2014 Chambliss Annual Health Care Seminar - PowerPoint Presentation

1. Health Law Seminar
Presented by
© 2014 Chambliss, Bahner &
Stophel, P.C. All Rights Reserved.
Justin L. Furrow * James L. Catanzaro, Jr. * Mark A. Cunningham *
Calvin B. Marshall, Jr. * Jed Roebuck * Alicia Brown Oliver
Chambliss, Bahner & Stophel, P.C.
Liberty Tower • 605 Chestnut Street, Suite 1700 • Chattanooga, TN 37450
chamblisslaw.com
November 11, 2014

2. 2
Justin L. Furrow
Employment Law Basics
Which ones you should know, and why!

3. The Alphabet Soup of Employment
Law
3

4. Basic Employment Laws
• Title VII
– Tennessee Human Rights Act
• Age Discrimination in Employment Act
• Americans with Disabilities Act
– Tennessee Disability Act
• Family and Medical Leave Act
• Fair Labor Standards Act
• Tennessee Public Protection Act
4

5. What Do These Laws Protect?
• Employees in a protected category
– Race
– Color
– Gender
– Pregnancy
– National origin
– Religion
– Age
– Disability
5

6. What Do These Laws Prohibit?
• Discrimination
• Harassment
• Retaliation
6

7. Employment Law Basics
• Whether employment laws apply generally
depends on the number of employees
– Tennessee Employment Security Law: 1 employee
– Tennessee Human Rights Act: 8 employees
– Title VII: 15 employees
• Can also depend on volume of sales
– Fair Labor Standards Act: $500,000 in sales or
receipts
7

8. Employment Law: Why Does It
Matter?
• Provide rights to employees
– Anti-discrimination, anti-harassment, and anti-retaliation
laws
– Required minimum wage and overtime payments
• Impose obligations on employers
– Medical leave
– Voting leave
– Workers' compensation insurance
– Jury duty leave
8

9. Employment Law: 5 Main Impacts
• Hiring
• Compensation
• Discipline
• Leave
• Termination
9

10. Hiring Process:
How to Legally Hire Employees
• Disability-related issues
– Medical examinations and related inquiries
• Social Media
– Look at all of this information on Facebook!
• Job Descriptions and Qualifications
– Job-related and consistent with business necessity
• Background Checks
10

11. What About Non-Employees?
• We pay them by 1099, isn't that ok?
• Independent contractors
– Right to control is paramount
• Volunteers
11

12. Compensation
• Fair Labor Standards Act
– Minimum wage and overtime
– Exempt vs. Non-exempt
• Salaried ≠ Exempt
• Equal pay for equal work
12

13. Discipline: What to Do When the
Employee Does Wrong
13

14. Discipline: What to Do When the
Employee Does Wrong
• Well-documented employee personnel file that is
complete, thorough, accurate and up-to-date
• Legitimate business decisions will be evident
from the file
– This will be the basis on which you defend your
action to an administrative agency or court when
the organization is sued
14

15. Discipline: What to Do When the
Employee Does Wrong
• Be accurate.
– All documentation should contain information that
you know to be true and which can be objectively
substantiated
• Stick with the facts.
– The documents should contain a description of the
offense or problem, along with names, dates,
times, place of events and/or warnings, and the
duration and frequency of the problem or offense
15

16. Discipline: What to Do When the
Employee Does Wrong
• Be informative.
– Tell precisely what rule or policy was violated or
what performance, attendance, or behavioral
problem exists and explain what the employee
must do to correct the problem
– List previous steps taken to resolve the problem
and the consequences if the problem continues
16

17. Discipline: What to Do When the
Employee Does Wrong
• Be clear and precise in the Corrective Action
Report.
– Don't use the words "never" or "always." Don't say:
"You are not doing your job" or "You are always
late." Do say: "You did not finish the XYZ project by
the June 1 deadline."
• Be timely.
– Write down the information while it is still fresh
17

18. Discipline: What to Do When the
Employee Does Wrong
• Take care to keep.
– Keep in employee's personnel file any papers that
show mistakes, e.g., memos, phone messages,
purchase orders, as well as all prior warnings or
memos concerning the employee
• Have employee sign.
– It is important to show that the employee actually
received a Corrective Action Report or other write
up
18

