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Keeping an eye on health care law Thoughts and comments on the health care industry privacy security technology and other odds and ends
April 29,2012
12:24On April 11, 2012, the West Virginia Health Care Authority announced a new policy regarding the testimony for witnesses from the public before the Authority at certificate of need and rate hearings. The policy statement issued by James L. Pitrolo, Jr. Chairman, is effective from April 11, 2012 and states as follows:
I. PURPOSE
To establish procedures and guidelines governing the testimony for witnesses
from the public.
II. CANCELLATION
This policy cancels and supersedes all prior memoranda regarding testimony for
witnesses from the public.
III. POLICY
In order to ensure an orderly public hearing, all witnesses from the public
shall register in person during the first day of the hearing. If a witness fails to
register during the first day of the hearing, the witness will not be allowed to
testify during the hearing. If multiple witnesses are present on behalf of one
party, the group can elect up to three representatives. The representative's
comments will be limited to five minutes each up to a maximum of 15 minutes.
Individual comments will be limited to five minutes each. Further, a witness in the
hearing that has provided testimony shall not testify as a witness from the public
in the same hearing.
March 14,2012
13:13The HHS Office for Civil Rights (OCR) announced a settlement of $1.5M with Blue
Cross Blue Shield of Tennessee (BCBST) relating to potential violations under the HIPAA Privacy and Security Rules. According to the OCR press release, the enforcement action by OCR is the first reported as resulting from a breach report required under the new Breach Notification Rule implemented as a result of the HITECH provisions of HIPAA.
The breach involved 57 unencrypted computer hard drives that were stolen from a facility leased by BCBST in Tennessee. The hard drives contained protected health information of approximately 1 million individuals. The breach was reported by BCBST to OCR under the HITECH provisions and regulations that require reporting of potential breaches. The press release indicates that OCR’s investigation found that BCBST failed to implement appropriate administrative safeguards to adequately protect information remaining at the leased facility by not performing the required security evaluation in response to operational changes. In addition, the investigation showed a failure to implement appropriate physical safeguards by not having adequate facility access controls; both of these safeguards are required by the HIPAA Security Rule.
For more information check out the HHS press release "HHS settles HIPAA case with BCBST for $1.5 million" which includes a link to the HHS Resolution Agreement entered into between OCR and BCBST.
The breach involved 57 unencrypted computer hard drives that were stolen from a facility leased by BCBST in Tennessee. The hard drives contained protected health information of approximately 1 million individuals. The breach was reported by BCBST to OCR under the HITECH provisions and regulations that require reporting of potential breaches. The press release indicates that OCR’s investigation found that BCBST failed to implement appropriate administrative safeguards to adequately protect information remaining at the leased facility by not performing the required security evaluation in response to operational changes. In addition, the investigation showed a failure to implement appropriate physical safeguards by not having adequate facility access controls; both of these safeguards are required by the HIPAA Security Rule.
For more information check out the HHS press release "HHS settles HIPAA case with BCBST for $1.5 million" which includes a link to the HHS Resolution Agreement entered into between OCR and BCBST.
March 10,2012
15:57The latest West Virginia Health Care Association e-News Update announced that the Office of Health Facility Licensure and Certification (OHFLAC) has put into place a new Independent Informal Dispute Resolution
(IIDR) review of disputed deficiencies for all nursing homes in West Virginia. The new IIDR procedure goes into effect immediately and three out of state vendors experienced in IDRs were selected to be the third party reviewers. The current Informal Dispute Resolution (IDR) will remain as an alternative option.
According to the e-News Update, the new procedure will be detailed in a letter to providers when OHFLAC returns the Statement of Deficiencies to the provider after a survey. The letter will contain instructions on how to request an IIDR. OHFLAC is proposing to use the following language in the letters:
According to the e-News Update, the new procedure will be detailed in a letter to providers when OHFLAC returns the Statement of Deficiencies to the provider after a survey. The letter will contain instructions on how to request an IIDR. OHFLAC is proposing to use the following language in the letters:
INFORMAL DISPUTE RESOLUTION:
In accordance with 42 CFR 488.331, you have an opportunity to question cited deficiencies through an informal dispute resolution process. To request an informal dispute resolution, please submit in writing the specific deficiencies being disputed and an explanation of why you are disputing those deficiencies to:
Informal Dispute Resolution Review Committee
Office of Health Facility Licensure and Certification
408 Leon Sullivan Way
Charleston, WV 25301-1713
You may also send your request via email to DHHR.OHFLAC.@wv.gov.
