches from Pebble, Withings, Samsung, Microsoft, the upcoming Apple Watch and others – offer such capabilities to log, track and trend exercise activity.
As the wellness movement gained momentum last year, the FDA first indicated it was tending toward deregulation when the agency down-classified from Class III high-risk to Class I low-risk what it calls mobile device data systems – which include smartphone app-tethered wellness devices.
In doing so, however, the FDA also sparked criticism from some safety advocates worried that when wellness systems start to move into true medical settings, some of these devices could be under regulated.
Also last year, the FDA issued similar guidance on medical image storage and communications devices, saying they largely pose little safety threat to patients.
With its most recent move, on Jan. 20, the agency also noted a second category of general wellness systems that, using tracking or motivational tools as part of a healthy lifestyle, may help reduce the risk of — or promote “living well” with — certain chronic diseases or conditions.
With this group of products, the FDA cautioned “general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.”
Though it has a handle on measuring the safety and effectiveness of medical devices, the FDA isn’t sure there’s enough publically-accessible information for patients and clinicians to make fully-informed decisions about medical products.
The road to a firm medical device surveillance policy began in 2012, when the Center for Devices and Radiologic Health (CDRH) at the FDA created an action plan. Last year, the CDRH and the Engelberg Center for Healthcare Reform at Brookings Institution assembled a planning board to develop a national postmarket surveillance strategy for medical devices.
The planning board was then funded by the FDA to write a report on what it would take to create a long-term medical device surveillance program that would “generate meaningful and reliable information about medical devices.” The chief objective of the national surveillance program would be to offer more evidence on the benefits and risks of medical devices and inform better regulation of such devices. The program would be separated into two stages. In the first two years, a pilot or “incubator” project would develop a five-year plan installing the surveillance system. The implementation and adjustments to the system would occur in years three through seven.
An FDA blog post — co-authored by the CDRH Director Jeffrey Shuren, M.D., and Thomas P. Gross, M.D., director of the Office of Surveillance and Biometrics in the CDRH — offered insight into the postmarket plan. The authors submit that no amount of premarket evaluation can predict how well a medical device will work for patients and providers once it’s put into action. Due to this fact, Shuren and Gross stressed that building an effective postmarket surveillance system will be a cooperative endeavor. They emphasized this writing, “Achieving our vision for a national system requires thoughtful input and active participation from many key national and international stakeholders.”
In the Strategic Priorities document, covering the FDA’s goals for 2014 through 2018, the agency stated it plans to move from a passive to an active medical device surveillance system. The priorities report left no doubt about the agency’s intentions: “postmarket surveillance of FDA’s regulated products is a major part of our mission to protect public health.”
I’m getting déjà vu from ICD-10, and not in a good way.
As the healthcare industry marches forward on the ICD-10 implementation on Oct. 1, 2015, a look at the coding system’s history shows that the federal government again got caught in a weird time warp.
This situation brings me back to the days I used to cover fire safety in hospitals. Fire protection folks faced a similar dilemma with Uncle Sam using outdated standards.
Today, CMS enforces the year-2000 edition of a guideline called the Life Safety Code. A new version of the code is published by the National Fire Protection Association every three years, so the 2015 version is the most current code book available. That’s 15 years of fire-related engineering developments lost in the Life Safety Code gap, including any advances following the Sept. 11 attacks.
So I have to shake my head when I see another important update tripped up in red tape. ICD-10 has been the subject of several delays owing to concerns and outright opposition to the coding standard. The U.S. Department of Health and Human Services issued its last delay of ICD-10 in April 2014, which led to the latest implementation date.
The punch line is that right now, the United States recognizes ICD-9, which the country adopted a long time ago, in a decade far, far away … 1979 to be exact.
Last week, most members of the House Energy and Commerce Subcommittee on Health voted in favor of keeping ICD-10’s Oct. 1 deadline on track. The subcommittee’s chairman, Rep. Joe Pitts (R-PA), acknowledged the currently-used, timeworn standard.
“ICD-9 is more than 30 years old and does not capture the date needed to track changes in modern medical practice and healthcare delivery,” Pitts said in a statement. Watch the clip below for a taste of the witness testimony during the subcommittee’s hearing.
ICD-10 has about 10 times as many codes for medical conditions compared to its predecessor. Supporters say the increase in codes will lead to better data about patient conditions, although critics say such an onslaught of new information will hinder doctors.
