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By
Thomas Hess
 Each
year, the Department of Health and Human Services (DHHS)
Office of Inspector General (OIG) publishes a work plan
announcing where it will focus its resources. Among OIG’s
agenda items for 2005 are plans to:
Medicare Hospitals
·
Determine the appropriateness of payments for nursing and
allied health (NAH) education programs;
·
Study the appropriateness of alternate payment
methodologies for graduate medical education involving the
costs of training residents in nonhospital settings;
·
Assess the ability of Medicare contractors to limit
payments to acute care hospitals for patients who are
discharged from a prospective-payment-system inpatient
hospital and admitted to one of the several postacute-care
settings;
·
Examine diagnosis-related groups that have a history of
aberrant coding to determine whether some acute care
hospitals exhibit aberrant coding patterns;
·
Continue to determine whether claims for inpatient outlier
payments were submitted in accordance with Medicare laws
and regulations; and
·
Determine whether Medicare beneficiaries in long-term care
hospitals are receiving acute-level services or could be
cared for in skilled nursing facilities.
Medicare Home Health
·
Assess the effect of the prospective-payment system on
access to home health services by Medicare beneficiaries
who have been discharged from the hospital; and
·
Assess the quality of home health care since the
implementation of the home health prospective-payment
system.
Medicare Nursing Homes
·
Determine whether the prospective-payment system for
skilled nursing facilities has adversely affected Medicare
beneficiaries’ access to care;
·
Examine the nature and extent of survey and certification
deficiencies in nursing homes and identify patterns of
repeated noncompliance with Federal quality standards;
·
Examine nursing home compliance with reporting
requirements related to the Minimum Data Set;
·
Examine the type, frequency and severity of deficiencies
related to assessment and care planning for nursing home
residents; and
·
Determine whether skilled nursing facility care provided
to Medicare beneficiaries with consecutive inpatient stays
was medically reasonable and necessary.
Medicare Physicians and Other Health Professionals
·
Identify and review the relationships among billing
companies and the physicians and other Medicare providers
who use their services;
·
Examine Medicare Part A and Part B claims with overlapping
services for skilled nursing facility patients and
determine whether duplicate payments were made to either
the physicians or the nursing homes for the same patient
services;
·
Review Medicare claims for therapy services provided by
physical and occupational therapists to determine whether
the services were reasonable and medically necessary,
adequately documented, and certified by physician
certification statements; and
·
Determine whether claims for wound-care services were
medically necessary and billed in accordance with Medicare
requirements.
Medicare Medical Equipment Supplies
·
Determine the appropriateness of Medicare payments for
certain items of durable medical equipment, such as power
wheelchairs and therapeutic footwear; and
·
Compare Medicare payment rates for certain medical
equipment and supplies with the rates of other Federal and
State health programs, as well as with wholesale and
retail prices (items covered will include wheelchairs,
enteral nutrition, and oxygen equipment and supplies).
Medicaid Mental Health Services
·
Assess the Preadmission Screening and Resident Review (PASRR)
program for Medicaid nursing facility residents aged 22 to
64 with a serious mental illness or mental retardation.
Medicaid Drug Reimbursement
·
Analyze Medicaid paid claims data to identify
beneficiaries who have received significant amounts of
OxyContin and the prescribing physicians as well as
evaluate the appropriateness of the prescriptions.
This
list is just a sampling of the areas the OIG will focus on
in the upcoming year. All of the areas the OIG intends to
focus on in 2005 are listed in the OIG’s “Work Plan Fiscal
Year 2005,” which is available at:
www.healthlawyers.org/docs/ask2004/OIG_2005_workplan.pdf.
______________________________
Tom Hess
is a Shareholder and Co-Leader of the
Health & Medicine Practice Group. He can be contacted at
thess@bdblaw.com
or
614.227.4260.
By:
Richard Milligan
So now
that the laws have been passed and the judges elected, is
the battle won? Not yet.
