Showing posts with label healthcare. Show all posts
Showing posts with label healthcare. Show all posts

Wednesday, January 20, 2016

Senate HELP Committee Releases Draft of Bill to Help Improve Health Information Technology for Doctors & Patients

The Senate HELP Committee has released for feedback a staff discussion draft of the committee’s bipartisan legislation to improve health information technology, including electronic health records. The draft legislation is the result of a bipartisan, full committee health information technology working group announced last April as well as hearings in the committee.

Chairman Lamar Alexander announced the committee will hold an executive session considering bills on biomedical innovation on Tuesday, February 9. At that meeting the committee will consider at least seven bipartisan bills:

  • Bipartisan HELP Committee legislation to improve electronic health records. 
  • The FDA Device Accountability Act of 2015 (S.1622); 
  • The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030); 
  • The Advancing Research for Neurological Diseases Act of 2015 (S.849); 
  • The Next Generation Researchers Act (S.2014),; 
  • The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800); 
  • and Legislation regarding FDA regulation of duodenoscopes.

“The House has completed its work on the 21st Century Cures Act. The president has announced his support for a precision medicine initiative and a cancer ‘moonshot.’ It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American,” said Senator Alexander. "“The committee has also been working for months on legislation to help achieve interoperability of electronic health records for doctors, hospitals and their patients," he added. This is the discussion draft now released for public comment.

I am impressed with the draft so far. It emphasizes using technology to actually improve care, provide transparency, and empower patients. Information is power and it is good to see that the Senators are including patients and putting them at center of health information exchange. Strong language on information blocking practices will give some teeth to future regulations. Significantly it also combines the HIT Standards Committee and HIT Policy Committee into one HIT Advisory Committee.

Requiring that one EHR product is capable of trusted exchange with multiple other EHR product would be another certification criterion and testing regime that would hopefully address some of the challenges that have occurred in real world exchanges. It is also striking that they are instructing the Governmental Accountability Office (GAO) to conduct a study to review methods for securely matching patient records to the correct patient. Perhaps this will finally do away with the annual provision that Federal funds can not be used to research or create patient identifiers. Overall this draft is a very good start and it will be worth watching as the process plays out in the Senate HELP Committee.

Below is a summary of the legislation provided by the Committee:
  1. Assisting Doctors and Hospitals in Improving Quality of Care for Patients
    1. Reduces documentation burdens by convening public and private stakeholders to develop goals, a strategy, and recommendations to minimize the documentation burden on providers while maintaining quality.
    2. Allows and encourages health professionals to practice at the top of their license, allowing non-physician members of the care team, such as nurses, to document on behalf of physicians.
    3. Encourages the certification of health information technology (HIT) for specific specialty providers, like pediatricians, where more specialized technology is needed.
  2. Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT)
    1. Establishes an unbiased rating system for HIT products to help providers better choose HIT products.
    2. Allows HIT users to share feedback on the user experience of specific HIT products related to security, usability, and interoperability, among other concerns.
  3. Information Blocking
    1. Gives the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information
  4. Interoperability
    1. Convenes existing data sharing networks to develop a model framework and common agreement for the secure exchange of health information across existing networks to help foster a “network of networks.”
    2. Creates a digital provider directory to both facilitate exchange and allow users to verify the correct recipient.
    3. Requires that HHS give deference to standards developed in the private sector.
    4. Combines the HIT Policy Committee and HIT Standards Committee into the HIT Advisory Committee.
    5. Creates a process for prioritizing the adoption of standards to focus on the most pressing problems faced by the health care community. 
    6. Establishes an initial set of common data elements, such as a standard format for entering date of birth, to facilitate interoperability and streamline quality reporting.
  5. Leveraging Health Information Technology to Improve Patient Care
    1. Requires that certified HIT transmit and receive data from certified physician registries and that registries be certified to transmit and receive from certified HIT
    2. Includes vendors in Patient Safety Organizations to allow for improvements in the safety and effectiveness of HIT.
  6. Empowering Patients and Improving Patient Access to Their Electronic Health Information
    1. Supports the certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software that may update automatically.
    2. Encourages the use of Health Information Exchanges to promote patient access by educating providers and clarifying misunderstandings.
    3. Requires HHS to clarify situations where it is permissible for providers to share patient information by providing best practices and common cases where sharing is allowed.
  7. Encouraging Trust Relationships for Certified Electronic Health Records (EHR)
    1. Supports the secure exchange of electronic health information by certifying that one EHR product is capable of trusted exchange with multiple other EHR products.
  8. GAO Study on Patient Matching
    1. Directs the Governmental Accountability Office (GAO) to conduct a study to review methods for securely matching patient records to the correct patient.