“We don’t treat by statistics. This is just something that gets in our way of taking care of our patients,” William Jefferson Terry, M.D., said during the hearing. Terry is a urologist from Mobile, Ala., who spoke on behalf of the American Urological Association.
The College of Healthcare Information Management Executives (CHIME) wants to see ICD-10 move forward without further delays, which have repeatedly caused providers to waste time and money preparing for the stop-and-go provisions.
“If we’re going to do it, let’s do it and do it well,” Russell Branzell, FCHIME, CHCIO, president of CHIME, told me.
I’ve learned you can’t predict what the government will do with regulations, including the ICD-10 implementation. But at this point, arguing for ICD-9 to stay in place is like hoping your music will always remain on CDs instead of a digital format: There might be great reasons not to modernize, but with that stance, you risk being frozen in the past.
Scott Wallask is news director at SearchHealthIT. Follow him on Twitter @Scott_HighTech.
Verona, Wisc.-based Epic confirmed the plan to the Wisconsin State Journal without elaborating. But the co-founder and former CEO of the biggest consulting firm that works with Epic customers told the paper that such a venture would be a huge stimulus for companies to develop apps for Epic users.
“Once they officially launch this, then it’ll be very, very easy. It will really open the floodgates for anyone that knows Epic to really get their product on the market quickly and in front of Epic’s customers. So the distribution channel is huge,” Marc Bakken, the former CEO of Nordic Consulting, told the Journal.
Beyond expanding its market, Epic’s apparent intentions also raise questions about whether the EHR giant’s move is in response to widespread criticism that its systems aren’t open to working with those from other vendors.
Ironically, in pursuing an app store, Epic may be following the lead of one of its most trenchant critics, athenahealth, whose executives have alleged that Epic’s platforms are not interoperable.
Last year, Watertown, Mass.-based athenahealth opened its “More Disruption Please” online marketplace for its customers.
While an athenahealth spokeswoman declined comment on the Epic strategy, athenahealth sees its marketplace as similar to Apple’s App Store in that customers don’t pay a fee to use the forum, although athenahealth does get a cut of each sale in a revenue-sharing arrangement.
And all of the marketplace companies’ products and services fit in with athenahealth’s cloud-based EHR and billing systems.
In a similar development a few months ago, Epic, which has long disavowed the cloud-based EHR approach that athenahealth is perhaps the most vocal exponent of, confirmed that it is building a cloud hosting data center.
There is a distinct gap between how often patients in the United States are able to use digital technology to access their health information compared to how often they wish they could. If the next generation of patients gets its way, the difference between those two values will shrink considerably.
Just under three-quarters of patients from ages 18 to 34 that responded to Salesforce’s 2015 State of the Connected Patient report stated they value the ability to book appointments and pay bills online when they’re choosing a doctor. In comparison, of the 1,700 total respondents of various ages, 76% said they currently schedule medical appointments over the phone.
A combined 31% of all patients use the Web and email as means of reviewing healthcare information from their physicians. A greater percentage (39%) look at their health information during an in-person visit. Almost two-thirds said they rely on their physician to keep track of their health data, while only 36% use EHRs to do so. Nearly 10% of patients believe nobody is keeping tabs on their health information.
Millenials (those people in the 18-to-34-year-old range) want to take action and avoid feeling disconnected from their medical records. Of that age group, 71% expressed interest in receiving a mobile health application from their physician that would allow them to manage their own care, schedule appointments and view their health data. A slightly higher number would approve of their physician using a mobile device to share information with them during an appointment.
In addition, Millenials hope technology will do more than aid them in making appointments and accessing health data. For example, six out of 10 Millenials are interested in telehealth, in which a patient with questions or concerns about a minor illness could avoid traveling to an in-person doctor’s visit and instead discuss a condition with a medical professional through videoconference.
Changes proposed by CMS to the Medicare Shared Savings Program that could also alter the future of accountable care organizations (ACOs) aren’t significant enough to satisfy a collection of healthcare provider groups.
The opposing group comprises provider healthcare improvement alliance Premier, Inc., the National Association of ACOs and the American Medical Association (AMA). Group members made several major suggestions to CMS, including that the agency:
• Provide medical specialists with the flexibility to take part in more than one ACO,
• Reward ACOs for quality performance
• Provide ACOs with more timely data
“The future of the ACO program is important to the future of Medicare and the health system as a whole. In just three years, physician-led ACOs have made a major impact on improving care coordination and quality while also reducing costs,” Robert M. Wah, M.D., president of the AMA, said in a release.
