Presenting a live 90-minute webinar with interactive Q&A

Retail Clinics in Healthcare:Overcoming Complex Legal ChallengesComplying with Corporate Practice of Medicine, Licensure, and Scope of PracticeLaws; Navigating Emerging Relationships with Physicians, Hospitals and Payers

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

THURSDAY, MARCH 10, 2016

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Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

Patricia S. Hofstra, Partner, Duane Morris, Chicago

Lester J. Perling, Partner, Broad and Cassel, Ft. Lauderdale, Fla.

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Retail Clinics in Health Care:Overcoming Complex Legal ChallengesSponsored by Stafford Publications

The EvolutionRetail Clinics in Health Care:Overcoming Complex Legal ChallengesPresented By:

Patricia Hofstra, Esq.Duane Morris LLP

pshofstra@duanemorris.com

Lester J. Perling, Esq. CHCBroad and Cassel

lperling@broadandcassel.com

The Evolution

What is Retail Medicine?• Walk in healthcare delivered in retail setting• Limited scope of services• Usually staffed by a Physician’s Assistant or Nurse Practitioner• Services:

• Primary care• Dental• Optical• Hearing

• Walk in healthcare delivered in retail setting• Limited scope of services• Usually staffed by a Physician’s Assistant or Nurse Practitioner• Services:

• Primary care• Dental• Optical• Hearing

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Growing Threat of Retail MedicineIn 2008, David Miller of the Healthcare StrategyGroup recommended the following threestrategies for hospitals and physicians to addressthe growing threat of retail medicine :1. Compete;2. Ignore them; or3. Resist.

In 2008, David Miller of the Healthcare StrategyGroup recommended the following threestrategies for hospitals and physicians to addressthe growing threat of retail medicine :1. Compete;2. Ignore them; or3. Resist.

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2016 StrategyHere is what is happening in 2016

Collaboration with Hospitals and Physicians

Here is what is happening in 2016

Collaboration with Hospitals and Physicians

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CVS/MINUTE CLINICHas affiliations with 32 health systems

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WALGREENS• Advocate Healthcare taking over ownership and operations of

56 healthcare clinics in Walgreens stores• Walgreens has similar deal with Providence Healthcare

Services in Seattle and other health systems• Advocate has exclusive contract with Blue Cross/Blue Shield

for certain product lines• Will those patients be directed to lower cost retail settings

• Advocate Healthcare taking over ownership and operations of56 healthcare clinics in Walgreens stores

• Walgreens has similar deal with Providence HealthcareServices in Seattle and other health systems

• Advocate has exclusive contract with Blue Cross/Blue Shieldfor certain product lines• Will those patients be directed to lower cost retail settings

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Retail Medicine• Started with acute conditions• Moved to preventative care, vaccinations, school/camp

physicals to wellness, skin cancer analysis to chronic caremanagement: diabetes/hypertension/asthma

• Shift from wholesale provider – insurance company toconsumer

• Employer to retail – on-line shopping for healthcare• Demographics – young, insured and without a doctor• Marceau McKinlay predicted in Social Science and Medicine

Journal that by 2025, all low-acute cases would shift fromPCPs to retail clinics

• Started with acute conditions• Moved to preventative care, vaccinations, school/camp

physicals to wellness, skin cancer analysis to chronic caremanagement: diabetes/hypertension/asthma

• Shift from wholesale provider – insurance company toconsumer

• Employer to retail – on-line shopping for healthcare• Demographics – young, insured and without a doctor• Marceau McKinlay predicted in Social Science and Medicine

Journal that by 2025, all low-acute cases would shift fromPCPs to retail clinics

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INSURANCE COVERAGE• Movement from cash business to 80% covered by insurance in

2013• Walmart Clinics assist customers with selecting insurance and

offer Web portals• Walmart and United Health Group are implementing a sleep

product and six week sleep analysis project• Some payers now waive copays for retail clinics

• Movement from cash business to 80% covered by insurance in2013

• Walmart Clinics assist customers with selecting insurance andoffer Web portals

• Walmart and United Health Group are implementing a sleepproduct and six week sleep analysis project

• Some payers now waive copays for retail clinics

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Telemedicine and Retail MedicineIntersect• Off-Site Physician Consultation• After Hours Coverage

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Telemedicine / Telehealth• Although typically referred to as “telemedicine,” the term

“telehealth” often is defined to capture a broader array ofservices than “telemedicine.”

