Archive for November, 2011

Recap of Recent Federal HIT Policy Developments: Part 7

November 28, 2011 Leave a comment

On November 28, the Centers for Medicare and Medicaid Services (CMS) published its Medicare Physician Fee Schedule final rule for 2012.  The final rule includes a change to the EHR Incentive Program that allows reporting via attestation for the clinical quality measures (CQMs) through 2012, as opposed to requiring electronic reporting of the CQMs in 2012.  The rule also establishes a pilot program for electronic reporting of the CQMs for the EHR Incentive Program and Physician Quality Reporting System.

Last week, Dr. Donald Berwick (CMS Administrator) announced December 2 as the date of his long-expected resignation.  Dr. Berwick was appointed by the President during a Congressional recess, which meant that barring a re-nomination (which he was) and a Senate confirmation (which he was not), his term would expire at the end of 2011.

Also last week, the President announced his intent to nominate Marilyn Tavenner, the CMS Principal Deputy Administrator, to be the next CMS Administrator.  Tavenner will need to go through the traditional confirmation process; however, her selection is viewed as relatively noncontroversial by many policymakers.

On November 25, the Office of the National Coordinator for HIT (ONC) published its final rule to provide clarity regarding the conduct and responsibilities of the ONC-Approved Accreditor (ONC-AA) in the Permanent Certification Program regulatory paradigm.

Categories: EHR, meaningful use, Medicare

National Academies Report on CMS IT Strategies and Priorities

November 22, 2011 Leave a comment

The National Academies Press released a prepublication copy of the National Research Council’s report titled “Strategies and Priorities for Information Technology at the Centers for Medicare and Medicaid Services.”  The report provides recommendations to CMS about implementing strategies and IT infrastructure needed to support its various quality and healthcare payment reform programs.

Note that the document is currently in “draft” form and there are a few noticeable inaccuracies/typos that will likely be corrected prior to final publication.

The National Research Council is comprised of council members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.  The committee that put together the report included several familiar experts, including Dr. John Glaser (former ONC advisor) and Dr. George Hripcsak (member of the HIT Policy Committee’s Meaningful Use Workgroup), among others.

Categories: EHR, IOM, meaningful use, Medicare

2011 ACR Informatics Summit Questions: Part 2

November 16, 2011 Leave a comment

At the recent ACR Informatics Summit, I received several questions regarding the Medicare/Medicaid EHR Incentive Program, or “meaningful use” (MU). I thought it might be useful to reexamine some of the questions in a series of entries.  If interested, please also see the first part of the series.

Question: What do I need to provide to patients in terms of the “clinical summary,” and are radiology results part of it?

Answer: CMS answered this question directly in guidance through a specification for the associated functional measure here, and a FAQ here.  CMS’ basic message is that EPs should share with their patients any data that can be populated into the clinical summary by their certified EHR technology which, at a minimum, must be the problem list, diagnostic test results, medications, and medication allergies.  The other information that EPs should include in the clinical summary if their certified EHR technology is able to do so is listed in the previously mentioned specification and FAQ.

The key is that the content of the electronic clinical summary is also limited by the functionality of the EP’s certified EHR technology, so it is helpful to look at ONC’s product certification criteria, standards, and implementation specifications associated with clinical summaries to find out what vendors’ HIT products must, at a minimum, enable EPs to do.  To be certified for the associated certification criterion at 45 CFR 170.304(h), HIT products are required to enable EPs to make available as human-readable and electronic: 1) problem list (ICD-9 or SNOMED); 2) lab-test results (LOINC); 3) medications (any source vocabulary included in RxNorm); and 4) medication allergies.  The electronic version of the clinical summary must be in the HL7 CDA CCD format (with the associated implementation specification) or the ASTM CCR format.

The electronic clinical summary can be shared with the patient via a PHR, patient portal on the web site, secure e-mail, or electronic media (CD, DVD, USB flash drive, etc).  The EP is allowed to provide a printed copy of the clinical summary instead of an electronic version.  If the patient specifically requests it, the EP must provide a paper copy regardless.

Categories: EHR, meaningful use, Medicare

Meaningful Use: ACR Advocacy Update

November 10, 2011 Leave a comment
Presentation on MU: ACR Advocacy Update

Meaningful Use: ACR Advocacy Update

On November 3, I had the privilege of speaking at the American College of Radiology’s Informatics Summit on advocacy activities related to the Medicare/Medicaid EHR Incentive Program, or “meaningful use” (MU).  In the interest of making the slides publicly available, I thought it would be useful to post them here.

