Early Meaningful Users Promised Stage 2 Extension

On November 30, 2011, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius issued a press release announcing proposed steps to encourage physicians and hospitals to adopt electronic health records (EHRs) this year and receive incentive payments made available under the Health Information Technology for Economic and Clinical Health (HITECH) Act), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA). 

Under the HITECH Act, physicians and hospitals have the opportunity to earn financial incentives from Medicare and Medicaid if they demonstrate the adoption and meaningful use of certified EHRs in a series of three stages. Under the current rules, physicians and hospitals that adopt EHRs in 2011 and attest to meeting Stage 1 meaningful use standards by February 28, 2012 must meet Stage 2 standards in 2013. If they wait until 2012 to attest to Stage 1, providers could delay Stage 2 compliance until 2014. To encourage more providers to adopt EHRs in 2011, instead of waiting until 2012, HHS proposes to allow providers who qualify for Stage 1 meaningful use in 2011 an extension until 2014 to meet Stage 2 standards. HHS clarified that providers first attesting to meaningful use in 2011 qualify for both 2011 and 2012 incentive payments.

These proposed steps are consistent with June 2011 recommendations from the Health IT Policy Committee (HITPC).  As we reported this summer, HITPC advocated that providers who begin to attest to meaningful use in 2011 be provided an extra year “to phase in the stage 2 expectations (i.e., Stage 2 for those who attest in 2011 would begin in 2014).”  HHS listened!

HHS intends to publish this extension in the Stage 2 meaningful use Notice of Proposed Rulemaking (NPRM) in February 2012.

At the same time, HHS also released new data from the Centers for Disease Control and Prevention (CDC) showing increased adoption of EHRs by physicians.  The CDC report documented that physicians’ adoption of health information technology (IT) doubled in two years, and 52% of physicians intend to apply for meaningful use incentives, up from 41% in 2010.  Click here to access additional information about achieving meaningful use, including the CDC report.

Office of Civil Rights Launches Privacy and Security Audits

Section 13411 of the the Health Information Technology for Economic and Clinical Health Act (HITECH Act) requires United States Department of Health & Human Services (HHS) to provide for periodic audits to ensure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards.   The HHS Office of Civil Rights (OCR) announced yesterday, November 8, 2011, the launch of long-expected privacy and security audits.

In our blog on July 13, 2011, we posted information concerning OCR’s hiring of contractors to conduct new periodic audits of covered entities and business associates to ensure compliance with the Privacy and Security Standards found in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as amended by the HITECH Act. Yesterday, OCR announced a pilot program to perform up to 150 audits to assess privacy and security compliance. Audits conducted during the pilot phase will begin in November 2011 and conclude by December 2012.

The initial 150 audits will focus on covered entities, and the audits will begin this month and end by December 2012. Business Associates may have a brief respite but should expect to be the target of future audits.

OCR’s stated goals of the audits are to “examine mechanisms for compliance, identify best practices and discover risks and vulnerabilities that may not have come to light through OCR’s ongoing complaint investigations and compliance reviews.” OCR will “share best practices gleaned through the audit process and guidance targeted to observed compliance challenges.”

Covered entities will be notified in writing if selected for an audit and should be on the lookout for these notices because selected entities have only a short period of time, 10 business days, in which to respond and provide any requested information. After the initial request for information, auditors may conduct onsite audits at an organization. Covered entities will receive 30 to 90 days advance notice of an onsite visit, and auditors expect to spend three to ten days onsite reviewing records, policies and practices. Prior to an auditor’s submission of a final report to OCR, the covered entity will have an opportunity to provide written comments on the auditor’s findings.

Click here to link to OCR’s website with additional details concerning the OCR HIPAA Audit Program.

Final Rule on ACOs encourages EHR adoption but eliminates “meaningful use” requirement

The Centers for Medicare and Medicaid Services (CMS) announced today, October 20, 2011, that the use of certified electronic health records (EHRs) will be the highest-weighted quality measure for an Accountable Care Organization (ACO) under the new Medicare Shared Savings Program.

