healthcare fraud: identifying and assessing fraud...
TRANSCRIPT
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Presenting a live 90-minute webinar with interactive Q&A
Healthcare Fraud: Identifying and Assessing
Fraud Risks, Implications of Current
Enforcement, Ensuring Compliance
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
THURSDAY, JUNE 9, 2016
Benjamin J. Fenton, Partner, Fenton Law Group, Los Angeles
Matthew M. Curley, Member, Bass Berry & Sims, Nashville, Tenn.
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Assessing Healthcare Fraud Risks, Implications of Current Enforcement & Ensuring Compliance
Matthew M. Curley Bass Berry & Sims PLC Nashville, Tennessee
Benjamin J. Fenton Fenton Law Group
Los Angeles, California [email protected]
June 9, 2106
Healthcare Fraud Enforcements Efforts
6
0
1
2
3
4
5
6
2011 2012 2013 2014 2015
$3.1
$4.9
$3.8
$5.7
$3.6
Healthcare Fraud Enforcement Results
Civil Fraud Recoveries FY 2011 - 2015 ($ in Billions)
Source: Fraud Statistics – Overview, Civil Division, U.S. DOJ 7
False Claims Act
Prohibits knowingly making or causing the submission of false claims for payment to the federal government
Prohibits knowingly retaining money owed to the government
Provides for treble (3x) damages and per claim penalty of between $5,500 and $11,000
Allows for private parties (qui tam relators) to bring suit on behalf of the government and participate in % of any recovery
8
Damages Theories in Civil Investigations
Establishing Damages in FCA Cases
• Guiding principle is “to make the government whole” for damages incurred “because of” a violation of the FCA
• Measure of damages may depend on the nature of the conduct under investigation
Government typically seeks money paid out because of the false claim over and above what would have been paid if the claims were truthful
E.g., healthcare provider would have received no reimbursement for claims tainted by violation of the Anti-Kickback Statute
No credit for “value” received by the government for the goods or services provided to beneficiaries of government healthcare programs
9
New Qui Tam Lawsuits
Number of New Qui Tam Lawsuits
Filed by Year (FY 2011 - 2015)
Source: Fraud Statistics – Overview, Civil Division, U.S. DOJ
500
550
600
650
700
750
800
2011 2012 2013 2014 2015
635 632
10
FCA Relator Recoveries
Relator Recoveries
FY 2011-2015 ($ in Millions)
Source: Fraud Statistics – Overview, Civil Division, U.S. DOJ
0
100
200
300
400
500
600
2011 2012 2013 2014 2015
11
Stark Law
Prohibits physicians and immediate family members with a direct or indirect financial interest in an entity from referring Medicare patients to that entity for “designated health services”
Strict liability statute
Numerous exceptions may apply
Space leases Medical directorships EHR donations
Violations may result in civil monetary penalties and possible exclusion
May form basis of False Claims Act violation
12
Business Arrangements: Exceptions to Stark
Safe Harbor for personal services and management contracts, 42 C.F.R. § 411.357(d)):
• Agreement is set out in writing and signed
• The agreement covers and specifies all of the services to be provided
• Specifies the schedule and length of time
• Not less than 1 year: If arrangement is terminated, the parties may not enter into a similar arrangement during the first of the original term.
• Compensation is set out in advance and is consistent with fair market value
• Cannot take into account volume or value of referrals
• Hold over month-to-month (up to 6 months) following a term of at least one year is permitted assuming all provisions of the exception are satisfied.
13
Business Arrangements: Exceptions to Stark Bona Fide Employment Exception, 42 C.F.R. §
411.357(c)):
• An employer may employ a bona fide employee physician (or immediate family member) if the following conditions are met:
The employment is for identifiable services
The amount of remuneration under the employment is consistent with fair market value
Remuneration does not take into account the volume or value of any referrals by the referring physician
The remuneration is provided under a commercially reasonable agreement.
Payment may include productivity bonus based upon physician’s personally performed services. (i.e. RVUs)
14
Business Arrangements: Exceptions to Stark Rental of office space or equipment,
42 C.F.R. § 411.357(a) , (b):
• Payment of the use of office space made by a lessee to a lessor if there is a rental or lease agreement meeting the following conditions:
Agreement is in writing, signed and specifies the premises covered.
If the lease only provides access to the premises for periodic intervals, rather than on a full-time basis, the lease must specify the exact schedule and the rent for such intervals.
