WVHCA: Proposed Amendment to West Virginia CON Law Defintion of "Private Office Practice"

On June 15, 2010, the West Virginia Health Care Authority filed a Notice of a Comment Period on a Proposed Rule with the West Virginia Secretary of State amending West Virginia CSR 65-7, Certificate of Need Rule.

According to the Summary and Statement of Circumstances filed with the Proposed Rule the "amendment clarifies the definition of "private office practice" for purposes of administering the Certificate of Need Program. Those entities meeting this criteria may be eligible for an exemption from Certificate of Need review pursuant to West Virginia Code 16-2D-R(a)."

Written comments on the Proposed Rule are due on or before July 16, 2010.

What Health Care Employers Need to Know about the West Virginia Patient Safety Act

Ryan Brown, a health care attorney at Flaherty Sensabaugh Bonasso PLLC who specializes in medical malpractice defense, health care regulatory work and health care related employment issues wrote this summary of the West Virginia Patient Safety Act.

In 2001, the West Virginia Legislature passed the Patient Safety Act (“PSA”), W.Va. Code § 16-39-1 et seq. The purpose of the PSA was to provide an avenue for health care workers to report instances of waste or wrongdoing without the fear of retaliatory or discriminatory treatment by their employers through termination, demotion, reduction of time, lost wage, or lost benefits. The PSA requires the identity of a health care worker who reports waste or wrongdoing to a health care entity (e.g., hospital, clinic, nursing facility, etc.) or appropriate governmental authority to remain confidential. Health care entities are also required to post a summary of the important provisions of the PSA on the premises for its employees.

It is important for health care entities to understand that the PSA prohibits retaliation or discrimination against a health care worker who made a good faith report; advocated on behalf of patients, services or conditions of a health care entity; or cooperated in any investigation relating to the care, services or conditions of the health care entity. A health care worker who has been retaliated or discriminated against by his or her employer in violation of the PSA may file a civil suit and recover payment of back wages, costs of the litigation, reasonable attorney fees, and even reinstatement.

Many employers in West Virginia have had experience with the West Virginia Human Rights Act (“WVHRA”), W.Va. Code § 5-11-1 et seq, and its exception to the “at-will” employment doctrine. The WVHRA prohibits discrimination on the basis of race, religion, color, national origin, ancestry, sex, age, disability, and familial status. The WVHRA has been used by former employees as a way to defeat “at-will” employment by alleging that they were wrongfully terminated based on a protected status, rather than for unsatisfactory job performance. Although initially designed to improve the quality of patient care, the PSA has also been used by some former health care employees as a way to get around the concept of “at-will” employment. For example, a discharged health care worker could potentially sue his former employer using the PSA to allege that he was discriminated against after he reported instances of the employer’s waste and wrongdoing.

Health care entities must take special care not only to document the unsatisfactory performance of its employees, but also document and investigate complaints of waste or wrongdoing to shield itself from such PSA lawsuits. These lawsuits can be quite complicated as they encompass elements of both employment litigation and medical professional liability litigation.

ONC Issues Final Rule for EHR Temporary Certification Program

Last Friday the Office of National Coordinator for Health Information Technology (ONC) issued a final rule providing the details on how organizations can be authorized by ONC to test and certify EHR technology. ONC discusses the details the Temporary Certification Program.

Certification is important because the Medicare and Medicaid EHR incentives under HITECH require the use of certificate EHR technology for eligible hospital and providers to recieve payments under the incentive program.

For more information check out the Temporary Certification Program information on the ONC Health IT website, including a link to a complete copy of the Temporary Certification Program Final Rule.

More information from Government Health IT, ONC launches health IT certification program and iHealthBeat, ONC To Start Accepting Bids for Entities to Certify EHR Products.

UPDATE (6/24/2010): The official Federal Register version of the Final Rule is now available: 45 CFR Part 170, Establishment of the Temporary Certification Program for Health Information Technology; Final Rule (75 Fed. Reg. 36158, June 24, 2010). The Final Rule is effective on June 24, 2010.

