Research in Dialysis Patients Conference

1
Research in Dialysis Patients Conference

• Key Legal Issues and Practical Solutions
• March 20-21, 2006
• Washington, D.C.
• Neil S. Olderman, J.D.
• Robyn S. Shapiro, J.D.

2
Opening Remarks

• Observations Based on Perspective of Each
  Constituency
• Not an easy task at hand.
• Original objective was to eliminate impediments
  to the efficient conduct of dialysis research.
• We all agree on the benefits to patients that
  this initiative can provide and the merits of
  such an endeavor.
• Constituencies are diverse and the issues (e.g.,
  legal, financial, practical) are numerous.

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Opening Remarks

• With this in mind, what do we do?
• Start by understanding each constituents
  perspective. We are engaged in this today.
• Need an avenue to keep open the dialogue between
  all the constituents.
• We need to allocate resources to furthering the
  objective.
• Commit to regular planning and meeting sessions
  by key representatives.
• Agree on a by-product of the process/discussions
  (i.e., Best Practices Guide, legislative
  relief, model agreement, additional research
  funding, etc.).

4
General Contractual Issues

• Relationship Governed by Clinical Research
  Agreement
• Binding researchers, sub-investigators, etc. may
  present enforcement issues.
• Several approaches to addressing enforceability
  issue.
• Indemnification typically creates the biggest
  contractual issue to surmount.
• Typically burden is shifted to Principal
  Investigator (P.I.).
• Research and credentialing applications appended
  to the Agreement containing joinder clauses can
  complicate the issues.
• State contract law applies. Also, some state
  constitutions prohibit state institutions from
  contractually assuming liability through
  indemnification.

5
Protected Health Information Issues

• Patient Privacy and Other Related Rights
• Regulatory Framework
• Health Insurance Portability and Accountability
  Act of 1996 (HIPAA) and the implementing
  regulations (collectively referred to as the
  Privacy Rule).
• Privacy Rule establishes category of health
  information or protected health information
  (PHI) which may be used or disclosed by covered
  entities in certain circumstances or under
  certain conditions.
• PHI includes patients personal health
  information, such as demographic information,
  information from the medical chart, test results,
  as well as billing information.
• Also, state law may be more stringent and in that
  case, it controls.

6
Protected Health Information Issues

• Dialysis facilities and dialysis providers that
  transmit health information electronically in
  connection with certain defined HIPAA
  transactions are covered entities.
• HIPAA authorization (i.e., patient authorization)
  is generally required for each use or disclosure
  of PHI for research purposes.
• Use/disclosure of PHI to create a research
  database and use/disclosure of PHI from the
  database for a future research purpose are
  considered separate research activities under
  HIPAA.

7
Protected Health Information Issues

• Built-in Exception Privacy Rule permits a
  covered entity to use or disclose PHI for
  research without patient authorization in limited
  circumstances.
• For reviews preparatory to research.
• Where covered entity receives appropriate
  documentation that an IRB or a privacy board has
  granted an alteration to or waiver of the
  authorization requirement.

8
Protected Health Information Issues

• Options for compliance with HIPAA authorization
  requirement
• Subjects HIPAA authorization may include all
  future research studies
• May obtain waiver or alteration of authorization
  requirement from IRB or privacy board in
  accordance with 45 CFR 164.512(i), but this is
  not easy to justify because must conclude that it
  cannot be done without the waiver
• Future research may use only a limited data set
  of PHI with a data use agreement or
• May obtain additional future authorization(s)
  from subject.

9
Protected Health Information Issues

• Form of Authorization
• Description of research should be broad enough to
  permit inclusion of data and biospecimens in
  repository as well as future research studies.
• Must be approved by each institutions IRB.
• See privacyruleandresearch.nih.gov for helpful
  guidance.