Summary Prepared by the Majority and Minority Staff of the Senate Committee on Health, Education, Labor, and Pensions

Thursday, December 19, 2013

Dr. Karen DeSalvo Named National Coordinator for Health IT

Dr. Farzad Mostashari tipped me off to the interesting video below:

"
Dr. Karen DeSalvo at the 2012 ONC Annual Meeting

Below is a note from Secretary Sebelius to HHS staff, followed by a note from Dr. Reider to ONC staff.


Colleagues,

I would like to announce that Dr. Karen DeSalvo, who currently serves as the City of New Orleans Health Commissioner and Senior Health Policy Advisor to Mayor Mitch Landrieu, will be the next National Coordinator for Health Information Technology here at the Department.

During her tenure, Dr. DeSalvo has been at the forefront of efforts to modernize the New Orleans health care system. Following Hurricane Katrina, for example, she led projects to increase access to care by augmenting the city’s neighborhood-based medical homes for low income, uninsured and other vulnerable populations in the New Orleans area.

Throughout her career, Dr. DeSalvo has advocated increasing the use of health information technology (HIT) to improve access to care, the quality of care, and overall population health outcomes –including efforts post-Katrina to redesign of the health system with HIT as a foundational element. She served as President of the Louisiana Health Care Quality Forum, the Louisiana lead for their health information exchange and regional extension center grants. She has also served as a member of the Steering Committee for the Crescent City Beacon Community grant.

As the New Orleans Health Commissioner she has made the increased utilization of HIT a cornerstone of the city’s primary care efforts and a key part of the city’s policy development, public health initiatives and emergency preparedness. Further, she has led the planning and construction of the city’s newest public hospital, which will have a fully-integrated HIT network. Her work as commissioner has led to positive changes to the way healthcare providers deliver care to their patients, improved accessibility and outcomes for patients, and improved the health of all New Orleanians. Dr. DeSalvo is a graduate of Suffolk University, Tulane Schools of Medicine and Public Health, Harvard School of Public Health.

Dr. DeSalvo’s hands-on experience with health delivery system reform and HIT and its potential to improve health care and public health will be invaluable assets to the Office of the National Coordinator and the Department. I would also like to take this opportunity to thank Dr. Jacob Reider, the Acting National Coordinator for his leadership of ONC during this time of transition. I am pleased she is joining our committed team, and ask you to join me in welcoming her to HHS when she starts on Monday, January 13th.

Sincerely,


Kathleen Sebelius


Tuesday, April 9, 2013

The Healthcare Revolution Away From the Mainframe

Over ten years ago Intel launched the Proactive Health Research Project, a multiyear effort to bring ubiquitous computing to eldercare. Since that time Eric Dishman, an Intel Fellow and now general manager of the Health Strategy & Solutions Group, has been promoting healthcare innovation with a specific emphasis on home and community-based technologies and services for chronic disease management and independent living. He has often expanded on the concept initially proposed by Andy Grove in Fortune magazine where he described the "mainframe" era of healthcare. He said at the time, "It took us 50 years to move from the mainframe to personal computing, but health care needs to go through a similar transformation in ten years or less."

I riffed off of this a bit at the recent Dell Healthcare Think Tank entitled "The Future of Information Driven Healthcare," where I also described the launch of the HIMSS project within the Clinton Global Initiative, the Healthcare Transformation Project. With cloud services, mobile health technology and telemedicine advances, we may just be seeing a similar revolution in healthcare that the computer industry underwent. I think the Healthcare Transformation Project will help to spur this revolution...



Here is a TED Talk of Eric's where he discusses some of the ideas I referenced:

Saturday, March 16, 2013

The High Price of Healthcare

Steven Brill, Giovanni Colella, M.D., and Ezekiel Emanuel, M.D. Ph.D. examined how to lower the high price of healthcare at a recent Center for American Progress event, "The High Price of Health Care" on March 13, 2013. Steve Brill's widely cited Time cover story exposed a “uniquely American gold rush” for hospitals, pharmaceutical companies, and medical device makers at the expense of patients and payers. After analyzing healthcare bills and interviewing patients, hospital executives, and billing advocates, Brill found that patients and other healthcare purchasers are charged ridiculous prices, with markups as high as 10,000%. I agree that transparency in pricing and engaging patients are key to actually reducing healthcare costs.

Leading experts in the field of healthcare joined the Center for American Progress to develop a plan to address the crisis of rising healthcare costs. The 11 cost-containment solutions were the subject of a New England Journal of Medicine article, authored by 23 prominent health care experts, including Dr. Ezekiel Emanuel, former administrator of the Centers for Medicare & Medicaid Services Dr. Donald Berwick, former director of the Office of Management and Budget Peter Orszag, and Center for American Progress President Neera Tanden. There was some interesting alignment between the NEJM article and Brill's piece. The Center for American Progress hosted this panel discussion with opening remarks by Tanden and moderated by Topher Spiro, Vice President of Health Policy at the Center for American Progress. The video below is from the event, the infographic below that was created by Maura Calsyn, Emily Oshima Lee, and Danny Schwaber.


