Private Clinic Set-up Requirements Overview - FSOMA
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2/10/21
Private Clinic Set-up
Requirements Overview
Federal, State and Local Agency
Documentation
Presented by: FSOMA President .
David Bibbey, MSOM, Dipl.Ac, L.Ac
1
Outline: Clinic Licensing Requirements
u Commercial Lease – Rental Agreement – Other Agreement
u General Liability Insurance Policy (Theft, Damage, Slip/Fall)
u HIPAA Privacy and Security Rule Compliance
u Website and Patient Data Security
u ADA Accessibility Compliance
u Business License (aka, City and/or County Tax Receipt)
u County Tangible Personal Property Inventory and Tax Filing
u Medicare and Medicaid Plans – Credentialing & CAQH
u Biomedical Waste Generator Permit (County Health Dept)
u Red Book
u Biomedical Waste Generator and Disposal Plan
u Fire Evacuation Plan
u Material Safety Data Sheets
u Professional License (State Dept of Health)
u Professional Liability Insurance
u AHCA Exemption from Health Care Clinic Licensure Requirements
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Commercial Lease & Rental Agreement
Other Agreements
u Commercial Lease Agreement
u Read and Understand the agreement terms
uDuration, SqFt, Rent $$, CAM Fees, taxes,
Insurance Requirements, Equipment Liability,
Lease Renewal, Cost Increases, Termination.
u Rental Agreement
uUse of space, assets, staff
u Other: Understand fully. Agreements must
be IN WRITING & reviewed by attorney!
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HIPAA Privacy and Security Rule Compliance
u Website and Patient Data Security
u Clinic Websites should be on a Secure Server
uIntegrated forms & programs that collect protected
health info (PHI) – must be secure
u Email/Text communications w/ PHI – secure
u Wireless modems to mobile devices – secure
u Complete annual Security Risk Analysis (SRA)
uHHS Final Guidance SRA
u ADA Website Accessibility WCAG 2.1 AA Standards
u Website programming / Subscription Service
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Business License
(aka, City and/or County Tax Receipt)
u Contact Town/City Hall Business Office to apply for
Business License.
u Based on business location: you may be required to maintain
both city and county business licenses.
u Complete & provide any requested documentation
u Professional license (copy)
u Proof of General Liability Insurance
u Clinic “Fire Plan” (Exits drawing)
u Expect inspection from Building Code Enforcement and Fire
Dept Inspector
u Review for electrical and building code violations
u Inspect fire extinguisher equip/locations/expirations and
redundant wiring for powered exit signs at egresses.
5
County Tangible Personal Property Inventory
and Tax Filing
u Generate an inventory list of all clinic assets and values
u fixed assets not for sale: furniture, computers, linens,
decorations, equipment, inventory, etc.
u The list is edited annually to indicate “no change, changed,
removed, sold.”
u Provide list to accountant with business ledger annually
u Most business receive a $25,000 exemption eligibility
u County: Tangible Personal Property Tax Return (April 1st)
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What is Medicare
u Medicare is the federal health insurance program created in
1965 for people ages 65 and over, regardless of income, medical
history, or health status. The program was expanded in 1972 to
cover certain people under age 65 who have a long-term
disability.
u Today, Medicare plays a key role in providing health and
financial security to 60 million older people and younger people
with disabilities. The program helps to pay for many medical
care services, including hospitalizations, physician visits,
prescription drugs, preventive services, skilled nursing facility
and home health care, and hospice care.
u In 2017, Medicare spending accounted for 15 percent of total
federal spending and 20 percent of total national health
spending.
7
The A, B, and C’s of Medicare
u Part A covers inpatient hospital stays, skilled nursing facility
(SNF) stays, some home health visits, and hospice care.
u Part B covers physician visits, outpatient services, preventive
services, and some home health visits. Many Part B benefits are
subject to a deductible ($185 in 2019), and, typically,
coinsurance of 20 percent.
u Part C refers to the Medicare Advantage program. Beneficiaries
can enroll in a private health plan, such as a health
maintenance organization (HMO) or preferred provider
organization (PPO), and receive all Medicare-covered Part A and
Part B benefits and typically also Part D (Drug) benefits.
u More than 4.6 million Floridians are Medicare beneficiaries,
nearly 50% are enrolled in Medicare Advantage plans in 2020.
