TreatiseAnswer Book

Health Care Litigation and Risk Management Answer Book (2015 Edition)

 by David S Greenberg , Brian D Schneider , Arent Fox LLP
 
 Copyright: 2015

 Product Details >> 

Product Details

  • ISBN Number: 9781402423826
  • Page Count: 1060
  • Number of Volumes: 1
  •  

Health Care Litigation and Risk Management Answer Book is designed to provide health care industry leaders and attorneys with a comprehensive and easy-to-use reference guide to risk management and litigation in the health care sector. The book covers government regulation, including the False Claims Act, the Stark law, the Anti-Kickback Statute, and EMTALA, as well as major areas of private litigation risk, such as employment litigation and insurer/provider disputes. The book also provides discussion of compliance strategies to avoid investigations, fines, and litigation, and litigation strategies should the need arise.

This Answer Book provides clear and concise information in a Q&A format, and also includes extensive appendices of reference material, such as key statutes, compliance guidance from the DOJ, FTC, and OIG, and a sample corporate integrity agreement.
  Table of Contents
  Introduction
Chapter 1: Managing Government Investigations
  • Q 1.1 : How does a government False Claims Act investigation begin?2
  • Q 1.2 : How does the government choose a target?3
  • Q 1.3 : How does the government use informal phone calls or requests for information?3
  • Q 1.4 : How does the government use subpoenas or Civil Investigative Demands?4
    • Q 1.4.1 : How should a company respond to a government subpoena or Civil Investigative Demand?4
  • Q 1.5 : How does an administrative subpoena differ from a grand jury subpoena?5
  • Q 1.6 : What is a trial subpoena?5
  • Q 1.7 : What is a search warrant?6
  • Q 1.8 : What other ways might the government seek information?6
  • Q 1.9 : Should there be a dialogue with the government?6
  • Q 1.10 : Must the company produce documents?7
  • Q 1.11 : What happens if the company fails to cooperate?7
  • Q 1.12 : What are the requirements to look for in a search warrant?7
  • Q 1.13 : How should a company respond when a search warrant is executed?8
  • Q 1.14 : What happens after a search is conducted?9
  • Q 1.15 : Does a grand jury investigation impose different obligations from a typical search warrant?10
    • Q 1.15.1 : What is a target?10
    • Q 1.15.2 : What is a subject?10
    • Q 1.15.3 : Will the target be notified?10
    • Q 1.15.4 : What is a target letter?10
    • Q 1.15.5 : Can a target testify at the grand jury?11
  • Q 1.16 : Are there often parallel criminal and civil proceedings and administrative actions?11
  • Q 1.17 : Who should handle the company’s internal response?11
  • Q 1.18 : What opportunities are there to discuss a subpoena with the government in order to clarify or narrow the requests?12
  • Q 1.19 : How should a corporation respond to the government’s request for information?13
  • Q 1.20 : What should a company do if a witness is requested?13
  • Q 1.21 : Should a company provide notice to its employees of the investigation?14
  • Q 1.22 : How can employees be trained to improve the response to a government request for information?14
  • Q 1.23 : Should employees have access to legal counsel?15
  • Q 1.24 : Should a company employ legal counsel for its employees?16
  • Q 1.25 : What is the company’s obligation to preserve documents?17
  • Q 1.26 : What are some other reasons to establish a document preservation protocol?17
  • Q 1.27 : What happens if the company destroys files requested by the government?18
  • Q 1.28 : How should the company’s production efforts be memorialized?18
  • Q 1.29 : Where should a company look for documents?18
  • Q 1.30 : Do we need to produce original documents?19
  • Q 1.31 : What are “hot documents” and how should they be handled?19
  • Q 1.32 : Who should review the production before it is turned over to the government?19
  • Q 1.33 : How should a company produce the requested documents to the government?19
  • Q 1.34 : What should a company withhold in its production to the government?20
  • Q 1.35 : Should a company conduct an internal investigation?20
  • Q 1.36 : What is the role of inside counsel in internal investigations?21
  • Q 1.37 : How should the internal investigation begin?22
  • Q 1.38 : How and when should employees be notified of the internal investigation?22
  • Q 1.39 : How should witness interviews be handled?23
  • Q 1.40 : In what order should interviews be conducted?23
  • Q 1.41 : Are there attorney-client privilege issues to be aware of when conducting employee interviews?24
  • Q 1.42 : Should the company hire an expert or investigator to assist with the investigation?24
  • Q 1.43 : Should a report of the internal investigation be made to management?24
  • Q 1.44 : How should communication with the government be handled while an internal investigation is ongoing?25
  • Q 1.45 : What is a joint defense agreement?25
  • Q 1.46 : Is it a good idea to enter into a joint defense agreement?26
  • Q 1.47 : What are some advantages and disadvantages of entering into a joint defense agreement?26
  • Q 1.48 : How are joint defense agreements terminated?26
Chapter 2: The Civil False Claims Act
  • Q 2.1 : What is the origin of the False Claims Act?31
  • Q 2.2 : When did the False Claims Act become the federal government’s most powerful anti-fraud statute?31
  • Q 2.3 : Have there been any recent amendments to the False Claims Act?32
  • Q 2.4 : Who is responsible for enforcing the False Claims Act?33
  • Q 2.5 : Who are the defendants in False Claims Act litigation?35
  • Q 2.6 : How are False Claims Act cases initiated?35
  • Q 2.7 : How does a relator initiate a False Claims Act case?36
  • Q 2.8 : How long does a False Claims Act case filed by a relator remain under seal (non-public)?36
  • Q 2.9 : What happens while a case is under seal?37
  • Q 2.10 : What happens when the case is no longer under seal?37
  • Q 2.11 : If the government intervenes, what happens next?38
  • Q 2.12 : If the government declines to intervene and take over the case, giving the relator the right to proceed on his or her own, what happens next?38
  • Q 2.13 : Can the government initiate a False Claims Act case on its own without a relator first bringing suit under the qui tam provisions of the Act?39
  • Q 2.14 : Do False Claims Act cases generally proceed all the way to trial?39
  • Q 2.15 : What type of conduct gives rise to False Claims Act liability under the statute?39
  • Q 2.16 : What is “knowing” conduct under the False Claims Act?40
  • Q 2.17 : What is a “claim” for the purposes of the False Claims Act?41
  • Q 2.18 : What is an “obligation” for purposes of the False Claims Act?42
  • Q 2.19 : What does the term “material” mean in reference to a false or fraudulent claim or an obligation under the False Claims Act?42
  • Q 2.20 : What is the statute of limitations for filing a False Claims Act suit?42
  • Q 2.21 : What are some common False Claims Act legal theories applicable to the health care sector?43
  • Q 2.22 : What is a “factually false” claim?43
  • Q 2.23 : How does False Claims Act liability accrue under the “false certification” theory of liability?44
    • Q 2.23.1 : What is the “express false certification” theory under the False Claims Act?44
    • Q 2.23.2 : What is the “implied false certification” theory under the False Claims Act?45
  • Q 2.24 : What is the “worthless services” theory of False Claims Act liability?45
  • Q 2.25 : What is a “reverse false claim”?46
    • Q 2.25.1 : How can retaining overpayments from the Medicare and Medicaid programs lead to “reverse false claims”?46
  • Q 2.26 : Do conditions of participation provide a basis for a False Claims Act case?47
  • Q 2.27 : What is a “retaliation claim” under the False Claims Act?48
  • Q 2.28 : What damages can the government recover under the False Claims Act?48
    • Q 2.28.1 : How are False Claims Act damages calculated?49
