Urgent Care Centers: Key Legal And Business Considerations

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Presenting a live 90-minute webinar with interactive Q&AUrgent Care Centers:Key Legal and Business ConsiderationsComplying With Corporate Practice of Medicine Laws,State Licensure Requirements, EMTALA Mandates, and Reimbursement LawsWEDNESDAY, SEPTEMBER 21, 20161pm Eastern 12pm Central 11am Mountain 10am PacificToday’s faculty features:Jon M. Sundock, General Counsel and Chief Administrative Officer,CareSpot Express Healthcare, Brentwood, Tenn.David F. Lewis, Esq., Butler Snow, Nashville, Tenn.The audio portion of the conference may be accessed via the telephone or by using your computer'sspeakers. Please refer to the instructions emailed to registrants for additional information. If youhave any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

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Continuing Education CreditsFOR LIVE EVENT ONLYIn order for us to process your continuing education credit, you must confirm yourparticipation in this webinar by completing and submitting the AttendanceAffirmation/Evaluation after the webinar.A link to the Attendance Affirmation/Evaluation will be in the thank you emailthat you will receive immediately following the program.For additional information about continuing education, call us at 1-800-926-7926ext. 35.

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Forming Urgent Care Centers:Addressing Complex Legal ChallengesSeptember 21, 2016David F. LewisButler SnowJon SundockCareSpot andMedPost5

What is an Urgent Care Center? No universal definition Provide services that fall in between primary care and emergencydepartment Can also include some primary care services and could branch into otherareas, e.g., weight loss, allergy care, wellness, etc.Urgent Care Association of America: The delivery of ambulatory medical care outside of a hospital emergencydepartment on a walk-in basis, without a scheduled appointmentGenerally focused on episodic, acute care rather thanon long-term management of chronic illness or preventive care6

Common Features of Urgent Care Centers Retail healthcare High focus on customer convenienceNo appointments required and short wait timesExtended hours, including weekends and eveningsBroad list of services beyond primary care offices X-rayEKGOnsite lab for CLIA waived testingAbility to perform minor procedures like laceration repair andsplints7

Why the Growth in Urgent Care Centers? Growth spurt began in mid-1990s and has continued Since 2008, the number of urgent care centers has increased from 8,000to more than 11,000Why the continued growth? Acceptance by the public Lack of access to primary care (no access or delayed access) Overcrowding in Emergency Departments (ED) Affordable Care Act has not slowed growth in ED visits Long wait times at other providers (EDs especially) Convenience of longer hours and walk-ins Emphasis on high-quality care Increased healthcare consumerism spurred byhigh-deductible plans8

Current State of Urgent Care Centers Over 150 million patient visits to urgent care centerseach year in the United States By 2018, total urgent care industry revenue is projectedto exceed 18 billion There have been significant transactions in the urgentcare industry Tenet Healthcare’s purchase of CareSpot Express Healthcare Wellpoint’s purchase of Physicians Immediate Care Dignity Health’s purchase of US Healthworks9

Current State of Urgent Care Centers Would anticipate additional consolidation in the industry More health systems acquiring urgent care centers anddeveloping additional urgent care centersContinued interest by private equity players in having interests inurgent care companiesVarious strategies remain viable: Urban focusRural focusPure play urgent careHybrid models primary care focusedTelemedicine10

Current State of Urgent Care Centers 2015 UCAOA Benchmark Report Nearly 90% of urgent care centers saw an increase in thenumber of patient visits from 2013 to 2014Nearly 25% of all urgent care centers are owned by hospitals orhealth systemsApproximately 20% of urgent care centers are owned by two ormore physiciansAbout 27% of all emergency room visits could take place inurgent care centers (with approximate cost savings of 4.4billion)By 2019, large metropolitan areas could support two to threetimes the number of current urgent care centers11

Current Distribution of Urgent Care Centers12

Key Legal Considerations Corporate Practice of Medicine Staffing Models State Licensure and Permits Documentation and Coding Other Focus Areas Medical Director Accreditation EMTALA Other Compliance Matters13

Corporate Practice of Medicine The corporate practice of medicine doctrine prohibitsemployment of clinical personnel by corporations Purpose is to protect the integrity of medical professionby keeping it separate from corporate interests State laws vary on the doctrine Strict prohibitions Some Limitations No prohibitions14