19. Employee Leave
• Generally dictated by company policy, unless….
• Family and Medical Leave Act
– 50 or more employees
– Employee worked for one year
– 1,250 hours during the preceding year
• 12 weeks of leave (or up to 26 for servicemember
leave)
• But also consider the Americans with Disabilities
Act
19

20. Employee Terminations
How to End the Relationship
20

21. Employee Terminations
How to End the Relationship
• Tennessee is an at-will employment state!
– But what does that mean?
• Know what laws do (or might) apply
– Has person recently filed or made a
discrimination/harassment claim or been part of
investigation?
– Has she recently had a workers' comp injury or is
he in middle of a claim?
– Has he engaged in whistleblowing?
21

22. Employee Terminations
How to End the Relationship
• Review the personnel file.
• Make sure the punishment fits the crime
– Consistent with past disciplinary actions
– No differential treatment of employees
22

23. Employee Terminations
How to End the Relationship
• Meet with the employee to convey the decision
– ALWAYS have a witness!
• Be truthful and accurate in describing the reason
for discharge
– BUT be concise!
• Separation Notice
23

24. James L. Catanzaro, Jr.
Knock, Knock.
Who's There?
What you should do and expect if the
Board of Examiners comes knocking
24

25. Areas that Drive Board Interest:
"Unprofessional, dishonorable or unethical
conduct" includes failure to comply with Board
policies:
1)Sexual misconduct
2)Supervising mid-levels
3)Prescribing or dispensing controlled substances
25

26. Most times, your first contact is from an
investigator who is requesting records.
Typically, the complaining party has completed
a consent form authorizing the disclosure of
his/her records to an investigator.
26

27. If, after review of records,
concerns appear substantiated,
an investigator may request to speak with the
physician involved.
27

28. Should you have counsel present when you
speak with the investigator?
28

29. Typically, a letter from counsel for the Board
will advise of proposed findings and an offer to
settle per a consent order with disciplinary
actions outlined.
29

30. If the proposal is not satisfactory, there is
usually little time to attempt to negotiate.
30

31. If the physician is dissatisfied, he/she may
request a screening panel (which is
discretionary) and/or a hearing before the full
board of Medical Examiners.
31

32. When the screening panel process might
be to your advantage.
Understanding the process,
risks and limitation.
32

33. Remember to report adverse results to carriers
and providers where credentialed.
The board may also report adverse results to
databank.
33

34. Reviewing and approving the reports to the
databank as an option.
34

35. Mark A. Cunningham
Risky Business:
Perspectives on EMR and Similar
Vendor Contracts
• November 11, 2014
35

36. PHASE I
Negotiating the Contract
36

37. Will You Even Call?
37

38. EMR/EHR Platforms are in Flux
Various Payment Initiatives/Requirements Correlate to anticipated
EHR/EMR Upgrades or Overhauls and Related Vendor Contracts
– Meaningful Use
– Physician Quality Reporting System (PQRS)
– Hospital Inpatient Quality Reporting (Hospital IQR)
– Coding Programs
– Billing Agreements
The New ICD-10 "Deadline" Will Demand Material Changes to
Many of These Arrangements
"Physicians have been … saying, 'Why should I invest because they're
moving the date every year…' And then there is the problem of vendors
not being ready -- the vendors don't want to invest much either, thinking
the date may never stick. It's a terrible situation."
http://www.medpagetoday.com/PracticeManagement/Reimbursement/
47424
Firm Date for ICD-10 Switch Still Not Raising Urgency, Aug. 30, 2014
38

39. Selection
Who is "Representing" the Provider in the
Negotiation?
– Many physician practices and smaller providers delegate the
selection process to one physician/owner and staff; hospitals
have a range of parties
– Selection is often overly influenced by recommendations
from others that have a vested interest in their own purchase
or relationship with a particular vendor
– On the other hand, it is important that a relationship of trust
be fostered between the provider and vendor outside
contract considerations
– When is your attorney involved?
39

40. Costs – Hidden In Plain Sight
• EHR and vendor contracts involve a variety of fees
• Common Types of Fees
– Licensing Fees
– Third Party Software Fees
– Consulting Fees
– Equipment Fees
– Set-Up Fees
– Professional Services Fees
– Maintenance Fees
– Implementation Fees
– Interface Fees
– "Functionality" Fees
• Each type of fee is associated with a different service/item
requiring different legal and practical considerations
40
Pick a fee.
Any fee.