Spurred on by the medical malpractice liability crisis,
physicians and health care providers have become engaged
in the political process like never before in Ohio
history.
Legislators have been lobbied. Legislation has been
passed. Supreme Court judges have been supported and
elected.
What more is to be done?
The driving force behind the political activism of the
medical community has been the burdensome cost of medical
liability insurance coverage. Nearly all the enacted
reforms are intended to reduce malpractice liability costs
for physicians and other health care providers. With
reduced costs, stabilized or lower medical malpractice
insurance premiums should result.
There is understandable frustration that the efforts to
date have not substantially altered the cost of liability
insurance.
The reality is that the impact of the legislation adopted
in 2003 has yet to be felt “on the ground.” By its terms,
the 2003 law (HB 281) does not apply to any injury or
claim that occurred before April 11, 2003. Since medical
malpractice claims must generally be filed within a year
and a half, we are just now seeing lawsuits to which the
new law applies.
The last time “tort reform” was enacted in Ohio, the Ohio
Supreme Court struck it down. There will no doubt be
challenges to the new law. This writer is unaware of a
medical malpractice case that has been tried to verdict
under the 2003 law and its damages cap. As this is written
in January of 2004, not a single court has yet been asked
to determine the constitutionality of the act.
Lawyers for physicians and other medical providers will be
doing battle over the medical malpractice reform bill for
many years. A challenge to the act will likely reach the
Ohio Supreme Court sometime in late 2005 or early 2006. In
part through your good work, the case will be heard by at
least four of the justices who have a record of giving due
deference to the law as written by the elected
representatives in the Ohio House and Senate.
Hopefully the Ohio Supreme Court will do what the Utah
Supreme Court recently did; find the caps on non-economic
damages constitutional. See, Judd v. Drezga,
2004 UT 94.
In the meantime, the election of three Supreme Court
judges supported by the medical community is a positive
sign that the broader community is becoming aware of the
costs imposed by unmeritorious claims and over-the-top
jury verdicts. Ultimately, it is restraint exercised by
jurors and the courts that will restrain the costs of
medical liability. A sign of this is the concern expressed
by jurors following a recent trial. They were all
concerned that the physician involved not leave the
community as others have because of liability costs.
Finally, one practice reminder. Avoid publicly blaming
other health care providers for bad outcomes in shared
patients. However tempting, pointing a finger at another
is not a foolproof way to avoid liability.
Patients and families see lawyers when negative comments
are made to them. Documenting criticisms is a red flag to
plaintiff lawyers that the case is worth investigating.
Don’t put anything in the record that is not necessary to
document the medical care received by the patient. Save
any criticisms for the quality or peer review committee
where they can be analyzed and addressed in a
confidential, privileged setting.
When you criticize another's care you are not helping
yourself. What you are doing is advertising to every
plaintiff's lawyer who looks at the chart that there might
be a problem. A chart is the place to document the care,
not assign blame.
Hopefully, the coming years will see a decline in medical
liability costs and a corresponding decline in liability
insurance premiums.
This article was previously published
in M.D. News.
Rich Milligan
is a Shareholder in the Health and Medicine Practice
Group. He may be reached at
rmilligan@bdblaw.com or
330.491.5280.
By:
Joseph J. Feltes
 Not long ago, the Stark County Common Pleas Court
Judges addressed a group of physicians, who attended a
program to learn more about today’s gripping malpractice
crisis from the judicial perspective.
Judge V. Lee
Sinclair
told the story of a discussion he had in chambers with an
embittered plaintiff, the wife of a deceased patient, who
sued her husband’s physician for medical malpractice. The
Judge wanted to speak with this woman, who adamantly
rebuffed all reasonable monetary attempts to settle the
case.
The plaintiff admitted to the Judge that her
bitterness—stemming from the physician’s not communicating
with the family—rather than money, motivated her to file
the lawsuit and reject settlement efforts. “My husband
had been his patient for 20 years, and he (the doctor)
never even said ‘I’m sorry’ that my husband died. He
didn’t even bother to talk with us. He didn’t seem to
care.”
