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18 posts from November 2007

November 29, 2007

EHR/PHR pros and cons

Item: WSJ Online/Harris Interactive poll says

Overall, 60% of 2,153 respondents said the benefits of electronic medical records outweigh the risks; 63% said electronic records can significantly decrease the frequency of medical errors, 55% said they can significantly reduce costs, and 51% said they make it more difficult to ensure patients’ privacy.

Item:  My friend Richard Dale, a VC at Sigma Partners, spoke about PHRs at the Personally Controlled Health Records Infrastructure Conference here in Boston this week, describing 26 or more economic models for dissemination and use of PHRs in materials posted on his blog.  Richard says that there was at last year's conference,

and even more so now (viz. Dossia), a feeling that PHRs really can deliver value for all players in the health care system.

The trouble is that there is no clear business model that has emerged. The work on PatientSite at BIDMC, HealthVault from Microsoft, and Dossia illustrate three of many disparate approaches, any one or more of which may take root and grow well.

Item:  Managed Care Plans Push PHRs, says an article in the October issue of Health Data Management.  Some plans focus on so-called PHRs, other on fuller EHR systems.   Some are limited to claims data, others have more information that allows both patients and  providers to get a handle on a history. 

Some observers . . . question the value of a record based primarily on the codes used in claims. "Those codes are not really diagnostic codes; they are reimbursement codes," says Margret Amatayakul, president of Margret/A Consulting LLC, a Schaumburg, Ill.-based firm specializing in electronic records. "They don't provide enough detail on treatment."

The American Health Information Management Association, a Chicago-based group representing medical records managers, has voiced similar concerns. "We really think that it's preferable that PHRs be integrated with providers' electronic health records," says Linda Kloss, CEO at AHIMA.

Group Health, in Seattle, is cited in the article as an organization that is integrating EHR data into the PHR.

Consistent with the general public opinion survey cited above, many folks in the field are in favor of putting PHR/EHR data on line, and see it as a boon for maintaining and communicating data needed for treatment.  Not everyone is quite so sanguine, however:

"If my insurance company puts my PHR on the Internet, they better have some good lawyers," says Vincent Ciotti, principal at H.I.S. Professionals, LLC, a Santa Fe, N.M.-based consulting firm. "Internet security is going to be breached. You're asking for trouble if you share PHRs on the Internet."

Instead, Ciotti advocates that patients retain control of all their records by storing them on a smart card or on their home computers. "Medical records are extremely confidential and private, and need to be kept that way," he stresses.

. . .

Ciotti also argues that the real reason managed care plans want to create PHRs is to gather more information that can be used to deny future claims or reject potential applicants for coverage.  And Amatayakul expresses concern about the potential for payers to share data with employers without asking the permission of the enrollee.

"There isn't any explicit federal protection against secondary uses of the data in a PHR," notes Kloss of AHIMA. "Patients need to control how the data in a PHR is accessed, used and controlled."

AHIMA argues that the federal HIPAA privacy and security regulations should be extended to protect against inappropriate use of PHR data.

Payers say they are taking appropriate steps to make sure PHRs are not misused.

"We assure our enrollees that we won't use the data in PHRs for any underwriting purposes," says McCa
be [Meg] McCabe [head] of Aetna [e-health products]. "Where no specific regulatory controls exist, we have strong ethical controls on how the data should be used. And we allow a member to suppress line items."

Item:  The reformed Dr. Drug Rep (Daniel Carlat) published his Big Pharma kiss-and-tell story in last Sunday's NY Times Magazine, bringing his story to MSM from his blog.  Not news, but an extraordinary personal story.  The WSJ Health Blog reports today that he is now giving "unsales" pitches to atone for his Effexor detailing lunches. One point made by Carlat was that there is a tremendous amount of information available about prescribing habits of physicians, based on the prescription records of their patients, which is mined by the drug reps in order to tailor presentations to the docs.