ACOs are designed to encourage primary care doctors, specialists, hospitals, and other health care providers to coordinate their care. The CMS Final Rule on ACOs bases the amount of shared savings that an ACO may receive for its performance on four domains of quality: 1) quality standards on patient experience; 2) care coordination and patient safety; 3) preventive health; and 4) at-risk populations.  To earn shared savings the first performance year, providers must report across all four domains of quality, which include a total of 33 quality measures.  Providers will begin to share in savings based on how well they perform on 23 of the 33 quality measures in the second performance year and on 32 of the 33 measures in the third performance year. 

Measure 20 of the 33 quality measures requires ACOs to report the percentage of primary care providers (PCPs) who successfully qualify for an EHR Incentive Program payment.  CMS expanded the scope of PCPs who can be counted in this measure by eliminating the requirement that the PCP be a “meaningful EHR user” as defined in 42 C.F.R. § 495.4 of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.  CMS stated that it “decided to . . . expand [measure 20] to include any PCP who successfully qualifies for an EHR Incentive Program incentive rather than only including those deemed meaningful users.”

Conversion to electronic health record and retention of paper records

Update: On August 8, 2010, Medicare issued MLN Matters Article SE1022 on Medical Record Retention and Media Formats for Medical Records, which states that the Centers for Medicare and Medicaid Services (CMS) requires records of providers submitting cost reports (most hospitals) to be retained in their original or legally reproduced form (which may be electronic), for at least 5 years after closure of the cost report.

Many hospitals have electronic health records (EHRs) that are hybrid digital records. While the hospital may be using electronic data entry in the ER, inpatient nursing care, pharmacy, lab, and pre-op anesthesia, oftentimes, these EHRs are not integrated and, thus, are not merged into a single EHR. The short-term solution may have been to scan printed records from some department, like lab or pharmacy, into the patient’s on-line digital record. As a result, the hospital’s “electronic health record” contains information that is not captured in a “coded format.”  For one, this will not meet the Stage One “meaningful use” criteria under the HITECH Act.

But let’s assume that the hospital can overcome this hurdle by working with vendors to integrate these records in a way that will meet HITECH EHR certification standards.  If the hospital has been maintaining certain portions of patient records in a paper format, what does it do with those paper records after converting to an EHR?   If the hospital scans all the paper patient records into its EHR, how long should the hospital retain the paper record after it is scanned into their EHR? 

HHS Releases Final Rule on “Meaningful Use” of Electronic Health Records

Update: On December 29, 2010, HHS published in the Federal Register a “Correcting Amendment” to its Final Rule on Meaningful Use, which can be viewed here.

HHS Secretary Kathleen Sebelius wasted no time in putting the brand new CMS Director to work on July 13, 2010, in announcing the release of two rules under the Health Information Technology for Clinical and Economic Health Act (HITECH), including the Final Rule on Meaningful Use and the Final Rule on Initial Set of EHR Standards and Certification Criteria. Donald M. Berwick, MD, MPP, FRCP, was sworn in as Director of the Centers for Medicare and Medicaid Services on Monday afternoon, July 12, 2010, and by the next morning was primed to discuss the important role of health information technology (HIT) in America. In addition to Dr. Berwick’s participation at the press briefing, other participants included David Blumenthal, MD, the Chief Coordinator for the HHS Office of National Coordinator of HIT (ONC), Regina Benjamin, MD, U.S. Surgeon General, and Regina Holiday, an individual who shared a personal experience involving access to health information and how such access impacts the care of patients. 

Quick Reference: The CMS Fact Sheet on both Final Rules is available here. 

