Policy and Medicine

Health Information Technology: Office of the National Coordinator to Charge User Fees to HIT Vendors

We previously wrote about President Obama’s FY 2014 budget for the U.S. Department of Health and Human Services (HHS).  Given the large size of the budget and the vast array of agencies it covers, we are devoting a separate story on the budget for the Office of the National Coordinator for Health IT (ONC), which received a big financial boost, jumping 28 percent to $78 million, reported FierceHealthIT. 

“With HITECH funding ending in FY 2013, the proposed funding is needed to ensure that progress towards secure, interoperable health IT systems is continued,” National Coordinator for Health IT Farzad Mostashari said.  “ONC’s budget will ensure that investments such as the EHR Incentive Programs continue to yield meaningful results, and that health IT fulfills its important role in modernizing and transforming the nation's healthcare system.” 

What is unique about ONC’s budget is that it imposes a new "user fee" on electronic health record (EHR) vendors and developers to support ONC's certification and standardization activities, reported FierceEMR.  “The fee would be assessed on vendors who certify their products through the ONC health IT certification program.  The estimated $1 million fee is part of ONC’s $26.3 million request to support standards, interoperability and certification,” the article noted.  “The fee will be imposed on vendors and developers because they are the primary beneficiaries of the certification program.  Providers must use a certified product to qualify for Meaningful Use incentive payments.” 

The user fees were justified by ONC because of their increasing workload, and the funds for certification activities from the American Recovery and Reinvestment Act (ARRA), which created the Meaningful Use incentive program, are scheduled to expire in 2013.  “Consequently, a new revenue source is necessary to ensure that ONC can continue to fully administer the certification program, as well as invest resources to improve its efficiency,” the proposed budget notes.   Some of the improvements contemplated include additional tools and resources and technical assistance, FierceEMR writes.  

The HIMSS EHR Association, in a statement released late last week, said it did not support the fee and suggested that HHS evaluate the necessity and value of “all requirements in the Meaningful Use program and the associated certification activities.”  As of March 2013, the Certified Health IT Product List on ONC’s website included over 1,750 unique certified EHR products from 945 vendors and developers.  

FierceHealthIT reported that “Approximately $16 million of the $78 million would go toward policy development and coordination, according to the ONC's budget.  The funding will help implement the much anticipated Health IT Patient Safety Action and Surveillance Plan, expected to be finalized in early summer, as well as support health IT governance efforts.  The latter, according to the budget, will be achieved by ‘funding emerging private-sector governance collaboratives, publishing a series of governance guides and launching a monitoring program to ensure that governance goals are being addressed.’”

Another $26 million will be allocated to both maintain and develop standards supporting an “interoperable and secure health IT infrastructure,” the article reported. The funding will also go toward sustaining health information exchange, as well as continued operation of the ONC Health IT Certification Program.  Finally, more than $14 million will go toward supporting the Meaningful Use Incentive Program, as well as monitoring its results.  According to the budget: “As adoption rates accelerate, ONC will begin focusing on developing and distributing best practices to providers and consumers in order to help them make the most of their health IT investments to improve patient care, population health and increase the value of every health dollar.” 

HHS’ Office of Civil Rights, will receive a $1 million increase in funding to $42 million in FY 2014 to go towards enforcing the updated HIPAA Security Rule, which took effect in March 2013.  

Senators Call for Review of HITECH

Six Republican Senators have formally requested that U.S. Department of Health & Human Services Secretary Kathleen Sebelius provide a written plan to address how the agency is implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act. 

In an April 16 letter—signed by Senators Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Tom Coburn (R-Okla.), Mike Enzi (R-Wyo.), Pat Roberts (R-Kan.) and John Thune (R-S.D.)—they state that Congress has an obligation to conduct oversight of government programs. To that end, they released a 28-page white paper entitled “REBOOT: Re-Examining the Strategies Needed to Successfully Adopt Health IT” that outlines their concerns with current health IT policy, including the costs, interoperability, the potential for waste and abuse, patient privacy and sustainability.

The Senators asked that in conjunction with ONC and the Centers for Medicare and Medicaid Services (CMS), the Secretary provide a detailed written plan to address the concerns in the enclosed white paper, to ensure that health IT taxpayer investments today are sound and result in a safe, secure, interoperable health IT system in the future. Specifically, please address your plans to achieve interoperability, control billing costs, prevent waste and abuse, protect patient privacy, and ensure the program is sustainable.  The Senators also asked for answers to the following questions by June 16, 2013: 

1. A list of every contract or task order awarded to perform work related tothe HITECH Act, including the recipient, the amount and length of the contract, and the nature of the work to be performed.
2. An update on ONC’s planned contract with Mathematica Policy Research to build a model to understand the linkages between all of the different health IT programs, as well as the cost and quality implications of health IT, and copies of any findings reported to HHS, ONC or CMS
3. An update of ONC’s contract with the National Opinion Research Center at the University of Chicago (NORC) to conduct an evaluation of state health IT programs as mandated in HITECH and a copy of any findings
4. ONC funded $250,000,000 in cooperative agreements to Beacon Communities that, according to ONC, “have already made inroads in the development of secure, private, and accurate systems of EHR adoption and health information exchange.”  How many of these communities will have to reduce their standards in Stages 2 and 3 to avoid penalty payments?  What work has HHS, ONC,or CMS done to evaluate the progress of each of the Beacon Community awardees and how they will be impacted by Stage 2 and 3 milestones?
5. An update on the status of a contract with the American Institute for Research (AIR) to evaluate the effectiveness of different HIT activities.  The evaluation was to include a survey of providers and regional extension centers (RECs) and capture information such as how the RECs affected EHR adoption in the region.
6. ONC was planning to conduct evaluations of HITECH implementation in three cycles with separate deliverable dates to the National Coordinator on February 1, 2012; April 1, 2012; and September I, 2012. ONC was also expected to produce an overall summary of all three reports.  The Senators asked for copies of all reports delivered by ONC to the National Coordinator and expected dates of publication for unpublished reports.
7. Section 232 of the HITECH Act required the National Coordinator to assess and publish the impact of health IT in communities with health disparities and in areas with a high proportion of individuals who are uninsured, underinsured, and medically underserved (including urban and rural areas), identify practices to increase the adoption of health IT by health care providers in such communities, and assess the use of health IT to reduce and better manage chronic diseases. The Senators asked for an update on the status of this assessment and provide copies of any related findings reported to ONC to date. 