This request must be sent during the same ten (10) calendar days you have for submitting a Plan of Correction (POC) for the cited deficiencies and must be contained on a document separate from the CMS-2567L, which contains the POC.
You may choose between an informal dispute resolution (IDR) and an independent informal dispute resolution (IIDR). You must clearly indicate your choice in the attention line of your request and the subject line of your email. An IDR will be completed by OHFLAC staff not associated with the referenced survey event.
Per West Virginia State Code §16-5C-12a, an IIDR will be completed by an independent review organization. If an independent informal dispute resolution process is selected, the matter will be assigned to one of three independent review organizations accredited by the Utilization Review Accreditation Commission. The facility may be subject to certain costs such as:
• The cost of a face-to-face conference if one is requested; and
• The cost charged by the independent review organization, should the facility not be successful in its dispute.
Please call us at 304-346-4575 if you have any questions.The new IIDR procedure will allow nursing homes an alternative option to the standard IDR process when questions arise during the survey process and related POC requirement. The new procedure will allow a nursing home provider to challenge the particular survey finding through an alternative/independent process. Whether this new alternative procedure will be valuable to nursing home providers is yet to be seen.
February 26,2012
15:15This past week health care colleague and CEO of the West Virginia Health Care Association, Patrick D. Kelly, advised me that the association has launched a new website to provide a resource for families and seniors who are
researching residential and health care options in West Virginia. The website is called West Virginia Senior Care: Helping Seniors Make Informed Decisions About Senior Care and can be found at: http://www.wvseniorcare.com/.
The website is designed to help all of us find information and make better decisions regarding care for our parents and the elderly. The website includes everything from in home care services, such as home health, hospice, and other in home services, to care offered in assisted living facilities, residential care, nursing homes, hospitals, etc. The press release issued by the West Virginia Health Care Association provides additional details.
After looking around the website it looks like a great resource of health care information for West Virginia seniors.
The website is designed to help all of us find information and make better decisions regarding care for our parents and the elderly. The website includes everything from in home care services, such as home health, hospice, and other in home services, to care offered in assisted living facilities, residential care, nursing homes, hospitals, etc. The press release issued by the West Virginia Health Care Association provides additional details.
After looking around the website it looks like a great resource of health care information for West Virginia seniors.
February 24,2012
9:30Yesterday the Centers for Medicare & Medicaid Services (CMS) announced the proposed rule for Stage 2 Meaningful Use under the the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs which is a part of the Health Information Technology for Economic and Clinical Health Act (HITECH).
The incentive program is part of the national health information technology reform effort under the American Recovery and Reinvestment Act of 2009 which provides incentive payments to eligible health care professionals, eligible hospitals and Critical Access Hospitals who adopt certified EHR technology and use it to demonstrate “meaningful use” of that technology to CMS.
The proposed rule also revised certain Stage 1 criteria, as well as criteria that apply regardless of the Stage, as finalized in the final rule titled Medicare and Medicaid Programs; Electronic Health Record Incentive Program published on July 28, 2010 in the Federal Register. The provisions included in the Medicaid section of the proposed rule (which relate to calculation of patient volume and hospital eligibility) would take effect shortly after finalization of this rule, not subject to the proposed 1 year delay for Stage 2 of meaningful use of certified EHR technology. Changes to Stage 1 of meaningful use would take effect for 2013, but most would be optional until 2014.
CMS provides the following Fact Sheet summary of the Stage 2 requirements. The complete proposed rule can be found here and should be published in the Federal Register in the next week. If you are interested in submitting comments to the proposed rule the deadline for submission will be 60 days from the date of publication of the proposed rule in the Federal Register.
