Monday, 11 March 2013

CLIA Program and HIPAA Privacy Rule

 Patients' Access to Test Reports

A Proposed Rule by the Centers for Medicare & Medicaid Services on 09/14/2011

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.

Thursday, 7 March 2013

HHS Sets Goal of 50% of Physicians Using EHRs by Year End



2013 Agenda to Focus on Improving Care through Health IT

Yesterday the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Marilyn Tavenner and the National Coordinator for Health Information Technology Farzad Mostashari, M.D., announced HHS’s plan to accelerate health information exchange (HIE) and build a seamless and secure flow of information essential to transforming the health care system.
“Thanks to the Affordable Care Act, we are improving the way care is delivered while lowering costs,” said Acting Administrator Tavenner.  “We are already seeing benefits, such as a reduction in hospital readmissions due to these reforms.  Health IT and the secure exchange of information across providers are crucial to reforming the system, and must be a routine part of care delivery.”
This year, HHS will:
  • Set aggressive goals for 2013: HHS is setting the goal of 50 percent of physician offices using electronic health records (EHR) and 80 percent of eligible hospitals receiving meaningful use incentive payments by the end of 2013.
  • Increase the emphasis on interoperability: HHS will increase its emphasis on ensuring electronic exchange across providers.  It will start that effort by issuing today a request for information (RFI) seeking public input about a variety of policies that will strengthen the business case for electronic exchange across providers to ensure patients’ health information will follow them seamlessly and securely wherever they access care.
  • Enhance the effective use of electronic health records through initiatives like the Blue Button initiative.  Medicare beneficiaries can access their full Medicare records online today. HHS is working with the Veterans Administration and more than 450 different organizations to make health care information available to patients and health plan members.  HHS is also encouraging Medicare Advantage plans to expand the use of Blue Button to provide beneficiaries with one-click secure access to their health information.
  • Implement Meaningful Use Stage 2:  HHS is implementing rules that define what data must be able to be exchanged between Health IT systems, including how data will be structured and coded so that providers will have one uniform way to format and securely send data.
  • Underscoring program integrity: HHS is taking new steps to ensure the integrity of the program is sound and technology is not being used to game the system.  For example, it is conducting extensive medical reviews and issuing Comparative Billing reports that identify providers.
The goals build on the significant progress HHS and its partners have already made on expanding health information technology use.  EHR adoption has tripled since 2010, increasing to 44 percent in 2012 and computerized physician order entry has more than doubled (increased 168 percent) since 2008.
“The 2014 standards for electronic health records create the technical capacity for providers to be able to share information with each other and with the patient,” said Dr. Mostashari. “Through the RFI, we are interested in hearing about policies that could provide an even greater business case for such information sharing.”
In addition to seeking public input, the RFI also discusses several potential new policies and ideas to accelerate interoperability and exchange of a patient’s health information across care settings so that they can deliver better and more affordable care to their patients.
The RFI can be found at http://www.ofr.gov/OFRUpload/OFRData/2013-05266_PI.pdf. Deadline for comments is April 21, 201

Sunday, 3 March 2013

What meaningful use stage 3 could require


Preliminary recommendations for stage 3 of the federal electronic health record program — starting for some doctors in 2016 — would retire some measures, increase thresholds for others and add new requirements to achieve meaningful use. Key changes proposed include:
  • Removing the requirement to record smoking status during at least 80% of patient visits. Instead, smoking status would be tracked by a clinical quality measure.
  • Implementing 15 clinical decision support intervention requirements, up from five in stage 2 and one in stage 1.
  • Requiring clinical summaries that are pertinent to office visits be sent to patients within one business day during 50% of eligible encounters. The threshold is the same, but the summary cannot be just an abstract of the record.
  • Directing practices to use EHRs to query research systems for clinical trials. The new certification criteria would identify patient eligibility for relevant trials.
  • Requiring the identification of education resources in five non-English languages and mandating that 80% of materials written in at least one of those languages be made available to patients.
Source: “Request for Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records,” HHS Office of the National Coordinator for Health Information Technology, HIT Policy Committee, Nov. 27, 2012  (www.healthit.gov/sites/default/files/hitpc_stage3_rfc_final.pdf)

Meaningful use stage 3

Proposed meaningful use stage 3 Criticized as hasty and too strict

Rigid requirements to meet electronic health record measures will trip up physicians attempting to stop upcoming penalties, warn the AMA and others in organized medicine.

