Physician Contracting and
Compliance: To Disclose or
Not to Disclose
December 7, 2011
Steven R. Smith, Sarah E. Swank & Craig Holden
www.healthcaregcinstitute.com
Welcome
• Today’s speakers
• Upcoming Ober|Kaler Health Care General
Counsel webinars
• Overview of the topic
• Discussion
• Questions
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Meet Today’s Speakers
Steven R. Smith
Principal, Ober|Kaler
ssmith@ober.com | 202.326.5006
Moderator
Sarah E. Swank
Principal, Ober|Kaler
seswank@ober.com | 202.326.5003
Speaker
S. Craig Holden
Principal, Ober|Kaler
scholden@ober.com | 410.347.7322
Speaker
Steve and Sarah are cofounders of the
Ober|Kaler Health Care General Counsel Institute.
LOOK FOR US ON LINKEDIN: Ober|Kaler Health
Care General Counsel Institute Group
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Physician-Hospital Relationships Series
• Part 1:
Courting Physicians: Pros and Cons of Six
Integration Models
(October 20, 2011)
• Part 2:
Physician Contracting and Compliance:
To Disclose or Not to Disclose
(December 7, 2011)
• Part 3:
Disruptive Physicians: A Roadmap to
Avoid Dangerous Behavior
(January 18, 2012)
Visit www.healthcaregcinstitute.com for more information.
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Voluntary Disclosure of Physician
Contracting Issues: If, When and How
• Outline of presentation.
– Legal obligations to disclose.
– Potential benefits/risks of disclosure.
– Where to disclose.
• OIG Self-Disclosure Protocol.
• CMS Self-Referral Disclosure Protocol.
– Tough disclosure decisions.
– Compliance and auditing issues and best practices.
– Hypotheticals.
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Sources of Legal Obligation to Disclose
• Medicare statute.
– Felony for anyone “having knowledge of the occurrence of
any event affecting his initial or continued right to any such
benefit or payment, or the initial or continued right to any such
benefit or payment of any other individual in whose behalf he
has applied for or is receiving such benefit or payment” from
concealing or “failing to disclose” such an event with an
“intent fraudulently to secure” payment which is excessive or
unauthorized.
• 42 U.S.C. §1320a-7b(a)(3).
• 2002 CMS proposed rule purporting to implement the statute
“clarified” that providers must return excess payments within 60 days
of “identifying or learning of the excess payment.” (67 Fed. Reg. 3,662
(Jan. 25, 2002).) Regulation never finalized.
• No known prosecutions.
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Sources of Legal Obligation to Disclose
• False Claims Act – Changes to the FCA language made
as part of Fraud Enforcement and Recovery Act of 2009
(FERA).
– Effective June 2009 it is illegal to “knowingly conceal…or
knowingly and improperly avoid…or decrease…an obligation
to pay or transmit money or property to the Government…”
• 31 U.S.C. § 3729(a)(1)(G).
• Eliminated the old statutory requirement for a “false
statement or record” – mere knowledge arguably is
apparently enough.
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Sources of Legal Obligation to Disclose
• PATIENT PROTECTION AND AFFORDABLE
CARE ACT.
– § 6409 of the ACA.
• Protocol to disclose actual or potential violations.
• Secretary is authorized to reduce amounts due and owing for all
violations under section 1877 of the Social Security Act.
– § 6402 of the ACA.
• Must report and return overpayment within 60 days of either
identification of overpayment or date on which any corresponding cost
report is due, whichever is later.
– CMS implementing regulations under development.
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Potential Benefits of Disclosure
• Potential to avoid criminal liability.
– Self-disclosure unlikely to result in criminal investigations or
prosecutions of the disclosing entity.
• Potential to minimize civil exposure.
– Fines and penalties are reduced more often than not, and may
actually be eliminated.
• In 2007, OIG statistics indicated it had referred more than half of its
Self-disclosures to Medicare contractors for resolution, presumably
without penalty.
• Potential to avoid Corporate Integrity Agreements.