Judge Sinclair confirmed what many physicians have
known or intuited—breakdowns in communications with
patients and their family members can lead to hard
feelings and lawsuits. He admonished physicians to make
the time to talk with patients or their families when
mistakes are made or when any unanticipated clinical
outcome occurs, even in the absence of mistakes.
Up to this point, that good piece of advice has
been difficult for physicians to put into practice,
particularly after having been reminded repeatedly by
counsel of their “Miranda” rights: “Anything that you say
can and will be used against you in a court of law.”
Ironically, this “defend and deny” approach may actually
have led to lawsuits that might have been adverted if
patients (or family members) had not perceived the doctor
as being insensitive, uncaring, or as trying to hide
something.
Physicians heretofore have found themselves between
a rock and a hard place. Sub.
H.B.
215, recently passed by the Ohio general Assembly, may
help to alleviate that dilemma. The Act prohibits the use
of a physician’s apology or expression of sympathy as
evidence of liability in a medical malpractice action.
Simply put: A physician, who talks with the
patient or family following an unanticipated clinical
outcome from medical care, should no longer need to worry
about having his words come back to haunt him during cross
examination by the plaintiff’s attorney at trial.
The statue declares “all statements, affirmations,
gestures, or conduct expressing apology, sympathy,
commiseration, condolence, compassion, or a general sense
of benevolence” to be inadmissible, i.e. such
discussions are off limits at trial in a
malpractice case.
Beyond creating a layer of evidentiary protection
for physicians to speak candidly with patients or their
families, the statute—which is patterned after Colorado’s
“I’m Sorry” law—may have the additional prophylactic
benefit of deterring the filing of some potential
malpractice claims in the first place. One medical
professional, quoted in a recent Wall Street Journal
article, opined that “nothing is more effective in
reducing liability than an authentically offered
apology.”
Even if suit were brought, a physician’s apology or
sincere expression of condolence may facilitate lower
settlements. According to one
Ohio
legislator, State Sen. Jay Hottinger, who supported H.B.
215, “A growing number of hospitals, doctors and insurers
believe that apologies could end up quelling victim anger
and perhaps reducing some of the huge sums paid out to
settle disputes over medical care. By protecting such
statements from being used as evidence of an admission of
liability in subsequent litigation, the bill we passed
better safeguards physicians when they apologize.”
Prominent hospitals throughout the country, such as
Johns Hopkins and Dana-Farber Cancer Institute, have
adopted policies that encourage physicians to talk to
patients, admit their mistakes when they occur, and
apologize. Additionally, insurers like COPIC now are
conducting programs that focus on teaching physicians how
to discuss medical errors with families, as a matter of
risk management.
Translating what appears in
Ohio’s Sub. H.B. 215 into practical application, may
largely be a matter of applying common sense. It is
helpful to keep these guidelines in mind:
·
Physicians should take the initiative in contacting the
patient or family, sooner rather than later. The longer a
physician waits, the more uncaring and evasive he or she
may be perceived as being. Time allows feelings to fester
and anger to mount and harden.
·
Physicians need to calm their emotions, have a good
understanding of what happened, and not speculate or jump
to conclusions before meeting with the patient or family.
·
Physicians should be factual, candid, sincere and
forthcoming in explaining what happened and answering
questions.
·
It
is not necessary for physicians to “fall on their sword”
by accepting responsibility or blame when they did not
make a mistake.
·
Apologizing or expressing condolences should not turn into
“finger pointing” at others.
·
Sometimes the only thing necessary and appropriate to say
is something like: “I’m sorry about your loss. Your
husband was a good man.” Expressions of sympathy do not
equate to admissions of wrong-doing.
·
If
you have any questions, doubts or concerns about meeting
with a patient/family, or what you should or should not
say, first contact your legal counsel or insurance carrier
for guidance.