Note that two slight modifications have been made post-presentation.  The first was a typo correction on slide 10, middle panel, which previously displayed the year of the Stage 1 NPRM/IFR publication as “2010” instead of the correct year of “2009.”  The second was an update to slide 15, second panel, to reflect the Office of the National Coordinator’s  notice of extension of the temporary certification program, which was published in the Federal Register the day of the ACR Informatics Summit.

Categories: EHR, meaningful use, Medicare

IOM Publishes Anticipated Report on HIT and Patient Safety

November 8, 2011 1 comment

Earlier today, the Institute of Medicine (IOM) released its report on “HIT and Patient Safety: Building Safer Systems for Better Care.”  The report examines and puts forward recommendations on the safety aspects of HIT adoption.  It also explores, to a certain degree, research gaps and risk minimization opportunities.

One of the many considerations for researchers identified in the IOM report is related to radiology information systems and other so-called “niche health IT products developed for specialties.”  The report suggests that researchers should explore the potential safety implications of these products and their interactions within EHRs.

The most controversial component of the IOM report is probably the appendix authored by Dr. Richard Cook (one of the IOM committee members) that argues for FDA regulation of all HIT solutions as class III medical devices.  Dr. Cook’s views in this appendix are not reflected in the formal recommendations of the IOM committee, and are only presented as a dissenting statement and alternative recommendation.

2011 ACR Informatics Summit Questions: Part 1

November 8, 2011 1 comment

At the recent ACR Informatics Summit, I received several questions regarding the Medicare/Medicaid EHR Incentive Program, or “meaningful use” (MU). Some of the questions were about compliance with specific functional measures, which are always inadvisable to discuss without the regulations and guidance in hand; while others were about ACR’s advocacy on MU or how the agencies involved view certain concepts. I thought it might be useful to dive into some of the more memorable questions in a series of entries over the next couple of weeks.

Question (paraphrased): How does CMS view the exclusions from individual MU measures?  Will we get dinged later for invoking some of these exclusions?

Answer: When I thought about this after the event, I realized there is a four-part answer to this question:

  • Eligible professional s (EPs) who meet the exclusions for specific functional measures are not doing anything wrong or negative if they invoke the exclusion. The exclusions were designed by CMS because the agency had to provide flexibility in order to allow EPs with varying scopes of practice to comply with a single set of requirements.
  • CMS is tracking the exclusions — not to penalize the EPs who invoked them, but rather to see which functional measures are in need of modification or removal. If a given functional measure shows a high percentage of EPs invoking the exclusion, something is wrong with the measure itself.
  • CMS is concerned with an unintentional loophole in the regulations that allows EPs to lower the number of menu set functional measures they need for compliance by invoking menu set measure exclusions AND then still reporting the excluded menu set functional measures.  This scenario was discussed by CMS staff during a recent HIT Policy Committee meeting.
  • I have heard on a few separate occasions from (nongovernmental) primary care folks who thought the exclusions made MU compliance “easier” for specialists. This view is misinformed and is not shared by the agencies.
Categories: EHR, meaningful use, Medicare

ONC Extends Temporary Certification Program Until Approximately Summer 2012

November 7, 2011 1 comment

The Office of the National Coordinator for HIT (ONC) recently published a notice of extension for the temporary certification program.  The temporary certification program, which was previously scheduled to be replaced by the permanent certification program in January 2012, will now continue until the effective date for the ONC’s Stage 2 EHR standards, implementation specifications, and certification criteria final rule (i.e., around summer 2012).

The temporary certification program dictates the various roles and responsibilities for ONC authorized testing and certification bodies (ONC-ATCBs), among other things related to HIT product certification.  ONC-ATCBs verify that products meet certain criteria required for Complete EHR or EHR Module certification for use in the Medicare/Medicaid EHR Incentive Program, or “meaningful use” (MU).  ONC-ATCBs do so using test tools for each criteria provided by the National Institute of Standards and Technology (NIST).

In the future, the permanent certification program will add accreditation elements and split testing from certification.

Categories: EHR, meaningful use, Medicare
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