• Potential to neutralize qui tam suits.
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What Does Disclosure Guarantee?
• While disclosure can minimize penalties, fines, and
criminal liability, no reduction in penalties is
guaranteed, and the OIG reserves the right to make
criminal referrals.
• Changes announced in OIG’s most recent “open letter”
mean that no self-disclosure can be settled in the selfdisclosure program for less than $50,000.
• May not eliminate vulnerability to qui tam suits.
– U.S. ex rel. Rost v. Pfizer, Inc. and Pharmacia Corporation.
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To Whom To Disclose?
•
•
•
•
DOJ?
OIG?
CMS?
CMS contractors?
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What Gets Disclosed?
• To the OIG – only “potential fraud against the Federal
health care programs, rather than merely an
overpayment.” “Potential fraud” does not include Stark
violations only – there must be at least a “colorable”
violation of the anti-kickback statute.
• “Merely an overpayment” – disclose to the Contractor.
• To CMS – Stark Violation only.
– Contractor an option?
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OIG’s Self-Disclosure Protocol
• First Displayed in the Federal Register in 1998. 63 Fed
Reg. 58,399 (October 30, 1998).
– Created out of a pilot program operated by the HHS-OIG and
the Department of Justice.
• Based on the belief that “providers must be willing to
police themselves, correct underlying problems and
work with the Government to resolve these matters.”
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OIG’s Self-Disclosure Protocol
• For disclosure of matters that the provider believes
are “violative of Federal criminal, civil, or
administrative laws.”
• Not for matters which “exclusively
involv[e]…overpayments or errors that do not
suggest that violations of law have occurred.”
– Such matters “ should be brought directly to…[a
Medicare contractor].”
• OIG will refer criminal matters to the DOJ, as
appropriate, but will also report the provider’s level
of cooperation.
• Prior experience under the OIG protocol.
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OIG’s Self-Disclosure Protocol
• March 24, 2009 Open Letter.
– “Narrowed the scope” of the protocol’s application to
Stark and Anti-Kickback.
– Requires a “colorable” violation of AKS – no selfdisclosure of Stark-only violations.
– AKS violations now require a minimum $50,000
settlement (the statutory maximum penalty for each
kickback, not including 3x assessment).
– Reaffirmed inclination to settle matters at “lower
end” of damages “continuum.”
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CMS Self-Referral Disclosure Protocol
• Mandated by the Affordable Care Act.
–Purpose is to resolve actual or potential
violations of the Stark self-referral law.
• Separate from the advisory opinion process.
–Large number of disclosures have been
made.
• No solid indicators of how CMS will
compromise potential Stark disclosure.
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CMS Self-Referral Disclosure Protocol
• Stated factors considered in compromising
overpayments.
– Nature and extent of the improper or illegal practice.
– Timeliness of the self-disclosure.
– Cooperation in providing additional information.
– Litigation risk to CMS.
– Ability to pay.
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Self-Referral Disclosure Protocol
• First Stark Settlement.
– Saints Medical Center.
– $579,000
• Reserves apparently were between $14.5 million and $785,000.
– Issues with written agreements for call coverage,
night coverage and stipends.
– Issue was raised in due diligence.
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CMS Self-Referral Disclosure Protocol
• Cooperation among the OIG & DOJ.
• CMS only accepts violations or potential violations of
self-referral law.
• If additional violations or potential violations of other
criminal, civil, and administrative laws send to OIG.
• Cannot submit disclosure concurrently under SRDP and
OIG’s Self-Disclosure Protocol.
• Coordination with Law Enforcement.
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CMS Self-Referral Disclosure Protocol
• Required Elements of Submission.
– Description of Actual or Potential Violation(s).
•
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Identifying Information of party disclosing.
Description of the nature of the matter being disclosed.
Duration of violation.
Disclosing party’s legal analysis of how the matter is a violation.
– Specify Stark exception AND which elements are/are not met.
Circumstances under which the matter was discovered and measures
taken to address the issue and prevent future abuses.
