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CMS publishes Stage 3 Meaningful Use proposal

The rumor I heard this morning was true. CMS has published its proposed rules for Stage 3 of Meaningful Use, once again waiting until late on a Friday to release a major document. Stage 3 will start no earlier than 2017.

Simultaneously, ONC released its proposed update to EHR certification regulations, to be known as the 2015 edition.

Both documents will appear in the Federal Register March 30, triggering a public comment period. CMS will take comments on the MU rule through May 29, while ONC will do so on the certification plan through June 30. Expect to see final rules before the end of the year.

From an HHS e-mail announcement:

Together, these proposed rules will give providers additional flexibility, make the program simpler and reduce burden, drive interoperability among electronic health records, and increase the focus on patient outcomes to improve care.

The proposed rules are one part of a larger effort across HHS to deliver better care, spend health dollars more wisely, and have healthier people and communities by working in three core areas: to improve the way providers are paid, improving the way care is delivered, and improving the way information is shared; to support transparency for consumers, health care providers, and researchers; and to strengthen decision-making.

“The flow of information is fundamental to achieving a health system that delivers better care, smarter spending, and healthier people. The steps we are taking today will help to create more transparency on cost and quality information, bring electronic health information to inform care and decision making, and support population health,” said HHS Secretary Sylvia M. Burwell.

The Meaningful Use Stage 3 proposed rule issued by CMS specifies new criteria that eligible professionals, eligible hospitals, and critical access hospitals must meet to qualify for Medicaid EHR incentive payments (Medicare incentive payments end in 2016). The rule also proposes criteria that providers must meet to avoid Medicare payment adjustments (Medicaid has no payment adjustments) based on program performance beginning in payment year 2018.

The 2015 Edition Health IT Certification Criteria proposed rule aligns with the path toward interoperability – the secure, efficient, and effective sharing and use of health information – identified in ONC’s draft shared Nationwide Interoperability Roadmap. The proposed rule builds on past editions of adopted health IT certification criteria, and includes new and updated IT functionality and provisions that support the EHR Incentive Programs care improvement, cost reduction, and patient safety across the health system.

The Stage 3 proposed rule’s scope is generally limited to the requirements and criteria for meaningful use in 2017 and subsequent years. CMS is considering additional changes to meaningful use beginning in 2015 through separate rulemaking.

Enjoy perusing the 301 pages of the Stage 3 proposal and 431 pages of the certification proposal this weekend!

March 20, 2015 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

Stage 3 Meaningful Use proposals at White House for final review

Why do these things always seem to happen late on Friday afternoons? At least this time it’s not right before a holiday. Actually, with a bit more inspection, I see that it did happen right before a holiday.

HIMSS is reporting today that the White House’s Office of Management and Budget is “in its final stages of review” of the proposed rules for Stage 3 of the Meaningful Use EHR incentive program. OMB always goes over proposed and final regulations to measure the fiscal — and, presumably, political — impact before allowing executive-branch agencies to make public releases.

A peek at OMB’s reginfo.gov site indicates that the MU Stage 3 proposal from CMS and related ONC plan for certification of EHRs are indeed at OMB for final review.

“We are proposing the Stage 3 criteria that [eligible professionals], eligible hospitals, and [Critical Access Hospitals] must meet in order to successfully demonstrate meaningful use under the Medicare and Medicaid EHR Incentive Programs, focusing on advanced use of EHR technology to promote improved outcomes for patients. Stage 3 will also propose changes to the reporting period, timelines, and structure of the program, including providing a single definition of meaningful use. These changes will provide a flexible, yet, clearer framework to ensure future sustainability of the EHR program and reduce confusion stemming from multiple stage requirements,” CMS states in a rule summary on the OMB site.

A placeholder date (“02/00/2015 “) on the same page suggests that the proposal will be published in February. However, a placeholder date on the page for the forthcoming ONC certification standards indicates that the plan was supposed to come out in November.

And the date the two notices appeared on the reginfo.gov? Dec. 31, when pretty much everyone was already checked out for the extended New Year’s weekend.