41. How to Manage Fees in the
Contracting Process
• Limit Fee Increases
– Seek to set percentage/CPI caps
– Seek limitations on frequency – for example no more than
one fee increase every year
• What are Key Fee Change Events?
– Upgrades
– Add-ons
– New Equipment/Staffing Needs
• Use these opportunities to address shortfalls in
the contract.
41

42. Hidden Costs
42

43. Hidden Costs – Surprise!
• Clearly define the responsibilities of the vendor and the
provider up front.
• Many times hardware, training, product set up, and travel
are not discussed during the initial contract period. The
persons that are often left "staging" the system and
building it are also doing their day jobs during the
transition and this can be extremely burdensome and
costly.
• Negotiate downtime and expect workflow interruptions
during installation and transitions. Negotiate a fee for
anything that disrupts workflow and revenue if this is
exceeded.
• For EMR, if converting from a legacy system- who will be
responsible for the Q/A of the new data to insure accuracy
of the data?
43

44. Phase II
The Contract Term
44

45. Phase II
The Contract Term
45

46. Installation: Now the Fun Starts
• The impact of a key vendor contract is felt once the
installation begins.
• Providers often have not adequately invested in the cost
of training and conversion
• The physicians that did not participate in the selection
process are quick to criticize and refuse to participate in
the use of the product.
• Providers that are dissatisfied will often want to withhold
payment regardless of the contract terms.
• There is shock when providers learn what the terms of
contract dictate for changes and modifications to make
the system operate as they would like
• Vendors may restrict the use of the system if the
physicians do not comply with their end of the contract.
This is particularly true of cloud based systems.
46

47. Performance Standards
• Service level agreements are critical.
• These should be included for installation,
support, updates and upgrades.
• Make sure that you (and your attorney)
understand the metrics.
• What are the timelines for each of these and
more important, what are the consequences of
these not being met?
47

48. Performance Standards
Many contracts terms that must be adhered to, but there is no
consequence if the term is not met. For instance, what happens
when you have a spectacular SLA that says all urgent support items
are to be addressed and solved within 24 hours but you have not
addressed the consequences. Your only option may be to
terminate the agreement for breach of contract which is often not
the optimal solution for any party.
Some potential "penalties" for SLA violations may include:
•A payment deduction from vendor payment for each occurrence.
•A reduction in the length of the contract term for specified
occurrences.
•The ability to have another vendor provide services (such as
support) and this be reimbursed by the contracted vendor.
•Damages for lost revenue based on severity of the interruption.
48

49. Critical Issues: Data Back-Up
• Data backup. What is being backed up, by
whom, to where, how often? Who ultimately is
responsible for the recreation of this data and
system if there is a hard crash?
• How long would this process take?
• Disaster recovery program. Can the system be
recreated at another location quickly and easily if
there is a hard crash?
49

50. Phase III
50
Nothing in his life
Became him like the leaving it.
Macbeth (1605), Act I, scene 4, line 7.

51. Critical Issue: Data Conversion
• Many vendors do not have a way to provide
clean electronic data for conversions
– This issue must be explored
• The cost to convert from an old system to
another system may be significant
• What is the right format for you?
51

52. Ka-Boom
• Boom goes the warehouse!
• The cloud goes poof (e.g. vendor goes out of
business)
• Vendor won't release data until payment of
"outstanding fees"
• Data is piecemeal, incomplete or just a big ole
hunk of mess
STANDARD WARNINGS: limitation of liability
clauses, forum selection clauses and disclaimers
of warranties
52