Saying “I’m sorry” or expressing condolences is not
a panacea. Nor is it the miracle drug that will cure the
malpractice epidemic. But, hopefully it will prove to be
an effective prescription for physicians to control damage
and avoid potential claims.
_________________________________
This article was previously published
in M.D. News.
Joe Feltes is a Shareholder
in the Health & Medicine Group. He can be reached at
jfeltes@bdblaw.com
or
330.491.5225.
By:
Donald A. Antrim
 The
health care industry often overlooks the breadth of the
corporate compliance scheme envisioned by the Office of
the Inspector General of the Department of Health and
Human Services (“OIG”). Beginning with the corporate
compliance program for clinical laboratories released in
March 1997, the OIG has published a series of compliance
programs for various sectors of the health care industry.
The OIG compliance programs are in the form of compliance
guidance because the releases are not model plans, but
rather discuss what a model plan should contain. The
program for individual and small-group physician practices
was published in the Federal Register on October 5, 2000
(65 FR 59434). This compliance program is directly
applicable to physicians and physician practices.
The
publication of a compliance program, however, leads to the
question, “compliance with what and for what purpose?”
“Compliance with what” means compliance with the
significant array of statutes and rules affecting the
Medicare and Medicaid programs, all other governmental
payors and, in some instances, private health care
programs. The “for what purpose” question is answered by
the desire to avoid an enforcement action or a prolonged
investigation, or to survive a billing audit.
The
OIG maintains that the benefit of developing a corporate
compliance program is the creation of effective internal
controls which lead to efficiencies in billing practices
and procedures. The adoption of a compliance plan also
assures adherence to applicable federal and state law and
the satisfaction of program requirements for federal,
state and private health plans, not to mention the
prevention of fraud and abuse. Additionally, the
penalties under these statutes, both civil and criminal,
can be enormous. The existence of an effective compliance
program can significantly reduce fines and penalties.
The
names of the federal laws for which the OIG compliance
programs were established give a fair sense of their
import:
-
Medicare/Medicaid Conditions of Participation (42 C.F.R.
482)
-
Anti-kickback Law (42 U.S.C. §1320a-7b(b))
-
False Claims Act (31 U.S.C. §3729-3733)
-
Physician Anti-Self Referral Law (Stark II) (42 U.S.C.
§1395nn)
-
Civil Monetary Penalties Law (42 U.S.C. §1320a-7a)
-
Medicare/Medicaid Exclusion (42 U.S.C. §1320a-7)
The
following strictly criminal statutes have an impact on the
health care industry and should be covered by any
compliance plan as well:
-
Health Care Fraud (18 U.S.C. §1347)
-
Theft or Embezzlement Affecting Health Care Plans (18
U.S.C. §669)
-
False Statements (18 U.S.C. §1035)
-
Obstruction of Criminal Investigation of Health Care
Offenses (18 U.S.C. §1518)
The
primary goal for the adoption of a corporate compliance
program is to create an internal program which assures
compliance with these statutes and the health care
programs which they impact.
The
compliance programs proposed by the OIG are fairly
uniform. They all have seven basic components or steps,
which have their origin in the Federal Criminal Sentencing
Guidelines. If this fact isn’t enough to advise the
industry that compliance is serious business, the fines,
penalties and potential term of imprisonment under the
various federal laws should be enough to suggest that
every physician should pay close attention to the creation
of a compliance program.
All
compliance programs should start from the same base—an
assessment of the operations of your practice.
Thereafter, the OIG recommends the creation of a
Compliance Plan which progresses through the following
seven steps:
Step 1: Audit and Monitor:
Under this step the practice should establish standards
and procedures to review the claims submission process and
gather an understanding of what is billed and on what
basis. There should be periodic auditing of the billing
process to assure compliance with Medicare and Medicaid
guidelines on coding and billing procedures.
Step 2: Establish Practice Standards and Procedures:
A compliance plan should be a written document and it
should identify specific risk areas. The Plan should
contain a clear statement of purpose indicating that the
goal of the practice is to be in compliance with the
various federal programs and that no deviations from full
compliance will be tolerated.