Stage 3 is scheduled to start no earlier than Oct. 1, 2016, for hospitals and Jan. 1, 2017, for individual providers.

 

January 9, 2015 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

Health Wonk Review talks turkey

I’ve been a bit remiss the last few days, in that the latest Health Wonk Review came out Thursday, and I’m  just getting around to sharing it now.( Blog carnivals work best when contributors link back to the compilation.) But, better late than never, right?

In that spirit, and in the spirit of Thanksgiving, I invite you to check out Health Wonk Review: The Turkey Edition, hosted by David Harlow on his HealthBlawg. The big stories this time around are all about insurance coverage under the Patient Protection and Affordable Care Act, a.k.a., Obamacare, but there is also an interesting posts about “wrist slaps” given to pharmaceutical executives for allegedly violating drug-marketing laws.

My post at Forbes.com about the American Medical Association belatedly but predictably fighting the impending Medicare penalties for not meeting Meaningful Use makes the cut. I’m particularly proud of the line, “Ruthlessly Defending the Status Quo Since 1847. :)

Check it out, and for those of us here in the United States, have a happy Thanksgiving. I’ll see you after the long weekend.

November 25, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

CMS extends 2014 MU hospital attestation until end of year

Just days before the clock was to run out on hospitals, including Critical Access Hospitals, hoping to attest to Meaningful Use of EHRs for 2014, the Centers for Medicare and Medicaid Services has pushed back the attestation deadline by a month, until Dec. 31.

In an announcement posted yesterday on the CMS Meaningful Use registration and attestation login page, CMS said: “CMS is extending the deadline for Eligible Hospitals and Critical Access Hospitals (CAHs) to attest to meaningful use for the Medicare Electronic Health Record (EHR) Incentive Program 2014 reporting year from 11:59 pm EST on November 30, 2014 to 11:59 pm EST on December 31, 2014.”

Just don’t expect to do so online during a short period in a couple of weeks, as CMS says the site will be down for maintenance from Friday, Dec. 12 at 10 a.m. EST to Saturday, Dec. 13 at 12:30 p.m. EST. CMS also says people “may experience intermittent connectivity” Nov. 30 between 12:01 and 5 a.m. EST.

This extension “will allow more time for hospitals to submit their meaningful use data and receive an incentive payment for the 2014 program year, as well as avoid the 2016 Medicare payment adjustment,” CMS says.

 

I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

Podcast: Scot Silverstein talks health IT safety risks

In a sidebar to the September cover story I did for Healthcare IT News, I reviewed some of the work of Scot Silverstein, M.D., who has long been chronicling problems with EHRs and other health IT systems. Unfortunately, he wasn’t available for an interview in time for that report, but he was last week, so I got him for a new podcast.

Silverstein, a professor of health informatics at Drexel University in Philadelphia, considers EHRs to be experimental and, sometimes, less safe than paper records and would like to see health IT subjected to the same kind of quality controls as aerospace software or medical devices. “Suboptimal system design could lead even careful users to make mistakes,” Silverstein said in this interview.

During this podcast, we refer to a couple of pages that I promise links to, so here they are. Silverstein writes regularly for the Health Care Renewal blog, a site founded by Roy Poses, M.D., a Brown University internist who runs the Foundation for Integrity and Responsibility in Medicine. His definitions of good health IT and bad health IT appear on his Drexel Web page.

Podcast details: Scot Silverstein, M.D., on health IT safety risks. MP3, mono, 128 kbps, 33.8 MB. running time 36:59.