In their white paper, the Senators point out additional concerns.  For example, they note early reports, which suggest that federal incentive payments are being made without clear evidence that providers can achieve “meaningful use,” or the ability to use the health IT program internally, and without an adequate plan to ensure providers can share information with each other.  In addition, they noted that although CBO estimated that HITECH will save Medicare and Medicaid programs about $12.5 billion through 2019, health IT may have actually accelerated the ordering of unnecessary care as well as increased billing for the same procedures. 

The white paper also pointed out reports that “taxpayer dollars being paid to providers who cannot or do not have to demonstrate that the technology is actually used as prescribed, because the administration relies on provider “self-attestation” in many cases to determine eligibility for payments.  In some cases, contractors receiving government funds may be creating obstacles to interoperability.”  In other cases, providers who have previously received federal incentive grants are reportedly now forced to adopt less advanced technologies to meet current standards, effectively forcing them to scrap prior federally subsidized investments. 

Finally, the Senators raised concerns about patient privacy and program sustainability.  For example, HHS-OIG found that the security policies and procedures at the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology – two federal entities that oversee the administration of the health IT program – are lax and may jeopardize sensitive patient data.   

Additionally, “it is unclear how much it will cost to maintain their health IT systems after the initial grant money and incentive payments run out.”  Further, penalties are most likely to affect small providers who may not have the economies of scale needed to make complex electronic systems cost-effective.

Overview of Electronic Health Records

We have written about health information technology (HIT) and electronic health records (EHRs) over the past few years given their critical role in advancing high quality healthcare, as well as various requirements institutions and healthcare providers must meet with respect to the use of HIT and EHRs.  Consequently, a recent article from Software Advice gave a detailed analysis of EHR Software Systems and some of the trends, updates, and developments to look for. 

There are several hundred electronic medical record (EMR) and electronic health record (EHR) systems available for just about every medical specialty and clinic size.  EMR vendors have customized systems for outpatient care, inpatient care, solo practices, enterprise groups, primary care, therapy, mental health, ophthalmology, chiropractic and so on.  Furthermore, various systems span the full range of pricing, from free to several hundred thousand dollars.

With so many medical EMR companies catering to so many specialties, physicians face a big challenge as they determine which medical software is right for their needs.  As a result, Software Advice put together a “buyer’s guide—and list of the top 10 EMR software programs—to help physicians understand the market and know where to start. 

Using data from the government—CMS—the company was able to capture EHR market size and share and quickly calculate the number of eligible professionals (EPs) in an ambulatory care setting (i.e. outpatient setting) that have attested for meaningful use (MU)--115,918 EPs. 

According to their research, 107,112 of those are for a complete EHR, while 8,806 are for a modular EHR.  This data is readily available in an Excel download at Data.gov, but only includes data through October 2012.  They also identified 387 vendors that have attestations for a modular or complete EHR.  Out of that number, 355 have attestations for a complete EHR.  Surprisingly, the Office of the National Coordinator for Health Information Technology (ONC) lists 623 vendors in their Certified Health IT Product List (CHPL).  “So there is a large number of vendors without any attestations,” they write. 

The article notes that a large percent of EPs have not attested.  According to the CMS December 2012 report, 350,844 EPs are actively registered (240,695 Medicare, 110,149 Medicaid).  However, MU attestation data that includes the names of EHR products is only available through October 2012. 

Their initial analysis from 2010 reveals the top five vendors haven’t changed.  “Though, SOAPWare, Eclipsys and Sage Health are noticeably absent from the top ten.  Eclipsys merged with Allscripts in August 2010, which explains their absence.  Presumably, the other two have been beat by e-MDs, McKesson and/or athenahealth.” 

Deployment Types

Buyers must consider if they want a stand alone EMR solution or one that has integrated billing and scheduling features. Buyers should consider a stand alone solution if they have unique needs that a vendor cannot address, if they outsource their medical billing, or if they have already invested heavily in an existing billing solution.

The benefit of an integrated system is having a centralized solution to manage all aspects of operating a medical business (clinical, administration and financial). EMR vendors such as GE Centricity, Allscripts and eClinicalWorks are all popular vendors that can provide both stand alone EMR options and integrated suites.

EMR Software Buyer Types

Assessing the type of buyer you are can help narrow your search to software solutions that can best fit your needs.

Small practice owners. Typically, these buyers manage a practice of one or two physicians. They’re looking for a simple solution that can integrate with labs as they upgrade from paper charts.

Medium to large-sized practice owners. Buyers in this market typically manage practices with anywhere from 5 to over one hundred physicians. In addition to improving the efficiency of their practices, these buyers need integration with healthcare network systems, track information at multiple sites and help provide consider regardless of provider.