10
Protected Health Information Issues

• Recruitment of Patients for Research Studies
• Dialysis facility may permit P.I. to review the
  facilitys patient records to establish
  eligibility for recruitment purposes.
• Dialysis facility typically requires
  representations from the researcher that
• Use or disclosure is sought to review PHI as
  necessary to prepare a research protocol or for
  similar purposes preparatory to research
• No PHI is removed from the dialysis facility by
  the researcher in the course of the review and
• The PHI for which use or access is sought is
  necessary for the research purpose.
• Clinical Research and the HIPAA Privacy Rule Fact
  Sheet, February 2, 2004, provides that Covered
  entity may allow a researcher, either within or
  outside the covered entity, to identify, but not
  contact, potential study participants under the
  preparatory to research provision with the
  proper representations (described in 5.b. above).

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Protected Health Information Issues

• Contacting Potential Research Study Participants
• To contact potential research study participants,
  a researcher may do so, without authorization
  from the individual where
• Researchers working for the covered entity may
  contact the potential study participant as part
  of covered entitys health care operations
• Covered health care providers may discuss
  treatment alternatives, including participating
  in a clinical trial or research study, as part of
  the patients treatment or the covered entitys
  health care operations or
• Business associate may be engaged to assist in
  contacting individuals on behalf of the covered
  entity.
• If covered entity receives documentation that an
  IRB or privacy board has partially waived the
  authorization requirement to disclose PHI to a
  researcher for recruitment, the covered entity
  could disclose PHI necessary to contact the
  potential study participants.

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Protected Health Information Issues

• In the case of limited waivers, dialysis facility
  typically must approve the IRB waiver approval.
• Where IRB waiver is obtained, P.I. becomes
  responsible to dialysis facility for providing
  information in order to facilitate accounting of
  disclosures under HIPAA. One form of accounting,
  which is typical, would include providing
• Research location
• Name and description of protocol
• List of patients whom medical records were
  accessed
• Description of the type of PHI accessed
• Time frame during which access, review occurred
  and
• Researchers contact information.

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Protected Health Information Issues

• Enrollment of Study Participants
• Specific patient authorization required unless
  IRB or privacy board has waived the authorization
  requirement entirely.
• Privacy Rule requires signed permission from the
  individual study participant that allows a
  covered entity to use or disclose the
  individuals PHI for the purposes and to the
  recipients stated in the authorization.
• Privacy Rule compliant authorization must be
  obtained before giving the name of the study
  participant to the Sponsor or CRO or study
  participant must contact the Sponsor or CRO
  directly.
• Record reviews that analyze de-identified records
  do not require patient authorization.

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Reimbursement and False Claims Act Issues

• Billing and Reimbursement Issues
• Medicare/Medicaid reimbursement for routine
  dialysis service or medication.
• Risk of becoming ineligible for Medicare/Medicaid
  coverage.
• Dialysis facility relies on fact that research
  will not impact its ability to bill third party
  payors and study participants.
• National Coverage Decision cost recovery.

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Reimbursement and False Claims Act Issues

• What if routine services and medications become
  ineligible for coverage under Medicare/Medicaid?
• P.I. can reimburse dialysis facility
• P.I. can furnish non-routine services and
  medications to study participants.
• Requirement of dialysis facility not to bill
  non-routine services or medications to study
  participants.
• No billing of study participants for services,
  treatments, or other items furnished by the
  research institution in connection with the study
  (unless set forth in study proposal).

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Reimbursement and False Claims Act Issues

• Liability Exposure Related to Clinical Trial
  Billing False Claims Act, 31 USC 3729 et.
  seq.
• False Claims Act language Liability attaches to
  any person who knowingly presents or causes to be
  presented any false claim or false statement to
  the U.S. government. (Employers can be held
  liable for actions of individual employees.)
• Knowingly includes actual knowledge, deliberate
  ignorance or reckless disregard for the falsity
  of the information.

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Reimbursement and False Claims Act Issues

• False Claims Act Violations
• Fines as much as 11,000 per violation plus three
  times the amount of damages sustained by
  government potential exclusion from Medicare and
  Medicaid.
• Individuals may bring suit by private causes of
  action, or in conjunction with government,
  against anyone suspected of violating the False
  Claims Act (qui tam lawsuit) and if is
  determined that violation occurred, qui tam
  relator is entitled to a portion (up to 30) of
  the governments recovery.

