CMS and ONC Issue Rules on Proposing a Definition of Meaningful Use and Setting Standards for EHR Incentive Program

Yesterday the Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued two regulations laying the foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology.

The two regulations are part of the implementation of the EHR incentive programs for physicians and hospitals enacted under the HITECH provisions of the American Recovery and Reinvestment Act of 2009 (ARRA). CMS issued a proposed rule outlining the proposed provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology. ONC issued an interim final regulation setting forth the initial standards, implementation specifications, and certification criteria for EHR technology.

For more details see the following CMS Press Release. Also, CMS has issued Fact Sheets on the proposed regulations:

• CMS Proposes Requirements for the Electronic Health Records (EHR) Medicaid Incentive Payment Program
  
• CMS Proposed Requirements for the Electronic Health Records (EHR) Medicare Incentive Program
  
• CMS Proposes Definition of Meaningful Use of Certified Electronic Health Records (EHR) Technology

Below are links to complete copies of the rules. Once they are published in the Federal Register I will update with the specific Fed Reg details. Some light reading for the New Year!

Medicare and Medicaid Programs; Electronic Health Record Incentive Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
SUMMARY: This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. The proposed rule would specify the-- initial criteria an EP and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements. Also, as required by ARRA the Office of the National Coordinator for Health Information Technology (ONC) will be issuing a closely related interim final rule that specifies the Secretary’s adoption of an initial set of standards, implementation, specifications, and certification criteria for electronic health records. ONC will also be issuing a notice of proposed rulemaking on the process for organizations to conduct the certification of EHR technology.

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology
AGENCY: Office of the National Coordinator for Health Information Technology,
Department of Health and Human Services.
ACTION: Interim final rule.
SUMMARY: The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.

Tweet By Hospital Employee: What information is considered PHI?

Interesting Tweet HIPAA Breach story coming out of Mississippi involving Governor Haley Barbour. The incident involved a response to Governor Barbour's tweet by a University Medical Center employee.

Ves Dimov, M.D. at Clinical Cases and Images Blog posts about the story - Single tweet by hospital employee to Mississippi Governor allegedly violates HIPAA, forces her to resign.

The incident will provide a good case study for health privacy lawyers who regularly consider the question of what information is and is not protected health information (PHI) under 45 CFR 160.103. PHI is defined under HIPAA as:

The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)."

“Individually identifiable health information” is information, including demographic data, that relates to:

• the individual’s past, present or future physical or mental health or condition,
• the provision of health care to the individual, or
• the past, present, or future payment for the provision of health care to the individual,

and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).

Thanks for the tip @RLBates and @EdBennett.

Lorman Medical Records Law Seminar: March 18, 2010

On March 18, 2010 I will be speaking on Medical Records Law at a seminar in Charleston, West Virginia. The seminar is sponsored by Lorman Educational Services. Joining me for the day long seminar will be three very knowledgeable health care colleagues:

• Michael T. Harmon, MPA, CIPP/G, Compliance Specialist for the West Virginia Mutual Insurance Company, a Medical Professional Liability Insurance Company
• Sallie H. Milam, J.D., CIPP/G, Executive Director of the West Virginia Health Information Network and Chief Privacy Officer for the West Virginia State Government
• James W. Thomas, Esq., Manager of the Charleston, West Virginia Business Law Department of Jackson Kelly PLLC whose practice focuses primarily upon health care matters of a business, regulatory and operational nature
  

Additional information about the seminar and how to register can be found at Lorman Educational Services. Following is the full seminar agenda:

8:30 am – 9:00 am			Registration
9:00 am – 9:15 am			Overview
9:15 am – 10:30 am			HIPAA Compliance: Reality and Perspective
			— Michael T. Harmon, MPA, CIPP/G
			Overview Enforcement Complaints Case Examples Summary of HITECH Changes
10:30 am – 10:45 am			Break
10:45 am – 12:00 pm			HITECH Financial Incentives for Implementation of HIT
			— James W. Thomas, Esq.
			Qualifying an Electronic Health Record System Available Financial Incentives
12:00 pm – 1:00 pm			Lunch (On Your Own)
1:00 pm – 2:00 pm			Health Information Exchange in West Virginia: Impact on Patient Records
			— Sallie H. Milam, J.D., CIPP/G
2:00 pm – 2:15 pm			Break
2:15 pm – 3:30 pm			Consumer Driven Health Care: HITECH, Health 2.0, Social Media and Personal Health Records
			— Robert L. Coffield, Esq.
			HITECH Breach Notification Requirements Impact of Health 2.0 and Social Media Technology on the Future of Health Care Development and Adoption of Personal Health Records Discuss the Legal Implications of Emerging Technology
3:30 pm – 4:30 pm			Panel Discussion
			— Robert L. Coffield, Esq., Michael T. Harmon, MPA, CIPP/G, Sallie H. Milam, J.D., CIPP/G and James W. Thomas, Esq.