Statement identifying a history of similar conduct or enforcement action.
Description of any compliance program.
If applicable, a description of appropriate notices provided to other
government agencies.
Whether the matter is under current inquiry by the government.
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CMS Self-Referral Disclosure Protocol
• Core Stark Compliance Analysis.
– Is there remuneration?
– Is there a compensation arrangement?
• Direct?
• Indirect?
– Is there a referral, as defined by the regulations, for
DHS?
– Is the organization furnishing the DHS an “entity” (as
defined in the regulations)?
– Is Medicare the payor?
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CMS Self-Referral Disclosure Protocol
• Core Stark Analysis (cont’d).
– Apply rules that were in effect during the various
periods of the arrangement.
• The Stark rules have changed a number of times and the
analysis may be different during certain points in the
arrangement.
– Give proper, but not excessive, weight to preamble
language.
• Statutory and regulation text govern.
– Focus on Period of Disallowance.
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Self-Referral Disclosure Protocol
• Exceptions to Consider:
– Temporary Noncompliance (42 C.F.R. 411.353(f)).
– Compensation Unrelated to DHS (42 C.F.R.
411.357(g)).
– Payments by a Physician (42 C.F.R. 411.357(h)).
– “Grace Periods” (42 C.F.R. 411.353(g)).
– Isolated Transactions (42 C.F.R. 411.357(f)).
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Self-Referral Disclosure Protocol
• Overpayment Calculation.
– With respect to physician-hospital arrangements:
• Is the referring physician the admitting physician?
• Did furnishing the improperly referred DHS affect the DRG payment?
– Does this impact the amount of the overpayment?
– Consider the SRDP “look back” period (in contrast to the
reopening period for cost reports or Part B claims).
– Which programs do you consider?
•
•
•
•
Medicare FFS.
Medicare Advantage.
Medicaid FFS.
Medicaid Managed Care.
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Tough Decisions
Disclose to OIG or CMS, but not both.
• In cases where there is a potential or actual anti-kickback statute violation,
entity could choose OIG self-disclosure protocol in lieu of the Stark SRDP.
– Conduct that raises liability risks under the physician self-referral statute
may also raise liability risks under the OIG’s civil monetary penalty
authorities regarding the federal anti-kickback statute and should be
disclosed through the OIG’s Self-Disclosure Protocol. Disclosing parties
should not disclose the same conduct under both the SRDP and OIG’s SelfDisclosure Protocol.
• Effect on overpayment obligation.
– OIG cannot release the 1877(g) liability, so party disclosing under the OIG
protocol arguably still has CMS/Stark overpayment liability and failure to
return the overpayment is an FCA violation.
– Will CMS sign off on mixed Stark/AKS settlements reached under the OIG
protocol?
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Compliance
• Maintain a compliance policy and plan.
– Not necessary to include copy with disclosure.
– If not, call counsel NOW.
• Set a compliance audit plan.
– Look to OIG work plan (http://oig.hhs.gov/reports-andpublications/archives/workplan/2012/Work-Plan-2012.pdf).
– Consider adding physician contracting and arrangements to
this year’s audit list.
– Ongoing monitoring and evaluation key.
– NOTE: sprinkle in privacy, security and EHR issues.
• Provide clear guidance to the compliance officer and
audit team.
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Compliance
• Compliance Committee.
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You need the right people in the room.
Look to job specific positions for membership.
Regular meetings.
Track attendance.
Minutes.
• Perhaps a standardized form.
• Should be reviewed.
– Legal should attend and participate.
– Promote open discussion while maintaining privilege.
– Create subcommittees that report to the larger group.
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Compliance
• Link Compliance and Governance.
– Transactional or compensation committee of the Board.
• Statement of the role of members.
• Consider who staffs the committee from executive team.
• Frequency of meetings.
– Preapproval of certain arrangements?
• Oversight of the packets.
• Detailed agenda or chart of agreements.
– Include list of other contracts and financial relationships.
– Copy of agreement may not be necessary.
– FMV and other documentation – perhaps a summary.