Term of the agreement must be at least 1 year (If lease is terminated before the first year, the parties may not enter into a similar arrangement during the first year of the original term)
Space rented or leased does not exceed that which is reasonable and necessary for the legitimate business purpose of the lease or rental.
Space used exclusively by the lessee when being used by the lessee, except that lessee can make pro rata payments for the use of common area space
Rental charges over the term are set in advance and consistent with fair market value.
Rental charges over the term are set in advance and consistent with fair market value
15
Business Arrangements: Exceptions to Stark Rental of office space or equipment (cont.)
• Rent is not determined in a manner that takes into account the volume or value of referrals
• Not determined using a formula based on –
A percentage of the revenue raised, earned, billed, collective or otherwise attributable to the services performed or business generated or
Per-unit of service rental charges, to the extent that such changes reflect services provided to patients referred by the lessor to the lessee
• Agreement would be commercially reasonable even if no referrals were made between the lessee and lessor
• Holdover month to month rental for up to 6 months immediately following the expiration of an agreement of at least 1 year that otherwise met all the conditions above, provided the holdover period is on the same terms.
16
Business Arrangements: Exceptions to Stark Physician recruitment, 42 CFR § 411.357(e):
• Remuneration by a hospital to a physician to induce the physician to relocate his or her medical practice to the “geographic area” served by the hospital in order to become a member of the hospital’s staff, if the following conditions are met:
Arrangement is set out in writing and signed by both parties
Not conditioned on the physician’s referral of patients to the hospital
Remuneration is not determined by the volume or value of actual or anticipated referrals by the physician or other business generated between the parties
Physician must be allowed to establish staff privileges at any other hospital(s) and to refer business to any other entities
17
Business Arrangements: Exceptions to Stark
Physician recruitment (cont.)
• “Geographic Area” defined as lowest number of contiguous zip codes drawing at least 75 percent of its inpatients
Recruited physician must join medical staff
Recruited physician must move his/her practice location from outside hospital’s service area into hospital’s service area.
– Must move at least 25 miles or
– Over the next 3 years the physician’s new medical practice derives at least 75 percent of its revenues from medical services furnished to patients not see or treated by physician during the preceding 3 years, measured on an annual basis
18
Business Arrangements: Exceptions to Stark
Physician recruitment (cont.)
• Payment to group practice: Remuneration provided by a hospital to a physician either indirectly through payments made to another physician practice or directly to a physician who joins a physician practice
All remuneration must be passed directly to the recruited physician
– Except for actual costs incurred by the medical group, which the group can keep
– In the case of income guarantee , costs allocated by the physician practice must not exceed the actual additional implemental costs attributable to the recruited physician
19
Anti-Kickback Statute
Prohibits asking for or receiving anything of value in exchange for referrals of federal healthcare program business
OIG has issued safe harbors
Space and equipment leases Personal services and management contracts
Criminal statute; violation punishable by $25,000 per violation and/or up to five years in prison
Conviction implicates OIG mandatory exclusion from federal healthcare programs
May form basis of False Claims Act violation
20
Anti-Kickback Statute: Safe Harbors
Employment safe harbor, 42 CFR § 1001.952(i):
• Monies paid by an employer to an employee for “covered items or services” does not constitute illegal remuneration provide that:
There is a bona fide employment relationship with the employer
The employment constitutes the furnishing of any item or service for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs
21
Anti-Kickback Statute: Safe Harbors Personal Services Safe Harbor, 42 CFR § 1001.952(d):
• The agreement is set out in writing, signed by the parties and specifies the services covered by the agreement.
• If the agreement is for periodic, sporadic, or part-time work, the agreement must specify the schedule of intervals in which services will be performed, the length of said intervals and the exact charge.
• The agreement is for not less than a year.
• Compensation
set in advance,
consistent with fair market value
not determined in a manner that takes into account the volume or value of referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs
• Services do not involve counseling or promotion of a business arrangement or other activity that violates any State or Federal law
• Services contracted for do not exceed those which are reasonably necessary to accomplish the commercially reasonable business purposes of the services
22
Anti-Kickback Statute: Safe Harbors
Practitioner Recruitment Safe Harbor, 42 CFR § 1001.952(n):
• Remuneration to induce a practitioner to relocate primary place of practice into a “shortage area” for his or her specialty, as long as the following conditions are met:
Arrangement is in writing and signed by both parties.