Hospitals and inpatient care providers. These buyers typically work in a hospital setting and need a solution to manage rooms (and beds), nurse assignments, and physician rounds. Because of these needs, buyers in this market typically need robust EMR solutions that can also integrate with other medical applications.

Primary care (MD/DO) providers and related specialists. Physicians and assistants that work privately and offer internal medicine, family practice, Ob/Gyn, orthopaedics, urology, and other services. The buyers’ needs in this market typically vary and require templates for the speciality.

Specialists with special designations. These specialists may have a DC, PT, PhD, OD, LCSW, and other designations, and are commonly therapists, chiropractors, physical therapists and optometrists. These buyers often need very straight-forward, affordable solutions to help manage their practice.

Market Trends to Understand

Buyers should be aware to the biggest trends in the EHR Market. Here are a few important ones:

ONC-ATCB Certification. The American Recovery and Reinvestment Act (ARRA) ushered in the HITECH (Health Information Technology for Economic and Clinical Health) era in 2009. The HITECH Act includes almost $20 billion to incentivize adoption EHRs. Providers that successful attest “meaningful use” of systems that have been certified by the ONC-ATCB allow providers to be eligible for $44,000 in Medicare/Medicaid reimbursements.

Market Consolidation. We expect top companies to make key strategic purchases in the future to accelerate growth and increase market share. As a recent example, ADP acquired AdvancedMD and McKesson acquired Med3000. We expect this trend to continue and reduce the number of vendors in this market (currently over 300).

Software as a Service (SaaS). In Software Advice’s estimates, a quarter of buyers are interested in Web-based EHRs, and another half are open to the idea early-on in their research. Web-based EMR solutions are now viable options thanks to increased data security, encryption, backup methods and service reliability. In addition, many of these systems require less up-front investment thanks to Web-based solution providers’ monthly payment structure.

iOS 6 Support. Many popular EHR software providers support the latest version of Apple’s mobile operating system, iOS 6. MediTouch EHR by HealthFusion, for example, has been updated to take full-advantage of the new features in iOS.

New Mobile EHR Apps. In addition to support for iOS 6, many EHR vendors have developed other applications that support mobile devices. Aprima Mobile, for example, launched in July 2012 and can run on both iOS and Android devices.

Benefits and Potential Issues

There are a number of benefits that can be realized through successfully impleneting an EHR solution, including:

• Increased number of patient visits;
• Improved data collection capabilities;
• Improved care for patients; and
• Improved practice efficiency.

A common concern for healthcare providers is data security. Proper implementation is necessary to ensure both HIPAA compliance and data privacy. Most vendors provide the necessary resources to avoid security breaches, but healthcare providers should also be vigilant.

A second consider is the associated learning curve with electronic health records. Many vendors provider training and technical support to help providers learn to use navigate systems and utilizes features.

Finally, viability is the last common concern among buyers. If a vendor goes out of business or is acquired, its support levels may change or be discontinued. This makes the importance of assessing vendor viability (as well as the market share report data above) all the more valuable.

 

Health Information Technology: Meaningful Use AMA Comments and OIG Report

One of the central pieces to the Affordable Care Act (PPACA), along with the American Reinvestment and Recovery Act (ARRA) was the implementation and “meaningful use” of electronic health records (EHRs)—through the HITECH provision.  Consequently, the Office of the National Coordinator for Health IT's (ONC) HIT Policy Committee has released a copy of its proposed recommendations for public comment. 

Under the 2009 federal economic stimulus package, health care providers who demonstrate “meaningful use” of certified electronic health record systems can qualify for Medicaid and Medicare incentive payments.  To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services. 

CMS expects to pay about $6.6 billion in incentive payments to providers who use certified HER technology between 2011 and 2016.  So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals.  By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. 

The Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) reported that the percentage of doctors adopting electronic health records has increased from 48 percent in 2009 to 72 percent in 2012.  The ONC report shows that since 2009, the percent of physicians with computerized capabilities to e-prescribe has more than doubled, from 33 percent to 73 percent.  

While HHS and the Obama Administration have been busy issuing rules and regulations, as well as various guidance, and holding numerous forums and educational opportunities for individual providers and institutions, a recent report from HHS’ Office of Inspector General (OIG) found that the Centers for Medicare & Medicaid Services (CMS) is falling down on the job when it comes to verifying if providers receiving incentive payments are entitled to them.   We previously noted that the government is already concerned that doctors and providers may be using EHRs to upcode medical bills.  

In addition to OIG’s report, the American Medical Association (AMA) sent comments to ONC, expressing its extreme concern that ONC is moving full speed ahead with Stage 3 of the meaningful use EHR program “without a comprehensive evaluation of the program and resolving existing barriers, including HIT infrastructure flaws.”  The 20-page letter outlined the following top five concerns and recommendations to improve the meaningful use program: 

1. An evaluation process is lacking. An external, independent evaluation is necessary to improve and inform the future of the program.
2. 100 percent pass rate is not the right approach. The pass rate should be reasonable and achievable. Failing to meet just one measure by one percent would make a physician ineligible for incentives and subject to financial penalties
3. One size does not fit all. Under the current program, every physician regardless of their specialty must meet the same measures (i.e., core measures), and there are few exceptions. The program requirements should be appropriately flexible and better structured to accommodate various practice patterns and specialties. Also, additional resources and time to develop and test e-specified electronic measures focused on outcomes must be allotted to ensure successful implementation of the meaningful use program.
4. Usability of certified EHRs should be addressed. The EHR certification process should address physician usability concerns.
5. Health IT infrastructure barriers should be resolved. The health IT infrastructure does not enable physicians to readily electronically share patient data with other health care providers; infrastructure improvement to allow an efficient and secure electronic information exchange must be a priority. Improving the Health IT infrastructure to allow physicians to readily and securely exchange patient data with other health care providers should be made a top priority and take precedence over the development of future stages of the meaningful use program. 