West Virginia State Bar and Office of Disciplinary Counsel News

The West Virginia State Bar announced today that the Office of Disciplinary Counsel has a new website. Also, the West Virginia State Bar has redesigned its website design..

The new Office of Disciplinary Counsel website contains information about the disciplinary complaint process the function of the Lawyer Disciplinary Board, the Rules of professional Conduct and the disciplinary complaint process. The website also has links to all Legal Ethics Opinions issued by the Lawyer Disciplinary Board and recent disciplinary decisions issued by the Supreme Court of Appeals of West Virginia.

Also, the West Virginia State Bar announces that the West Virginia Supreme Court of Appeal has entered order with a proposed amendment to Rule 8, Rules for Admission Pro Hac Vice. The proposed amendment increases the fee pad to the West Virginia State Bar for each individual applicant for pro hac vice admission from $250 to $350. Public comment on the proposed rule is being received through January 25, 2010.
A copy of the proposed order:

Request for Comments on Proposed Amendment to Rule 8.0 Admission pro hac vice, of the West Virginia Rules of Admission to the Practice of Law

UPDATE (3/16/10):

The West Virginia State Bar's Unlawful Practice of Law Committee released Advisory Opinion 10-001, relating to questions from attorneys regarding its interpretation of Rule 8 of the West Virginia Rules of Admission to the Practice of Law, relating to admissions pro hac vice.

Advisory Opinion 10-001 addresses the following issues:

1. Whether the requirement in Rule 8 of of admission pro hac vice extends to matters in which no action, suit or proceeding is pending;

2. To what extent is the responsible local attorney required to participate in proceedings involving the attorney admitted pro hac vice;

3. Whether presiding judicial officers can "excuse" local counsel form participation or "waive" the requirement of participating; and

4. What limitations exist for attorneys seeking to be admitted pro hac vice, particularly their ability to be admitted on a frequent basis, or in multiple or consolidated actions.

Drug and Device Law: Herrmann's Farewell Post

Farewell and congratulations go out to fellow health law blogger, Mark Herrmann, (formerly) co-author of the Drug and Device Law Blog and author of The Curmudgeon's Guide to Practicing Law.

In Mark's Farewell Post he announced that he is leaving Jones Day after 20 years to become the VP and Chief Counsel - Litigation at Aon Corporation. Fellow co-author, James Beck, has this to say (Long Live the Blog) about Mark's departure. He also announces 3 new lawyers joining the blogging team to replace Mark. Wow! 3 lawyers to replace 1. What a complement.

Although not much of my practice focuses on drug and device work, I have been a periodic reader since the early years of blogging. Why? Because I've always loved the tone of their posts - informal, practical and lighthearted. Great to see Beck link to a post that I remember reading (and liking) about why big firms don't blog well. Great advice for any law blogger.

Thanks to the Likelihood of Confusion post that tipped me on Mark's departure.

Thanks Esse Diem: The Best Blogs You're Not Reading Yet

A quick thanks to Elizabeth Damewood-Gaucher author of the Esse Diem Blog for including the Health Care Law Blog on her short list of The Best Blogs You're Not Reading Yet.

I would agree with her list and glad that am a regular reader of 4 out of the 5. All produce great content and cover distinct niche areas. For example, the Rainmaking Blog focuses on the business of law and tells you where to wear you nametag. Lee Kraus' Learning and Technology is the place I first learn about new technology tools that I can use - he is always thinking on the edge of the practical use of technology. Professional Studio 365 focuses on bridging the gap between college and the workforce for those just starting their career. I don't follow the Bad Leader Blog, but what a great name. You've got to love the lead in line, "what we can learn from bad leaders . . ."

"Thanks You" Elizabeth for including us on your list.

Blawg Review #242: The Age of Illumination

These days I don't always get around to religiously reading Blawg Review every week - but I'm glad I took the time to read Ron Coleman's Blawg Review #242 hosted at Likelihood of Confusion.

In the past I often submitted blog posts to the editor - but have gotten out of the habit. Ron's post reminded me of the importance of keeping this blogging carnival tradition alive. I'm glad that Blawg Review has survived the onslaught of the 140 character micro-blawg post (aka legal tweet).