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Liability Exposure Related to Remuneration
between Dialysis Facility and Research
Institution Anti-Kickback Statute, 42 USC. 1320
A-76 (b)

• Anti-Kickback Statute Language Illegal for
  individual or entity to knowingly and willfully
  offer or pay remuneration directly or
  indirectly, overtly or covertly, in cash or in
  kind to induce another individual or entity
  to
• Refer individual to a person for the furnishing
  (or arranging for furnishing) of any item or
  service for which payment may be made under
  federal health care program (covered
  item/service)

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Liability Exposure Relating to Conducting
Clinical Trials Anti-Kickback Statute

• Purchase, lease, or order any covered
  item/service.
• Arrange for or recommend the purchase or order
  of any item/service.
• Also illegal to solicit or receive
  remuneration for above purposes.

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Liability Exposure Relating to Conducting
Clinical Trials Anti-Kickback Statute

• Safe Harbors An arrangement that meets all of
  the requirements of a safe harbor will be
  protected from prosecution. An arrangement that
  fails to meet a safe harbor is not a per se
  violation of the statute, but must be evaluated
  to determine the parties have the requisite
  intent to knowingly and willfully induce or
  encourage referrals based on the facts and
  circumstances surrounding the arrangement.

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Liability Exposure Relating to Conducting
Clinical Trials Anti-Kickback Statute

• Safe harbors that may be useful in relation to
  the conduct of dialysis research include
• Space Rental
• Equipment Rental
• Personal Services and Management Contracts

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Liability Exposure Relating to Conducting
Clinical Trials Anti-Kickback Statute

• Applicability in the context of Clinical Research
  in Dialysis Facilities
• Fees
• Research Procedures blood draws, injections,
  etc.
• Lab Tests
• Application Fees research applications,
  credentialing applications
• Equipment
• Computers
• Personnel
• Office Space

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Liability Exposure Relating to Conducting
Clinical Trials Anti-Kickback Statute

• Violations may result in
• Criminal sanctions (felony punishable by up to 5
  years imprisonment, fine of up to 25,000)
• Civil monetary penalty of 50,000/violation and
  assessment of not more than 3 times the amount of
  remuneration involved and
• Exclusion from participation in federal health
  care programs.

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Intellectual Property Issues

• Rights in Intellectual Property
• Investigation is not an end in itself.
• Studies are designed to develop understanding
  and, eventually, solutions.
• Solutions whether methods, or processes or
  formulations can be (and often are) the subject
  to intellectual property rights.

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Intellectual Property Issues

• So who owns those rights to new developments
  growing out of these studies?
• Unless spelled out in the initial agreement,
  subject to a variety of state laws and complex
  precedent.
• Many different parties may have claims on those
  rights, ranging from the university, to the
  individual professors, to dialysis facility
  itself.

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Intellectual Property Issues

• What kind of rights are present?
• Who maintains the rights to confidential
  information discerned in the study?
• What about broader rights to publish?
• To what purposes can that information be used?

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Intellectual Property Issues

• Even though the agreement says that no right is
  transferred by the agreement, in the absence of
  a specific description of who owns what
  everyone may be able to claim rights.
• The relationship between the professors in their
  role at the academic medical center, and their
  role performing the study at the dialysis
  facilities, needs to be spelled out.
• This is only a problem if you succeed the only
  reason not to address these issues up front is if
  you expect the studies to yield no interesting or
  useful information. Anything useful will
  immediately become the subject of dispute.

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Rules Governing Research Approvals and
Credentialing

• Criteria for Approval
• Credentialing
• Research Approved by IRB
• Manuscripts to be presented at conferences
• Nature and information required for approval

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Performance Criteria Issues

• Benchmarks of Performance
• Access to Electronic Information
• Timing for approvals
• Credentialing
• Research studies
• Non-cost neutral vs. Cost-Neutral