The American Hospital Association (AHA) and The College of Healthcare Information Management Executives (CHIME) echoed AMA’s concerns in their own comment letters.   

OIG Report 

The OIG report found that the EHR system is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, reported the New York Times.  The report mirrors a report earlier this year from the Government Accountability Office, which also expressed concern that CMS was not verifying provider attestation information before distributing payments to them. 

According to the New York Times, the report states that “Medicare has not audited any of the $3.6 billion payments it has made to date, which faults the agency for its lack of prepayment review and reliance on self-reporting after money has been spent.” 

The OIG report blasts CMS for not verifying the accuracy of providers’ attestation information both before and after paying the incentive, leaving the program “vulnerable,” reported FierceHealthcare.  “Currently, CMS has not implemented strong prepayment safeguards,” the report states.  “CMS does not verify the accuracy of professionals’ and hospitals’ self-reported information prior to payment because data necessary for verifications are not readily available.  CMS also does not direct high-risk professionals and hospitals to submit supporting documentation for prepayment review.” 

OIG also found that ONC’s requirements for EHR reports in certified EHR technology may be contributing to CMS’ oversight obstacles, since those reports are not sufficient for CMS to verify providers’ reports.  “Absent changes to the definition of Meaningful Use, CMS should consider ways to strengthen its program oversight to protect the $4 billion in Medicare EHR incentive payments that it has paid, as well as billions of dollars in future incentive payments," OIG said. 

OIG recommended that CMS obtain and review supporting documentation prior to payment to verify the accuracy of self reported information and issue guidance with specific examples of documentation that providers should maintain to support the compliance.  OIG also recommended that ONC require that certified EHR technology be capable of producing reports for yes/no meaningful use measures where possible and improve the certification process for EHR technology to ensure accurate EHR reports. 

Previously, a group of Republicans from the House of Representatives, including the Chairs of the Ways and Means and Energy and Commerce Committees, sent a letter to HHS Secretary Kathleen Sebelius expressed their concern that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.  They asserted that the State 2 Meaningful use program rules are “in some respects, weaker than the proposed Stage 1 regulations released in 2009,” which will result in a “less efficient system that squanders taxpayer dollars and does little if anything, to improve outcomes for Medicare.”  Due to their concerns, they urged the Secretary to: 

• Immediately suspend the distribution of incentive payments until HHS promulgates universal interoperable standards, which would also require a commensurate delay of penalties for providers who choose not to integrate HIT into their practice
• Significantly increase what’s expected of Meaningful users (e.g., requiring a summary transfer when a  patient moves to a different care setting in electronic format only 10% of the time is insufficient; requiring radiology and laboratory orders to be electronic 30% of the time and medication reconciliation and e-prescribing to occur just 50% is woefully inadequate, they wrote.
• Take steps to eliminate the subsidization of business practices that block the exchange of information between providers.   

The NY Times reported that Sebelius responded in an unpublished by dismissing the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.”  She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate. 

While CMS agreed with some of OIG’s comments and recommendations, Marilyn Tavenner, the acting administrator for Medicare, strongly disagreed with the idea that the agency should do more to ensure payments are appropriate before writing a check.  Requiring an audit before paying hospitals and doctors “could significantly delay payments to providers,” she said, and these reviews “would also impose an increased upfront burden on providers,” Ms. Tavenner said. Medicare took some steps to make sure providers were eligible for the payments but “does not believe prepayment audit is necessary at this juncture.”  Medicare maintains that it has systems in place to verify the information being submitted.

Congress Putting Pressure on HHS to Tighten EHR Meaningful Use Standards

Several Republican Senators and House Members recently have increased pressure on Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) expressing several concerns over several issues related to the adoption of EHRs through the Centers for Medicare & Medicaid Services (CMS) and the Office for the National Coordinator for Health IT (ONC)’s meaningful use program. 

In early October, House Republicans sent a letter to Sebelius asserting that the Stage 2 rules fail to achieve comprehensive interoperability, and leave our healthcare system in silos.  The letter was penned by Ways and Means Committee Chairman Dave Camp (R-MI), Energy and Commerce Committee Chairman Fred Upton (R-MI), Ways and Means Health Subcommittee Chairman Wally Herger (R-CA), and Energy and Commerce Health Subcommittee Chairman Joe Pitts (R-PA). 

“More than four and a half years and two final Meaningful Use rules later, it is safe to say that we are no closer to interoperability in spite of the nearly $10 billion spent.,” the letter’s authors say.  “With the bar for Meaningful Use set so low and with a focus instead on trying to pad participation rates, these challenges are predictable.  Incentive payments, particularly those funded by the Medicare trust funds and taxpayers, should be given to providers who are truly ‘meaningful users’ of EHR.” 

Camp and others want HHS to increase what is expected of meaningful users.  They say requiring a summary of transfer document 10 percent of the time is “insufficient.”  Electronic prescribing only 50 percent of the time, they say is “woefully inadequate.”   The letter also mentions the recent New York Times investigative report on coding, and how many providers may be using EHRs to abuse Medicare reimbursements.  “Hospitals and physicians who are deemed Stage 1 'meaningful users' are not required to know with certainty whether their systems are capable of exchanging information," they wrote.  