  • Q 2.29 : How are False Claims Act penalties calculated?49
  • Q 2.30 : When can a defendant be excluded from federal health care programs?50
  • Q 2.31 : What other penalties may be imposed?50
  • Q 2.32 : What are the largest civil awards (damages and penalties) recovered by the government under the False Claims Act from companies operating in the health care sector?51
  • Q 2.33 : How are relators’ awards calculated under the False Claims Act?52
  • Q 2.34 : What are the grounds to dismiss a qui tam complaint?52
  • Q 2.35 : What is a Rule 9(b) pleading defense?53
  • Q 2.36 : What does it mean to fail to state a claim under Rule 12(b)(6)?53
  • Q 2.37 : What is the False Claims Act’s public disclosure bar?54
  • Q 2.38 : What is the False Claims Act’s first-to-file bar?55
  • Q 2.39 : Are trials in False Claims Act cases common?55
  • Q 2.40 : How do settlements occur in False Claims Act cases?56
  • Q 2.41 : Are there other risks to consider when settling a False Claims Act case?56
  • Q 2.42 : Do state laws impose similar restrictions and risks?57
  • Q 2.43 : What are some trends emerging from recent False Claims Act enforcement activity?58
Chapter 3: The Federal Anti-Kickback Statute
  • Q 3.1 : What is the Anti-Kickback Statute?63
  • Q 3.2 : What are the elements of an Anti-Kickback Statute violation?65
    • Q 3.2.1 : What does it mean to act knowingly and willfully for purposes of the Anti-Kickback Statute ?65
    • Q 3.2.2 : What is remuneration?65
    • Q 3.2.3 : When does remuneration induce a referral?68
    • Q 3.2.4 : What constitutes a referral?68
    • Q 3.2.5 : Does the Anti-Kickback Statute prohibit all payments to referral sources?69
  • Q 3.3 : How does the Anti-Kickback Statute impact business relationships in joint ventures?69
    • Q 3.3.1 : Why is the Anti-Kickback Statute so broad?70
  • Q 3.4 : Are there any exceptions to the general prohibition against payments to referral sources?71
    • Q 3.4.1 : Does the Anti-Kickback Statute prohibit referrals by a hospital-employed physician to his or her employer hospital?73
    • Q 3.4.2 : What if the physician is not employed, but provides services to the hospital as an independent contractor?75
    • Q 3.4.3 : Do leases for space or equipment rental violate the Anti-Kickback Statute?76
    • Q 3.4.4 : What is the investment interest safe harbor?78
    • Q 3.4.5 : Can manufacturers and suppliers provide discounts or rebates to health care providers on product purchases without violating the Anti-Kickback Statute?80
    • Q 3.4.6 : What other safe harbor protections apply?81
  • Q 3.5 : What are the potential sanctions for violating the Anti-Kickback Statute?82
  • Q 3.6 : Can violations of the Anti-Kickback Statute form the basis of a civil action under the False Claims Act?83
  • Q 3.7 : Who enforces the Anti-Kickback Statute?85
  • Q 3.8 : Are there state laws that impose Anti-Kickback Statute-like prohibitions?86
  • Q 3.9 : What can health care providers do to ensure compliance with the Anti-Kickback Statute?88
    • Q 3.9.1 : Does the OIG offer guidance on specific arrangements that could implicate the Anti-Kickback Statute?91
    • Q 3.9.2 : What specific steps can providers take to minimize Anti-Kickback Statute exposure?93
  • Q 3.10 : What do I do if I believe an arrangement might implicate the Anti-Kickback Statute?94
  • Q 3.11 : What are the current hot topics in Anti-Kickback Statute enforcement?96
    • Q 3.11.1 : What new government enforcement initiatives are aimed at combating health care fraud?96
    • Q 3.11.2 : Can the mere opportunity to generate business amount to an illegal kickback?100
    • Q 3.11.3 : Could an equipment sublease which bases lease payments on business expected to be generated under the arrangement violate the Anti-Kickback Statute?100
    • Q 3.11.4 : Does the government view overfill amounts required in the packaging of certain drugs as a potential remuneration under the Anti-Kickback Statute?101
    • Q 3.11.5 : Can the provision of specimen cups by a clinical laboratory to physicians violate the Anti-Kickback Statute?101
    • Q 3.11.6 : Can fee arrangements between an electronic health records vendor and health care providers violate the Anti-Kickback Statute?102
    • Q 3.11.7 : Can a transaction or arrangement that involves private pay ever implicate the Anti-Kickback Statute?102
Chapter 4: Physician Self-Referral (“Stark”) Law: Risks and Enforcement Concerns
  • Q 4.1 : What activities are prohibited by the Stark law?112
  • Q 4.2 : How can a health care provider or entity determine whether an arrangement violates the Stark law?113
    • Q 4.2.1 : Who is a physician for purposes of the Stark law?114
    • Q 4.2.2 : How is referral defined under the Stark law?114
    • Q 4.2.3 : What are designated health services?115
    • Q 4.2.4 : Who is an immediate family member of a physician?116
    • Q 4.2.5 : What is a financial relationship?116
    • Q 4.2.6 : What is remuneration?117
    • Q 4.2.7 : What is an entity furnishing designated health services?117
  • Q 4.3 : What are the exceptions to the Stark law?118
    • Q 4.3.1 : What exceptions apply to ownership or investment interests?119
    • Q 4.3.2 : What exceptions apply to compensation arrangements?119
    • Q 4.3.3 : What exceptions apply to both ownership/investment interests and compensation arrangements?120
    • Q 4.3.4 : What are common requirements for exceptions to the Stark law?120
  • Q 4.4 : Who is responsible for enforcing the Stark law?122
  • Q 4.5 : Will CMS advise an entity regarding whether a financial relationship with a physician complies with the Stark law?122
  • Q 4.6 : How does the Stark law differ from the federal Anti-Kickback Statute?123
  • Q 4.7 : How important is Stark law compliance?123
  • Q 4.8 : What types of policies, procedures, and other measures promote Stark law compliance?124
  • Q 4.9 : How should an entity respond to a potential violation?127
  • Q 4.10 : What is the Self-Referral Disclosure Protocol?127
  • Q 4.11 : What are the potential penalties for violating the Stark law?129
  • Q 4.12 : How has the Stark law been enforced?130
    • Q 4.12.1 : What types of judgments have been entered against entities after trials for False Claims Act violations?130
    • Q 4.12.2 : What types of settlements have been agreed to by entities facing False Claims Act allegations?131
    • Q 4.12.3 : What other types of settlements have been reached?132
  • Q 4.13 : Are future changes to the Stark law’s requirements likely?133
Chapter 5: HIPAA: Risks and Enforcement Concerns
  • Q 5.1 : What information does HIPAA protect?139
    • Q 5.1.1 : When does health information identify the individual?140
  • Q 5.2 : Who must comply with HIPAA?142
    • Q 5.2.1 : When can a covered entity disclose protected health information to a business associate?143
  • Q 5.3 : What legal obligations are imposed by HIPAA?143
    • Q 5.3.1 : What is required by the Privacy Rule?143
    • Q 5.3.2 : What are permitted uses and disclosures of protected health information?143
    • Q 5.3.3 : What are an individual’s rights regarding protected health information?146
    • Q 5.3.4 : What is required by the Security Rule?147
    • Q 5.3.5 : What is required by the Breach Notification Rule?149
  • Q 5.4 : What if a HIPAA requirement conflicts with state law?151
  • Q 5.5 : How can a covered entity or business associate ensure compliance with HIPAA?153
  • Q 5.6 : What are the necessary elements of an effective HIPAA compliance program?153
    • Q 5.6.1 : What personnel must be appointed to oversee a HIPAA compliance program?154
    • Q 5.6.2 : What should be included in HIPAA compliance program policies and procedures?155
    • Q 5.6.3 : How should employees be trained to implement HIPAA requirements?155
    • Q 5.6.4 : What harm mitigation policies should be included in a HIPAA compliance program?157
  • Q 5.7 : How often do breaches of unsecured protected health information occur?157