Blawg Review #242 is an eloquent Chanukah edition containing an insightful look at the whys of blogging (especially for those of us who have been doing this for years). Ron provides a glimpse at the current state of law blogging and what the future may hold. He leaves us with this wonderful thought.

"It's the Age of Illumination. A light in every window. A blawg for every shingle. Photons and pixels souring across the either, generating, light yes! Fluorescent, halogen, you name it; sparkling, illuminating all . . . Generating light . . but no heat."

As past host of Blawg Review (Edition #97) and Grand Rounds (Grand Rounds 3.5) I understand the time and effort put into digesting and creatively weaving together the posts from the week. Incredible job Ron - thanks for giving me the pleasure of reading your post.

Florida Judicial Ethics Advisory Opinion on Social Media: Accept or Deny? Deny

The Florida Judicial Ethics Advisory Committee issued JEAC Opinion 2009-20 on November 19, 2009, indicating that judges may not add lawyers who may appear before the judge as "friends" on a social networking site, nor may judges permit such lawyers to add the judges as their "friend".

However, the Committee did not entirely ban judges from using social media tools. Judges may post comments and other materials on their social media pages as long as the materials do not otherwise violate the Code of Judicial Ethics.

So, if you are a Florida judge using Facebook the answer to invitations to connect from lawyer colleagues must be "deny." Interesting decision that may have significant impact in the legal community as it relates to the use of social media tools by litigation lawyers.

For more analysis and thoughts on the topic check out the NYT article, For Judges on Facebook, Friendship Has Limits. Additional coverage and posts via the Mike Frisch at Legal Professional Blog, Ashby Jones of WSJ Legal Blog and Dan Macsai of Fast Company. Thanks to Denise Howell for the tweet tip about the recently issued opinion.

This is not the first look by judicial ethics committees at the evolving role of social media relationships between lawyers and judges. As reported by the ABA Journal back in June, a North Carolina judge was publicly reprimanded by the North Carolina Judicial Standards Committee for "friending" a lawyer in a pending case.

Following are the specific questions/answers the Florida Committee addressed in the Opinion.

Q: Whether a judge may post comments and other material on the judge's page on a social networking site, if the publication of such material does not otherwise violate the Code of Judicial Conduct. ANSWER: Yes.
Whether a judge may add lawyers who may appear before the judge as "friends" on a social networking site, and permit such lawyers to add the judge as their "friend." ANSWER: No.
Q: Whether a committee of responsible persons, which is conducting an election campaign on behalf of a judge's candidacy, may post material on the committee's page on a social networking site, if the publication of the material does not otherwise violate the Code of Judicial Conduct. ANSWER: Yes.
Q: Whether a committee of responsible persons, which is conducting an election campaign on behalf of a judge's candidacy, may establish a social networking page which has an option for persons, including lawyers who may appear before the judge, to list themselves as "fans" or supporters of the judge's candidacy, so long as the judge or committee does not control who is permitted to list himself or herself as a supporter. ANSWER: Yes.

UPDATE (12/14/09): Over the weekend Ernie Swenson tweeted (via @LALegalEthics) about a South Carolina Advisory Opinion (Opinion No. 17-2009) issued in October 2009 looking at the propriety of a magistrate judge being a member of a social networking site such as Facebook.

The facts presented to the Advisory Committed on Standards of Judicial Conduct by the magistrate judge were:

A magistrate judge has inquired as to the propriety of being a member of Facebook, a social networking site. The Magistrate is friends with several law enforcement officers and employees of the Magistrate’s office. The Magistrate is concerned about the possibility of an appearance of impropriety since the list of Facebook subscribers is vast.

The South Carolina Advisory Committee reached a less restrictive conclusion than the Florida Judicial Ethics Advisory Committee discussed above. The Committee reasoned that a judge "shall act at all times in a manner that promotes public confidence in the integrity and impartiality of the judiciary." The Committee continued by stating that "complete separation of a judge from extra-judicial activities is neither possible nor wise" and that a judge should nto become isolated from the community. The Committee found that allowing a magistrate to be a member of a social networking site allows the community to see how the judge commicates and gives the community a better understanding of the judge.

The Committee's conclusion was the following:
A judge may be a member of Facebook and be friends with law enforcement officers and employees of the Magistrate as long as they do not discuss anything related to the judge’s position as magistrate.