53. Doomsday Prevention Techniques
• Source Code Escrow Agreements
• Not for every occasion
• May be a necessity in bigger deals
– Don't forget to actually escrow it!
• Contractually Required Periodic Downloads
• Require Vendor to provide periodic downloads of
relevant data to Client controlled server or in Client
friendly format
– Daily? Weekly? Monthly?
53

54. Cal Marshall & Jed Roebuck
HIPAA, Physician Payment Sunshine Act
and Tennessee Law Update
• November 11, 2014

55. HIPAA Review and Update
55

56. HIPAA – Key Compliance
Measures
• Risk assessment
• Privacy, security and breach notification policies
and procedures
• Staff training and sanctions
• Business associate agreements
56

57. HIPAA – Risks and Enforcement
• Risk assessment and electronic data safeguards
are more important than ever
– Apr/June 2014 – Community Health Systems
hacker attack – 4.5 MM individuals affected
– April 24 – 92,000 patient breach at Long
Island/Queens radiology/multi-specialty practice –
former radiologist employee able to bypass system
security measures
– Dec. 2013 – Discovery of hacker initiated data
breach at Ohio medical supply company – 4,200
people
57

58. HIPAA – Risks and Enforcement
• Failure to have compliance measures in place can
lead to trouble
– December 26, 2013 - $150,000 fine for MA and NH
dermatology practice
– Investigation resulted from data breach
– Fine for failure to conduct risk assessment, create
breach notification policies and provide training
58

59. HIPAA Phase 2 Audits
• Phase 2 audits planned, will be enforcement
tool
• Audit entity projections
– 350 covered entities, including 232 providers
– 50 business associates
• Audit issues
– Privacy Rule compliance – 67 providers
– Breach compliance – 65 providers
– Security Rule compliance – 100 providers, all 50
business associates
59

60. HIPAA Audit Focus
• Round 1 – Covered Entities
– Security – risk analysis and risk management
– Breach – content and timeliness of notification
– Privacy – notice and access
– Round 2 – Covered Entities
• Security – device and media controls, transmission
security
• Privacy – safeguards, training on policies and
procedures
• Round 1 – Business Associates
– Security – risk analysis and risk management
– Breach – breach reporting to covered entities
60

61. HIPAA Audit Process & Timing
• Pre-audit surveys to 550-800 entities
– Initially Summer 2014, now likely 2015
• Round 1 audits of CEs
– Initially Fall 2014, now likely 2015
• Round 2 audits of CEs and Round 1 audits of BAs
– Initially 2015, now likely later 2015
• Initial plan for mostly "desk" audits, new plan for
more on-site audits
61

62. Sunshine Act
62

63. Sunshine Act – Basic Outline
• Part of Affordable Care Act
• Requires disclosure of:
– (1) Payments from drug, device, biological or
medical supply manufacturers to
• (a) Physicians; and
• (b) Teaching hospitals
– (2) Certain ownership and investment interests in
manufacturers and group purchasing organizations
("GPOs") of physicians or immediate family
members, including payments to owners/investors
• Information disclosed on publicly accessible
website
63

64. Sunshine Act – Information
Disclosed
• Manufacturers required to report information on
payments, including:
– Name (including information on certain third parties)
– Business Address
– Identifiers, including specialty, NPI, state license #
– Amount, date and context of payment
– Related drug, device, biological or medical supply
– Form and nature of payment (including reason)
– Indicate whether payment made to physician or
immediate family with ownership/investment
interest
64

65. Sunshine Act – Review and
Dispute Process
(1) Prior CY information reported by around end of
March
(2) Review and dispute period – 45 days
– Notification sent to physicians registered with CMS
(3) Disputes must be resolved by 15 days from end of
review and dispute period – otherwise disputes merely
flagged
(4) Information published roughly June 30 of each year
(5) Disputes can still be initiated by year end but likely
not flagged until following year
65

66. Tennessee Law Update
66

67. SB 1630 / HB 1426
• Controlled substance database report
– Includes in the list of persons who may receive
patient-specific information from the controlled
substance database (CSD) a prescriber, healthcare
practitioner, or dispenser who may place a copy of
a patient's report from that CSD in that patient's
medical records.
– Once in a patient's medical record, the CSD report
is subject to the same terms and conditions as
other medical records.
– Effectively expands the ability of prescribers,
dispensers and health care practitioners to receive
patient-specific information from the CSD
67

