Digitized Medicine

Dangerous Precedent Set To Financially Penalize Doctors Who Fail to Influence Patient Behavior

I strongly oppose use of quality measures that incentivize or penalize physicians based on their ability to influence patient actions when those actions are beyond reasonable control of physicians or if there is no evidence linking such actions to improvements in patient outcomes.    That is why I believe there is a dangerous precedent being set in the Stage 2 electronic health record (EHR) incentive payment rule which will penalize physicians if they fail to influence patient behavior in a manner desired by the Centers for Medicare &  Medicaid Services (CMS).    

Two of the 17 Stage 2 core objectives hold physicians accountable for ensuring that their patients use technology at home.   One measure requires at least 5% of unique patients seen during the reporting period to send a secure message to the physician's practice using the electronic messaging function of the EHR.   A second measure requires at least 5% of unique patients seen during the reporting period electronically view, download or transmit their health information.   

In order to qualify for Medicare and/or Medicaid EHR incentive payments and avoid financial penalties, physicians must meet all 17 core measures as well as three from a menu of six additional measures.    Physicians must also report on nine of a total of 64 specific clinical quality measures.  Physicians who fail to do so by 2015 will not only fail to receive annual EHR incentive payments, but also be penalized by CMS through annual payment adjustments. 

In the final rule for the Stage 2 EHR Incentive Program CMS responded to public comments on these two new core objectives. CMS argued that physicians are in a unique position to strongly influence the use of technologies by patients "to improve their own care."    They did acknowledge a potential barrier of limited broadband internet access that could impact some physician practices and patients.   So in the final rule CMS lowered the threshold from 10% to 5% and added an exclusion for practices that are impacted by limited broadband access.   CMS summarized their response with, "We believe that this lower threshold, combined with the broadband exclusion detailed in the response, will allow all EPs (eligible physicians) to meet the measure of this objective."

I can agree with CMS that physicians should leverage the influence we have on patient behaviors as part of the care we provide.   We certainly are in a unique position to help patients become more engaged in and compliant with their healthcare.   I even agree with CMS that the lower thresholds should not be difficult to meet and that it is important for physicians to offer these technologies for patients to use.    

My key point of contention with CMS is with the presumption that use of these specific technologies at home allows patients to "improve their own care".    If use of these technologies were objectively linked to improved patient outcomes, I could understand the value in financially incentivizing physicians to move patients in that direction.   Without such evidence the government's relationship with physicians would be better served through a more tactful approach to promote the use of promising technologies by patients without the strong-armed threat of financial penalties on doctors. 

CMS misses the point on this one.    Precedent should not be set to penalize physicians based on measures of their ability to engineer desired patient behaviors when those behaviors are not objectively linked to improved patient outcomes.   I am not saying that we should not offer these technologies to our patients.    I am saying that we should promote their use and then study how that use impacts the quality of care

 

 

CMS Decision on ICD-10 Spurns Optional Path to ICD-11 Without Comparing Value

 

"The decision to mandate ICD-10 for covered entities has already been made."  

This response in the ICD-10 final rule published last Friday by the Department of Health and Human Services (HHS) bluntly spurns the option of foregoing ICD-10 to implement ICD-11.   HHS predictably argues that the considerable investments already made by healthcare organizations into ICD-10, the years of rulemaking with previous analyses of ICD-10 value/costs and the "uncertainties" over the timeline and value of ICD-11 all justify a decision to eliminate ICD-11 as an option.  

I am disappointed that HHS made no estimates on the comparative value of ICD-10 to ICD-11.   Instead of comparing the total cost of proceeding with ICD-10 and then implementing ICD-11 to the total cost of foregoing ICD-10 to implement ICD-11, HHS candidly explains that "we do not participate in this debate in this rule, except to say that we are convinced of the benefit of ICD-10 to health care delivery in this country."  There clearly was no intent to revisit a previous decision to implement ICD-10, even though there is an opportunity to gather and analyze new information to assure we make an informed decision on the optimal pathway to an inevitable ICD-11 implementation. 