Bob Ambrogi at Legal Blog Watch provides additional analysis and comparison of the South Carolina and Florida opinions. Bob points out a distinction between the two rulings in that one deals with the friending of "attorneys" by judges while the other deals with friending of "non-lawyers" (law enforcement officials and courtroom employees) by judges. He concludes by making this point:

The key difference between the two opinions is in who a judge may friend without calling into question the judge's impartiality and integrity. A judge who friends courtroom employees provides no cause for concern, South Carolina says, but a judge who friends courtroom advocates does, Florida finds.

HIPAA: Michigan Supreme Court Examing Preemption, Confidentiality and Ex Parte Interview of Treating Physicians in Medical Liability Litigation

The AMANews reports that the Michigan Supreme Court is examining whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) preempts state law to allow a defendant physician in a medical liability case to interview the plaintiff/patient's other treating physicians.

The history and docket information on the case before the Michigan Supreme Court, Andrea L. Holman v. Mark Rasak, SCt Case Number 137993, can be found via search here. Oral arguments were held on November 3, 2009. The Michigan Supreme Court provides a background summary of the case along with links to the briefs filed by the parties, including Amicus Curiae Briefs filed by the Michigan Association for Justice, Michigan Defense Trial Counsel, Michigan Health and Hospital Association, Michigan State Medical Society and ProAssurance Casualty Company and American Physicians Assurance Corporation.

The case involves a defendant physician who sought to interview the treating physicians, but the plaintiff/patient refused to waive her confidentiality rights under HIPAA. Plaintiff signed a HIPAA Authorization releasing the medical records but refused to provide a release for "oral communications." Defendant physician then sought a protective order to permit the ex parte interviews of the treating physicians but the circuit court denied the motion.

The circuit court concluded that the HIPAA provisions relative to the protective order only pertain to documentary evidence and that HIPAA does not authorize ex parte oral interviews.

On appeal the State of Michigan Court of Appeals in Andrea L. Holman v. Mark Rasak, D.O. ruling on November 18, 2008, reversed the circuit court's order denying the defendant physician's motion for a protective order to allow him to conduct ex parte interviews with the plaintiff/patient's treating physicians. The court held that HIPAA supersedes Michigan law to the extent that its protections and requirements are more stringent than those provided by stat law. The court held that the defendants may conduct an ex parte oral interview if a qualified protective order, consistent with 45 CFR 164.512(e)(1), is first put in place.

This will be an interesting ruling to watch. Stay tuned!

WVHCA Report: $1.1B Cost Saving from Adoption of HIT

iHealthBeat reports on the release of a new report prepared by CCRC Actuaries for the West Virginia Health Care Authority.

The full report is available via the West Virginians for Affordable Health Care website and is titled, Health Care Financing in the State of West Virginia: An analysis and Projection of the Current System and Potential Transformations, August 2009.

According to the articles, the report indicates that the adoption of health information technology (HIT) and implementation of centralized medical care through medical home concepts could save West Virginia's health care system more than $1.1B in 2014. The estimates in the report used insurance claims data from more that 800,000 West Virginia residents, including data from Medicaid and Mountain State Blue Cross Blue Shield.

More details in the AP article by Tom Breen from the Charleston Gazette and Washington Post, Report: Health strategy could save W.Va. $1B.

The Washington Post article indicates:

. . . In the case of electronic prescriptions, the report estimates an overall savings of $164 million in 2014, including nearly $51 million in savings to private insurers and $42 million in savings to policyholders. . .

. . . The report estimates that a statewide rollout of medical homes would cost about $45 million up front and incur ongoing costs of about $368 million . . .

. . . Estimates suggest that about nine in 10 health care offices still keep everything in paper. As the new report says, up front costs for physicians run from $25,000 to $45,000 and have annual costs thereafter of between $2,000 and $9,000, steep amounts for small practices . . .

UPDATE: Thanks to a reader comment - you can now read the full report. The report is titled, Health Care Financing in the State of West Virginia: An analysis and Projection of the Current System and Potential Transformations, August 2009.

Following is the Executive Summary of the report which contains some very interesting statistics on the state of health care in West Virginia.


Executive Summary

• A cohort model was developed to simulate health care eligibility, utilization and insurance availability of the projected 1,828,538 West Virginians in 2009.
• The model utilizes 8,640 cohorts to represent current insured status, health care utilization, age, gender, and household income.
• The projected average age in 2009 is 40.2 years.
  