Corporate Practice of Medicine Certain states are very strict - any corporationemploying a licensed physician to treat patients andreceive fees for those services is unlawfully engaged inthe practice of medicine Texas, New York, California, and Illinois are examples of stateswith strict corporate practice of medicine perspectives Employee-physician subject to disciplinary action orlicense revocation In strict states, structuring arrangements carefully is veryimportant.15

Strict Prohibition Against CorporatePractice of Medicine Narrow exceptions could apply: Professional corporations formed by physicians – this is acommon permitted corporate structure in states Texas utilizes the “501(a)” structure as a unique exception California permits the use of a “foundation” modelThe “Friendly PC Model” is commonly used in strictcorporate practice of medicine states Physician owned professional corporation is managed by acorporate entity for a fair market value management fee.16

Less Strict Approach toCorporate Practice of Medicine Permits physician employment as long as the terms ofrelationship do not violate statutory requirements: “Entity does not direct or control independent medical acts,decisions, or judgment of the licensed physician” Most physician-entity employment relationshipspermitted as long as physician’s professional medicaldiscretion is preserved Indiana and Florida are examples of states with thisapproach.17

Urgent Care Staffing Models Common staffing models for urgent care centers: Physician-only staffingPrimarily physician staffing supplemented on a limited basis bymid-level providersPrimarily mid-level staffing with supervision provided byphysicians most often through “indirect supervision”Considerations for choice of staffing models: Economic considerationsPublic perception considerationsAvailability of staffing to meet needs18

Urgent Care Staffing Models Here are some 2014 statistics on staffing models used aturgent care centers: 11% are physician only Will this percentage decrease over time?29% have a physician and midlevel working together54% have physician supervision with the physician not onsite4% have no physician supervision (permitted by state regulation)For non-clinicians, over half of the urgent care centers usemedical assistants (40% used RNs) and nearly all urgent carecenters (93%) use X-Ray Technicians19

Urgent Care Staffing Models Direct Supervision versus Indirect Supervision Direct supervision - when the physician is working at the sametime in the same building with the mid-level providerIndirect supervision – when the physician and the mid-levelprovider are not working at the same time but the physician isavailable for consultationState requirements impact supervision arrangements Scope of practice for nurse practitioners and physicianassistants may not be the sameSupervision requirements for NPs and PAs may not be sameState requirements may be harder to satisfy20

Urgent Care Staffing Models Items to Consider when Exploring Indirect Supervision Can PAs and NPs perform the same scope of services?What written agreement is required?With what agencies are forms or agreements to be submitted?What requirements must the supervising physician fulfill? Chart reviews – a certain percentage each month, other charts?Availability?Regular meetings?Periodic reviews of protocols?Clinical quality assessments?What are the legal consequences for the supervising physician?21

Urgent Care Staffing Models Additional considerations for indirect supervision: Limits on the number of mid-levels that may be supervised atany one timePrescription pad requirements vary widely by statePrescribing controlled substancesHow do you document that supervision requirements are met?Key to indirect supervision – follow the rules and domore than simply “check the box” in satisfying the staterequirements22

State Licensure Facility licensing varies greatly from state to state The general rule is that most states do not have an urgent carelicense or any state licensure for urgent care centers Will that remain the case?Some states do have license requirements for urgent carecenters: Florida Massachusetts ArizonaStates with urgent care licensure require pre-opening surveysand periodic surveys thereafter23

State Licensure (continued) Case Study: Massachusetts State license process is very involved, complicated and lengthyMassachusetts has many requirements with respect to thephysical layout of the urgent care center, for exampleThe application is substantial and the review process is verydetailed.At the inspection, multiple inspectors took three days tocomplete the reviewCase Study – Florida While not as involved as Massachusetts, Florida has anapplication and physical space review requirement prior toopening24

State Licensure (continued) Even if a state does not have an urgent care license,patient complaints may lead to an inspection or surveyUrgent care centers should have documented policiesand procedures in place and a way to confirm that thosepolicies and procedures are consistently followedAn example of a key policy and procedure is a triagepolicy: Front desk staff need to understand what to do when anemergent patient comes into the center and requires immediateattention25