Step 3: Designate a Compliance Officer:
A Compliance Officer should be identified for the purposes
of assuring implementation of the compliance plan as
embodied in a policy and procedures manual. The
Compliance Officer should have responsibility for
overseeing the auditing and monitoring function, as well
as all other components of the Plan.
Step 4: Training and Education:
This step involves identification of the individuals
within the practice who need to be trained and the types
of training that would be most effective. The OIG
recommends specific training on at least an annual basis.
Step 5: Detection of Offenses and Development of
Corrective Action Initiatives:
The plan should create protocols for reviewing the claims
submission process. There should be a clearly identified
investigatory process, which can be modeled after the
self-reporting protocols published by the OIG. The Plan
should also indicate that there may be circumstances which
call for consultation with outside counsel, and
consideration should be given to self-reporting.
Step 6: Develop Open Lines of Communication: The Plan, in addition to designating a Compliance
Officer, should establish an open-door policy with respect
to the Compliance Officer and the practice leaders. There
should be a bulletin board and an anonymous drop box
established for the purposes of encouraging reporting, and
there should be a published no-retaliation policy.
Step 7: Enforcement of Disciplinary Standards: What constitutes a violation of the Compliance
Plan should be clearly specified. Appropriate
disciplinary action may range from written reprimands to
temporary suspension all the way to termination.
The
above seven components provide an outline for the creation
of a Compliance Plan. Compliance Plans do not fit into
the category of “one size fits all” and there is no
benefit in preparing a Plan that only sits on the shelf
and collects dust. Compliance Plans do not need to be
overly elaborate or call for the creation of unreasonable
documentation or reporting. The recommended course of
action is to assess your practice in light of the
governmental payor services that your practice performs,
examine your business relationships, and consider your
resources from a financial and personnel standpoint. Then
the practice administrator or leader should work with a
professional experienced in health care corporate
compliance to prepare a Plan that fits your practice’s
particular needs.
Compliance programs do not need to be overly costly nor
complex, but they should reflect the practice’s commitment
to corporate compliance. It is also essential to establish
individual responsibilities to assure that the Compliance
Plan remains a viable component of the practice’s
operation.
There are presently 11 compliance programs, for the
following health care industry segments: hospitals;
clinical laboratories; home health agencies; durable
medical equipment; suppliers, third party medical
billing companies; hospices; Medicare +Choice
organizations offering coordinated care plans and
nursing facilities; individual and small group
physician practices; ambulance suppliers; and
pharmaceutical manufacturers.
________________________________
Don Antrim
is a Shareholder in the Health & Medicine
Group. He can be reached at
dantrim@bdblaw.com
or
614.227.4292.
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Brenda Coey joined Buckingham,
Doolittle & Burroughs in 2003 as an Associate,
bringing to the firm her background in health care
both as an attorney and as an administrator with over
15 years of experience in nursing home management. She
is a member of the firm’s Health & Medicine practice
group and is based in Canton.
“I focus my practice on health law,
particularly as it pertains to long-term care
entities, and on medical malpractice defense,” Brenda
explains. Her clients include nursing homes, adult day
care centers, assisted living centers and independent
living facilities as well as continuing care
retirement communities. She also works with home
health service providers and hospices.
Brenda provides counsel in matters of
administrative and regulatory compliance and
administrative hearings. She helps health care
organizations construct policies and procedures,
drawing on her experience in health care
administration as well as her knowledge of the law.
“What I find fascinating is how different
organizations and administrators develop creative
approaches to resolving similar problems. Using
problem-solving skills, they develop policies and
procedures unique to the organization. I enjoy
helping them work through the process and reach a
workable solution,“ she says.
In the course of her work, Brenda
frequently visits her clients’ facilities and provides
advice on minimizing risk. As a member of the firm’s
medical malpractice defense team, she is also active
in investigations following an incident where there is
potential liability. “We can help our clients get a
handle on what really happened,” she says. “And we
help them work through the business and insurance
issues that arise from the litigation process.
