2013 Health Law Seminar


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  • 2013 Health Law Seminar

    1. 1. Health Law Seminar November 7, 2013 Presented by Stephen D. Barham * James L. Catanzaro, Jr. * Justin L. Furrow Douglas S. Griswold * Rosemarie L. Hill * Calvin B. Marshall, Jr. © 2013 Chambliss, Bahner & Stophel, P.C. All Rights Reserved. Chambliss, Bahner & Stophel, P.C. Liberty Tower • 605 Chestnut Street, Suite 1700 • Chattanooga, TN 37450 chamblisslaw.com
    2. 2. Stephen D. Barham and Douglas S. Griswold Legal Update ACA, Health Care Liability and State Statutory Update 2
    3. 3. Douglas S. Griswold Affordable Care Act 2014 Update 3
    4. 4. Employer Mandate • On July 2, 2013, Treasury Department delayed the Employer Shared Responsibility provision until 2015. 4
    5. 5. Impact to Other ACA Provisions • Delay of employer mandate does not impact: – Individual mandate • However, open enrollment through Exchanges pushed back to March 31 – Implementation of Exchanges • SHOP Exchange delays(?) – Tax subsidies for individuals – Other fees and taxes, including PCORI fees and transitional reinsurance fees 5
    6. 6. Other Delays • Department of Labor has delayed until 2015 certain reporting obligations on large employers about the health care coverage offered to employees – Employers still "encouraged" to report in 2014 6
    7. 7. Reporting Requirements for 2013 and 2014 7
    8. 8. W-2 Reporting • Employers must report aggregate cost of health insurance on each employee's W-2 – Effective for 2012 tax year • Applicable to employers that file 250 or more W2s 8
    9. 9. Summary of Benefits and Coverage • Uniform, concise, easy to read 4 page summary of benefits and coverage • Provided to all employees • Provided at initial enrollment, open enrollment and upon request • Effective on all plans renewing after October 1, 2012 9
    10. 10. Notice of Exchange • Employers required to notify all employees regarding availability of subsidized health insurance exchange coverage – Model notice available at www.dol.gov • Required as of October 1, 2013 10
    11. 11. Small Business Tax Credits 11
    12. 12. Who Qualifies? • Applies to small businesses with fewer than 25 full-time equivalent employees making an average of $50,000 a year or less and who pay at least 50% of full-time employees' premium costs – Don't need to offer coverage to part-time employees or dependents 12
    13. 13. Tax Credit • Starting in 2014, tax credit worth up to 50% of employer contribution towards employees' premium costs – 35% for tax-exempt employers • Credit is highest for employers with 10 or less employees who are paid an average of $25,000 or less 13
    14. 14. Example • Number of employees: 10 • Wages: $250,000 • Employer contribution to premiums: $70,000 • Tax credit amount: $35,000 (50% of employer's contribution) 14
    15. 15. Hospitals & Physicians Payment Reforms 15
    16. 16. Primary Care Physicians' Bonus • 10% bonus payment to primary care physicians and to general surgeons practicing in health professional shortage areas • Ends December 31, 2015 16
    17. 17. Medicaid Incentives • Medicaid payments increased to 100% of Medicare rates for primary care services furnished by primary care physicians • Applies for 2013 and 2014 17
    18. 18. Physician Quality Data Reporting • Physicians who fail to submit quality data to Physician Quality Reporting System (PQRS) will have Medicare payments reduced starting in 2015 18
    19. 19. Hospital Readmission Reductions • Payments reduced for hospitals experiencing hospital-acquired infections or excessive readmissions. – Maximum payment reduction is 2% in 2014 and will be capped at 3% in 2015 and beyond. 19
    20. 20. DSH Payment Reductions • Effective on or after FY 2014, hospitals will receive 25% of the amount they previously would have received under the current formula for Medicare DSH. 20
    21. 21. Questions? 21
    22. 22. Stephen D. Barham Health Care Liability 22
    23. 23. Medical Malpractice Lawsuits Year State Hamilton County 2006 – 2007 583 20 2007 – 2008 537 17 23
    24. 24. Health Care Liability Lawsuits Year State Hamilton County 2006 – 2007 583 20 2007 – 2008 537 17 2011 – 2012 374 32 24
    25. 25. Griffith v. Goryl • Bladder cancer diagnosis and treatment case • Appeal focused on expert's knowledge of the local community • Expert must know the community and explain his/her opinion with more than just what the majority of the community does 25
    26. 26. Watkins v. Affiliated Internists • 27 year old died from acute drug intoxication from prescription drugs • Doctor allegedly failed to properly oversee the physician assistant prescribing drugs • Family attempted to establish case by negligence per se – meaning so obvious as to not even require an expert • Medical malpractice must have a qualified expert to testify as to the breach and causation in almost every case 26