State Licensure (continued) These licenses and permits are commonly required: CLIA Certificate Necessary if the center offers certain clinical laboratory testing Make sure the correct level of CLIA certificate is obtained (i.e,waived versus provider performed microscopy)X-ray permit Watch out for extra requirements (Texas, for example) Pharmacy license - in some states, highly restrictive pharmacyprovisions have led urgent care centers to forego offeringprescription medications Other licenses and requirements depend on the location City or county business permits or special signage requirements26

State Licensure (continued) Be aware of additional requirements that may come withlicenses and permits Annual inspection of the labInspection of the X-ray equipment and other diagnosticequipment not located in the labProper storage of medicines and suppliesSignage requirements: Notice to patient requirementsX-Ray noticesPosting of provider licensesNotification to patients if a mid-level provider is on duty27

Documentation and Coding Not unlike other areas of healthcare, a key area ofcompliance for urgent care is appropriate documentationand coding of claims for services Expectation is that proper training and oversight ismaintained for clinician documentation and coding Evaluation and Management (E/M) coding is a keyaspect of urgent care coding: New patients (99201 – 99205) Established patients (99212 – 99215) 1995 versus 1997 Guidelines28

Documentation and Coding If using an electronic health record system: Does the system suggest an E/M code? If so, then need to understand how the system determinesIs it entirely up to the provider to determine the E/M code?Does the system have one check box that results in multipleboxes being checked?Is “copy – paste” features available to clinicians?Who is responsible for completing the Review of Systems andPast Family and Social History?Medical Decision Making Do providers understand the elements in deciding the proper level?How much time they spend with the patient is not a factor29

Documentation and Coding Even if an electronic medical record system is used, theurgent care center should have a paper process fordocumentation available with related policies andprocedures for proper completion A paper documentation process is necessary when theelectronic medical record system is not availableWhen locum tenens are used, they may need to document onpaper because they are not trained on the electronic systemDo you give the regular clinicians the option to document onpaper when the center is busy or when they are still new in usingthe electronic system?30

Documentation and Coding Beyond E/M coding, other aspects of documentation areimportant to consider Is a modifier, like the 25 modifier, appropriate to use?Are procedures, like fracture care and laceration repair, properlydocumented to support the charge for the procedure?Does the documentation contain all of the elements to establish notonly the results of testing but what action the provider takes inresponse to testing results?The “hindsight test” is a good way to evaluate documentation –would the documentation in a professional liability case stand upto scrutiny if challenged by the patient?31

Documentation and Coding How do you properly monitor documentation andcoding? No financial incentive for providers with respect to codingMonitoring programs should be implemented, followed anddocumented Random claims reviewsStatistical analyses should also be performed to detect outliersParticular focus paid to high coding – 99205/99215Proper documentation also avoids malpractice issues Does the electronic medical record system prompt clinicians at all?Balancing complete documentation and need for efficiency is aconstant effort32

Other Areas of Focus Medical Directorship Requirements Some states require urgent care centers have a medical director Florida requires a “market medical director” (maximum of 5locations per medical director)Massachusetts requires a “professional services director” for eachurgent care centerThose states with required medical directors, applicable statutesspell out the duties of those medical directors Florida requires medical directors review charts to ensure properdocumentation and codingMost states have no medical director requirement How does an urgent care center ensure proper provision of medicalservices to patients without medical directors?33

Other Areas of Focus Case Study – Allstate Ins. Co. v. Vizcay (No. 14-13947(11th Cir, June 23, 2016) Company was accused of violating False Claims Act becausemedical director did not review documentation and coding asrequired by Florida statute spelling out medical director dutiesCourt found medical director did not fulfill the statutory dutiesand permitted claims to go out for services not provided andincorrectly documented and coded“The plain meaning of the statutory language shows that theFlorida legislature intended to establish, not eschew, a principalagent relationship between a clinic and its medical director.”34

Other Areas of Focus Accreditation There is no regulatory requirement that urgent care centers seekand obtain accreditationTwo organizations will provide urgent care accreditation: Joint CommissionUrgent Care Association of AmericaBenefits of Accreditation Forces operational discipline and consistency across locationsEstablishes minimum requirements, particularly for states which donot license urgent care centersCreates perception of quality to patientsMay differentiate urgent care centers with payors35