The final rule dismisses the call from several commenters on the proposed rule for an analysis of the total costs of the two pathways to an ICD-11 implementation.   One argument made against such an analysis is that the "the disruption and costs of transitioning to ICD-11 are highly unlikely to be less those of transitioning to ICD-10."  I agree that each individual implementation may have comparable costs, but that does not compare the cost of the two pathways which are: 

1. Implement ICD-10, then implement ICD-11 (two complete implementations)
2. Forego ICD-10 to implement ICD-11 (one implementation + sunken ICD-10 investments)

What is the comparable cost of each pathway? A comparison of the cost and benefits could have a significant impact on the decision.  Let's learn from this for next time. 

By the way, there will soon be a next time.  I fear that this decision locks the U.S. into another cycle of the same-- using a diagnosis coding system that rapidly becomes archaic and leads to another decade of desperate efforts into the 2030s to upgrade after the rest of the world has already transitioned to ICD-11.

I also fear that that the burden will be excessive on healthcare organizations in 2014 to implement ICD-10 and meet the 2014 Stage 2 Meaningful Use requirements which were both announced by CMS this week.   This burden will be greatest on the small, individual physician practices are already throttled by meaningful use, 5010, e-prescribing and healthcare reform.  They are struggling to find the time and resources for the ICD-10 effort. Since the EHR Incentive Program has a specified timeline under ARRA, I believe this excessive burden is likely to trigger another delay of ICD-10, at least for small physician practices.  

Will we be left wondering why we didn't just stop investing in ICD-10 back in 2012?

Keep the data collection cart behind the trailblazing horse

In today's Health IT News there is an article expressing dissappointment with the recently released proposed rules for Stage 2 of the Electronic Health Record (EHR) Incentive Program.   Some alarming viewpoints are evident in this article regarding the collection of data for use by the federal government to improve public health .

The proposed rule for Meaningful Use Stage 2 on page 13702-13703 specifically states that the purpose of Stage 2 Meaningful use is to "“encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible”.    No where in the rule does it state that the primary purpose of Stage 2 Meaningful Use is to collect data for use by the federal government as is suggested by concerns expressed in this article.   Let's keep the data collection cart behind the trailblazing horse so that it does not aimlessly roll down the steepest part of the hill instead of steering toward most beneficial path.   Stage 2 objectives draw a sensible roadmap to the next planned destination where we can finally begin realizing the maximum potential value of health IT and EHRs.   We currently have the horse trotting around potholes toward the widespread adoption and successful use of EHRs, the development of robust HIE networks, the maturation of EHR product functionalities and an improved understanding of safe EHR usage.   If we fail to align Stage 2 activities with Stage 2 goals by taking unplanned shortcuts to collect and use data in hopes of improving care now, I fear the cart will crash and cripple the momentum that Stage 1 has initiated.

Healthcare Industry's Triple Strand of DNA: health IT, payment reform and patient empowerment

Earlier this month I used a genetics anology to describe the amazing progress with electronic health record (EHR) usage by physicians over the past two years (see Progress being made to splice information technology into the healthcare industry's genome in Texas).   Facilitating this progress are the EHR Incentive Program and other federal health IT initiatives that the Office of the National Coordinator for Health IT (ONC) oversees. 

Last Thursday the National Coordinator of ONC, Dr. Farzad Mostashari, took my genetics analogy one step further in his keynote speech at the HIMSS12 Annual  Conference for health IT in Las Vegas.   And I have to admit that he improved upon it.  I guess that's why he's in Washington D.C. and I'm not. 

Dr. Mostashari warned the 36,000  conference attendees that along with this continued progress there are two other societal trends to align health IT with.   He advocated for "twisting health IT to create a triple strand of DNA" with payment reform and patient empowerment. 

Health IT, payment reform and patient empowerment.  The triple strand of DNA to splice into the healthcare industry.  I like that. 

Payment reform is seriously needed to align incentives with the provision of quality care in an efficient manner.   Right now I am basically paid to "encounter" patients and to do procedures.       Although I am personally motivated to provide high quality care, the incentives are oddly there for physicians to "see more" and "do more" rather than to "see it done best".     In addition, my documentation is based on meeting reimbursement rules to make sure I get paid rather than being based on communicating a clear picture of my findings and care plan.   I absorb the extra time it takes to do both.