The incentive program is part of the national health information technology reform effort under the American Recovery and Reinvestment Act of 2009 which provides incentive payments to eligible health care professionals, eligible hospitals and Critical Access Hospitals who adopt certified EHR technology and use it to demonstrate “meaningful use” of that technology to CMS.
The proposed rule also revised certain Stage 1 criteria, as well as criteria that apply regardless of the Stage, as finalized in the final rule titled Medicare and Medicaid Programs; Electronic Health Record Incentive Program published on July 28, 2010 in the Federal Register. The provisions included in the Medicaid section of the proposed rule (which relate to calculation of patient volume and hospital eligibility) would take effect shortly after finalization of this rule, not subject to the proposed 1 year delay for Stage 2 of meaningful use of certified EHR technology. Changes to Stage 1 of meaningful use would take effect for 2013, but most would be optional until 2014.
CMS provides the following Fact Sheet summary of the Stage 2 requirements. The complete proposed rule can be found here and should be published in the Federal Register in the next week. If you are interested in submitting comments to the proposed rule the deadline for submission will be 60 days from the date of publication of the proposed rule in the Federal Register.
February 24,2012
9:10
On February 21, 2012, the U.S. Supreme Court vacated a
ruling by the Supreme Court of Appeals of West Virginia in the matter of Marmet Health Care Center, Inc. v. Brown et al., 565 U.S.(2012). The Supreme Court of Appeals of West Virginia previously
held that all pre-dispute arbitration agreements that applied to personal
injury and wrongful death claims against nursing homes were unenforceable.
In
a strongly worded opinion, the U.S. Supreme Court held that the West Virginia
court misread and disregarded national precedent and controlling federal law
regarding the Federal Arbitration Act.
The litigation involved three negligence suits
against nursing homes in West Virginia for the care they provided to three
separate residents: Clayton Brown, Jeffrey Taylor, and Sharon Marchio. In
each of the cases, a family member entered into a binding arbitration
agreement on behalf of the resident with the respective nursing home. In all
three cases, after the resident died, lawsuits were filed in state circuit
courts alleging personal injury and wrongful death against the nursing homes.
The Brown
and Taylor
cases were dismissed by the circuit courts based on the arbitration
agreements. The Marchio
case was consolidated with the other two cases when it was brought before the
West Virginia Supreme Court on a certified question.
In a decision concerning all three cases, the West
Virginia Supreme Court held that "as a matter of public policy under
West Virginia law, an arbitration clause in a nursing home admission
agreement adopted prior to an occurrence of negligence that results in a
personal injury or wrongful death, shall not be enforced to compel
arbitration of a dispute concerning the negligence." Brown
v. Genesis Healthcare Corp., No. 35494 (W.Va., June 29, 2011).
The
West Virginia Supreme Court found unpersuasive the U.S. Supreme Court's prior
interpretation of the Federal Arbitration Act, calling it
"tendentious" and "created from whole cloth." Brown
v. Genesis Healthcare Corp., No. 35494 (W.Va., June 29, 2011).
In vacating the West Virginia court's ruling, the
U.S. Supreme Court held that the West Virginia court's interpretation of the
Federal Arbitration Act was incorrect and inconsistent with its clear
instruction and prior precedents. On remand, the West Virginia court was
instructed to consider whether, absent the general public policy issue, the
arbitration clauses in the Brown
and Taylor
cases are unenforceable under state common law principles that are not
specific to arbitration and preempted by the Federal Arbitration Act. This
leaves the possibility that certain arbitration clauses may be invalidated on
such general contract grounds, such as fraud, duress, and lack of capacity,
to name a few.
For additional information you can review the documents filed in the matter the U.S. Supreme Court docket for the Marchio portion of the case. Also, the briefs filed in the Brown, Taylor, and Marchio matters filed before the Supreme Court of Appeals of West Virginia can be found here.
Thanks to Ryan A. Brown, a member of the Flaherty Sensabaugh Bonasso PLLC Health Care Practice Group who represents the
defendant nursing home, Clarksburg Nursing & Rehabilitation Center, Inc., in the Marchio matter for the above summary of the decision. Also involved in the case was my partner, Mark Robinson.
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