  • Q 5.8 : What are the most common causes of breaches?158
  • Q 5.9 : How should a covered entity or business associate respond to a potential breach?159
  • Q 5.10 : When has a breach of unsecured protected health information occurred?159
  • Q 5.11 : What notifications must be provided in response to a breach?161
  • Q 5.12 : How can a covered entity prove it has responded appropriately?163
  • Q 5.13 : What other types of HIPAA violations frequently occur?164
  • Q 5.14 : Is HIPAA compliance really something to worry about?164
  • Q 5.15 : Who is responsible for enforcing HIPAA?165
  • Q 5.16 : What are the civil penalties for violating HIPAA?165
  • Q 5.17 : What are the criminal penalties for violating HIPAA?167
  • Q 5.18 : How does the Office for Civil Rights investigate and resolve HIPAA violations?168
    • Q 5.18.1 : How can the Office for Civil Rights force cooperation with an investigation?170
  • Q 5.19 : How does the Office for Civil Rights ensure HIPAA compliance other than through investigations?171
  • Q 5.20 : What types of enforcement actions have been taken by the Office for Civil Rights for HIPAA violations?171
  • Q 5.21 : What enforcement actions have been taken by state Attorneys General?176
  • Q 5.22 : What enforcement actions have been taken by the Department of Justice?178
  • Q 5.23 : Are future changes to HIPAA’s requirements expected to occur?180
Chapter 6: U.S. Foreign Corrupt Practices Act (FCPA) and Related Laws
  • Q 6.1 : Who is subject to the FCPA?191
  • Q 6.2 : What practices are prohibited by the FCPA?191
    • Q 6.2.1 : Who is a foreign official under the FCPA?192
    • Q 6.2.2 : What is a payment under the FCPA?192
  • Q 6.3 : What affirmative requirements are imposed under the FCPA?193
  • Q 6.4 : How is the FCPA relevant to the health care industry?194
  • Q 6.5 : What are the consequences of violating the FCPA?195
  • Q 6.6 : Are there any exceptions or defenses to the FCPA?196
  • Q 6.7 : What steps should a company take to limit FCPA liability?197
  • Q 6.8 : What other anti-bribery laws may affect health care companies?199
Chapter 7: Managed Care Disputes and Litigation
  • Q 7.1 : Who are the key players in provider/payer disputes?207
    • Q 7.1.1 : What role does the patient play?207
    • Q 7.1.2 : What is a “health care provider”?207
    • Q 7.1.3 : What is a plan or payer?208
    • Q 7.1.4 : With respect to group health plans, what are plan sponsors, fiduciaries, and administrators, and how do their roles differ?208
    • Q 7.1.5 : What is a network?210
    • Q 7.1.6 : What are “re-pricers”?211
  • Q 7.2 : How is the legal relationship between the provider and payer created and defined?212
    • Q 7.2.1 : What is a patient intake process?212
    • Q 7.2.2 : What is an assignment of benefits?212
    • Q 7.2.3 : What happens during the insurance verification process?213
    • Q 7.2.4 : What are the different kinds of legal relationships a provider could have vis-à-vis a payer?214
    • Q 7.2.5 : How do you know which body of law will apply to disputes between payers and providers?215
  • Q 7.3 : What is an Explanation of Benefits?216
    • Q 7.3.1 : What are typical types of disputes that arise upon receipt of an Explain of Benefits?217
    • Q 7.3.2 : What other types of disputes between providers and payers might arise, independent from an Explain of Benefits?218
    • Q 7.3.3 : If a dispute arises, can (and should) a provider rush to court?218
  • Q 7.4 : What is ERISA?218
  • Q 7.5 : What is an ERISA plan?219
  • Q 7.6 : Is a health care provider recognized with standing under ERISA?219
  • Q 7.7 : Does ERISA provide for a claims review or dispute resolution process?220
  • Q 7.8 : What is “administrative exhaustion”?220
  • Q 7.9 : What types of information is a beneficiary or assignee entitled to receive through the ERISA administrative claims process?220
  • Q 7.10 : What are the types of claims that an assignee-provider can bring under ERISA?221
  • Q 7.11 : Where are ERISA claims filed?222
  • Q 7.12 : Is there a right to a jury trial under ERISA?222
  • Q 7.13 : What is the standard of review on a claim for benefits?222
  • Q 7.14 : When can a provider bring fiduciary claims under ERISA?222
  • Q 7.15 : What is the remedy for a failure to produce plan documents?223
  • Q 7.16 : What is the remedy for a plan’s failure to provide full and fair review of claims?223
  • Q 7.17 : Does a provider have to sue under ERISA or can it sue under state law?224
  • Q 7.18 : What types of plans or insurance policies are subject to state law, as opposed to ERISA?224
  • Q 7.19 : How do you know if you if you have a provider/insurer dispute?224
  • Q 7.20 : What state laws govern health insurance policies?225
  • Q 7.21 : Are state insurance laws uniform?225
  • Q 7.22 : What types of state insurance laws bear on a provider/insurer relationship?225
  • Q 7.23 : Will the Affordable Care Act play any role in a reimbursement dispute between a provider and health insurer that is otherwise governed by state law?226
  • Q 7.24 : What types of legal processes are available in state law–governed disputes between providers and health insurers?226
  • Q 7.25 : What are federal employee health benefits plans?227
  • Q 7.26 : What laws and rules govern the administration of Federal Employee Health Benefits plans?228
  • Q 7.27 : How are disputes with Federal Employee Health Benefits plans resolved?228
    • Q 7.27.1 : What are the basic administrative procedures for challenging an adverse benefit determination made by an Federal Employee Health Benefits plan?228
    • Q 7.27.2 : Can Federal Employee Health Benefits plan beneficiaries file suit in court?229
    • Q 7.27.3 : What must be considered when filing a lawsuit challenging an Federal Employee Health Benefits plan’s benefit decisions?229
  • Q 7.28 : How have class actions changed the dynamic of managed care disputes?230
    • Q 7.28.1 : What is a class action lawsuit?230
    • Q 7.28.2 : Are there recent trends in class action litigation that may impact managed care class actions?230
  • Q 7.29 : What is the Ingenix class action litigation and how does it affect health care providers, insurers, and plans?231
    • Q 7.29.1 : What is the genesis of the Ingenix litigation?232
    • Q 7.29.2 : How was this discovered and what types of litigation resulted?233
    • Q 7.29.3 : Have the Ingenix-related investigations and class action lawsuits been resolved?233
    • Q 7.29.4 : What should health care providers and plans take away from the Ingenix litigation?234
  • Q 7.30 : What is In re Managed Care Litigation?235
  • Q 7.31 : What types of cases figure to be the “next wave” of significant managed care litigation?236
  • Q 7.32 : Will the Affordable Care Act increase litigation between providers and insurers/plans?237
Chapter 8: Antitrust and the Health Care Industry
  • Q 8.1 : What are the primary antitrust statutes?242
  • Q 8.2 : Who is covered by the antitrust laws?243
  • Q 8.3 : Who enforces the antitrust laws?243
  • Q 8.4 : What types of conduct are generally prohibited?243
  • Q 8.5 : What penalties may apply?245
  • Q 8.6 : Are certain types of conduct exempt?245
  • Q 8.7 : What types of arrangements with competitors may violate the antitrust laws?246
    • Q 8.7.1 : When can joint purchasing agreements violate the antitrust laws?247
    • Q 8.7.2 : How do Accountable Care Organizations fit into the joint venture scheme?250
  • Q 8.8 : What types of vertical arrangements with suppliers, buyers, or payers may violate the antitrust laws?251
  • Q 8.9 : What types of conduct may constitute a group boycott?252
  • Q 8.10 : How can exclusive contracts with physicians or practice groups violate the antitrust laws?253
  • Q 8.11 : Are most-favored nation clauses legal?254
  • Q 8.12 : What type of conduct could risk allegations of monopolization?255
  • Q 8.13 : When are mergers problematic?256
  • Q 8.14 : When can patents conflict with the antitrust laws?257
  • Q 8.15 : What constitutes illegal price discrimination?258