Conclusion: Whether or not you believe the studies tying use of EHRs or PHRs to improved clinical outcomes and cost-effective care, this train has left the station, and as the Aetnas, Microsofts and Googles of the world continue to focus on personal health information, more and more of it will be finding its way on line.  While the simple truth may be that no one can guarantee security of personal health information, there are steps that should be taken to restrict secondary use of PHI -- though much of it is truly worthwhile population health, not just extracting data for use in drug detailing and other marketing efforts. 

As usual, the regulatory framework is playing catch-up with the technological realities in the world.

-- David Harlow

November 28, 2007

Health Wonk Review is up at Health Care Renewal

Roy Poses is hosting a thought-provoking edition of Health Wonk Review at Health Care Renewal

The next edition will be right here at HealthBlawg, week after nextGiven the season, I invite submissions that have something to do with light.  Check out the HWR rules of engagement and submit here or via email.

-- David Harlow   

HIPAA goes dark in New York

Well, Broadway is still dark this week, and it seems the judges of the New York Court of Appeals don't want the courts of the Empire State to do much work either -- at least not the sort of work that entails thinking hard about whether litigants who put their medical status in issue need to consent -- under HIPAA -- to informal interviews of their treating physicians by opposing counsel, conducted under New York discovery rules.

A tip of the hat to Eric Turkewitz, who wrote yesterday in his NY Personal Injury Law Blog:

The decision in Arons v. Jutkowitz is expected to open a small floodgate of attempts by insurance companies and defense lawyers to privately approach treating physicians without the knowledge or permission of the patients and take statements without their counsel or any court reporter being present.

The conservative Justice Read, writing for the majority, concluded that plaintiffs can be forced to sign HIPAA compliant authorizations to allow the interviews. Because this will be done outside the formal deposition process, however, the usual safeguards regarding relevance and accuracy are no longer in place.

-- David Harlow

November 27, 2007

David Harlow to speak on blawging at the Boston Bar Association

For my brothers and sisters at the bar in the Boston area:

Join Edward Wiest of Edward R. Wiest, PC, Zak Barron of Constant Contact, and me, for a BBA brown bag session sponsored by the Solo and Small Firm Section Thursday December 6, 2007 entitled:
Electronic Marketing: Using E-Mail Newsletters & Blogs to Enhance your Practice.

Update 12/5/07:  My blawging presentation slides are available here, with links to a variety of relevant resources.

-- David Harlow

CMS submits its value-based purchasing plan to Congress

Pay for performance (P4P) continues to capture a great deal of attention.  (See some of my earlier posts on P4P.)

Following the issuance of an options paper and holding two listening sessions earlier this year, CMS, as required by the DRA, filed a value-based purchasing (VBP) plan with Congress (see more information about the listening sessions on the CMS hospital center page, halfway down on the right).  The law calls for a plan to be submitted so that enabling legislation for VBP (that's CMS-speak for P4P) can be rolled out in time for implementation in FFY 2009.  The CMS VBP press release issued yesterday says:

The proposed VBP program . . . ties directly to two of the four cornerstones of the Secretary’s initiative to build a value-driven health care system: measuring and publishing quality information, and promoting the quality and efficiency of care.

The proposed VBP program contains the following key components:

    * A measure development and selection process, including selection criteria for choosing performance measures for the VBP financial incentive and candidate measures to support ongoing expansion of the measure set.

    * A Performance Assessment Model that incorporates quality measures, including clinical process of care, patient perspectives of care, and clinical outcomes, to calculate a hospital’s Total Performance Score. The proposed model scores a hospital’s performance on each measure during a 12-month measurement period based on the higher of “attainment” compared with national thresholds and benchmarks or “improvement” compared with the hospital’s own performance in the preceding 12-month baseline period.

    * The incentive is created by making a specified percentage of the base operating payment amount for all discharges contingent on performance.  The percentage of incentive earned would be determined by the hospital’s Total Performance Score.

    * Enhancements to the Hospital Compare site to support expanded and more user-friendly public reporting.