An AMA release — linking the organization to the larger group — reports Medicare ACOs have created more than $705 million in savings and more than 50% of ACOs in the Shared Savings Program reported savings in the first year. However, the savings haven’t totaled enough to provide ACOs immediate financial justification for their decision to join up, as only 25% have started regaining the money lost in changing over to a different care delivery model.
The group’s major theme of greater flexibility was exemplified by its assertion that ACO participants should receive waivers from some Medicare regulations that served as barriers to quality care. The group also said ACOs should be allowed to pick from a wider selection of payment models. It publicly disclosed its recommendations on Feb. 6 — the same day the 60-day public comment period on CMS’ proposal closed.
On Dec. 1, 2014, CMS released the proposed rule that aims to change some of the policies of the Shared Savings Program. The rule presented a few adjustments to encourage more providers to join an ACO, including removing a stipulation that required an ACO’s medical director to also be an ACO supplier/provider or someone who bills for Medicare services under an ACO participant taxpayer identification number.
At 13 pages, it reads a lot longer.
Even officials of the Office of the National Coordinator (ONC) of Health IT at their annual meeting in Washington, D.C., earlier this week sometimes sheepishly acknowledged that their new “10-year Vision to Achieve an Interoperable Health IT Infrastructure” is a somewhat dense document.
But a lot of folks are taking the so-called interoperability roadmap seriously as a spur to action on the part of EHR vendors, health IT software and standards developers, health information exchanges and even patients.
The immediate goal is to start moving past the relatively easy data collection parts of meaningful use and toward the hardest parts: making the data flow and squeezing dramatically better health outcomes out of that interoperability.
The ultimate objective, a decade from now, is the “learning health system,” ONC officials’ and other health IT thinkers’ vision of an interconnected national healthcare network in which all hospitals can absorb and freely use health data from other providers and from individual patients.
It is a world, too, for empowered patients, because they will possess their own health data and share it with whomever they want.
“The evolution of standards, policies, and data infrastructure over the next 10 years will enable more standardized data collection, sharing, and aggregation for patient-centered outcomes research,” the roadmap reads in the concluding section. “Continuous learning and improvement will be feasible through analysis of aggregated data from a variety of sources. Health IT systems will enable both analysis of aggregated data and use of local data at the point of care through targeted clinical decision support (CDS).
“CDS will improve care by taking into account information such as an individual’s genetic profile, local trends in disease prevalence, antibiotic resistance, occupational hazards, and other factors,” the roadmap continues.
By the way, don’t confuse the interoperability roadmap with the Federal Health IT Strategic Plan for several dozen federal agencies. However, the latter plan, which is also stimulating much discussion, was coordinated by ONC and covers the next five years, until 2020.
As for the roadmap, it describes a U.S. health IT “ecosystem” in which:
- Patients access and share health information
- The health IT industry values quality and safety in care deliver
- Population health management efforts and regional information exchanges are widespread and work effectively
- People within the ecosystem use big data and analytics
In drafting the plan, which will remain open to public discussion and changes until April, ONC “spent 2014 on a path to unlock data so we can put it to use,” ONC chief Karen DeSalvo, M.D., said at the annual meeting.
Closing the books on a deal that was at least six months in the making, Cerner Corp. announced it has finalized its purchase of Siemens Health Services, an EHR and business unit of Siemens AG.
Cerner made the acquisition for $1.3 billion, and now projects its revenues to sit somewhere in the range of $4.8 to $5 billion in 2015. An official release announcing the move also included details on a health IT alliance between Cerner and Siemens AG. The two companies first plan to work together on “integrating diagnostics and therapeutics into the electronic health record,” with each investing $50 million over the first three years of the agreement.
Cerner will continue support for existing Siemens platforms, including the Soarian EHR system — which the company plans to further develop over the next 10 years. Soarian users that previously spoke to SearchHealthIT about their experiences with the EHR expressed hope that Cerner’s association with the product would benefit both the functions of the system and their organizations.