    • Q 8.15.1 : When can discounts be provided?259
    • Q 8.15.2 : Are any sales exempt?259
Chapter 9: Laws and Regulations Governing Employment Relationships in the Health Care Industry
  • Q 9.1 : Is the exposure of health care employers to liabilities arising from employment any different from risks faced by all employers?265
  • Q 9.2 : What is the difference between an individual claim and a class action?266
  • Q 9.3 : Who is a “health care worker”?267
  • Q 9.4 : Are all “health care workers” employees?268
  • Q 9.5 : What government agencies have authority over employment-related matters?269
  • Q 9.6 : Are there recordkeeping requirements employers must follow?270
  • Q 9.7 : What notice-posting obligations are imposed by federal laws?270
  • Q 9.8 : What practices or decisions by health care employers may be the basis for legal claims or enforcement by government authorities?271
  • Q 9.9 : Are there rules or regulations governing recruitment of new employees?271
  • Q 9.10 : Are there limitations on the information employers can request from prospective applicants?273
  • Q 9.11 : Are there limitations on an employer’s ability to check an applicant’s references?274
  • Q 9.12 : Can an employer be liable for asking for information about an applicant’s health?274
  • Q 9.13 : What information should employers require relating to an applicant’s citizenship status?275
  • Q 9.14 : What rules apply if an applicant is not a citizen of the United States?276
  • Q 9.15 : When a new employee is hired, are they entitled to an employment contract?277
  • Q 9.16 : What is employment at will?277
  • Q 9.17 : Are there exceptions to the rule of employment at will?278
  • Q 9.18 : Are the company policies stated in an employee handbook or oral promises enforceable?278
  • Q 9.19 : Are there rules and regulations that protect employee privacy?279
  • Q 9.20 : Can employers be liable for the wages they pay to their employees?280
  • Q 9.21 : What are the basic requirements of the wage and hour laws?280
  • Q 9.22 : Is the FLSA the only law that regulates wages and hours?281
  • Q 9.23 : When do claims of failure to pay overtime arise?281
  • Q 9.24 : Are there any special rules that recognize the unique staffing requirements of health care employers?282
  • Q 9.25 : Why do health care employers fail to pay overtime to employees who earned it?283
  • Q 9.26 : What are some best practices that employers can follow to avoid wage and hour claims?283
  • Q 9.27 : What federal agency enforces wage and hour laws?284
  • Q 9.28 : How can employees challenge employment decisions?284
  • Q 9.29 : How prevalent are discrimination charges against health care employers?285
  • Q 9.30 : How long does an employee have to file a charge of discrimination?285
  • Q 9.31 : If a charge of discrimination is filed, how is it handled?285
  • Q 9.32 : What happens at the conclusion of an agency’s processing of a discrimination charge?286
  • Q 9.33 : What is a collective bargaining agreement?286
  • Q 9.34 : Who decides if employees will be represented by a union?287
  • Q 9.35 : If employees are not represented by a union, are they protected if they engage in concerted activity?287
  • Q 9.36 : Are there legal protections for employees who report misconduct by their employer or others?288
  • Q 9.37 : What procedures exist for whistleblowers to complain about retaliation?288
  • Q 9.38 : Are there safety standards that apply to health care employers?289
  • Q 9.39 : How does OSHA enforce safety and health standards?290
  • Q 9.40 : What happens during an OSHA inspection?290
  • Q 9.41 : If OSHA issues a citation, what are an employer’s rights?291
  • Q 9.42 : What is an employer’s obligation if an employee is injured on the job?291
  • Q 9.43 : How does workers’ compensation insurance work?292
  • Q 9.44 : Does a worker who is injured on the job have a right to return to work?293
  • Q 9.45 : What is the Family and Medical Leave Act?293
  • Q 9.46 : What agency enforces the Family and Medical Leave Act?294
  • Q 9.47 : Can an employee sue alleging violations of the Family and Medical Leave Act?294
  • Q 9.48 : What is the Employee Retirement Income Security Act?295
  • Q 9.49 : What is the Affordable Care Act?295
  • Q 9.50 : What benefits does the Affordable Care Act require an employer to provide?296
  • Q 9.51 : Does the Affordable Care Act penalize non-compliant employers?296
  • Q 9.52 : Does the Affordable Care Act impose requirements other than the obligation to provide insurance?297
  • Q 9.53 : What is a covenant not to compete?297
Chapter 10: Credentialing and Privileging
  • Q 10.1 : What is credentialing and privileging?304
    • Q 10.1.1 : How do health care providers credential practitioners?304
    • Q 10.1.2 : How do health care providers grant privileges to practitioners?305
  • Q 10.2 : What are red flags in the credentialing process?305
  • Q 10.3 : Can applicants be denied medical staff membership?308
    • Q 10.3.1 : What is a “closed staff”?308
    • Q 10.3.2 : What is an “open staff”?308
  • Q 10.4 : What is the role of the National Practitioner Data Bank?309
  • Q 10.5 : How are new procedures approved and privileges granted?309
  • Q 10.6 : What is the purpose of reappointments?310
  • Q 10.7 : Why do employed physicians have to go through credentialing and privileging?310
  • Q 10.8 : How are physicians decredentialed?311
  • Q 10.9 : What is an incomplete application?311
  • Q 10.10 : What is the Healthcare Quality Improvement Act?312
    • Q 10.10.1 : What constitutes a reasonable belief that the action was in furtherance of quality health care and reasonable effort to obtain the facts of the matter?313
    • Q 10.10.2 : Why are a practitioner’s privileges legally protected?314
  • Q 10.11 : Why is the Healthcare Quality Improvement Act important?315
Chapter 11: Emergency Medical Treatment and Active Labor Act (EMTALA)
  • Q 11.1 : What are the citations for the EMTALA statute and regulations?319
  • Q 11.2 : Who is subject to EMTALA (or has some EMTALA responsibilities)?319
  • Q 11.3 : What are the basic responsibilities under EMTALA?319
  • Q 11.4 : What are the consequences for hospitals that fail to comply with EMTALA?320
  • Q 11.5 : What are the consequences for physicians who fail to comply with EMTALA?320
  • Q 11.6 : Are there private causes of action for an EMTALA violation?321
  • Q 11.7 : Where does CMS publish its interpretation of EMTALA and provide additional guidance?321
  • Q 11.8 : What does it mean to “come to the emergency department”?322
  • Q 11.9 : What is “hospital property”?323
  • Q 11.10 : What is a “dedicated emergency department”?323
  • Q 11.11 : What is an emergency medical condition?324
  • Q 11.12 : What is a medical screening examination?325
  • Q 11.13 : What does it mean to stabilize an individual with an emergency medical condition?325
  • Q 11.14 : What does it mean to have the “capability” to provide a medical screening examination and stabilizing treatment?326
  • Q 11.15 : What does it mean for the hospital to have “capacity” to provide a medical screening examination and stabilizing treatment?326
  • Q 11.16 : Where must a medical screening examination and stabilizing treatment be performed?326
  • Q 11.17 : Who may perform a medical screening examination?327
  • Q 11.18 : How does the law apply to minors?327
  • Q 11.19 : When can a hospital register the individual and inquire about insurance?327
  • Q 11.20 : What about patients who come to a dedicated emergency department, but are not seeking treatment for a potential emergency medical condition?328
  • Q 11.21 : What if an individual presents to a hospital department that is not a dedicated emergency department and is not on the hospital’s main campus?328
  • Q 11.22 : When do EMTALA obligations end?328
  • Q 11.23 : What if a patient refuses a medical screening examination or stabilizing treatment?329
  • Q 11.24 : What is a transfer?329
  • Q 11.25 : When can a hospital transfer a patient?329