INFOGRAPHIC:

Tuesday, January 1, 2013

Healthcare Impact of the "Fiscal Cliff" Deal

Members of the U.S. House of Representatives have voted by 257-167, with 172 Democratic votes and only 85 Republicans voting in favor, to approve the previously Senate-passed bill that will avert the so-called "fiscal cliff" of automatic tax increases and mandated spending cuts. Under the plan, taxes will increase for individuals making more than $400,000 a year and couples earning more than $450,000, as well as on investment profits and dividends, the first U.S. income tax increase in 20 years. The package will extend unemployment benefits for a year and boost taxes on large inheritances. It also allows payroll taxes to go back up to 6.2% this year from 4.2 percent in 2011 and 2012, amounting to a $1,000 tax increase for someone earning $50,000 a year. The "fiscal cliff" bill is the result of two days of marathon negotiations between the White House and Senate Republicans. It was passed in an unusual vote early on New Year's Day, 89-8. Senate Minority Leader Mitch McConnell said the compromise was an "imperfect agreement" that will keep tax hikes from affecting most Americans. There are significant effects on healthcare as part of this package.

The nonpartisan Congressional Budget Office released a report estimating that the Senate bill would add $329 billion to deficits in 2013 and $3.9 trillion to deficits over the next 10 years, relative to current law. The CBO analysis of the bill shows fiscal 2013 revenues would be $280 billion lower and spending $50 billion higher, resulting in a $330 billion deficit increase, for a total deficit of around $971 billion in 2013. The bill would apply another temporary SGR fix and block the scheduled 27% payment cuts to Medicare providers, and keep rates frozen at current levels for one year. A companion CBO report (PDF) entitled Detail on Estimated Budgetary Effects of Title VI (Medicare and Other Health Extensions) of H.R. 8, the American Taxpayer Relief Act of 2012, As passed by the Senate on January 1, 2013 gives the details of the impact to Medicare. Among the provisions affecting healthcare (hat tip to Matthew Taber) are:
  • elimination of funding for Medicare Improvement Fund
  • rebasing of State DSH allotments
  • repeal of the CLASS program (part of the ACA)
  • creates commission on Long Term Care
  • ambulance add-on services
  • extension of payments for low-volumne hospitals
  • extension of MDH program
  • extension Medicare Advantage special needs programs
  • extension of medicare reasonable cost contracts
  • extension of qualifying individual program
  • extension of transitional medical assistance program
  • extension of S-CHIP Express Lane
  • extension of family-to family health information center
  • extension of indian diabetes program
  • coding adjustment for MS-DRGs
  • revisions to Medicare ESRD bundled payments
  • treatment of multiple service payment policies for therapy services
  • payment for certain radiology services
  • adjustment of equipment utilization rate for radiology 
  • elimination of overpayment for diabetic supplies
  • removes obstacles to collection of overpayments
  • improves medicare advantage coding intensity adjustment
The bill rescinds all unobligated funds for a program in the health care law to help set up consumer-oriented nonprofit health plans. The bill will create a contingency fund of 10 percent of current unobligated funds to help co-op plans that have already been approved. Savings from this provision amount to $2.3 billion. Also under the bill, the Medicare Improvement Fund would be eliminated, saving $1.7 billion.

The legislation cuts $4.9 billion by changing the bundled payment given for end-stage renal disease services. An additional $300 million will come from cutting payment rates by 10 percent for non-emergency ambulance services used by patients with end-stage renal disease. There is also $1.8 billion projected to be saved by reducing reimbursement for multiple therapy procedures when performed on the same day.

The bill is a mixed bag in that it would require that hospitals pick up nearly half of the approximately $30 billion cost of stopping the 27% payment cut. The legislation will reduce hospital payments in two ways: number one, it will cut $10.5 billion from projected Medicare hospital payments over 10 years for inpatient or overnight care; number two, it will reduce Medicaid disproportionate share payments to hospitals by an additional $4.2 billion over the next decade.

Statements from stakeholders:

American Hospital Association

Federation of American Hospitals

National Association of Public Hospitals and Health Systems

Saturday, December 24, 2011

Healthcare Innovation Challenge Materials

The CMS Innovation Center's Health Care Innovation Challenge

The Centers for Medicare & Medicaid Services (CMS) hosted four webinars on its Health Care Innovation Challenge, which will spend a billion dollars through awards of up to $30 million over three years to projects that identify and test promising new payment and care delivery models for Medicare, Medicaid and the Children's Health Insurance Program. I have synced the slides with the audio to make the webinar archive easier to view.