    27. 27. Barnett v. Tennessee Orthopaedic Alliance • Plaintiff fired counsel and acted on her own • Dispute was over course of care for neck injury • Plaintiff was granted multiple extensions to obtain expert • Plaintiff's expert admitted not having knowledge of the key standard of care at issue • Defendant received Summary Judgment based on plaintiff's failure to obtain an expert • Defendant was also awarded discretionary costs and costs of defending the appeal 27
    28. 28. Williams-Ali v. Mountain States Health Alliance • Plaintiff fell from the table during a nuclear stress test • Plaintiff alleged ordinary negligence and did not comply with the medical malpractice statutes • Plaintiff was 68 years old, over 300 lbs. and had suffered prior stroke leading to some paralysis • Dispute turned on whether proper restraint of patient for test was within Medical Malpractice Act coverage 28
    29. 29. Williams-Ali v. Mountain States Health Alliance • Are the alleged negligent acts "basic" or "routine non-medical?" • Was the injury unrelated to the performance of an actual medical service that required specialized skill or training? • Here the technicians made decisions based on their assessment of the patient using their training expertise and experience • The Medical Malpractice Act applies and Plaintiff should give the presuit notice and provide an expert to testify regarding the standard of care 29
    30. 30. New State Laws • Mammography records must be retained for 10 years following patient discharge from a hospital or death 30
    31. 31. New State Laws • Breast Cancer Prevention Act – Sets out warning to patients with dense breast tissue regarding the tissue making it harder to evaluate test results and potential association with an increased risk of breast cancer – Expressly states there is no legal obligation for failure to comply 31
    32. 32. Pharmacy • Prohibits nurse practitioners and physician assistants from prescribing schedule II, III, and IV controlled substances unless certain limited conditions are met 32
    33. 33. Pharmacy • Limits the schedule II or III opioid that nurse practitioners and physician assistants can prescribe to an opioid listed on the formulary and only for a maximum of a non-refillable, 30-day course of treatment, unless prescription in question is specifically authorized by the formulary or expressly approved after consultation with the supervising physician before the prescription or before dispensing the medication 33
    34. 34. Pharmacy • Chasing over prescribers – The Department of Health instructed to: • Identify the top 50 prescribers of controlled substances from the previous calendar year • Send a notice letter to each nurse practitioner, physician assistant, and physician on the list 34
    35. 35. Pharmacy • Within 15 business days of receiving the letter, the supervising physician or physician shall submit to the Department an explanation justifying the amounts of controlled substances prescribed by the nurse practitioner or physician assistant in the relevant period of times, demonstrating that these amounts were medically necessary and that the supervising physician had reviewed and approved the amounts and that the amounts prescribed by the physician are justifiable 35
    36. 36. Pharmacy • The State may hire an expert reviewer to determine if the explanation is acceptable • The Board which has licensed the prescriber may have the matter referred to it • Relevant records may be used to build a case against a nurse, physician assistant, physician, or supervising physician by the licensing board • Sets the roadmap for suspending licenses for over prescribing controlled substances 36
    37. 37. Pain Clinics • New statute places restrictions on pain clinic prescriptions, oversight, and operations 37
    38. 38. Questions? 38
    39. 39. James L. Catanzaro, Jr. and Calvin B. Marshall, Jr. Think You Know HIPAA'S Impact? Understanding the "Omnibus Rule" Changes 39
    40. 40. The "HITECH Act" • In 2009, Congress enacted the Health Information Technology or Economic and Clinical Health Act (HITECH) to strengthen the privacy and security protections for health information under HIPAA 40
    41. 41. • As a result of HITECH, DHHS implemented the "Omnibus Rule," which radically changed privacy/security obligations and breach reporting effective 9/23/13 41
    42. 42. • As a result, covered entities (CEs) must realize the new world in which they operate and restructure business associate agreements (BAAs) and policies to catch up to these changes 42
    43. 43. • The changes for BAAs and policies go beyond merely copying over technical phrases and require a new evaluation of added risks/obligations and how a CE protects itself 43
    44. 44. • New Risk: • Under the Omnibus Rule, the CE may now be liable for the acts of its business associate (BA). Issue is one of control • Old Rule: • No such liability, if can demonstrate good procedures 44