• The Health Resources and Services Administration (“HRSA”)defines telehealth as “the use of electronic information andtelecommunications technologies to support long-distanceclinical healthcare, patient and professional health-relatededucation, public health, and health administration.”

• Although typically referred to as “telemedicine,” the term“telehealth” often is defined to capture a broader array ofservices than “telemedicine.”

• The Health Resources and Services Administration (“HRSA”)defines telehealth as “the use of electronic information andtelecommunications technologies to support long-distanceclinical healthcare, patient and professional health-relatededucation, public health, and health administration.”

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Telemedicine Under Medicare• Medicare allows services provided through telemedicine if

certain criteria are met.• The “Telehealth services” regulation defines when and where

Medicare Part B will cover telemedicine services. 42 C.F.R. §410.78. There are four key conditions:

• State Licensure• Practitioner Type• “Originating Site” type requirements• “Originating Site” distance requirements

• Medicare allows services provided through telemedicine ifcertain criteria are met.

• The “Telehealth services” regulation defines when and whereMedicare Part B will cover telemedicine services. 42 C.F.R. §410.78. There are four key conditions:

• State Licensure• Practitioner Type• “Originating Site” type requirements• “Originating Site” distance requirements

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Telemedicine Under MedicareCriteria for Medicare coverage:(1) Is the service a Medicare-approved telemedicine service?(2) Does the service involve the use of real-time video and

audio?(3) Is the practitioner who provides the service appropriately

licensed?(4) Is the patient at an approved health care facility in a rural

market at the time of service?

Criteria for Medicare coverage:(1) Is the service a Medicare-approved telemedicine service?(2) Does the service involve the use of real-time video and

audio?(3) Is the practitioner who provides the service appropriately

licensed?(4) Is the patient at an approved health care facility in a rural

market at the time of service?

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Telemedicine Under Medicare• Examples of approved services:

• Outpatient and other office visits• Professional consultations• Individual psychotherapy• Transitional care management• Substance abuse counseling and treatment• Certain nutrition therapy services

• Examples of approved services:• Outpatient and other office visits• Professional consultations• Individual psychotherapy• Transitional care management• Substance abuse counseling and treatment• Certain nutrition therapy services

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Telemedicine Under MedicarePractitioner Type:• The practitioner at the distant site is one of:

• physician as described in § 410.20.• physician assistant as described § 410.74.• nurse practitioner as described in § 410.75.• clinical nurse specialist as described in § 410.76.• nurse-midwife as described in § 410.77.• clinical psychologist as described in § 410.71.• clinical social worker as described in § 410.73.• registered dietitian or nutrition professional as described in §

410.134.

Practitioner Type:• The practitioner at the distant site is one of:

• physician as described in § 410.20.• physician assistant as described § 410.74.• nurse practitioner as described in § 410.75.• clinical nurse specialist as described in § 410.76.• nurse-midwife as described in § 410.77.• clinical psychologist as described in § 410.71.• clinical social worker as described in § 410.73.• registered dietitian or nutrition professional as described in §

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Telemedicine Under MedicareOriginating Site• The services are furnished to a beneficiary at an “originating

site,” which is one of the following:• The office of a physician or practitioner.• A critical access hospital.• A rural health clinic.• A Federally qualified health center.• A hospital.• A hospital-based or critical access hospital-based renal dialysis

center (including satellites).• A skilled nursing facility.• A community mental health center.