• Legal review of minutes.
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Compliance
• Linking Compliance and Governance (cont’d).
– Reports on compliance issues to full Board.
– Important to including legal.
•
•
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Good governance.
Work through difficult issues.
Preserve privilege.
Sometimes include outside counsel.
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Compliance
• ACOs – What is on CMS’s mind?
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Hot off the presses – Final Regs. October 20, 2011.
Emphasized flexibility on plan development.
Need for reporting to ACO.
Need for reporting on fraud to federal agencies.
Periodically update plan.
• Example: changes in the law.
– Lawyer cannot be the compliance officer.
• But can go to law school.
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Auditing Physician Agreements
• Why?
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Determine compliance level.
Stop the bleeding.
Under a corporate integrity agreement (CIA).
Acquisitions and due diligence.
Whistleblowers.
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Auditing Physician Agreements
• When?
“There is no time like the present!”
Vs.
“What you don’t know can’t hurt you.”
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Auditing Physician Agreements
• Where do I start?
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Gather all your written agreements.
Select your “look back” period.
Pull AR.
Pull timesheets and FMV documentation.
Find tax forms (e.g., W-9s).
Understand your legal obligations.
• 60 day repayment period.
• Working knowledge of requirements.
– Use an organizational tool to track.
– At the direction of an attorney.
HINT: Follow the money.
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Auditing Physician Agreements
• Some Auditing Pitfalls.
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Mismatched names.
Physicians with multiple agreements and payments.
Finding the agreement.
Amendments and holdover provisions.
• Commencement and termination.
• Are amendments bandages that fix non-compliance periods?
– Finding a signature and agreement together.
• Reviewing emails, invoices and other documentation.
• Contract under state law.
– FMV and other documentation issues.
– Family members and office staff.
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Auditing Physician Agreements
• Auditing Surprises.
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Medical director timesheets.
Real Property leases with annual increases.
Defining set in advance.
CME (on site vs. off site).
A contract for a muffin.
Board retreats.
Advocacy activities.
Expert witness.
Research.
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Physician Contracting Best Practices
• Maintain a Contract policy.
• Create a work flow.
• All signatures before services start.
– Is it possible? Required?
– To date or not to date?
• Determine documentation requirements.
• Centralize storage of physician agreements and
documentation (perhaps electronic).
• Set reminders of expiring agreements.
• Retention – a plug for Record Retention policies.
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Physician Contracting Best Practices
• Stopping others from providing “stuff” or contracting
with physicians outside your process.
– Gift baskets.
– “Side” contracts.
– Process with safeguards for payments to physicians.
• Integrate contract approvals into compliance plan and
governance.
• Employed physicians .
– Consistent intake process with HR.
– Compliant recruitment process.
• Educate.
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Auditing – EHRs
•
•
•
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•
•
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Revenue informatics positions.
Differs from compliance.
Pay-back obligations.
Sample size.
Committee and team approach.
Government audits become proactive.
Pattern of noncompliance or worse yet – fraud.
HINT: If you are making a lot of $, better to
double check.
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In-House Perspective
• Get executive buy in and set expectations for audits.
• Engage appropriate departments and individuals.
• Conduct audits under privilege.
– You or outside counsel?
•
•
•
•
•
Set a work schedule.
When it looks bad, keep digging.
If it looks really bad, have the disclosure conversation.
Don’t let people play the blame game.
Create “learning opportunities.”
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In-House Perspective
• An ounce of prevention is worth a pound of
cure.
– Get a seat at the table.
– Legal involved in physician contracting process and
governance from the beginning.
– Keep an open-door policy.
– Be visible along with the compliance officer.
• Walk the halls.
• Eat lunch in the cafeteria.
• Round on certain days if you have multiple sites or are off
site.
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Hypothetical 1
In the course of its general compliance activities,
Community Heart Hospital has an outside consultant
conduct a review of procedures performed at the
hospital by cardiac surgeons and interventional
cardiologists. The results indicate that two of the
physicians have unusually high rates of stent use. A
chart review for these two physicians procedures finds
an error rate of 19% over the past 12 months which
results a Medicare overpayment of $38,000.