    * Ongoing evaluation and monitoring efforts to assess experiences early in VBP implementation, allowing for timely corrective action and building the evidence base for future VBP programs in other settings.   

Per Modern Healthcare, CMS's Acting Administrator Kerry Weems says VBP enabling legislation could find its way into a Medicare bill now being worked up in the Senate.  The DRA timetable for VBP implementation is pretty aggressive.  Given the delays in getting the report in to Congress, one has to wonder about the likelihood of getting things rolling by FFY 2009 (which starts just ten months from now).

In some of my earlier posts (linked to above) I've expressed my concerns about P4P in general, which also apply to VBP in particular.  For example:

  • Provider focus on that which is measured (and rewarded financially) may cause other issues to fall off the table.
  • In a budget-neutral world, P4P bonuses to successful providers are drawn out of the pockets of less-successful providers -- and those health care resources, perhaps located in the communities that truly need them most, are less able to provide services in the future.

It remains to be seen whether the government is capable of engineering a change in course for the supertanker that is the U.S. health care system. 

Update 11/28/07:  See the AHA's perspective in today's Kaiser Daily Health Policy Report, and other comments on the plan, collected in yesterday's Kaiser Daily Health Policy Report.  One observation: Despite an understandable industry concern about the fact that the propopsal would require that "payments to all facilities would be cut by a flat 2% to 5% to fund the incentive pool for distribution to hospitals that show the most improvement or meet quality-of-care standards," the hospital industry's call for paying incentives out of a new bucket of cash is a nonstarter.  Consider the British P4P experience, which nearly bankrupted the NHS in 2004See earlier post on P4P and CMS here.   

-- David Harlow

November 26, 2007

Blawg Review is up Down Under

This week's media-enhanced edition of Blawg Review is up -- hosted at Aussie law prof's Peter Black's Freedom to Differ.

-- David Harlow

November 20, 2007

Grand Rounds is up at Mexico Medical Student

Enrico, at Mexico Medical Student, does a masterful job of weaving the past week's medblogger posts (and even this blawger's post) into a music-infused carnival experience.

-- David Harlow

Imaging measures: We're from the government and we'd like your help

Which is scarier?

(A)  "We're from the government and we're here to help."


(B)  "We're from the government and we'd like your help."

If you answered (B) and you're in the imaging biz, then: Be afraid.  Be very afraid.

CMS has contracted with L&M Policy Research (a self-described "small, minority/women-owned health policy research firm") and its partners, National Imaging Associates (the "clear leader" in radiology benefits management) and The Lewin Group (OK, we know who they are), "to develop a preliminary set of imaging efficiency measures."

You know where this is heading, right?

Check out the Imaging Measures website, review the draft measures, and file comments (comments due  December 14).  Here are the summary descriptions of the four measures:

Measure One
MRI Lumbar Spine for Low Back Pain

Lumbar MRI is a common study to evaluate patients with suspected disease of the lumbar spine. The most common, appropriate, indications for this study are low back pain accompanied by a measurable neurological deficit in the lower extremity(s) unresponsive to conservative management.

Measure Two
Mammography Follow-up Rates

A recall/call-back following a screening mammography nearly always results in the performance of a diagnostic study. A high percentage (over 10%) of mammogram codes submitted as post-screening diagnostic studies is unusual unless the facility serves as a center specializing in patients with known positive findings on previous exams.

Measure Three
Abdomen CT - Use of Contrast Material

Current literature clearly defines indications for the use of combined studies, that is, examinations performed without contrast followed by contrast enhancement.  The intent of this measure is to assess questionable utilization of contrast agents that carry an element of risk and significantly increase examination cost.

Measure Four
Thorax CT - Use of Contrast Material

Current literature clearly defines indications for the use of combined studies, that is, examinations performed without contrast followed by contrast enhancement.  The intent of this measure is to assess questionable utilization of contrast agents that carry an element of risk and significantly increase examination cost.