Originating Site• The services are furnished to a beneficiary at an “originating

site,” which is one of the following:• The office of a physician or practitioner.• A critical access hospital.• A rural health clinic.• A Federally qualified health center.• A hospital.• A hospital-based or critical access hospital-based renal dialysis

center (including satellites).• A skilled nursing facility.• A community mental health center. 19

Telemedicine Regulation• Many states have considered proposals, with varied

results, to revise health professional standards andlicensure requirements when using telemedicine.• According the American Telemedicine Association, over 40 states

provide some Medicaid coverage for telehealth services.

• Some states are creating new laws that impact access tocare via telemedicine, while others are amending existingpolicies with greater implications.

• Few state medical boards are adopting practicestandards with higher specifications for telemedicinethan in-person care.

• Many states have considered proposals, with variedresults, to revise health professional standards andlicensure requirements when using telemedicine.• According the American Telemedicine Association, over 40 states

provide some Medicaid coverage for telehealth services.

• Some states are creating new laws that impact access tocare via telemedicine, while others are amending existingpolicies with greater implications.

• Few state medical boards are adopting practicestandards with higher specifications for telemedicinethan in-person care.

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Florida Board of Medicine Rule:64B8-9.0141• The rule defines “telemedicine” as “the practice of medicine

by a licensed Florida physician or physician assistant wherepatient care, treatment, or services are provided through theuse of medical information exchanged from one site toanother via electronic communications. Telemedicine shall notinclude the provision of health care services only through anaudio only telephone, email messages, text messages,facsimile transmission, U.S. Mail or other parcel service, or anycombination thereof.”

• The rule defines “telemedicine” as “the practice of medicineby a licensed Florida physician or physician assistant wherepatient care, treatment, or services are provided through theuse of medical information exchanged from one site toanother via electronic communications. Telemedicine shall notinclude the provision of health care services only through anaudio only telephone, email messages, text messages,facsimile transmission, U.S. Mail or other parcel service, or anycombination thereof.”

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Florida Board of Medicine Rule:64B8-9.0141Application of the Rule:• Rule does not prohibit consultations between physicians or

the transmission and review of digital images, pathologyspecimens, test results, or other medical data by physicians orother qualified providers related to the care of Floridapatients.

• Rule does not apply to emergency medical services providedby emergency physicians, emergency medical technicians(EMTs), paramedics, and emergency dispatchers.

• Rule does not apply where a physician or physician assistant istreating a patient with an emergency medical condition thatrequires immediate medical care.

Application of the Rule:• Rule does not prohibit consultations between physicians or

the transmission and review of digital images, pathologyspecimens, test results, or other medical data by physicians orother qualified providers related to the care of Floridapatients.

• Rule does not apply to emergency medical services providedby emergency physicians, emergency medical technicians(EMTs), paramedics, and emergency dispatchers.

• Rule does not apply where a physician or physician assistant istreating a patient with an emergency medical condition thatrequires immediate medical care. 22

Medicaid and TelemedicineGenerally• Federal Medicaid law does not recognize telemedicine as a

separate and distinct billable service.• However, federal matching funds (FFP) are available to State

Medicaid programs to cover telemedicine services in the sameexact way and amount as they do for face-to-faceservices/visits/consultations without submitting a MedicaidState Plan Amendment (SPA).

• However, if a State Medicaid Program wants to reimbursetelemedicine services differently than is being done for acorresponding face to face service, then a SPA is necessary ifthe State wants federal matching funds.

• Federal Medicaid law does not recognize telemedicine as aseparate and distinct billable service.

• However, federal matching funds (FFP) are available to StateMedicaid programs to cover telemedicine services in the sameexact way and amount as they do for face-to-faceservices/visits/consultations without submitting a MedicaidState Plan Amendment (SPA).

• However, if a State Medicaid Program wants to reimbursetelemedicine services differently than is being done for acorresponding face to face service, then a SPA is necessary ifthe State wants federal matching funds.

