Transcript HEALTHCARE CASELAW AND REGULATORY UPDATE

LEGAL ISSUES FOR
HOSPITALS
By: Brian G.Jackson
and
A. Craig Carter
Davis & Davis, P.C.
PO Box 1588
Austin, TX 78767
(512) 343-6248
Types of legal issues currently
impacting Texas Hospitals
Malpractice Lawsuits
Legal Exposure for Hospital
Employees (i.e. nurses)
Responsibility for Physician
Negligence
Who came up with the 200/600
policy and who is penalized because
of it?
Legal Exposure for acts of Hospital
Boards
Do you have “that guy” on your
Board?
SECURITY BREACH NOTIFICATION RULES
- August 19, 2009 Interim Final Rule issued by HHS containing Security
Breach Notification regulations implementing parts of the HITECH Act.
- 2009 Texas Legislative session added health care information to existing
Texas security breach notification law. Texas law only applies to
“computerized data” but may contain stricter requirements that federal
regulations in some respects.
- Security breach rules require that covered entities under HIPAA must
timely notify affected individuals if their “unsecured PHI” was the
subject of a “security breach” and must report such breaches to HHS
either concurrently or annually and, in certain circumstances, the media.
Business Associates must timely notify their covered entities of
reportable security breaches so the covered entity can make the required
reports.
SECURITY BREACH NOTIFICATION RULES
Definition of “Unsecured PHI”
Defined in the HITECH Act as PHI that is that is not secured with a
technology or methodology that renders PHI unusable, unreadable, or
indecipherable to unauthorized individuals; April 27, 2009, HHS
guidance further specified encryption and destruction (shredding,
erasing) as the technologies and methods for securing PHI.
SECURITY BREACH NOTIFICATION RULES
Definition of “Breach”
Act defines “breach” as the “unauthorized acquisition, access, use, or
disclosure of PHI which compromises the security or privacy of the PHI,
except where an unauthorized person to whom such information is disclosed
would not reasonably have been able to retain such information.”
Regulations clarify that 1) acquisition, access, use, or disclosure must be
impermissible under the HIPAA Privacy Rule, and 2) such an unauthorized
activity “compromises the privacy or security of PHI” if it poses a significant
risk for financial, reputational, or other harm to the individual. This will
require covered entities and business associates to conduct a risk assessment
for each occurrence that otherwise fits within the definition of a “breach” to
determine whether there is a significant risk of harm to the individual as a
result of the impermissible activity.
Regulations contain various factors to consider in making risk assessment and
exceptions to breach notification requirements
SECURITY BREACH NOTIFICATION RULES
Notification Requirements in general:
-Covered entities must notify individuals when their unsecured PHI is breached, notice
must be given no more than 60 days from the time the breach was discovered or
should have been discovered using reasonable diligence
-Covered entities timely notify the media if 500 or more individuals had their
unsecured PHI breached in a given state or jurisdiction; notice in no more than 60
days
-Covered entities concurrently notify the HHS Secretary of any breach if it involves
500 or more individuals, regardless of location, and provide an annual log of
breaches that involved fewer than 500 individuals
-Business Associates must timely notify covered entities when an individual's
unsecured PHI is breached; notice in no more than 60 days
-Notice can be delayed based on request from law enforcement that notice would
impede a criminal investigation
Regulation also contains specific requirements regarding content of notice and how
notice should be delivered
Civil Rights Cases
No Insurance and No Caps!!!
Premises Liability
EMTALA UPDATE
Community Call Plan
Authorized by regulations added in 2009 IPPS rule and by 3/6/09
revisions to EMTALA Interpretive Guidelines
Alternative process for fulfilling EMTALA on-call obligations involving
community call plans between hospitals. Neither regulation nor
Interpretive Guidelines defines “community.”
Physician from other hospital required to be credentialed at your
hospital?
Does a transfer under a community call plan still have to comply with all
other EMTALA transfer requirements?
EMTALA UPDATE
August 14, 2009 CMS Fact Sheet regarding planning for ED surge
related to H1N1:
http://www.nasemsd.org/documents/SCLetter09_52.pdf
Emphasizes flexibility hospitals have under EMTALA to perform
MSE on patients with influenza-like illnesses, including:
- setting up alternative screening sites on campus
- setting up off-campus, hospital controlled screening sites
- hospitals encouraging individuals in the community to go
to other sources in the community for screening.
EMTALA UPDATE
Recent EMTALA Case:
St. Joseph’s Medical Center case - Facts and Ruling: Patient came to the
hospital emergency room for treatment, remained in the emergency room
for almost three hours without receiving a medical screening exam or
stabilizing treatment, then went into cardiopulmonary arrest and died. On
January 30, 2009, an HHS Administrative Law Judge upheld the
imposition of a $50,000 civil monetary penalty against the hospital for an
EMTALA violation.
Significance: Although the neither the EMTALA statute, the regulations,
nor the interpretive guidance state exactly how quickly a medical
screening exam must be performed after an individual arrives at the
emergency department and requests treatment, it is clear that waiting too
long to perform the exam can result in an EMTALA violation. An
important tool in avoiding bad outcomes due to long emergency room
waits is an effective triage process that ensures that patients are seen in the
proper order and the most critical patients are seen in a timely manner.