68. SB 1391 / HB 1295
• Illegally taking a narcotic drug while pregnant
– A mother can be prosecuted for an assaultive
offense or homicide if she illegally takes a narcotic
drug while pregnant and the child is born addicted
or dies because of the drug
– Senate Amendment
• Clarifies that a woman may be prosecuted for assault
against her viable fetus.
• Creates an affirmative defense to such prosecution if
the woman is actively enrolled in a recovery program
before the child is born.
68

69. SB1631 / HB 1427
• Opioid Antagonists
– Authorizes a healthcare practitioner licensed to
prescribe opioid antagonists, acting in good faith, to
provide opioid antagonists prescriptions for a person at
risk of experiencing an opiate-related overdose
– Also authorizes an individual who received an opioid
antagonist prescription to administer it to another, if
they exercise reasonable care and in good faith believe
the person is experiencing an opioid related overdose.
– Provides immunity for the practitioner and the person
administering the drug, unless they show gross
negligence or willful misconduct.
69

70. SB 1832 / HB 1466
• ID required – certain drugs dispensed
– Valid government issued photo ID to a pharmacist
or such other person designated by a pharmacist to
dispense a prescription for more than a 7 day
supply of certain drugs
– Person retrieving the dispensed prescription must
be same person pictured in the ID, but need not be
the person for whom prescription written
– Pharmacy must maintain a retrievable record of
sale, including: names, addresses, ID types and
numbers, prescription numbers and initials/codes
of pharmacists
– Should be readily retrievable within 24 hours
70

71. SB 1886 / HB 1788
• Infant CPR
– Revises the list of medical providers who must
make available information concerning infant CPR
to at least one caregiver or parent of a newborn
infant to include the following:
• Obstetrical provider who treats a prenatal patient on
at least two different occasions
• Hospitals and birthing centers where a baby is born,
and such information must be provided before the
baby is discharged
• Primary care provider who treats a newborn in an
ambulatory care setting within 28 days after birth
71

72. SB 2458 / HB 2389
• Nursing Care Facilities – Certificates of Need
– Revises the requirement for a nursing home's CON
for "qualified partial relocation" of nursing homes
– Adds that "qualified partial relocation" also refers
to a request to relocate up to 20 licensed nursing
home beds from one nursing home to another, if:
• Old and new location of beds are in same county;
• Location beds moving from licensed for over 100 beds;
• Both locations are under common ownership/control;
and
• New location on the campus of a rehabilitation hospital
72

73. SB 2050 / HB 1895
• Telehealth insurance coverage
– Adds definitions for "qualified site" and "store and
forward telemedicine services"
– Requires the provider be a qualified site and that
the patient be at a qualified site or school clinic
equipped to engage in telemedicine.
– Makes telehealth providers subject to the same
contractual requirements as other providers in the
network.
– Clarifies that the insurer is not required to
reimburse an amount that exceeds the amount
paid for in-person services.
73

74. SB 1636 / HB 1432
• Non-payment of professional privilege tax
– Removes old provision
• First nonpayment – warning letter
• Second nonpayment – grounds for suspension
• Third nonpayment – revocation of license
– New provision
• At time tax assessed, tax payer notified in writing failure to cure tax
delinquency prior to the renewal date may result in license being held in
abeyance until delinquency cured
• Commissioner of revenue shall compile a list of tax payers who are
delinquent 90 days or more (from the date of their tax) and have not
pursued a proper remedy
• The Lists are sent to the appropriate licensing boards
• Licensing boards are prevented from processing license renewals fro any
name on the list and must instead hold such licenses in abeyance
74