The objectives of this initiative are to:
  • Engage a broad set of innovation partners to identify and test new care delivery and payment models that originate in the field and that produce better care, better health, and reduced cost through improvement for identified target populations. 
  • Identify new models of workforce development and deployment and related training and education that support new models either directly or through new infrastructure activities. 
  • Support innovators who can rapidly deploy care improvement models (within six months of award) through new ventures or expansion of existing efforts to new populations of patients, in conjunction (where possible) with other public and private sector partners.
You can view and listen to each of the webinars below. There are resources listed under that. I will also be updating this post with additional useful information for those who are applying for this opportunity. The expanding FAQ for this funding is available at innovations.cms.gov


CMS Innovation Center staff hosted the first is a series of informational webinar on
the Health Care Innovation Challenge for all interested individuals and organizations
on Thursday, November 17, 2011. Staff provided an overview of the initiative and
were available to answer questions from the audience.



This second webinar was held on Tuesday, December 6th, 2011 to provide guidance on the application process with specific attention towards designing effective project proposals.



In this third of four-webinar series on the Innovation Challenge held December 19, 2011,
CMS Innovation Center staff presented an explanation of "Total Cost of Care" and how
potential applicants can demonstrate their path to achieving lower costs through improvement.



This fourth presentation was the final overview webinar on the Innovation Challenge
before applications are due. CMS Innovation Center staff presented how potential
innovative proposals can demonstrate measurable impact on the aims of better care
and better health in addition to considerations for operational planning for potential applications.

RESOURCES:

Public Sources for CMS or HHS Approved Quality Measures 

Friday, January 28, 2011

Enabling Personalized Medicine through Health Information Technology


On January 28, 2011 the Center for Technology Innovation at Brookings hosted a policy discussion focused on the challenges of enabling personalized medicine, as well as the policy and operational changes that would facilitate connectivity, integration, reimbursement reform and secondary analysis of information. Vice President and Director of Governance Studies Darrell West presented key findings and recommendations from his paper Enabling Personalized Medicine through Health Information Technology about the public policy actions needed to ensure that health information technology facilitates the adoption of personalized medicine in the U.S. healthcare system. David Brailer, chairman of Health Evolution Partners and the first National Health Information Technology Coordinator during the Bush administration, delivered the keynote address. Afterwards speakers took questions from the audience. The podcast is below:



"With federal officials pursuing the goal of a personal human genome map under $1,000 in five years (White House, 2010), it is possible to envision a future where treatments are tailored to individuals’ genetic structures, prescriptions are analyzed in advance for likely effectiveness, and researchers study clinical data in real-time to learn what works," said Mr. West in the Executive Summary of the report.

"Implementation of these regimens creates a situation where treatments are better targeted, health systems save money by identifying therapies not likely to be effective for particular people, and researchers have a better understanding of comparative effectiveness," he adds, citing the PCAST Report.

The summary goes on to say, "Interoperability represents a major challenge because of the difficulty of integrating data from different sources. If researchers and healthcare providers are not able to exchange information, it raises the cost of health care and makes it difficult to learn in real-time. A considerable amount of medical information is collected, but too little of it is integrated or put into data bases that are usable for research or public health purposes."

The report identifies three revolutions and how they affect healthcare:
  1. The Medical Delivery Revolution: New Actors and New Relationships
  2. A shift from a hierarchical delivery system to one that features greater transparency, collaboration, and patient involvement with more more empowered relationship between primary care doctors and their patients.
  3. The Digital Revolution and Ways to Convert Data into Knowledge
  4. An explosion of digital resources available over the Internet for patients as well as physicians.
  5. Genomics and the Impact on Medical Care
  6. The work of the Human Genome Project and further research has established links between gene structures, human illnesses, treatment effectiveness, and adverse effects.
The report goes on to identify policy challenges and provides recommendations including new approaches to privacy and access control. This is an excellent paper and I recommend studying it carefully.


...

Wednesday, January 26, 2011

Information Exchange Workgroup Provider Directory Task Force 1-24-11

The Information Exchange Workgroup Provider Directory Task Force met on January 24, 2011 and continued their discussion on Individual Level Provider Directories. The webinar is below:

Monday, January 24, 2011

Stage 2 Meaningful Use Request for Comments

The Health Information Technology Policy Committee, which advises the Department of Health and Human Services, is seeking comments through Feb. 25 on an initial set of proposed requirements for stage 2 meaningful use of electronic health records. The committee plans to hold public hearings this spring, and to issue final recommendations to HHS this summer for consideration in rulemaking. We should all plan to submit comments on the proposed stage 2 requirements currently under consideration. This will give ample opportunity for broad stakeholder input into the process before the proposed rule and final rule are published. Comments can be submitted here on regulations.gov. Below is information on the request for comment from the Meaningful Use Workgroup Regarding Meaningful Use Stage 2 [PDF]


HIT Policy Committee:
Meaningful Use Workgroup Request for Comments Regarding Meaningful Use Stage 2

I. Background

The Health Information Technology Policy Committee (HITPC) is a federal advisory committee that advises the U.S. Department of Health and Human Services (HHS) on federal HIT policy issues, including how to define the ―meaningful use‖ (MU) of electronic health records (EHRs) for the purposes of the Medicare and Medicaid EHR incentive programs. The HITECH portion of the American Recovery and Reinvestment Act (ARRA) of 2009 specifically mandated that incentives should be given to Medicare and Medicaid providers not for EHR adoption but for ―meaningful use‖ of EHRs. In July of 2010, HHS released that program’s final rule, thus defining stage 1 MU and strongly signaling that the bar for what constitutes MU would be raised in subsequent stages in order to improve advanced care processes and health outcomes.