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42/10/21
2020 Medicare National Coverage
Determination (NCD) - Acupuncture
u The Centers for Medicare & Medicaid Services (CMS) will cover acupuncture
for chronic low back pain under section 1862(a)(1)(A) of the Social Security
Act. Up to 12 visits (units) in 90 days are covered for Medicare beneficiaries
under the following circumstances:
• For the purpose of this decision, chronic low back pain (cLBP) is defined as:
o Lasting 12 weeks or longer;
o nonspecific, in that it has no identifiable systemic cause (i.e., not
associated with metastatic, inflammatory, infectious, etc. disease);
o not associated with surgery; and
o not associated with pregnancy.
u An additional 8 visits (units) will be apprv’d with documented improvement
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2020 Medicare National Coverage
Determination (NCD) - Acupuncture
• In an outpatient hospital/CAH setting, services would be furnished under
general supervision (per §410.27(a)(1)(iv), as amended by the recent CY 2020
OPPS/ASC rule).
o Per §410.26(a)(3), general supervision means the service is furnished
under the physician's (or other practitioner's) overall direction and control,
but the physician's (or other practitioner's) presence is not required during
the performance of the service.
u
• In office settings, services would be furnished under direct supervision (per
§410.26(b)(5)).
o Per §410.32(b)(3)(ii), direct supervision in the office setting means the
physician must be present in the office suite and immediately available to
furnish assistance and direction throughout the performance of the
procedure. It does not mean that the physician must be present in the room
when the procedure is performed.
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Part C: Medicare Advantage
u Medicare Advantage is an “all in one” alternative to Original
Medicare. These “bundled” plans include Part A, Part B, and usually
Part D (Prescription Plan).
u Most plans offer extra benefits that Original Medicare doesn’t cover —
like vision, hearing, dental, and more. Medicare Advantage Plans have
yearly contracts with Medicare and must follow Medicare’s coverage
rules. The plan must notify you about any changes before the start of
the next enrollment year.
u Each Medicare Advantage Plan can charge different out-of-pocket
costs. They can also have different rules for how you get services.
u Medicare Advantage Plans cover Acupuncture services based on the
plan guidelines, BUT no supervision is generally required for these
acupuncture services. Patients pay copay and carrier billed for care.
11
Florida – full list
Statewide Medicaid Managed Care
u United Health Care
u Staywell Health Plan
u Sunshine State Health Plan
u Humana Medical Plan (BLUE PLANS) – Optum Health managed
u Florida Community Care
u Simply Healthcare Plans
u Aetna Better Health Plan
u Clear Health
u Molina Healthcare
u Prestige Health Choice (GREEN PLANS) – ASH Network
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Differences: Medicaid vs. Medicare
Medicaid Medicare
Provides health insurance to low- Provides health insurance for seniors
income children and some parents, aged 65 years and older, and for some
seniors and disabled individuals people with disabilities
Provides medical care and long-term Provides medical care coverage, but
care coverage very limited long-term care coverage
Has eligibility rules based on income Has no income limit
and categorical criteria
Receives federal funding collected by
Receives state and federal funding payroll deduction
Administered on a state level, within Administered on a federal level
federal guidelines
13
Florida Medicaid and Medicare Statistics
u Florida Medicaid: Adults
u 4,300,000 (No Acupuncture coverage)
u FL Statewide Medicaid Managed Care:
u 900,000 (1:14 FL adults have direct access acupuncture coverage
u FL Medicare Original
u 2,400,000 (Supervised Acu coverage)
u FL Medicare Advantage Plans
u 2,200,000 (1:6 FL adults have direct access Acupuncture coverage)
* 08/2020 source FL Medicaid
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Medicare Advantage Plans in Florida
u Medicare Advantage Plans - Available by ZIP CODE
u Before credentialing individual insurance plans!!