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Telemedicine under CommercialInsurance• Commercial insurers have varying approaches when it comes

to coverage for telemedicine services.• Example – UnitedHealthcare

• Covers "telemedicine" and "telehealth" services provided overthe phone, via the Internet or other communication devices.

• Modeled after Medicare's telemedicine payment policies (similarlist of originating sites).

• Use of modifiers to signal that the service was a telemedicineservice.

• Commercial insurers have varying approaches when it comesto coverage for telemedicine services.

• Example – UnitedHealthcare• Covers "telemedicine" and "telehealth" services provided over

the phone, via the Internet or other communication devices.• Modeled after Medicare's telemedicine payment policies (similar

list of originating sites).• Use of modifiers to signal that the service was a telemedicine

service.

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Telemedicine Under CommercialInsurance• UnitedHealthcare covered services include:

• E/M services with patients over telephone or Internet;• Interprofessional telephone/internet assessment and

management services;• Online evaluation and management provided by physician or

other qualified health care professionals.

• UnitedHealthcare covered services include:• E/M services with patients over telephone or Internet;• Interprofessional telephone/internet assessment and

management services;• Online evaluation and management provided by physician or

other qualified health care professionals.

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STATE REGULATION OF RETAILMEDICINESTATE REGULATION OF RETAILMEDICINE26

Licensure Requirements• States may require retail clinics to be licensed as specific

health care entities• Florida

• Health Care Clinic Act + corresponding regulations• Clinic: an entity where health care services are provided to

individuals and which tenders charges for reimbursement forsuch services that are not owned by certain enumerated licensedprofessionals, including nurse practitioners, or licensed facilitiessuch as hospitals.

• States may require retail clinics to be licensed as specifichealth care entities

• Florida• Health Care Clinic Act + corresponding regulations• Clinic: an entity where health care services are provided to

individuals and which tenders charges for reimbursement forsuch services that are not owned by certain enumerated licensedprofessionals, including nurse practitioners, or licensed facilitiessuch as hospitals.

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Licensure Requirements• Other unique licensure states:• Massachusetts (separate licensure category for retail clinic)• California (retail clinic exempt from licensure)

• Some states have no licensure requirements• Illinois – same as doctor’s office

• Other unique licensure states:• Massachusetts (separate licensure category for retail clinic)• California (retail clinic exempt from licensure)

• Some states have no licensure requirements• Illinois – same as doctor’s office

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Medical Directors• Many states require a physician to act as the Medical Director

• Florida: a licensed health care clinic requires a physician medicaldirector

• The Medical Director may or may not need to be presentdepending on state law• Florida: Physical presence is not required

• Many states require a physician to act as the Medical Director• Florida: a licensed health care clinic requires a physician medical

director• The Medical Director may or may not need to be present

depending on state law• Florida: Physical presence is not required

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Fee Splitting Prohibition• States have fee-splitting provisions that prohibit licensed

medical professionals from splitting professional fees withother individuals or entities in exchange for referrals.

• Example: Florida• Patient Brokering Act: prohibit split-fee arrangements (Fla. Stat.

817.505)• Fee-Splitting prohibitions in individual acts as well

• States have fee-splitting provisions that prohibit licensedmedical professionals from splitting professional fees withother individuals or entities in exchange for referrals.

• Example: Florida• Patient Brokering Act: prohibit split-fee arrangements (Fla. Stat.

817.505)• Fee-Splitting prohibitions in individual acts as well

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State Prohibition on Self Referral• Many states have equivalents of the Stark law that prohibit

self referrals or patient brokering• Examples:

• Florida (Florida Patient Self Referral Act, disclosure of financialinterest)

• Georgia (Patient Self-Referral Act of 1993)• North Carolina (self-referrals prohibited)• Tennessee (investment interest only)

• Many states have equivalents of the Stark law that prohibitself referrals or patient brokering

• Examples:• Florida (Florida Patient Self Referral Act, disclosure of financial

interest)• Georgia (Patient Self-Referral Act of 1993)• North Carolina (self-referrals prohibited)• Tennessee (investment interest only)