Washington Criteria floated for the final stage of the federal electronic health record incentive program would be extremely difficult for physicians to meet, causing those using the systems at their practices to fall short of requirements and exposing them to lower Medicare payments, organized medicine groups say.
A health information technology committee under the Dept. of Health and Human Services has drafted preliminary recommendations for stage 3 of the EHR meaningful use program. The committee wants the program to support new care models, apply broadly to specialties and reflect technologies that are becoming available. But physician organizations, including the American Medical Association, are urging federal officials to review and improve the first two stages of paperless record standards before jumping ahead too hastily.
“The AMA shares the administration’s goal of widespread EHR adoption and use, but we again stress our continuing concern that the meaningful use program is moving forward without a comprehensive evaluation of previous stages to resolve existing problems,” said Steven J. Stack, MD, chair of the AMA Board of Trustees. “A full evaluation of past stages and more flexible program requirements will help physicians in different specialties and practice arrangements successfully adopt and use EHRs.”
The earliest physicians will see stage 3 is 2016. Stage 2 won’t begin until 2014 for the earliest adopters, and physicians who have not yet adopted EHRs will spend two years under stage 1 criteria before they start progressing to the next stages.
Physicians can earn up to $44,000 in Medicare bonuses or $63,750 from Medicaid. Incentives taper off over time, with Medicare and Medicaid bonuses ending in 2016 and 2021, respectively. Those not achieving meaningful use by October 2014 stand to be assessed Medicare payment penalties beginning in 2015.
The committee had sought comments from stakeholders on its recommendations to retire several meaningful use measures and strengthen other requirements in stage 3. Even though the meaningful use program has spurred adoption of EHRs and led to more than 125,000 physicians receiving bonuses, the AMA and others have identified several areas that they say need improvement before the program can move forward.
“A number of the proposed stage 3 measures necessitate significant increases in clinical documentation, involve new and potentially complex work flows, are likely to be difficult for many eligible professionals to understand and implement, or depend on technologies that are not yet widely deployed or shown to be usable in busy practices,” said Michael H. Zaroukian, MD, PhD, chair of the American College of Physicians medical informatics committee.
The American Academy of Family Physicians said the issues are serious enough that stage 3 should be delayed until at least 2017. “Rather than prematurely impose stage 3 requirements, HHS should first focus on improving the ability for physicians to achieve meaningful use stage 1 and 2 requirements,” wrote AAFP Board Chair Glen Stream, MD.

No partial credit for some measures

Physicians already having trouble meeting core and optional meaningful use measures in stage 1 will experience far greater difficulties in the third phase of the program, the organized medicine groups said. The committee’s proposal would nearly double the number of measures that a practice must meet for every eligible patient encounter to avoid Medicare pay penalties.
“Failing to meet just one measure by 1% would make a physician ineligible for incentives and face the same financial penalties during the penalty phase as those physicians who make no effort to adopt EHRs,” the AMA stated in a Jan. 14 comment letter.
The AMA does not support the financial penalties, which will lower Medicare pay by 1% in 2015 for physicians not using the technology adequately by October 2014. However, the policy committee could provide physicians with more options to prevent lower payments, the Association stated.
For instance, similar regulations to the ones adopted by the Centers for Medicare & Medicaid Services for electronic prescribing and quality reporting programs would lower the number of physicians penalized by the EHR initiative. Reporting e-prescribing activity during 10 eligible patient encounters over six months stops the pay cut in that program even though it is not enough to secure a pay bonus. The AMA recommended that physicians meet only 10 meaningful use measures to avoid that penalty, instead of requiring them to meet all of the measures to be compliant.
Medical group administrators also believe that the decision to set 2014 as the reporting year that determines the 2015 penalties should be revisited. Payment adjustments should be assigned the same way bonuses are paid, wrote MGMA-ACMPE, the medical practice management association, in a Jan. 14 letter.
“If penalties are to be assigned, we urge the imposition of payment adjustments to start Jan. 1, 2016, for failing to meet the 2015 meaningful use requirements,” the MGMA-ACMPE said. “We believe this is the appropriate interpretation of the statute’s requirement that payment adjustments begin in 2015.”

Dismissing EHR “science fiction”

Physicians and hospitals have been tasked with purchasing EHRs and transitioning the health care system to paperless records. However, there are gaps in the national health information technology network that must be closed for doctors and facilities to meet the objectives, the American College of Cardiology stated in its Jan. 14 comment letter.
“Without those pieces, much of what the [committee] proposes seems more like science fiction than mere forward thinking,” the ACC said. “Indeed, the proposals seem ambitious and imaginative, but almost impossible to actually accomplish, especially without much in the way of underlying data, interoperability and communication standards.”
The AMA recommended that the new standards for stage 3 be optional and placed on a menu set, from which physicians can choose measures to meet for meaningful use. For example, one such new measure would require a physician to acknowledge receipt of external information when receiving a patient referral at least 50% of the time. The physician then would be required to return referral results electronically during at least 10% of the encounters.
Measures requiring such communication could lead to message fatigue and defeat the purpose of the meaningful use objective, the ACC wrote. “While larger systems may not encounter difficulties with message acknowledgements, small physician practices will be overwhelmed and could potentially be distracted from providing the highest patient care.”