Consequently it is no surprise that for decades EHR vendors developed products based on episodic care.    Physician's sought out products that would help them document and get paid for patient encounters.  Documentation templates and charge capture functionalities were developed to maximize chances for reimbursement.    

The potential for EHRs to improve quality and chronic disease management is just now starting to be realized.    The ONC's health IT initiatives enacted by CMS under the HITECH portion of the 2009 Recovery Act are providing the push.   But as payment reform proceeds, whether it be value-based purchasing, accountable care or some other program, EHR vendors will be incentivized even more to shift development efforts into chronic disease management and clinical decision support that are a basis for improving patient care. 

And the third strand of DNA to splice into the healthcare industry, patient empowerment, is indeed an active and growing societal influence.  But I will have to blog about that another day...

Progress being made to splice information technology into the healthcare industry's genome in Texas

It's amazing-the progress being made to splice information technology into the health care industry's genome.   When I first dove into health IT a decade ago the use of electronic health records (EHRs) was dismal and healthcare stakeholders rarely sat at the same table with mutually beneficial, collaborative objectives in mind.   Even within the same healthcare organization it was not uncommon for individual department leaders to disrupt an integrated health IT effort in order to protect some of their department's self-interests.   Less than 5% of hospitals had implemented fully functional computerized provider order management (CPOM) systems; less than 1 in 5 physicians were using an ambulatory EHR; and less than 5% of those were fully functional EHRs.    Today the percentage of physicians and hospitals using robust EHRs is rising at a rate that was unthinkable back then.  

This progress parallels the launch of health IT initiatives established through the federal HITECH funds such as the EHR Incentive Program.   In the past two years these funds have been a catalyst here in Texas to engage diverse groups of healthcare stakeholders  to use health IT to improve quality of care.   As a result:  

• Increasing numbers of Texas physicians are using EHRs (approaching 50%)
• More and more hospitals are using CPOM
• Over a dozen of community-wide health information exchanges (HIEs) are up and running
• New health IT workforce training programs are established
• Four regional extension centers were formed covering all geographic areas of the state and are doing a phenomenal job assisting thousands of physicians with EHR selection, implementation and meaningful use
• Texas became the first state to have it’s HIE plan approved by ONC
• Texas was one of the first states to stand up the Medicaid EHR incentive program making our program a model for other states
• Texas was one of four to receive a SHARP grant
• And Texas leads the way with the number of physicians attesting to meaningful use; Texas physicians and hospitals have received over $270 Million in EHR incentives

This rate of progress is only possible when individuals with diverse backgrounds and from different healthcare stakeholder groups are able to collaborate.  In Texas these stakeholders have demonstrated an ability to park their self-interests in order to drive forward with a common vision to improve the quality and delivery of patient care in our communities.

Snapshot of EHRs Used in Texas to Achieve Meaningful Use Gives Glimpse of Regional EHR Market Consolidation

Over 400 electronic health record (EHR) vendor products are certified by the Office of the National Coordinator of Health IT (ONC), but only a handful of them are used by a majority of the physicians in Texas who have been awarded EHR incentive payments by the Centers for Medicare and Medicaid Services (CMS) according to an ONC database released last week.

Physicians who successfully meet CMS criteria that demonstrate their “meaningful use” of an ONC-certified EHR become eligible for incentive payments up to $44,000 over 5 years under the Medicare program or $21,500 over 6 years under the Medicaid program. The ONC database includes the records of 21,697 physicians who have received EHR incentive payments so far, de-identified by physician but including the physician’s EHR product name, the physician’s state and whether payment was received through the Medicare or Medicaid programs. There are 217 EHR vendors listed as having products that had been used successfully by at least one eligible physician.

In Texas 1,585 physicians have received EHR incentive payments according to the database. Although 75 different ambulatory EHRs were used by at least one physician, only six of them were used by more than 100 physicians. These six EHRs account for 69% of the EHRs used in Texas to achieve meaningful use.    They are listed here with the number and percent of physicians using each to achieve meaningful use:

• Epic 277 (17%)
• eClinicalWorks 249 (15%)
• e-MDs 177 (11%)
• Allscripts 170 (11%)
• Athenahealth 128 (8%)
• NextGen 114 (7%)

The following graph displays the 25 EHRs that at least 10 Texas physicians have used to achieve meaningful use payments (click to enlarge):

There are 50 other EHRs used by less than 10 physicians in Texas who have successfully attested for meaningful use incentive payments.   These are listed at the end of this blog.