1:10 How this interest came about
3:05 His blogging
3:45 His 11 points demonstrating why he believes the FDA should be concerned about health IT risks
5:00 IOM, FDA and ECRI Institute statements on health IT safety
5:50 Comparing EHRs to medical devices and pharmaceuticals
8:35 Lack of safety testing in health IT
9:25 Issues with EHR certification
10:00 Safety validation of software
10:35 EHR’s role in Texas Health Presbyterian Hospital’s initial discharge of Ebola patient
11:50 EHR failure causing medical harm to a close relative
13:10 Poor design vs. poor implementation
14:35 Who should regulate?
15:55 Billions already spent on EHRs
16:45 Threat of litigation
17:40 “Postmarket surveillance” of “medical meta-devices”
18:50 EHRs now more like “command and control” systems
19:30 Movement to slow down Meaningful Use
20:17 Safety issues with interoperability
21:40 Importance of usability
22:30 His role at Drexel
24:18 “Critical thinking always, or your patient’s dead”
25:05 Lack of health/medical experience among “disruptors”
29:30 Training informatics professionals and leaders
31:15 Concept vs. reality of “experimental” technology
32:50 Advice for evaluating health IT
33:55 Guardians of the status quo
35:10 Health IT “bubble”
36:10 Good health IT vs. bad health IT

 

October 20, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

Digital health at the Mid-America Healthcare Venture Forum

In case you haven’t seen the official announcements or caught my tweets, later this month I will be moderating a panel at the Mid-America Healthcare Venture Forum, an event being put on by MedCity News, April 22-23 at the J.W. Marriott hotel in Chicago.

The panel is called “Opportunities (and Challenges) in Digital Health. Per the official description: “Digital health — and its business models — are coming of age. Promising young companies are integrating into healthcare and, in some cases, beginning to find exit partners. But that’s also meant new scrutiny from everyone from investors to the FDA. Learn about the challenges, opportunities and promising new markets in digital health.”

Panelists include: Amy Len, director of Chicago-based accelerator Healthbox; Julie Kling, director of mobile health at Verizon Wireless; and Jack Young, who heads the Qualcomm Life Fund for Qualcomm Ventures. I’ll just be there to keep order, and, of course, to cast my usual, skeptical eye on the field and continue to wonder why investors are throwing so much money at me-too fitness trackers and countless direct-to-consumer products that don’t stand a chance in an industry where nearly everything is paid for by third parties. Or at least that’s my thought at the moment, until we have our conference call next week. :)

The session is scheduled for Wednesday, April 23, at 8:55 a.m. CDT. The hotel is located at 151 W. Adams St. in the heart of the Financial District. Years ago, I worked about two blocks west of there, so I know it’s about 40-45 minutes away from me by public transit, and I’m not a morning person. This could get  interesting. (If any MedCity people are reading this, I’m kidding. I’ll be there on time. Hopefully.)

Our session follows a keynote from James Rogers, chairman of Mayo Clinic Ventures. After the panel is a break, then breakout sessions featuring presentations to investors from startups in digital health, medical devices and pharma/biotech. I hope I don’t prematurely burst anyone’s bubble with too much of a reality check. But, in honor of this week being the 25th anniversary of the release of the great Gen X satire, “Heathers,” I offer this quote from the movie: “Heather told me she teaches people ‘real life.’ She said, real life sucks losers dry.”

Wait, was that too cynical?Let me just say that the panel just got another thing to talk about today, as the FDA, FCC and ONC just released their proposed health IT regulatory strategy, as called for by the Food and Drug Administration Safety and Innovation Act (FDASIA). To nobody’s surprise, they recommend a “risk-based framework” to regulation of health IT and digital health. Now to figure out if there are any details people should be concerned about…

In the meantime, you can register for the conference here.

April 3, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

All my HIMSS coverage in one place

The last of my 10 MedCity News stories from HIMSS14 has been posted. It’s a nice mix of news, features, analysis and commentary. Here are links to all of them, in chronological order.
NantHealth launches Clinical Operating System – biggest of big data startups – with $1B (Feb. 25)

Body + biology + behavior: Intel exec explains how technology is making N=1 care possible (Feb. 26)

Tavenner: 2014 is your last chance for a hardship exemption for Meaningful Use 2 (Feb. 27)

HIMSS crowd skeptical of promise for flexibility on MU2 hardship requests (Feb. 27)

Google Glass startup expecting third healthcare client in less than 6 months (Feb. 27)

DeSalvo: True EHR interoperability – and a national HIE – is possible by 2017 (Feb. 28)

DeSalvo meets and greets – briefly – while Tavenner keeps her distance at HIMSS (March 3)