CMS Posts Updated and New EHR Incentive FAQs

On September 27, 2010, CMS updated its answers and posted a few new ones to frequently asked questions (FAQs) about the electronic health record (EHR) incentives available under the HITECH Act’s Meaningful Use (“MU”) Final Rule.  Here is a sampling of answers addressed in the FAQs: 

• Registration for Medicare MU incentives is to be available on-line in January 2011 with more information to come near end of 2010.
• All EHR products must be certified through the ONC Authorzied Testing and Certification Body (ATCB) in order to meet MU.
• Providers, not vendors, must demonstrate MU of certified EHRs.
• Payment of Medicare MU incentives is expected to begin in May 2011.
• There is no funding to reimburse a provider for EHR implementation costs that exceed the established MU incentive payment caps.
• Ambulatory Surgery Centers are not eligible for the EHR incentives.
• There is no funding under the HITECH Act for nursing home EHRs. 
• Eligible Professionals (EPs) may assign their incentive payments to their employer or an entity with whom the EP has a contractual arrangement.
• EPs cannot receive an incentive payment under both the Medicare MU program and the MIPPA E-Prescribing Incentive Program in the same year.
• EPs can receive both the Medicaid MU Program incentive and the MIPPA E-Prescribing Incentive Program payment for the same year.
• An EP in a hospital-based ambulatory care clinic may be eligible to receive the Medicare MU Incentives if such EP is not providing 90% of his or her services in the hospital ED or inpatient care setting.
• EPs eligible for both the Medicare MU incentive and Medicaid MU incentive payment in the same year must choose one.
• Once an EP receives an MU incentive payment under either Medicare or Medicaid, that EP can switch between the programs only once before 2015.
• The reporting period for EPs is 90 consecutive days during the first calendar year that the EP qualifies and a full calendar year thereafter.
• Medicare payment adjustments begin in 2015 for both EPs and hospitals who do not demonstrate MU.
• CMS will publish the names, addresses and business phone numbers of all EPs and hospitals receiving EHR incentive payments.
• The meaning of numerators and denominators in the measures required to establish MU is briefly summarized in this FAQ.
• Patients admitted through the Emergency Department (ED) will be included in the MU measures respecting inpatients.

As of today’s date, there were 103 FAQs related to EHR incentives. To read all the FAQs about EHR incentives, go to the CMS FAQs webpage and enter the search terms “EHR incentives.”

EHR Certification Organizations and Certified EHRs

Just to recap where we are today, the U.S. Health & Human Services Department (HHS) Office of National Coordinator for Health Information Technology (ONC) has authorized three organizations to perform complete EHR and/or EHR module testing and certification under the Temporary Certification Program Rules. Certification means that the EHR or EHR module has the capabilities necessary to support the efforts of eligible hospitals and eligible professionals in meeting the Meaningful Use requirements under Final Rule issued by Centers for Medicare and Medicaid Services (CMS) for Meaningful Use.  The three ONC-Authorized Testing & Certification Bodies (ATCBs) to date are Certification Commission for Health Information Technology (CCHIT), Drummond Group, Inc. (Drummond), and InfoGuard Laboratories, Inc. (InfoGuard). For additional information about the ONC process for achieving ATCB status, as well as more information about Standards & Certification generally, see the ONC webpage.

Critical Access Hospitals to Submit Part C Informational Only Claims to Medicare Contractors for EHR Incentive Payment Purposes

On October 15, 2010, the Centers for Medicare and Medicaid Services (CMS) issued Transmittal 2066 to address the submission of informational only claims by Critical Access Hospitals (CAHs) as well as Maryland Waiver Hospitals in order to track Part C patient days for purposes of  calculating the Electronic Health Record (EHR) incentives available to such hospitals. Informational only claims are billed for patients enrolled in a Medicare Advantage (MA) Plan.  The Transmittal also includes the Incentive Payment formula for Subsection (d) hospitals as well as CAHs, as follows: 

CMS Posts Helpful EHR Incentive Program Registration Guides

CMS has posted very helpful Electronic Health Record (EHR) Registration User Guides, one for Eligible Hospitals and one for Eligible Professionals. The Guides provide an excellent overview of the path to receiving EHR Incentives available under the Health Information Technology for Economic and Clinical Health (HITECH) Act.  As I pointed out in my previous post, CMS is encouraging Eligible Hospitals and Eligible Professionals to go ahead and register in advance of making an attestation to meaningful use of a certified EHR.  CMS has set up the system so that registrants do not have to fear that registration alone could somehow subject them to penalties later for failing to follow through with implementing and making an meaningful use of an EHR.  This is evident by reviewing the way in which the registration system is broken down into four parts or “tabs”: Registration, Attestation,  Status and Account Management.