u Go To: CAQH ProView Provider Portal
u What is CAQH? CAQH Fact Sheet
u CAQH is a database containing all the necessary
provider details used to streamline credentialing
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Florida
Statewide Medicaid Managed Care
u OptumHealth Physical Health Provider Network
uUnited Health Care
uStaywell Health Plan
uSunshine State Health Plan
uHumana Medical Plan
u OptumHealth Credentialing Contact Link
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Contact for Credentialing
u Florida Community Care FCC Network Join
u Simply Healthcare Plans Simply Health Care Join
u Aetna Better Health Plan Aetna Better Health Join
u Clear Health *Simply Health Care Join
u Molina Healthcare Molina Healthcare Join
u Prestige Health Choice Prestige Health Choice Join
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92/10/21
Florida Medicaid and Medicare Statistics
REMINDER
u Florida Medicaid: Adults
u 4,300,000 (No Acupuncture coverage)
u FL Statewide Medicaid Managed Care:
u 900,000 (1:14 FL adults have direct access acupuncture coverage
u FL Medicare Original
u 2,400,000 (Supervised Acu coverage)
u FL Medicare Advantage Plans
u 2,200,000 (1:6 FL adults have direct access Acupuncture coverage)
* 08/2020 source FL Medicaid
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Understanding Care Reimbursement
u The Centers for Medicare and Medicaid Services establish and publish a rate
schedule annually.
u A Relative Value Unit (RVU) assessment is used to determine the rate or
reimbursement for any CPT code / per unit.
u Acupuncture is billed in timed increments of 8-15 minutes for the first unit
and 15 minutes for any additional units. (max 3 units)
u Insertion, manipulation, retention and removal of separate needle sets is
required when claims contain multiple units of acupuncture.
u Claims can not be processed for multiple acupuncture units, simply based on
needle retention of a single set for 15-30-45 minutes.
u The RVU for acupuncture is currently valued: (+/- .50 / region)
u 97810 - $38.00 97811 - $28.00
u 97813 - $42.00 97814 - $34.00
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102/10/21
Other Considerations
u Must be familiar with Acupuncture policies in the
individual plans
u Understanding and following the rules will make life a lot easier
u Creating and managing more documentation
u This should not really be the case, but if you are new to managing
insured patients and submitting claims – this will likely create
additional work depending on your office software.
u Reviewing office policies and procedures to reflect
changes in staff expectations and patient trends and
needs
21
Biomedical Waste Generator Permit
(County Health Dept)
u Red Book – 3-inch Ring Binder (Red)
u Biomedical Waste Generator and Disposal Plan
u Model Language - Biomedical Waste Generator Operating Plan
u Florida County Environmental Health Contact List
u Fire Evacuation Plan
u Detailed drawing of office with exits marked
u Material Safety Data Sheets
u The Hazard Communication Standard (HCS) requires chemical manufacturers,
distributors, or importers to provide Safety Data Sheets (SDSs) (formerly
known as Material Safety Data Sheets or MSDSs) to communicate the hazards of
hazardous chemical products. As of June 1, 2015, the HCS will require new
SDSs to be in a uniform format, and include the section numbers, the
headings, and associated information under the headings. (ref. OSHA.gov)
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112/10/21
Professional License (State Dept of Health)
u 457.105 Licensure qualifications and fees.— Overview:
u 21 years of age or older
u Completed 4-year course of study in AOM
u Has successfully completed a board-approved national certification process
u Is actively licensed in a state that has examination requirements that are
substantially equivalent to or more stringent than those of this state, or passes an
examination administered by the department
u Pays the required fees set by the board by rule not to exceed the following
amounts
u Examination fee: $500 plus the actual per applicant cost to the department for
purchase of the written and practical portions of the examination from a
national organization approved by the board.
u Application fee: $300.
u Reexamination fee: $500 plus the actual per applicant cost to the department
for purchase of the written and practical portions of the examination from a
national organization approved by the board.
u Initial biennial licensure fee: $400, if licensed in the first half of the biennium,
and $200, if licensed in the second half of the biennium.