SAMHSA and ONC: FAQs on Substance Abuse Confidentiality Regulations for HIEs

The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of the National Coordinator for Health Information Technology (ONC) announced last week the release of FAQs for Applying the Substance Abuse Confidentiality Regulations to Health Information Exchanges (HIEs).

Cover letter regarding the FAQs by Pamela S. Hyde, the Administrator of SAMHSA, and David Blumenthal, National Coordinator for ONC. The letter describes that the the Substance Abuse Confidentiality Regulations under 42 CFR Part 2 were enacted years ago (circa 1975). Due to the age of the regulations SAMHSA and ONC created the FAQs to provide guidance and understanding of the scope of these regulations in the context of today's move toward an electronic health information system.

The FAQs outline the general requirements under 42 CFR Part 2, provide guidance on its application to HIEs, and identify methods for including substance abuse related health information into HIEs that is consistent with the Federal statute.

As a follow-up to the release of the FAQs, SAMHSA and ONC will convene a meeting of concerned or interested parties from both the Behavioral Health and Information Technology (BH-IT) communities on August 4, 2010. The meeting will be an opportunity for SAMHSA and ONC to receive questions and comments on the FAQs.

The FAQs for Applying the Substance Abuse Confidentiality Regulations to Health Information Exchanges (HIEs) provide information on the following 37 questions:

1. Does the federal law that protects the confidentiality of alcohol and drug abuse patient records allow information about patients with substance use disorders to be included in electronic health information exchange systems?
2. What types of providers are covered programs under 42 CFR Part 2 (“Part 2”)?
3. What patients, and which records and information, are protected by 42 C.F.R Part 2?
4. For the purposes of the applicability of 42 CFR Part 2, does it matter how HIOs are structured?
5. Does 42 CFR Part 2 permit the disclosure of information without a patient’s consent for the purposes of treatment, payment, or health care operations?
6. Under Part 2, can a Qualified Service Organization Agreement (QSOA) be used to facilitate communication between a Part 2 program and an HIO?
7. May information protected by Part 2 be made available to an HIO for electronic exchange?
8. If Part 2 information has been disclosed to the HIO, either pursuant to a Part 2- compliant consent form authorizing such disclosure or under a QSOA, may the HIO then make that Part 2 information available to HIO-affiliated members?
9. How do different HIO patient choice models regarding whether general clinical health information may be disclosed to or through an HIO (e.g., no consent, opt in or opt out) affect the requirements of 42 CFR Part 2?
10. If an HIO is holding or storing Part 2 patient data through a QSOA, can the HIO redisclose the data coming from the Part 2 program to a third party without patient consent?
11. What are the required elements of a patient consent under Part 2?
12. What must a Part 2 program do to notify the HIO, or any other recipient of Part 2 protected information, that it may not redisclose Part 2 information without patient consent?
13. Can a single consent form be used to authorize the disclosure of Part 2 information to an HIO, as well as authorize the redisclosure of that information to other identified parties, such as HIO affiliated members?
14. Does Part 2 allow the use of multiple-party consent forms?
15. Does Part 2 require the use of original signed consents?
16. Under Part 2, may an HIO release demographic information about Part 2 patients without patient consent?
17. Under Part 2, can an HIO reveal that a patient had an encounter at a mixed use facility (or “general medical” facility – see FAQ #2) as long as the HIO does not reveal that the patient was in the mixed use facility’s Part 2 program? A mixed use facility can be defined as a service provider organization that provides substance abuse treatment services as well as other health services such as primary care, dental care, mental health services, social services, etc.
18. Under Part 2, can an HIO use a consent form that provides for disclosure to “HIO members” and refers to the HIO’s website for a list of those members?
19. Can an HIO use a consent form under Part 2 to allow for the disclosure of information to future HIO affiliated health care providers?
20. Can an HIO use a consent form under Part 2 to allow for the disclosure of information to health care providers who are providing on-call coverage for HIO affiliated health care providers or with whom those affiliated providers consult?
21. Can a Part 2 patient consent be used to enable multiple disclosures?
22. Can a Part 2 program or HIO use a consent form that has no specific expiration date but rather states that disclosure is permitted until consent is revoked by the patient?
23. Is “treatment” a sufficient description of the intended purpose of a disclosure on a Part 2 consent?
24. Under Part 2, can any health care provider make the determination that a medical emergency exists, or must a Part 2 provider make that determination?
25. May a computer system be used to automatically determine whether a medical emergency exists and whether a disclosure of Part 2 data can be made without the patient’s consent?
26. If a medical emergency exists, can the entire Part 2 record be released?
27. For documentation purposes, if a medical emergency is present, would it be permissible under Part 2 to have treating providers simply check a drop down box signifying the existence of such a medical emergency?
28. Under Part 2, may an HIO system make clinical decision support functions (such as showing a patient’s medications to clinicians when they write prescriptions, automatically ordering medications, and/or alerting clinicians about potential drug interactions) available to HIO affiliated health care providers in a medical emergency?
29. Does the Part 2 definition of medical emergency also include mental health emergencies?
30. When the HIO keeps an electronic record of a medical emergency, does that fully meet Part 2’s requirement to document disclosures made in a medical emergencies in the patient’s record?
31. If an HIO’s electronic system makes a disclosure in a medical emergency, would documenting the name of the discloser as “electronically disclosed through the system administered by HIO” meet Part 2’s requirement that the name of the person who made the disclosure be documented in the patient’s record?
32. If an HIO’s electronic system sends Part 2 data in a medical emergency to a printer or fax machine in the emergency room, can “the printer in the emergency department” meet Part 2’s requirement to document in the patient’s record the name of the person to whom the disclosure was made?
33. Once Part 2 information is disclosed in a medical emergency, can that information be redisclosed without obtaining patient consent?
34. If a patient has previously refused to consent to the release of his/her Part 2 record to a particular HIO affiliated health care provider, and then the patient is brought to that provider in a bona fide medical emergency situation, can that provider gain access through the HIO to the information without the patient’s consent under Part 2?
35. Can an HIO disclose data for Disease Management purposes under Part 2 without patient consent?
36. Under Part 2, would an HIO be permitted to disclose to an HIO affiliated payer the data of several patients held by the HIO, which may include Part 2 data, in order for the payer to target where interventions could be made with particular patients to improve care and management of disease?
37. If an HIO affiliated health care provider wishes to gain access to a minor’s Part 2 record held by the HIO, may the HIO or provider obtain only the consent of a parent or guardian, or must the minor’s consent also be obtained?

Thanks Blogger Team! Blogs of Note - June 14, 2010

Wow! Thanks to the Blogger Team for highlighting my Health Care Law Blog as a Blogs of Note on Blogger Buzz, the official buzz from Blogger at Google, for Monday, June 14, 2010. More on the Historie of Blogs of Note.

Welcome to all stopping by the Health Care Law Blog for the first time. If you are interested in health care law, privacy, security, and technology I hope you will check out my recent posts and add my blog to your regular reading list. You can follow my future posts via RSS or on Twitter at @HealthLawBlog.

Reversal of Conviction Because Undisclosed MySpace Friendship Between Defendant and Juror

Brian Peterson posts on a fascinating West Virginia Supreme Court of Appeals decision involving the use of social media between a juror and defendant and the issue of disclosure of such connections during voir dire.

In State v. Dellinger, No 3573 (W.Va. Supr. Ct. June 3, 2010) (PDF version) the West Virginia Supreme Court reversed a felony conviction of a Braxton County Sheriff due to a juror's "complete lack of candor" during voir dire. The juror and defendant were MySpace friends, but hardly knew each other. The Court found that the juror should have disclosed the relationship.