The HITPC held six public hearings in 2010 including testimony from several dozen stakeholders and received additional dozens of public comments via its blog. All of this input helped to inform its many hours of public deliberations regarding the future vision of MU (e.g., stage 3) as well as the interim stepping stone of stage 2 MU that will set expectations for 2013 and 2014.

The HITPC has developed a preliminary set of recommendations specifically designed to solicit additional public feedback. The goal of sending out this request for comment (RFC) early is threefold.

  1. Provide some signal to the industry of potential new EHR functionalities that the HITPC may recommend to help the industry get a head start on developing new functionalities.
  2. Extend the public discussion of future stage MU definitions through a more formal public comment process well in advance of its formal final stage 2 recommendations to be issued in the summer of 2011.
  3. Request input on specific questions.

Following analysis of the comments received through the approximately 45-day public comment period, the HITPC intends to revisit these recommendations in its public meetings in the spring of 2011. At that time, the HITPC will be able to review public comments in the context of the early feedback from providers on experience with stage 1 MU. That input will come through many vehicles: the Medicare program, the Medicaid program (both federal and state constituencies), the HIT regional extension program, and other sources. Note, this RFC solely represents the preliminary thinking of the HITPC and its Meaningful Use Workgroup.

Structure and Relevant Concurrent HITPC Activities

The HITPC has created a matrix of objectives and measures that it is considering for its recommendations to HHS. These objectives are organized into four of the five health outcome priorities that formed the stage 1 MU organizing structure. The HITPC approached its task of developing proposed stage 2 objectives by first developing a longer-term vision for MU and then determining what an appropriate stage 2 stepping stone is to get there. For this reason, the matrix includes possible stage 3 objectives, but they are only included in the matrix in order to provide context for the Stage 2 recommendations. Therefore, for the purpose of this Request for Comments, the HITPC is primarily interested in comments on the proposed Stage 2 objectives at this time.

The HITPC has a concurrent activity that is developing Stage 2 and 3 recommendations for the fifth health outcome priority — ensure adequate privacy and security protections for personal health information. The HITPC and its Privacy & Security Tiger Team will subsequently release recommendations for this domain.

In addition, the HITPC has a Quality Measures (QM) Workgroup that is concurrently developing a framework for the evolution of clinical quality measures to be electronically reported as part of Stages 2 and 3 MU. The HITPC recently collected public input through a request for comment on a set of proposed measure concepts, and it will provide more guidance on its measure development priorities in the near future following synthesis and analysis of those public comments. Other recommendations about information exchange are being developed by the HITPC’s Information Exchange Workgroup.

Proposed MU Objectives and Measures for Stages 2 and 3


Meaningful Use: Stage 1 Final Rule and Proposed Objectives for Stages 2 and 3
Improving Quality, Safety, Efficiency & Reducing Health Disparities
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
CPOE for medication orders (30%)
CPOE (by licensed professional) for at least 1 medication,  and 1 lab or radiology order for 60% of unique patients who have at least 1 such order (order does not have to be transmitted electronically)
CPOE (by licensed professional) for at least 1 medication, and 1 lab or radiology order on 80% of patients who have at least 1 such order (order does not have to be transmitted electronically)

Drug-drug/drug-allergy interaction checks 

Employ drug-drug interaction checking and drug allergy checking on appropriate evidence-based interactions
Employ drug-drug interaction checking, drug allergy checking, drug age checking (medications in the elderly), drug dose checking (e.g., pediatric dosing, chemotherapy dosing), drug lab checking, and drug condition checking (including pregnancy and lactation)  on appropriate evidence-based interactions
Reporting of drug interaction checks to be defined by  quality measures workgroup 


E-prescribing (eRx) (EP) (40%)
50% of orders (outpatient and hospital discharge) transmitted as eRx 
80% of orders (outpatient and hospital discharge) transmitted as eRx 
If receiving pharmacy cannot accept eRx, automatically generating electronic fax to pharmacy OK
Record demographics (50%)
80% of patients have demographics recorded and can use them to produce stratified quality reports
90% of patients have demographics recorded (including IOM categoriesi) and can use them to produce stratified quality reports

Report CQM electronically
Continue as per Quality Measures Workgroup and CMS
Continue as per Quality Measures Workgroup and CMS
The HIT Policy Committee’s Quality Measures Workgroup issued a request for comment in December; new measures will be considered after review of public comments

Maintain problem list (80%)
Continue Stage 1
80% problem lists are up-to-date
Expect to drive list to be up-to-date by making it part of patient visit summary and care plans