 

Registration Tab. Here is where hospitals and physicians (as well as other practitioners eligible for incentives under State Medicaid programs) can register for the EHR Incentive Program.  Registrants also will access this Tab to take one of the following actions: Continue an Incomplete Registration, Modify an Existing Registration, Resubmit a registration that was previously deemed ineligible, Reactivate a Registration, Switch Incentive Programs (Medicare/Medicaid), Switch Medicaid State, and Cancel Participation in the EHR Incentive Program.

 

Attestation Tab.  Under this Tab is where registrants can submit their Attestation of meaningful use when ready.  This Tab also provides options and instructions for Registrants wanting to: Continue an Incomplete Attestation, Modify an Existing Attestation, or Discontinue an Attestation.

 

Status Tab.  Here, registrants can view the status of Registration, Attestation and their EHR Incentive Payment.

Account Management Tab.  Here, registrants can Update Account Information, Request Access to Organizations, or Remove Access to Organizations.

 

The Hospital Guide can be accessed here and the Eligible Professional Guide can be accessed here.

Certified EHRs Expected to Transmit Data for Medicare’s New Hospital Inpatient Value-Based Purchasing Program

On January 13, 2011, the Centers for Medicare and Medicaid Services (CMS) released its Proposed Rule on the Medicare Hospital Inpatient Value-Based Purchasing (VBP) Program. The VPB Program is being established per the directive of the Patient Protection and Affordable Access to Care Act of 2010 (PPACA). CMS is to begin making incentive payments under the VBP Program for discharges on or after October 1, 2012.

Seven years before PPACA required CMS to establish the VBP Incentive Program, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) gave CMS authority to establish the Hospital Inpatient Quality Reporting (IQR) Program. The clinical quality measures that CMS has adopted for the IQR Program will feed into the measures for the VBP Program.

The IQR Program measures were generally based on recommendations from the National Quality Forum (NQF), a voluntary consensus standard-setting organization with a diverse representation of consumer, purchaser, provider, academic, clinical, and other health care stakeholder organizations. The IQR measures began as a set of 10 quality indicators that have since expanded to 45 clinical quality measures for the FY 2011 IQR program payment determination. The FY 2011 IQR hospital measures focus on four topics: 1) Acute Myocardial Infarction (AMI); 2) Heart Failure (HF); 3) Pneumonia (PN); and 4) Surgical Care Improvement Project (SCIP).

So how does this relate to the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and a hospital’s “meaningful use” of a “certified EHR“? Ahhh, there is a method to the madness. As the CMS VBP Proposed Rule points out, the Hospital IQR program and the Hospital VBP Program have “important areas of overlap and synergy with regard to the reporting of quality measures under the HITECH Act.”

CMS notes in the Proposed Rule that the certification standards for EHRs under the HITECH Act are directed at enabling EHR submission of quality measures. CMS is striving “to align the [VPB] measures with the adoption of meaningful use standards for health information technology (HIT), so the collection of performance information is part of care delivery.” As a result, CMS anticipates that hospitals will use their certified EHRs for the reporting of clinical quality measures under both the Hospital IQR program and the subsequent Hospital VBP Program.

The proposed initial measures for the FY 2013 Hospital VBP Program include 18 measures. Of these 18 measures, 17 measures will focus on the four clinical process of care topics set forth for the 2011 IQR Program (AMI, HF, PN, and SCIP), and will add Healthcare-Associated Infections (HAI). The 18th measure will include a measure from the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) that will fall under a patient experience of care domain.