The Senate letter, written by senators, Tom Coburn (R-Okla.), Richard Burr (R-N.C.), Pat Roberts (R-Ks.), and John Thume (R-S.D.), asked the relevant staff from CMS and ONC to meet with Senate Finance and Senate Health, Education, Labor, and Pensions (HELP) Committees, noting a recent briefing by the government agencies did not give “enough time and opportunity” to cover the final rule. 

Some of the questions they asked in the letter came out of various recent media reports. This included asking if EHRs increase or reduce diagnostic tests, inappropriate EHR payments to providers, increased billing of Medicare due to EHRs, and meaningful interoperability. The senators say because Stage 2 of meaningful use directly affects the direction of health information technology in the country, they need a better understanding of these issues to conduct a proper oversight.  The Senators asked to meet no later than October 26, 2012.  

We previously wrote that the HHS Office of Inspector General (OIG) is also investigating EHRs closely, so it is likely that Congress will continue pressing HHS and ONC for more information, particularly given the amount of money being spent on implementing EHRS, the potential for abuse, and the tremendous dependence many of the provisions of the ACA have on EHRs. 

Ways and Means Committee Expresses Concern for Use of Health IT Funds

Over the past few months, we have reported several times that Congress is particularly interested in how the Department of Health and Human Services (HHS), the Office of the Inspector General (OIG) for HHS, and the Centers for Medicare and Medicaid Services (CMS) are using funds to implement programs and systems, particularly those that root out fraud, waste and abuse.   

An article back in April of this year expressed doubt over whether the money being spent by CMS was worth its return.  Specifically, a computer system designed to prevent fraud had only returned approximately $8,000—only one bad claim.   

Pushing for more transparency about how money is spent to implement programs not related to the Medicare and Medicaid programs, as a result of assignments that have been made to CMS through the Affordable Care Act (ACA), the Ways & Means Committee of the U.S. House of Representatives requires that the Government Accountability Office’s (GAO) Financial Management and Assurance (FMA) team review such expenditures.   

In a letter sent to GAO, the Committee explained how the Obama Admistration chose to move the Center for Consumer Information and Insurance Oversight (CCIIO), the agency in charge of implementing much of the ACA, into a business unit within CMS.  As was expected, Democrats “vastly understated” the extent of funding necessary to implement the law, as a result, leading to spending of CMS dollars that may be inappropriate.   

One news outlet reported that “By embedding the CCIIO within CMS, the administration should have greater ease finding funds within CMS to enable CCIIO to operate as part of the HHS secretary’s office.”   

In order to better understand the magnitude of money and resources being taken from the Medicare program, the Committee requested GAO’s FMA to conduct a complete full financial analysis, including financial and forensic audits, of CMS activity since the ACA was signed into law.  They asked for specifics about CMS’ financial and staff resources regarding the CCIIO.  The information is due to the committee by October 15, 2012. 

It will be interesting to see just exactly how much money is being spent on the CCIIO, particularly in light of the fact that CMS has recently delayed several important pieces of the ACA, most notably, the Physician Payment Sunshine Act.  Moreover, if Obama is reelected, will the Administration continue its current structure and use of CMS funds to operate the CCIIO? 

The revelation that healthcare reform is taking more resources and staff than expected is no surprise.  According to a study from Georgetown University's Center on Education and Workforce issued last month, the nation needs 5.6 million new jobs by 2020 to meet the growing demand for care under health reform.

HHS Offers Look into the Future for Meaningful Use Stage 3

One of the central pieces to the Affordable Care Act (PPACA), along with the American Reinvestment and Recovery Act (ARRA) was the implementation and “meaningful use” of electronic health records (EHRs)—through the HITECH provision.  Consequently, the Office of the National Coordinator for Health IT's (ONCHIT) HIT Policy Committee has released a copy of its proposed recommendations for public comment. 

Under the 2009 federal economic stimulus package, health care providers who demonstrate meaningful use of certified electronic health record systems can qualify for Medicaid and Medicare incentive payments.  The final rules for Stage 3 of the program are expected to take effect in 2016. 

The 38-page document, unveiled at the committee’s meeting Nov. 7, recommends some of the percentage thresholds be increased and suggests several new objectives for stages beyond Stage 3.  Some of the provisions new to Stage 3 include offering patients the capability to submit patient-generated information, and to request amendments to their records online, requiring electronic health records to receive, generate or access appropriate immunization recommendations, and requiring EHRs to be able to query other entities for outside records. 

One recommendation would require participating hospitals and physicians to “provide 10% of patients with the ability to submit patient-generated health information to improve performance on high-priority health conditions and/or to improve patient engagement in care.”  The committee also is seeking input about: 

• Whether existing standards could incorporate medical device data from the home; and
• How consumer-reported data could be incorporated into clinical quality measures.  

In a prior meeting this past June, some of the concepts addressed included aligning with emerging payment, supporting population health, and tools to assist interaction with patients "that may be a bit more difficult" according to the meeting materials.  At another meeting in late October, the Committee had several potential opportunities for inclusion of prescription drug abuse: 

• Including prescription drug monitoring program (PDMP) prescription drug history in medications reviews before a prescriber finalizes a controlled substance prospection order;
• Adopting a clinical quality measure that reports a provider's performance based on the use of the PDMP prescription drug history;
• Mandatory provider registration with the applicable state PDMP drug monitoring program
• Requiring a single sign-on or hyperlink to access PDMP data. 

Reporting the release of the recommendations, FierceEMR noted that the committee explained that to be considered for Stage 3, an objective should support new models of care, address national health priorities, have broad applicability, promote advancement, be achievable, and reflect the reasonableness/feasibility of EHR products.  The committee prefers that standards for EHRs should be available if not widely adopted.