Across the nation Epic is the early leader with over 25% of physicians using it to achieve meaningful use. The top five EHRs nationally–Epic, eClinicalWorks, Allscripts, athenahealth and Community Computer Services–are used by nearly 49% of the physicians.    The top 13 EHR vendors nationally are used by more than 75% (see list below).   There are variations in regions across the nation, though, as seen with the Texas data.

It is interesting to note in Texas that the first three of the top six EHRs used to achieve meaningful use–Epic, eClinicalWorks and e-MDs–are all private companies.   The other three are public companies–Allscripts, NextGen and athenahealth.  They all all generally have positive reputations and perennially receive a variety of “Best in KLAS” rankings.    Epic’s ambulatory EHR is used primarily by physicians affiliated with large health centers and is not currently a feasible option for many small practices in rural Texas.    Athenahealth is marketed as a web-based EHR, but the others can be web-based as well.   Although e-MDs is popular nationally, their market share in Texas benefits from their headquarters being located locally in Austin.    

In the past decade many speculated that CCHIT certification of EHRs, which is more comprehensive than the ONC-certification for meaningful use, would spur a consolidation of what is currently a disperse EHR market with hundreds of vendors supplying products.  Others felt that free market forces, with physicians in the center creating demand for EHRs that worked well, would eventually swing the pendulum toward consolidation.   It is still early, but the data set in the ONC database gives a provocative glimpse at the EHR market forces in play today.  There is clearly some consolidation around a small number of EHR products after the first year of the CMS EHR Incentive Program.    I suspect physician demand for EHRs that simplify their ability to receive incentive payments will continue to play a significant role in swinging the EHR market pendulum towards consolidation over the next decade. 

 

Additional data:

The top 13 EHRs used by physicians nationally for EHR incentive payments were:

#Providers         Vendor Name

6330                     Epic Systems Corporation

1847                    eClinicalWorks LLC

1502                    Allscripts

1158                    athenahealth, Inc

999                      Community Computer Service, Inc.

921                       GE Healthcare

899                      NextGen Healthcare

770                      e-MDs, Inc.

712                     Greenway Medical Technologies, Inc.

567                     Cerner Corporation

565                     Sage

397                     BioMedix Vascular Solutions

252                     AmazingCharts.com, Inc.

 

The following 50 vendors had less than ten physicians in Texas using them to achieve meaningful use incentive payments:

Meditab Software, Inc.

HealthFusion

Pulse Systems

Altos Solutions, Inc.

Integrated Health Care Solutions

MED3000, Inc

Waiting Room Solutions

BizMatics Inc

Compulink

Crystal Practice Management

digiChart, Inc.

NexTech Systems Inc.

American Medical Software

ICANotes, LLC

MicroFour, Inc.

Prime Clinical Systems, Inc.

ADP AdvancedMD

Altapoint Data Systems, LLC

Ingenix

Intivia, Inc.

MedPlus, A Quest Diagnostics Company

MTBC (Medical Transcription Billing Corporation)

Nuesoft Technologies, Inc.

Spring Medical Systems, Inc.

SuiteMed

UnisonCare Corporation

AllegianceMD Software, Inc.

Cerner Corporation

CodoniX

CureMD Corporation

Data Strategies, Inc.

DoctorsPartner, LLC.

DrChrono.com Inc.

DrFirst

EMRlogic Systems

Encite, Inc.

Exemplo Medical LLC

E-Z BIS, Inc.

gMed, Inc.

Health IT Services Group

Insight Software, LLC

Medical Office Online, Inc.

MedInformatix, Inc

MedLink International, Inc

Medrium Inc.

Midwest Software, LLC

MPN Software Systems, Inc.

Net Health Systems, Inc.