  • Q 11.26 : What is an “appropriate transfer”?330
  • Q 11.27 : What if a patient refuses a transfer?331
  • Q 11.28 : Under what circumstances must a hospital accept a transfer?331
  • Q 11.29 : What is a “specialized capability or facility”?331
  • Q 11.30 : Do hospitals have to accept “lateral” transfers from other hospitals?332
  • Q 11.31 : How is “capacity” assessed?332
  • Q 11.32 : Does the hospital have to accept the transfer of an inpatient from another hospital?332
  • Q 11.33 : Does the receiving hospital have any reporting requirements?332
  • Q 11.34 : What are EMTALA’s basic requirements regarding call panels?333
  • Q 11.35 : What medical specialties must be present on a call panel?333
  • Q 11.36 : What are the obligations of physicians who are on call?335
    • Q 11.36.1 : What happens if an on-call physician fails to come to the hospital when asked?335
    • Q 11.36.2 : May a physician serve on more than one hospital’s call panel at once?335
    • Q 11.36.3 : May a physician see scheduled patients while on-call?336
    • Q 11.36.4 : May a hospital pay for physician service on the call panel?336
    • Q 11.36.5 : May groups of hospitals establish community call panels?339
    • Q 11.36.6 : May an on-call physician evaluate the patient through a telemedicine connection?340
    • Q 11.36.7 : May the hospital identify a physician group, rather than individual physicians, on the on-call panel?341
    • Q 11.36.8 : May an on-call physician send a physician extender (such as a physician assistant or nurse practitioner) to the emergency department in his or her stead?341
    • Q 11.36.9 : May an on-call physician direct the dedicated emergency department to send the individual to his or her office or to another hospital, rather than the on-call physician coming to the dedicated emergency department to see the patient?342
    • Q 11.36.10 : May on-call physicians inquire about a patient’s payment or insurance status?342
    • Q 11.36.11 : Will an on-call physician’s failure to come to the emergency department always be deemed an EMTALA violation?342
  • Q 11.37 : Can the hospital exempt certain classes of individuals from call-panel participation?343
  • Q 11.38 : What kinds of policies does EMTALA require a hospital to have?343
  • Q 11.39 : What signage does EMTALA require a hospital to have?344
  • Q 11.40 : Are there reporting requirements in EMTALA?345
  • Q 11.41 : How do CMS and the OIG learn about potential EMTALA violations?345
  • Q 11.42 : What happens once CMS learns of a potential EMTALA violation?346
  • Q 11.43 : What is the purpose of a survey?346
  • Q 11.44 : What happens after the survey concludes?346
  • Q 11.45 : Does the hospital have an opportunity to submit additional information prior to CMS issuing a Statement of Deficiencies?347
  • Q 11.46 : If CMS finds that an EMTALA violation occurred, what determines whether it will begin a termination action?348
  • Q 11.47 : Can hospitals that violate EMTALA avoid termination from the Medicare program without having to submit to an administrative hearing?349
  • Q 11.48 : Can hospitals that violate EMTALA avoid or reduce a civil monetary penalty without having to submit to an administrative hearing?350
  • Q 11.49 : How can a hospital challenge the termination of its provider agreement and/or a civil monetary penalty?351
  • Q 11.50 : How can a hospital improve its compliance with EMTALA?351
  • Q 11.51 : How does EMTALA affect state laws?352
  • Q 11.52 : When should a hospital contact its attorney regarding EMTALA compliance?352
  • Q 11.53 : Are EMTALA requirements and sanctions ever waived?353
Chapter 12: Fraud and Abuse Litigation in the Pharmaceutical Industry
  • Q 12.1 : What are some legal bases for lawsuits against pharmaceutical manufacturers related to alleged fraud and abuse?358
  • Q 12.2 : What does the AKS prohibit?359
    • Q 12.2.1 : What are the penalties for violating the AKS?359
    • Q 12.2.2 : What activities are exempt from the AKS?359
  • Q 12.3 : What does the False Claims Act prohibit?362
    • Q 12.3.1 : Who can bring a lawsuit under the fraud and abuse laws?362
    • Q 12.3.2 : What penalties may be imposed for violations of the FCA?363
  • Q 12.4 : What does the FDCA require and prohibit?363
  • Q 12.5 : Do state laws also raise fraud and abuse concerns?363
  • Q 12.6 : What fraud and abuse laws are implicated by the sales and marketing activities of pharmaceutical manufacturers?364
  • Q 12.7 : What types of sales and promotional practices can implicate federal and state anti-kickback laws?365
  • Q 12.8 : What guidance is available to manufacturers relating to fraud and abuse exposure stemming from sales and marketing activities?365
    • Q 12.8.1 : How can a manufacturer mitigate fraud and abuse exposure related to the provision of discounts?366
    • Q 12.8.2 : How can a manufacturer mitigate fraud and abuse exposure related to consulting/speaker arrangements?366
    • Q 12.8.3 : How can a manufacturer mitigate fraud and abuse exposure related to educational grants?368
    • Q 12.8.4 : How can a manufacturer mitigate fraud and abuse exposure related to the provision of gifts and meals?368
  • Q 12.9 : What pricing issues create fraud and abuse concerns under Medicaid?369
  • Q 12.10 : What aspects of drug pricing may raise fraud and abuse concerns?370
    • Q 12.10.1 : What risks arise out of reporting AWP?373
    • Q 12.10.2 : What risks arise out of reporting AMP and Best Price?374
  • Q 12.11 : How do price reporting and pricing practices related to the Department of Veterans Affairs/FSS program create fraud and abuse concerns?376
  • Q 12.12 : What are manufacturer-sponsored drug coupon programs?377
  • Q 12.13 : What risks may arise from manufacturer-sponsored drug coupon programs?378
    • Q 12.13.1 : Has there been litigation involving coupon programs?379
    • Q 12.13.2 : Is there any federal guidance addressing coupon programs?380
  • Q 12.14 : What constitutes off-label promotion?380
    • Q 12.14.1 : May a health care practitioner prescribe a drug for an off-label use?380
    • Q 12.14.2 : Is it illegal for a pharmaceutical manufacturer to promote a drug for an off-label use?380
  • Q 12.15 : Is there any FDA guidance governing the distribution of scientific materials discussing the off-label use of a drug by pharmaceutical manufacturers to physicians and health care professionals?381
  • Q 12.16 : What are the legal bases for lawsuits alleging off-label promotion?381
  • Q 12.17 : What are some examples of litigation against pharmaceutical manufacturers alleging off-label promotion?381
  • Q 12.18 : What risks are there related to marketing an unapproved drug?384
  • Q 12.19 : What is the “responsible corporate officer” or Park doctrine?386
  • Q 12.20 : Have pharmaceutical manufacturer executives been held personally liable under the Park doctrine?386
  • Q 12.21 : When can a pharmaceutical company executive be excluded from Medicare and Medicaid due to pharmaceutical manufacturer conduct?387
    • Q 12.21.1 : Has the OIG excluded any pharmaceutical manufacturer executives under its permissive exclusion authority?387
    • Q 12.21.2 : Has the OIG promulgated any guidance interpreting its permissive exclusion authority?388
Chapter 13: Civil Monetary Penalty Law
  • Q 13.1 : What is the purpose of the Civil Monetary Penalty Law?396
  • Q 13.2 : Who enforces the Civil Monetary Penalty Law?396
  • Q 13.3 : What types of conduct are generally prohibited under the Civil Monetary Penalty Law?396
  • Q 13.4 : Who is subject to the Civil Monetary Penalty Law?397
  • Q 13.5 : Is the Civil Monetary Penalty Law a strict liability statute or intent-based?397
  • Q 13.6 : Did the Patient Protection and Affordable Care Act of 2010 affect the Civil Monetary Penalty Law?397
  • Q 13.7 : What is the statute of limitations for when the OIG can commence an action to recover Civil Monetary Penalties?398
  • Q 13.8 : Is there one flat rate for Civil Monetary Penalties?399