The committee also said that it recommends that “Stage 3 is the time to begin to transition from a setting-specific focus to a collaborative, patient- and family- centric approach. 

ONC added several additional items for public comment, including questions on identity matching, transitions of care and the need for health IT safety risk assessments.  The recommendations will be published in the Federal Register later this month; public comments will be accepted for 45 days after that date.  Here is where public comments are to be submitted. 

The committee said that it will analyze the comments and hold further public meetings about Stage 3 in 2013 before formal rules are issued.

In addition to these rules, ONCHIT recently announced applications to be considered for Health IT Policy and Standards Committee Workgroups.  Also, ONCHIT released a new primer on the 2014 Edition of the certification criteria for electronic health records under Stage 2 of the Meaningful Use program. The primer provides an overview of the new certification requirements and compares the 2014 Edition to the current 2011 Edition. The materials also detail how to prepare for the objectives and clinical quality measures, and outline timing and penalty concerns

 

CMS Rule and 1 Year Delay on ICD 10 Promises More Time for a Smooth and Coordinated Transition

The Centers for Medicare & Medicaid Services (CMS) have officially pushed back the timeline for healthcare organizations to convert to the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD–10–PCS) for inpatient hospital procedure coding, including the Official ICD–10–PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.   

The U.S. remains one of the few developed countries that has not transitioned to ICD-10 or a clinical modification. ICD-9, which was implemented in the U.S. in 1979, is an antiquated code set that no longer adequately meets the challenge of a 21st century healthcare system. 

 ICD-10-CM/PCS classifications are the foundation for critical national healthcare initiatives such as meaningful use, value-based purchasing, payment reform, quality and quality reporting and patient and population safety. ICD-10-CM/PCS will yield information that will optimize health data, allow for a more uniform health information exchange and create a move to a reimbursement system based on quality and outcomes. 

“We believe the change in the compliance date for ICD-10 gives covered healthcare providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition by all covered entities,” the U.S. Department of Health & Human Services (HHS) said in its 208-page rule.  The regulations are effective on November 5, 2012.  

According to an announcement, which comes on the heels of CMS’s unveiling of the final rule for Stage 2 of Meaningful Use, CMS also will establish a unique health plan identifier (HPID).  Currently, when a health care provider bills a health plan, that plan may use a wide range of different identifiers that do not have a standard format.  As a result, health care providers run into a number of time-consuming problems, such as misrouting of transactions, rejection of transactions due to insurance identification errors, and difficulty determining patient eligibility. The new rule will “greatly simplify these processes.” 

Health plans with the exception of small health plans must obtain an HPID by November 5, 2014. Small health plans must obtain an HPID by November 5, 2015.  Covered entities must use HPIDs in the standard transactions on or after November 7, 2016. An organization covered health care provider must comply with the implementation specifications in §162.410(b) by May 6, 2013.  HHS said providers can expect savings from two indirect consequences of HPID implementation: 

• Decreased administrative time spent interacting with health plans;
• Material cost savings after processes go from manual to electronic formats. 

“HPID’s anticipated 10-year return on investment for the entire healthcare industry is expected to be between $1.3 billion [and] $6 billion,” HHS said.  “These new standards are a part of our efforts to help providers and health plans spend less time filling out paperwork and more time seeing their patients,” HHS Secretary Kathleen Sebelius said. 

Response to CMS ICD-10 Delay 

The American Health Information Management Association (AHIMA) was pleased with CMS’s decision for a one-year delay.  “ICD-10-CM/PCS implementation is inevitable, but today's news gives the healthcare community the certainty and clarity it needs to move forward with implementation, testing and training,” AHIMA CEO Lynne Thomas Gordon said in a statement. “We realize that a few are still apprehensive about the implementation process, and that is why AHIMA remains committed to assisting the healthcare community with its transition to a new code set that will lead to improved patient care and reduced costs.”

Previously, the American Medical Association (AMA) expressed concern over the initial proposal of a one-year delay, calling for two years back in May.  While showing some support for CMS’ recent decision, AMA still expressed concern in its statement.  While AMA appreciated “the administration's decision to provide a one year delay in response to AMA advocacy, … we have urged CMS to do more to reduce the regulatory burdens on physician practices so physicians can spend more time with patients. The AMA recommended that CMS delay the move to ICD-10 by a minimum of two years.” 

The main argument in favor of delay: The sheer number of government programs and deadlines that health IT leaders and organizations face.  

As the AMA recognized, “The move toward ICD-10 comes at a time when physicians are dealing with the implementation of multiple Medicare incentive and penalty programs. Implementing ICD-10 alone requires physicians and their office staff to contend with 68,000 codes – a five-fold increase from the current 13,000 codes.  Physicians are also already trying to engage in new delivery and payment models.  The implementation of ICD-10 will create more challenges for physicians when our Medicare system is broken and cannot provide adequate funding to cover the cost of these additional administrative burdens.” 

The Medical Group Management Association (MGMA), “said in May that the ICD-10 process lacked several steps, and wanted to see a staggering of the implementation dates so that health plans and clearinghouses would be ready one year before providers,” FierceHealthIT reported.  MGMA also noted that HHS did not take particular care to prevent physician practices from experiencing “debilitating cash flow disruptions.” 