Sammy Systems

WellCentive

Health Information Exchanges and Physicians Share Accountability for Safe Patient Care

The $800 billion 2009 American Recovery and Reinvestment Act (ARRA) set aside $36 billion toward health information technology (health IT) initiatives, including over $500 million for the State HIE Cooperative Program.  This federal program provides funds to each state for the successful planning and development of infrastructure that supports the exchange of electronic health data between physician electronic health records (EHRs), hospital EHRs, lab systems, radiology centers and other clinical IT systems.    For example, in Texas we are using these funds to support the development of local health information exchange entities, called HIEs, across the state and to concurrently develop the policies, standards and infrastructure needed to safely/securely connect these HIEs to each other.     The statewide HIE network will also be built to be compatible with national standards and efforts.      

Each state's effort to develop a network of community HIEs and/or a statewide HIE will be more successful with physicians involved upfront with governance and policy development.   When working with local HIEs most physicians will generally understand and appreciate the importance of protecting the privacy and security of electronic patient health information.  Their inherent knowledge on this issue will help guide policies in the right direction.   A more complex issue for physicians to understand is the relationship between HIEs and patient care.   A heightened awareness of this issue will allow physicians to properly inform HIE policymakers about the need to establish an environment where local HIEs, HIE networks and physicians share accountability for safe patient care.   

To deepen physician's understanding of this issue I encourage them and others to think about an HIE as a tool physicians use as a part of patient care, similar to a surgical tool.   If a patient is harmed by a surgical tool that broke because the physician used it incorrectly, the physician is negligent.  If the physician used the tool correctly but it still broke, but it has only broken 8 times in over 10,000 surgeries and the patient consent explains this remote risk of breakage, then no one is negligent.  However, if it broke and the issue had been reported to the vendor by many physicians on a repetitive basis, but the vendor failed to investigate the issue and fix the problem, or failed to inform physicians and patients of the increased risk in the meantime, then the vendor is negligent. 

This perpsective will help physicians advocate for policies that lead to an environment where HIEs and physicians share accountability for safe patient care.   Effective policies will lead to contracts and agreements which acknowledge that:

1. HIEs and HIE infrastructure are tools used by physicians during the course of patient care
2. HIEs are responsible for informing patients and doctors about the inherent risks of  the electronic health information exchange including changes in risks when issues are identified
3. HIEs have a responsibility to continually monitor for and mitigate risks associated with their services that may impact quality of care provided by physicians

 

Bipartisan Health IT Support and ARRA Insulate EHR Incentive Funds From Budget Cuts

A physician colleague recently asked me why I am confident that CMS will not cut off EHR incentive funding in the future.   This question is important to him and other physicians who plan to qualify for up to $44,000 in CMS incentive payments by achieving the meaningful use of EHRs.   They fear that the dragging economy and political discord will result in budget reductions that will cut this and other important health IT funding programs.    What I see, though, is a decade-long track record of bipartisan support for health IT initiatives and a 2009 federal law that requires CMS to provide funding for the EHR incentives and other health IT programs.

In his 2004 State of the Union speech President Bush envisioned the adoption of EHRs for all Americans by 2014.   Since then bipartisan support at both the state and federal levels for health IT initiatives toward the achievement of that vision has held strong.   At the federal level CMS  not only established a new office in 2004 to support health IT, the Office of the National Coordinator of Health IT (ONC) but has also increased funds to support ONC initiatives which promote the adoption and use of EHRs.  CMS works collaboratively with ONC and has consistently shown an understanding that the broad adoption and effective use of EHRs are necessary to better manage spiraling healthcare costs.   CMS understands that the data captured by EHRs is superior to claims-based data when attempting to analyze quality and establish benchmarks.    Physicians have long complained that claims-based data is incomplete and does not fairly demonstrate the quality of care they provide.     EHRs must be broadly adopted in order to capture accurate and meaningful data that can then be used to improve quality or save costs.  

It is important to recognize that CMS is required to provide EHR incentives to physicians by law.   Specifically, the $800 billion American Recovery and Reinvestment Act (ARRA) of 2009, commonly refered to as the Stimulus Bill, allocates over $36 billion to health IT programs through the Health Information Technology for Economic and Clinical Health (HITECH) Act.   This funding includes an estimated $34 billion for the Medicare and Medicaid EHR Incentive Program and over $300 million to support state-wide health information exchange efforts.