75. SB 1853 / HB 2171
• Nurse practitioners: change of supervising physician
– Adds the name of the supervising physician of a nurse
practitioner or a physician assistant to information each
board regulating such providers must collect and
provide to the Department of Health in order for the
DOH to create individual profiles on licensees.
– Supervising physician authorized to contact the DOH
about changes regarding status as supervising physician,
if nurse or assistant fails to do so within 30 days of
change.
– Nurse or assistant given 10 calendar days from date of
receipt of notice of change to dispute the fact that the
physician is not the supervising physician.
75

76. SB 1754 / HB 1556
• Nurse Practitioners Testimony
– Includes nurse practitioners on the list of persons
that are exempt from subpoena to trial but are
subject to subpoena to deposition.
76

77. Byrge v. Parkwest Medical Center
• HIPAA Compliant Medical Authorization
– Plaintiff in a healthcare liability action sent the required pre-suit notice
and medical authorization to the defendants
– The medical authorization was not HIPAA compliant pursuant to Tenn.
Code Ann. 29-26-121(a)(2)
– Case dismissed at trial level
– On appeal, issue was whether the case was filed within the statute of
limitations. A case filed outside the 1-year statute, may still receive a
120-day extension to file if proper pre-suit notice and HIPAA compliant
medical authorization are sent to defendants.
– Tennessee Court of Appeals affirmed that the medical authorization was
not compliant with HIPAA and the case was dismissed.
– Impact: complying with the pre-suit notice Statute can be a very
technical process, and other Tennessee cases have discussed the
concept of "substantial compliance." If your practice receives such a
pre-suit notice, be sure to forward it to your attorney as soon as
possible, as the plaintiff's case may be procedurally vulnerable to
dismissal if the notice is deficient.
77

78. Cullum v. McCool
• Plaintiff hit in Wal-Mart parking lot by drunk driver who
had just been denied her medication by the Wal-Mart
pharmacy because of intoxication
• Plaintiff sued Wal-Mart and its employees for negligence,
asserting that they should have protected Plaintiff from
drunk driver
• Because Wal-Mart had specific knowledge that driver was
drunk, driver had previously been into its store while
drunk, and plaintiff was still on Wal-Mart's premises when
injured, Wal-Mart owed a duty of care to Plaintiff
• The Tennessee Supreme Court held it was inconsequential
that Wal-Mart did not contribute to driver's intoxication
• Applications for healthcare providers may exist if faced
with situations in which an individual presents intoxicated
on the premises
78

79. Alicia Brown Oliver
Advertising Rules of The Road: Branding,
Testimonials, Social
Media & More!
79

80. What Are the Benefits of
Branding?
• Patients Can Find You in the Marketplace
• Distinguishes You From Competitors
• Builds Value as goodwill increases
80

81. What Is Your Brand?
In legal terms, Brands are Trademarks and Services Marks:
•Words, phrases, designs, logos or a combination of these elements used to
indicate source
•Trade Dress – distinctive packaging or product configurations
•Trade Names – names of businesses; can also function as trademarks and service
marks
81

82. Continuum of Trademark
Protection
82

83. Descriptive/Generic Names
• How much protection is there? Weak Rights can
be strengthened by:
– Use of logos
– Long periods of use to acquire distinctiveness & brand
awareness
83

84. Why Should I Protect My Brand?
• Federal Registration
– Extends to the borders of the U.S.
• State Registration
– Extends to the border of the state
• Common Law Rights
– Protects common law "trading area"
84

85. Websites & Advertising Legal
Issues
• Rights of Privacy/Publicity
– Always obtain a written release
– Confirm release is broad enough to cover the use
• Copyright Infringement/Ownership
– Confirm you have ownership rights or proper
license for photos/video and text
85

86. Websites & Advertising Legal
Issues
• Subject to State Regulation & the Federal Trade
Commission Guidelines for "Deceptive Advertising"
– "Unsubstantiated" Claims
– Photoshop/manipulated Patient Results
86

87. Promotions, Contests &
Giveaways
• Regulated by State
Laws
• Legal Issues:
– Illegal Lotteries
– Official Rules
Requirements
– Advertising Requirements
87

88. Use of Social Media/Blogs
• Disclosures of "Material Connections"
• Disclosure that SM Post is Commercial In Nature
Wrong
Correct
88

89. Questions
89

90. 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.
90