Specific benefits provided, terms of arrangement, and obligation of each party.
If practitioner is leaving an established practice, at least 75 percent of the revenues of the new practice must be generated from new patients
23
Anti-Kickback Statute: Safe Harbors
Practitioner Recruitment Safe Harbor (cont.)
• Benefits provided cannot last longer than 3 years and the agreement cannot be renegotiated during that period.
• No requirement that the practitioner make referrals or otherwise generate business for the entity.
• Practitioner is not restricted from establishing staff privileges at, referring any services to, or otherwise generating any business for any other entity of his or her choosing
• Benefits may not vary based on business generated for entity
24
Anti-Kickback Statute: Safe Harbors
Practitioner Recruitment Safe Harbor (cont.)
• Practitioner agrees to treat patients receiving Federal Health care program benefits in nondiscriminatory manner
• At least 75 percent of new practice revenues must be from patients residing in the shortage areas, Medically Underserved Area or who are part of a Medically Underserved Population
• Payment or exchange of anything of value may not directly or indirectly benefit any person or entity (other than the practitioner) in a position to make or influence referrals
25
Anti-Kickback Statute: Safe Harbors
Medical Office Lease Arrangements (Office/Equipment)
• Lease is in writing and signed by the parties
• Term must be at least for a year
• If lease is intended to provide lessee with periodic access, the lease must specify the schedule of such intervals, their precise length, and the exact for such intervals
• Rental charge must be set in advance, consistent with fair market value and does not take into account the volume or value of any referrals or other business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs
• Lease must be commercially reasonable to accomplish the reasonable business purpose of the lease
26
Enforcement Trends
27
Enforcement Trend: Business Arrangements
28
Financial Arrangements with Referral Sources U.S. ex rel. Schaengold v. Memorial Health, Inc. (S.D. Ga.) (Dec. 23,
2015)
• $9.8 million settlement to resolve allegations that the hospital entered into physician employment arrangements as part of physicians’ practice purchase that exceeded FMV, took into account the volume or value of referrals, and were not commercially reasonable
U.S. ex rel. Payne, et al. v. Adventist Health (Sept. 21, 2015)
• $118 Million settlement to resolve allegations that Adventist violated the False Claims Act by maintaining improper compensation arrangements with referring physicians and by miscoding claims
U.S. ex rel. Reilly v. North Broward Hosp. Dist. (Sept. 15, 2015)
• $69.5 million settlement to resolve FCA allegations related to physician compensation arrangements that were above FMV and not commercially reasonable due to internal tracking of contribution margins from referrals
29
U.S. ex rel. Barker v. Columbia Regional Healthcare System Inc. (Sept. 4, 2015)
• $35 Million settlement to resolve former executive’s False Claims Act suits accusing the Georgia Hospital chain of overpaying referring oncologist
U.S. ex rel. Drakeford v. Tuomey (Oct. 16, 2015)
• $72.4 million settlement before sale following protracted litigation related to improper 10-year employment contracts to 19 specialists in exchange for performing all outpatient procedures at the Hospital or its other facilities
U.S. ex rel. Baklid-Kunz v. Halifax Hosp. Med. Ctr. (M.D. Fla.)
• $85 million settlement to resolve FCA allegations that the hospital violated the Stark Law by entering into employment contracts with six oncologists above FMC and containing improper incentive bonus
Financial Arrangements with Referral Sources
30
Devender Batra, M.D. and Belmont Cardiology, Inc. (N.D. W. Va.)