Other Areas of Focus EMTALA Emergency Medical Treatment & Labor ActTreatment obligations of EMTALA do not apply unlessthe urgent care center is owned by a hospital or in a jointventure with a hospital AND services provided are billedas a department of the hospital No obligation to treat patients who arrive at the center Triage policy – stabilize and transport36

Other Areas of Focus Additional Compliance Focus Areas Regular and consistent compliance trainingHIPAA privacy requirements Small spaces and thin wallsFront desk personnel – critical staff memberMedical records requestsHIPAA security requirementsAgreements with providers Compensation and bonus arrangements37

Other Areas of Focus Liability Risks Malpractice risk for urgent care centers generally falls betweenthat of primary care practitioners and emergency departmentsRisk factors for UCCs Lack of long-term, well established patient relationships Target for drug seekers Discharge management—patient follow-up plan Potential for underdiagnosing patients Rely on patients to correctly self-triage and select appropriate facility forcare Example of risk area – pulmonary embolism38

Key Business Considerations Location, management, and services Issues in buying or selling an Urgent Care Center Partnering with hospitals and investors39

Location Volume key to financial success Onestudy showed that a population of 20,000 to30,000 was needed to sustain an urgent care center Currently, urgent care centers are concentrated in urbanareas Convenience for patients Population demographics, e.g., age, average income Free-standing v. hospital-associated40

Management of Urgent Care Centers How will the urgent care center be managed? Physicianmanaged Managementcompany Customer service oriented management improvesfinancial success of urgent care centers Leadership with a healthcare background is key41

Services Provided Target population Specialty v. General Know the community’s demographic in order to tailor services tocommunity’s needsFor example, some urgent care centers focus specifically onpediatric careOne stop shop All services within the urgent care center or nearby referrallocations Goes back to the convenience factor42

Buying or Selling an Urgent Care Center Buying an existing urgent care center Location Competition Reputation Property—leasedor owned Valuation Due Diligence Exclusivity Agreement Employment & Non-Compete Agreements43

Buying or Selling Urgent Care Centers Due Diligence – areas of focus Documentation and codingPolicies and proceduresTraining for staffMarketingLines of businessPatient satisfactionTurnover ratesLitigation experienceOperational audit results44

Buying or Selling an Urgent Care Center Governing and Ownership Agreements Voting Officers Compensation Decisionmaking—Management and Control Retirement Sale of Ownership Interest Tax Considerations45

Partnering with Hospitals and Investors Possible Ownership Models Physicianor group of physicians Hospital Corporation Non-physicianindividual Franchise With the wide range of services offered and extendedservice hours, integration is key to the successful growthof an urgent care center46

Management Company Model Provides the facilities, office space, equipment, nonphysician personnel, and non-professional services to anexisting practice or other healthcare services provider Must be commercially reasonable and reflect fair marketvalue payment for the goods and services Do you obtain a third party fair market valuation? Does state law permit a percentage-based management fee or isa flat fee required? May the fee be adjusted and how?47

Investor Model Private equity firm or investor group provides equityfunding for the businessInvestors typically own a majority of the equity in thecompanyManagement holds a minority stake Board of Directors is dominated by the investorsUltimate fate of the company’s control is up to the investorsTiming and consideration for when and to whom to sell may notbe what management anticipatesTiming to achieve center-level profitability andcompleting beneficial acquisitions are very important48

Joint Venture Model Hospital or health system and company jointly ownurgent care centersProper structure is very importantOperating agreement describes key business terms How are decisions made on important decisionsWhat decisions may the manager make without BoardparticipationHow are the centers brandedDo each of the members to the joint venture have the samegoals in mind for the jointly owned locations49

David F. LewisJon M. SundockButler SnowCareSpot Express HealthcareThe Pinnacle at Symphony PlaceMedPost150 3rd Avenue South, Suite 1600115 East Park Drive, Suite 300Nashville, TN 37201Brentwood, TN .com50

6 What is an Urgent Care Center? No universal definition Provide services that fall in between primary care and emergency department Can also include some primary care services and could branch into other areas, e.g., weight loss, allergy care, wellness, etc. Urgent Care Association of America: The delivery of ambulatory medical care outside of a hospital emergency

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