2014 Health Care_Seminar.pptx

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© 2014 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

Health Law Seminar

Justin L. Furrow * James L. Catanzaro, Jr. * Mark A. Cunningham *Calvin B. Marshall, Jr. * Jed Roebuck * Alicia Brown Oliver

November 11, 2014

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Employment Law Basics Which ones you should know, and why!

Justin L. Furrow

The Alphabet Soup of Employment Law

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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

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What Do These Laws Protect?

• Employees in a protected category– Race

– Color– Gender– Pregnancy– National origin– Religion– Age– Disability

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What Do These Laws Prohibit?

• Discrimination• Harassment• Retaliation

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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

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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

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Employment Law: 5 Main Impacts

• Hiring• Compensation• Discipline• Leave• Termination

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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

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What About Non-Employees?

• We pay them by 1099, isn't that ok?• Independent contractors

– Right to control is paramount

• Volunteers

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Compensation

• Fair Labor Standards Act– Minimum wage and overtime

– Exempt vs. Non-exempt• Salaried ≠ Exempt

• Equal pay for equal work

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Discipline: What to Do When the Employee Does Wrong

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• 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

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• 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

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• 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

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• 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

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• 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

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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

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Employee TerminationsHow to End the Relationship

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• 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?

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• Review the personnel file.• Make sure the punishment fits the crime

– Consistent with past disciplinary actions

– No differential treatment of employees

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• 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

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Knock, Knock.Who's There?

What you should do and expect if the Board of Examiners comes knocking

James L. Catanzaro, Jr.

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

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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.

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If, after review of records,

concerns appear substantiated,

an investigator may request to speak with the

physician involved.

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Should you have counsel present when you

speak with the investigator?

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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.

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If the proposal is not satisfactory, there is

usually little time to attempt to negotiate.

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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.

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When the screening panel process might

be to your advantage.

Understanding the process,

risks and limitation.

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Remember to report adverse results to carriers

and providers where credentialed.

The board may also report adverse results to

databank.

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Reviewing and approving the reports to the

databank as an option.

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Risky Business: Perspectives on EMR and Similar

Vendor Contracts

Mark A. Cunningham• November 11, 2014

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PHASE I

Negotiating the Contract

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Will You Even Call?

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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

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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?

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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

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Pick a fee. Any fee.

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.

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Hidden Costs

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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?

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Phase IIThe Contract Term

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Phase IIThe Contract Term

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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.

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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?

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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.

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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?

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Phase III

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Nothing in his lifeBecame him like the leaving it.Macbeth (1605), Act I, scene 4, line 7.

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?

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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

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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?

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Cal Marshall & Jed RoebuckHIPAA, Physician Payment Sunshine Act

and Tennessee Law Update

• November 11, 2014

HIPAA Review and Update

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HIPAA – Key Compliance Measures

• Risk assessment• Privacy, security and breach notification policies

and procedures• Staff training and sanctions• Business associate agreements

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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

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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

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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

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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

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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

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Sunshine Act

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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

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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

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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

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Tennessee Law Update

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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

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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.

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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.

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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 hours70

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

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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

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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.

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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

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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.

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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.

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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.

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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

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Alicia Brown OliverAdvertising Rules of The Road: Branding,

Testimonials, SocialMedia & More!

What Are the Benefits of Branding?

• Patients Can Find You in the Marketplace• Distinguishes You From Competitors• Builds Value as goodwill increases

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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

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Continuum of Trademark Protection

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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

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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"

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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

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Websites & Advertising Legal Issues

• Subject to State Regulation & the Federal Trade Commission Guidelines for "Deceptive Advertising"

– "Unsubstantiated" Claims

– Photoshop/manipulated Patient Results

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Promotions, Contests & Giveaways

• Regulated by State Laws

• Legal Issues:– Illegal Lotteries

– Official Rules Requirements

– Advertising Requirements

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Use of Social Media/Blogs

• Disclosures of "Material Connections"

• Disclosure that SM Post is Commercial In Nature

Wrong

Correct

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Questions

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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.

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Healthcare

2014 Health Care_Seminar.pptx