The Court describes the juror misconduct as follows:

At the direction of the trial judge, an investigation into alleged juror misconduct was conducted concerning Juror Amber Hyre. During the course of the investigation and at the June 11, 2008, hearing, it was learned that on February 7, 2008, approximately one week before Appellant's trial began, Juror Hyre sent a message to Appellant on “www.MySpace.com,” a social networking website. In that message, Juror Hyre, known as “Amber,” wrote to Appellant:

Hey, I dont know you very well But I think you could use some advice! I havent been in your shoes for a long time but I can tell ya that God has a plan for you and your life. You might not understand why you are hurting right now but when you look back on it, it will make perfect sence. I know it is hard but just remember that God is perfect and has the most perfect plan for your life. Talk soon!

According to Juror Hyre, after she sent this message to Appellant, the two became MySpace “friends,” which allowed Appellant to view postings on Juror Hyre's MySpace page and vice versa.

At the end of the decision, the Court in footnote 11 highlights the need for lawyers and judges to instruct jurors of their responsibility and provides a cautionary note to them about using technology during the trial process and deliberation. The Court provides a link to the model jury instruction developed by the Committee on Court Administration and Case Management of the Judicial Conference of the United States. I previously blogged about this Model Jury Instruction here.

The footnote reads:

As noted above, Juror Hyre posted a message on her MySpace page during the course of the trial in which she wrote, “Amber Just got home from Court and getting ready to get James and Head to church! Then back to court in the morning!” Next to “mood,” she wrote the word “blah.” The trial court found that Juror Hyre “did not state which trial she was hearing or any facts or opinions about the trial.” Though this Court does not condone any communication about a case by a sitting juror, we agree with the trial court's apparent finding that Juror Hyre's posting was benign in nature. We believe that, standing alone, it was not sufficient to find that she engaged in juror misconduct. However, we also believe some cautionary words are warranted concerning the prominent presence of the internet and routine use of and dependence upon various technologies by everyday Americans called to jury service. In an effort to preclude jurors from using cell phones, computers and social media websites such as MySpace, the Committee on Court Administration and Case Management of the Judicial Conference of the United States has endorsed a model jury instruction for federal district court judges to help deter jurors from using such technology for improper purposes (such as communicating about their case or conducting their own research). [Rules for Jurors: No Talking, Texting, Tweeting,] The National Law Journal, February 9, 2010, available at http//www.law.com/jsp/law technologynews/PubArticleLTN.jsp?id=1202442983764. For example, the jury instruction to be given before trial cautions, inter alia:
I know that many of you use cell phones, Blackberries, the internet and other tools of technology. You also must not talk to anyone about this case or use these tools to communicate electronically with anyone about the case. . . .You may not communicate with anyone about the case on your cell phone, through e-mail, Blackberry, iPhone, text messaging, or on Twitter, through any blog or website, through any internet chat room, or by way of any other social networking websites, including Facebook, MySpace, LinkedIn, and YouTube.”

The jury instruction to be given at the close of the case similarly provides:
During your deliberations, you must not communicate with or provide any information to anyone by any means about this case. You may not use any electronic device or media, such as a telephone, cell phone, smart phone, iPhone, Blackberry or computer; the internet, any internet service, or any text or instant messaging service; or any internet chat room, blog, or website such as FaceBook, MySpace, LinkedIn, YouTube or Twitter, to communicate to anyone any information about this case or to conduct any research about this case until I accept your verdict.

We note that, presently, there are no similar uniform standards for jurors in state trials. Id.

Lesson: If you are called for jury duty be sure to review all your MySpace, Facebook, Twitter, etc. contacts to make sure you have no connection to the parties in the matter. The case also highlights that technology has allowed all of us to develop new (more extended, not necessarily deeper) relationships with people that we don't really consider part of our "in person" social circle.The case also points out that jurors need to "go off the grid" during trial and deliberation process.