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Analysis of Hypothetical 1
• Disclose or just repay?
• If disclose, to whom?
–
–
–
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FI?
CMS?
OIG?
DOJ/AUSA?
• Additional audit work?
– How far back do you go?
• Notify the physicians?
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Hypothetical 2
Same facts as Hypothetical 1, except that the error rate
is 48% with an overpayment of $376,000. Further, one
of the physicians in question has significantly increased
his rate of stenting procedures in the last year. The
beginning of this increase roughly coincides with when
he began to be heard muttering that he needed to make
more money because of his divorce.
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Analysis of Hypothetical 2
• Disclose or just repay?
• If disclose, to whom?
–
–
–
–
FI?
CMS?
OIG?
DOJ/AUSA?
• Additional audit work?
– How far back do you go?
• Notify the physicians?
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Hypothetical 3
• A large health system has agreed to purchase a failing community
hospital. In the course of the due diligence, you find the following:
– Several issues exist with MOB leases.
• One lease expired 7 months ago. The physician tenant remains in the
space paying rent at the lease rate. The lease has a hold-over clause, but
it calls for a 5% rent increase if triggered.
• One lease remains in effect, but has a rent escalator clause based on CPI
that was to take effect 4 months ago, has not been implemented.
– Their highest admitting neurosurgeon’s group has been getting paid
for her services as a medical director even though the contract
expired 7 months ago. Medicare payments to the Hospital for the
surgeon’s patient’s over this period total $2.5 million.
– The CEO took Dr. Smith, a cardiac surgeon, to dinner and things got
out of control with the wine list. The total dinner tab totaled $425.
Dr. Smith has already received $275 in non-monetary compensation
this year.
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Hypothetical 3 Analysis
• Lease and Personal Services exceptions permit
6-month holdover terms.
• For amendments to compensation, CMS
recommends (requires?) terminating existing
agreement and entering into new agreement.
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Hypothetical 3 Analysis
• Non-monetary Compensation Exception expressly
permits repayment by physician.
–
–
–
Amount repaid limited to 50% of limit.
Repay within earlier of end of calendar year or 180 days.
Once per physician every 3 years.
• Apply limit by hospital, not by health system.
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Hypothetical 3 Analysis
• Temporary non-compliance rule.
– In compliance for 180 days preceding non-compliance.
– Fell out for reasons beyond control of entity & promptly
corrected upon discovery.
– Within 90 days of non-compliance.
• Missing Signature Rule.
– Only for failure of “signature” requirement .
– 30 days for “non-inadvertent”; 90 days for inadvertent.
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Hypothetical 3 Analysis
• Period of Disallowance.
– “begins at the time the financial relationship fails to satisfy the
requirements of an applicable exception.”
– Ends “no later than” (i) date FR satisfies an exception; (ii)
excess comp is returned and FR satisfies exception; or (iii) any
below-FMV payments are remedied and FR satisfies
exception.
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Hypothetical 3 Analysis
• Indirect Compensation.
– The compensation received by the referring physician from the
entity with which he has a direct financial arrangement must
be FMV and not take into account the value or volume of
referrals or other business generated by the physician for the
DHS entity. Where the physician’s direct financial
arrangement is an ownership interest, such as an LLC
investment, the compensation test is applied to the
compensation arrangement closest to the physician.
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Hypothetical 3 Analysis
• Indirect Compensation.
– Compensation arrangement must be set out in writing, signed
by the parties, and specify the services covered by the
arrangement.
– Compensation for space or equipment leases cannot be based
on
• % of revenues, billings or collections on services provided in space or
using equipment.
• Per-click fees cannot be used if charges reflect services to patients
referred by lessor to lessee.
– Arrangement cannot violate anti-kickback statute or any
federal or state law or regulation governing billing or claims
submission.
• Stand in the Shoes.
– Only applies to owners of physician organizations.