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Professional Staff• Mid-level non-physician practitioners

• APRN (Advanced Practice Registered Nurse)• PA (Physician's Assistant)

• Supervision and collaborative agreement requirements• Physician supervision varies (examples below)

• Constant on-site supervision• Remote telemedicine supervision• Specific physician/non-physician ratio (Florida: physician may not

supervise more than 4 offices in addition to physician's primarypractice location)

• No specific supervision requirement

• Mid-level non-physician practitioners• APRN (Advanced Practice Registered Nurse)• PA (Physician's Assistant)

• Supervision and collaborative agreement requirements• Physician supervision varies (examples below)

• Constant on-site supervision• Remote telemedicine supervision• Specific physician/non-physician ratio (Florida: physician may not

supervise more than 4 offices in addition to physician's primarypractice location)

• No specific supervision requirement

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Scope of Practice• Scope of practice

• Each state has laws and regulations that determine servicesdifferent health care professionals may provide – often vague

• In many states the scope of practice for nurse practitioners isexpanding. 21 states now give nurse practitioners full practiceand prescriptive authority

• Licensure laws, rules and regulations normally outline the scopeof practice for that professional

• Prescription writing• Many states limit who may write prescriptions; and beyond that

who might write prescriptions for controlled substances

• Scope of practice• Each state has laws and regulations that determine services

different health care professionals may provide – often vague• In many states the scope of practice for nurse practitioners is

expanding. 21 states now give nurse practitioners full practiceand prescriptive authority

• Licensure laws, rules and regulations normally outline the scopeof practice for that professional

• Prescription writing• Many states limit who may write prescriptions; and beyond that

who might write prescriptions for controlled substances

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Licensure RequirementsLaboratory & CON• Clinical Laboratory Improvement Amendments of 1988 (CLIA)

(42 C.F.R. 493.2)• CMS regulates laboratory testing• Retail clinics may be eligible for CLIA certificate of waiver if it

restricts lab testing to one of the waived tests found at 42 C.F.R.493.15(c).

• Certain states may require a separate lab license• Certificate of Need (CON)

• Certificate of Need is a state-specific regulatory requirement inorder to ensure public need and financial feasibility for healthcare providers

• Some states may require a CON in order to establish a retail clinic(New York recently considered this)

• Clinical Laboratory Improvement Amendments of 1988 (CLIA)(42 C.F.R. 493.2)• CMS regulates laboratory testing• Retail clinics may be eligible for CLIA certificate of waiver if it

restricts lab testing to one of the waived tests found at 42 C.F.R.493.15(c).

• Certain states may require a separate lab license• Certificate of Need (CON)

• Certificate of Need is a state-specific regulatory requirement inorder to ensure public need and financial feasibility for healthcare providers

• Some states may require a CON in order to establish a retail clinic(New York recently considered this) 34

Corporate Practice of Medicine• Corporate Practice of Medicine is a state specific doctrine that

imposes restrictions of the ability of business entities toprovide medical services• The scope and manner of the potential restrictions vary from

state to state• Certain states have no CPOM restriction (Florida)• Others have CPOM restrictions to prevent unlicensed practice (CA)• Some states allow exceptions if the entity is licensed as a health care

facility (NJ)

• Corporate Practice of Medicine is a state specific doctrine thatimposes restrictions of the ability of business entities toprovide medical services• The scope and manner of the potential restrictions vary from

state to state• Certain states have no CPOM restriction (Florida)• Others have CPOM restrictions to prevent unlicensed practice (CA)• Some states allow exceptions if the entity is licensed as a health care

facility (NJ)

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Pharmacy Referrals• Practitioners cannot be compensated based on services

provided, including the number of prescriptions filled in thelandlord/retail space