To get the full context of what occurred I recommend reading the full decision. Also, jump over to Brian's blog post to read more of his comments on the decision. I agree with his conclusion, "It's clear that voir dire and jury instructions need to catch up with technology."

UPDATE (6/15/10): Eric Goldman at the Technology & Marketing Blog and Molly DiBianca at Going Paperless provides additional analysis and thoughts on the decision.

UPDATE (6/18/2010): Ry Rivard at the Charleston Daily Mail covers the decision in his story, Web stirs problems in jury selection.

WVBOM: Policy Statement - Guidelines for Physicians in Collaborative Relationships with Advanced Nurse Practitioners

On May 10, 2010, the West Virginia Board of Medicine has issued a new Policy Statement - Guidelines for Physicians in Collaborative Relationships with Advanced Nurse Practitioners or Certified Nurse Midwives; Standard of Practice.

The new Policy Statement provide West Virginia physicians with guidance on the role and responsibility they play in the collaborative relationship with advanced nurse practitioners and certified nurse-midwifes. In summary, the guidance provides:

A. The physician must be permanently and fully licensed in West Virginia without restriction or limitation.

B. There should be a written collaborative agreement should should include certain specific provisions as outlined in the Policy Statement.

C. Other considerations that are outlined in the Policy Statement

The Policy Statement indicates that the failure by a physician to adhere to these minimum requirements and guidelines may result in discipline by the Board of Medicine.

Credentialing and Privileging Telemedicine Physician and Practitioner

Last week the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule revising the conditions of participation (CoPs) for hospitals and critical access hospitals allowing for a new credentialing and privileging process for physicians and practitioners who provide telemedicine services. The proposed rule should make it easier on smaller hospital (especially critical access hospitals) who don't have the in-house medical staff to adequately evaluate and privilege a wide range of specialty physicians who provide services through telemedicine.

The proposed rule was published in the Federal Register on May 26, 2010, and titled, Credentialing and Privileging of Telemedicine Physicians and Practitioners, 75 Fed Reg 29479 (May 26, 2010). Comments on the proposed rule must be submitted by July 26, 2010.

Traditionally the CoPs have required the governing body of the hospital to make all privileging decisions based on the recommendations of its medical staff using specific criteria. Hospitals often use third-party credentialing verification services to assist in compiling the voluminous documents needed to verify credentialing and then have the governing body of the hospital review and sign off on the privileging decision.

The proposed rule points out that there has been a Joint Commission standard policy that allows "privileging by proxy," which has been in direct conflict with CoPs. "Privileging by proxy" allows Joint Commission accredited hospitals to utilize a different methodology to privilege"distant-site" physicians and practitioners. Basically, allowing one Joint Commissioned accredited hospital to accept the privileging decisions of another Joint Commissioned accredited hospital. In the past, hospitals were deemed (deemed status) to meet the CoPs if they were accredited by the Joint Commission. However, changes in the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) will halt (effective July 15, 2010) the statutory recognition of the Joint Commission's hospital accreditation program and now requires the Joint Commission to meet CMS standards in order to confer Medicare deemed status.

CMS has decided that requiring each hospital to independently privilege providers is a duplicative and burdensome process, especially for small hospitals who often use telemedicine services from larger academic medical centers and hospitals to provide access to needed specialty services. Thus, CMS is proposing in the rule to revise the hospital credentialing and privileging requirements to allow a hospital who obtains telemedicine services by agreement with another hospital that the agreement can specify that the hospital providing the telemedicine services is responsible for credentialing the telemedicine provider and can provide this information to the medical staff of the hospital receiving the telemedicine services who can then rely upon the credentialing and privileging decisions of the hospital providing the telemedicine services.

For a more detailed discussion and understanding of the proposed revisions read the proposed rule in the May 26, 2010, Federal Register.