• $1 million settlement by Dr. Batra to resolve allegations of improper compensation between Dr. Batra and two hospitals
• Investigation into alleged Stark and FCA violations involving Dr. Batra followed a 2011 settlement with the hospitals after the hospitals self-disclosed noncompliant compensation arrangements with Dr. Batra and Belmont Cardiology
• Hospitals cooperated in investigation against Dr. Batra and Belmont Cardiology
Financial Arrangements with Referral Sources
31
Financial Arrangements with Referral Sources
OIG Special Fraud Alert (June 25, 2014)
• Any transfer of value from lab to physicians presents a substantial risk of fraud and abuse under AKS
• Paying physicians to collect, process, and package patients’ specimens is considered suspect
Health Diagnostics Laboratory (Virginia) and Singulex (California) (April 9, 2015)
• Defendants paid $48.5 million to resolve allegations they paid remuneration to cardiologists in exchange for patient referrals
• Induced physicians to refer patients for blood tests by paying them processing and handling fees of between $10 and $17 per referral and by routinely waiving co-pays and deductibles
32
Tips to Ensure Compliance
Develop process for review and approval of all physician arrangements
• Appropriate business justification for arrangement
• Fair market value
• Satisfies applicable legal requirements
Update agreements if there is a change in the relationship
Detailed tracking of remuneration between all parties to arrangements
• No payment without documentation
• If the arrangement involves services, track service and activity logs
• If the arrangement involves space or equipment, monitor the use of leased space or equipment
33
Enforcement Trend: Retention of Overpayments
34
Feb. 12, 2016: CMS issues final rule on reporting and returning overpayments
• Providers must act promptly to investigate any credible information of a potential overpayment
• CMS will institute a six-year “look back” for overpayments (and not ten years as originally proposed)
• Providers must report and return overpayments even if they did not cause the overpayment
Knowing Retention of Overpayments
35
U.S. ex rel. Kane v. Healthfirst, Inc. (S.D.N.Y.)
Allegations: Defendant failed to timely make refunds to Medicaid as a result of MCO’s software glitch
• 2009: Overcharges began
• 2010: Continuum discovered overcharges and asked Kane to determine scope of affected claims
• 2011: Kane fired four days after sending email attaching spreadsheet of claims noting 900+ claims (>$1M)
• 2013: Continuum eventually repaid all claims, but only after issuance of Civil Investigative Demand
Knowing Retention of Overpayments
36
U.S. ex rel. Kane v. Healthfirst, Inc. (S.D.N.Y.)
• Allegations: Continuum failed to timely make refunds to Medicaid as a result of MCO’s software glitch
2009: Overcharges began
2010: Continuum discovered overcharges and asked Kane to determine scope of affected claims
2011: Kane fired four days after sending email attaching spreadsheet of claims noting 900+ claims (>$1M)
2013: Continuum eventually repaid all claims, but only after issuance of Civil Investigative Demand
Knowing Retention of Overpayments
37
U.S. ex rel. Kane v. Healthfirst, Inc. (S.D.N.Y.)
• ACA “60-day Overpayment Rule”: “Report and return” a Medicare or Medicaid overpayment within 60 days “after the date on which the overpayment was identified.”
• Kane decision represented first judicial opinion interpreting 60-day overpayment rule.
• District Court: “Identification” of overpayments, which triggers the 60-day repayment obligation, occurs when a company is put “on notice” of potential overpayments, rejecting the Defendant’s argument that “identified” means when the overpayment is “known with certainty.”
Knowing Retention of Overpayments
38
U.S. ex rel. Odumosu v. Pediatric Servs. of Am. Healthcare (N.D. Ga.)
• $6.88 million settlement with Pediatric Services of America (PSA) to resolve claims that PSA failed to report and return overpayments.
• Allegations: Defendants did not refund credit balances owed to TRICARE and 20 states' Medicaid programs between 2007 and 2013
• First settlement based upon a healthcare provider's failure to identify potential overpayments.
• DOJ press release promised zero tolerance for providers "keeping American taxpayer dollars unjustly."
Knowing Retention of Overpayments
39
Tips to Ensure Compliance
Implement processes to ensure potential overpayments are timely identified and investigated
Establish multiple layers of billing oversight
Consider third-party verification for subjective components
Monitor patient complaints
Monitor employee complaints
40
Enforcement Trend: Medical Necessity
41
Medical Necessity
FCA liability asserted on grounds that the services provided were not “reasonable and necessary” and therefore should not have been billed
• No dispute that the challenged services have been provided to Medicare beneficiaries or that billings accurately reflect the services provided
• FCA liability often prefaced on a retrospective review of patients’ medical records regarding the services receive; key legal issue has become whether claims submitted by provider are “objectively false”
Medically Unnecessary Invasive Cardiac Procedures
• Continued civil and criminal enforcement against hospitals and physicians concerning the medical necessity of cardiac procedures
Cases Involving Patient Status
• Allegations that inpatient admissions should have been billed as outpatient or observation services
Medical Necessity of Long Term Care Services
• Increasing number of FCA cases and settlements based on challenges to the medical necessity of hospice, home health and skilled services provided to Medicare beneficiaries
42
“Lies, Damned Lies, and Statistics”
Extrapolation to Establish Liability Across Universe of Claims
Courts increasingly willing to allow government to argue that liability should be extrapolated across a universe of claims based on review of a sample
District court decisions in LifeCare Centers of America and AseraCare allowed government to rely upon statistical sampling to establish liability
US ex rel. Michaels v. Agape Senior Community, Inc.