CMS says it's doing what it can to rein in diagnostic imaging costs.  The new website cites MedPAC, which notes that Medicare's volume and complexity of diagnostic imaging costs rose at nearly twice the rate of physician services costs from 1999 to 2003 (9.9% vs. 5.4%). 

Physicians reading this, and contemplating the looming 10% SGR cut, might have a different take
. . . .

Not to head off on a tangent, but physicians have gotten into ancillary services in a big way for three principal reasons -- quality control, convenience (doc and patient) and in order to make money, partly in response to declining reimbursement for personally-provided professional services.

Are there some imaging services now being provided that would be deemed inappropriate (and therefore, presumably, eventually unreimbursable under the new measures now being field-tested)
but aren't stopped by current Stark and anti-kickback enforcement?  Sure.  Should CMS develop a professional services fee schedule and update system that doesn't box physicians into a budget-neutral la-la land?  Of course.

Here's hoping that CMS is able to tackle both of these issues at the same time.  (Surely there are additional issues that need to be put into the mix as well.)  Otherwise, we're back to pushing in on one side of the balloon without giving thought to where it will expand on the other side.

-- David Harlow


November 19, 2007

Blawg Review -- the Equal Opportunity Day edition is up

Jillian Todd Weiss hosts Blawg Review's Equal Opportunity Day Edition at Transgender Workplace Diversity and focuses the Blawg Review lens on equal opportunity issues spanning a broad range of discrimination issues: discrimination on account of race, sexual orientation, gender identity and other factors.  Tune in again tomorrow to this week's bonus edition at Denise Brogan-Kator's Rainbow Law Center blog.

-- David Harlow

November 15, 2007

Stark III partial effective date delay published today

CMS today published a rule delaying the effective date of the Stark III "stand in the shoes" rule, as it applies to AMCs and 501(c)(3) integrated health systems, for one year (i.e., until December 4, 2008). The one-year delay in the effective date of part of the Stark III rule was announced November 9, as academic medical centers and their advisors sought to have CMS delay, amend or clarify portions of the rule that would remove Stark exception protections from many current mission support payment arrangments between faculty practice plans and other components of AMCs.

In one of the few bits of editorializing in this brief issuance, CMS staff responded to the suggestion by some that tax-exempt AMCs need to toe the line in order to maintain their tax-exempt status and avoid intermediate sanctions that may be imposed by the IRS -- thus insinuating that "double oversight" by two Federal agencies is unnecessary -- thus:

We note that, in a prior rulemaking (Phase I), in response to a comment that compensation arrangements between organizations regulated under the IRS rules pose minimal risk of program or patient abuse, we indicated that regulation under IRS rules, though beneficial, is not necessarily sufficient to prevent fraud or abuse (66 FR 917).  Our action delaying the date of applicability of the Phase III provisions in § 411.354(c)(1)(ii), § 411.354(c)(2)(iv), and § 411.354(c)(3) with respect to integrated section 501(c)(3) health care systems should not be read as a reversal of our previous position. As stated above, we are delaying the date of applicability of these provisions in a targeted manner in order to evaluate any unintended impact of the Phase III ‘‘stand in the shoes’’ provisions.

While CMS may end up clarifying some ambiguities in the rule, a wholesale rollback is probably too much to ask for.  There will, nevertheless, likely be some significant back-and-forth between CMS and the regulated community between now and next December.

In the interim, it is worth reiterating that the delay in effective date applies to a very narrow range of situations -- see the relevant portion of the regulation with the delayed-effective-date "stand in the shoes" language highlighted.  The delayed sections of the reg only apply to two narrow categories of provider: (1) AMC, as defined in the Stark reg, and (2) integrated 501(c)(3) health system, where each component of the system is a 501(c)(3) tax-exempt entity.

While the good folks at CMS further "evaluate" this reg, they will also be pondering the Stark 2.5 rule (or is that now Stark IV?) embedded in the 2008 MPFS.  As that reg works its way through the process, it may have even more far-reaching effects.

-- David Harlow