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Transfer Agreements• A transfer agreement is entered into between the entity and a

nearby hospital to transfer patients to the hospital inappropriate circumstances• In theory this is not necessary because under EMTALA hospitals

must accept patients through the emergency department• State law or accrediting bodies may require a transfer

agreement with a hospital• Florida Health Care Clinic Act does not require this…

nonetheless it may be a practically reasonable thing to have inplace

• A transfer agreement is entered into between the entity and anearby hospital to transfer patients to the hospital inappropriate circumstances• In theory this is not necessary because under EMTALA hospitals

must accept patients through the emergency department• State law or accrediting bodies may require a transfer

agreement with a hospital• Florida Health Care Clinic Act does not require this…

nonetheless it may be a practically reasonable thing to have inplace

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Medical Records• States have varying records retention policies for health care

entities and may have specific requirements for what isincluded in the medical record and their ownership

• Florida:• Policies, procedures and other compliance documents: 5 years• Medical Records: 7 years• Fla. Stat. 456.057 – Medical record belongs to practitioner who

created it unless there is a written agreement stating the recordbelongs to the practitioner's employer

• Massachusetts:• Diagnosis and treatment records: 20 years after the discharge or

final treatment of patient;• Certain records like radiological films and image records: 5 years

following date of service

• States have varying records retention policies for health careentities and may have specific requirements for what isincluded in the medical record and their ownership

• Florida:• Policies, procedures and other compliance documents: 5 years• Medical Records: 7 years• Fla. Stat. 456.057 – Medical record belongs to practitioner who

created it unless there is a written agreement stating the recordbelongs to the practitioner's employer

• Massachusetts:• Diagnosis and treatment records: 20 years after the discharge or

final treatment of patient;• Certain records like radiological films and image records: 5 years

following date of service 38

FEDERAL LAW CONSIDERATIONS39

AntitrustFederal Trade Commission warns of possible antitrust violationsif states place overly strict limits on retail clinics

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Stark Law• Not Applicable• Unless a physician refers patients to a retail clinic where

physician or physician’s organization has a financialrelationship

• Not Applicable• Unless a physician refers patients to a retail clinic where

physician or physician’s organization has a financialrelationship

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Anti-Kickback• Host retailer avoid paying for referrals• Avoid revenue based lease payments• Comply with safe harbor for space, equipment rental and

personal services• Implement business conduct rule to assure compliance

• Host retailer avoid paying for referrals• Avoid revenue based lease payments• Comply with safe harbor for space, equipment rental and

personal services• Implement business conduct rule to assure compliance

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HIPAA Privacy and Security• Record Management

• Electronic Health Records• Restrictions on marketing activities• Consents and Authorizations

• Transmitting information to patient’s primary care physician

• Record Management• Electronic Health Records

• Restrictions on marketing activities• Consents and Authorizations

• Transmitting information to patient’s primary care physician

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Handicapped Accessibility• https://www.ada.gov/medcare_mobility_ta/medcare_ta.htm

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Key Points• Accessibility is essential• Medical care provides required to make services available in

an accessible manner• Any private entity that owns, leases, leases to or operates a

place of public accommodation must comply• Tenants and landlords

• Accessibility is essential• Medical care provides required to make services available in

an accessible manner• Any private entity that owns, leases, leases to or operates a

place of public accommodation must comply• Tenants and landlords

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Accessible Exam Rooms• An accessible route to and through the room• Entry door with adequate clear width, maneuvering clearance

and accessible hardware• Appropriate and accessible examination equipment• Adequate clear floor space for side transfers and lift

equipment

• An accessible route to and through the room• Entry door with adequate clear width, maneuvering clearance

and accessible hardware• Appropriate and accessible examination equipment• Adequate clear floor space for side transfers and lift

equipment

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Accreditation• Convenient Care Association certification• Joint Commission• Accreditation Association for Ambulatory Health Care

• Convenient Care Association certification• Joint Commission• Accreditation Association for Ambulatory Health Care