    45. 45. • NEW RISK EXAMPLE • Assume that a BA employee performing billing functions for the CE takes home a laptop with unsecured health information involving over 500 patients. The employee leaves the laptop on the bus 45
    46. 46. • When a breach like this occurs, compliant notifications must be sent, a proper risk assessment or investigation completed and breach effects mitigated. Costs can run into six figures 46
    47. 47. • Relevant Questions for Your BAA • Is the BA your agent? Too much control? • How soon must the BA report? • Who pays for all of this and is subject to resulting CMPs (if any?) 47
    48. 48. • Is there an indemnity clause? • Beware: If you simply signed a BAA provided by the BA, it may include limitation of liability and/or other limitations 48
    49. 49. • New Risk Example #2 • Same set of facts as above but assume CE terminates contract and goes with new billing company. Old company does not destroy or return PHI to CE and its databases are no longer secured. PHI is disclosed when hackers gain access and sell info. 49
    50. 50. • Relevant Questions for Your BAA: • Does your BAA require the BA to return, destroy or protect PHI here? • Do you have indemnity or other protections? • Is the BA required to mitigate under limitations acceptable? 50
    51. 51. • Beware: • BAAs proposed by BAs may limit its liability or remove responsibility for such action. The BAA may not address what happens when the service agreement terminates. 51
    52. 52. • Ultimately, a CE that does not understand potential risks and how its BAAs addresses such risks is sticking its head in the sand. • NOTE: HIPAA liability insurance might be something to look into as well. 52
    53. 53. • New Risk: • When a CE discovers a potential breach, it must report the breach unless it can by 4 part risk assessment show a low probability of compromise for the PHI. • Old Rule: • No reportable breach unless significant risk of financial, reputational or other harm. 53
    54. 54. • NEW RISK EXAMPLE • A CE employee leaves a laptop with unsecured PHI in an open area where others congregate. No evidence of tampering or that anyone viewed PHI. Unless can show a low probability, this must be treated as a breach! 54
    55. 55. • Relevant Questions for Your Policies • Are you prepared to perform a 4 part risk assessment? – Factors are: Nature and extent of PHI involved; to whom PHI was disclosed; was PHI actually accessed; and to what extent risk to PHI mitigated • Who makes the difficult call on reporting (or not)? 55
    56. 56. • NEW RISK - TECHNOLOGY • Mobile devices used to communicate about patient information store such data in memory or on a SIM card and therefore must comply with HIPAA security rules 56
    57. 57. • NEW RISK EXAMPLE – TECHNOLOGY • Example: CE employees are allowed to use their own smart phones to receive patient data or images. 57
    58. 58. • Relevant Questions for Your Policies • What protections have been established? • Passwords • Secure Wi-Fi • Encryption 58
    59. 59. • By the way, do your BAs have similar policies? • Does your BAA require it? 59
    60. 60. QUESTIONS
    61. 61. Rosemarie L. Hill and Justin L. Furrow Understanding and Preventing Retaliation Claims and Whistleblowers 61
    62. 62. What is Retaliation? • Taking an "adverse employment action" against an employee who has engaged in "protected activity" under a number of state and federal statutes regulating the employment relationship 62
    63. 63. Retaliation is Forbidden By a Number of Laws That Affect Your Workplace • Discrimination/harassment (Title VII and the Tennessee Human Rights Act, Age Discrimination in Employment Act, Americans with Disabilities Act) • Compensation (wage claims – Fair Labor Standards Act) • Medical and family leave (FMLA) • Unfair labor practices • Health and Safety • Military Service • Workers' Compensation Injuries 63
    64. 64. Protected Activity • Protected activity includes: – Internal complaints about discrimination/harassment – Complaints to government agencies (Equal Employment Opportunity Commission; Department of Labor, Occupational Safety and Health Administration, and so on) – Lawsuits – filing them or participating in them – Opposition to allegedly unlawful activity (more to follow in Whistleblowing portion of seminar) 64
    65. 65. Adverse Employment Action • Adverse employment action can include: – Termination of employment – Demotion – Hour reduction – Wage reduction – Reassignment – Relocation – Threats – Harassment 65
    66. 66. Adverse Employment Action • Adverse employment action can also include retaliation beyond the job: – Conduct that occurs outside the workplace can be prohibited under the anti-retaliation provision of all of these employment laws – If it is determined to be a "materially adverse action" – it is not limited to actions that occur in the workplace or that directly affect the employee's terms and conditions of employment 66