• West Virginia is projected to have a population of 1,806,545 in 2019 and the average age is projected to increase to 42.2 years.
• The number of commercially insureds is 757,884 in 2009.
• The number of non-Medicare PEIA insureds is 175,324 in 2009.
• The number of non-dual eligible Medicaid insureds is 321,113 in 2009.
• The number of dual eligible Medicaid/Medicare insureds is 57,118 in 2009.
• The number of Medicare eligible PEIA insureds is 37,784 in 2009.
• The number of other Medicare insureds is 168,571 in 2009.
• The number of West Virginia CHIP insureds is 24,480 in 2009.
• The number of uninsured West Virginians is 286,264 in 2009.
• Health care costs can be defined as charges or as allowed charges. In terms of allowed charges, projected West Virginia expenditures total $13.1 billion in 2009.
• Allowed charges are projected to grow to $24.4 billion in 2019.
• In 2009, the uninsured population is projected to incur $3.2 billion in allowed charges, resulting in bad debt and charity care of almost $900 million.
• Initiative I, Adult Medicaid Expansion, is projected to cost the State of West Virginia $56.8 million and the Federal Government $162.0 million in 2014, while overall health care expenditures will decrease $611.5 million. Low income residents see the majority of the savings, spending $591.5 million less on health care.
• Initiative II, Adult Medicaid Expansion Combined with an Insurance Mandate for Employers and Individuals, is projected to cost the State of West Virginia $56.8 million in higher Medicaid expenditures and $1,004.3 million in insurance premium subsidy. The initiative will cost the Federal Government $162.0 million in 2014, while overall health care expenditures will decrease $2,176.0 million. Low income residents see the majority of the savings, spending $2,212.8 million less on health care.
• Initiative III, Adult Medicaid Expansion combined with an Insurance Mandate for Individuals, is projected to cost the State of West Virginia $56.8 million, $983.4 million in insurance premium subsidy. The initiative will cost the Federal Government $162.0 million in 2014, while overall health care expenditures will decrease $1,634.7 million. Low income residents see the majority of the savings, spending $1,656.2 million less on health care.
• Initiative IV, Medical Home, is projected to save the State of West Virginia $57.3 million in claim expenditures and the Federal Government $199.3 million in 2014, and overall health care expenditures will decrease $642.6 million. Low income residents and insurance companies see the majority of the savings, spending $170.6 million and $173.2 million less on health care, respectively. This initiative requires $45 million of initial costs and a total of $368.2 million of ongoing physician reimbursement per year.
• Initiative V, e-Prescribing, is projected to save the State of West Virginia $16.0 million in claim expenditures and the Federal Government $53.8 million in 2014, and overall health care expenditures will decrease $164.0 million. Low income residents and insurance companies see the majority of the savings, spending $41.9 million and $45.6 million less on health care, respectively. The cost of implementing e-prescribing has not been projected.
• Initiative VI, Electronic Medical Records, is projected to save the State of West Virginia $28.3 million and the Federal Government $98.5 million in 2014, and overall health care expenditures will decrease $317.6 million. Low income residents and insurance companies see the majority of the savings, spending $84.3 million and $85.6 million less on health care, respectively. This initiative requires around $25,000 to $45,000 of initial costs and an annual cost of $3,000 to $9,000 per provider. However, these cost estimates appear to be declining over time.
  

FTC Exploring Privacy: Rountable Series

Over the next couple of months the Federal Trade Commission (FTC) will be hosting the Exploring Privacy: A Roundtable Services.

The roundtable discussions are day-long public roundtable discussions to explore the privacy challenges posed by the vast array of 21st century technology and business practices that collect and use consumer data.

The FTC indicates that the "roundtable discussions will cover topics including social networking, cloud computing, online behavioral advertising, mobile marketing, and the collection and use of information by retailers, data brokers, third-party applications, and other diverse businesses. The goal of the roundtables is to determine how best to protect consumer privacy while supporting beneficial uses of the information and technological innovation."

More information can be obtained on the FTC's Exploring Privacy website, including the dates and locations of the upcoming roundtable events in Berkeley, CA and Washington, DC, submitted public comments and other information.

The first roundtable was held this week in Washington, DC. Details of the event are available on the website including two interesting charts -- Data flow chart (personal data ecosystem) and Data flow charts (medical, social networking, mobile, behavioral advertising, and retail loyalty card).

Chief Data Rights Officer

I love the creative and mind opening nature of Twitter tweets. Simple 140 character thoughts, questions, queries, etc.

As a lawyer who deals with pages, reams, volumes, boxes, rooms of written information on a daily basis I'm often amazed (and pleased) by the depth of concepts that can be expressed through 140 characters.

Example from today, @SusannahFox's tweet:

@SusannahFox What if, instead of a chief #privacy officer, ONC changed the conversation and appointed a chief data rights officer?

Susannah gets my "tweet of the day" award.