“Cerner remains focused on . . . population health, physician experience, open platforms, revenue cycle and mobility. We see these as critical areas of investment to ensure providers can meet growing regulatory demands and control cost,” said Neal Patterson, Cerner chairman, CEO and co-founder, in the company’s release.
The buildup of Cerner’s acquisition of Siemens Health Services caught the attention of people from across the health IT spectrum. Analysis from health IT market research firm KLAS Enterprises, LLC showed Cerner was catching up to Epic Systems Corp. by making deals with new hospitals, but its purchase of Siemens Health Services would only nominally place it ahead of Epic. Even Carl Dvorak, president of Epic, weighed in last August when he said the still-in-the-works deal would make Epic an “underdog” in the market.
Relief is coming for thousands of providers who worried about gathering and reporting EHR data for 365 days as part of stage 2 of the government’s meaningful use program.
CMS announced on its blog this morning that it intends to relax its meaningful use reporting period to 90 days for stage 2 in 2015, a move that industry groups such as the College of Healthcare Information Management Executives (CHIME) and the American Medical Association pushed hard for.
“The agencies have listened,” said Russell Branzell, FCHIME, CHCIO, president and CEO of CHIME. “CMS and the ONC have been nothing but supportive.”
The time and money required to attest for a 365-day reporting period gave heartburn to many hospitals and physicians.
Specifically, CMS proposed today to update its Medicare and Medicaid EHR Incentive Programs to accomplish the following goals:
- Adjust hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to install and implement 2014 edition software
- Modify other aspects of the program to match long-term goals, reduce complexity, and lessen provider reporting burdens
- Shorten the EHR reporting period in 2015 to 90 days to accommodate these changes
These actions will be part of a proposed rule from the agency, and as such, related public comment and deliberation will take time, Branzell said.
However, CMS’ announcement allow providers who had become pessimistic about the 365-day reporting period — and dropped out of the incentive program — to reconsider with the 90-day timeline, he added.
“For many that were giving up … now they can go back and say, ‘Let’s start collecting data,’ because now they can collect data without incurring penalties and participate,” he said.
The stage 2 announcement is separate from CMS’ upcoming stage 3 rule, which it expects to publish in March, Patrick Conway, M.D., wrote in the agency’s blog post.
“CMS intends to limit the scope of the Stage 3 proposed rule to the requirements and criteria for meaningful use in 2017 and subsequent years,” wrote Conway, who is deputy administrator for innovation and quality and CMS’ chief medical officer.
At the end of 2014, a coalition of healthcare industry groups attempted unsuccessfully to insert a 90-day clause into a federal government spending package.
The point of the government’s reporting mandates is to increase the adoption and meaningful use of EHRs.
Scott Wallask is news director at SearchHealthIT. Follow him on Twitter @Scott_HighTech.
Unlike in European countries with single-payer or similar health insurance systems, the U.S. healthcare market is fragmented among a large number of individual private payer companies and groups.
That setup brings technological problems when it comes to exchanging information between payers and providers, and between payers and members, or customers.
Enter HL7 International.
The influential non-profit standards and interoperability organization — the steward of HL7 health data exchange standards and the popular emerging new health IT standard, (FHIR) Fast Healthcare Interoperability Resources) – has decided to try to bring more order to the payer world.
In furtherance of that goal, HL7 has launched a payer user group to support insurers that use HL7 standards and protocols to better manage member care, promote better medical outcomes and work toward the long-term objective of more affordable healthcare, according to a release.
The main areas of focus for the HL7 Payer User Group are to:
- Educate and train the payer community on how to put into action HL7 standards
- Share lessons learned during implementations
- Provide feedback to HL7 work groups that are responsible for creation of the standards that affect the payer community
- Be a collaborative resource for other stakeholders at HL7 from the payer perspective
“Over the past year, HL7 has become increasingly active within the payer community. These efforts have provided critical support through the introduction of the payer summit program, and now enabled the launch of the HL7 Payer User Group,” Charles Jaffe, M.D., CEO of HL7, said in the release.
The payer user group is the second user group HL7 has started recently.
Last year, HL7 created an immunization user group in collaboration with the American Immunization Registry Association.
Similarly, HL7 is working on the payer group initiative with insurers such as BlueCross BlueShield, Cambia Health Solutions, Inc., Cigna Health and Life Insurance Company, Humana Inc., and other payers, according to HL7 spokeswoman Andrea Ribick.