    • Q 13.8.1 : What factors are considered when determining the amount of the Civil Monetary Penalty or assessment?399
    • Q 13.8.2 : What are some recent examples of the OIG assessment of Civil Monetary Penalties?400
  • Q 13.9 : Are the OIG’s implementing regulations identical to the Civil Monetary Penalty Law?401
  • Q 13.10 : What types of conduct may lead the OIG to seek Civil Monetary Penalties?402
    • Q 13.10.1 : What types of conduct potentially constitute “false claims” under the Civil Monetary Penalty Law?402
    • Q 13.10.2 : How does the Civil Monetary Penalty Law differ from the False Claims Act?403
    • Q 13.10.3 : How can working with “excluded persons” get you in trouble under the Civil Monetary Penalty Law?403
  • Q 13.11 : Are gainsharing arrangements a violation of the Civil Monetary Penalty Law?403
    • Q 13.11.1 : Does the Civil Monetary Penalty Law make a distinction between paying a physician to refrain from furnishing medically unnecessary services vs. paying a physician to refrain from furnishing medically necessary services?404
  • Q 13.12 : How does the OIG seek Civil Monetary Penalties?404
  • Q 13.13 : Is a Civil Monetary Penalty proceeding criminal in nature?404
  • Q 13.14 : Can the imposition of Civil Monetary Penalties be appealed?404
  • Q 13.15 : For what kinds of violations is CMS authorized to assess Civil Monetary Penalties?405
  • Q 13.16 : Has the Affordable Care Act expanded CMS’s ability to impose Civil Monetary Penalties?406
  • Q 13.17 : Has HHS ever imposed Civil Monetary Penalties for a violation of HIPAA?406
Chapter 14: Medicare Administrative Litigation
  • Q 14.1 : What are the basic requirements to engage in a Medicare appeal?410
  • Q 14.2 : What levels of appeal are generally available in the Medicare appeals processes?410
  • Q 14.3 : How is an Administrative Law Judge hearing requested?411
    • Q 14.3.1 : What can be expected at an Administrative Law Judge hearing?412
    • Q 14.3.2 : Are witnesses permitted at an Administrative Law Judge hearing?412
    • Q 14.3.3 : What happens at the pre-hearing conference?413
    • Q 14.3.4 : What happens after the Administrative Law Judge hearing?413
  • Q 14.4 : What is the Departmental Appeals Board review process?413
  • Q 14.5 : When does the Medicare Appeals Council review an Administrative Law Judge’s decision?414
  • Q 14.6 : Is judicial review available?414
  • Q 14.7 : What informal appeal rights exist?415
  • Q 14.8 : What is the time limit to file appeals?416
    • Q 14.8.1 : When must appeals be filed for denied claims?416
    • Q 14.8.2 : When must an appeal be filed for an Administrative Law Judge hearing?417
    • Q 14.8.3 : What is the time limit to file suit?417
  • Q 14.9 : Who bears the burden of proof in Medicare appeals?417
  • Q 14.10 : Is discovery generally available to appellants?418
    • Q 14.10.1 : Which appeals processes permit the appellant to seek discovery?418
  • Q 14.11 : How is an Administrative Law Judge hearing conducted?420
  • Q 14.12 : How does a reopening differ from an appeal?421
    • Q 14.12.1 : What is the time limit to request a reopening?421
  • Q 14.13 : Are National Coverage Determinations and Local Coverage Determinations appealable?422
    • Q 14.13.1 : How are Local Coverage Determinations appealed?423
    • Q 14.13.2 : How are National Coverage Determinations appealed?424
    • Q 14.13.3 : Under what standard will an Administrative Law Judge review a National Coverage Determination or Local Coverage Determination appeal?424
  • Q 14.14 : What is the Provider Reimbursement Review Board appeals process?424
    • Q 14.14.1 : How can a Provider Reimbursement Review Board decision be appealed?425
  • Q 14.15 : What is the process for a provider to appeal the termination of its provider agreement?425
  • Q 14.16 : How can a supplier appeal the National Supplier Clearinghouse’s determinations regarding a Medicare Supplier Number?426
  • Q 14.17 : What appeals are available to challenge a Quality Improvement Organization determination?427
  • Q 14.18 : What is the process for a Clinical Laboratory Improvement Amendments laboratory to appeal an initial determination?428
  • Q 14.19 : What appeals are available to challenge a Medicare Geographic Classification Review Board determination?429
  • Q 14.20 : How does a hospital appeal the amount of its Electronic Health Record incentive payment award?430
  • Q 14.21 : What is the process for appealing Hospital Value-Based Purchasing Program awards?431
  • Q 14.22 : What appeals are available under Medicare Part D?432
    • Q 14.22.1 : What is the process for a Medicare Part D plan sponsor to appeal a contract termination, non-renewal of a contract, or immediate sanction?432
    • Q 14.22.2 : How does a Medicare Part D plan sponsor appeal an initial determination regarding the imposition of a civil monetary penalty?433
    • Q 14.22.3 : How does a Medicare Part D enrollee request a redetermination or reconsideration of a Part D sponsor’s coverage determination?434
  • Q 14.23 : What is the appeals process for Medicare Advantage enrollees?434
    • Q 14.23.1 : What are the levels of appeals for Medicare Advantage appeals?435
  • Q 14.24 : What is the process for appealing Medicare Advantage contract determinations?437
  • Q 14.25 : What is the process for appealing Medicare Advantage intermediate sanctions?438
  • Q 14.26 : What is the process to appeal an exclusion from the federal health care programs or appeal a Civil Monetary Penalty assessed by the OIG?438
  • Q 14.27 : What appeal rights are available to practitioners and entities that have been sanctioned following a Quality Improvement Organization recommendation?439
  • Q 14.28 : What less-common appeals may be available?440
Chapter 15: Patent Protection & Enforcement
  • Q 15.1 : What types of patents are relevant to the health care sector?446
  • Q 15.2 : How does one obtain a patent?447
  • Q 15.3 : How are patents enforced?447
  • Q 15.4 : What is patent infringement?448
  • Q 15.5 : Does owning a patent guarantee protection?448
  • Q 15.6 : Does the cost of patent litigation differ from typical civil litigation?449
  • Q 15.7 : How long can a patent litigation matter last?451
  • Q 15.8 : In which courts may patent disputes be litigated?451
    • Q 15.8.1 : Why would a company choose a U.S. District Court?451
    • Q 15.8.2 : Why choose the International Trade Commission?453
    • Q 15.8.3 : When are proceedings before the Patent Office?454
  • Q 15.9 : How do initial pleadings (including the complaint) differ from other litigation?454
  • Q 15.10 : How does discovery differ from civil litigation?455
  • Q 15.11 : How will the court construe the scope of the applicable patent?455
  • Q 15.12 : Are patent cases often decided through summary judgment?456
  • Q 15.13 : What remedies are available in patent cases?457
  • Q 15.14 : What is Hatch-Waxman litigation?457
  • Q 15.15 : How common is Hatch-Waxman litigation?458
  • Q 15.16 : How does Hatch-Waxman litigation differ from a typical patent case?458
  • Q 15.17 : How can a company protect employees’ development of valuable patent and IP rights?459
  • Q 15.18 : How can patents be managed if federal funding was used to invent the subject matter?460
  • Q 15.19 : What are NPEs (non-practicing entities—otherwise known as “patent trolls”) and what risk do they pose?461
  • Q 15.20 : What strategies may strengthen the ability to challenge a patent troll?462
  • Q 15.21 : How does licensing fit into dispute management?462
Chapter 16: Contractual Non-Compete and Confidentiality Clauses
  • Q 16.1 : Are non-compete agreements governed by any laws?469
    • Q 16.1.1 : What state laws regulate non-compete agreements?469
    • Q 16.1.2 : What federal laws regulate non-compete agreements?470
    • Q 16.1.3 : What professional health care organizations regulate non-compete agreements?472
  • Q 16.2 : Are non-compete agreements permissible in every state?473
  • Q 16.3 : Are non-compete agreements in the health care industry viewed differently from those in other industries?473