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Hypothetical 4
A physician performs certain needed and necessary
administrative services for the Hospital. The ball is
dropped and an agreement is not executed for six
months. Physician is a major referral source to the
Hospital. One year into the two-year term, the Hospital
discovers that there is no executed written agreement
with Physician.
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Hypothetical 4 Analysis
•
•
•
•
Is there a Stark issue?
Can this mistake be “cured?”
Should it be disclosed? If so, to whom?
What if, during the course of your review, you discover
an internal e-mail/memo to the file stating, “Dr. Big is
one of the largest referral sources to the Hospital and
this PSA is essential to ensure his loyalty?”
• What if the payment rate is 2X Fair Market Value?
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Hypothetical 5
Community Hospital has exclusive contracts with radiology,
anesthesiology and pathology groups to provide services at Hospital. Under
each of the agreements, the physicians agree to provide 24/7 coverage of all
Hospital’s needs for their services as well as medical directorship services.
Hospital provides all necessary space, equipment and personnel. No money
changes hands under the contracts. Hospital bills for the technical
component of the services; the physicians bill for the professional
component.
Hospital opens a separate hospital-based ASC that provides both surgical
and pain management services. The contracts give the physicians a right of
first refusal at any new hospital site. No new contracts are executed, but the
physicians provide services on the same terms at the new site.
Does the lack of a written contract for the ASC/Pain Management
site create a Stark violation?
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Hypothetical 5 Analysis
• Is there a referral?
– Referral defined: Request/ordering or certifying medical
necessity (including tests ordered pursuant to consult).
• Special favorable rules for pathologists, radiologists and radiation
oncologists.
• Surgical anesthesia?
• Pain management?
• Is there a financial relationship?
– Remuneration?
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Hypothetical 5 Analysis
• U.S. ex rel. Kosenske v. Carlisle HMA et al., 554 F.3d 88
(3d Cir. 2009).
– Former member of BMA, an anesthesiology group,
brought FCA action on Stark theory.
• Alleged that arrangement where BMA provided exclusive anesthesiology
and pain management services to freestanding Hospital Outpatient Clinic
did not qualify for Stark exception because written contract applied only to
Hospital itself.
– Trial Court granted summary judgment finding
compliance with personal services exception.
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Hypothetical 5 Analysis
• U.S. ex rel. Kosenske v. Carlisle HMA et al., 554 F.3d 88
(3d Cir. 2009).
– Court of Appeals reverses.
• Written agreement did not cover new site.
• Exclusivity is remuneration under Stark.
• Use of space, equipment and employees was remuneration even though
hospital billed payers/patients a facility fee.
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Hypothetical 5 Analysis
• Problems with Kosenske.
– Did not address applicability of “indirect” rules.
– Conclusion that space, etc., is “remuneration” ignores applicable
reimbursement rules.
– Potential impact on other physicians.
– Exclusivity as “remuneration.”
– What is a referral?
• Hospitalist
• ED Physician
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Hypothetical 6
Community physicians do not maintain after-hours answering
services. Their respective answering machine messages state, “In
the event of an emergency, contact the Hospital at 818-327-9696.”
At some unknown date in the past but for at least five to ten years,
the Hospital began routing all non-emergent calls back to the
physicians using phone numbers that the physicians provided to the
Hospital. The Hospital has no record of how many calls were
handled on behalf of any particular physician.
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Hypothetical 6 Analysis
• Is there an AKS issue?
• Is there a Stark issue?
• Can this mistake be “cured?”
• Should it be disclosed?
• Does it help if other hospitals in the region are providing a
similar service?
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Questions
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More questions? Contact us.
Steven R. Smith
Principal, Ober|Kaler
ssmith@ober.com | 202.326.5006
Sarah E. Swank
Principal, Ober|Kaler
seswank@ober.com | 202.326.5003
S. Craig Holden
Principal, Ober|Kaler
scholden@ober.com | 410.347.7322
Steve and Sarah are cofounders of the
Ober|Kaler Health Care General Counsel Institute.
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