HIMSS Intelligent Hospital tracks patients, pills and clinicians in completely connected loop (March 5)

Interoperability Showcase uses car crash to show how connected data really can improve patient care (March 5)

Athenahealth’s first inpatient product isn’t quite an EHR, but a ‘Trojan horse’ into hospitals (March 10)

 

March 12, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

CMS clarifies MU2 hardship exemptions

As I reported for MedCity News at HIMSS14 nearly two weeks ago, CMS Administrator Marilyn Tavenner announced plans to provide unspecified flexibility in claims for Meaningful Use Stage 2 hardship exemptions this year. Tavenner then left without speaking to the media.

The news left a lot of people scratching their heads and waiting for some details. Today, CMS issued some clarification, confirming that there would be exemptions for healthcare providers unable to have EHRs certified to 2014 standards in place for the 2014 reporting year. This is particularly important now because Medicare penalties for not achieving Meaningful Use take effect next year, but they are based on the 2014 reporting year (Oct. 1, 2013-Sept. 30, 2014 for hospitals, the 2014 calendar year for physicians and other individual “eligible providers.”)

The guidance confirms that CMS is aware of the problems caused by the slow pace of certification to the new, 2014 standards that Stage 2 requires. As of today, according to the ONC Certified Health IT Products List (CHPL), there are 3,736 ambulatory and 1,200 EHRs and EHR modules certified to 2011 standards, but just 899 total that meet 2014 certification.

Here’s the one-page CMS guidance for hospitals/critical access hospitals and the one for eligible providers.

March 11, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

HIMSS, Continua launch Personal Connected Health Alliance

ORLANDO, Fla.—As HIMSS President and CEO hinted at yesterday in his podcast with me, HIMSS today announced the formation of the Personal Connected Health Alliance, in conjunction with the Continua Health Alliance and the HIMSS-owned mHealth Summit.

This short video from HIMSS explains:

Also, Lieber mentioned that HIMSS has not signed on to a letter from 48 organizations—led by CHIME—to HHS Secretary Kathleen Sebelius, calling for more time and flexibility in meeting Meaningful Use Stage 2 requirements., Lieber said HIMSS declined to sign because the requests were, in his opinion, “very vague.”

Today, the letter, dated Feb. 21, was made public:

February 21, 2014
The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Ave., S.W.
Washington, DC 20201

Dear Secretary Sebelius:

The undersigned organizations write to express immediate concerns confronting our respective members’ ability to comply with the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program. We recognize the vital role your department has taken in advancing the adoption of health information technology in the United States and appreciate your willingness to be flexible in extending the start of Stage 3 to 2017. We fear the success of the program is in jeopardy, however, if steps are not taken now to address our shared concerns.

Over the next seven months, more than 5,000 hospitals and 550,000 eligible professionals must adopt the 2014 Edition of Certified Electronic Health Record Technology (CEHRT) and meet a higher threshold of Meaningful Use criteria. Failure to do so will not only result in a loss of incentive payments, but also the imposition of significant penalties. With only a fraction of 2011 Edition products currently certified to 2014 Edition standards, it is clear the pace and scope of change have outstripped the ability of vendors to support providers. This inhibits the ability of providers to manage the transition to the 2014 Edition CEHRT and Stage 2 in a safe and orderly manner.

We are concerned this dynamic will cause providers to either abandon the possibility of meeting Meaningful Use criteria in 2014 or be forced to implement a system much more rapidly than would otherwise be the case. The first choice limits the success of the program to achieve widespread adoption of EHR, while the second is highly disruptive to healthcare operations and could jeopardize patient safety. As you know, our members’ number one priority must be to provide safe and high quality care to patients.

Providers need adequate time to learn how to use the newly deployed technology, including examining staff assignments, workflows, and practice processes. If providers move forward, as dictated by the current policy, our concerns regarding rushed implementations are heightened. Furthermore, we believe the “all or nothing” approach – where missing a single objective by even a small amount results in failure for the program year – compounds our concerns.