The proposed performance period is to begin July 1, 2011 and will continue through March 31, 2012 for the FY 2013 payment determination. This is already less than five months away! Another reason for Eligible Hospitals under the HITECH Act to focus on implementation of a certified EHR. Did I hear someone ask how the VBP incentive payments will be funded? Answer: By a reduction of the Fiscal Year 2013 base operating DRG payments for each discharge of 1%. “What one hand giveth, the other hand taketh away.” (Unknown)

For more information about the IQR Program, visit QualityNet.  For additional details about the VBP Program, see the Proposed Rule.  CMS will accept comments on the VBP Proposed Rule until March 8, 2011.  CMS expects to issue a final rule in 2012.

Health IT Policy Committee Recommends Delay for Stage 2 Meaningful Use

UPDATE: On July 6, 2011, Farzad Mostashari, M.D., ONC Chief, backed the ONC Policy Committee’s recommendation to delay implementing Stage 2 meaningful use criteria.

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On June 16, 2011, Paul Tang, M.D. , as Vice Chair of the Health IT Policy Committee for the  Office of National Coordinator (ONC), wrote a letter to Farzad Mostashari, M.D., the ONC National Coordinator, requesting a delay in implementing Stage 2 of the meaningful use criteria that eligible healthcare providers must meet in order to obtain the monetary incentives for adoption of electronic health records (EHRs).  The monetary incentives were established pursuant to the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA).  Dr. Tang states in the letter:

The HITPC has heard from both the vendor community and the provider community that the current schedule for compliance with stage 2 meaningful use objectives in 2013 poses a nearly insurmountable timing challenge for those who attest to meaningful use in 2011. With the anticipated release of the final rule for stage 2 in June, 2012, it would require EHR vendors to design, develop, and release new functionality, and for eligible hospitals to upgrade, implement and begin using the new functionality by the beginning of the reporting year in October of 2012. After careful consideration of the trade-offs between the urgency with which new functionality is needed and the ability to safely deliver and to effectively use the new functionality, the HITPC recommends that—only for those who begin to attest to MU in 2011—an extra year be provided to phase in the stage 2 expectations (ie., Stage 2 for those who attest in 2011 would begin in 2014).

The Committee asserts that the delay would only affect providers who implement Stage 1 in 2011.  This assumes that providers who wait until 2012 to implement Stage 1 would not have been ready to implement Stage 2 until 2014 anyway.  The letter also sets forth the proposals for stengthening Stage 1 criteria in Stage 2.  The Committee voted 12 to 5 in favor of the recommendations in the letter.  To read the entire 14-page letter, click here.

Office of Civil Rights Steps Up HIPAA Audits

SUMMARY:  In June 2011, the  United States Department of Health & Human Services (HHS) Office of Civil Rights (OCR)contracted for new periodic audits of covered entities and business associates to ensure compliance with the Privacy and Security Standards found in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act).  Announcement of these new audits followed closely on the heels of a May 2011 report from the HHS Office of Inspector General (OIG) criticizing oversight and enforcement of the HIPAA Security Rule requirements and recommending that the OCR conduct random audits. 

Proposed Federal Regulation Requires HIPAA-Covered Labs to Release Test Results to Patients

On September 12, 2011, the Office of National Coordinator (ONC) for the United States Department of Health & Human Services (HHS) announced a Proposed Rule that will enable direct access to laboratory test results by patients.  Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), laboratories must hold a CLIA certificate in order to perform one of three levels of complex laboratory tests regulated by CLIA.  Even before the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH Act), concerns have been expressed regarding the lack of clarity under state law, and the literal prohibition in some states, regarding whether a CLIA laboratory that is independent (as opposed to hospital based) may release laboratory test results directly to a patient.  

ONC Releases Model Privacy Notice for Personal Health Records

After the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, the interest in storing and accessing health information online increased, prompting increased concerns about the privacy and security of such information.  In September 2011, the Office of the National Coordinator for Health Information Technology (ONC) released a Personal Health Record (PHR) Model Privacy Notice for public use.  This Model Notice meets ONC’s initial goal in a multi-phased, consumer project to increase consumer awareness of PHR companies’ data practices.  The next phase seeks to empower consumers by providing them with an easy way to compare the data practices of two or more PHR companies.