Maintain active med list (80%)
Continue Stage 1
80% medication lists are up-to-date
Expect to drive list to be up-to-date via medication reconciliation

Maintain active medication allergy list (80%)
Continue Stage 1
80% medication allergy lists are up-to-date
Expect to drive the list to be up-to-date by making it part of visit summary

Record vital signs (50%)
80% of unique patients have vital signs recorded
80% of unique patients have vital signs recorded


Record smoking status (50%)
80% of unique patients have smoking status recorded
90% of unique patients have smoking status recorded


Implement 1 CDS rule
Use CDS to improve performance on high-priority health conditions.
Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action
Use CDS to improve performance on high-priority health conditions.
Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action


Implement drug formulary checks* 
Move current measure to core
80% of medication orders are checked against relevant formularies
What is the availability of formularies for eligible professionals?

Record existence of advance directives (EH) (50%)*
Make core requirement. For EP and EH: 50% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists
For EP and EH: 90% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists
Potential issues include: state statutes; challenges in outpatient settings; age; privacy; specialists; needs to be accessible and certifiable; need to define a standard 
Incorporate lab results as structured data (40%)*
Move current measure to core, but only where results are available

90% of lab results electronically ordered by EHR are stored as structured data in the EHR and are reconciled with structured lab orders, where results and structured orders available

Generate patient lists for specific conditions*
Make core requirement. Generate patient lists for multiple patient-specific parameters
Patient lists are used to manage patients for high-priority health conditions


Send patient reminders (20%)*
Make core requirement. 
20% of active patients who prefer to receive reminders electronically receive preventive or follow-up reminders
How should ―active patient‖ be defined?

(NEW)
30% of visits have at least one electronic EP note
90% of visits have at least one electronic EP note
Can be scanned, narrative, structured, etc.
(NEW)
30% of EH patient days have at least one electronic note by a physician, NP, or PA
80% of EH patient days have at least one electronic note by a physician, NP, or PA
Can be scanned, narrative, structured, etc.
(NEW)
30% of EH medication orders automatically tracked via electronic medication administration recording
80% of EH inpatient medication orders are automatically tracked via electronic medication administration recording

Engage Patients and Families in Their Care
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Provide electronic copy of health information, upon request (50%)
Continue Stage 1

90% of patients have timely access to copy of health information from electronic health record, upon request
Only applies to information already stored in the EHR

Provide electronic copy of discharge instructions (EH) at discharge (50%)
Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 80% of patients (patients may elect to receive only a printed copy of the instructions)

Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 90% of patients in the common primary languages (patients may elect to receive only a printed copy of the instructions)
Electronic discharge instructions should include a statement of the patient’s condition, discharge medications, activities and diet, follow-up appointments, pending tests that require follow up, referrals, scheduled tests  [we invite comments on the elements listed above]
EHR-enabled patient-specific educational resources (10%)
Continue Stage 1

20% offered patient-specific educational resources online in the common primary languages

(NEW for EH)
80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human-readable and structured forms (HITSC to define). 
80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human readable and structured forms (HITSC to define). 
Inpatient summaries include: hospitalization admit and discharge date and location; reason for hospitalization; providers; problem list; medication lists; medication allergies; procedures; immunizations; vital signs at discharge; diagnostic test results (when available); discharge instructions; care transitions summary and plan; discharge summary (when available); gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
Provide clinical summaries for each office visit (EP) (50%)

Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human-readable and structured forms (HITSC to define)

Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human readable and structured forms (HITSC to define)

The following encounter data are included (where relevant): encounter date and location; reasons for encounter; provider; problem list;medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders: future appointment requests, referrals, scheduled tests; gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]

demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human-readable and structured forms (HITSC to define). 

demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human readable and structured forms (HITSC to define). 

locations; reasons for encounters; providers; problem list; medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders; longitudinal care plan;gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]

This objective sets the measures for ―Provide timely electronic access (EP)‖ and for ―Provide clinical summaries for each office visit (EP)‖

EPs: 20% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet
EPs: 30% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet

(NEW)
EPs: online secure patient messaging is in use

EPs: online secure patient messaging is in use


(NEW)
Patient preferences for communication medium recorded for 20% of patients
Patient preferences for communication medium recorded for 80% of patients
How should ―communication medium‖ be delineated?