• Fourth Circuit to consider whether statistical sampling can be used to establish liability
43
Enforcement Trend: Parallel Proceedings
44
Navigating Parallel Proceedings
“To be parallel, by definition, the separate investigations should be like side-by-side train tracks that never intersect.” United States v. Scrushy, 366 F. Supp. 2d 1134, 1139 (N.D. Ala. 2005)
“There is nothing improper about the government undertaking simultaneous criminal and civil investigations . . .”
United States v. Stringer, 535 F.3d 929 (9th Cir. 2008)
45
Parallel Proceedings
• Government need not bind itself to a single remedy at the outset of an investigation
• Rather, it may proceed criminally, civilly, administratively or on parallel tracks
Enforcement Options
Criminal Civil Administrative
46
“[I]t is important that criminal [and civil … attorneys coordinate in a timely fashion, discuss common issues that may impact each matter, and proceed in a manner that allows information to be shared to the fullest extent appropriate to the case and permissible by law.”
47
Why Pursue Parallel Proceedings?
Parallel proceedings maximize the government’s available tools and remedies against those committing fraud in a variety of ways, including:
► Criminal penalties: prison sentence, fines, restitution and asset forfeiture on the criminal side
► Additional tools available in criminal matters: search warrants, HIPPA subpoenas,
undercover operations, faster recovery.
► Different statutes of limitations: The statute of limitations for civil actions may be as long as six to ten years. See, e.g., 28 U.S.C. §§ 2415(a); 31 U.S.C. § 3731(b). As a result, civil cases may have a much larger “liability window” than criminal cases.
► Larger damages and penalties: Certain civil statutes, such as the False Claims Act, allow
for the government to recover treble damages and certain penalties.
► Lower burden of proof: In civil cases, the burden typically is only a preponderance of the evidence. Also, reckless or willful disregard for the truth may result in liability in a civil case.
► Different constitutional considerations: In civil cases, the right to invoke the Fifth
Amendment privilege against self-incrimination may carry consequences, and the court may draw adverse inferences if Fifth Amendment privileges are invoked.
► Creative civil remedies are available: In the civil context, the government may obtain
asset freezes or injunctions under 18 U.S.C. § 1345 or otherwise (discussed further below); garnishments; suspension and debarment from participation in regulated activity or government programs; or pre-indictment restraint of assets through civil forfeiture actions.
48
Era of Heightened Criminal Enforcement
49
Era of Heightened Criminal Enforcement
Yates Memorandum Key Points:
• DOJ instructed to focus on pursuit of parallel civil and criminal recovery
• DOJ to focus on individual liability:
Settlements with companies will not release civil or criminal claims against individuals
Factors beyond ability to pay will drive consideration of whether to pursue civil actions against individuals
• Cooperation credit in resolving a matter with DOJ will require disclosure of all relevant facts about conduct and individuals involved
50
Self-Disclosure
51
Self-Disclosure: Legal Obligations to Disclose
Why Disclose? Legal and ethical duties
Effective compliance program
Avoid risk of further liability
Affordable Care Act (ACA), 42 U.S.C. § 1128J(d) Providers must “report and return” overpayments within 60
days of identification of overpayment
Retention of overpayment after 60-day deadline results in an “obligation” under the False Claims Act
False Claims Act, 31 U.S.C. § 3129(a)(1)(G) Violation of the FCA if a person “knowingly conceals or
knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the government”
FCA violations subject to treble damages and penalties
52
OIG Self-Disclosure Protocol
Self-Disclosure Protocol issued in 1998
Matters must involve potential violations of federal criminal, civil or administrative laws
Overpayments or errors must be processed through contractor
Supplemented by Open Letters in 2006, 2008, and 2009
Updated SDP issued by OIG in April 2013 Supersedes previous protocol issued in
1998 and Open Letters
53
OIG Self-Disclosure Protocol
2013 Updated SDP Contains Significant Changes:
Available for:
Providers seeking to disclose potential violations of federal criminal, civil or administrative laws for which exclusion or CMPs are authorized
Not available for:
Overpayments or errors