MGMA President and CEO Susan Turney said in a statement that the group wants to see ICD-10 pilot tested before it is rolled out.  She noted their lack of confidence in that critical trading partners, including Medicare and Medicaid, “will be ready in time to conduct testing well in advance of the October 2014 compliance date.”  The trade group was also “disappointed that CMS missed a significant administrative simplification opportunity to create true claims revenue cycle transparency with the Health Plan Identifier rule.  By not requiring health plans to enumerate at a more granular level, physicians will continue to face the burden of manually identifying these entities.” 

College of Healthcare Information Management Executives (CHIME) President and CEO Richard Correll said his organization was pleased with the delay—but adds that the industry can’t put off the coding overhaul much longer.  “[A]s HHS itself recognizes, a longer delay would significantly increase the costs of converting to ICD-10,” he said in a statement.  “[W]e urge the department to develop a clear path forward, with benchmarks, so that healthcare industry stakeholders can make the conversion in 2014.” 

The Health Information and Management Systems Society (HIMSS) also praised CMS for giving the industry just a little more breathing room to prepare for compliance.

CMS to Begin Audits on Electronic Health Records Practices

Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified electronic health record (EHR) technology and use it in a meaningful way—also known as the EHR Incentive Program.  What is considered “meaningful use” is evolving in three stages: 

• Stage 1 (which began in 2011 and remains the starting point for all providers): “meaningful use” consists of transferring data to EHRs and being able to share information, including electronic copies and visit summaries for patients.
• Stage 2 (to be implemented in 2014 under the proposed rule): “meaningful use” includes new standards such as online access for patients to their health information, and electronic health information exchange between providers.
• Stage 3 (expected to be implemented in 2016): “meaningful use” includes demonstrating that the quality of health care has been improved. 

Now that providers have begun receiving payments under the EHR Incentive Program, the Centers for Medicare and Medicaid Services “has quietly begun to audit providers, according to an alert from the law firm Ober Kaler.  The Garden City, N.Y.-based accounting firm Figliozzi and Company, acting on behalf of CMS, has started to send letters to providers requesting them to submit documentation to support their attestation that they have met the Meaningful Use requirements.   

According to Ober Kaler, the auditor is asking for four types of information: 

• A copy of the provider's certification from the Office of the National Coordinator for the technology used to meet the program's requirements, to show that the provider has a certified EHR system.  “Presumably, this documentation will be used to demonstrate that the entity ‘possesses’ a certified Electric Health Record technology system as required under Program rules.”
• The method (observation services or all emergency department visits) used to report emergency department admissions, which affects some of the required measures 
• Supporting documentation for the completion of the attestation regarding the “core set” objectives and measures
• Supporting documentation for the completion of the attestation regarding the “menu set” objectives and measures 

Ober Kaler noted that, “Based on questions from recipients, an amended version of the audit letter has been sent out, adding "(i.e., a report from your EHR system that ties to your attestation)" to the latter two categories of requested documentation. This clarifies that the audit letters seek additional detailed information but are not, at this time, requesting identifiable or detailed patient records.” 

The audit letters do not provide audited entities much time to respond – a short, two-week response time is specified.  Unfortunately, it is also unclear how audit candidates are selected, so hospitals and professionals will not be able to "plan ahead" for an audit they can be certain is coming. 

CMS is required to conduct audits of providers attesting under the EHR incentive program, but has posted only general information about the audits. CMS does provide contact information for the auditing firm on its website. 

CMS has implemented some automatic checks built into its databases to verify information submitted by providers and plans to audit a sample of eligible professionals and hospitals to verify that payments made to hospitals are accurate, according to a recent GAO report. 

However, GAO found that these audit processes were insufficient and was particularly concerned about auditing providers only after they're paid incentive money.  

CMS Releases Final Rule for Stage 2 Meaningful Use Requirements

The Centers for Medicare & Medicaid Services (CMS) recently published the final rule outlining the requirements for Stage 2 of the Meaningful Use incentive program, adopting many, but not all of the provisions they proposed in March. 

Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA), eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt and meaningfully use certified electronic health record (HER) technology. 

More than 120,000 eligible health care professionals and more than 3,300 hospitals have qualified to participate in the program and receive an incentive payment since it began in January 2011. That exceeds a 100,000 goal set earlier this year.

That includes more than half of all eligible hospitals and critical access hospitals and 1 out of every 5 eligible health care professionals.  The program is divided into three stages: 

• Stage 1 sets the basic functionalities electronic health records must include such as capturing data electronically and providing patients with electronic copies of health information.
• Stage 2 (which will begin as early as 2014) increases health information exchange between providers and promotes patient engagement by giving patients secure online access to their health information.
• Stage 3 will continue to expand meaningful use objectives to improve health care outcomes.   

ONC already is working on Stage 3 of the program, which won't be implemented until 2016 at the earliest. 

CMS’s 672-page rule delays the Stage 2 requirements to 2014, giving providers more time to meet the Stage 2 criteria.  No provider will have to follow the Stage 2 requirements before then. Stage 2 originally was slated to begin in 2013.  Other changes to the rule include: 

• There will be 20 measures for eligible professionals and 19 for eligible hospitals and critical access hospitals;
• There are two new core objectives: one on the use of secure electronic messaging to communicate with patients, and another requiring hospitals to automatically track medications from order to administration using assistive technology with electronic medication administration records (eMAR);
• Several proposed measurement thresholds--such as for patient engagement and electronic exchange summary of care documents--have been reduced from those suggested in the proposed rule. Specifically for the former, both eligible providers and hospitals now will need "more than 5 percent" of unique patients to view, online, download or transmit their information to a third party (the proposed threshold was 10 percent);
• Batch reporting for medical groups and the process for implementing penalties for not meeting Meaningful Use have both have been finalized;
• An outpatient lab reporting requirement has been added;
• Eligibility of the Medicaid incentive program has been expanded to 12 children's hospitals that originally didn't meet the eligibility requirements. 