Offer electronic self-management tools to patients with high priority health conditions
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3 objective


EHRs have capability to exchange data with
We are seeking comment on what
PHRs using standards-based health data exchange
steps will be needed in stage 2 to achieve this proposed stage 3objective


Patients offered capability to report experience of care measures online
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


Offer capability to upload and incorporate patient-generated data (e.g., electronically collected patient survey data, biometric home monitoring data, patient suggestions of corrections to errors in the record) into EHRs and clinician workflow
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Improve Care Coordination
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Perform test of HIE

Connect to at least three external providers in ―primary referral network‖ (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange
Connect to at least 30% of external providers in ―primary referral network‖ or establish an ongoing bidirectional connection to at least one health information exchange
Successful HIE will require development and use of infrastructure like entity-level provider directories (ELPD)

Perform medication reconciliation (50%)*

Medication reconciliation conducted at 80% of care transitions by receiving provider (transitions from another setting of care, or from another provider of care, or the provider believes it is relevant)
Medication reconciliation conducted at 90% of care transitions by receiving provider


Provide summary of care record (50%)*

Move to Core

Summary care record provided electronically for 80% of transitions and referrals 

(NEW)
List of care team members (including PCP) available for 10% of patients in EHR

List of care team members (including the PCP) available for 50% of patients via electronic exchange


(NEW)
Record a longitudinal care plan for 20% of patients with high-priority health conditions

Longitudinal care plan available for electronic exchange for 50% of patients with high-priority health conditions

What elements should be included in a longitudinal care plan including: care team members; diagnoses; medications; allergies;goals of care; other elements?
Improve Population and Public Health
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
 Comments
Submit immunization data*

EH and EP: Mandatory test. Some immunizations are submitted on an ongoing basis to Immunization Information System (IIS), if accepted
and as required by law
EH and EP: Mandatory test. Immunizations are submitted to IIS, if accepted and as required by law. During well child/adult visits, providers review IIS records via their EHR.

Stage 2 implies at least some data is submitted to IIS. EH and EP may choose not, for example, to send data through IIS to different states in Stage 2. The goal is to eventually review IIS-generated recommendations
Submit reportable lab data*
EH: move Stage 1 to core 

EP: lab reporting menu. For EPs, ensure that reportable lab results and conditions are submitted to public health agencies either directly or through their performing labs (if accepted and as required by law).
Mandatory test.

EH: submit reportable lab results and reportable conditions if accepted and as required by law.
Include complete contact information (e.g., patient address, phone and municipality) in 30% (EH) of reports.

EP: ensure that reportable lab results and reportable conditions are submitted to public health agencies either directly or through performing labs (if accepted and as required by law)

Submit syndromic surveillance data*

Move to core.

Mandatory test; submit if accepted




Public Health Button for EH and EP: Mandatory test and submit if accepted. Submit notifiable conditions using a reportable public-health submission button. EHR can receive and present public health alerts or follow up requests.
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


Patient-generated data submitted to public health agencies
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Ensure Adequate Privacy and Security Protections for Personal Health Information
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Conduct security review analysis & correct deficiencies


Additional privacy and security objectives under
consideration via the HIT Policy Committee’s Privacy & Security Tiger Team
* menu option for Stage 1

Additional Specific Questions for Public Comment
The Health Information Technology Policy Committee welcomes public comment on all proposed objectives and their associated definitions. In addition, the Committee seeks specific input on the following additional questions.

  1. How can electronic progress notes be defined in order to have adequate specificity?
  2. For patient/family access to personal health information, what standards should exist regarding accessibility for people with disabilities (e.g., interoperability with assistive technologies to support those with hearing, visual, speech, or mobile impairments)?
  3. What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed?
  4. What are providers’ and hospitals’ experiences with incorporating patient-reported data (e.g., data self-entered into PHRs, electronically collected patient survey data, home monitoring of biometric data, patient suggestions of corrections to errors in the record) into EHRs?
  5. For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures (e.g., can either satisfy utilization measures for recording allergies, conducting CPOE, drug-drug interaction checking, etc, or demonstrate low rates of adverse drug events)?
  6. Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group?
  7. In stage 1, as an optional menu objective, the presence of an advance directive should be recorded for over 50% of patients 65 years of age or older. We propose making this objective required and to include the results of the advance-directive discussion, if available. We invite public comment on this proposal, or to offer suggestions for alternative criteria in this area.
  8. What are the reasonable elements that should make up a care plan, clinical summary, and discharge summary?
  9. What additional meaningful-use criteria could be applied to stimulate robust information exchange?
  10. There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives.

E. Evidence Base/Rationale for Proposed New Objectives

The HITPC identified proposed new objectives because of their potential impact on the five health outcome priorities to be achieved through the meaningful use of EHRs. Some of the relevant evidence to these proposed objectives is reflected below.