Naturally, when a lawsuit is filed, we are there to
aggressively defend the facility’s interests.”
Brenda earned her J.D. at the
University of Akron School of Law. She also has a B.S.
in Health Planning and Administration from the
Pennsylvania State University. She is a member of the
American, Ohio State and Stark County bar associations
and maintains her Nursing Home Administrator’s
License. |
Newly Issued CMS Survey
and Certification Letters for Nursing Home Providers
By: Priya Bathija
 The
Centers for Medicare and Medicaid Services (CMS) issued
new survey and certification letters to state survey
agency directors in December 2004. Those of particular
interest to nursing home providers are as follows:
·
Federal Requirements for the Information
Dispute Resolution (IDR) Process for Nursing Homes (S&C
05-10);
·
Improving Enforcement via the Special Focus
Facility Program for Nursing Homes (S&C 05-13); and
·
Clarification of Nursing Home Reporting
Requirements for Alleged Violations of Mistreatment,
Neglect, Abuse, Including Injuries of Unknown Source, and
Misappropriation of Resident Property (S&C 05-09).
The last letter (S&C 05-09) is especially important
because it clarifies the definition of “injuries of an
unknown source.” The letter states that an injury will be
classified as an “injury of unknown source” when both of
the following conditions are met: (1) The source of the
injury was not observed by any person or the source
of the injury could not be explained by the resident;
and, (2) The injury is suspicious because of
the extent of the injury or the location of the
injury (e.g., the injury is located in an area not
generally vulnerable to trauma) or the number of
injuries observed at one particular point in time or
the incidence of injuries over time.
Complete copies of these letters are available at
http://www.cms.hhs.gov/medicaid/survey-cert/letters.asp.
Priya Bathija
is an Associate attorney and member of the Health &
Medicine Practice Group. She can be contacted at
pbathija@bdblaw.com or
614.227.4282.
____________________________________
HIPAA’S SECURITY RULE
By:
Shila Nalawadi
 HIPAA’s
Security Rule involves the national implementation of
standards designed to safeguard the electronic creation,
use, storage, maintenance, and transmission of an
individual’s health information. Compared to HIPAA’s
Privacy Rule, which broadly mandates covered entities to
safeguard protected health information (PHI) in both
electronic and non-electronic media; the Security Rule
applies only to an individual’s health information
as created, transmitted, or maintained in electronic form
or “electronic protected health information” (EPHI).
The Security Rule directs covered entities to use certain
administrative, physical, and technical safeguards to
protect the confidentiality, integrity, and availability
of EPHI. Like HIPAA’s Privacy Rule, the Security Rule
allows a covered entity to take into account its size,
complexity, and capabilities to reasonably and
appropriately implement the Rule’s standards. Covered
entities—health care providers, health plans, and health
care clearinghouses—must comply with the Security Rule by
April 20, 2005 (small health plans have an additional year
to comply).
Shila Nalawadi
is an Associate attorney and member of the Health &
Medicine Practice Group. She can be contacted at
snalawadi@bdblaw.com
or 330.491.5238.
 In
December 2004,
Christopher Parker was one of three
speakers for a Continuing Legal Education seminar titled
"Advanced Deposition Tactics
for Expert Testimony."
______________________________
In November 2004, the Health & Medicine
Group and the Litigation Group held their annual seminar
titled, "Litigating a
Healthcare Negligence, Fraud and Abuse, and Medical
Malpractice Claim." The seminar designed to
instruct administrators on legally and ethically operating
a facility while minimizing the risk of fraud and abuse
issues.
______________________________
If you are interested in obtaining information on
upcoming seminars or would be interested in having
speakers from BDB make a presentation to your
organization, please contact: Lorna J. Henderson, Client
Relations Administrator, at
800.686.2825 ext. 473
or
lhenderson@bdblaw.com.
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