    67. 67. Adverse Employment Action • Some activities are not considered adverse employment actions: – Getting the "cold shoulder" from co-workers (if employer has forbidden retaliation) – Disciplinary actions that have no effect on pay or advancement, if accurate – Poor performance reviews that have no effect on pay or advancement, if accurate 67
    68. 68. Illegal Retaliation • Examples of Illegal Retaliation Outside of the Workplace – "They stopped asking me to go to lunch" – "They invited me to lunch, but then went somewhere else" – "They stopped inviting me to Happy Hour" – "He spread rumors about my sexual conduct around the community" – "She threatened to ruin my marriage" – "I don't get to go to trade shows any longer" 68
    69. 69. Illegal Retaliation • U.S. Supreme Court says illegal retaliation is: – Any action against an employee (regardless of where it takes place) that would discourage a reasonable employee from making, supporting, or participating in the investigation of a (discrimination/harassment) claim 69
    70. 70. Illegal Retaliation • Is everything an employer might do after someone makes a complaint illegal retaliation? – NO – An Employer should not be "held hostage" to an employee who has engaged in protected activity even if it might be accused of retaliatory behavior: • Employee conduct can be so disruptive or unreasonable that it falls outside the protection of anti-retaliation provisions 70
    71. 71. Illegal Retaliation • For instance, courts have held that the following activities are not protected: – Violating legitimate workplace rules or employer orders or instructions – Stealing confidential documents (even if documents are ones the employee wants to use in her lawsuit or complaint) – Illegal or violent activities 71
    72. 72. Illegal Retaliation – Refusing to perform your job, or neglecting it (particularly to work on your lawsuit) – Harassing co-workers to get them to support your or their discrimination complaint 72
    73. 73. Illegal Retaliation • So - how does one prove a retaliation claim? – Employee engaged in protected activity (made a complaint) – Employee was subjected to adverse action – There is a CAUSAL LINK between the activity and the adverse action 73
    74. 74. Illegal Retaliation • What proves a CAUSAL LINK time-wise? – Courts generally look at time passed between the protected activity and the adverse employment action – the shorter the window, the more it will look to a jury/trier of fact as if the employer is retaliating – There is no safe period, and some courts say temporal proximity is ALWAYS important; and some say it is not sufficient to prove a causal link 74
    75. 75. Illegal Retaliation • Why do we worry so much about retaliation claims? – BECAUSE AN EMPLOYER CAN WIN THE UNDERLYING CLAIM/LAWSUIT BROUGHT BY THE EMPLOYEE BUT LOSE THE RETALIATION CLAIM AND PAY JUST AS MUCH IN DAMAGES – BECAUSE RETALIATION CLAIMS ARE ON THE RISE – for instance, 22% of 1997 EEOC charges included retaliation claims and 34% in 2008 – 36.3% by 2010 75
    76. 76. Illegal Retaliation • Self-help against retaliation claims starts immediately – There are ways to protect yourself from retaliation claims • Forbid it and publicize that it's forbidden (policies) • Emphasize at every step of an investigation that it's forbidden • Deal with it immediately if it occurs 76
    77. 77. And Now for Our Paid Political Announcement • A little bit of time and money spent with and on your lawyers on the front end can prevent a lot of time and money spent with and on your lawyers on the back end – when you are sued for retaliation 77
    78. 78. Retaliation Only an Employment Law Concern? • Retaliation is not limited to complaints about employment-related issues • Federal and state laws prohibit retaliation against "whistleblowers" 78
    79. 79. What is a "Whistleblower?" • Generally speaking, someone who exposes alleged misconduct, or dishonest or illegal activity occurring in an organization • Definition of whistleblower depends on statutory definition of "protected activity" 79
    80. 80. Whistleblowers are Protected from… • Termination • Discrimination • Demotion • Suspension • Harassment • Threats Generally—Adverse Employment Actions 80
    81. 81. Examples of Whistleblower Laws • Tennessee Public Protection Act – Protects persons who refuse to "participate in" or "remain silent about" illegal activities • Violation of state or federal criminal or civil law designed to protect public health, safety, or welfare • Tennessee common law – Protects person attempting to exercise a constitutional or statutory right – Prohibits termination in violation of "public policy" 81
    82. 82. Examples of Whistleblower Laws • Affordable Care Act – Protects persons who "object to" or "refuse to participate in" any activity the person believes violates the Act (or any rule, regulation, standard, or ban under the Act) 82