Patient and Family Engagement
In a randomized control trial assessing the efficacy of a home-based computer system in providing information and decision support as well as expert and other patient contacts to patients with HIV, findings were significant for improved quality of life indicators such as cognitive function, social support and participation in their health care, and also for decreased time spent during ambulatory visits, fewer phone calls to providers, and decreased number and length of hospitalizations.
Qualitative data analysis of provider impressions of a patient centered CDSS (Patient Assessment, Care and Education) designed to increase identification and treatment of chemotherapy related symptoms affirmed the increased awareness of underreported symptoms and additional benefits such as better communication with patients.
A retrospective cross-sectional study analyzing the adoption of and patient satisfaction with a PHR reported 25% of patients registered with PHR and reported over 90% satisfaction with the PHR, with greatest satisfaction with test results, medication refills, and secure messaging.
A CDSS electronic checklist specifically aimed to improve delivery of evidence based discharge instructions for patients with heart failure (HF) or acute myocardial infarction (AMI) was evaluated to be effective in increasing delivery of discharge instructions (from 37.2% pre-intervention to 93.0% post-intervention). In addition, prescription of ACEI or ARB in patients with HF and AMI improved to 96.7% from 80.7% and to 100% from 88.1%, respectively.
An interventional study assessing the effect of patient messaging reminding patients of screening, diagnostic and monitoring tests in accordance with evidence based guidelines found an increase in adherence to clinical recommendations by 12.5% (p < 0.001).
A randomized control trial of 246 patients who were newly diagnosed with breast cancer assessed the effect of a home-based computer system with information, decision-making and emotional support. The study found that patients in the intervention group were significantly more competent in seeking information, more comfortable participating in care, and more confident in their interactions with physicians at two months post intervention and had better social support and information competence at five months post intervention. Furthermore, the relative benefits in the intervention group were greater for patients in underserved populations.

Quality and Safety
A randomized control trial evaluating effect of CDSS alerting physicians to order venous thromboembolism (VTE) prophylaxis showed the intervention resulted in 41% decreased risk for VTE at 90 days.
Using CDS to alert physicians and pharmacists to 8 critical drug interactions resulted in 31% decrease in dispensed drugs known to have adverse interactions.
A prospective analysis of an antimicrobial surveillance system using evidence based guidelines in a children’s hospital showed successful identification of prescribing errors allowing for early intervention.
Analysis of a CDS system intervention aimed at improving asthma documentation and management in the emergency department found that asthma severity, asthma precipitants, ICU admission history and smoking status were recorded significantly more often with the CDSS. Additionally, 76% of patients received a discharge asthma plan compared with 16% before the intervention.
A prospective cohort study assessed efficacy of CDSS in identifying patients with acute lung injury (ALI) compared to physician diagnosis alone. This study is significant because early treatment of ALI is critical to overall prognosis. The CDSS had a sensitivity of 96.3% and specificity of 89.4% whereas physician diagnosis was 26.5% sensitive and 99.5% specific. Although the CDSS was less specific, physician diagnosis alone missed 239 cases while the CDSS missed 12.
A survey of ambulatory care providers assessed attitudes toward CPOE and e-prescribing systems and found that the majority reported improved quality of care and efficiency, prevention of medical errors, and increased patient satisfaction as advantages to the system. More than one third reported that in the last month they had avoided a medication error because of system alerts In addition, slightly less than half reported better counseling of adverse effects and improved monitoring. (Despite this only 47% reported satisfaction with the system. Complaints included alerts regarding medications discontinued, alert fatigue, and alerts inappropriately identifying drug interactions.)
Implementation of a web-based laboratory information system to treat multi-drug resistant tuberculosis patients in Peru greatly improved timely access to lab results and user satisfaction. The system was expanded to other institutions based on its success to serve a network for over 3.1 million patients. The system is at relatively low cost amounting to 1% of National Peruvian Tuberculosis annual budget.

Population Health
Population based surveillance system in a large multicenter primary care network identified patients overdue for mammography screening. The interventional study showed that providers successfully contacted 63% of over 3,000 patients at risk.
A computer based smoking cessation program designed after extensive review of the literature on the barriers associated with such a program, was found to be effective, inexpensive and required little time or skill from staff. The program was continued following the conclusion of the study because of the satisfaction rates from providers and patients.
Study showed feasibility and reliability of EHR based chronic kidney disease (CKD) registry composed of 57,276 patients in accurately relaying demographics and most comorbidities when compared to individual EHR chart review (κ >0.80). Study concluded such a registry has the potential to improve quality of care in this patient population and contribute to the development of a national CKD surveillance project.

Care Coordination
A study assessing the effect of a medication reconciliation program in an ambulatory oncology clinic found at least one error in 81% of all patients’ medication lists. In the group that received the intervention, 90% of incorrect medication lists were corrected, while only 2% were corrected in the control group (p < 0.001).
2007 cross-sectional survey of US home health and hospice agencies found 33% increase in use of EHRs since 2000. The agencies used available EHR functionalities in general, including telemedicine and information sharing..

Efficiency
Antibiotic approval system guiding use of 28 restricted antibiotics improved appropriate use of antibiotics and led to increased susceptibility of S. aureus to methicillin and of pseudomonas to several antibiotics. Patients with gram negative bacteremia did not suffer increased adverse outcomes as a result.
An interventional study (n=2200) compared RBC transfusions in critically ill patients before and after evidence based CDS intervention significant decrease in number of RBC transfusions per patient and percentage of patients transfused (p = 0.045 and p = 0.01 respectively) and net savings of almost $60,000 (n=1100 patients).