Stark law violations
Requirements for disclosure under SDP
Must “acknowledge conduct is a potential violation” and “explicitly identify the laws that were potentially violated”
Waive statute of limitations
Ensure that corrective actions are implemented and misconduct has stopped
Must complete internal investigation within 90 days of submission (no longer 90 days from acceptance)
Avoid CIA and typical multiplier of 1.5 applied to single damages
Acceptance into protocol suspends obligation to return overpayment
54
OIG Self-Disclosure Protocol
Mechanics of Disclosure:
11 categories of information, including: Concise statement of details of misconduct
Statement regarding laws potentially violated
Description of corrective action
Estimation of damages
Conduct specific information for: False billing
Excluded parties
Violations of AKS and Stark
55
CMS Self-Referral Disclosure Protocol Section 6409 of the ACA
Required HHS to establish protocol to enable providers to disclose actual or potential Stark violations
Authorized HHS to reduce the amounts owed for Stark violations based upon:
Nature and extent of the improper or illegal practice
Timeliness of the self-disclosure
Cooperation in providing additional information
Other relevant factors
CMS Voluntary Self-Referral Disclosure Protocol issued on September 23, 2010
56
CMS Self-Referral Disclosure Protocol Under the SRDP, each disclosure must contain:
Description of actual or potential violations & legal analysis
Financial analysis
Certification
Submission of a disclosure suspends ACA obligation to return overpayment until settlement or withdrawal of disclosure
SRDP may not be used to obtain determination from CMS whether Stark violation occurred
57
CMS Self-Referral Disclosure Protocol Congressional Report to Congress – March 2012
150 self-referral disclosures under SRDP by 148 providers 125 hospitals; 11 clinical labs; 8 physician practice groups
Most commonly reported violations: Personal service arrangement exception Fair market value Space rentals, physician recruitment, non-monetary
compensation
Through September 2013, 320 provider disclosures under SRDP: 35 providers (32 hospitals) have settled
cases for a total of $3.7 million and averaging > $100,000 per settlement
58
Disclosure to U.S. Attorney/ U.S. Department of Justice
Consideration of whether to self-disclose to DOJ: What is the likelihood an FCA violation has occurred – only
DOJ can release FCA liability
Was the conduct a mere mistake, or reckless?
Prepare for full and complete disclosure
Has the conduct at issue ceased?
Can the provider quantify potential FCA damages?
Negotiating the Settlement Defining “Covered Conduct”
Arriving at settlement amount
59
Best Practices in Dealing with Whistleblowers
60
Whistleblower Protection
FCA Anti-Retaliation Provisions
Provides protection for employee, contractor, or agent
Prohibited actions include:
• Discharge
• Demotion or suspension
• Threats or harassment
• Other discrimination in terms or conditions of employment
61
Whistleblower Protection
FCA Anti-Retaliation Provisions
Requirements for FCA Retaliation Claim: • Whistleblower must be engaging in protected activity by acting
in furtherance of a qui tam suit
• Employer must know about the lawful acts
• Employer must take adverse action as a result of the lawful acts
Relief includes:
Reinstatement with same seniority
2x back pay, interest, compensation for special damages
Attorneys fees
62
Navigating Compliance and Enforcement Matters
Hypothetical Facts
Qui tam action filed asserting FCA allegations and alleging that Cardiologist and Cardiology Group performed medically unnecessary cardiac stenting at Hospital’s Cath Lab.
In addition to inserting cardiac stents in the Hospital’s Cath Lab, Cardiology Group also leases space from Hospital’s Medical Office Building and Cardiologist serves as the Medical Director of the Hospital’s Cath Lab.
63
Navigating Compliance and Enforcement Matters
Hypothetical Facts
Cardiology Group receives Authorized Investigative Demand (AID) requesting documents regarding financial relationships with Hospital.
Hospital receives Civil Investigative Demand (CID) for medical records and for testimony regarding Hospital’s financial relationships with Cardiology Group.
64
Navigating Compliance and Enforcement Matters
Hypothetical Facts
DOJ considers intervention in qui tam action and considers criminal charges concerning Cardiologist.
Cardiology Group evaluates how to accomplish resolution of civil, criminal, and administrative issues.
65