For these reasons, our organizations strongly recommend that HHS:
1. Extend the timelines providers have to implement 2014 Edition Certified EHR software and meet the Program requirements (Stages 1 and 2) through 2015;
2. Add flexibility in Meaningful Use requirements to permit as many providers as possible to achieve success in the program.

Given that we are well into 2014, immediate attention to these concerns is warranted. This additional time and new flexibility are vitally important to ensure that hospitals and physicians continue moving forward with technology to improve patient care. By making such changes, HHS would be demonstrating needed flexibility to maximize program success, without compromising momentum towards interoperability and care coordination supported by health IT.

We remain committed to the success of the program and look forward to hearing from you on this important matter. Please contact Jeffery Smith, Senior Director of Federal Affairs, CHIME, (jsmith@cio-chime.org) should you have any questions. Thank you for your consideration.

Sincerely,

AMDA-Dedicated to Long Term Care Medicine
American Academy of Allergy, Asthma & Immunology
American Academy of Dermatology Association
American Academy of Family Physicians
American Academy of Home Care Medicine
American Academy of Hospice and Palliative Medicine
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Orthopaedic Surgeons
American Academy of Otolaryngology—Head and Neck Surgery
American Association of Neurological Surgeons / Congress of Neurological Surgeons
American College of Cardiology
American College of Osteopathic Family Physicians
American College of Osteopathic Internists
American College of Osteopathic Surgeons
American College of Physicians
American College of Radiology
American College of Rheumatology
American College of Surgeons
American Health Information Management Association
American Hospital Association
American Medical Association
American Osteopathic Academy of Orthopedics
American Osteopathic Association
American Psychiatric Association
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Radiation Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery
American Society of Hematology
American Urological Association
America’s Essential Hospitals
Association of American Medical Colleges
Catholic Health Association of the United States
Children’s Hospital Association
College of Healthcare Information Management Executives
Federation of American Hospitals
Heart Rhythm Society
Infectious Diseases Society of America
Medical Group Management Association
National Rural Health Association
North American Spine Society
Premier healthcare alliance
Society for Cardiovascular Angiography and Interventions
Society of Thoracic Surgeons
The Endocrine Society
VHA Inc.

Yes, that is kind of vague, but that’s what you get when you involve four dozen organizations. Will it be effective? As I mentioned yesterday, ONC Chief Medical Officer Jacob Reider, M.D., hinted that there will be news about Stage 2 flexibility, likely Thursday morning at a joint ONC-CMS town hall. Reider made that statement at the CIO Forum, hosted by CHIME.

 

 

February 24, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.

Breaking: ONC releases proposed 2015 EHR certification criteria

If you want something buried, release it late on a Friday so it doesn’t hit people’s desks until Monday morning. If you really want something buried in health IT, put it out there late on the Friday before the annual HIMSS conference because nobody will get any real work done for another week.

I’m not sure if ONC is trying to hide anything, or just wanted to get this done before all its top people head to Orlando, Fla., for HIMSS14, but this afternoon, the office issued proposed criteria for the 2015 edition of EHR certification. This is the first time certification criteria haven’t accompanied Meaningful Use standards, which means ONC wants to tighten certification requirements in the midst of Meaningful Use Stage 2, rather than waiting for Stage 3, which won’t start before 2017.

However, the plan is to make the proposed 2015 standards voluntary; vendors would be just fine with 2014 certification and providers would not have to upgrade their systems to achieve or maintain Stage 2 Meaningful Use, according to ONC.

ONC says the proposal will officially appear in the Federal Register on Wednesday, triggering a 60-day comment period that will run through April 28. Expect a final rule this summer.

UPDATE, 5:11 pm CST:  It appears that they’re just happy to have it done and to be able to talk it up. In fact, ONC’s Steven Posnack seems downright giddy.

 

Also, self-described HIT standards geek Keith Boone is reading through the whole thing and posting real-time updates on his observations.


 

February 21, 2014 I Written By

I'm a freelance healthcare journalist, specializing in health IT, mobile health, healthcare quality, hospital/physician practice management and healthcare finance.