  • Q 16.4 : Who can be subject to a non-compete agreement?475
  • Q 16.5 : How do the courts generally construe the applicability of non-compete agreements?475
  • Q 16.6 : What types of conduct violate a non-compete agreement?476
  • Q 16.7 : Is any type of conduct exempt from non-compete agreements?478
  • Q 16.8 : How do courts determine whether a non-compete agreement is lawful?478
    • Q 16.8.1 : How do courts determine whether timing is reasonable?479
    • Q 16.8.2 : How do courts determine whether geographical restrictions are reasonable?480
    • Q 16.8.3 : How do courts determine whether an employee subject to a non-compete has been unreasonably injured by it?481
    • Q 16.8.4 : How do courts determine whether a non-compete agreement is necessary?481
    • Q 16.8.5 : How do courts determine whether the public’s interest in the employee’s inability to practice should overcome enforcement of the non-compete?482
  • Q 16.9 : What are the cross-border implications of non-compete agreements?483
  • Q 16.10 : What are some circumstances in which non-compete agreements are enforceable?483
  • Q 16.11 : What are some circumstances in which non-compete agreements are unenforceable?484
  • Q 16.12 : How are non-compete agreements enforced or challenged?484
  • Q 16.13 : What penalties may apply if a party violates a non-compete agreement?485
  • Q 16.14 : How do courts handle a non-compete agreement that is only partially enforceable?486
  • Q 16.15 : What laws regulate confidentiality agreements?488
    • Q 16.15.1 : How does the Uniform Trade Secrets Act regulate confidentiality agreements?488
    • Q 16.15.2 : How does the Computer Fraud and Abuse Act regulate confidentiality agreements?489
    • Q 16.15.3 : How does the Economic Espionage Act regulate confidentiality agreements?489
    • Q 16.15.4 : How does state common law regulate confidentiality agreements?490
  • Q 16.16 : Who can be held liable for violation of confidentiality laws?490
  • Q 16.17 : Is there a time limit for enforcing a confidentiality agreement?491
  • Q 16.18 : Are confidentiality agreements in the health care industry viewed differently from those in other industries?492
  • Q 16.19 : Are certain types of conduct exempt from confidentiality agreements?492
  • Q 16.20 : What other laws could impact contracts with confidentiality agreements?492
  • Q 16.21 : What is the scope of a confidentiality agreement?493
  • Q 16.22 : Is a confidentiality agreement enough to protect the company’s proprietary information?493
  • Q 16.23 : How specific do confidentiality agreements need to be?494
    • Q 16.23.1 : How specific do confidentiality agreements protecting trade secrets need to be?494
    • Q 16.23.2 : How specific do confidentiality agreements protecting other confidential information need to be?495
  • Q 16.24 : What types of conduct comprise misappropriation of trade secrets in violation of confidentiality agreements?495
  • Q 16.25 : What types of conduct comprise misappropriation of other confidential information in violation of confidentiality agreements?497
  • Q 16.26 : How are confidentiality agreements enforced?497
    • Q 16.26.1 : How are confidentiality agreements enforced under state law?498
    • Q 16.26.2 : How are confidentiality agreements enforced under the Computer Fraud and Abuse Act?499
    • Q 16.26.3 : How are confidentiality agreements enforced before federal agencies?499
  • Q 16.27 : What remedies may apply if a party violates a confidentiality agreement?500
  • Q 16.28 : Can a confidentiality agreement be enforced where a companion non-compete agreement is found unlawful?501
Chapter 17: Elder Abuse and Quality of Care Issues in the Long-Term Care Setting
  • Q 17.1 : How can I avoid being sued in the first place?512
  • Q 17.2 : What are some signs that a lawsuit may be coming?513
  • Q 17.3 : What should I do if I receive a demand from the resident or their family member requesting a copy of their medical record?513
  • Q 17.4 : The medical record is missing important entries. How does this affect my case?513
  • Q 17.5 : If I believe a lawsuit may be forthcoming, what can I do now to prepare?514
    • Q 17.5.1 : What should I look for in choosing defense counsel?514
  • Q 17.6 : If a lawsuit has just been filed, should I start investigating the allegations in the complaint?515
  • Q 17.7 : Must I go to court?515
    • Q 17.7.1 : What does the mediation process entail?515
    • Q 17.7.2 : What are some considerations to take into account in choosing a mediator?515
    • Q 17.7.3 : When is an arbitration agreement enforceable?516
    • Q 17.7.4 : The arbitration agreement was signed by the resident’s “responsible person.” Is that enough to make the agreement binding on the resident?517
    • Q 17.7.5 : Is arbitration “better” than going to court?517
    • Q 17.7.6 : If the trial court denies enforcement of the arbitration clause, do I have to go to court?518
  • Q 17.8 : What can the facility do to challenge the allegations in the lawsuit?518
  • Q 17.9 : Can the facility cross-claim against the individual practitioner who actually provided the care at issue?518
  • Q 17.10 : How can I best protect the facility’s parent company from liability?519
  • Q 17.11 : What experts should I retain in defending the case?519
  • Q 17.12 : What should I look for in hiring an expert?519
  • Q 17.13 : Should I hire an independent nurse expert?520
  • Q 17.14 : Is it necessary to have both physician and nursing experts?520
  • Q 17.15 : When should I retain the experts?520
  • Q 17.16 : What sort of information should I focus on in propounding discovery?521
  • Q 17.17 : What are some strategies to use in responding to the plaintiff’s discovery requests?521
  • Q 17.18 : Should I settle even if I believe I have a strong case?521
  • Q 17.19 : Is it ever preferable to agree to an exorbitant settlement rather than go to trial?522
  • Q 17.20 : Is there a way to estimate how much it would cost to settle the case?522
  • Q 17.21 : Is there anything that I can do to encourage my insurance carrier to agree to a settlement within policy limits?523
  • Q 17.22 : What factors are considered in determining settlement value?523
  • Q 17.23 : If the plaintiff agreed to take care of Medicare and Medicaid liens, does this mean that the facility need no longer worry about these liens?524
  • Q 17.24 : Are plaintiffs motivated to settle?524
  • Q 17.25 : What are some indications that a case is not amenable to settlement?525
  • Q 17.26 : What are some important clauses to include in a settlement agreement?525
  • Q 17.27 : Is there a way to keep certain evidence or issues from being presented to the jury?525
  • Q 17.28 : Do I really need to have facility staff testify at trial?526
Chapter 18: Criminal Enforcement in the Health Care Sector
  • Q 18.1 : Who enforces the criminal laws governing the conduct of health care providers?530
  • Q 18.2 : How do federal criminal statutes apply in the health care sector?532
  • Q 18.3 : What are the primary criminal statutes applicable specifically to the health care industry?533
    • Q 18.3.1 : What is the Anti-Kickback Statute?534
    • Q 18.3.2 : How can violations of the federal Food, Drug, and Cosmetic Act lead to criminal liability?534
    • Q 18.3.3 : How can violations of the Health Insurance Portability and Accessibility Act lead to criminal liability?535
    • Q 18.3.4 : What other criminal statutes do prosecutors frequently utilize when prosecuting health care–related offenses?535
    • Q 18.3.5 : Can a person be held criminally liable for interfering with a government investigation?536
    • Q 18.3.6 : What are the non-health-care-specific sources of criminal liability?537
  • Q 18.4 : Who investigates criminal violations related to health care?539
    • Q 18.4.1 : How do federal agencies coordinate health care–related investigations?539
    • Q 18.4.2 : How do federal agencies investigate criminal violations related to health care?541