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Applying for FL DOH – Acupuncture License
u Create Your MQA Account
u Gather all the documents and elements needed for
your application
u Evidence of Coverage for Professional Liability is
needed for licensure
u Contact Malpractice Insurance Carrier for application
and coverage limits
u Healthcare Providers Service Organization (HPSO)
u America Acupuncture Council (AAC)
u Schlitt Insurance Services
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122/10/21
Agency for Healthcare Administration (AHCA)
u Agency for Health Care Administration is responsible for administering
Florida’s Medicaid program, licensure and regulation of Florida’s
health facilities and for providing information to Floridians about the
quality of care they received.
u The Agency was statutorily created as the chief health policy and planning
entity for the state primarily responsible for the state’s estimated $25
billion Medicaid program, the licensure of the state’s 45,000 health
care facilities and the sharing of health care data through the Florida
Center for Health Information and Policy Analysis.
u Agency for Health Care Administration
u 2727 Mahan Drive
u Tallahassee, FL 32308
u Toll free: (888) 419-3456
u Website: www.ahca.myflorida.com
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Acupuncture Office: Exemption under
AHCA – FS 400.9905(4)(g)
u (4) “Clinic” means an entity where health care services are provided
to individuals and which tenders charges for reimbursement for such
services, including a mobile clinic and a portable equipment provider.
As used in this part, the term does not include, and the licensure
requirements of this part do not apply to:
u (g) A sole proprietorship, group practice, partnership, or corporation
that provides health care services by licensed health care
practitioners under chapter 457, chapter 458, chapter 459, chapter
460, chapter 461, chapter 462, chapter 463, chapter 466, chapter
467, chapter 480, chapter 484, chapter 486, chapter 490, chapter
491, or part I, part III, part X, part XIII, or part XIV of chapter 468, or
s. 464.012…
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132/10/21
Acupuncture Office: Exemption under
AHCA – FS 400.9905(4)(g)
u Impact: A health care facility determined to be a “Clinic” must:
u Complete and Submit Lengthy Application
u Pay Biennial Clinic Licensure Fee ($2,000.00)
u Provide Medical Director Attestation [MD, DO, DC, (NP)]
u Bi-Annual Disclosure of Personnel and Ownership – Payment of Fees
u Provide Financial Bond in lieu of Proof of Financial Ability to Operate
u To file an AHCA Acupuncture Office Exemption
u AHCA Clinic Exemption Application CHECKLIST
u AHCA Clinic Exemption APPLICATION
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Takeaways
u Operating an acupuncture practice that prioritizes self-
governance and patient-centered care demonstrates
professionalism and respect for the law and your patients.
u Understanding and following state and federal law voluntarily is
a sign of seriousness and commitment to running your business
the right way.
u A Busy Practice – Thriving
u Patient Centered
u Community Minded
u Respected
u Valued
u Modelled by colleagues
u Successful in Every Way
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Takeaways
u Acupuncturists looking for ways to minimize, avoid and ignore
compliance with State and Federal regulations are NOT examples to
follow or emulate.
u There are no shortcuts to compliance.
u Ignorance of the laws and rules is no excuse under the law.
u Operating illegal offices is just “bad practice.”
u It reflects poorly on the profession and very poorly on the provider.
u If you need help understanding or implementing compliance
standards, then ask a trusted colleague for help or contact the
FSOMA.
u Take pride in your office, your profession, and yourself.
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Comments and Questions:
u Thank you to Everyone for Joining
tonight
u Any questions for David Bibbey – david@fsoma.org
u Thank: Ellen Teeter, AP – FSOMA Executive Director
u Natalia Morrison, L.Ac – FSOMA Comm. Director
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