In order to cut funding for EHR incentives, this means that bipartisan support would have to be garnered in the House and Senate to rescind ARRA or part of ARRA.   The intent of ARRA  initiatives is to stimulate economic activity and produce jobs.   In the current economic environment it would seem very risky, perhaps even foolish, for a politician to drum up support for new legislation that eliminates economic stimulus activity, especially if that activity is already producing jobs.

So, is the EHR Incentive Program stimulating the economy and producing good jobs?   I am not an economic expert, but from what I see around me the answer is clearly, "yes".    I see job openings in the local paper for healthcare system IT analysts and other staff, I speak with IT consultants most of whom are actively seeking personnel, I hear about physician offices investing into the economy $10,000-$70,000/doctor to implement EHRs or upgrade other office technologies, I read about physicians receiving $44,000 federal incentive payments and about hospitals receiving larger amounts, some of which is surely returned into local economies.  The graph below is a composite view of the 3-year stock performance of the health IT sector since 2009.   EHR vendors and other health IT companies appear to be thriving well since ARRA was passed despite the depressed economy.

I suspect that several years from now when experts analyze the impact of the $800 billion stimulus package, the puny $36 billion provided to health IT initiatives through the HITECH portion of ARRA will go down as perhaps the most bang for the buck in terms of stimulating the economy.  

The EHR incentive funds appeared to be well insultated from budget cuts for these same reasons. 

Texas Medical Association video provides in-depth look at meaningful use, how RECs can help physicians

This video does a good job of describing Meaningful Use, the electronic health record (EHR) incentive program and how the four regional extension centers (RECs) in Texas leverage federal grants to subsidize services for physicians that help them select/implement or upgrade an EHR, and then use their EHR to improve quality of care and meet the Meaningful Use requirements.  

The four RECs in Texas currently charge primary care physicians only $300 for consulting services valued at $5,000.  These services include:

o    Select and implement a certified EHR (or upgrade your current EHR to a certified version)

o    Optimize your practice workflow,

o    Achieve meaningful use,

o    Qualify for EHR incentives, and

o    Obtain CME credit hours      

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Modifications to the HIPAA Privacy Rules Under HITECH Will Burden Small Physician Practices

The HITECH Act requires HHS to revise the HIPAA Privacy Rule to remove the exclusion for Accounting of Disclosures for treatment, payment and health care operations to the extent that the disclosures are made through an EHR.    In addition, it requires HHS to determine what information is to be collected and then included in these disclosures.    In 2010 HHS published a Request For Information (RFI) to seek comments on individual’s interests in learning of disclosures, the burdens on Covered Entities in accounting for these disclosures and the capabilities of current technologies to facilitate disclosures.    The resulting proposed rule is an attempt by HHS to balance the individual’s privacy rights against the burdens on Covered Entities.    HHS is accepting comments on this proposed rule up until August 1, 2011. 

At a high level, it appears that the proposed rule primarily does two things:

1. Provides individuals a right to request a new "Access Report" that lists who has accessed their PHI in an electronic designated record set (which is basically medical records, billing records, or other electronic information that is used for payment or treatment decisions) for any purpose including for treatment, payment and health care operations.    The proposed rule limits the information in an Access Report to content which is already required by the Privacy Rule to be collected.    The assumption is that limiting content in this manner will enable a more automated process by which Covered Entities could produce an Access Report and that this would therefore ease their burden.
2. Makes changes to "streamline" the Privacy Rule's current Accounting of Disclosures provision, such as limiting the types of disclosures that must be accounted for.     As with the Access Report, HHS showed consideration to the burden placed on Covered Entities by making a number of changes to the individual's existing right to an Accounting of Disclosures that would make it easier for Covered Entities to comply with the requirements.   

Despite these positive changes, the proposed rule significantly underestimates the burden on small physician practices.    Although I agree that these changes do, in general, ease some of the burden on Covered Entities, it is primarily the large healthcare systems that will be able to leverage these changes to their advantage.    I do not believe that these changes sufficiently ease the excessive burden on providers in small practices who do not have the resources to leverage the changes to their advantage.    