    83. 83. Examples of Whistleblower Laws • Federal False Claims Act – Protects persons who "act in furtherance of a qui tam action" • Bringing a qui tam action • Investigating a qui tam action • Supplying information that could prompt an investigation • Generally taking steps to expose fraud • Also a Tennessee False Claims Act offering similar protections 83
    84. 84. But We've Done Nothing Wrong! • Whistleblower retaliation claims do not depend on whether company actually committed a violation • Whistleblower must simply have "reasonable belief" that violation has occurred • Company's "innocence" is largely immaterial in whistleblower retaliation lawsuit 84
    85. 85. Questions? 85
    86. 86. Stephen D. Barham Qui Tam Actions 86
    87. 87. State Qui Tam Action • May be brought by the State or an individual • Case involves knowingly defrauding the State or a political subdivision 87
    88. 88. Action Brought by 3rd Party • Case is sealed and not served for 60 days (or longer if extended) • Initial service only on Attorney General – along with supporting evidence • AG investigates and decides whether to take over the case • After AG decision defendant is served with Complaint • The individual bringing the action case receive 25 – 33% of the proceeds or settlement 88
    89. 89. Federal False Claims • False claims include claims for service simply not rendered, essentially theft by deception, they also include an assortment of other attempts to manipulate the Medicare and Medicaid payment systems 89
    90. 90. Federal False Claims • Cost report fraud • Upcoding • Unbundling, or • Billing for unnecessary services 90
    91. 91. Federal False Claims • False claims are punishable as: – Crimes – Civil violations • Exclusion from federal program payment opportunities • Civil money penalties 91
    92. 92. Federal False Claims • Private individuals can also bring qui tam actions to enforce the FCA 92
    93. 93. Federal False Claims • Administrative sanctions to providers who submit false claims • Impose civil penalties of up to $11,000 per false claim plus three times the amount claimed 93
    94. 94. Federal False Claims • Common problems resulting in sanctions – Billing for unnecessary services – Upcoding – Unbundling – Billing Medicaid for name-brand drugs when generics were supplied – Double billing – Filing of inflated cost reports or cost reports that include non-allowable costs 94
    95. 95. Federal False Claims • Any private person can bring a qui tam action on behalf of the government to enforce the Civil FCA 95
    96. 96. Federal False Claims • Award of bounties of up to 25 - 30% of the false claim recovery creates a significant incentive for private litigants to bring such cases • Potential for statutory attorney's fees • Makes these cases very attractive to attorneys as well 96
    97. 97. Federal False Claims • Qui Tam actions are filed under seal, and often remain sealed for a considerable period of time while the government is investigating the claim 97
    98. 98. Federal False Claims • Qui tam filings are increasing exponentially in the health care area, and every health care provider should be attentive to this threat 98
    99. 99. Federal False Claims • Tendency toward civil enforcement – Only meet the civil, preponderance of the evidence, standard of proof – Recoveries without proof of specific intent to defraud – Standard of knowledge is whether he or she "should know" 99
    100. 100. Federal False Claims • The government only intervenes in less than one quarter of qui tam cases • Beginning in 2010, the recoveries and relators' shares where the government has declined to intervene have increased substantially 100
    101. 101. Federal False Claims • Statute of limitations for FCA actions is: – 6 years from the date on which the violation of the FCA was committed – Up to 10 years after the date of the violation of the act • The statute of limitations is tolled when the defendant conceals its violation of the FCA 101
    102. 102. Questions? 102
    103. 103. 103
    104. 104. Health Care Section William P. Aiken E. Stephen Jett Stephen D. Barham Calvin B. Marshall, Jr. James L. Catanzaro, Jr. Jason R. Mirmelstein Mark A. Cunningham Rosemarie L. Hill Douglas S. Griswold Justin L. Furrow Frederick L. Hitchcock 104
    105. 105. Disclaimer This presentation is provided with the understanding that the presenters are not rendering legal advice or services. Laws are constantly changing, and each federal law, state law, and regulation should be checked by legal counsel for the most current version. We make no claims, promises, or guarantees about the accuracy, completeness, or adequacy of the information contained in this presentation. Do not act upon this information without seeking the advice of an attorney. This outline is intended to be informational. It does not provide legal advice. Neither your attendance nor the presenters answering a specific audience member question creates an attorney-client relationship. 105