EMTALA UPDATE
Recent EMTALA Case:
Martinez v. Porta, M.D., et al. - Facts and Ruling: February 19, 2009
decision; federal district judge in Fort Worth. Female patient with
multiple health problems; came to ED with chest pain radiating down
arms, back and neck. Blood serum chemistry panel, chest CT, cardiac
markers tests, an electrocardiogram and a second enzyme test all came
back normal. Discharged then returned to the ER an hour later with
radiating pain in her neck and back, a second CT scan and EKG were
performed with normal results, and the woman was admitted. Died in the
hospital from a heart attack approximately 11 hours after admission.
The federal judge refused to dismiss the EMTALA claims, noting that the
hospital’s chest pain protocol was not followed in all respects. The Court
cited to earlier cases that have held that “[i]f there was any departure from
standard screening procedures, the screening was in violation of
EMTALA.” The Court also refused to dismiss the family’s EMTALA
claim for failure to provide stabilizing treatment.
EMTALA UPDATE
Recent EMTALA Case:
Martinez v. Porta, M.D., et al. - Significance: Highlights the interaction
between ER protocols and EMTALA liability. Some courts have held
that any deviation from a hospital’s screening protocol is a violation of
EMTALA’s MSE requirements, without considering whether the
deviation was medically indicated. Plaintiffs’ lawyers use this to their
advantage in EMTALA cases by looking for any possible departure from
an ER screening protocol, and then arguing that an alleged departure is a
per se EMTALA violation. Lessons are that protocols need to be
expressly framed as guidelines, need to clearly state that each aspect of
the protocol is not required in every case, and need to clarify that the
practitioner’s medical judgment controls in every instance. Also,
anytime a medical screening exam deviates from the standard protocol,
that deviation needs to be charted, along with an explanation for the
deviation.
EMTALA UPDATE
Recent EMTALA Case:
Moses v. Providence Hospital - Facts and Ruling: U.S. Sixth Circuit
Court of Appeals held that EMTALA stabilization requirement applied
to man who had been admitted as an inpatient
Significance: Court disagrees with EMTALA regulations that say the
EMTALA obligation generally ends upon admission. Case may make it
to U.S. Supreme Court.
Suspending Physicians
Make sure you know WHY there is a
call for suspension
MEDICAL STAFF ISSUES
NPDB Reporting
- HHS Division of Practitioner Databanks issuing letters in mid-2009 to
hospitals that have not queried and/or reported to NPDB; based on
concern that hospitals are not properly reporting or not sufficiently
disciplining physicians and report to HHS by Public Citizen
- Shows that more attention will be paid to failure to make required
reports to NPDB
MEDICAL STAFF ISSUES
NPDB Reporting
- July 30, 2009 clarification letter from the Director of the Division of
Practitioner Data Banks discussing whether reporting is required for
disciplinary actions for over 30 days related to: 1) misrepresentations by
physician in credentialing process and 2) failure to complete medical
records.
- clarifies that adverse action of over 30 days for conduct that “have the
potential to adversely affect patients” is reportable
- NPDB views intentional misrepresentations by physician in credentialing
process “almost per se as having the potential to adversely affect… patient”
and thus normally reportable
- suspension of over 30 days for failure to complete medical records will
generally be reportable
-link to letter:
http://www.healthlawyers.org/Members/PracticeGroups/MSCPR/emailalerts/D
ocuments/DatabankResponse.PDF
-NPDB Guidebook link: http://npdb-hipdb.hrsa.gov/npdbguidebook.html
Don’t pick a fight with a little guy
that doesn’t talk that much.
Following Med Staff By-Laws
Reinstating Physician’s to the
medical staff
Defending Lawsuits filed by
Physicians
PHYSICIAN EMPLOYMENT ALTERNATIVES
The physician employment bill was vetoed – so now what?
501a organizations
- 2007 amendment to Health and Safety Code clarified that a
hospital district may form and sponsor a non-profit corporation
to provide health care services
- must have board directors made up of at least three actively
practicing physicians
- hospital district can be the “member” of the corporation and
can retain the right to approve financial decisions of the 501a
- the 501a is a separate corporation, so it would not have the
same governmental immunities as a governmental hospital
PHYSICIAN EMPLOYMENT ALTERNATIVES
Professional Service Agreements
- examples: covering clinics, ER, on-call coverage
OB Malpractice Premiums Subsidy Agreements
- allowed in rural area, primary care HPSA, etc.
PHYSICIAN EMPLOYMENT ALTERNATIVES
Recruitment Agreements
- paying physician to relocate to geographic area served by hospital
- changes to definition of geographic area, including changes for
hospitals in a rural area
- changes regarding allocation of income guarantee when recruiting
physician into a group practice in a rural area or HPSA
- non-compete when recruiting into a group practice?
Suing Physicians for Breach of
Physician Recruitment Agreements
Upper Payment Limit Programs
(UPL)
Will the Party ever end??
The new matching amount
REFUNDS ANNOUNCED LAST
WEEK
WHO OWNS THE REFUND?
WHY IS YOUR NEIGHBOR ON
THE LIST – AND YOU AREN’T?
UPL $ for Nursing staff? The good,
bad, and ugly.
The pitfalls still lurk.
Representing Nurses in Litigation
and Deposition Preparation
Our Crystal Ball
Preparing for the future.
How you can help.