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COMPLIANCE, QUALITY ASSURANCEAND PEER REVIEWCOMPLIANCE, QUALITY ASSURANCEAND PEER REVIEW48

Compliance• A compliance program is an internal program the clinic should

implement in order to meet governmental standards asdetermined through federal and state laws and regulations

• A compliance program begins with established policies andprocedures and becomes effective if the organization has aculture of compliance

• A compliance program is an internal program the clinic shouldimplement in order to meet governmental standards asdetermined through federal and state laws and regulations

• A compliance program begins with established policies andprocedures and becomes effective if the organization has aculture of compliance

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Elements of an EffectiveCompliance Program1. Establish policies, procedures and controls2. Exercise effective compliance and ethics oversight3. Exercise due diligence and avoid delegation of authority to

unethical individuals4. Communicate and educate employees on compliance and ethics

programs5. Monitor and audit compliance and ethics programs for

effectiveness6. Ensure consistent enforcement and discipline of violations7. Respond appropriately to incidents and take steps to prevent

future incidents

1. Establish policies, procedures and controls2. Exercise effective compliance and ethics oversight3. Exercise due diligence and avoid delegation of authority to

unethical individuals4. Communicate and educate employees on compliance and ethics

programs5. Monitor and audit compliance and ethics programs for

effectiveness6. Ensure consistent enforcement and discipline of violations7. Respond appropriately to incidents and take steps to prevent

future incidents50

Quality Assurance• Convenient Care Association Quality and Safety Standards• https://ccaclinics.org/about-us/quality-of-care

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Mechanisms of Review• Formal chart review by experienced clinicians• Peer-review by clinicians• Medical diagnosis and treatment code auditing• Processes to ensure that all clinicians are certified and

credentialed in their specialty by their respective governingbodies

• Compliance with state regulations regarding the practice ofhealth care clinicians

• Formal chart review by experienced clinicians• Peer-review by clinicians• Medical diagnosis and treatment code auditing• Processes to ensure that all clinicians are certified and

credentialed in their specialty by their respective governingbodies

• Compliance with state regulations regarding the practice ofhealth care clinicians

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Liability and Risk Management• Supervising physicians face potential liability from allegations

that standards were not met• Potential liability of retail host

• Supervising physicians face potential liability from allegationsthat standards were not met

• Potential liability of retail host

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REIMBURSEMENT54

Medicare EnrollmentRequirements• 855-B Enrollment Requirements:

• National Provider Identifier (NPI)• Submit enrollment application and supporting documentation to

the fee-for-service contractor• Sign certification statement• Submit verifiable information to CMS• Complete applicable state surveys, certifications and provider

agreement• Be operational to furnish Medicare covered items or services• Meet additional compliance and reporting obligations• Prepare for an on-site review (CMS has discretion)

• 855-B Enrollment Requirements:• National Provider Identifier (NPI)• Submit enrollment application and supporting documentation to

the fee-for-service contractor• Sign certification statement• Submit verifiable information to CMS• Complete applicable state surveys, certifications and provider

agreement• Be operational to furnish Medicare covered items or services• Meet additional compliance and reporting obligations• Prepare for an on-site review (CMS has discretion)

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Medicare Enrollment• Clinic must enroll in Medicare using the 855-B form• Medicare does not recognize a retail clinic as a separate provider; must

likely enroll as a "clinic/group practice"• Group practice defined by Medicare:

• A group practice is a group of two or more physician and non-physicianpractitioners legally organized in a partnership, professional corporation,foundation, not-for-profit corporation, faculty practice plan, or similarassociation (Medicare General Information, Eligibility, and EntitlementManual, Chapter 5, Sec. 90.4 for more details)

• Other practitioners:• Advanced Practice Nurse Practitioners can operate independently subject

to compliance with state law• PAs may only bill through their employer

• Hospital Outpatient Department status• If a hospital operates the clinic – it could be treated as either a group

practice OR as a provider-based clinic

• Clinic must enroll in Medicare using the 855-B form• Medicare does not recognize a retail clinic as a separate provider; must

likely enroll as a "clinic/group practice"• Group practice defined by Medicare:

• A group practice is a group of two or more physician and non-physicianpractitioners legally organized in a partnership, professional corporation,foundation, not-for-profit corporation, faculty practice plan, or similarassociation (Medicare General Information, Eligibility, and EntitlementManual, Chapter 5, Sec. 90.4 for more details)

• Other practitioners:• Advanced Practice Nurse Practitioners can operate independently subject

to compliance with state law• PAs may only bill through their employer

• Hospital Outpatient Department status• If a hospital operates the clinic – it could be treated as either a group

practice OR as a provider-based clinic 56

Medicare Reimbursement• Group practice reimbursement:

• Fee for service based on the Medicare Physician Fee Schedule(MPFS).

• Mid-level practitioners will also be reimbursed on the MPFS,however at a 15% reduction rate

• Incident-to services reimbursement• A provider-based clinic would be on the Outpatient Prospective

Patient System (OPPS), not the MPFS

• Group practice reimbursement:• Fee for service based on the Medicare Physician Fee Schedule

(MPFS).• Mid-level practitioners will also be reimbursed on the MPFS,

however at a 15% reduction rate• Incident-to services reimbursement

• A provider-based clinic would be on the Outpatient ProspectivePatient System (OPPS), not the MPFS

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Medicaid Enrollment• The clinic will need to enroll in Medicaid similarly to Medicare• Many states may not recognize "retail clinic" as a separately

category; use group practice• Some states may specifically use retail clinic terminology

(Massachusetts)

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Medicaid Reimbursement• Like Medicare, Medicaid normally pays mid-level practitioners

differently than physicians• Each state will have different Medicaid payment policies• Example: Florida

• Practitioner handbook with separate chapters for differentproviders

• Like Medicare, Medicaid normally pays mid-level practitionersdifferently than physicians

• Each state will have different Medicaid payment policies• Example: Florida

• Practitioner handbook with separate chapters for differentproviders

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Other Third Party Payers• Contract concerns• Reimbursement and coverage• Still must comply with various federal laws and meet state

licensure requirements

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Collection of Co-Payments andDeductibles• Routine waiver

• Implicates the anti-kickback statute (specifically addressed at 42CFR 1001.952(h)(5)(iv)).

• Medicare contractor may investigate if the waivers constitute areduction of the provider's actual charges in violation ofMedicare rules requiring physician services reimbursement to bebased on the lesser of actual charges or the applicable feeschedule amount.

• Financial hardship exception to routine waiver prohibition• Must be based on objective standards

• State law potential insurance fraud and unlawful patientinducement concerns. However, some insurance companiesare now waiving co-payments through contracting.

• Routine waiver• Implicates the anti-kickback statute (specifically addressed at 42

CFR 1001.952(h)(5)(iv)).• Medicare contractor may investigate if the waivers constitute a

reduction of the provider's actual charges in violation ofMedicare rules requiring physician services reimbursement to bebased on the lesser of actual charges or the applicable feeschedule amount.

• Financial hardship exception to routine waiver prohibition• Must be based on objective standards

• State law potential insurance fraud and unlawful patientinducement concerns. However, some insurance companiesare now waiving co-payments through contracting. 61

Retail Medicine• Is retail medicine the next “medical home”?

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Key Business Issues• Zoning• Business Use• Hazardous Waste• Leases

• Subleases

• Zoning• Business Use• Hazardous Waste• Leases

• Subleases

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Questions?Patricia S. HofstraDuane Morris LLP

312.499.0180pshofstra@duanemorris.com

Lester J. Perling, Esq. CHCBroad and Cassel

954.764.7060lperling@broadandcassel.com

Patricia S. HofstraDuane Morris LLP

312.499.0180pshofstra@duanemorris.com

Lester J. Perling, Esq. CHCBroad and Cassel

954.764.7060lperling@broadandcassel.com

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