As noted by InformationWeek Healthcare, “the final rule does dial back some proposed thresholds. Notably, providers now only have to offer online access to health information and secure messaging for 5% of patients, not 10%, as had been proposed.

The final certification rule adds a requirement that all personally identifiable health data be encrypted while “at rest,” in response to a recommendation from the Health IT Policy Committee, a federal advisory board, and public comments.  

All told, physicians, chiropractors, dentists, physical therapists, and other individual providers have to meet 17 core measures for EHR usage, and also choose three from a menu of six additional measures.  Hospitals must achieve 16 core measures plus three of six menu items.  

In a Thursday conference call with journalists, national health IT coordinator Dr. Farzad Mostashari called the menu items “potentially more relevant to specialists” than those in Stage 1. Many people have criticized the current stage as being skewed toward primary care.  “The big message here is the push on standards-based interoperability of information,” Mostashari said.  “We are staying on course with the roadmap that we set in Stage 1.” 

Eligible providers also must report on nine of a total of 64 specific clinical quality measures, while hospitals need to choose 16 of 29.  Starting with the 2014 reporting period, providers will have to submit their Meaningful Use-related clinical quality measures electronically, Elizabeth Holland, director of health information technology initiatives for CMS, said during the teleconference.  To date, CMS has paid out $6.6 billion in incentive money to about 3,600 hospitals and more than 128,000 individuals, Holland said. 

CMS received 6,100 comments on the proposed rule.  Health and Human Services (HHS) Secretary Kathleen Sebelius the final rule “will lead to more coordination of patient care, reduced medical errors, elimination of duplicate screenings and tests and greater patient engagement in their own care.” 

The Office of the National Coordinator for Health IT's (ONCHIT) Standards and Certification criteria, which weighs in at 474 pages, adopts the certification criteria to support the changes in the program.  It also updates the certification program to make it easier and more efficient, and changed the name of the permanent certification program to “ONC HIT Certification Program.”     

“Certified EHR technology used in a meaningful way is one piece of a broader health information technology infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety,” CMS said in a fact sheet explaining the rules.   

CMS also provided additional guidance to stakeholders by issuing answers to three frequently asked questions about changes to the Medicaid electronic health records meaningful use incentive program under Stage 2.  The changes cover determination of patient volume calculations that are intended to ease eligibility requirements, the types of CHIP patients eligible to be considered in Medicaid patient volume, and changes to the base year for hospital incentive payment calculation.   

Among the answers, CMS officials confirmed that there are, in fact, changes to the base year for the Medicaid hospital incentive payment calculation under the Stage 2 rules. "In an effort to encourage timely participation … the rule was amended to allow hospitals to use the most recent continuous 12 month period for which data are available prior to the payment year," CMS officials said. 

CMS also issued a series of tip sheets to help eligible professionals and hospitals transition to Stage 2 of the Meaningful Use requirements on its Website.  The tip sheets include an overview of the new rules, comparison tables between Stage 1 and Stage 2, tips on the clinical quality measures, and explanations of the mechanisms of the hardship exceptions and upcoming payment adjustments.  Electronic health record vendor Greenway, meanwhile, created a nifty sheet detailing the Stage 2 measures and threshold requirements. The sheet also outlines changes from Stage 1.  

Reaction to Final Rule on Meaningful Use Stage 2 

According to FierceHealthIT, initial responses to the final rule thus far, have been mostly positive.  Drex DeFord, CIO of Boston-based Steward Health Care, was pleased with the delay in making the transition to Stage 2.   

John Halamka, CIO of Beth Israel Deaconess Medical Center, also in Boston, wrote in a blog post that with regard to the standards and certification criteria published by ONCHIT, “the vocabulary, transport, and content standards" lined up perfectly with recommendations made by the Health IT Standards Committee.” 

Halamka seemed particularly interested in the fact that Simple Mail Transfer Protocol--which now is part of the base EHR definition--will be the required transport standard for all certified electronic health records.  “[A]ll EHR technology used by [eligible providers, eligible hospitals and critical access hospitals] that meets the [Certified Electronic Health Record Technology] definition will, at a minimum, be capable of SMTP-based exchange,” he said. 

The College of Healthcare Information Executives (CHIME), of which DeFord serves as chairperson for the board of trustees, was happy that CMS added more measures to the menu set, and that they implemented a 90-day EHR reporting period for 2014 for providers to demonstrate Meaningful Use.  

The American Health Information Management Association (AHIMA), meanwhile, praised the decision to maintain patient engagement requirements, even though the threshold for those requirements was lowered.  “We believe patients must be partners and work side-by-side with their providers to achieve the best possible healthcare outcomes,” AHIMA CEO Lynne Thomas Gordon said in a statement.

However, Indranil Ganguly, CIO at Freehold, N.J.-based CentraState Healthcare System, told FierceHealthIT in an email that he was disappointed by the patient engagement measures.  “I understand the desire to drive patient’s online and change behavior, but feel that it is unreasonable to put that burden on the healthcare provider,” he said. 

Additionally, the American Hospital Association (AHA) said the final rule makes the path toward IT adoption for hospitals “more challenging.”  It is disappointed “that this rule sets an unrealistic date by which hospitals must achieve the initial Meaningful Use requirements to avoid penalties,” Linda Fishman, senior vice president of public policy, analysis and development for AHA, said in a statement.  “In addition, CMS complicated the reporting of clinical quality measures and added to the Meaningful Use objectives, creating significant new burdens.”