  • Q 18.5 : What is an administrative subpoena?541
    • Q 18.5.1 : Who can issue an administrative subpoena?543
    • Q 18.5.2 : How are administrative subpoenas enforced?544
  • Q 18.6 : What is a grand jury subpoena?544
  • Q 18.7 : If I don’t want to comply with a subpoena, can I ask a court to intervene?545
  • Q 18.8 : Are there any special considerations that arise when a health care provider or other HIPAA “covered entity” gets a subpoena for records?546
  • Q 18.9 : What other traditional law enforcement tools can investigators use in health care cases?547
  • Q 18.10 : How are grand jury investigations conducted?549
  • Q 18.11 : How are criminal charges filed?551
  • Q 18.12 : What happens post-indictment?552
  • Q 18.13 : What types of penalties may be incurred for violations of federal criminal laws?553
Chapter 19: Health Care Compliance
  • Q 19.1 : What laws and regulations should compliance programs target?559
  • Q 19.2 : What are the objectives of maintaining an effective compliance program?560
  • Q 19.3 : Who should have a compliance program?562
  • Q 19.4 : Are there other resources that providers and suppliers can look to while the government finalizes its regulations?563
  • Q 19.5 : What are the characteristics of an effective compliance program?564
    • Q 19.5.2 : Does the compliance program have to be documented in writing?565
    • Q 19.5.3 : What are the functions of the compliance officer and compliance committee?565
    • Q 19.5.4 : What is included in an effective compliance training and education program?568
    • Q 19.5.5 : What are the objectives of the communication component of a compliance program?569
    • Q 19.5.6 : What steps should an organization take to monitor compliance and the effectiveness of its compliance program?571
    • Q 19.5.7 : What can an organization do to enforce its standards and deter misconduct?572
    • Q 19.5.8 : How can an organization respond promptly to detected offenses and develop corrective action?573
  • Q 19.6 : How can an organization identify its particular risk areas?573
  • Q 19.7 : What are the ACA compliance requirements that are specific to skilled nursing facilities and nursing facilities?574
  • Q 19.8 : What do I do if I identify a significant compliance concern?576
Chapter 20: E-Discovery
  • Q 20.1 : What is electronically stored information?582
  • Q 20.2 : When did parties become obligated to include electronically stored information in discovery in litigation?583
  • Q 20.3 : What role does the party’s document retention policy play in the discovery process?584
  • Q 20.4 : What issues beyond e-discovery should be considered in setting retention policies?585
    • Q 20.4.1 : Who within the organization develops and applies document retention policies?585
    • Q 20.4.2 : What types of outside assistance may be required to manage electronically stored information preservation?585
  • Q 20.5 : What is a litigation hold?586
  • Q 20.6 : What is a “safe harbor”?587
    • Q 20.6.1 : What is the “routine” operation of an information system?587
    • Q 20.6.2 : What is the “good faith” required for the safe harbor to apply?587
  • Q 20.7 : What are the sanctions for a failure to preserve electronically stored information?588
  • Q 20.8 : What are the requirements for preserving electronically stored information?589
  • Q 20.9 : How do parties plan for discovery?589
    • Q 20.9.1 : When do the parties hold the discovery planning conference?591
    • Q 20.9.2 : What is prepared following the discovery planning conference?591
  • Q 20.10 : How does a producing party review electronically stored information?591
    • Q 20.10.1 : What is a “quick peek” protocol?592
    • Q 20.10.2 : What is a “clawback” protocol?592
  • Q 20.11 : How is electronically stored information produced?592
  • Q 20.12 : How is a production supplemented with newly available information?593
  • Q 20.13 : How can HIPAA-protected information be managed in an electronically stored information production?593
Chapter 21: Attorney-Client Privilege and Work Product Doctrine
  • Q 21.1 : What is required for the attorney-client privilege to apply?596
    • Q 21.1.1 : What is a communication?597
    • Q 21.1.2 : Whose communications may be privileged?598
    • Q 21.1.3 : Who qualifies as an attorney?599
    • Q 21.1.4 : Who qualifies as a privileged agent of the client and the lawyer?600
    • Q 21.1.5 : When is communication between privileged parties considered to be “in confidence”?602
    • Q 21.1.6 : What is considered “legal assistance”?602
    • Q 21.1.7 : What is the crime-fraud exception to the attorney-client privilege?604
  • Q 21.2 : What is the work product doctrine?604
    • Q 21.2.1 : What constitute “documents and tangible things”?605
    • Q 21.2.2 : What does it mean for work product to be “prepared by or for a party”?605
    • Q 21.2.3 : What does it mean for the document to be prepared “in anticipation of litigation or trial”?605
    • Q 21.2.4 : When will a court order disclosure of otherwise protected work product?606
  • Q 21.3 : Who may assert or waive the attorney-client privilege and work product protection on behalf of the company?607
  • Q 21.4 : How are attorney-client privilege and work product protections asserted?607
  • Q 21.5 : How are the attorney-client privilege and work product protections waived?608
    • Q 21.5.1 : What is involved in a voluntary waiver of attorney-client privilege and work product protections during a government investigation?608
    • Q 21.5.2 : What are intentional uses of privileged communications that may result in unintentional waivers?610
    • Q 21.5.3 : What is an inadvertent waiver and how can it be cured?612
    • Q 21.5.4 : What happens when a privileged communication or protected work product is disclosed involuntarily?613
    • Q 21.5.5 : What is the scope of waiver when a client waives attorney-client privilege or work product protection?614
  • Q 21.6 : What is the joint defense privilege and common interest doctrine?615
  • Q 21.7 : Does the attorney-client privilege apply internationally?616
  • Q 21.8 : What is the self-critical analysis privilege?616
Chapter 22: Alternative Dispute Resolution
  • Q 22.1 : What is alternative dispute resolution?628
  • Q 22.2 : What are the different models of alternative dispute resolution?628
  • Q 22.3 : What are the benefits of alternative dispute resolution?632
  • Q 22.4 : Who provides health care–specific alternative dispute resolution services?634
  • Q 22.5 : What are the benefits of mediation?635
  • Q 22.6 : What are the different styles of mediation?635
    • Q 22.6.1 : What is evaluative mediation?636
    • Q 22.6.2 : What is facilitative mediation?636
    • Q 22.6.3 : What is transformative mediation?637
  • Q 22.7 : What are important qualifications when selecting a mediator?637
  • Q 22.8 : What happens at the mediation?638
  • Q 22.9 : What are relevant laws and legal issues in mediation?639
  • Q 22.10 : Is health care fraud amenable to mediation?640
  • Q 22.11 : What happens in an arbitration?640
  • Q 22.12 : What are important qualifications when selecting an arbitrator?641
  • Q 22.13 : What issues will need to be determined by the parties when agreeing to arbitrate a dispute?641
  • Q 22.14 : What are relevant laws and legal issues in arbitration?643
  • Q 22.15 : What are the drawbacks of arbitration?644
Appendix A: The False Claims Act Statute
Appendix B: The Anti-Kickback Statute
Appendix C: The Stark Law
Appendix D: DOJ & FTC Statements of Antitrust Enforcement Policy in Health Care
Appendix E: OIG Compliance Guidance for Hospitals
Appendix F: OIG Compliance Guidance for Hospices
Appendix G: OIG Compliance Guidance for Durable Medical Equipment Suppliers
Appendix H: OIG Compliance Guidance for Nursing Facilities
Appendix I: OIG Compliance Guidance for Pharmaceutical Manufacturers
Appendix J: Sample Corporate Integrity Agreement
  Index

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