HHS uses the assumption that limiting content in the Access Report to that which is already required to be collected [i.e. in an EHR] will enable a more automated report and therefore ease the burden on Covered Entities when an individual requests a report.  This assumption is misleading because it assumes that all Covered Entities have the resources necessary to produce a report that meets all the requirements.   According to the proposed rule, the Access Report must meet certain specifications as defined in the rule, must consolidate content from multiple systems if they exist, must allow individuals to limit their requests to specific time periods or persons, and must be made available in an electronic format as requested by the individual if possible.    Although the information in the Access Report is limited to content already required to be collected, EHR vendor products are not required to provide an automated process to produce an electronic report that meets the proposed rule’s requirements.     Therefore, it will not typically be a simple automated process to produce the report.     Instead, the Covered Entities will have to produce the report through a manual process in which some technical skills are needed to design and configure the report to meet the proposed rule’s specifications, to consolidate content from multiple systems, to customize the report to meet requested limitations and/or to re-format the report.   

For example, programming skills will be needed to create an Access Report from a typical EHR that produces an automated audit log that only shows the User’s ID when a record is accessed, but not the individual’s name as required for the Access Report.    In that case the report must be re-configured to map the actual name of the individual in place of the recorded User ID.    As we know, when one change is made in an electronic report, other changes may be needed to accommodate the change.    In this example, mapping content from the NAME field to the USER ID field might also require the report writer to increase a character limit in the USER ID field so as to not cut off long names.    This second change could cause the report to extend beyond the set margins of the report’s design, therefore requiring the report writer to change the design of the report.    A small practice will not typically have someone with the expertise to program such a report and will therefore have to hire an IT consultant.

Covered Entities must utilize the time and effort people who have the needed technical skills to meet the proposed rule’s reporting requirements.    The difference between small practices and large providers is the availability of technical expertise to do this manual work.     Most large healthcare systems and some large physician practices have an IT Department or employ IT personnel who have the expertise and skills needed to design, configure and format reports.    For large entities, the Access Report does not create a significant new burden because they already have the expertise to produce their reports. But very few small physician practices have the resources necessary to do this.     So in order to produce an Access Report, a small practice will have to hire outside resources to design, configure and format the reports at variable costs.    The actual cost will be dependent on the complexity of each report and the IT consultant’s hourly rates ($100-$250/hour).     As the proposed rule is currently written, a small practice will typically have to hire external resources, at their own expense, to write the report and then be required to provide the report at no cost to the requesting individual.

As acknowledged in the proposed rule, the Accounting of Disclosure is recognized by HHS to be more complex and will require a “manual, expensive, and time consuming process for Covered Entities and Business Associates.”   One purpose of the new Access Report is to be an alternative to Accounting of Disclosures in order to mitigate this known burden of disclosures.    Nevertheless, the Access Reports will still require “manual” work that involves technical skills and will be a significant burden on small practices.    Also, since the Accounting of Disclosure reports are more complex they will require more manual work and technical skill than Access Reports.    The burden of disclosures on small practices will therefore be much greater than for large systems that already employ the technical expertise to design, configure and format the reports.

 In summary:

1. The proposed rule requires small practices to provide requesting individuals with a new Access Report which places excessive burden on small practices at an unreasonable cost.    The burden of producing an Access Report should be on the vendor’s EHR product and not on the physician.     The proposed rule should be modified to require small practices to provide the system’s automated audit log, as configured by the vendor, if available, from any of their systems that store PHI.    The burden should be placed on the vendors to configure their products to produce automated reports that meet the specifications and requirements.    If a small practice has to hire IT consultants to design and configure or modify an Access Report, they should be allowed to charge the individual for the actual costs incurred.
2. This proposed rule also requires small practices to provide requesting individuals with an Accounting of Disclosure which also places excessive burden on small practices at an unreasonable cost.    The burden of producing Disclosure reports should be on the vendor’s EHR product and not on the physician.    The burden should be placed on the vendors to configure their products to produce automated reports that meet the specifications and requirements.    If a small practice has to hire IT consultants to design and configure or modify an Accounting of Disclosure report, they should be allowed to charge the individual for the actual costs incurred.